Public Listing of Comments on Request for Information (RFI): Input into the Scientific Strategic Plan for the proposed National Institute of Substance Use and Addiction Disorders

Comments requested in the February 8, 2012 NIH Guide Notice
Entire Comment Period: 02/08/2012 - 05/11/2012


ID Entry Date Affiliation Organization
Name
Organization
City, State
Comment 1 Comment 2 Attachments
2 02/08/2012 at 05:22:10 PM Self     The merger is long overdue and should be commenced sooner than 2014. Program staff who I know are eager to integrate the portfolios. It will also help reduce duplicative studies.

Research shows that it takes the average addict who presents for treatment 30 years to achieve 1 or more years of sobriety (abstinence from alcohol and drugs). The new institute should have grant mechanisms that extend data collection 5 to 10 years after a study completes in order to begin to learn how much progress were are making in achieving recovery; and not just demonstrating that we can get somebody drug free for a couple of months. Attached find a white paper outlining one way to achieve this.

Longitudinal Investment in Medical Intervention Trials (LIMIT) Awards BACKGROUND: Mostly, NIH funds “safe” science. The entire NIH enterprise is designed to identify and fund projects that: 1. evolve from recent research findings, 2. does not reach too far into complex hypotheses or designs, 3. does not confront directly any important zeitgeists of the major fields of study – not too controversial, 4. performed by teams of proven journeyman researchers who are by design ethnically, geographically, disciplinarily, politically, etc., diverse; 5. science that can be completed within 5 years for less than $2.5M. Business practices that ensure safe science gets funded also stymie longitudinal follow-up research. Certain studies provide unique and important opportunities to follow patients long-term, but NIH business practices minimize the likelihood that such projects will be funded if continued follow-up is the primary aim. The 5-year limit is most problematic because continuation studies require innovation (interpreted by most grant application reviewers as being different from the last project). The innovation criterion thwarts continuation of what was once considered innovative science, effectively undermining the collection of longitudinal outcome data. PROPOSAL: Longitudinal Investment in Medical Intervention Trials (LIMIT) grants. Upending NIH review and funding processes is impractical und unworkable. However, there are ways to introduce small changes that can have broad impact. LIMIT grants would be modeled after the R37 MERIT grants which extend meritorious R01s in time. 1. Nominated by POs and approved by Council (like MERIT awards) LIMIT awards would be made when a clear case for advancing public health can be made. a. The initial application would undergo normal peer review, program review, and Council approval processes. b. Prior to the end of the initial award period, program staff would nominate grants to extend data collection beyond the initial award for up to five additional years. c. Nominees would make a clear case for advancing public health through the extension of data collection activities. d. Funding for any LIMIT extension would be capped at the cost of continued data collection, and would be approved by the Institute’s Advisory Council. e. LIMIT awards would be less costly (perhaps 33% of the parent R01) because: i. There are no data collection start-up costs because activities such as IRB reviews, enrollment and consent, data collection protocols, measures, and database programming were borne by the initial award. ii. Personnel costs would be limited to those essential to carry out data collection functions and directly related costs, including development of analytic files. f. ICs would decide when follow-up analyses would be appropriate, and determine a mechanism for supporting them (e.g., R00) or a supplement – either way Council will be kept informed. g. Although LIMIT awards would be well below the typical R01 funding levels, the NIH data sharing policy could be invoked in these cases to ensure maximum return on IC investment. 2. UPSIDE: Research clamored for by Ioannidis (2005) and others to extend data collection long enough to observe trends in effectiveness could be conducted as National Advisory Councils saw fit. a. Initially effective but subsequently ineffective or harmful interventions and practices would be more quickly identified. b. New insights would be enabled when studying chronic diseases such as diabetes, heart disease, addictions, and arthritis. i. Treatment protocols ii. Compliance iii. Immune reactions iv. Drug resistance c. Studies would become powerful enough to enable dynamic modeling to better understand mechanisms of recovery. 3. DOWNSIDE: LIMIT awards would reduce funds available for new projects. a. LIMIT grants would likely cost one third of a typical R01, thus NIH would fund one less R01 project for every three LIMIT grants i. This would be offset to some extent by new secondary studies enabled by the LIMIT data. ii. Continuation grants might be reduced when the underlying motivation was mainly to continue collecting longitudinal data from the parent project. b. There would be an increase in identifying ineffective evidence-based practices. i. Although embarrassing, it would improve the public health by stopping harmful or ineffective and costly healthcare interventions and practices. ii. New discoveries and new understandings of how best to treat and enhance recovery would likely overshadow identified problems in some treatments. c. As in the case of MERIT awards, peer review would be circumvented by LIMIT awards. i. Peer review is unnecessary, because the study being continued has previously been judged innovative and the public health problem verified as important. ii. Council review is adequate to deflect unworthy projects. Ioannidis JPA. (2005). Why most published research findings are false. PLoS Medicine, 2(8):e124. Accompanied by editorial in the same issue.
3 02/09/2012 at 05:40:09 PM Organization University of Washington Seattle, WA I am strongly in favor of the proposed of NIAAA and NIDA merger. There is no scientific justification for separating the study of addiction to alcohol, nicotine, and other drugs of abuse. The existing funding structure creates artificial barriers to the study of common mechanisms and treatments. Co-morbid addictions are common and common mechanisms are likely, but the present NIH structure is not optimally arranged to study addictions.

I have heard from colleagues in the alcohol field who fear hat any change will hurt their research. We heard very similar cries when NIH moved RO1 reviews from the institutes to CSR, but the predicted dire outcomes did not develop, and NIAAA/NIDA grants are fairly reviewed by CSR. Similarly, it seems likely that the best drug abuse work will be supported by a new addiction institute.

A balance in the funding portfolio in basic and clinical research should be maintained after the merger. A diversity of support is essential for the progress. We see 'funding fads' emerge based on little credible evidence, where large amounts of support are channeled into fashionable topics. Program staff are very good at balancing these portfolios and are generally responsive to the the extramural scientists, but sometimes political pressure distorts the funding process.

 
4 02/10/2012 at 10:42:54 AM Self   Monroe Township This new agency must place a high emphasis on tobacco use and dependence. NOT-OD-12-045 mentions co-morbidity with other addiction and psychiatric disorders, and this is extremely important as the co-morbidity is exceedingly high. An additional target population for tobacco use and dependence is low-income smokers.

Lastly, treatment development - especially psychosocial treatment development for tobacco use will be important in the future. While there has been innovation in pharmacotherapy for smoking cessation in the last 20 years, there has been little innovation in psychosocial smoking cessation treatments.

438,000 people die a smoking-related death in the United States annually.

 
5 02/10/2012 at 12:20:02 PM Self   Nashville, TN Smoking is, and has been, a #1 killer. It is a crossover substance and a substance of initiation to drugs of dependence. It is addictive. It is chronic. And it needs to have a much more significant, and frequent, placement on the Strategic Plan priority list

   
6 02/10/2012 at 12:20:53 PM Self     Tobacco kills more people than all other substance abuse conditions combined. It MUST be a top priority. Our current treatment success is woefully inadequate. We need more research and each year less and less is going into helping smokers quit. Please make this a leading priority.

   
7 02/10/2012 at 01:05:33 PM Self     I think tobacco use should be a scientific priority. It is the number one cause of premature death in the United States today. One concer I have is the number of young people that are currently smoking (20-44 age group). What will happen if these people do not stop using tobacco? What will the health consequences be in the future? We see more disease, tooth loss, and less of a good response to dental treatment in our patients that smoke. We also see most of the oral cancer cases in people who are smokers. This is a serious health concern. I know tobacco use rates are lower than they were, but it is still a major health concern. Where is the outrage!

I think tobacco control issues - government legislation on tobacco products as well as prevention and cessation efforts among the highest users (those 20-44 years of age, the poor, and the mentally ill).

 
8 02/10/2012 at 01:22:22 PM Self     tobacco use disorder

Tobacco use disorder has significant negative impact on health of US and global population. We need to understand how to help people quit. We need to understand why some people are more successful at quitting than others. We need to understand how menthol flavoring causes more disease in those who smoke menthol cigarettes.

 
9 02/11/2012 at 10:18:04 AM Self Syracuse University Syracuse, NY I would like to note that I am in full support of this consolidation. It is increasingly apparent that the etiology of substance use disorders and behavioral addictions share many biological, psychological and social factors. Moreover the prevalence of anxiety, depression and ADHD among adolescents and young adults are equally present in behavioral/process addictions and substance use disorder. The move toward integrated research and practice further supports holistic approaches to treatment and prevention. In my professional opinion the following areas are of utmost importance because they hold the greatest potential for mitigating the progression to addiction from moderate or experimental use. -Encouraging research to elucidate the impact of using one substance (e.g., alcohol) on likelihood of relapse to other substances (e.g., other drugs); -Targeting efforts to prevent substance abuse in adolescents and young-adults; - Understanding the implications of policy changes on substance use patterns and trajectories, especially in youth I also believe that designing clinical trials that accurately reflect real-world conditions (e.g., greater inclusion of polydrug users) is critical to the progression of diverse user populations and again hold potential for halting progression to full blown addictive disorders if they allow for real-world conditions that may include people not yet in treatment.

The move toward integrated research and practice further supports holistic approaches to treatment and prevention. Increased focus, research and applied practice in the areas of substance abuse prevention targeting adolescents and young-adults is vital to preventing progression to addiction from moderate or experimental use. This hints at a recognition that real world application is not simply a division between abstinence and addiction there is in fact a wide range of use in between. Moreover this opens the door to more honest factual education about alcohol, other drugs and their connection to behavioral addictions and mental health.

Understanding the implications of policy changes on substance use patterns and trajectories, especially in youth, is vital to the development of effective evidence based policies rather than ideology based policies. Current public policy sentiment focuses so heavily on the legal status of alcohol and other drugs that it pushes people to the margins and we lose the opportunity to keep them connected in ways that address the core issues. E.g. is the problem "underage drinking" or is it "problematic drinking" or drinking before people are cognitively and socially able to use in moderate or healthier ways? I believe it is the latter.

 
10 02/11/2012 at 06:52:02 PM Self     Developing strategies to enhance stakeholder interest in developing medications to treat various addictions, including nicotine and alcohol: For addiction to cocaine, amphetamine, methamphetamine, etc, would it be possible to grant such medications orphan drug status to encourage companies to participate in such research?

Alleviating the translational bottleneck for treatments to move from the bench to the bedside to the community: Would it be possible to encourage pharmaceutical companies to partner with academic institutions in drug development for addictions by granting them extended proprietary periods, so that they might be more willing to conduct trials with academic instituions in addictions such as cocaine, amphetamine and methamphetamine?

It is necessary to encourage pharmaceutical companies to enter the addictions arena with incentives of various types. In the absence of these, there will be no major investment.

 
11 02/12/2012 at 08:36:37 AM Self     Tobacco Dependence.

Tobacco use disorders ought to be, in my opinion, among the highest priorities of health issues. While the rate of smoking cigarettes has significantly declined since the 1960's when about 1/2 the population smoked, still today about 20% of the US adult population continue to smoke cigarettes. That equates to 1 in every 5 individuals. Smoking affects most every aspect of the body, contributes to a vast variety of health conditions, and is extremely costly to the healthcare system. As a certified tobacco treatment specialist and a healthcare provider on the front lines of caring for individuals with complex, chronic conditions such as diabetes, I fully support tobacco dependence remaining as a high priority for the NIH to address. Dr. Brenda Douglass, DNP, FNP-BC, RN, CTTS

 
12 02/13/2012 at 09:06:39 AM Self     It is absolutely crucial that attention and resources are directed to the comorbidity of substance misuse (alcohol and drugs) and imtimate partner violence. We need to better understand factors contributing to the etiology, prevention, and treatment of these highly comorbid problems. Treatments that target substance misuse are likely to have collateral benefits on partner violence outcomes, in both teens and adults.

The prevalence of intimate partner violence (IPV) in the United States is alarming. The Centers for Disease Control and Prevention define IPV as actual or threatened physical, sexual, or psychological harm committed by a spouse, ex-spouse, or current or former boyfriend or girlfriend and occurring among heterosexual or same-sex couples. A national survey of a representative sample of U.S. women and men revealed that close to 25% of women and 8% of men are raped and/or physically assaulted by an intimate partner in their lifetime. Research has consistently demonstrated that the prevalence of psychological aggression in dating relationships is approximately 80%, physical aggression is 20-30%, and sexual aggression is 10-20% each year.

The consequences of IPV are enormous. Direct medical and mental health services for female victims of IPV exceeded $5.8 billion annually as reported in 1995. IPV results in devastating consequences, including acute and chronic physical and mental health problems, divorce, suicide, and even spousal homicide. In an effort to better understand IPV, numerous studies have been conducted on risk factors for perpetration and victimization.

Substance use and abuse have been found to be consistent correlates of IPV perpetration and victimization in women and men. In men, a relationship between drinking and IPV has been established such that men in alcohol treatment programs are 11 times more likely to be physically violent towards female partners on drinking days relative to non-drinking days. Similarly, women in treatment for alcohol use are approximately 4 times more likely to perpetrate physical or sexual IPV on heavy drinking days relative to non-drinking days. In terms of victimization, male and female alcoholics were approximately 3 times more likely to be victims of physical IPV on drinking days, relative to non-drinking days. Similarly, other drugs, particularly cocaine use, are temporally associated with increased risk of violence perpetration and victimization.

 
13 02/13/2012 at 08:17:38 PM Self     The identification of gaps in knowledge relative to behavior require in depth investigation. Brain remodeling associated with drug abuse is very important. Cardiovascular effects of drug abuse such as vessel stiffening and myocardial fibrosis is of great importance. Weight gain/loss and drug use is crucial as well.

All four. knowledge gaps in specific behavior (i.e. why is it so hard to convince young women not to smoke) is problem #1.

 
14 02/13/2012 at 08:20:05 PM Self     Substance abuse in adolescents is becoming very high, and I don't believe the effects of this on the developing reward system in the brain are very well understood. It is now known from imaging studies that parts of the brain associated with reward are highly plastic during the adolescent stage, and it is rather frightening to realize that substance abuse is increasing occurring at this period of time. This needs to be attacked with education, basic and clinical research.

Only one issue identified.

 
15 02/13/2012 at 09:04:29 PM Self     (1) Identify the critical issues(s): TO foresee the clinical research direction; it is important to know how the intervention would look like and how it would be implemented two-three decades from now. The direction of etiological research demonstrates high promises of developing a thorough understanding of the pathological precursors. The speed of identifying causation and their effects needs coincidence with robust intervention applications in coming three decades. The idea of findings expression analysis, epigenetic, brain activation sites as evidentiary biomedical markers to support and create foundations of intervention also leads to thought of multifocal intervention concepts targeting various etiological, pathological and symptomatic pathways of disease/disorder course. Concentration of intervention to a certain type or time-frame would not be therefore novel/applicable/genuine for the extent of outcome anticipated comparing with the extent of investments involved so far.

The idea of overlapping of precision micro/nano- level therapeutics; regulated DNA and controlled RNA expression; regulated brain activation sites and time-elastic shifting interventions could lead to a practical approach of successful individualized medicine/therapeutics. These interventions would be targeting multiple receptor gradient regulation (and not single category/type of receptor regulation) based on the severity, Taking account of co-morbid conditions with parallel focus of pathological level at the time of etiological intervention strategy; as well as neutralizing the symptoms and their consequential complications to determine complete intervention course. What would be needed is a feedback regulation for both acute and chronic timecourse of pathological cascades to standarize and quantify the intervention involvement spontaneously by individuals in real-time course. Etiological interventions must foresee and develop spontaneous intervention strategies in next two-three decades to come close to anticipated positive prognosis.

 
16 02/13/2012 at 09:06:28 PM Self     The consolidation of NIAAA and NIDA is long overdue and will benefit patients in the long run. Any scientist carrying out research in either of these areas or clinicians treating patients with either of this class of disorders knows their high co morbidity. The comorbidity can be at the same time or over a life time.. The separation is artifical and hamrful.

THE MOST IMPORTANT ISSUE WILL BE TO EDUCATE THE LAY PUBLIC ABOUT THE VALUE OF THIS CONSOLIDATION.. rESEARCHERS AND CLINICIANS KNOW IT ALREADY .

 
17 02/13/2012 at 09:08:23 PM Self     There will be no scientific benefit from the merger.

The merger into an addiction-oriented division will leave out many other important interests now served by NIAAA.

There will be no benefit from this merger, just changes, additional costs, and confusion.

 
18 02/13/2012 at 09:23:56 PM Self     Anabolic steroids and growth hormone abuse should be among the targeted areas since public awareness of the adverse effects of these drugs is so poor and so much of their use may be a result of scam and marketing.

It is unlikely anabolic steroids and growth hormone are addictive though their abuse is highly prevalant and associated with significant physical and financial harm.

Attachment #1: PDF copy of article: “New Developments in the Illegal Provision of Growth hormone for “Anti-Aging” and Bodybuilding” by S. Jay Olshansky and Thomas T. Perls; published by JAMA in June 2008 (vol. 299, no. 23) Attachment #2: PDF copy of article: “Growth hormone and anabolic steroids: athletes are the tip of the iceberg” by Thomas T. Perls; published by Drug Testing and Analysis in 2009
19 02/13/2012 at 09:45:35 PM Self     Basic behavioral issues that are fundamental to a tendency to initiate and sustain substance abuse should be explicitly supported. These issues include the study of impulsivity, risk seeking, and some aspects of decision making. It is important to understand the behavioral and biological profiles of individuals who are at an increased risk in order to target preventative interventions. Perhaps more importantly, it is critical to examine the environmental conditions that give rise to impulsivity, risk seeking, and poor decision making (e.g., scarcity of resources, hopelessness, environmental uncertainty, family stress) regardless of the individual.

Prevention should be a central part of the puzzle.

 
20 02/13/2012 at 09:55:58 PM Self     It is critical that the budget for NIAAA and NIDA is not reduced due to the plan.

Fear among NIAAA colleagues that the alcohol portfolio will be diminished relative to other drugs of abuse as studied by NIDA. A new director needs to protect both sets of expertise.

 
21 02/13/2012 at 11:23:19 PM Self charles chabal   The issue of prescription drug abuse is of great concern. We cannot agree even on the definition of abuse in the medical patient. Terms such as "pseudoaddiction" complicated the diagnosis of abuse. This issue is a national epidemic but little is known about patterns of misuse, and when misuse becomes a clinical issue threatening quality of life. Not much is know how these meds get diverted into society and into the hands of young people who are opiate naive. There are plenty of other societal and public health aspects of this issue. I'm not sure that this is what you have in mind but I could submit a whole list of areas of need related to this issue.

   
22 02/14/2012 at 02:39:44 AM Self     Substance abuse and addiction do not happen in a vacuum. One of the recent strengths (even highlighted by Volkow's commentary this week in Science) is the recognition that individual differences play a major role in the development and maintenance of addiction. In particular, the various domains of externalizing and internalizing are critical variables that need to be considered when trying to understand addiction. Continued focus on these latter issues I believe is critical to developing a better understanding of, and eventually more effective treatment for, addiction

   
23 02/14/2012 at 05:49:30 AM Self     Research Area: vaccines to induce anti-drug antibody responses that block the pharmacologic activity of the drug

Critical Issues: It seems that a better organized, more systematic approach could be implemented to manage the various groups working to develop vaccines for drugs of abuse.

1. Many of the studies performed to develop vaccines for drugs of abuse are performed using a single vaccine candidate making it difficult/impossible to determine the potency of that candidate vaccine relative to another candidate vaccine. It may be helpful to scientists and the public if NIH would use a contract mechanism to develop a central laboratory that would test vaccine candidates for a particular drug of abuse in parallel to begin to build a database that would rank the immunogenicities/efficacies of the vaccine candidates.

I believe it is important for NIH to address the issue I stated above since the current development of vaccines for drugs of abuse is progressing at a very slow pace. The pace of vaccine development for drugs of abuse may be increased if there was a better collaboration/coordination between laboratories experienced with vaccine research and laboratories experienced with drug hapten/immunogen development.

 
24 02/14/2012 at 06:13:01 AM Self     RE: design of longitudinal treatment outcome studies. The severity of substance addiction/abuse/use appears to decline with age even for people who are "untreated" for these disorders. Longitudinal outcome studies generally do not correct for this effect when making claims about the success rates of particular programs. It should be standard practice when publishing results to include some reference to this, especially when doing long term followup (5 or 10 years) with individuals. The data to create these age-adjustments are already available in the national survey data collected over the last 4 decades.

Making the age-adjustment in published research as described above.

 
25 02/14/2012 at 09:19:56 AM Organization MPRC, U. of Maryland Baltimore Baltimore, MD Alcohol and substance abuse in the mentally ill

Major public health problem with high cost to society and to afflicted individuals. Alcohol and substance abuse contribute to mortality, impair functional outcomes, and undermine therapeutics. Persons with psychotic illness have high rates of alcohol and substance abuse.

 
26 02/14/2012 at 09:25:57 AM Self     Little work has been done on the follow up community based care of people following intensive addiction therapy. As a family physician who practiced in a rural area and developed an in patient and out patient mental health clinics, I had limited information to suggest metrics to monitor, early indicators of relapse, how to supplement attendance at groups such as AA, and how to develop co-management with addiction specialists strategies for these individuals.

The follow up programs with metrics for early warnings signs of relapse are most important for primary care or the medical home physician.

The burden to the health care system, public health system, and to families and individuals of recurren relapses is well documented. We need to realize that continuing care goes beyond the care provided by intensive programs and addiciton specialists.

 
27 02/14/2012 at 09:54:31 AM Self     Investigating physiological and pathological molecular mechanisms of addictive substances, including the targeting proteins and DNAs of addictive substances.

We can elucidate the problems caused by addictive substances only when we understand the targeting molecular mechanisms of the addictive substances. Understanding of how these substances act in vivo (molecular mechanisms) is critical to solve the problems caused by addictive substances.

 
28 02/14/2012 at 10:31:01 AM Organization Emory University School of Medicine Atlanta, Georgia I am deeply concerned that this strategic plan will develop an institute that focuses exclusively on the abuse and addiction problems. While this is obviously of critical value in addressing health problems such as alcohol and other drug abuse, what could be lost is the fact that many of the devastating consequences of alcohol and drug use occu in individuals who do not meet the criteria for substance abuse.

For example, our research group has devoted the past 15 years to studies of how chronic alcohol ingestion renders the lung susceptible to infections and injury. As a practicing pulmonary & critical care investigator as well as a biomedical researcher, I am keenly aware that there are enormous health consequences of alcohol use on vital organs (lung, heart, etc.)for which we must find effective therapies. If a 29 y/o with a history of heavy alcohol use dies of pneumonia or acute lung injury in the intensive care unit after a prolonged illness, they will never have the chance to attend addiction therapy. Each year in the U.S. hundreds of thousands of individuals die of alcohol- and drug-related illnesses and biomedical investigators from many disciplines are working to define the pathophysiology of these illnesses and to develop novel therapies.

To focus only on addiction would be akin to directing all resources for common illnesses such as type II diabetes and lung cancer to weight loss and smoking cessation programs only. Although in a 'perfect world' that might work, we all know that would not only be naive but would be an abdication of our responsibilities. In fact, we must develop better therapies for drug and alcohol addiciton in parallel with research that defines the biomedical consequences and that identifies novel therapies.

The NIH must address the plain fact that an enormous component of the health burden of alcohol and drug use is in end-organ damage and failure, and that to focus only on why people drink alcohol or use other drugs cannot possibly improve our society's overall health. For example, although 'safe sexual practices' is an important component of our overall strategy to limit the burden of HIV and other STD's, we all recognize that we cannot address and solve the problem solely by trying to modify human behavior.

If the NIH essentially merges NIAAA and NIDA and this new institute focuses exclusively on funding studies on addiction, a valuable cadre of biomedical investigators will have no advocates at NIH and their research activity will be sharply curtailed if not ended. If NIH does proceed with this merger then it must allocate resources and promote support for this important research to the other institutes. I just know that every time I submit a research proposal on alcohol and lung biology, it is automatically referred to NIAAA for funding consideration. NHLBI has not developed any interest in this research because they have deferred to NIAAA. What will happen to investigators studying alcohol and the liver, alcohol and the lung etc. if NIAAA's role in supporting this research is suddenly eliminated?

Attachment #1: PDF copy of pre-publication version of the now published article: “Alcohol Abuse, the Alveolar Macrophage and Pnuemonia” by Ashish J. Mehta and David M. Guidot; published by American Journal of the Medical Sciences in March 2012 (vol. 343 no. 3) Attachment #2: PDF copy of pre-publication version of the now published article: “Focus on the Lung” by David Quintero and David M. Guidot; published by Alcohol Research and Health in 2010 (vol. 33 no. 3)
29 02/14/2012 at 11:02:07 AM Self Oregon Health & Science University Portland, Oregon see attachment

see attachment

Addictions Institute - Potential Synergies February 14, 2012 Behavioral dysregulation A new Addictions Institute should focus, in part but not completely, on aspects of the addictive disorders that are common across the target of the addiction. The most obvious characteristic linking all such targets is their dependence on seemingly voluntary behavior. One general way of parsing addictive disorders concentrates on seeking the biological explanations for two key aspects of behavior directed toward the target: 1. the overemphasis on positive reinforcement derived from the addiction target; and 2. the failure to avoid the negative consequences of overindulgence in the target. These two behavioral dysregulations are described using concepts derived from physiological psychology’/behavioral neuroscience as too much response to positive and too little response to negative reinforcement, respectively. The scientific traditions exploring reinforcement dysregulation have evolved differently depending upon the behavioral and biological nature of the specific target. Thus, studies of the positive reinforcement derived from alcohol differ from those exploring the positive reinforcement derived from eating and exercise. Studies of failure to avoid lung cancer in smokers are configured differently from studies of how to avoid producing children with Fetal Alcohol Spectrum Disorder. One area of focus, therefore, should be to compare biological dysregulation across patients with different addictions. There will be much to be learned from finding similarities across alcohol dependence, smoking, stimulant abuse, other drug abuse, obesity, gambling and other addictions. Given the different study approaches specific to each addiction, this sort of convergence is not going to arise easily from simply comparing outcomes of ongoing studies, but will require design and execution of new protocols. Each of the addictions has its own set of preclinical animal models. This includes biological animal models (e.g., lines of mice or rats selectively bred to have ingestive or response extremes for alcohol or other drugs; targeted mutants for important genes) and behavioral protocols reflecting the rewarding aspects of the drug, food, or behavior. Thus, parallel studies to those suggested above for human patients can be undertaken with laboratory animals to assess biology more directly. Here are some areas of potential convergence: 1. Obesity (e.g., diabetes) is a clear, multigenically-driven complex trait that has been one of the platforms on which many methodological advances in gene mapping and identification have been built. As gene finding efforts throughout the addictions continue to make the transition to systems-level genomics/proteomics/gene network analyses, they should be focused at least in part on understanding the underlying behavioral dysregulations. Obesity and alcohol dependence are especially synergistic because each has such a strong taste component that must be understood. 2. The role of early exposure to an addiction target as a risk factor for subsequent abuse has been demonstrated for all the addictive drugs. The analogous role of risk-taking behavior for adult gambling; childhood obesity for adult obesity; and childhood smoking for adult nicotine addiction and lung cancer have also been documented. There is an opportunity for comparative studies of genomic risk factors to allow targeted prevention before the crucial biological conversions characteristic of addiction have had time to solidify. 3. Studies of genetic risk factors for addictions have had difficulty identifying specific genes or gene networks that predict risk. There is evidence for each addiction that environmental risk factors play an important role, and that they interact with genetic predisposing factors. The somewhat limited genomic evidence suggests that there are both common sources of genetic risk for multiple addictions, as well as addiction-specific risks. There is a huge opportunity to examine commonalities in environmental risk factors. Perhaps more importantly, we may be able to identify some environmental treatments that confer protection from addiction diagnosis broadly. It is not infeasible that common environmental factors may help ameliorate risk for many different addictions.
30 02/14/2012 at 11:23:25 AM Self     In addition to the important topics included in the RFI, I recommend 2 research areas: 1. The organization, cost, and funding of services for treating and preventing substance use. 2. Understanding the process of change or recovery from substance use, and the role of treatment services.

Together, these areas address the effectiveness (and cost effectiveness) of programming for substance use or other addictive behaviors, the “key ingredients” of programming, adequacy of access, and success at retention in care. These are important healthcare questions with direct bearing for public health. Following the proposed reorganization, the new Institute will be uniquely positioned to support scientific inquiry into the specialized delivery system for substance use programs – a system that will bear much responsibility for translating new interventions and medications developed through Institute funding.

The research areas described above in Comment 1 are especially important for NIH to address. They concern the existing treatment and prevention system, and therefore affect current public health. In addition, new interventions and new medications to be developed will require a delivery system to reach their intended targets; improving and strengthening the current system will lead to better translation, and better return on investment, for future development efforts.

 
31 02/14/2012 at 11:28:06 AM Self     What about ways to identify emerging drugs of abuse (like bath salts and sythetic MJ), determine if it is worth developing testing for those drugs and looking out how they may synergize in VIVO with other drugs. Also are there ways to adapt current treatment methods to these drugs (like adaptine the MATRIX model to bath salt use) although maybe that is more of a SAMHSA thing. Have you thought about offering grants where you pair up with them?

Probably testing and treatment.

 
32 02/14/2012 at 12:28:20 PM Self     Establishing linkages across levels of analysis from gene to protein to systems to phenotypes to addictive behavior. This should foster not only interdisciplinary collaboration but real advances in terms of translating basic science to clinical outcomes and vice versa, and along the way, advance basic science.

Alleviating the translational bottleneck for treatments to move from the bench to the bedside to the community; Improving prevention efforts by developing a better understanding of the patterns and trajectories of drugs of abuse and their influence on brain development

I believe these are critical issues because their elucidation can contribute to a basic and incremental science of understanding not only drug abuse but the mechanisms that lead to it, which will foster incremental and progressive science, by which NIDA and NIAAA have previously made such great strides.

 
33 02/14/2012 at 12:45:37 PM Self     I agree with the merger because there is so much co-morbidity among substance misuse.

Please don't forget that the individuals with substance dependence are more likely to abuse and neglect their children and be victims of abuse and neglect. These individuals tend to be treatment resistence. These issues cannot be forgotten in research. New neuroscience work also suggest some differences in the reward system that may be common to all addictions and be present before addiction. I suggest retaining individuals like Cheryl Boyce PhD and others who know this area well. I also suggest multicite funding where all the neuro-biological, psychological, genetic, and social issues can be addressed, through the psychobiology of prevention and treatment studies.

 
34 02/14/2012 at 12:58:37 PM Organization INCASE S. Dakata Suggest put for an extended effort to study as many element of addiction counselors as you can.

Most pressing are their ability to critically think.

Simply, there are better counselors and worse. It would be interesting to see who are who. That information would bode well in many an addictioin program classroom.

The addiction field has been plaged with poor thinking. Time to set out recommendations for those who assess and select treatments for clients.

 
35 02/14/2012 at 04:32:55 PM Self     Loss of commitment to research on end-organ damage by alcohol is a critical negative consequence of the proposed reorganization. The NIH notice makes no mention of studies to fund this vital area. Lack of sufficient research support for end organ damage - especially to the liver - will have an enormous negative public health impact. Specifically, alcohol-related morbidity and mortality continue to exact a substantial toll on the American public, with liver disease and cirrhosis as a leading cause of death in the US, especially in specific ethnic groups such as Native Americans, where it is the 5th leading causing of death, according to the National Center for Health Statistics (http://www.cdc.gov/nchs/). The overall mortality of alcoholic hepatitis ranges from 10-60%, with alcoholic liver disease accounting for almost half of all deaths from cirrhosis in the US. Moreover, there remain few disease-specific treatments for alcohol-related liver disease.

The NIH must preserve the research portfolio that supports alcohol-related end organ damage INTACT and not simply transfer the funds to another institute, where the support is diluted among other disease areas. Otherwise this vital area of research will be lost. If, for example, the research portfolio is transferred to NIDDK, there should be a separate budget preserved for alcohol related disease of the GI tract and liver. Funds should not be distributed according to the NIDDK funding distribution formula.

 
36 02/14/2012 at 04:39:25 PM Self     Research in the field of alcohol should include basic scientific research into positive and negative impacts of alcohol on public health and disease. A focus on positive and negative effects should also take into account specific windows of exposure (e.g. puberty, pregnancy) where the effects of alcohol on health and disease processes may be counterintuitive.

Incorporating alcohol-related research wholly into abuse and prevention research program seems to eliminate basic research.

 
37 02/14/2012 at 05:42:35 PM Organization McLean Hospital Belmont, MA 1. Developing a compendium of the pharmacokinetic and pharmacodynamic interactions between alcohol and the therapeutics used to treat general medical and psychiatric conditions

2. Encouraging patient recognition and utilization of effective substance abuse treatments;

3. Encouraging research on the generation of novel metabolites resulting from the in situ interaction of alcohol with opiates, stimulants, hallucinogens, or inhalants (e.g., the production of cocaethylene when alcohol and cocaine are co-ingested) and their pharmacokinetic and pharmacodynamic properties and toxicity;

4. Alleviating the translational bottleneck for treatments to move from the bench to the bedside to the community;

5. Encouraging research to elucidate the impact of using one substance (e.g., alcohol) on likelihood of relapse to other substances (e.g., other drugs);

6. Understanding the mechanisms by which alcohol and other drugs of abuse increase risk for certain diseases (e.g. cancers), particularly when used in combination.

1. Encouraging extensive modeling of substance abuse and addiction disorders, based on epidemiologic and human genetic findings; 2. Developing sharing mechanisms for use of these clinically-based models to understand etiologies and to develop medications; 3. Increasing the priority of funding the research on the modeling and the use of the models.

The reason is that humans are a unique but diverse species.

 
38 02/14/2012 at 08:59:40 PM Organization Group Health Research Institute Seattle, WA Prescription opioid abuse and misuse deserves increase d NIH research attention. In 2011, the White House Office of National Drug Control Policy, FDA and DEA recognized a national prescription drug abuse epidemic, and formulated a national action plan to mitigate risks associated with markedly increased prescribing of opioid analgesics. There are now over 14,000 fatal overdoses involving prescription opioids a year, and over 140,000 admissions for treatment of non-heroin opiate addiction. These rates increased 3 to 4-fold from 1999 to 2006. Unfortunately, research on the causes and mitigation of risks due to abuse and misuse of prescrition opioids is sparse, particularly research on how to reconcile risks and benefits of opioid prescribing for chronic non-cancer pain which accounts for over 85% of opioid morphine equivalents dispensed in community practice.

   
39 02/14/2012 at 09:52:12 PM Self     I am an eating disorders and obesity researcher and NIH grantee. It apparently has been decided to not expand the scope of the existing two addiction-related institutes to any additional substances or activities. There is tremendous interest in how over-consumption of highly palatable foods contributes to both bulimia nervosa and obesity. There appear to be both significant similarities and differences between drug use and over-consumption of palatable foods and I thought the new institute would be a home for such research, which currently is not supported by any other institute. Given the obesity epidemic and significant clinical problems involving recurrent binge eating, I am surprised and disappointed that the new institute apparently will not include addictive-like eating problems within its purview. The paper I am appending below reflects some of our efforts to address this topic.

   
40 02/15/2012 at 07:33:12 AM Self     Having spent half a century publishing 700 articles in the scientific and public domains on alcohol, cocaine, anesthetics, antipsychotics, ketamine, methamphetamine. LSD, and related compounds, my advice to the NIH is to name your new Institute as: National Institute on Addiction.

the full spectrum from bench to bedside to the wider community and public.

 
41 02/15/2012 at 10:38:07 AM Self     The over prescription of opiate pain meds. There should be some way to better determine if the request is legitimate. Doesn't the brain respond differently when pain meds are used for pain as opposed to being misused for other purposes? I think the medical community needs some help here.

How to determine if pain meds are a ligitmate need.

 
42 02/15/2012 at 10:39:02 AM Self     I'm an administrator in the scientific academia so received this email. I am writing based on my personal experiences. I have been in the Al-anon program for 3 years. I would be curious to know if outcomes for individuals with substance abuse issues fare better when their close relatives and friends are also participating in a 12 step program. I think that is the perception, but it might be helpful to society at large to know this quantitatively.

If we think of substance abuse as a disease, what are the factors that prohibit individuals who suffer from this disease from getting treatment.

 
43 02/15/2012 at 10:59:15 AM Organization indiana university indianapolis, indiana In the addiction literature, pain medicine prescription is the most commonly used substance of abuse. The reasons for pain medication abuse are likely multifactorial. For certain, one of the major reasons for pain medication abuse is inadequate treatment of pain in the first place. Inadequate treatment of pain can be traced back to incomplete understanding of the pathobiology of pain. It is extremely important for NIH to invest in more pain research. Pain is an extremely expensive illness (almost half a trillion according to the Institute of Medicine).

   
44 02/15/2012 at 12:57:05 PM Self University of Texas School of Public Health El Paso, TX Self-help techniques for the treatment of substance use is a highly underdeveloped area of scientific inquiry. Self-help groups are low cost and have a strong evidence base supporting their effectiveness. Yet we know little about how to effectively support their use in practice. Unstanding how to support their use can help more people recover.

Type II translational research needs more explicit attention. We have so many programs that have proven to be effective and save money in the long run but we have yet to figure out how to get these programs disseminated widely. Gains in this area can have tremendous public health benefit.

Relatedly, the institute needs to support research on how to effectively promote policy change that can reduce substance use.

Science can contribute substantially to the prevention of substance use if it can improve our understanding of these complex but critical elements of effective substance use control.

1) How to create policy changes that will improve substance use prevention. Policy change is difficult because of the monetary interests of tobacco and alcohol companies but extremely powerful when successful. Once adopted, the new policies are very sustainable and do not require taxpayer dollars. 2) How to support the effective use of self-help groups for the treatment of substance use. These groups are effective, self-sustaining and do not require taxpayer funding. Science can help us understand how to get more substance abusers involved in these programs. 3) Type II translational research. So many effective prevention programs exist, but we do not yet know how to effectively support broad dissemination and high-quality implementation.

 
45 02/15/2012 at 01:17:13 PM Self     Increased funding for basic science studies about pain mechanisms is needed. The recent shift in the dollars to the much needed clinical pain studies has left many basic scientists, including prominent senior scientists, without funding forcing moves to other non-research career options.

Basic research in pain mechanisms Pre-clinical drug therapy development Pain and addiction

 
46 02/15/2012 at 01:46:59 PM Self     Since the beginning of 12-step approaches to the treatment of addiction (Alcoholics Anonymous World Services, 1939), there has been popular acceptance that spirituality is a resource in addressing addictions (Neff & MacMaster, 2005a; 2005b. Twelve-step programs have become one of the most commonly available approaches to treatment for substance use disorders (Alcoholics Anonymous World Services, 1939). The connection between spirituality and recovery has subsequently received empirical support (Daugherty McLarty, 2003; Galen & Rogers, 2004; Gorsuch & Butler, 1976; Koenig, McCullough & Larson, 2001; Leigh, Bowen, & Marlatt, 2005; Patock-Peckham, Hutchinson, Cheong, & Nagoshi. 1998; Piedmont, 2004; Richard, Bell & Carlson, 2006; Wills, Yaeger & Sandy, 2003). Nonetheless, available spiritual interventions for substance dependence have been developed without benefit of comprehensive, reliable, empirically-based, longitudinal research on the multidimensional relationship between spirituality and addictions (Sharma, 2006). Until recently, most research on the relationship between spirituality and mental health, including substance use/abuse, has treated spirituality as a unitary construct, and there has been little agreement as to which spiritual variable should be the definitive representation of spirituality. Research defining spirituality as unidimensional has yielded inconsistent results (Koenig, McCullough & Larson, 2001).Most research on spirituality and alcoholism has focused on healthy aspects of spirituality, such as seeking support from a Higher Power or faith community, and associates healthy spirituality with better outcomes. Few studies investigate spiritual distress, such as guilt, lack of existential worth, or conflict with one’s Higher Power, and while there is preliminary evidence that spiritual distress is related to alcohol use and treatment outcomes, existing studies are small and results inconsistent.

Because referrals to 12-step programs have become ubiquitous in addiction treatment, despite very few studies on the spiritual mechanisms of action involved, further studies in spirituality and addiction are necessary to support existing treatment and develop more effective assessment and treatments.

   
47 02/15/2012 at 02:25:32 PM Self Albert Einstein College of Medicine and Montefiore Medical Center Bronx, NY There exists a significant and serious gap in the current NIH ownership of research funding in the Behavioral Addictions. Currently this area is not funded by NIMH, NIDA or NIAAA, and no Institute takes ownership for these conditions. The proposed National Institute of Substance Use and Addiction Disorders fails to address this deficiency.

This is of concern given the DSM-V proposal to broaden addiction to Behavioral and Substance Addictions, specifically including Pathological Gambling with Addictions. The AMA has highlighted the growing problem of Behavioral Addictions including Internet Gaming. Prevalence studies demonstrate very high rates for behavioral addictions. Public policy decisions to increase the development of Casino's contibute to the growth of the problem. If the proposed National Institute of Substance Use and Addiction Disorders fails to address this deficiency, then what Institute will take on this responsibility?

   
48 02/15/2012 at 03:43:39 PM Self University of Illinois Urbana This comment refers to the entire solicitation. The cost of sequencing a human genome is now down to about $3000 and will fall foreseeably to $1000 in the near future. It is now possible at reasonable cost to correlate genetic variation with propensity to addiction, and also with response to different interventions. I hope that NIDA will incorporate this into its planning, in synergy with other approaches.

   
49 02/15/2012 at 04:36:46 PM Self     The movement created by health care reform necessitates that we look at more closely how the collaboration between the PCP and the provider of addiction services would be most successful. This may require education for both groups. I am specifically interested in how physicians can learn more about how prescription drugs can create or reinforce addiction; and increase the pharmacological alternatives available to physicians. On the other hand addiction services may have to recognize that appropriate utilization of some medications may assist in creating a "recovery" life style

Addressing prescription drugs: 1. specifically the appropriate use of them to supports a recovery life style 2. developing non-pharmacological and pharmacological alternatives to medical/mental health conditions that we know lead to or reinforce addiction 3. developing collaborative working relationships within the medical model that addresses both PCP and addiction treatment specialty

 
50 02/16/2012 at 10:17:37 AM Self     I believe that there are a number of areas that should be taken on by the new National Institute of Substance Use and Addiction Disorders. These areas include:

The extremely high co-morbidity between drug and alcohol abuse and psychiatric illness - this is critical for the public since there are data showing that more than 50% of all cigarettes are consumed by individuals with mental illness, and there is high co-morbidity between addiction disorders and mental illness, in general. This is important for scientists because currently, there is no mandate to take on the issue of co-morbidity in a single institute. These projects are often not funded by the NIMH because they are thought to be in the realm of NIDA or NIAAA. The new institute would be an excellent "home" for scientific studies of co-morbidity between substance use and mental illness.

The neurobiological and behavioral overlap in brain mechanisms governing food intake/obesity and drugs/alcohol

This is a critical issue for the public because of the rising obesity epidemic, and the clear dissociation between caloric need and food intake. The similarities and differences between drug addiction and food addiction are becoming a very important area for the development of novel therapeutics. This is an important area for scientists, because new tools are unraveling the neurobiological underpinnings of these disorders, but there is again, no scientific home for this type of study. NIDDK is more interested in studies of metabolic systems and obesity, whereas NIDA is focused on abuse of licit and illicit substances rather than food. An "addictions" Institute would be the ideal home for this type of research.

The role of drugs of abuse in inducing risk-taking behaviors as a predisposition to HIV infection

This is important for the public because the primary role that drug addiction plays in the spread and severity of HIV has been clear for years, but the role that brain changes following exposure to drugs of abuse plays in the increased risky behaviors, such as unprotected male-male sex, in the spread of HIV is less recognized. This is important to scientists because the study of the behavioral basis for HIV transmission is not appropriate for the NIAID and therefore should find a home in the new addictions Institute.

Each of these areas are critical research areas that should be priorities for NIH as a whole, and that are currently not well supported under current structures.

 
51 02/16/2012 at 11:06:10 AM Self     Effects of alcohol on the CNS that results in impaired metabolic control of glucose and lipid metabolism leading to obesity and diabetes.

Important as we need to better understand the link between alcohol consumption (both binge as well as chronic).

 
52 02/16/2012 at 11:36:03 AM Self     In human prenatal neurotoxicology related to substances of abuse and maternal lifestyle, the critical issue is the interaction of known teratogens, alcohol and tobacco, with drugs of abuse still under investigation, in particular, opiate exposure. The crisis in Maine for prenatal opiate exposure is particular complicated by alcohol abuse and there has been few mechanisms for funding this interaction effect. From the perspective of public health, measurement of exposures and the quantification of clinical outcomes for infants and children is generally poor related to the cost of such research and the poor interdisciplinary expertise of research teams. Additionally, longitudinal studies have yielded mixed results primarily explained by environmental quality risk. One strategy that would capitalize on interdisciplinary strengths is to use teams that are composed of genetic/molecular and animal model neuroscientists working on these models alongside human neuroscientists and clinical groups (e.g. neonatology, pediatrics, neurology, psychiatry, addiction experts) in a partnership of university/medical center or school collaboration. This mechanism of funding does not currently exist. Second, there is a need to study populations at high risk who have geographic stability such as in rural underserved communities to afford the benefits of research participation to this willing segment.

   
53 02/16/2012 at 01:19:44 PM Self Virginia Tech Blacksburg, VA Vaccine development towards nicotine and other abusive drugs. This is a critical research area that could help our combat against drug abuse. Currently, there are no effective vaccines against most of the drug molecules. If vaccinated during adolescence stage, it is possible to significantly reduce the number of addicts from those curious young adults. In addition, effective vaccines could also help addicts to stop the addiction and relapses.

It is critical for NIH to suppor the vaccine development effort. Private industries usually do not have the resources or foresight to do so due to the relatively long development time.

 
54 02/17/2012 at 09:41:17 AM Self Univ. of Pittsburgh PITTSBURGH, PA Many of the addictive substances have peripheral toxic effects on several tissues. The current scheme does not address the institutional or funding structure under which research in these effects can be supported. NIAAA is a typical case in point. It has served as a nexus for studying effects on alcohol on liver, brain and other tissues. It provided a coalescing point for investigators from many disciplines to study the mechanisms of such toxicity. I see no scheme put in place (none that has been announced anyway) to analyze critical pathways involved in the diseases resulting from alcohol (or other addictive substance) toxicity.

The above issues are important because many of the addictive substances are actually legal and the population can engage in excess without limits on access. The diseases resulting from the addictive drugs are the ones that are costly and impact negatively on US society and economy. Cures to the causes of addiction may be a long way off (and some may never come, if, for example, they are based on receptor polymorphisms, or other germ line alterations. Cures or alleviations on the diseases caused by the addictive drugs are in principle easier to combat, and it is research in these areas that is likely to be truncated with the creation of the new institute.

 
55 02/17/2012 at 02:26:26 PM Self     There are risk factors common to alcohol and drug abuse. One critical area of overlap is in the functioning of the 'reward' circuitry. More specifically, there is growing evidence that endogenous opioids contribute to the rewarding effect of alcohol and that such processes as stress and cue induced craving can drive both. In addition, clinically, it is rare that an individual abuses a single substance and there is insufficient work on polydrug abuse, especially if alcohol is one of the abused substances. A combined research effort makes much more sense than the artificial separation that currently exists.

The artificial separation of neurobiological studies of alcohol and drug abuse.

 
56 02/17/2012 at 04:42:13 PM Self     Overdose prevention research should be included in the portfolio.

Accidental overdose is a significant cause of morbidity and mortality in the U.S. There are promising strategies to help address the issue (e.g., take-home naloxone prescriptions) and further research is needed to institutionalize these promising strategies.

See: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6106a1.htm?s_cid=mm6106a1_w

 
57 02/17/2012 at 05:09:40 PM Self     Encouraging patient recognition and utilization of effective substance abuse treatments; This is one of your identified areas. There are several 'patient activation' measures, it would be interesting to use these in SUDs. What is 'patient centered care' in SUD? This is one of the quality care markers listed by the IOM as applicable to addiction treatment. Patients and public have many misconceptions, false hopes, etc. about addiction treatment, some of which amount to urban legends. Patients and their families spend lots of money on unproven 'rehab' efforts, and medical treatments that verge on snake oil. Second: quality measures we should use in pay for performance, related to addiction. We need our version of 'HEDIS' measures in order to fit in to healthcare reform, and show quality outcomes of our care. Third: models of integrated care.

   
58 02/18/2012 at 10:06:55 AM Self     Furthering knowledge of tobacco use and addiction, including co-morbidity with other addiction and psychiatric disorders. I feel like there should be ongoing research from nursing presented to the new NIH Institute concerning addictions and psychiatric disorders.

Nursing and counseling has lot to give as far as research for addictions and dual dx problems.

 
59 02/19/2012 at 10:43:24 AM Self     I would like to bring particular attention to the importance of prevention research and interventions for adolescents that operate across substances.

Risky substance-use behavior among adolescents tends to be correlated and often predicted by similar variables. Moreover, time (e.g., in the school context) and financial resources available for prevention among adolescents is in increasingly short supply, and single interventions appropriate for reducing uptake risk for multiple substances become increasingly important.

While there may be downsides to the integrated institute, one advantage may be greater interest in developing cross-substance prevention and intervention efforts.

An additional priority is development of approaches that are easily scaled upward and relatively low-cost (even if effect sizes are smaller)--in the current institutional and budget climate, it is hard to imagine that time-and-money intensive programs would be possible to deploy in a large-scale way.

 
60 02/20/2012 at 11:15:58 PM Self     Efforts should be made to encourage research at the basic and clinical sciences levels to study emerging drugs of abuse such as synthetic cathinones ("bath salts"), synthetic cannabinoids, piperazine analogues, etc. Thus far, grant applications proposing to study these emerging drugs of abuse have been met with lukewarm enthusiasm due to the recency of their rise in use and abuse.

Unlike previous epidemics such as the dramatic surges in crack cocaine use of the 1980's and methamphetamine use in the late 1990's and early 2000's, NIH should be proactive in their sponsorship of research on newer drugs of abuse, from prevention, education, and basic and clinical research perspectives.

In other words, don't wait until these drugs create an new epidemic! Active research into this area could avert such a crisis.

   
61 02/20/2012 at 11:16:20 PM Self     Efforts should be made to encourage research at the basic and clinical sciences levels to study emerging drugs of abuse such as synthetic cathinones ("bath salts"), synthetic cannabinoids, piperazine analogues, etc. Thus far, grant applications proposing to study these emerging drugs of abuse have been met with lukewarm enthusiasm due to the recency of their rise in use and abuse.

Unlike previous epidemics such as the dramatic surges in crack cocaine use of the 1980's and methamphetamine use in the late 1990's and early 2000's, NIH should be proactive in their sponsorship of research on newer drugs of abuse, from prevention, education, and basic and clinical research perspectives.

In other words, don't wait until these drugs create an new epidemic! Active research into this area could avert such a crisis.

   
62 02/21/2012 at 11:25:54 AM Self   NYC, NY As a public health professional for the past 18 years and a smoking cessation counselor I believe tobacco use is one of the most devistating health behaviors. It has been the scurge of public health for the past 50 years. More has to be done to curb its impact on the public. Research has shown heart disease risk, cancer and asthma rates increase due to this behavior for individual users and their family contacts. Studies indicate smoking can introduce young users to experiment with hard drugs and alcohol. Morer over, long time smokers have a hard time quitting, but face many increased health risk factors due to their use.

Please provide more opportunities for research for addiction treatment, prevention of use, and also health effects. Smoking and tobacco use effect users in multiple ways and more research has to be done to help users quit smoking in mulitiple ways.

   
63 02/21/2012 at 01:20:57 PM Organization Yale University New Haven, CT 06520 The merge helps development of research and treatment for various addictions, including nicotine and alcohol, especially in light of the comorbidity of these addictions.

The designs and methods that lead to the discoveries of great prevention and treatment potential.

 
64 02/21/2012 at 05:32:11 PM Self     Tobacco is the most prevalent and deadly form of drug addiction. Tobacco is largely absent from the list of potential research opportunities.

1. Where opportunities list alcohol separate from other drugs, include tobacco: tobacco, alcohol, and other drugs

2. Early detection, intervention, and motivating people with drug abuse/dependence to try to quit is a huge problem. There should be an opportunity that explicitly includes this as a research focus, especially for marijuana dependence but also for other drugs. For example, only 20% of tobacco smokers are ready to set a quit date. 2a. In terms of early intervention, the Institute could include reducing the decades-long gap between addiction onset and cessation as an explicit goal.

3. Include an opportunity on research and practice to understand the co-occurance of mental health and addiction disorders, and to identify effective treatment of co-occuring disorders

3a. It would be great if the Institute could develop strong links with NIMH.

4. Type II translational research should be targeted - there should be an opportunity targeting dissemination and implementation research to enhance widespread adoption of effective interventions

5. Because tobacco is the #1 cause of lung cancer (not to mention all of the other cancers it contributes to) and lung cancer is the #1 cancer killer, it is extremely important for the institute to maintain strong links to the NCI and for the NCI to count tobacco projects funded by this new institute as cancer-related research.

1) It is extremely important to ensure that net NIH investment in tobacco research does not decline as a result of the merger.

2) Promoting early detection and intervention is extremely important because it is poorly addressed so far.

3) Untreated mental illnesses are major causes of abuse onset and relapse, but they are poorly addressed in research and not addressed at all in most treatment settings.

 
65 02/23/2012 at 09:39:39 AM Organization City of Minneapolis Department of Health and Family Support Minneapolis, MN Use of alcohol, marijuana and other drugs during pregnancy. Our studies show that many women will acknowledge use, but most users are not using at levels which, outside of pregnancy, would not prompt referrals to treatment. Most do not meet DSM-IV criteria for susbtance use disorders, and if referred for assessment do not follow through. Some women quit spontaneously upon pregnancy awareness and most who continue use reduce frequency and quantity of use. Our studies show, however, that the quit rate is higher for alcohol use than for marijuana or cigarette use. Messages from providers and policy makers are confusing. Most laws regarding prenatal exposure target illicit drugs although evidence of harm appears most conclusive for alcohol and tobacco. Some providers will not address marijuana use, seeing it as a harm reduction strategy -- that is, preferable to alcohol. Education is not an adequate response. Among urban, low-income, pregnant women, stressors are abundant --- food insecurity, housing instability, exposure to violence, unreliable transportation -- and many women use substances to cope with stress. To achieve substance-free pregnancies, we need to better understand what promotes or impedes cessation during pregnancy (or when trying to become pregnant, and offer supportive interventions to help women quit. Engagement and cessation strategies need to be rigorously tested in a variety of populations.

  Attachment #1: PDF copy of article: “Alcohol and Drug Use Before and During Pregnancy: An Examination of Use Patterns and Predictors of Cessation” by Patricia A. Harrison and Abbey C. Sidebottom; published by Maternal and Child Health Journal in May 2009 (vol. 13 no. 3) Attachment #2: PDF copy of article: “Systematic Prenatal Screening for Psychosocial Risks” by Patricia A. Harrison and Abbey C. Sidebottom, published by Journal of Health Care for the Poor and Underserved in 2008
66 02/23/2012 at 02:00:57 PM Self     Understanding the short and long term effects of adolescent substance abuse health and especially neural function should have immense implications for understanding and treating addiction and other mental illnesses

Tobacco use continues to be a major health issue and thus understanding the relationships between tobacco use, addiction, and psychiatric disorders is critically important.

Adolescences is associated with higher rates of substance use. This combined with the fact that the adolescent brain is still developing may not only make adolescents more susceptible to addiction, but substance abuse during this developmental period may lead to problems in adulthood that include other mental illnesses. Understanding how and why these changes occur will hopefully lead to treatments and interventions. In addition, increased research in this area should increase public awareness of these issues.

 
67 02/24/2012 at 03:15:34 PM Self     Three areas: 1 - Addressing drunk & drugged driving 2 - Addressing prescription drug abuse 3 - Best practices for addiction training

Drunk and drugged driving continue to be a major, preventable public health problem with a large cost in mortality, economic impact and legal costs. All the statistical indicators point to the rise of prescription drug abuse as a major health issue and, unfortunately, it's legal status will make it likely to be around as an ongoing public health issue like the two biggest drugs of choice (which are also legal): nicotine and alcohol. Finally, for all the research and evidence that might be uncovered, much of it will be meaningless unless we integrate such knowledge into the service provision workforce, which is tremendously understaffed and deficient in even basic training. Anyone who asks why the addiction treatment field has not been implementing the wonderful research that has developed over the years is probably not working near the service delivery system, whose problems are obvious at the ground level. Unless we develop and train the workforce, much of the taxpayer dollars spent on NIH's efforts around substance use and abuse will be for naught.

 
68 02/24/2012 at 05:46:03 PM Self Washington State University Pullman, WA Area for Inclusion: Understanding the mechanisms by which alcohol and other drugs of abuse increase risk for certain diseases (e.g. cancers), particularly when used in combination.

Use of alcohol, not necessarily at levels of abuse, increases the incidence of cancer. The impact of alcohol in increasing the risk of cancer is largely unknown and the statistics are woefully out of date. Much of the research in this area is not being conducted in the United States because of a low priority that has been placed on this area. The most recent statistics from 2002, which are ten years out of date suggests that 3.6% of cancer are attributable to alcohol. At that time the connection between alcohol use and cancer was largely confined to heavy users; however, we now know that low levels of alcohol can also exhibit a carcinogenic effect (i.e. breast cancer). Thus, the incidence is likely much greater. While the knowledge of alcohol as an independent factor in causation of cancer is currently escalating, little is known regarding how continued alcohol use impacts cancer progression (invasion and metastasis) and survival of patients with cancer. The role of the immune response in cancer survival and metastasis has recently re-emerged as an important area for research, and alcohol is largely known to be immunosuppressive. Thus, alcohol could have a major impact in progression of cancer. These are important and emerging areas, in which more research is desperately needed. The impact of cancer on human health is immense given the volume of people with cancer and in addition those who have survived cancer. The effect of alcohol consumption on re-occurrence of cancer is also is an important and underexplored area of research. Before the merger discussions NIAAA intended to increase research on alcohol and cancer through an RFA process. Emphasis in this area is currently stalled pending decisions on the merger.

Drugs of abuse are also linked to cancer. For example, tobacco is well known to be carcinogenic, marijuana use is linked to testicular cancer, and liver cancer from use of anabolic steroids. The influence of alcohol in combination with drugs of abuse requires further investigation. To date most is known about the alcohol and tobacco connection; however again, very little is known regarding the impact of combination alcohol and drug abuse on cancer progression and survival.

I believe that the most important area for NIH to address is the role of alcohol and drugs of abuse in cancer, especially on the progression of the diseases. Within the NCI, there is no champion or focused area of research for addressing these areas other than the role of tobacco and cancer. Furthermore, research now is largely from a public health perspective, finding ways to decrease the utilization of tobacco products. Study sections have not been very receptive to research on alcohol (and perhaps drug abuse) as it relates to cancer. Thus, it will also be important to push for the establishment of IRG’s that are more receptive to this type of applied research. The major focus of the NCI has and continues to be the development of new drugs to treat the various cancer diseases. Understanding factors such as alcohol and drugs of abuse and their role not only in cancer causation, but also in cancer progression receive little emphasis within NCI. To relegate this area of research to NCI and not include within NIAAA and NIDA (whatever the structure will be) will surely be the death of research in this area.

Researchers in this area currently comprise a small group. Thus, we do not have a lot of lobbying clout. Therefore, I urge you to consider this area based on need for more research not upon the magnitude of the input that you receive.

 
69 02/24/2012 at 06:56:32 PM Organization University of California San Diego La Jolla, California Regarding treatment, there is a yogic meditation technique that is claimed to be specific for the treatment of any form of addiction. This technique comes from the ancient yogic tradition called Kundalini Yoga, as taught by Yogi Bhajan. He taught this technique in 1974 and it was first published in the scientific literature in 2004 along with other meditation techniques that are claimed to be disorder-specific for different psychiatric disorders, in the following (see attached):

Shannahoff-Khalsa D, An Introduction to Kundalini Yoga Meditation Techniques that are Specific for the Treatment of Psychiatric Disorders, The Journal of Alternative and Complementary Medicine, 10(1), 91-101, 2004.

This technique is also published in the following encyclopedia article that will come out in March 2012 (see attached galleys):

Shannahoff-Khalsa DS. Meditation: The Science and the Art (chapter 228), in The Encyclopedia of Human Behavior, 2nd Edition, Editor, Vilayanur S. Ramachandran, Elsevier, 2012.

And the technique as part of a 7-part protocol called “Treating the Addictive, Impulse Control, and Eating Disorders” was published in the two following books (PDFs of the cover jackets are available on request and advance acclaims for NIH funded scientists are on the cover jackets):

Shannahoff-Khalsa DS, Kundalini Yoga Meditation: Techniques Specific for Psychiatric Disorders, Couples Therapy, and Personal Growth, W. W. Norton & Company, New York, London, 2006 (a professional book written by invitation).

Shannahoff-Khalsa DS, Sacred Therapies: The Kundalini Yoga Meditation Handbook for Mental Health. W. W. Norton & Co. Inc, (due for publication March 2012).

While this technique claimed to be specific for addictions has been used widely in non-academic treatment circles, there are no RCTs to date to test its validity. However, there is a meditation technique specific for treating OCD that was tested in 2 clinical trials and the latter one was funded by the NIH Office of Alternative Medicine in 1994. The final results of that trial were published in (see attached):

Shannahoff-Khalsa DS, Ray LE, Levine S, Gallen CC, Schwartz BJ, Sidorowich JJ. Randomized Controlled Trial of Yogic Meditation Techniques for Patients with Obsessive Compulsive Disorders, CNS Spectrums: The International Journal of Neuropsychiatric Medicine, vol 4, no. 12, pp 34-46, 1999.

Along with preliminary results of that OCD RCT in (see attached):

Shannahoff-Khalsa DS, Yogic Techniques are Effective in the Treatment of Obsessive Compulsive Disorders, In: Eric Hollander & Dan Stein, eds., Obsessive-Compulsive Disorders: Diagnosis, Etiology, and Treatment, Marcel Dekker Inc., New York, pp. 283-329, 1997. (available upon request)

In addition, David Shannahoff-Khalsa was invited and funded by NIDA (David Shurtleff) in 2010 to give the following stand-alone 1 hr lecture:

"Kundalini Yoga Meditation Techniques Specific for the Addictions, OCD, Impulse Control Disorders, and Compulsive Behavior," National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), Oct 15, 2010. This lecture had a slightly different name as advertised on NIH’s “yellow sheet.”

Also, the techniques for addiction and OCD are also taught at the Annual Meetings of the American Psychiatric Association in:

165th Annual Meeting, American Psychiatric Association, Full Day 6 Hour Accredited CME Course, “Kundalini Yoga Meditation Techniques for Anxiety Disorders Including OCD, Depression, Attention Deficit Hyperactivity Disorder, and Posttraumatic Stress Disorder” May, 2012, Philadelphia (to be presented).

This same Full Day 6 hr CME course also included teaching the OCD and addiction techniques to participants by Shannahoff-Khalsa at the American Psychiatric Association Annual Meetings in 2011, 2010, 2008, 2007, 2006, and 2005.

Therefore, I believe these achievements warrant substantial funding by the proposed new National Institute of Substance Use and Addiction Disorders as a well-designed professionally conducted RCT for at least one significant addictive disorder. An R21 study would not allow for the sufficient funding necessary to conduct a meritorious RCT.

In addition to the therapeutic value of Kundalini yoga meditation techniques for treating the substance abuse disorders, there is a very important value in these techniques for preventing substance use and abuse. In the earlier years (1969 through the 80’s) that these techniques were taught publically by Yogi Bhajan in the West, a high proportion of those that had learned the techniques found it very easy to get off of any illegal substances, including cigarettes, and quickly quit voluntarily without formal treatment. The original interest by these individuals was based on how “high” they could get naturally using these powerful techniques to achieve a new and healthy high and to experience expanded states of awareness and bliss. Therefore, if the techniques were more widely available and taught at younger ages, these techniques could add substantially as a form of prevention. Trial programs should be funded with young populations in the US in an attempt of prevention.

Attachment #1: PDF copy of article: “An Introduction to Kundalini Yoga Meditation Techniques that are Specific for the Treatment of Psychiatric Disorders” by David S. Shannahoff-Khalsa ; published by The Journal of Alternative and Complementary Medicine in 2004 (vol. 10 no. 1) Attachment #2: PDF copy of book chapter: “Meditation: The Science and the Art (chapter 228)” by David S. Shannahoff-Khalsa D; published in The Encyclopedia of Human Behavior, 2nd Edition, in 2012. Attachment #3: PDF copy of article: “Randomized Controlled Trial of Yogic Meditation Techniques for Patients with Obsessive Compulsive Disorders” by David S. Shannahoff-Khalsa et al; published by CNS Spectrums: The International Journal of Neuropsychiatric Medicine in December 1999 (vol. 4 no. 12)
70 02/25/2012 at 02:46:59 PM Self     An institute on "Addiction Disorders" should include research on addiction to high caloric foods which is, at least in part, responsible for the most serious epidemics confronting the nation, obesity and its sequelae of chronic diseases.

Much can be gained from the study of neurobiological pathways that are shared by addiction to high caloric foods, nicotine, alcohol and other drugs.

 
71 02/27/2012 at 06:23:27 PM Self     Part of the research portfolio for A National Institute of Substance Use and Addiction Disorders should focus on Pavlovian and operant conditioning processes in the development of addiction, including their neurobiological bases. Current addiction research often identifies brain areas that adapt with chronic drug self-administration, but the significance of these changes for behavior is often ignored. This is an important public health issue because addiction changes the way individual's make choices in their daily lives beyond the quantity and timing of drug use, often resulting in disadvantageous outcomes (e.g., fines, incarceration, loss of employment, poor health). Studying these learning processes it expected to inform the relationship between drug abuse, impulsive behavior and risk-taking.

Repeated excessive and uncontrolled drug abuse that is the hallmark of addiction is a learned behavior that is acquired in specific environments and subjective states. This learning is influenced by many vulnerabilities (e.g., genetics, age, sex, hypothalamic-pituitary-adrenal axis stress response), and pharmacokinetic and pharmacodynamic adaptation to repeated drug administration, which are important targets for identifying risk and possibly intervening to change the course of drug and/or alcohol dependence. Indeed, non-human primate models with great translational relevance have been used to reveal such risk factors for alcohol abuse. However, among vulnerable individuals, it is important to study the learning that leads to compulsive, addictive behaviors. The knowledge of vulnerable phenotypes identified in non-human primates and their human-like endocrine activity and drug pharmacokinetics make them an ideal translational model for extending studies of fundamental learning processes to the development of drug abuse habits. Such learning is why drug and alcohol dependence are considered life-long diseases, so studying this learning may be the only hope for "curing" addiction.

 
72 02/28/2012 at 10:00:21 AM Self     I am a professor at a major research university, but am choosing to respond anonymously because I am commenting as a recovering person (hence, anonymity at level of press, radio, tv and films). I have done substance abuse research for 10 years, although it is not one of my major foci. I will say that I think this idea to combine the institutes is excellent, and well overdue.

The comment I would like to make is that in my 22 years of sobriety, the single biggest challenge to recovery (of the sort the proposed institute can study) is the prescribing practices of physicians and psychiatrists. I cannot tell you the number of times a physician has tried to give me an addictive drug (e.g. a benzodiazepine or a narcotic) even though I am always clear that I am in recovery. More remarkable is that even when I do the "on the spot" intervention with the physician, I have occasionally been challenged by the physician! Recovering people in doctor's offices or emergency rooms should not have to be in the position of educating their physicians about the addictive potential of, say, Atavan. I am well educated, confident and assertive, and yet have also occasionally felt bullied by physicians with their prescription pads. There needs to be better training of medical professionals about substance abuse and recovery.

In particular, I am gravely concerned about the number of people attempting recovery whose doctors give them benzodiazepines on a long term basis. I have never seen anyone recover from this because of the nature of the pharmacology*addiction*my doctor-tells-me-to dynamic. It is quite shocking. I would like to see a lot more research into the role that the benzos play in recovery and relapse (especially since the benzos play such an important legitimate role in detoxification management). I have tried to do research online and neither NIAAA or NIDA has a presence. This is a problem--the NIH institutes should be one of the first sites that come up (as it would be if I searched for, say, cancer or heart disease). Instead, it is a lot of wacko.com advice from people about how to titrate, how to withdraw, how to justify staying on them, and so on...

Finally, it would be useful to study pain management and recovery. Some of the most spectacular relapses I have seen have been by individuals who have a real need to use narcotic pain relievers (e.g. major surgery), but then who do not get proper supervision by the medical professionals in charge of their care. If I ever have need to be in a hospital, then I have a team of aggressive people poised to intervene on my behalf. This is because I have no confidence in the ability of the typical modern American health care provider to treat the real threat of relapse in recovering people appropriately.

Health care providers--and physicians in particular--are a big part of the addiction and recovery problem (as in, they are promoting a lot of the addiction, and they are not good recovery partners). NIH needs to play a leadership role in trying to do something about this. Millions have died because of the substance abuse ignorance and incompetence of the typical physician. It is a tragedy--one that is quite unnecessary given that the federal and state governments subsidize medical training and supervise physicians. Although I agree with the Obama administration that aggressive anti-fraud measures are needed, this will just solve the criminal problem. What I am concerned about is the negligence that is our medical training system when it comes to dealing with substance abusers--whether in recovery or not.

 
73 02/29/2012 at 11:03:36 AM Organization Northam Psychotechnologies Ottawa, Ontario Non pharmacological approach to addictions and phobias is not addressed, though pharmacological treatments are not followed up by any quantitative testing in the person treated with a pharmacological agent except for observation or physician's opinion or patient's communication.

Non pharmacological approach to addictions and phobias. 1. Development of quantitative testing for diagnosis and follow up of patients with drugs, alcohol and gambling addictions or phobias. 2. Development of non pharmacological treatments for patients with drugs, alcohol and gambling addictions or phobias.

The physical health field has numerous ways of testing patients to determine an accurate course of treatment and has the tools to measure the effectiveness of treatment along the way. These tests also help the patient see their progress and keep them committed to the process. The mental health field does not have such approach and is mostly based on expert opinion rather than on the quantitative testing. Both patients and doctors rely on a patient’s personal opinion and communication and due to the complex nature of the disorders, we continue to have high rates of inaccurate diagnosis, treatment, prescriptions and disillusioned patients dropping out of treatment. Neither drug, alcohol, gambling addictions or phobias have a consistent record of successful treatments and the field represent rather a personal art of some physicians than a publicly well established practice with out well established quantitative testing.

PDF copy of article: “Psyche from within: Tree Case Studies” by Semyon Ioffe and Sergey Yesin, published by Psychology in October 2012 (vol. 1 no. 4)
74 03/04/2012 at 01:13:24 PM Self University of Vermont Burlington, VT We have an opportunity to create an NIH institute on substance use, abuse and addiction-related research that values and prioritizes behavioral science research. Behavioral science merits financial and intellectual support equal to that of the other disciplines that are also essential to addressing the scientific challenges that substance use, abuse, and addictions represent (e.g., genetics, molecular biology, neuroscience, neuropharmacology). Too often, behavioral science is treated in the addictions area as a dated science, a discipline that only has relevance as a stepping-stone to a genetic or neurobiological endpoint. Similarly, behavioral interventions are treated as being of secondary importance to pharmacological interventions in terms of funding and other indicators of scientific and intellectual priority. Perhaps this might be understandable if it was consistent with the scientific record in the area of substance abuse and addiction-related research. That is not the case. Research enterprises where behavioral science participated as a leader, or at minimum as an equal, have revolutionized the conceptualization of addiction-related problems (including obesity) and the development of efficacious interventions. Behavioral and cognitive psychology, behavioral pharmacology, and behavioral economics have contributed fundamental advances to scientific understanding and treatment development (behavioral and pharmacological interventions) for cocaine dependence, opioid dependence, tobacco/nicotine dependence, other addictions, and obesity (e.g., Bickel et al., 2007; Epstein et al., 2010; Henningfield, 2011; Higgins et al., 2004; Loewenstein et al, 2007). While making conceptual contributions, I am hard-pressed to identify any comparable advances in prevention or treatment emanating directly from neuroscience research on addictions despite what might be considered disproportionate support over the past several decades. Let me be clear, I am not arguing against neuroscience or interdisciplinary research. To do so would be absolutely foolhardy. Indeed, two of the exemplars that I offered above (behavioral pharmacology and behavioral economics) to illustrate the benefits of supporting behavioral science research represent interdisciplinary marriages. Instead, what I am advocating for is an institute that recognizes the fundamental importance of behavioral science to (a) understanding substance use, abuse and addiction-related problems and (b) to developing effective prevention and treatment interventions in these areas. I am advocating for an institute where such recognition is demonstrated within the institute’s mission statement, organizational structure and leadership hierarchy, and by equitable financial support. I am advocating for an institute that respects and treats behavioral science as an equal within the interdisciplinary enterprise that is necessary to effectively meet the challenges that substance use, abuse, and addiction represent. Of course, as a behavioral scientist by training I am especially sensitive to this need. However, I am not advocating this position out of narrow self-interest. I am advocating it because, as someone with almost 30 years of NIH research experience, I believe there is a palpable need for a course correction in this direction within the NIH generally and addictions area specifically. Currently existing biases against behavioral science as a “real science” and behavioral interventions as “real treatments” are at a level where they are impairing scientific progress in this important area of health research. Considering that approximately 40% of all premature deaths in the U.S. each year are attributable to substance abuse and other modifiable personal behavior patterns, getting this right in the development of this new institute is fundamentally important to advancing science and improving the U.S. public health (Schroeder, 2007).

References Bickel, W.K. (2007). Behavioral and neuroeconomics of drug addiction: Competing neural systems and temporal discounting processes. Drug and Alcohol Dependence, 90S, S85-S91.

Epstein L.H., Salvy, S.J., Carr, K.A., Dearing K.K., & Bickel, W.K. (2010). Food reinforcement, delay discounting, and obesity. Physiology and Behavior, 14, 438-445.

Henningfield, J.E. (2011). Tobacco psychopharmacology and public health policy: it takes a community. Experimental and Clinical Psychopharmacology, 19, 249-262.

Higgins, S.T. (2004). Clinical implications of reinforcement as a determinant of substance use disorders. Annual Review of Psychology, 55, 431-461.

Loewenstein, G., Brennan, T., & Volpp, K.G. (2007). Asymmetric paternalism to improve health behaviors. JAMA, 298, 2415-2417.

Schroeder, S.A. (2007). Shattuck lecture. We can do better—improving the health of the American people. New England Journal of Medicine, 357, 1221-1228.

Only addressed one overarching issue.

 
75 03/07/2012 at 02:56:02 PM Self     The new institute must support studies on the effects of the equivalent of moderate social and binge drinking at the integrative and organ system level in health and disease. These studies are expected to generate clinically relevant data that will eventually impact public health given the widespread use of moderate and binge drinking.

The issue of the cardioprotective effect of moderate alcohol drinking requires much more focused attention to the experimental settings used in reported studies from which this widely publicized conclusion has evolved. For example, the effects of moderate amounts of alcohol vary significantly in hypertensive and normotensive animals. In addition to potential interaction between ethanol and antihypertensive medications (monotherapy or polypharmacy), more studies are needed to investigate the effects of moderate and binge amounts of ethanol in models of “prehypertension” given the number of Americans now classified as “prehypertensive”. Another important issue are the needed studies in the female population in the absence and presence of ovarian hormones and also in hypertensive/prehypertensive animal models. Clearly, the studies devoted to understanding the effects of ethanol on the female biology need substantial boost for at least two reasons. First, the significant increase in binge alcohol consumption by college age females; and, second, the disproportionately low number of studies devoted to investigating the integrative and end organ effects of ethanol in females.

 
76 03/07/2012 at 04:44:15 PM Self     Since a major component of this institute will have a focus on addiction, it is important that the many forms of addiction that may share underlying mechanisms be part of this new institute, such as pathological gambling. Pathological gambling is current underfunded by NIH, despite is significant and consequential.

The majority of American adults that drink alcohol are not alcoholic but rather moderate drinkers. Therefore, this new institute must include the study of health benefits and risks associated with more moderate social and binge drinking.

   
77 03/08/2012 at 05:40:51 PM Self     Alcohol research encompases areas other than addiction, including fetal alcohol spectrum disorders and effects on targets organs such as liver, gastro-intestinal tract, immune system, cardiovascular system, etc. If a new institute is formed, these areas of alcohol research should remain within the portfolio of the new institute and not fragmented into other institutes where their importance will be diluted.

Tobacco research should be included into the new institute.

Other addictions should be included (obesity, gambling, etc).

Funding for alcohol, tobacco and ilicit drug research should be allocated considering the impact of each of these in the public. Economic cost of alcohol abuse is significantly greater than that of other substances.

The cost of this structural reorganization of NIH institutes is going to be enormous and it could have a tremendously negative impact on research. Rather than a structural reorganization, NIH should consider a functional reorganization (similar to the current neuroscience blueprint) that foster collaborations among different program based at NIAAA, NIDA and other institutes. Moreover, the feasibility and impact of combining the NIAAA and NIDA intramural research programs (which are currently very successful and are located in different cities) has not been carefully considered.

 
78 03/09/2012 at 11:11:35 AM Self     • Provide coverage of various levels of alcohol use (low, moderate, heavy) and the associated impact (positive, negative, neutral) on health outcomes across the lifespan. • Develop multi-targeted prevention and treatment programs to address the co-occurrence and comorbidity of addictive conditions. • Develop more of a translational focus for prevention and treatment programs including behavioral programs, pharmacologic programs, and joint behavioral and pharmacologic programs. • Strengthen the portfolio regarding the linkages between substance use/disorders and medical conditions, especially for multi-substance use patterns. • Focus on underlying genetic, biological, and environmental mechanisms and processes that impact multiple addictions (e.g., alcohol, nicotine, gambling, eating disorders). • Focus on the identification of critical common and unique neural circuits and neurobiological mechanisms that impact addictive behaviors. • Embrace a life course perspective for understanding differential susceptibility to stability and change in substance use and addiction across the lifespan.

I believe that all of these are important issues and are interrelated in attempting to provide some priorities for the new institute that would benefit the public by more rapidly identifying underlying mechanisms and translating prevention and treatment programs to practice.

 
79 03/09/2012 at 05:22:21 PM Self     The majority of adults in the United States that drink alcohol are not necessarily alcoholics, but are moderate drinkers. The new institute must include the study of the risks associated with more moderate social drinking and also binge drinking. In terms of teenagers and young adults the use of alcohol is high, especially socially, and involves binge episodes of drinking. My own research on Fetal Alcohol Syndrome shows that just one binge drinking episode during early pregnancy before a woman may even be aware of her pregnancy, can induce cardiac and neural defects in the embryo. This can have a tremendous societal impact, considering 49% of pregnancies in the US are unplanned. The impact of substance abuse and addiction on embryonic/fetal development should be part of the charge of this new institute. We should also keep in mind, it is not only the woman who must be aware of the risks, but also the man, as some recent alcohol research shows there are epigenetic DNA methylation related effects in relation to sperm of men who are moderate to heavy drinkers. For a new institute on substance use and addiction, it is imperative that health promotion be a high priority. Educational programs and the evaluation of the benefits of such programs are critical to initiate already in junior high school, high school, and be carried over into college campuses, as well as to the public at large. I have graduate students from the Public Health field who get involved with my basic research on alcohol and drug effects on the early embryo. We did a study locally of the community programs involved with early pregnancy, as Planned Parenthood and March of Dimes and some state initiated programs: None of them have material pertaining to developmental defects that arise due to exposure before pregnancy is confirmed which is usually 5 to 6 weeks of gestation. My research using mice shows, when we extrapolate to human pregnancy , that by the end of week 2 of human gestation, severe, but viable, cardiac developmental anomalies are induced by a single exposure to alcohol and drugs. The brain is also affected. We need better education on this aspect of early pregnancy. These defects can be prevented by use of higher levels of folate beginning with early pregnancy, at least taking it by the second week. Use of prenatal vitamins with higher folate are often prescribed only at weeks 5 to 6 which is too late, especially so, when the woman takes alcohol or drugs regularly or even by one binge episode that unfortunately coincided with a sensitive early period of pregnancy. Education one would hope would make an impact. This is currently not emphasized. NIAAA has used a systems biological approach to analyzing the impact of alcohol on the entire body . This has been important since alcohol has a rather wide effect on the organism. I have heard that it is expected certain areas of alcohol research be removed (prenatal alcohol exposure and end organ damage, as examples) to other institutes. This is not a good idea. As I work on fetal alcohol research specifically in relation to heart-related birth defects, by having an institute that focuses on multiple organ systems, one begins to see the commonalities in the pathways and molecules that are involved, as other organ systems are analyzed . This is where the breakthroughs will come and why, for example, folate will protect cardiac, brain and developmental disabilities from arising, if provided early in gestation. If these studies are parsed out to different institutes where cross-talk is decreased, it will take a lot longer for these common themes to be detected.

As based upon my experiences and our results from the basic research side, as well as public health studies initiated by some of my graduate students, we need to emphasize (1) effects of substance and alcohol abuse during the reproductive years and the embryo and fetus where a lot of damage already occurs; and (2) emphasize educating the public, beginning with junior high and high school. Possibly if these areas are done well, addiction as an adult may already be decreased due to the earlier interventions.

Attachment #1: PDF copy of article: “Fetal alcohol syndrome: cardiac birth defects in mice and prevention with folate” by Maria Serrano et al; published by American journal of Obstetrics & Gynecology in July 2010 (vol. 203 no. 1) Attachment #2: PDF copy of article: “Folate protection from congenital heart defects linked with canonical Wnt signaling and epigenetics” by Kersti K. Linask and James Huhta; published by Current Opinion in Pediatrics in October 2010 (vol. 22 no. 5) Attachment #3: PDF copy of article: “Folate rescues lithium-, homocysteine- and Wnt3A-induced vertebrate cardiac anomalies” by Mingda Han et al; published in Disease Models & Mechanisms in 2009.
80 03/09/2012 at 05:30:18 PM Self       Fetal alcohol research needs to be within the new National Institute of Substance Use and Addiction Disorders.

Removing fetal alcohol research to other institutes will have devastating effects on this area of research. It is critical that all aspects of alcohol research remain within this new institute. Fetal alcohol research needs to be within an institute that focuses its research program on how alcohol affects not only brain but various organ systems, immune function, behavior.

 
81 03/11/2012 at 06:36:17 PM Self     The proposed combined addictions institute will face some complex challenges as well as opportunities. Defining the boundaries of “addiction” is undoubtedly the premier challenge. As a quantitative scientist, I have had the privilege of working on research projects across the spectrum not only of addiction (as presently defined by the boundaries of NIAAA and NIDA), but also psychiatric disorders more broadly, obsessive-compulsive disorders in particular. The OCD scholars with whom I work are interested in gambling as a special type of compulsive disorder, while addictions researchers I know are interested in the comorbidity of gambling with substance use. Among addictions researchers, there is continuing debate about the distinction between “psychological” addiction (perhaps a compulsive disorder), vs. physiological dependence. I would also like to bring to the committee’s attention longitudinal research on the relationships among addictions, other Axis I disorders, and Axis II disorders, research that is not well known within the addictions research community. Addictions researchers are certainly aware of correlations among all these disorders cross-sectionally, but the longitudinal associations among the disorders are quite different (Shea, Stout, et al., 2004; Phillips & Stout, 2006).

One conclusion I draw from these considerations is that the phenomena we study probably do not respect the institutional boundaries that seem to be Plan A for the new institute much better than they respected the existing NIAAA-NIDA-NIMH-NCI boundaries. The brain is one organ. Dividing “addictions” from other behaviors may be convenient for bureaucratic or other purposes, but as scientists we ultimately cannot avoid studying the brain as a whole. Thus, understanding how the broad spectrum of addictive, compulsive, Axis I, and personality disorders interweave seems to me to be the core challenge, and opportunity, for the new institute, with a lot of help from other institutes.

I also am concerned that the scope of the new addictions institute might be construed too narrowly in another way. I fear there is a real danger in calling the institute an “addictions” institute because the public perception of “addictions” is that it has to do with “addicts” who are totally different from the rest of us. When I say “public” I specifically want to include “congress.” As scientists we understand that alcohol and drugs harm a lot of people who do not even faintly resemble the stereotype of “addicts.” Think of teenagers driving shortly after their first experience with beer, or victims of fetal alcohol, tobacco, or illegal drug exposure. There are very important public health dimensions associated with alcohol and tobacco in particular that need to be protected in the transition to the new institute because they tend to fall outside the general public view of “addiction.”

A third opportunity/challenge for a new addiction institute would be to maintain a systems approach to the substances and behaviors under study. There is a “dopamine disease” focus that is popular among some addiction scientists today. While I would not want to minimize the importance of dopamine systems, alcohol in particular (but also tobacco and other substances) affect not only a variety of brain systems beyond dopamine, but also other organ systems that interact with the brain in ways that we only dimly understand. And effects on other organ systems are responsible for many of the most devastating health effects of alcohol, tobacco, and other abused substances.

Finally, social and policy research integration across the proposed span for the new institute presents special challenges. The public policy methods for preventing and/or minimizing the social harm of the two legal substances, alcohol and tobacco, differ greatly from those appropriate for illegal substances. It is less clear how differently social influence processes function across the span of substances, gambling, and other related behaviors. The importance of social processes is becoming increasingly clear (Stout, Kelly, et al., 2012), so uncovering the commonalities and differences in how social processes affect substance initiation, use patterns, and outcome across substances should be a fruitful area for research.

I personally have mixed feelings about the concept of a single addictions institute. There are possible synergies from combining (primarily) NIDA and NIAAA, but my reading of the scientific opportunities and challenges is that much more would be gained by the creation of a broader human behavior institute. I do not think it essential that we hasten to finalize the current proposed integration without taking time to consider the larger opportunity we would pass up or delay.

I hope these comments are of some value to the committee.

Shea, M. T., Stout, RL et al. (2004). "Associations in the course of personality disorders and Axis I disorders over time." Journal of Abnormal Psychology 113: 499-508. Phillips KA, & Stout RL. (2006) Associations in the longitudinal course of body dysmorphic disorder with major depression, obsessive compulsive disorder, and social phobia. Journal of Psychiatric Research;40:360-369 . Stout, R. L., Kelly, J. F, Magill, M., & Pagano, M. E. (2012). Association Between Social In?uences and Drinking Outcomes Across 3 Years. Journal of Studies on Alcohol and Drugs, 73 (3), 489-497

The proposed combined addictions institute will face some complex challenges as well as opportunities. Defining the boundaries of “addiction” is undoubtedly the premier challenge. As a quantitative scientist, I have had the privilege of working on research projects across the spectrum not only of addiction (as presently defined by the boundaries of NIAAA and NIDA), but also psychiatric disorders more broadly, obsessive-compulsive disorders in particular. The OCD scholars with whom I work are interested in gambling as a special type of compulsive disorder, while addictions researchers I know are interested in the comorbidity of gambling with substance use. Among addictions researchers, there is continuing debate about the distinction between “psychological” addiction (perhaps a compulsive disorder), vs. physiological dependence. I would also like to bring to the committee’s attention longitudinal research on the relationships among addictions, other Axis I disorders, and Axis II disorders, research that is not well known within the addictions research community. Addictions researchers are certainly aware of correlations among all these disorders cross-sectionally, but the longitudinal associations among the disorders are quite different (Shea, Stout, et al., 2004; Phillips & Stout, 2006).

One conclusion I draw from these considerations is that the phenomena we study probably do not respect the institutional boundaries that seem to be Plan A for the new institute much better than they respected the existing NIAAA-NIDA-NIMH-NCI boundaries. The brain is one organ. Dividing “addictions” from other behaviors may be convenient for bureaucratic or other purposes, but as scientists we ultimately cannot avoid studying the brain as a whole. Thus, understanding how the broad spectrum of addictive, compulsive, Axis I, and personality disorders interweave seems to me to be the core challenge, and opportunity, for the new institute, with a lot of help from other institutes.

 
82 03/12/2012 at 04:50:55 PM Self     1) The big concern in this merger is the loss of identity and focus on alcohol as a substance that is both ubiqitous and has multiple effects on the human condition. While some of the most damaging effects relate to brain and behavior, many are on other organs e.e. liver, heart, ENT, fetus. Also, its relationship to atypical cell growth (e.g. cancer) is quite important. While some say these issues can be handled by various Institutes the concern is that the expertise for a fair review might not be availalbe and secondarily alcohol (and other substance abuse) for that matter is not given the same level of priority where there the focus is not specifically on this issue (stigma and lack of understanding plays a role here as well - see below). Congress created NIAAA and NIDA to focus on the public health issues of these substances - they did not specify the mandate to be only brain and behavior.

2) We are now just making headway on destigmatizing alcohol dependence. This is a very arduous task. There is fear that "lumping" the legal substance alcohol with many illicite substances would halt or reverse this destigmitazion process. That would not be good for public health. If the Institutes were to merge a large public awareness/marketing effort should be put forth to "destigmatize" alcohol dependence and differentiate it from othe substance dependence. Contrary to what some pundants and scientists believe, alcohol is still the most common, and perhaps treatable, substance addiction and in community samples it is far more prevalent, with causing considerably health care expenditures than most other substances except tobacco perhaps. Taken togehter with other societaly expenditures (auto accidents, fires, industrial accidents, domestic violence, murder, rape etc.) it is the most costly and deadly of abused substances. Therefore the largest share of the new Institute's budget should be directed towards alcohol research!

3) The pharmaceutical industry is just now becoming interested in investing in medications development for alcohol use disorders. This is not true of other addictions (except nicotine perhaps). There is concern that this momentum will be lost in a combined institute. This also relates to the stigma issue of point #2. Unless companies are supported in this fledging effort it will likely languish and reverse. This should be given a high priority whether NIAAA remains separate form NIDA or combined.

4)Screening for alcohol and other substance abuse in primary, and in some specialty care medicine, and offering treatment options is one of the highest public health care priorities. This needs to be supported, researched, and training made available in medical and other health professional (e.g. nursing, physician assistant) schools nationwide.This would include the use, and application, of various biomarkers for drinking and drug use with an attempt to translate research into practice where appropriate in both diagnostics and treatment.

5. Since alcohol (and many other substances) have known neurobiological effects they are prime candidates for pharmacogenomics. There is knowledge developing in this area - but not fast enough given the available technologies. A program where large numbers of individuals are genotyped and the reaction to alcohol (or other substances) under standard conditions, and possibly over developmental age and substance experience, should be started ASAP with an appropriate and large investment of funding. This process will likely lead to the most knowledge for the least investment. Genetic risk for variant reactions (e.g stimulation, euphoria, etc.) could be ascertained and individuals followed longitudinally to validate risk for developing addiction. This effort could be coupled ot brain imaging to enhance the knowledge on brain regional effects as it relates to genetic variability as well.

The last issue #5 ultimately is probalby the most important since it will serve as the basis for diagnostics, therapeutics and potentially prevention. However, all of the others are important as well.

 
83 03/13/2012 at 06:33:30 PM Self     The restructuring of NIH Institutes is a matter of concern to both scientists and public. The scientific areas of inclusion in the newly organized Institute and relationship of those areas within that Institute and the NIH as a whole is the point of my comments included as the attachment.

The most important issue is to structure the focus of the reorganized Institute on the overriding scientific theme for all of the subareas to be administered by this Institute. The new organization should not simply be a reshuffling of prior scientific portfolios, but be a reshaping of concept and approach. The new Structure offers the perfect opportunity to generate a core for trans-NIH efforts in obesity and motivation.

Dear Committee Members, My name is [redacted] and I am a Professor of Pharmacology at the University of Colorado School of Medicine. I have been continuously funded by NIH (both NIAAA and NIDA, and other Institutes) for my alcohol and other sedative hypnotic research since 1971. During the period of 1984-1991 I served as the first Scientific Director for NIAAA and during this period I also had the role of Acting Deputy Director for the Institute. I consider myself knowledgeable in the broad spectrum of alcohol-related research, not only from the experiences noted above, but also through my service on numerous study sections and my participation on the NIAAA National Advisory Council. I am pleased to be able to offer my views as the Committee contemplates the organizational structure of the new National Institute of Substance Use and Addiction Disorders. When contemplating the organization of this new Institute, my sincere hope is that the Committee takes diligent note of the scientific evidence distinguishing the predisposing environmental factors, the genetic factors and the biologic factors contributing to dependence on various substances. The critical importance of considering the differential etiology issue is the same as in the fields of cancer, cardiovascular or other disease states which are of importance to the American public and to NIH. There has been entirely too much rhetoric in the discussion preceding the decision to establish the new Institute regarding the similarities, if not identities, of the addictive mechanisms subserving all classes of dependence producing substances. Therefore, please let me emphasize several features that should not be lost or diminished in the process of structuring the new Institute, and several new features that may need to be added to the portfolio and structure of this new entity. I just returned from Europe where I gave a talk to 130 delegates who came from twenty countries and are opinion leaders on alcoholism treatment policy in those countries. This meeting generated some important impressions. First, there is significant separation in most international policy settings between alcohol and illicit addictive drugs. Second, at this time, the U.S. influence on guidelines, definitions and policy is extremely strong. Third, the NIH Institutes, both NIAAA and NIDA, are highly respected, world-wide, for leadership in alcohol and other addictive drug-related matters ranging from epidemiology to molecular biology to treatment and prevention strategies. It needs to be remembered that the new diagnostic guidelines which will guide the world research and treatment communities, the DSM-5 and the ICD-11, will still segregate alcohol and other drug dependence syndromes, and there are quite different intellectual and political needs around the world in the areas of alcohol addiction versus addiction to other drugs. Thus, my strongest recommendation is to keep the new Institute structure and leadership clearly sensitive and sympathetic to the realities of alcohol and other addiction issues worldwide and not diminish America’s leadership role. The reorganization does, however, open an opportunity to generate a novel view of addictive disorders, as well as a more informative view of human behavior in general. Motivational issues are certainly an important component of addictive disorders, but motivation is an evolutionarily-generated drive which affects all aspects of human life and species survival. Certainly, in terms of health, there are few areas not affected by motivation (from prevention of disease, to issues of medication compliance). Although “motivation”, as a concept, is deeply imbedded in etiological explanations of addiction, the study of brain mechanisms related to motivation in the whole variety of behavioral situations needs to be visibly addressed by NIH. The reorganization offers a platform for such a focus. The implications of understanding the biology of motivation are many, and need to be carefully considered, but the newly formed Institute can use past experience in addiction-related issues for such considerations. If the umbrella of studies of motivation is unfolded in the new Institute, not only do studies of addiction to alcohol and other drugs fit well under this umbrella, but so do other disorders such as obesity. I am not suggesting that obesity be classified as addiction, but motivational, as well as metabolic issues in obesity, can find a proper home and emphasis in the new Institute. In particular regard to obesity, the NIAAA research portfolio, over many years, has featured the examination of ethanol’s caloric properties, ethanol’s effects on metabolism and ethanol’s actions on non-caloric nutrients (vitamins, etc.). Certainly, this work has provided a great deal of information on ethanol’s contribution to human nutrition and metabolism. Instead of diminishing and dissipating this area of knowledge by distribution among other Institutes, I would suggest making this knowledge a focal point for nutrition and obesity research at NIH. Certainly, a Division of “Caloric” Disorders in the new Institute, which includes ethanol generated metabolic disorders as well as obesity-related metabolic disorders could bring significant worth to the reorganization effort (i.e., a perfect opportunity to generate value beyond what is currently thought of as the “addictions” arena). Several important scientific and political issues can be handled by providing to the new Institute the umbrella of research on motivation and its role in behavioral and metabolic malfunction (e.g., addiction and obesity). The most important issue is to put progressive science to work in this Institute in an atmosphere of diminished stigmatization related to addiction. Motivation is a universal issue, irrespective of the legal, medical or general behavioral status of the “reward” initiating the motivation. Motivation is a good thing to focus on politically, it affects everyone. The current lay perception still is that addiction affects a “few”, “bad” people. Internally (within NIH), fewer portfolios would have to be perturbed and a natural home and proper leadership could be generated for cross-cutting issues such as obesity. One would also stay away from the argument of whether alcohol or other drugs are a more important focus of the new Institute. Many other pros (and some cons) can be expressed in regard to my suggestions. I believe that organizing the new Institute around the issues I have raised could generate enthusiasm for the whole process rather than resignation and some resentment. Even the naming of the new Institute (not simply calling it the “National Institute on Substance Use and Addiction Disorders”) could become an interesting exercise. I certainly put myself at the Committee’s disposal if it wishes to receive the scientific basis for my thoughts, or an expanded version of my opinions and further thoughts on organizational structure.
84 03/13/2012 at 10:28:06 PM Organization Westcare foundation St Petersburg fla. The substance abuse field has a prescription drug epidemic which is resulting in many overdose deaths. From a policy to practice the field needs some well researched solutions.

The field has a new wave of synthetic drugs. This problem has baffled the current health and criminal justice intervention models. Again,from a policy to practice states need model state drug laws and agencies need education and treatment approaches that are tested.

Last..youthful offenders are increasing at a rapid pace..what are the treatment engagement strategies that work

Overdose needs to be studied..some cities have realized that over one third of their overdose deaths are committed by offenders who have recently been released from jails and prisons.

 
88 03/14/2012 at 12:03:56 PM Organization University of Mississippi Medical Center Jackson, MS 39216 With regards to the new title for the new Institute, if "alcohol" is belong to "Substances", the folowing new title looks good to me:

The new institute – working title: "National Institute of Substance Use and Addiction Disorders"

Thanks!

   
89 03/14/2012 at 12:50:51 PM Self     1) There are a number of issues on list presented in the RFA that I believe are of critical importance. These include: development of treatments of substance abuse, the issue of alcohol use in adolescence, and understanding the effects of alcohol exposure on brain development. These issues affect both scientists and the public.

Additional issues that are not covered on the list in the RFA: 2) The effects of alcohol are not restricted to the brain, but are found in many organs of the body. Moreover, it has been shown that effects outside the CNS can impact the CNS--for example liver damage can impact CNS damage following alcohol exposure. The interrelationship among organ systems needs to be included. These issues affect both scientists and the public.

3) Alcohol has differential effects at low doses. However, it is unclear whether there are long-term consequences to low dose exposure or even what doses causes problems and the factors that determine what dose is "safe" for any given individual. The establishment of these factors and the understanding of the effects of moderate doses needs to be studied. These issues affect both scientists and the public.

4) Alcohol is somewhat unique in that there is less of an age-relatedness to alcoholism. For example, few elderly individuals are likely to go and try cocaine. However, increasing level of alcohol consumption are often found in older individuals. The effects of alcohol consumption on the health of older individuals should be explored. These issues affect both scientists and the public.

I believe all of the issues identified above are important to study. The effects of moderate doses of alcohol, as well as the issues of effects in aging individuals, are important to study because each has the potential to improve the long-term health of the population. The evaluation of the effects of alcohol in a multi-organ system context is critical in identifying potential treatments to ameliorate some of the damage observed following higher doses of alcohol exposure.

 
90 03/14/2012 at 01:18:50 PM Self     More research is needed on behavioural addictions, such as gambling and internet/video game related addictions. The recent explosion of internet and video game use makes these addictions a particularly pressing concern, the full social impact of which is not yet known.

   
91 03/14/2012 at 05:58:43 PM Self     I am an Associate Professor at the University of Nebraska Medical Center in Omaha. My research is focused on the effects of alcohol, in particular moderate (short term) alcohol consumption, on iron metabolism and hepcidin expression in the liver. Hepcidin is an iron regulatory hormone synthesized by the liver. My R01 grant (obtained as a new investigator) is funded by NIAAA. I strongly believe that it is important to understand the effects of moderate alcohol consumption on human (public) health. NIAAA is best suited for these studies because other institutes (such as NIDDK or NCI) will mainly fund (support) studies looking at the effects of alcohol at later stages (i.e. chronic alcohol use and end-stage organ damage). My studies and reports from other laboratories (including clinical studies) show an effect of moderate alcohol consumption on iron metabolism. Clinical studies show that moderate alcohol consumption (2 drinks per day) causes an increase in serum iron indices. The impact of these changes is many-fold. It may have a protective effect for young females, who are at child bearing age and prone to anemia. However, it may cause iron overload and act as a risk factor in young males. We are all aware that alcohol is a widely consumed social drink in the western world. It is frequently exploited by young people of both sexes in college campuses. Public media also advertise alcohol to be beneficial for the heart. However, the effects of moderate alcohol use on the liver or other organs is not well understood. Understanding the effects of moderate alcohol use will result in better public awareness and patient care. My studies and others (with iron and alcohol) not only show the effect of moderate alcohol consumption but also emphasize the interaction between different organs. I have reported that moderate alcohol-induced decrease in hepcidin expression in the liver results in a significant increase in iron transporter expression in the small intestine in vivo. Moreover, iron a risk factor for infection and alcohol induces endotoxin release from the gut. Hence, moderate alcohol-mediated changes in iron metabolism may also have an impact on infection and public health. Please remember: Alcohol use is not always about (or due to) addiction. Are all college kids binge drinking addicts? Are all business men, who are traveling on the road away from family and killing boredom in pubs with more than 2 drinks a day, addicts? With the current state of the economy and high unemployment rate, people seeking consolation from alcohol is bound to increase (some statistics already indicate this trend). Are all these sad and unfortunate people addicts? Do we really know the effects of this type of drinking (moderate or binge) on public health? Are we doing justice, if we cut funding for these specific avenues of research and funding for the young and enthusiastic scientists, who are already striving to achieve these goals?

Are we doing justice to tax payers money, if we leave them in the dark regarding the public health effects of moderate and social drinking. Not to mention the intention to put it all under the umbrella of addiction (and labeling them as addicts)? Of note, there is already stigma attached to addiction. Will this "one size fits all" approach be more helpful or harmful regarding public health (including public perception)? Last, but not the least, please do not ignore the fact that these type of actions will shape the faith and trust of young investigators, such as myself, in the NIH funding system and mode of operation.

Putting everything under the umbrella of addiction is a narrow minded and simplistic approach.

This approach is going to kill many interesting, ongoing avenues of alcohol research, which will not be funded by the new addiction institute or other institutes (e.g. moderate alcohol use, alcoholic liver disease).

To us (the research community), the reasons for this change seem to be based more on NIH politics and money rather than science, and doing the best for the public and public health.

This move will also be detrimental for investigators like me, who are new to the alcohol field, and have invested time and effort and obtained interesting results. This is particularly true for investigators studying liver and alcohol. We will be forced out of the system and be in a very vulnerable situation.

It is therefore obvious that in the long-term, this will prove to be a costly and harmful exercise, which should be re-considered and stopped.

Attachment #1: PDF copy of article: “The Effect of Alcohol Consumption on the Prevalence of Iron Overload, Iron Deficiency, and Iron Deficiency Anemia” by George N. Ioannou et al; published by Gastroenterology in May 2004 (vol. 126 no. 5) Attachment #2: PDF copy of article: “Alcohol Metabolism-mediated Oxidative Stress Down-regulates Hepcidin Transcription and Leads to Increased Duodenal Iron Transporter Expression” by Duygu Dee Harrison-Findik; published by The Journal of Biological Chemistry in August 2006 (vol. 281 no. 32) Attachment #3: PDF copy of article: “Role of alcohol in the regulation of iron metabolism” by Duygu Dee Harrison-Findik; published by World Journal of Gastroenterology in October 2007 (vol. 13 no. 37)
92 03/15/2012 at 08:05:10 AM Organization Pittsburgh International Trauma Training Institute Pittsburgh The magnitude of the unintended and harmful consequences of illicit drug use worldwide constitutes one of the greatest and most daunting developmental challenges across the globe. The spectrum of the “collateral damage” resulting from illicit drug related harm (IDRH) is enormous and ranges from crime, violence and injuries to threatened transnational security. This problematic must be considered in conjunction with the direct harm related to the drug abuse itself. In fact, IDRH must be seen as a whole, single, global epidemic. Indeed, a true global health and developmental challenge affecting many if not ALL countries around the globe. Complicating this matter, is the fact that the effects of IDRH greatly affects the poorest and more disadvantaged societies in the world, while demand for illicit drug use is greatest in the richest and more affluent societies. As long as the multiple components of the IDRH epidemic are seen as unrelated issues, and attended to disjointedly, without an overarching common strategy, IDRH will grow exponentially and will continue to impact the well being of nations across the world. > > Therefore, there cannot be a better opportunity under the new NIH institute for the creation of a well-designed, comprehensive “consortium level” coalition of university academicians to engage in and design multipronged approaches aimed at identifying viable alternatives to reduce or eliminate IDRH globally. > > This coalition may be the only feasible developmental alternative capable of forming a universal strategy able to address this epidemic in a new and completely different approach from the current fragmented, uncoordinated, and unsuccessful worldwide efforts. Addressing the issues of IDRH specifically, drug abuse and related violence/injuries as one of the common problems affecting both the developed world and less developed countries seems to fit nicely with the potential objectives of this New NIH institute > > Using these approach to IDRH, there would be a potential to strengthen a network in the prevention of Drug Use, specifically around the area of the citizen security which is very relevant at local level. > > A variety of research programs could be structured by designing interventions and comparative effectiveness measurements of educational, preventive and policy interventions within the participating countries of the consortium. Emphasizing on the interaction between interventions on demand reduction (USA) and production control in Central and South America. > This consortium will unite experts in injury, public health, behavior, and international security to study the wide-ranging effects of substance abuse, failed war on drugs strategies and other aspects of IDRH on society in the U.S., Latin America, and beyond.

   
93 03/15/2012 at 09:18:10 AM Self     I am writing to request that the new institute have a high priority on a wider operationalization of the use of alcohol beyond just addiction and methods of prevention/intervention that are associate with more acute use of alcohol.

Here's why:

1) Most high school and college students are not addicted to alcohol. Yet, they drink in a manner that puts them at risk and contribute substantially to a major public health problem that is costly in terms of dollars, a burden on public services (e.g., medical community, law enforcement), and a detriment to positive mental and physical health.

2) Even several drinks for a young person can contribute heavily to risky decisions and behaviors as we have observed from the numerous studies examining the relationship between drinking and consequences in adolescents and emerging adults.

3) Most of the consequences (i.e., sexual assault, vomiting, fights, property damage, arrests, DUI, riding w/a DUI, etc.) are not necessarily the consequences of an individual that is addicted to alcohol, but rather a result of poor alcohol-influenced decision making.

4) The focus on increasing the use of parent communications and increased protective behaviors are not the treatment modalities for individuals who are addicted to alcohol. However, numerous studies show the benefits of these approaches to reducing acute use of alcohol and the problems associated with this behavior.

5) The acute abuse of a drug such as alcohol observed for adolescents and young adults is very different from being addicted to the drug as are the determinants and methods of prevention/intervention.

Again, I urge you to consider adopting a wider lens beyond just addiction.

   
94 03/15/2012 at 10:05:33 AM Self Eastern Virginia Medical School Dept. Pathology and Anatomy, Norfolk, VA •Targeting efforts to prevent substance abuse & alcoholism in older adults; •Understanding the interaction between alcohol and other drugs of abuse with the neurodegenerative disorders; •Coordinating activities with the National Institute of Mental Health; •Furthering our understanding of the interaction between substance use disorders and serious mental disorders; •Coordinating activities with the Substance Abuse and Mental Health Services Administration; •Targeting the role of substance use in suicide; •Developing better caregiver support programs; •Facilitating research on drug courts and drug-market intervention strategies; •Promoting research on jail-diversion programs, including Crisis Intervention Team Training; •Determining strategies to train more addictionologists and behavioral treatment providers; •Identifying more effective behavioral treatment strategies; •Addressing the issue of drug-seeking behavior in pain management; •Evaluating the potential therapeutic benefits of alcohol and various transmitter systems; (e.g., endogenous cannabinoid and NMDA receptor systems); •Improving community-based systems of care; •Establishing K-12 teacher training programs; •Furthering research on the true gateway drugs.

According to data from NIH itself, substance use disorders are the most costly health care problem in America, with annual direct and indirect costs in excess of $600B. Over 10 years this totals $6 trillion, which far exceeds the estimated cost of 10 years of war in Afghanistan and Iraq. Sadly, there is no better example of a failed system of care than that related to addiction prevention and treatment. This is especially true at the community-based level. An Institute declaring war on this unmet need is clearly needed as is one that addresses the overlapping issues of alcoholism and nicotine addiction. Also welcomed is the emphasis on prevention as well as on treatment.

 
95 03/15/2012 at 10:36:34 AM Self Penn State University State College I am concerned about the phasing out of NIAAA and feel strongly that the new addictions institute at NIH should make the study of alcohol abuse and prevention a priority. I study college student drinking and many of the college drinking behaviors we study would not necessarily be characterized as "addiction," despite the significant harm they cause. Because of their young age, most college students would not be classified as dependent; however, heavy drinking during college is a significant risk factor for problems with alcohol later in life. The determinants and antecedents of college student heavy drinking are often much different than thos associated with addiction (e.g., college students are heavily influenced by peers and environmental factors, whereas alcohol addiction is often a result of maladaptive coping mechanisms or underlying mental health issues). Finally, the treatment and prevention methods used for college populations (e.g., peer-delivered brief motivational feedback interventions) are not appropriate for dependent individuals. Therefore, I feel that NIH should continue to make the study of alcohol abuse and early prevention a priority, rather than focusing on addiction and treatment for dependence.

As I mentioned, most college students and emerging adults are not yet addicted to alcohol, but they tend to drink in ways that cause significant risks to public health, such as drinking and driving, experiencing injuries, getting into physical fights, and engaging in unprotected sex. Given that roughly half of the U.S. population attends college, and at least one third of college students engage in heavy episodic drinking at some point, college high-risk drinking is very prevalent (in fact it is more prevalent that individuals who meet criteria for alcohol dependence). In addition, because this high-risk drinking is a risk factor for later, more severe problems, early intervention has the potential to considerably reduce the costs associated with treating addiction later.

 
96 03/15/2012 at 12:11:20 PM Self     Targeting efforts to prevent substance abuse in adolescents and young-adults was identified in the notice and worthy of consideration. Most adolescents and young adults are not addicted to alcohol, however they drink in a manner that puts them at risk of future dependency and contributes substantially to a major public health problem that is costly in terms of dollars, a burden on public services (e.g., medical community, law enforcement), and a detriment to positive mental and physical health. This age group not only experiences problems first-hand, but their high risk behavior negatively impacts other individuals (e.g. dui, vandalism, etc.).

By investing in etiological, prevention, and intervention efforts targeting this age group we may be able to reduce rates of addiction and the associated costs in the long term from both individual and societal perspectives.

 
97 03/15/2012 at 12:45:46 PM Organization Penn State Prevention Research Center State College, PA It is my understanding that the new institute's focus is on addictions and substance use disorders. While our work does not focus on addiction or disorders per se, it is possible that all of the research we do and have funding for could either get phased out or be low priority in the new institute without our effort. The Penn State Prevention Research Center has a special lab dedicated to adolescent and young adult alcohol use. We spend a great deal of time researching use patterns among both college and non-college populations, as well as specific subsets of related consequences such as drinking and driving and sexual assault. We also study the role of parenting in alcohol intervention and in the development of high risk drinking.

Here are our main concerns:

1) Most high school and college students are not addicted to alcohol. Yet, they drink in a manner that puts them at risk and contributes substantially to a major public health problem that is costly in terms of dollars, a burden on public services (e.g., medical community, law enforcement), and a detriment to positive mental and physical health.

2) Even several drinks for a young person can contribute heavily to risky decisions and behaviors as we have observed from the numerous studies examining the relationship between drinking and consequences in adolescents and emerging adults.

3) Most of the consequences (i.e., sexual assault, vomiting, fights, property damage, arrests, DUI, riding w/a DUI, etc.) are not necessarily the consequences of an individual that is addicted to alcohol, but rather a result of poor alcohol-influenced decision making.

4) The focus on increasing the use of parent communications and increased protective behaviors are not the treatment modalities for individuals who are addicted to alcohol, but are vital for primary and secondary prevention efforts.

5) The acute abuse of a drug such as alcohol observed for adolescents and young adults is very different from being addicted to the drug, as are the determinants and methods of prevention/intervention.

As the points above highlight, by focusing narrowly on substance abuse and addiction disorders, we force research to focus on reactive, tertiary types of treatments instead of proactive, primary forms of prevention. While in some populations, this may be adequate, it is not appropriate for all age groups and populations. However, the adolescent and emerging adult populations are at high risk of experiencing alcohol-related problems without being classified as "addicted" or having a "disorder."

In this case, I would say the biggest concern is how the NIH's new institute plans to define these terms. If too clinically defined, it will preclude most of our current research, and any future research in this area, which impacts a large number of faculty and graduate students. More specifically, the NIAAA NRSA pre-doctoral training grants have been a wonderful resource and opportunity for our students--both through learning how to write a grant, and in the training the awards provide. The current restructuring proposal might prevent well-written grants and well-structured research projects from being funded, ultimately hindering our student training capabilities and professional growth within the field.

 
98 03/15/2012 at 02:25:41 PM Self     Regarding the working new title: “National Institute of Substance Use and Addiction Disorders” …

I propose an alternative title, for primarily 2 reasons: 1. The term “substance use” will preclude the potential in the future to include problem gambling (and perhaps other non-substance use disorders should enough data warrant inclusion). As the DSM-5 may very well move pathological gambling disorder/gambling addiction into the new diagnostic grouping along with substance use disorders, this makes sense to consider an institute name that can accommodate this as well. 2. The term “Disorders” is too exclusive. NIDA and NIAAA have long provided discovery and direction for topics not only relating to disorders themselves, but also hazardous use, risky use, as well as medical complications, etc. 3. You want a name that can stand the test of time and continue to represent an always growing and changing field.

Thus, I propose the following name, one that would also be shorter and have a more catchy abbreviation: “National Institute on Addiction-Related Conditions” or “NIARC” for short.

The term “addiction-related” affords flexibility as the field grows in the coming decades. It can accommodate all drugs of abuse, all behavioral issues (deemed appropriate in the future); as well as all related “conditions” such as risky drinking, medical complications, etc. Further, it has better face validity to the public in that the term “substance” is still a bit foggy for the public to understand what exactly that means, whereas addiction is a term more easily identifiable and understood.

   
99 03/15/2012 at 05:18:34 PM Organization pennsylvania state university state college, pa Using the term "addiction" narrows the focus on many of the problems associated with alcohol and drug use. It is important to have research that examines how alcohol/drug use affects non "addicted" individuals within society. By using such a narrow definition of requiring individuals to be "addicted" before research can be applicable to that population, many problems will go undetected, innovative research will become stiffed, and the research focus will remain as narrow as the definition. For example, most high school and college students are not addicted to alcohol, they do not meet this narrow criteria. Yet, they drink in a manner that puts them at risk and contribute substantially to a major public health problem that is costly in terms of dollars, a burden on public services (e.g., medical community, law enforcement), and a detriment to positive mental and physical health.

There also needs to be a push for research that uses a systemic approach to examine alcohol/drug use going beyond the narrow scope of addicted populations. For example, research that uses social network methodologies to explore how an individuals' social network influences their risky alcohol use, risky sexual behavior, and alcohol related consequences (i.e. rape, injury to self/others, poor decision making).

Individuals are embedded within a system, a network of people, institutions, that influence what they do, how they think; no individual is an island. Therefore, when it comes to examining the role alcohol plays in society research needs to 1)look beyond the individual for solutions and take a systemic approach 2) expand the tradition definition of addiction as the only way alcohol/drug use can be harmful. If addiction is the criteria that must be met before funding dollars can be given to researchers then only a minimal number of people will benefit from the research. The majority of people who have negative consequences related to alcohol and drug use are actually not addicted to alcohol/drugs. For example, most of research with adolescents/college students and their experiences with alcohol/drug use would be excluded.

In regards to using a network approach, social networks are associated positively and negatively with health and well-being. From a behavior change point of view, a number of theories suggest that a person’s social relationships can shape their intentions to act in particular ways through norms (subjective, Theory of Reasoned Action/Theory of Planned Behavior, injunctive, or descriptive) and through social support (instrumental or emotional). For this reason, many studies have attempted to shape people’s perceived norms or influence their social support in order to shape their behavior. For such studies to have the best chance of success, it is critical to investigate if different individuals develop different kinds of support networks, and if particular support networks are more likely to be associated with alcohol/drug use and alcohol related consequences (unwanted sexual encounters,injury, risky decision making.

In conclusion, if NIH wishes to support innovated research that will benefit the majority of individuals and society then 1) the term addiction needs to be more broad and inclusive and 2) systemic research designs should be supported(i.e. network analyses).

 
100 03/15/2012 at 09:12:22 PM Self   OAKLAND CA Current illegal drug policy results in pervasive, pernicious effects on the PUBLIC. This is a proposal to improve DRUG EDUCATION for illegal drug users, fund NIH sponsored RESEARCH, mitigate the pernicious effects of current policy on FAMILIES, social systems and the work environment, drastically reduce the economic costs that impact social, institutional and medical systems, diminish the profits of illegal drug gangs/cartels and would be instrumental in the PREVENTION of time served in prison/jail.

The heart of the problem is the costs of illegal drug use on children and families of drug related crime, prison time served, costs of MEDICAL, EMERGENCY ROOM and HOSPITAL CARE. We need more research on the effects of drugs and their interactions and this is a way to fund that, which in turn, will improve the accuracy of DRUG EDUCATION. I don't expect NIH has a way of implementing these ideas but some people in NIH are politically connected enough to promote them to government agents who can influence policy changes. I am not seeking any grant that awards money for research. Instead, i am suggesting ideas that could be researched to determine the economic realities of this plan.

Illegal Drug Policy Reform This is a plan to radically reform current US policy towards illegal “recreational” “street” and addictive drugs. The government (probably the FDA) would create the following program, which has 4 essential components. Drug centers would be created, each of which would have four components. Current drug rehabilitation centers could serve as the place to house most of the physical locations or buildings. The 4 component parts would be economically self-sufficient requiring no extra government funding. A person who wants to take currently illegal street drugs would go through the following steps. 1. Drug Education. An individual who wants a specific drug (e.g. cocaine, heroine, marijuana, amphetamine, etc.) would first walk into the drug center and get literature on their drug of choice, study it and then take an exam about the medical realities, dosages and risks of the drug. If they pass this test, they receive a certificate that allows them to purchase the drug. 2. Distribution. The drug seeker goes to the Distribution part of the Drug Center, presents the certificate to the sales personnel. They sell the drug for a price that is generally below that of the typical street value, but is profitable for the Drug Center. It is pharmaceutically pure, FDA approved and is sold with recommended dosages like any pharmaceutical. The sales of the drugs at the Distribution center would fund the other 3 components of the program. 3. Rehabilitation. When the drug user gets tired of the drug, “reaches rock bottom”, wants to detox and/or is ready to “get clean and sober”, they are welcomed into the rehabilitation program for free rehab services including medications such as methadone, suboxone, benzodiazepines, etc. 4. Research. Each center would keep records and conduct studies, which would be overseen by the FDA and coordinated with the National Health Organization, National Institute for Mental Health and/or the Center for Disease Control. Profits that are left over from the funding of components 1, 2 and 3 would be directed towards research that would further the accuracy of information provided at the Education component. It is important to note that while all drugs distributed from the Drug Center’s would be legal, there would continue to be criminal consequences for the illegal sale of drugs to minors under the age of 18 and for street sales outside the auspices of the Drug Center. Obviously, this plan could lead to a serious increase in drug usage. Initially, there could be a dramatic increase of addiction and drug dependency. Perhaps there would be an increase in medically related problems associated with drug use. These are probably the only negative consequence of initiating such a plan. The benefits, however, by far outweigh the risks. Benefits include: A. A significant decrease in our prison population, would amount to an estimated savings of $20 to $30 billion dollars per year. This is based on reports of the majority of prison space being filled by drug sellers and users and that the current prison costs are in excess of $80 billion per year. B. Billions of dollars that the US spends on illegal drugs goes directly to foreign drug cartels such as those in Columbia, Mexico and Afghanistan. This loss of income would be diverted to fund drug education, rehabilitation and research. C. The tragic and debilitating social costs of drug violence and disruption of family continuity would be dramatically alleviated. The cost of millions of potentially productive members of our work force, legal wage earners for stable family incomes, father’s who are unable to parent their children and husbands who could emotionally support their wives, who are jailed for drug related crimes is more destructive to the fabric of our society than the daily usage of the drugs themselves. By far the majority of drug users and addicts are able to maintain effective work performance. It is true that drugs seriously compromise a drug user’s ability to optimally engage with interpersonal relationships, but most addicts are able adequately maintain a routine of vocational and social responsibilities. D. Family life would be dramatically improved because the fathers and mothers, who would currently be in prison, would not be subjected to the debilitating effects of prison and/or be indoctrinated into lives of crime (the principle educational value of prisons). Instead these parents and community members would be allowed to pursue their educational and vocational interests and be involved members of their communities. E. With the legalization of drug usage would come the legitimization of drug use. Currently, the average drug user has to lie, cheat and steal in order to continue the habit. The new plan would allow for a more truthful approach to job applications and better medical care because doctors would be able to prescribe medications with a full knowledge of the complications resulting from drug interactions. This could actually save money in the health care system. F. Potentially drug gangs would suffer a significant loss of membership and the need for the proliferation of firearms would dramatically be reduced.
101 03/16/2012 at 11:35:57 AM Self     Self help groups such as AA and NA are key players in addiction treatment, particularly in the U.S. but also in many other countries. Several of the most potent advances in addiction treatment involve pharmacotherapies for opioid addiction (buprenorphine, methadone, extended release naltrexone formulations). Extended release naltrexone and acamprosate have been shown to help some alcoholics. Other advances are in appropriate use of medication for accompanying psychiatric disorders. Unfortunately many of the self-help groups and residential facilities rely entirely on psychosocial treatment and even actively oppose combining it with medication, a process that can be easily done. There is a great need for the new institute to do something to change this situation so that medical advances in addiction treatment are more widely used.

A related issue is getting insurance companies to pay for MAT - many do not.

Another issue is facilitating the development of addiction treatment programs that are staffed to address comorbidities. It is much easier and more effective to treat routine medical and psychiatric problems in one location rather than having to send patients to different providers for routine problems.

A final issue is continuing work on development of compounds with morphine-like analgesic potential that have no abuse liability. This is one of the holy grails of addiction research but work in that area seems to have stopped.

The have to do with more widespread application of scientific advances and discovering compounds that could take the place of morphine-like compounds to relieve the burden of prescription drug abuse that we are now having.

 
102 03/16/2012 at 06:01:13 PM Self Harbor UCLA Med Center Torrance Calif Please dissolve the NIAAA because this organization has granting bias to old boy entrenched investigators. Please liberate the granting system from this very stymied systamatic repressive organization. This will alow us to discover the mechanisms involved in chronic alcohol abuse pathologies

   
103 03/19/2012 at 03:48:22 PM Self Virginia Commonwealth University Richmond, VA A creation of a "National Institute of Substance Use and Addiction Disorders" will have a very negative impact of Fetal Alcohol Spectrum Disorders (FASD) Research. After decades of establishing models and understanding mechanisms, independent groups (my lab is one of them) are finally starting to test potential therapeutic interventions. To move FASD research to another institute, such as NICHD (which is already underfunded) will have disastrous consequences for the field.

The most surprising and critical issue of the whole proposal is that both NIAAA and NIDA are succeeding and generating important findings with their current structure. The current plan tries to fix something that is working, and the result will be a long lasting damage in the scientific production of both areas of research.

The study of the effects of alcohol exposure (no matter what developmental period) should be restricted to a single institute.

 
104 03/19/2012 at 04:16:15 PM Self     If a new institute should be established, FASD research needs to be included in the new institute.

I believe that the financial cost of this structural re-organization would be tremendous and less efficient.

 
105 03/19/2012 at 04:51:16 PM Self University of Iowa Iowa City Suggested areas of research on fetal alcohol spectrum disorder syndrome; 1. Identification of neuroprotective genes or pathways against alcohol toxicity 2. Identification of genes and pathways that confer susceptibility to ethanol-induced cell/tissue damage. 3. Pharmacological approaches for amelioration of FASD 4. Role of microRNAs in alcohol teratogenicity

   
106 03/22/2012 at 03:54:19 PM Organization University of Pittsburgh, Graduate School of Public Health Pittsburgh PA I'm struck that the list of potential scientific opportunities and public health needs identified by the NIH staff does not have a stronger focus on HIV/AIDS, given the enormous toll that this epidemic has taken on drug and alcohol abusers. Topics such as the efficacy of substance abuse treatment as HIV prevention, how drug and alcohol use directly and indirectly raises risks for HIV transmission, the effects of drug and alcohol use on treatment adherence among HIV seropositive individuals, the effects of interconnecting co-morbid conditions on HIV transmission risk and how lifelong patterns of drug and alcohol use shape HIV risks should be included in the planned list of scientific opportunities.

   
107 03/22/2012 at 07:23:53 PM Organization Syntrix Biosystems, Inc. Auburn, WA Of the 13 areas identified in the RFI, 6 focus on collecting data to elucidate mechanisms or make data compendia of various phenomena (i.e. if numbered in consecutive order as presented in the RFI, areas 1, 2, 3, 8, 10 and 13), and 5 focus on developing public health strategies or conducting descriptive epidemiologic studies of addiction (i.e. areas 5, 6, 9, 11 and 12).

While these 11 areas are essential to furthering basic knowledge about the science and social impact of addiction, and are therefore important to academic scientists and to increasing the archival literature, they will have (and have had) little impact on the "addicted" or "to become addicted" public because they fail to provide a tangible "real world" solution to addiction (i.e. they are largely of academic and public policy interest only).

On the other hand, we identify the two areas 4 and 7 in the RFI as being most responsive to the needs of the public, because they entertain producing a tangible product to address addiction (e.g. a "pill" someone could ingest to prevent and/or treat addiction). From the RFI, these are:

"Developing strategies to enhance stakeholder interest in developing medications to treat various addictions, including nicotine and alcohol;"

and

"Alleviating the translational bottleneck for treatments to move from the bench to the bedside to the community"

We offer for consideration the following additional obvious new area not yet considered by the NIH for the new institute:

"Developing new drugs and/or formulations with less abuse and/or addiction potential than existing marketed drugs (e.g. alternative pain therapies to existing marketed opiates used to treat pain that offer lower abuse/addiction potential)"

It is well known that the rise of prescription opiate addiction and deaths resulting therefrom is an urgent public policy concern with no obvious solution that will balance the legitimate needs of patients suffering from pain while preventing those who ultimately seek to abuse such drugs. One solution is the technological (i.e. scientific) development of new pain medications and/or pain medication delivery systems with lower abuse potential.

We believe the following are the most important areas for NIH to address, because they most directly go to finding a tangible solution (i.e. a real world product) to treat and/or address the problem of addiction in the U.S. population, including addiction arising from the initially legitimate use of prescription medications:

4 (as published in RFI): "Developing strategies to enhance stakeholder interest in developing medications to treat various addictions, including nicotine and alcohol;"

7 (as published in RFI): "Alleviating the translational bottleneck for treatments to move from the bench to the bedside to the community"

14 (newly presented to NIH herein): "Developing new drugs and/or formulations with less abuse and addiction potential than existing marketed drugs (e.g. alternative pain therapies to existing marketed opiates used to treat pain that offer lower abuse/addiction potential)"

Syntrix Biosystems, Inc. and other similarly situated private drug development companies are obvious stakeholders to execute on the above areas that have the highest-impact to the public. While the new institute will be able to leverage its SBIR program to partially tackle the above areas, such funds in total are generally limited, being only a few percentage points of the total extramural budget. In our opinion therefore, additional focused RFAs and/or PAs should be developed in the extramural budget of the new institute that are in addition to the SBIR program that would support development efforts in private corporations to conduct the translational research and clinical trials necessary to develop tangible products (i.e. a pill) that can eventually be used to treat addiction, or provide therapies will less addictive potential (e.g. pain medications as effective as opiates but with less addiction potential).

 
108 03/23/2012 at 11:26:02 AM Self     The Scientific Strategic Plan for the proposed National Institute of Substance Use and Addiction Disorders should incorporate three areas of research that address the application of research into policy and practice: 1) policy research, 2) translational and implementation research, and 3) effectiveness trials in practice-based research networks. Without a strong portfolio of policy, practice and implementation research, basic science discoveries are unlikely to affect the delivery of prevention and treatment services.

Policy Research

The policy arena radiates tension between inconsistent perspectives on the use of alcohol, tobacco and other drugs. Alcohol is a blessing and a curse. Opiates are valuable analgesics and illegal intoxicants. Possession and use of marijuana is a federal criminal offense that some states and communities ignore if the use is for medical purposes. Nicotine stimulates and relaxes; tobacco kills. Addiction is a brain disease; addicts are criminals. We seek to eliminate problems associated with the use and abuse of alcohol, tobacco and drugs while protecting the rights of industry to manufacture and market these products. Alcohol, tobacco and drug control policies in the United States are constructed from an admixture of state and federal legislation, voter referenda, judicial decisions, administrative regulations, local ordinances, program rules and practitioner licensing. The new institute must recognize that alcohol, tobacco, and drug use, misuse, and abuse reflect local, state, and federal policies and promote research to better understand how policy facilitates and inhibits the development and continuation of alcohol, tobacco, and drug use disorders and can support prevention, treatment and recovery.

The Robert Wood Johnson Foundation provides a role model for promoting policy research. Before closing in 2009, the Substance Abuse Policy Research Program (SAPRP) made 368 awards supporting investigations of the effects of policy on access to alcohol, tobacco and drugs and assessing the impacts of policy on access to treatment and prevention services. NIH and the new Institute have an opportunity to build on the SAPRP legacy and expand the potential for policy interventions in the prevention and treatment of alcohol, tobacco and drug use disorders.

Translational and Implementation Research

The Scientific Strategic Plan should embrace the scientific challenges associated with translation of basic research into clinical practice and the implementation of evidence-based practices in clinical settings. An institute that focuses on basic science will have little impact on prevention and treatment services and contribute little to addressing the public health consequences of alcohol, tobacco and drug use disorders. The Institute’s research portfolio needs to address the full spectrum of research to practice. Prevention and treatment services for substance use and addiction disorders have unique translational and implementation challenges and can serve as laboratories for facilitation of empirically-based practices. The treatment field remains ambivalent to the use of medication-assisted treatments even though the investments of NIDA and NIAAA in effective addiction medications are bearing fruit and more effective medications are emerging. Without scientific study of the translational and implementation research process, important science developments will have little influence on clinical practice. Translational and implementation research needs to be a central component of the Institute’s Scientific Strategic Plan.

Effectiveness Trials in Practice-based Research Networks

The 1998 Institute of Medicine report, Bridging the Gap Between Practice and Research: Forging Partnerships with Community-Based Drug and Alcohol Treatment, highlighted the need to partner with the organizations treating alcohol and drug use disorders in the design and implementation of trials that test the effectiveness of interventions in the complexity and chaos of the clinical settings. An institute that does not have a partnership of research and practice cannot lead the development and implementation of emerging interventions. The National Drug Abuse Treatment Clinical Trials Network has demonstrated the capacity of community-based addiction treatment providers to participate actively in the design, implementation and interpretation of data from clinical trials. The Scientific Strategic Plan needs to continue to prioritize a research and practice network that benefits from collaboration between practitioners and investigators, assesses the feasibility of using new interventions in practice settings, and documents the effectiveness of the interventions in clinical practice.

 
109 03/23/2012 at 01:07:30 PM Organization The University of North Carolina at Chapel Hill Nutrittion Research Institute, Kannapolis, NC 28081 I have been reviewing for and involved in professional activity for NIAAA, NIDA, and NICHD for almost three decades. They are very different agencies with different foci by definition and by demonstration of policy and prcatice. NIDA and NIAAA should not be merged. It is a very ill-advised and uninformed idea.

Alcohol abuse is not an addiction and the most common cause of alcohol-related morbidity and mortatlity. I therefore does not belong in an institute for addiction.

Fetal alcohol syndrome is a special topical area of research that will not be well served by any new agency on addiction, nor will it be well served being placed into NICHD or any of the other existing NIH agencies.

 
110 03/23/2012 at 03:40:06 PM Organization Texas Tech University Health Science Center Lubbock, Texas 79430 1. A vital area of research that is at risk of being critically damaged by the NIH reorganization is that which addresses the harmful effects of alcohol on the fetus (Fetal Alcohol Spectrum Disorder, FASD) and its mitigation. This is a serious public health problem (see below in Comment 2) that is well known to the general public and one which is connected to immense long-term costs and devastating impacts on affected individuals and their families. 2. Related to the above and to current and future scientists in this field, is the absolute need for experienced alcohol researchers to participate in the grant review processes as well as the availability of funds to support these projects. The funding should be in proportion to its impact on society. With respect to FASD, its cost to society is immense and high profile, yet the sources of adequate future funding have not been established.

1. Ethyl alcohol is a neuroteratogen. Of all abused substances, alcohol by far produces the most frequent, lasting neurobehavioral disabilities in the human fetus. Approximately 40,000 cases of FASD are reported each year in United States alone, which is far higher than the collective figures for Downs Syndrome, Spina Bifida, and Muscular Dystrophy. The estimated fiscal cost to society has been put at $6 billion. The impact of this on the affected individuals and their families is often devastating, a setting that has been chronicled in numerous scientific publications and published personal memoirs. Thus, this is an increasingly high profile public health problem that the public will and should demand be addressed by federally funded research. Concordant with this is a vital need to supply (ideally specifically target) funds for proposed projects that will address the complex mechanisms underlying this disorder and ultimately lead to clinical interventions. Clearly, structuring knowledgeable reviews of these proposals is central to meeting this need. Should this area of research be removed to another institute with limited to no alcohol expertise, the effect on the research would be devastating and we will be held responsible for such an action by an increasingly proactive public. In short, research addressing FASD must be administered within an institute that has a focus on alcohol-related system disorders. 2. I have been reviewing alcohol-related and other NIH grants for over 30 years. While participating in non-alcohol study sections (such as NOMD), I often reviewed alcohol/ toxicology-related proposals that contained science of the sort that was the central focus of that study section e.g. apoptotic signaling pathways, mitochondrial damage etc. Without the input of a reviewer cognizant of toxicological approaches and especially alcohol, a review of these proposals is considerably compromised, however strong the science and capability of the reviewers. Alcohol is a diffusely acting neurotoxin and research on it frequently appears to the uninitiated as lacking needed fixed references and consisting of excessive moving targets; read unfocused. It is our task as applicants to construct these proposals in a tight and focused manner, however we are addressing the toxicity of a volatile two carbon solvent that is consumed in rather immense quantities with varying patterns, metabolized by multiple pathways with a highly toxic reactive intermediate, the process of which damages multiple CNS components to vastly variable degrees. In the developing brain, there are added complexities which include temporally-dependent differentiation of multiple precursor cells, an array of cellular migration patterns, varying sensitivities of specific brain areas and their components. All of these parameters may respond differently to alcohol exposure at different stages of development. In short, if we are to develop clinical interventions to FASD, it is absolutely central that a review process be in place that will include developmental neurobiologists with experience with alcohol-related systems biology. Such a setting would best occur if these proposals were administered by an institute that had a focus on alcohol-related system disorders.

 
111 03/26/2012 at 02:37:27 PM Organization Iowa State University/College of Veterinary Medicine Ames, Iowa In your list of potential scientific opportunities and public health needs - there is one that I believe can be broadened to include developing better animal models of disease - particularly a model for pregnant mothers and ethanol +/- cigarette consumption affects on the innate immunity of the fetus/newborn; particularly in response to pathogens such as respiratory syncytial virus (RSV).

The original statement: • Understanding the mechanisms by which alcohol and other drugs of abuse increase risk for certain diseases (e.g. cancers), particularly when used in combination;

I believe could be broadened to state: "• Understanding the mechanisms by which alcohol and other drugs of abuse increase risk for certain diseases (e.g. cancers, viral infections, impaired fetal/newborn immunity, etc.), particularly when used in combination;"

Rationale for suggesting sheep as model for addiction/RSV studies:

Most commonly, RSV causes a mild upper or lower respiratory disease with cold-like symptoms but in a small percentage of patients, particularly the very young, severe disease can occur. Nearly every child in the United States has been infected with RSV at least once by age two. Because of its ubiquity, the low percentage of severe disease yields a significant number of hospital cases: 85,000-144,000 infants with RSV infection are hospitalized annually in the United States alone. This constitutes 20-25% of the pneumonia cases and up to 70% of all bronchiolitis cases in the hospital. Treatment currently is limited to supportive care and one of two FDA-approved treatments. Two major stumbling blocks in development of preventative and treatment have been the disastrous initial vaccine clinical trial and the lack of an available, clinically relevant model of human disease. Rodents, while a valuable tool in RSV research, undergo post-natal alveolar development as opposed prenatal alveologenesis that occurs in humans and sheep. Additionally, sheep and humans share a number of upper and lower airway traits including: airway branching pattern, nasal lymphoid tissue distribution, alveolar size, submucosal gland type and distribution, cartilage distribution, sensory nerves, airway capillary physiology, mast cell distribution, mucus-secreting cells, histamine effects, and cough/wheeze response. Natural RSV disease occurs in cattle and sheep with bovine respiratory virus (bRSV) and has a similar presentation: seasonal outbreaks of highly contagious, mild respiratory disease with infrequent severe disease that occurs in conjunction with other pathogens. A bovine model of RSV infection has been used by a number of groups and is useful in mimicking human disease, but limited by the cost of feed and housing and typical birth of a single offspring in cattle. Additionally, there is current use of a number of efficacious vaccines in cattle. Sheep are a particularly attractive model because of their smaller size, reduced cost, and increased offspring/parity when compared to cattle, and more human-relevant pulmonary development and structure than rodents. Additionally, they can be born pre-term (90% gestation) with a high rate of survival. These features make sheep/lambs the ideal candidate model for maternal addiction studies.

Respiratory syncytial virus (RSV) is the leading cause of hospitalization due to respiratory illness in infants and children of industrialized countries. Despite its ubiquity and potential for severity, knowledge of risk factors, efficacious prophylactics, and treatments remain inadequate. This is due in part to lack of a satisfactory model in the highest risk group: infants. The effects of ethanol and/or cigarette smoke on fetus and new born innate immunity could be investigated using sheep/lambs as the model to do so. Research using this model could reveal more about what maternal addiction (e.g. to ethanol and nicotine) does to the fetal/newborn innate immune system. Research in this area could help explain why fetuses and newborns are even more susceptible to RSV when mothers consume alcohol and nicotine, and perhaps expose new modes of therapy to counteract the immune deficits.

I feel it is important that this new institution also endorses the need to develop better animal models of maternal ethanol & nicotine consumption [addiction] and its association with increased fetal/newborn susceptibility to viral diseases, such as RSV.

Thank you for considering these ideas.

 
112 03/27/2012 at 01:05:56 PM Self     The development of statistical methodology is a traditional weak area in alcohol research, in which far less statisticians are involved than other health disciplines. For example, in 2011, out of 19,113 publications on the topic of “alcohol”, only 14 are in the “statistics and probability” category, of which a mere 2 (0.01%) papers were supported by NIAAA (data obtained from Web of Science). In comparison, 115 out of 18,403 papers on “AIDS”, and 388 out of 98,679 papers on “cancer” are in the “statistics and probability” category. The odds ratio of the proportion of statistical papers is 8.6 for AIDS vs. alcohol (p<.00001), and 5.4 for cancer vs. alcohol (p<.00001). This hinders the alcohol research as a whole, since more advanced and efficient study design and analytical tools cannot be adopted in alcohol field in a timely manner.

   
113 03/27/2012 at 07:13:35 PM Self     The impact of disease of mental illness and substance abuse is devastating to patients and families. As most of these issues arise in childhood, work on prevention in paramount. My fellowship through AACAP helped me understand the impact of very common diseases like depression as well as understand the staggering need for more people and research dollars committed to mental health promotion.

Resiliency factors can attenuate any number of unpredictable risk factors that people experience that predispose them to the world's most prevalent and devastating disease, depression. Rather than research more medication treatments, more needs to be done to recognize that relatively cheap and impactful interventions that can boost resiliency and prevent mental illness for years to come.

 
114 03/28/2012 at 01:49:06 AM Self     Substance use during pregnancy has a major impact on both the mother and her infants with increased neonatal morbidity, child abuse/neglect, foster care, and maternal mental illness. Targeting this area would have the biggest impact of all on the public health of the nation. As a psychiatrist who worked at the largest University Affiliated Program for Mental Retardation Albert Einstein College of Medicine, Bronx, NY - the poorest congressional district in the country, I have seen the effects of substance use during pregnancy on countless families.

A model for treating the mother to enable her to maintain her relationship with her baby while in rehabilitation for drug dependence should be developed. Children are subjected to repeated traumas after being returned to mothers from foster care without adequate supports because the women have multiple relapses.

 
115 03/28/2012 at 12:28:10 PM Self     Expand the information about the impact on brain chemistry/development in youth and adolescents who use/abuse drugs/alcohol. Explain/understand how those who are or became famous despite abuse do not represent the majority.

The biochemistry of brain development by mind altering substances. The appeal of the substances to the abusers is developmentally understandable - how to clarify the difficulties in use/abuse for the user/abuser has not been reliably found and must be. Successful stars who were former abusers and now no longer use even still play, write, make $$ seem to say, look at me, it's OK and feed the wish, I can too.

 
116 03/28/2012 at 06:41:33 PM Self     For Public: A great deal of emphasis on public Media to promote awareness in parents and kids combined, on deleterious effects of addictive chemicals.

For physicians/Scientists: 1-Specific training and curriculum in the field of Addiction Medicine for both general and child psychiatry residency training programs by formal didactics during training as well as workshops/CMEs. 2- Availability of testing kits in abundance for urine toxicology in primary care physician offices, mental health professional offices.

Further research and funding needed in neurobiological on "Reward Circuit" of brain in adolescents among Child psychiatrists/Scientists.

 
117 03/29/2012 at 09:57:22 AM Organization The National Center on Addiction and Substance Abuse at Columbia University New York, NY See attached letter

See attached letter

I would like to propose the following critical issues that should be addressed as top priority in the Scientific Strategic Plan of the proposed new National Institute of Substance Use and Addiction Disorders: Critical Issue: Research on the primary disease of addiction rather than separate research agendas related to specific substances (nicotine, alcohol, marijuana, etc.). Much of the research to date has focused on specific addictive substances and has not examined sufficiently the overarching disease; in particular, nicotine frequently is excluded from other types of addiction research. The benefit to the public of a disease rather than a substance focus will include an increased understanding of the disease, exploration of the possible existence of a syndrome disorder, a better understanding of the dangers of risky use of any substance and more effective prevention and treatment options. Critical Issue: Research to increase our understanding of addiction as a developmental disorder. We know that nine out of ten individuals with the disease of addiction began their substance use before age 18. Understanding the impact of addictive substances on the developing brain, the risk factors for teen substance use and addiction, and strategies and mechanisms to prevent teen substance use and addiction is critical to parents in particular and to the general public for reasons of public health, safety and costs to society. Critical Issue: Development of the capacity and imperative to prevent, screen, intervene, diagnose, treat and manage addiction in the health care system. Health care providers do not routinely provide effective prevention information to patients, screen for risky use, assess the nature and severity of the disease and treat or refer to specialty care as they do for other health conditions. Assuring appropriate education and training of all health care providers in how to address risky substance use and addiction and the developnent of the workforce of addiction medicine specialists is critical to improving the public health and reducing costs to the health care and other government systems. Critical Issue: The development of tailored treatments for addiction based on stage and severity of disease, co-occurring disorders and other personal and environmental risk factors. Like other diseases, there is no one treatment approach that works for everyone. Developing models to stage disease severity and assess the nature and extent of co-occurring conditions and other risk factors is critical to effective intervention, treatment and disease management.
118 04/02/2012 at 04:21:39 PM Self     The emphasis of the new Institute is decidedly focused on addiction. A major concern is what will happen to the area of basic research focused on biological, physiological and pathophysiological effects of agents such as alcohol on organ/cellular function. The Research portfolio section of the SMRB document states that; "portfolio analysis of NIDA and NIAAA should identify non-addiction research, and these programs should be reassigned to alternative institutes or centers". My own area of investigation relates to intestinal barrier function and how it can be affected by alcohol. These studies would presumably shift to NIDDK under the propsed restructuring. However, having sat on the relevant study section for this type of work (GMPB), I was struck that studies involving pathophysiological responses to alcohol were clearly viewed as not being at the same level of importance as other conditions, probably because alcohol consumption is by in large a voluntary activity, whereas the induction of most other GI conditions is not. My worry is that basic pathophysiology studies of the effects of alcohol will be a very low priority for NIDDK and this, coupled with the additional hurdle encountered in study section described above, will render it almost impossible to obtain funding for this type of research. Have these issues been considered and how does NIH propose to address them?

   
119 04/02/2012 at 05:41:58 PM Organization Stanford University Palo Alto, CA NIDA has had a long-standing history of supporting important pain related research, particularly in the intersection of pain and addiction. I submit that the new Institute should include within its portfolio pain research. As outlined below, pain has an incredible impact on the individual and society as a whole. Prescription opioid abuse represent one of the largest growing problems in our society. For many, their first exposure to prescription opioids occurred with treatment for an acute pain episode. We do not yet understand the individual vulnerabilities involved with the development of substance misuse and abuse after in acute pain episode. It is critical that we understand better the mechanisms behind these vulnerabilities and translate that information into effective preventative methods and treatments. We are also appreciating that many of the central mechanisms related to addiction overlap extensively with those related to chronic pain. Specifically, many of the central reward systems associated with addiction are also involved with the perception modulation of pain. There is also overlap from a psychological construct in that the negative reinforcing aspects of medication withdrawal overlap significantly with the negative reinforcement of pain and its impact on behavior. We need to better understand the mechanisms behind these phenomenon to design better therapies for this dual diagnosis of pain and substance abuse.

Pain affects over 100 million Americans and costs our country half a trillion dollars per year, more than cardiac disease, diabetes, and cancer combined. Vicodin is the most prescribed medication in our country with over 130 million prescriptions provided each year. On top of that we have an epidemic of prescription opioid misuse and abuse and a lack of clear sense of what the role opioids play in the management of chronic pain. Therefore, both pain and its intersection with substance abuse have clear societal impact on a grand scale.

 
120 04/02/2012 at 05:56:22 PM Self     1) Understanding and addressing how young adults/older teens are engaging in social media, interactive websites, and other technological advances will be essential for developing and implementing the intervention strategies of the future--whether these intervention strategies are focused on prevention or treatment. 2) The influence of the social environment, including the immediate social context (e.g., groups, families), the virtual social context (e.g., Twitter), and the community context (e.g., social policies, neighborhood effects) on individual behaviors. There has been an over-emphasis on studying the cellular level and mechanisms within the individual to the exclusion of the other influences on the individual. In order for this to be more balanced, there needs to be key decision-makers within the newly formed organization who appreciate and support this more balanced approach. Further, the organizational structure of the new organization must also reflect this balanced approach.

1)The issues of prevention studies and science are not adequately addressed and there is need for a strong and well-supported portfolio in the new Institute. From a cost perspective alone, the benefit of prevention strategies can be justified. But also, it is appealing to the average citizen and the average family to initiate action to prevent risky behaviors rather than try to help someone recover from addictions. Further, not all health consequences are connected to a level of problems that would meet DSM criteria. Prevention needs to be more broadly conceptualized and incorporate a variety of intervention strategies including policies, community-based, family-based, school-based, as well as individually focused prevention strategies. 2) The U.S. is not the only country with innovative and important strategies for addressing alcohol, drugs, and related concerns. We need to network with scientists around the globe to increase creative and innovative strategies and to learn from others successes and failures. More creative opportunities for linking scientists from around the world are needed. Publications in scientific journals are not sufficient for fostering the communication and interaction across the scientific community dedicated to trying to find answers. 3) In the process of creating the new Institute, is important to not discourage the core of the scientific community that has dedicated their lifetime energy to addressing alcohol/drug issues for the nation. Already, there is considerable discouragement by the lower level of funding available for new grants, the seemingly indecipherable comments and critiques brought about by the revised CSR review system, and the pall of more cuts hanging over anyone dedicating their life to the scientific inquiry within NIH. In this context, there is increased pressure on those of us who have longevity, to encourage and support younger scientists to engage in a life of scientific inquiry. Our words of enthusiasm for the life we have chosen cannot compete with the reality of seeing those of us with lots of experience, worry about whether we can keep our research teams together as we piece together funding. You cannot build a strong new cadre of young investigators if they see that it is difficult to economically survive in the field as a NIH scientist.

 
121 04/03/2012 at 08:36:19 AM Organization International Centre for Youth Gambling and High Risk Behaviors montreal, quebec Merging of NIAAA & NIDA into a broader category incorporating other addictive disorders.This is a necessary welcome initiative to help support and recognize other addictive disorders (e.g., pathological gambling).

   
122 04/03/2012 at 03:17:39 PM Self AToN Center Encinitas, California I believe that the Federal Agencies in existence have done a poor job at synthesizing and communicating the results of academic research into useful statistics.

In particular, when a provider attempts to find information on the life expectancy for someone with opioid dependence, we are unable to do so easily. Or the number of deaths believed to be caused by a combination of alcohol and benzodiazepines. Basic statistics rather than very narrow research are in need from a psychoeducational perspective and the Government should remember that education is an important part of addiction treatment and intervention and we need an unbiased and reliable database of information. If it can't reasonably be interpreted or analyzed by the reader then it's essentially useless information.

Easy to find statistics related to specific substance dependence and abuse disorders i.e.:

Mortality Rates Rates of individuals with each diagnosis that experience organ failure Rates of individuals with each diagnosis who experience early onset of dementia Rates of individuals with each diagnosis who experience trauma as opposed to a control group Divorce rates DUI rates Rates of individuals who contract STD's Overdose rates ER use rates Incarceration rates Relapse rates when anticraving meds are used % of domestic violence incidents where specific substance abuse was involved Suicide rates by substance Co-occurring disorder rates by substance Rates of uncontrolled HTN related to substance use

...

 
123 04/03/2012 at 03:23:13 PM Self University of Wisconsin-Madison Madison WI It will be very important to be able to accurately characterize the costs of addiction and the benefits of treatment to the patient, family, healthcare system and the economy more generally.

There are a lot of people who get better on their own. We need to understand under what conditions is treatment really beneficial.

Many investigations have the goal of keeping people in treatment. That is well and good, but what impact does treatment have on employment, family relationships, education, crime, etc. We have to move beyond a "more is better" process analysis to an assessment of impact on real outcomes.

The wide variation in provider quality suggests the need to minimize such variation so a customer can feel that service quality is highly predictable. Technology can help minimize variation in quality. Research and development need to create and evaluate such technologies.

There are thousands of apps and other technologies that suggest that they can help people deal with addictions. Which ones really help and how can a customer choose between the myriad of options.

Given the limitations on resources, the delivery of addiction treatment can't remain the same. Many families if properly prepared could make an enormous difference in recovery. They need respect, training and support and yet the field does not involve them or do they prepare them to be effective partners in recovery.

   
124 04/03/2012 at 05:05:35 PM Organization Michigan Association on Problem Gambling Eaton Rapids MI The research on Problem and Pathological Gambling needs to be encouraged by NIH. Financial support and recognition of it's importance in the addiction community is important. I urge you to include this health issue in your goals for future action. Thank you.

   
125 04/04/2012 at 09:14:31 PM Organization Chicago Recovery Alliance Chicago IL To more fully understand the Natural History of Intoxicant Use among Humans. Natural history studies are typically longitudinal and also minimized in their importance by politics, accepted norms, etc. Hopefully, the new agency will be empowered to support well done natural history studies of all kinds and accept the studies evidence beyond all obstructions to valid conclusions.

NIDA's last strategic planning document a few years ago neither mentioned the word overdose nor strategies for nor the role of mediating injection-related harm. This ignoring of massive causes of morbidity and mortality from drug use must stop. This new agency must be free from the distortions and death promotion that has existed of recent.

Drug-related morbidity and mortality must be among the highest priority of this agencies efforts.

A consistent and bold focus on drug-related morbidity and mortality with an eye on reducing same.

and

An urgency to apply the best investigative sciences to the true nature of the relationship between humans and their multiple intoxicants.

 
126 04/05/2012 at 03:48:13 PM Organization The Florida Council on Compulsive Gambling, Inc. Altamonte Springs, FL For the past 20+ years, the FCCG has provided problem gambling helpline services for the state of Florida, developed and implemented public awareness campaigns, education and awareness programs, treatment protocols and oversight of treatment programs for this population, and research for the general population as well as many other special populations.

The critical issue at hand is the need for inclusion of pathological gambling in the proposed institute, and the negative impact such an oversight would have on the general public and society as a whole as well as those directly affected by this addiction.

The time for inclusion of pathological gambling at the national healthcare level is now, and inclusion in the proposed National Institute of Substance Use and Addiction Disorders is necessary. To ignore the inclusion of pathological gambling in this proposed institute would be a loss to not only those suffering directly from this addiction, but also for those suffering from any other addictions as well. We encourage you to recognize the significance and importance of this inclusion in your discussions of a new institute.

 
127 04/05/2012 at 06:48:47 PM Organization ADAPT, Inc. Roseburg, OR 1. As you know, the National Institute on Drug Abuse Clinical Trials Network is a unique national collaborative of 12 Regional Research Centers (RRCs) and over 240 Community Treatment Programs (CTPs) across the United States. Founded to bridge the gap between science and practice in 1999, the hallmark of the CTN has been its bidirectional approach to research design, implementation and dissemination through constructive and ongoing dialogue between CTPs and RRCs. This dialogue between program staff in CTPs and researchers in RRCs has resulted in not only stellar research design and broad-based national clinical samples, but in real world applications of research results in a timely and efficient manner. As a representative of the CTPs, I would strongly urge the continuation of the CTN and the collaboration for which it has become known. 2. It has been a fact of daily existence amongst substance use disorder treatment providers that our patients/clients come to use with various combinations of alcohol and other drug issues, along with many other increasingly complicated factors. While a new institute is being considered, it would seem prudent to involve not only researchers in its creation, but providers from the CTN with an investment in research as well – providers who have been dealing with blended alcohol and other drug problems for decades. 3. There appears to be a disturbing trend away from research into the psychosocial treatment of substance use disorders and toward more biological models with an emphasis upon pharmacology. While there is no doubt that biological models and the medications they produce are extremely important, the reality is that most medications are not meant to be used in a vacuum when dealing with substance use disorders, and are best when combined with a recognized and evidence-based psychosocial treatment. I would urge that the issue of research into psychosocial interventions not be forgotten during this process.

All three issues are inextricably intertwined and crucial relative to the creation of a new institute. Good research is vital to our understanding of the factors that create substance use disorders and to the treatment of them. However, if that research does not have a real world basis, if there is no bridge from science to practice, then no matter how good the research is, lives will not be impacted. As I read the mission of NIH, there is explicit the dual missions of “fundamental knowledge” and “application of that knowledge” – science and practice. The CTN is an existing collaborative that strives to make this mission a reality. I would hope that the new institute would find that of great value and not only continue the CTN but also call upon its resources during the formation of this new institute.

 
128 04/09/2012 at 12:33:56 PM Self     I am concerned that HIV and hepatitis C research are not part of the plan. Both of these diseases have killed tens of thousands of people who use drugs or alcohol in recent years. NIDA-sponsored research has been important in guiding public health and medical responses. No other NIH institute can provide programs that address the research needs for reducing morbidity and mortality among substance users.

In addition, people who inject drugs, or who use large amounts of drugs or alcohol, are at high risk for acquiring and transmitting as-yet-unknown emerging diseases. If the new institute does not include capacity to conduct research among them, we may be delayed in learning these new diseases even exist. (We lost several years on HIV due to such delays--see Friedman, Samuel R.; de Jong, Wouter; Rossi, Diana; Touzé, Graciela; Rockwell, Russell; Des Jarlais, Don C.; Elovich, Richard. 2007. Harm reduction theory: Users culture, micro-social indigenous harm reduction, and the self-organization and outside-organizing of users' groups. International Journal on Drug Policy 18:107-117.) We will also have great difficulty getting research approved by other institutes whose staff know little or nothing about working with samples of substance users.

We are in a time of rapid social and economic change. We are also in a time of rapid improvement in our ability to study how social and economic change affects patters of substance use. Our team has been active in studying how metropolitan social, economic and policy changes affect rates of injection drug use, HIV among IDUs, and mortality among IDUs with AIDS. Hannah Cooper has been using multilevel techniques to study related issues within cities. From these studies, we have learned a great deal about geographic, economic and social determinants of substance use and its medical sequelae. This research is helping us learn how to predict outbreaks of substance use and diseases related to substance use as a consequence of social and economic change. It will help us understand how to avoid catastrophes such as the HIV outbreaks in the former Soviet Union or Indonesia after their economic and political transitions and, relatedly, how to minimize negative impacts of events here in the USA. Thus, I am concerned that this potential opportunity is not reflected in the Scientific Strategic Plan except possibly through the call for research on how policy changes affect substance use patterns and trajectories. The number of causal variables that are important go well beyond "policy changes," and the consequences we need to study include substance use by youth but go well beyond that.

 
129 04/09/2012 at 06:47:40 PM Self     The recent proposal to dissolve the National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse and create a new institute for substance use, abuse, and addiction is ill-considered and will not serve well the various constituencies with alcohol-related health problems and concerns. Harmonization of goals and policies related to legal use of alcohol versus illegal consumption of drugs will be difficult since important effects of alcohol relate to liver, pancreas, heart and fetuses -- not just a problem of the brain and addiction.

NIAAA has been doing an exemplary and well balanced job. Alcohol research will not benefit if alcholic liver disease research is farmed out to DK, heart research to HL, etc. More likely, such research of such great societal important will simply not be done, because the priorities of these other institutes are elsewhere.

The proposed merger is motivated not by an effort to improve alcohol research, but by the desire of NIH leadership to make room for new unrelated institutes. This is a bad reason. Don't do it.

   
130 04/10/2012 at 09:56:07 PM Self     There needs to be more acknowledgement of the varied etiological factors in development of substance use disorders, such as life stress, trauma, crime, violence and abuse. Violence results in major health problems in the population and increased healthcare costs and is both a contributor to substance abuse, as well as a consequence of alcohol and drug abuse. Given that epidemiological studies show that two-thirds of adults have experienced a traumatic event in their lives and that trauma exposure is linked with increased risk of PTSD and SUDs, this institute needs to explicitly encourage research on this topic.

We also need to encourage research that addresses underserved and disadvantaged subpopulations at higher risk of addictions and who face greater barriers to treatment and recovery, such as women, the poor, and racial/ethnic minority groups. This institute should encourage research on barriers to alcohol treatment for such groups including their use of informal supports such as 12 step recovery programs for addictions.

I would say violence and abuse and it's relationship to the development of addictions and comorbid disorders (e.g., PTSD-SUDs) is critically important, because these patients suffer the worst consequences, are harder to treat, and cost more in health care costs to society.

 
131 04/11/2012 at 01:27:48 PM Organization Stanford University Palo Alto According to the latest report from the Institute of Medicine, chronic pain affects more adults in the U.S. than heart disease, diabetes, and cancer combined. It is the number one reason why people miss work and costs the U.S. around 600 billion(!) per year. Furthermore, Vicodin (an opioid) was the number one prescribed drug in the last few years, a striking indication of the impact of pain on our society. I am a pain researcher at Stanford, and, given the obvious link between chronic pain and substance use and abuse, my lab receives considerable funding from NIDA. I am writing to express my deep concern that the new institute continue to fund pain research. In order for us to develop new therapies that will circumvent the pain/opioid addiction cycle, we must continue our research to understand the complexities of chronic pain. Please continue to support our efforts.

   
132 04/13/2012 at 04:57:41 PM Self     How should the current porfolios of NIDA and NIAAA, along with parts of other ICs, be parsed in forming NISUAD?

The most important issue is to create an new NISUAD so as to consolidate addiction related research within one NIH IC.

This creation must be accompanied by administrative savings and zero decrease in dollars going to support research, both intramurally and extramurally. In fact, given the administrative savings. funding for research should increase.

Planning the new National Institute on Substance Use and Addiction Disorders NIH’s decision to create a new institute organized around the science of addiction, called the National Institute on Substance Use and Addiction Disorders (NISUAD), continues to elicit considerable debate within the scientific and public advocacy communities. NISUAD would be created largely from the portfolios of the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA), both of which would cease to exist. However, as part of this reorganization, a major focus of current discussion—and ongoing controversy—is what pieces of these two institutes should be transferred to other NIH Institutes/Centers (ICs) and what from these other ICs should be housed within NISUAD? Unfortunately, too much of the discussion to date is defensive and based on parochial concerns among current NIH--‐funded researchers and advocacy groups representing a range of medical conditions. What will happen to my research or my syndrome of interest with the creation of the new institute? This is unseemly at best. Decisions as to what should or should not be included in NISAUD should be based solely on scientific considerations: how can we best invest tax payers’ money to learn more about drug addiction so that we can eventually develop better diagnostic tests, improved treatments, and ultimately cures and preventive measures? Additional warnings about NISUAD center on process, saying, for example, “this has to be done right.” Well, of course it has to be done right; concerns about not getting it right should not prevent us from doing what makes eminent scientific, clinical, and administrative sense. Consolidating two mid--‐sized institutes, both of which focus on drug addiction, into a consolidated institute will increase efficiency, decrease overall administrative costs, and increase funding for research. The creation of NISAUD should not be an excuse to cut funding for addiction research— such funding is already less, based on dollar/disease impact, compared to cancer, heart disease, and a range of other disorders. Since the creation of NIDA and NIAAA roughly 40 years ago, we have learned a great deal about addiction, and this fund of scientific knowledge drives the creation of NISUAD in a clear and compelling way: - While each drug of abuse binds initially to a unique target protein or small group of proteins in the brain, all drugs of abuse activate the same reward circuitry. That is, all acute drug actions converge on the same cellular and functional brain targets. There is nothing unique about alcohol, compared with cocaine, amphetamine, opiates, nicotine, and many others, with respect to either their molecular and cellular targets within this reward circuitry or the behavioral effects induced by these actions. - All drugs of abuse induce a common behavioral syndrome of addiction, which is virtually indistinguishable across all current dimensions of diagnosis. There is no feature of the behavioral syndrome of alcohol addiction that distinguishes it fundamentally from the other drugs. - All drugs of abuse induce a series of common, chronic molecular--‐cellular adaptations within the brain’s reward circuitry to underlie this syndrome of addiction. Knowledge of these chronic adaptations remains a focus of current investigation. Each drug also likely induces its own unique molecular--‐cellular adaptations, which define specific and more subtle differences across addiction syndromes. But here again there is nothing different about alcohol to distinguish it from all other drugs of abuse. - While most current medication therapies for addictive disorders target addictions to specific drugs, some agents show potential for several drugs. And there’s nothing that makes the development of anti--‐alcohol addiction treatments fundamentally unique compared with anti--‐cocaine addiction treatments, anti--‐nicotine addiction treatments, and so on. - Likewise, non--‐medication therapies for addictions to all drugs of abuse utilize essentially similar approaches, as do public health efforts to reduce drug use. There is zero scientific rationale to consider alcohol unique: - Alcohol is legal, though age--‐restricted; so is tobacco, and marijuana is close in several jurisdictions. - Alcohol has pro--‐health effects; several other drugs of abuse have enormous medicinal applications (opiates, amphetamines), and several others provide a path for novel drug discovery efforts (nicotine, cannabinoids). - Alcohol use has dramatic medical consequences; so does the use of several other drugs, including tobacco (cancers, others) and cocaine and other stimulants (lacunar strokes, cardiac dysrhythmias). - Alcohol use is widespread; so is tobacco and marijuana use. Consolidating our current efforts in alcohol and other drug addictions into NISUAD will enable a concerted effort to understand how drugs of abuse cause addiction. This focus on addiction biology—in animal models and in humans—should be at the heart of the new institute. Such a consolidation will also serve to heal serious fractures that currently exist in the nation’s addiction portfolio. Today, investigators actively avoid studying the combined effects of alcohol and other drugs of abuse because of our siloed structure. Indeed, it’s hard to find individuals who utilize one drug alone. Use of alcohol plus tobacco is very common. A large majority of people who use illegal drugs also use alcohol and tobacco. Yet, efforts to study such individuals are not readily feasible today. Rather, the current bureaucratic structure impedes scientific progress. All efforts aimed at understanding the biology of addiction and its treatment, and reducing potentially dangerous use of the drugs, should be placed within NISUAD. What about the medical consequences of drug addiction—where should those efforts be housed at NIH? This, too, should be driven by science. How tobacco causes lung cancer, and how alcohol causes cirrhosis of the liver, and what to do about it, should be housed with experts in chemical--‐induced cancer and liver disease at other NIH ICs. In contrast, certain medical concomitants of addiction are so intricately connected with addiction biology per se that this work should be retained by NISUAD. An example is provided by HIV. The behavioral abnormalities that are at the core of addictive disorders—and common across all drugs as noted above—are key determinants of the risky sexual behavior that drives HIV infection. Likewise, there is evidence that the use of certain drugs of abuse increases the brain’s vulnerability to HIV infection, and that HIV infection may increase vulnerability to those drugs. Decisions about a range of medical consequences of drugs of abuse should be based on these types of straightforward scientific principles. It is very exciting to see NIH launch a once in a several generation opportunity, like the creation of NIDA and NIAAA ~40 year ago, to take drug addiction research to the next level. Addictive disorders remain one of the greatest causes of disease burden worldwide. Design of NISUAD, and evaluation of its success, is simple. Let’s follow the science as a guide, and do what’s best for victims of these devastating syndromes.
133 04/16/2012 at 10:18:45 AM Self     There needs to be more gender differences research, and more of it supported by the NIH. Some reviewers do not believe money is worth spending on this issue. looking at novel mechanisms could also help. There are areas of research, or psychiatric groups, that have not been touched by scientists and it is impotant to support those research who attempt to investigate new domains which may help individuals with drug addiction.

This is relevant to both - there is not always ideal preliminary data to compromise one system or another , or one population of subjects or another (e.g. dif sexes) in addiction or mental illness. There need to be mechanisms to allow researchers to step out of everyone's comfort zone and test new areas that may impact our understanding of these disorders.

 
134 04/16/2012 at 01:39:07 PM Self Lifetree Clinical Research Salt Lake City I am writing to strongly urge the newly proposed National Institute of Substance Use and Addiction Disorders to fund continued research into the overlapping areas of pain and addiction. My request is driven by the need for greater scientific clarity into pain and its mechanisms and the need for newer, less addictive medications to treat pain.

More than 100 million Americans suffer from chronic pain, according to the Institute of Medicine. Chronic pain affects more people than cancer, heart disease, and diabetes combined yet receives far less funding for research. In addition, the increase in the use of prescription opioids to treat pain has brought a significant public health problem in the form of substance abuse, addiction, and overdose deaths. The challenge is to understand pain better so as to treat it more effectively without the attendant public health risk posed by substance abuse.

Patients who suffer from chronic pain and the doctors who treat them urgently need safer opioid and non-opioid alternatives to reduce the risk of abuse, addiction, overdose, and diversion to nonmedical use. Newer, safer therapies have shown promise but need further examination to determine their effectiveness in a variety of populations. Recent genetic findings show that individuals vary in their medication needs and pain response, suggesting that further research into these areas could produce new methods of treatment based on genetic profiles. Research indicates that addiction and pain may utilize common pathways in the central-nervous system and feed each other. These are just a few of the promising areas that are ripe for future research.

A dedication to funding quality research can yield great benefits. For example, in the War on Cancer, increased research has produced greater understanding of cancer biology and facilitated the development of improved treatments that are able to halt many cancers. Pain is similar in its complexity and the toll it takes on the public health. As such, it is deserving of the same commitment.

I am writing to strongly urge the newly proposed National Institute of Substance Use and Addiction Disorders to fund continued research into the overlapping areas of pain and addiction. My request is driven by the need for greater scientific clarity into pain and its mechanisms and the need for newer, less addictive medications to treat pain.

More than 100 million Americans suffer from chronic pain, according to the Institute of Medicine. Chronic pain affects more people than cancer, heart disease, and diabetes combined yet receives far less funding for research. In addition, the increase in the use of prescription opioids to treat pain has brought a significant public health problem in the form of substance abuse, addiction, and overdose deaths. The challenge is to understand pain better so as to treat it more effectively without the attendant public health risk posed by substance abuse.

Patients who suffer from chronic pain and the doctors who treat them urgently need safer opioid and non-opioid alternatives to reduce the risk of abuse, addiction, overdose, and diversion to nonmedical use. Newer, safer therapies have shown promise but need further examination to determine their effectiveness in a variety of populations. Recent genetic findings show that individuals vary in their medication needs and pain response, suggesting that further research into these areas could produce new methods of treatment based on genetic profiles. Research indicates that addiction and pain may utilize common pathways in the central-nervous system and feed each other. These are just a few of the promising areas that are ripe for future research.

A dedication to funding quality research can yield great benefits. For example, in the War on Cancer, increased research has produced greater understanding of cancer biology and facilitated the development of improved treatments that are able to halt many cancers. Pain is similar in its complexity and the toll it takes on the public health. As such, it is deserving of the same commitment.

April 16, 2012 To Whom It May Concern: I am writing to strongly urge the newly proposed National Institute of Substance Use and Addiction Disorders to fund continued research into the overlapping areas of pain and addiction. My request is driven by the need for greater scientific clarity into pain and its mechanisms and the need for newer, less addictive medications to treat pain. More than 100 million Americans suffer from chronic pain, according to the Institute of Medicine. Chronic pain affects more people than cancer, heart disease, and diabetes combined yet receives far less funding for research. In addition, the increase in the use of prescription opioids to treat pain has brought a significant public health problem in the form of substance abuse, addiction, and overdose deaths. The challenge is to understand pain better so as to treat it more effectively without the attendant public health risk posed by substance abuse. Patients who suffer from chronic pain and the doctors who treat them urgently need safer opioid and non-opioid alternatives to reduce the risk of abuse, addiction, overdose, and diversion to nonmedical use. Newer, safer therapies have shown promise but need further examination to determine their effectiveness in a variety of populations. Recent genetic findings show that individuals vary in their medication needs and pain response, suggesting that further research into these areas could produce new methods of treatment based on genetic profiles. Research indicates that addiction and pain may utilize common pathways in the central-nervous system and feed each other. These are just a few of the promising areas that are ripe for future research. A dedication to funding quality research can yield great benefits. For example, in the War on Cancer, increased research has produced greater understanding of cancer biology and facilitated the development of improved treatments that are able to halt many cancers. Pain is similar in its complexity and the toll it takes on the public health. As such, it is deserving of the same commitment.
135 04/18/2012 at 11:16:59 AM Organization Research Society on Alcoholism Austin, Texas Please see attached pdf from the Research Society on Alcoholism

  April 18, 2012 We at the Research Society on Alcoholism (RSA) very much appreciate that you (and NIH) have called for input from experts in the field as planning goes forward for the new Institute on Substance Use and Addictive Disorders. We have encouraged RSA members to respond to the RFI to offer creative synergies and to ensure that all alcohol research areas will be integrated within the new institute. As you read their communications, we believe it will become evident that NIAAA has already achieved, in the alcohol field, the synergies that are the aspiration of the new institute. These synergies have come from the interplay NIAAA has encouraged between the multiple components of our field—neuroscience, behavioral and social science, epidemiology, prevention and treatment science, alcohol-related end-organ disease, and policy research. In fact, the existence of RSA, an organization that we believe is exceptional as to the range of scientific disciplines that come together to stimulate, encourage, and support each other’s work, is itself an outgrowth of the synergies achieved, synergies that need to be preserved as plans for the new institute are developed. We cannot overstate how strongly we feel that the systematic encouragement of interaction among all these disciplines has been of scientific benefit to public health. So, when you ask how to achieve synergies, please keep this model in mind. This response to the RFI is written by the RSA leadership in behalf of the alcohol field as a whole. It offers suggestions to maintain scientific momentum as alcohol research is placed within a new institute with a broader focus. We were greatly encouraged by your message on the NIH Webinar on April 2, 2012, that the configuration of the new institute would not be based solely on whatever current portfolio items are selected for inclusion, but would arise from a strategic plan to be formulated with input from the scientific community. We hope that this strategic plan can be coalesced into a statement of the mission and scope of the new institute, so that researchers and their associated public health communities can plan accordingly. We also hope that the information gathered from the Webinar and the RFI represents the beginning of the process of bringing the scientific community into the planning of the new institute. Face-to-face meetings among experts about the configuration of the new institute have yet to take place. Many difficult issues need to be addressed, issues best addressed before the naming of a new institute director. Specifically: 1) We greatly appreciate your assurance that the collective budget for the new institute will be “revenue-neutral” across NIH. Along with scientific planning, explicit budget planning should precede the standing-up of the new institute. Adjustments in priorities and allocations need to be made to better match the actual public health burden. Prevailing estimates of the public health burden indicate it to be about one-third alcohol-related, one-third tobacco related, and one-third related to illicit and misused prescription drugs (with an as yet unspecified portion to be allocated to other “to-be-determined” conditions---another area for discussion). Such adjustments are essential if research efforts are to come close to matching the public health burden, but will be politically difficult for a new institute administration whose fiscal base derives largely from current allocations as represented in the existing portfolio items. 2) Extensive experience in the alcohol field has shown that public health is best served by researching medical complications of alcohol use (FASD and Liver disease) in concert with the factors that contribute to excessive alcohol consumption. The increasing appreciation of the enormous impact of these downstream consequences by those studying consumption patterns, along with increasing support from NIAAA, led us to understand just how significant were the associated public health burdens. In particular, the systems biology approach encouraged by NIAAA has been extremely effective in addressing the impact of alcohol on organ systems. Splitting research on the cause of a disease from its consequences most likely will slow progress, as will trying to develop approaches to ameliorate these disorders without reference to the factors that contribute to the disease process. Furthermore, the cause of these diseases goes beyond mere alcohol exposure, and includes complex social and family dynamics; separation of these lines of research into different institutes would defeat the very purpose of a new, consolidated, institute. Prevention efforts hinge on public communications about these potential outcomes. These are the very synergies NIH seeks. 3) Co-morbidity among substances is a huge public health issue, particularly the co-morbidity between alcohol and tobacco use, and is one critical reason for the creation of the new institute. The SMRB recommended that ALL research pertaining to tobacco (prevention, pharmacology, and end-organ disease) be included in the new institute, and not be spread across multiple institutes, as it is presently. Total re-assignment encountered, however, serious resistance by several non-government organizations that support such research. Although we understand their reluctance to disrupt longstanding relationships with ICs that have funded this research for many years, we continue to believe the public health would be better served by adhering to the SMRB’s recommendations. Without question, prevention and treatment of nicotine addiction must be included in the portfolio of the new institute if hoped-for research synergies are to be achieved. 4) Behavioral, developmental, and social science research, along with epidemiology, prevention, treatment (medical and behavioral), and policy research, must be emphasized equally with bioscience in the new institute if public health advances are to be made; that is, the new institute should not be exclusively devoted to neuroscience. Other recent developments in science also support this broad approach. The scientific synergies achieved in emerging areas outside the traditional “silos” (e.g., social-developmental-neuroscience; sociobiology, evolutionary behavioral science), if championed by the new institute, can better define this field, and have the potential to greatly inform prevention and treatment efforts. 5) In a similar vein, the scientific directions for the new institute should not be based on the assumption of a common etiology/neuropathway for all the included disorders. Differences in drug action suggest many distinctive processes, along with multiple targets for effective treatments and medications. 6) NIDA has had a longstanding relationship with the Office of National Drug Control Policy because of their common interest in illicit drugs. In contrast, alcohol has been accepted as a legal beverage. We in the alcohol field are concerned that without careful planning, the distinct agenda associated with illicit drugs may distract from the larger public health burden associated with alcohol use. Thank you again for this opportunity to contribute to efforts to make this new institute the best it can be. Hopefully, we can look forward to reading the other contributions made in response to the RFI, and to further opportunities to refine these ideas, including via face-to-face discussions. We also offer our assistance as the international search for a new director is undertaken.
136 04/18/2012 at 12:43:17 PM Self     The crucial issue to address in this proposal is how to integrate research across substances and across institutes that does not lose their unique strengths. The fact that alcohol can be used responsibly with minimal harms and even potential benefits clearly separates it from illicit drugs and tobacco. A new institute must keep a focus not only on addiction but also on use across the continuum. Integrating those two missions is not easy. I believe that researchers who focus on alcohol harms, below the threshold of addiction, may be marginalized by a new institute, and it is crucial that leadership of such an institute be inclusive of multiple disciplines and approaches from basic research to social research to policy research. As currently configured, the existence of multiple institutes provided some protection against an agenda overly focused on addiction as opposed to societal consequences of use and policy considerations. Finally, tobacco does belong in the new institute. To move alcohol and illicit drugs together, while keeping tobacco separate, would send a decidedly mixed message about the purpose of combing NIAAA and NIDA and would look more political than scientific. That said, it is crucial that the unique approaches and successes fostered by tobacco control within NCI be carried fully into a new institute. NCI's emphasis on behavior change, increasing reach (i.e., quitlines), and policy has been extraordinarily valuable.

The most important issue is to bring all substances under one roof while maintaining and enhancing the strengths associated with each Institute. I strongly believe this requires a leader who does come from NIAAA, NIDA, or NCI. Choosing a leader from one of those institutes would strongly bias the development of a new entity and create rifts among scientists who focus on alcohol vs. drugs vs. tobacco.

 
137 04/20/2012 at 07:49:42 PM Self     This letter is sent in response to the Request for Information (RFI) soliciting input into the Scientific Strategic Plan for the proposed National Institute of Substance Use and Addiction Disorders. In reviewing the Scientific Strategic Plan and after participating in the webinar, I have identified five critical issues and one point of clarification to consider as decisions about the new Institute are being made

  April 20, 2012 This letter is sent in response to the Request for Information (RFI) soliciting input into the Scientific Strategic Plan for the proposed National Institute of Substance Use and Addiction Disorders. In reviewing the Scientific Strategic Plan and after participating in the webinar, I have identified five critical issues and one point of clarification to consider as decisions about the new Institute are being made: Critical point 1. Maintain at least current funding levels. Although not necessarily conceptualized as such by the SMRB, Congress may see the merger as an opportunity for cutting total funding allocated to research in this area. Substance misuse, abuse, and dependence impose an enormous burden on the U.S. economy in terms of reduced worker productivity and costs associated with physical and mental health care, law enforcement, and criminal justice. Not only are these problems expensive, but they are widespread. Continued funding at current levels, or even increased funding, is vital to address these critical public health problems and reduce their impact on individuals and the U.S. as a whole. Studies of have shown that these investments often bring savings to the U.S. economy in the form of reduced social and health care costs and increased productivity. Critical point 2. Prevention must remain a priority. Establishment of a new combined institute should be used as an opportunity to strengthen NIH’s prevention portfolio. Prevention has demonstrated significant impacts in reducing onset and progression of substance abuse and it is essential that NIH not lose this focus (cites). Prevention is a national priority in the Obama administration and recognized as critical to the nation’s health. A recent report (2009) from The Institute for Medicine calls for Continued research on both the efficacy of new prevention models and real-world effectiveness of proven prevention and wellness promotion intervention as well as adaptation of research-based programs to cul¬tural, linguistic, and socioeconomic subgroups. I believe that the new institute’s mission statement must include an emphasis on prevention. I strongly endorse that the new institute elevate prevention to a research branch with funding allocated to alcohol and drug abuse prevention research at least equal to, and ideally greater than, the sum of the current levels at NIAAA and NIDA. This branch should also work to focus on translational research of prevention programs into real world settings. Prevention programming is a primary driver of the national economic benefits of substance use research investments. Critical point 3. Drug and alcohol use are social behaviors. The proposed strategic plan over-emphasizes biological science compared to social and behavioral science. Substance use and abuse, particularly of alcohol, usually occur in social situations. History, media, and social currents have made drug use a part of our national psyche. Both currently and historically, use of specific drugs has been linked to identification with particular social groups, movements, or philosophies. Research suggests that initiation of these behaviors is largely environmentally determined, and that socio-cultural environments (e.g., policy, peers, family) play pivotal roles in the initiation and, maintenance of, and desistence from drug use, abuse, and dependence. Certainly there is an interplay of environmental and biological influences in the development of addiction, however, to downplay the social, cultural, and psychological aspects of substance use disorder is a fundamental exclusion that will severely weaken efforts at prevention and treatment, and diminish the national economic contribution of work supported by the new institute. Critical point 4. Integration with the NIH Roadmap. The new combined institute should have a clear plan for implementation of the NIH Roadmap for the Science of Behavior Change, for example, it could be a plan for how the behavioral sciences will be integrated into the biological and neuroscience portfolios.. Critical point 5. Interdisciplinary research is critical. Research on prevention and treatment of alcohol and drug abuse requires maintaining an interdisciplinary, multilevel perspective that takes into account comorbid disorders, such as mental health issues, and recognizes the role of social and environmental factors. It will be important as the two institutes combine that there is a strong commitment to interdisciplinary research. Point of Clarification – What qualifies as “non-addiction research,”? Does “non-addiction research” include such things as HIV sexual risk behavior, health promotion and positive youth development interventions (that may have a number of benefits, including reduced or delayed drug use), and research on use or misuse that does not meet criteria for abuse or dependence (e.g., binge drinking)? Do these research areas fit into the new Institute or will they be referred elsewhere?
138 04/24/2012 at 12:57:49 AM Organization Social Development Research Group, University of Washington Seattle, WA Please see the attached letter outlining the critical issues I believe are worthy of consideration by NIH.

  [Note: The text of this attachment is similar to that of attachment #137; however, the letter did contain slight differences and has a different signatory.] April 17, 2012 As a member of the Executive Committee of the Social Development Research Group, I am submitting this letter in response to the Request for Information (RFI) soliciting input into the Scientific Strategic Plan for the proposed National Institute of Substance Use and Addiction Disorders. In reviewing the Scientific Strategic Plan and after participating in the webinar, we have identified five critical issues and one point of clarification to consider as decisions about the new Institute are being made: Critical point 1. Maintain at least current funding levels. Although not necessarily conceptualized as such by the SMRB, Congress may see the merger as an opportunity for cutting total funding allocated to research in this area. Substance misuse, abuse, and dependence impose an enormous burden on the U.S. economy in terms of reduced worker productivity and costs associated with physical and mental health care, law enforcement, and criminal justice. Not only are these problems expensive, but they are widespread. Continued funding at current levels, or even increased funding, is vital to address these critical public health problems and reduce their impact on individuals and the U.S. as a whole. Studies of have shown that these investments often bring savings to the U.S. economy in the form of reduced social and health care costs and increased productivity. Critical point 2. Prevention must remain a priority. Establishment of a new combined institute should be used as an opportunity to strengthen NIH’s prevention portfolio. Prevention has demonstrated significant impacts in reducing onset and progression of substance abuse and it is essential that NIH not lose this focus (cites). Prevention is a national priority in the Obama administration and recognized as critical to the nation’s health. A recent report (2009) from The Institute for Medicine calls for Continued research on both the efficacy of new prevention models and real-world effectiveness of proven prevention and wellness promotion intervention as well as adaptation of research-based programs to cul¬tural, linguistic, and socioeconomic subgroups. We believe that the new institute’s mission statement must include an emphasis on prevention. We strongly endorse that the new institute elevate prevention to a research branch with funding allocated to alcohol and drug abuse prevention research at least equal to, and ideally greater than, the sum of the current levels at NIAAA and NIDA. This branch should also work to focus on translational research of prevention programs into real world settings. Prevention programming is a primary driver of the national economic benefits of substance use research investments. Critical point 3. Drug and alcohol use are social behaviors. The proposed strategic plan over-emphasizes biological science compared to social and behavioral science. Substance use and abuse, particularly of alcohol, usually occur in social situations. History, media, and social currents have made drug use a part of our national psyche. Both currently and historically, use of specific drugs has been linked to identification with particular social groups, movements, or philosophies. Research suggests that initiation of these behaviors is largely environmentally determined, and that socio-cultural environments (e.g., policy, peers, family) play pivotal roles in the initiation and, maintenance of, and desistence from drug use, abuse, and dependence. Certainly there is an interplay of environmental and biological influences in the development of addiction, however, to downplay the social, cultural, and psychological aspects of substance use disorder is a fundamental exclusion that will severely weaken efforts at prevention and treatment, and diminish the national economic contribution of work supported by the new institute. Critical point 4. Integration with the NIH Roadmap. The new combined institute should have a clear plan for implementation of the NIH Roadmap for the Science of Behavior Change, for example, it could be a a plan for how the behavioral sciences will be integrated into the biological and neuroscience portfolios.. Critical point 5. Interdisciplinary research is critical. Research on prevention and treatment of alcohol and drug abuse requires maintaining an interdisciplinary, multilevel perspective that takes into account comorbid disorders, such as mental health issues, and recognizes the role of social and environmental factors. It will be important as the two institutes combine that there is a strong commitment to interdisciplinary research. Point of Clarification – What qualifies as “non-addiction research,”? Does “non-addiction research” include such things as HIV sexual risk behavior, health promotion and positive youth development interventions (that may have a number of benefits, including reduced or delayed drug use), and research on use or misuse that does not meet criteria for abuse or dependence (e.g., binge drinking)? Do these research areas fit into the new Institute or will they be referred elsewhere?
139 04/24/2012 at 08:01:15 AM Organization Journal of Caffeine Research: The International Multidisciplinary Journal of Caffeine Science New York City, New York The proposed National Institute of Substance Use and Addiction Disorders is to be welcomed as an important scientific and public health initiative, and this opportunity to contribute by way of comment to the Institute’s Scientific Strategic Plan is greatly appreciated. The core message of the present set of comments is: Taking account of the full range of issues and challenges posed by substance use and addiction disorders, it is essential, on scientific and public health grounds, that the priorities of the new Institute include the psycho-stimulant drug, caffeine. The author of these comments is a long-established caffeine researcher, with numerous peer-reviewed publications in the field, extensive public funding for research into caffeine (especially from the European Union), and is Founding Editor-in-Chief of the Journal of Caffeine Research: The International Multidisciplinary Journal of Caffeine Science. The comments included herein are intended to represent a cross-section of scientific and public interest concerning the consumption and effects of caffeine. The attachment that accompanies these comments contains the additional views of 11 prominent international and active caffeine researchers contained in an article published in Issue 1 of the Journal of Caffeine Research (Ferré et al., 2011).

Caffeine is easily the most widely consumed psychoactive substance in history (James, 1991, 1997). Consumption typically follows a lifelong course, transcending almost every barrier, including age, gender, geography, and culture. Its prevalence of use greatly exceeds that of any other drug, including nicotine, alcohol, and the panoply of non-legal drugs of abuse. Indeed, caffeine is unusual amongst psychoactive compounds in being part of the daily diet of most people on Earth. Moreover, caffeine is essentially alone amongst psychoactive compounds in being unregulated in most jurisdictions with respect to legal-age of consumption. While being of profound importance in its own right, knowledge of caffeine has and will continue to enhance understanding of substance use and addiction disorders of every description.

With reference to points highlighted in the “preliminary list of potential scientific opportunities and public health needs” contained in the NIH Notice NOT-OD-12-045, key scientific and public health issues and challenges concerning caffeine include the following:

• The NIH preliminary list of potential scientific opportunities and public health needs makes repeated mention of the importance of advancing knowledge of drug interactions. In that regard, it would be a grave oversight to omit caffeine from the list of priorities included in the proposed Institute’s Scientific Strategic Plan. Since almost the entire population consumes caffeine regularly, it necessarily follows that most drug interactions of interest (e.g., alcohol with therapeutic drugs; alcohol with opiates, stimulants, hallucinogens, or inhalants) occur against a background of potential interactions with caffeine. Knowledge of interactions between the innumerable drugs that individuals simultaneously ingest must necessarily be incomplete if account is not taken of the likely presence of caffeine as a background drug of use. Accordingly, knowledge of interactions between caffeine and other drugs is of great importance both scientifically and for reasons of public health.

• Increasingly, caffeine is being seen as a relevant variable in the development of patterns of use of other legal and non-legal drugs. For most individuals, caffeine is the first drug to be regularly ingested, with consumption often beginning in early childhood (e.g., through the regular consumption of cola drinks). Indeed, population studies show that caffeine is a strong predictor of smoking and alcohol use during adolescence (James et al., 2011; Kristjánsson et al., 2011). Though regular caffeine consumption typically precedes usage of other drugs, research is needed to examine the possible causal role of early caffeine exposure in the developmental trajectory of later usage of other drugs.

• Because brain structures involved in the regulation of higher-order cognitive functions and emotional experience are among the last to mature, not fully developing until a decade after mid-adolescence, substance use during childhood and adolescence may pose risks for cognitive and emotional development. The prevalence of caffeine consumption amongst children is particularly high (in excess of 70% in the United States and elsewhere), yet the possible effects of such exposure to brain development, and concomitant cognitive and emotional development, in children is substantially under-studied. One example of the importance of redressing this shortfall in knowledge is a recent study which found that increased daily caffeine consumption amongst adolescents is associated with increased expression of anger (Kristjánsson et al., 2011).

• The advent of energy drinks and growth in the number of brands of soft drinks that contain caffeine has been accompanied by a pronounced increase in the marketing of those products to young people, thereby giving rise to questions about the biobehavioral implications of increased consumption of caffeine by children and adolescents. For example, although adolescent smoking and alcohol use have long been known to predict adjustment problems during adolescence, including poorer academic achievement, recent research in a large adolescent population (N > 7,000) found caffeine consumption to be a stronger independent predictor of poorer school performance than smoking and alcohol use separately and combined (James et al., 2011; Kristjánsson et al., 2011). Furthermore, findings indicated that the mechanism responsible for the negative effect of caffeine on academic achievement was likely to involve daytime sleepiness, a finding that is consistent with the known pharmacological actions of caffeine, including its direct disruptive effects on nighttime sleep and the sleepiness-inducing effects of daytime caffeine withdrawal (James & Keane, 2007; Keane et al., 2007; Keane & James, 2008).

References Ferré, S., Jensen, M. B., Kempf, K., et al. (2011). What do you see as the main priorities, opportunities, and challenges in caffeine research in the next five years? Journal of Caffeine Research, 1, 5-12. James, J. E. (1991). Caffeine and Health (pp. 430). London: Academic Press. James, J. E. (1997). Understanding Caffeine: A Biobehavioral Analysis (pp. 227). Thousand Oaks, CA: Sage Publications. James, J. E. & Keane, M. A. (2007). Caffeine, sleep and wakefulness: Implications of new understanding about withdrawal reversal. Human Psychopharmacology: Clinical & Experimental, 22, 549-558. James, J. E., Kristjansson, A. L., & Sigfusdottir, I. D. (2011). Adolescent substance use, sleep, and academic achievement: Evidence of harm due to caffeine. Journal of Adolescence, 34, 665–673. Keane, M. A., & James, J. E. (2008). Effects of dietary caffeine on EEG, performance, and mood when rested and sleep restricted. Human Psychopharmacology: Clinical & Experimental, 23, 669-680. Keane, M. A., James, J. E., & Hogan, M. J. (2007). Effects of dietary caffeine on topographic EEG after controlling for withdrawal and withdrawal reversal. Neuropsychobiology, 56, 197-207. Kristjansson, A. L., Sigfusdottir, I. D., Allegrante, J. P., & James, J. E. (2011). Adolescent caffeine consumption, daytime sleepiness, and anger. Journal of Caffeine Research, 1, 75-82.

The processes and mechanisms outlined in the section headed Comment 1 of this submission argue for the importance of including caffeine as a major priority in the Scientific Strategic Plan of the proposed National Institute of Substance Use and Addiction Disorders. Specifically, that priority should give consideration to the scientific and public health importance of:

• Interactions between caffeine and other drugs;

• the potential causal role of early caffeine exposure in the developmental trajectory of later use of other drugs;

• the possible risks to developing brain structures of caffeine consumption during childhood and adolescence, and the concomitant implications for cognitive and emotional development; and

• the implications for public health of an increase in biobehavioral effects associated with the greatly increased range of caffeine products that are marketed specifically to children and adolescents.

In addition to the aforementioned priorities, it is profoundly important that the Scientific Strategic Plan of the proposed National Institute of Substance Use and Addiction Disorders also includes caffeine as a priority to be examined for the role that lifelong exposure may have in the development and course of major chronic diseases, including the following:

• Well-controlled experimental studies have shown definitively that dietary caffeine produces modest long-term increases in blood pressure (i.e., tolerance develops only partially to the acute pressor effects of the drug) (e.g., James, 1997, 2004, 2010). Nevertheless, epidemiological studies tend to show that, if anything, caffeine or caffeine beverages (notably, coffee) may provide modest protection against cardiovascular disease. However, epidemiological studies of caffeine are highly vulnerable to sources of confounding due to uncontrolled individual biological, behavioral, and social covariates of dietary caffeine consumption. Hence, research is needed to clarify whether dietary use of caffeine contributes to cardiovascular disease, and if not, what are the protective factors in caffeine beverages that counteract the likely long-term negative effects of caffeine on blood pressure.

• A major scientific and population health dilemma currently exists in relation to the possible involvement of caffeine in glucose metabolism and the development of type 2 diabetes (Lane, 2011). On the one hand, well-controlled experimental studies show that caffeine interferes with glucose metabolism, while on the other hand, there are epidemiological studies suggesting that coffee may protect against development of type 2 diabetes. This dilemma is in need of urgent resolution, especially considering the current pronounced increase in prevalence of type 2 diabetes.

• A further controversy of no less importance exists in relation to the putative neuroprotective effect of caffeine. The prospect that caffeine or caffeine beverages may offer protection against cognitive aging, in particular, has attracted considerable interest, especially in light of epidemiological findings supporting an inverse (i.e., protective) association between coffee and neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s disease. However, any actual benefit remains unclear, as evidenced by recent findings from Scotland suggesting that epidemiological evidence of caffeine neuroprotection may be spurious, being the result either of confounding or reverse causation (Corley et al., 2010). The counterevidence is distinctive because it derives from a large cohort of elderly participants (70+ years) whose IQ had been comprehensively measured at age 11 years. Individuals with higher childhood IQ performed better in adulthood than those with lower childhood IQ, irrespective of caffeine intake. Moreover, higher-IQ children consumed more caffeine/coffee in adulthood than lower-IQ children, a lifestyle-related choice by individuals possessing higher IQ and associated higher social status. Analyses showed that coffee-related superior cognitive ability in adulthood (an apparent protective effect of caffeine/coffee) was the result of lifelong cognitive advantage stemming from superior cognitive ability in childhood. In fact, caffeine/coffee had no protective effect for cognitive function. However, given the many other studies, both animal and human, that point to a possible neuroprotective effect of caffeine or coffee, the question is in need of further urgent examination.

• There is a large literature and much interest in caffeine as a possible sleep-loss prophylactic. However, sleepiness is a confirmed effect of caffeine abstinence (Juliano & Griffiths, 2004), and much of the relevant evidence of caffeine sleep prophylaxis derives from studies that inadequately controlled for confounding arising from reversal of abstinence-induced sleepiness (James & Keane, 2007). Indeed, there is evidence that caffeine use may actually be hazardous under certain circumstances where persons may experience unrelieved caffeine abstinence-induced sleepiness (James, 2012). Given that caffeine has been widely advocated as a sleep-loss prophylactic (e.g., for shift-workers of every description, airline pilots, air traffic controllers, military personnel, nurses, nuclear power plant operators, and long-distance hauliers), further urgent research is needed to evaluate comprehensively its net effects on sleep-wake cycles.

References Corley, J., Jia, X., Kyle, J. A. M., et al.. (2010). Caffeine consumption and cognitive function at age 70: The Lothian Birth Cohort 1936 Study. Psychosomatic Medicine, 72, 206-214. James, J. E. (1997). Caffeine and blood pressure: Habitual use is a preventable cardiovascular risk factor. The Lancet, 349, 279-281. James, J. E. (2004). A critical review of dietary caffeine and blood pressure: A relationship that should be taken more seriously. Psychosomatic Medicine, 66, 63-71. James, J. E. (2010). Caffeine. In B. Johnson (Ed.), Addiction medicine: Science and practice. New York, NY: Springer, pp. 551-583. James, J. E. (2012). Caffeine psychopharmacology and effects on cognitive performance and mood. In L. Riby, M. Smith, & J. Foster (Ed.), Nutrition and cognitive performance. London: Palgrave Macmillan, pp. 270-301. James, J. E. & Keane, M. A. (2007). Caffeine, sleep and wakefulness: Implications of new understanding about withdrawal reversal. Human Psychopharmacology: Clinical & Experimental, 22, 549-558. James, J. E., & Rogers, P. J. (2005). Effects of caffeine on performance and mood: Withdrawal reversal is the most plausible explanation. Psychopharmacology, 182, 1-8. Juliano, L. M., and Griffiths, R. R. (2004). A critical review of caffeine withdrawal: empirical validation of symptoms and signs, incidence, severity, and associated features. Psychopharmacology, 176, 1-29. Lane, J. D. (2011). Caffeine, glucose metabolism, and type 2 diabetes. Journal of Caffeine Research, 1, 23–28.

PDF copy of article: “What Do You See as the Main Priorities, Opportunities, and Challenges in Caffeine Research in the Next Five Years?” by Sergi Ferre et al.; published by Journal of Caffeine Research in 2011 (vol. 1 no. 1)
140 04/24/2012 at 01:11:55 PM Self     Developing a program which promotes physician and other health care provider training should be part of the mission of this Institute.

Training should specifically include education about alcoholism and addiction. This education should focus on several areas: 1. Meaningful curriculum in this area during medical school and in the curriculum of nursing and pharmacy schools; 2. Continuing education, principally for general practitioners, internists, and nurses; 3. Education concerning issues of prescribing pain medication to alcoholics and drug addicts who are in recovery; 4. Education concerning non-medical resources in treating alcoholism and addiction, e.g., Alcoholics Anonymous, and an acknowledgment and acceptance of its potential benefit; and 5. establishing a system or platform which physicians could use as a resource in diagnosing and treating alcoholism and addiction.

Number 3 above might be the most important from a practical standpoint. Too many physicians prescribe narcotics as pain medications to recovering alcoholics and drug addicts, when other forms of pain relief might be available.

 
141 04/24/2012 at 03:28:48 PM Self     I am currently funded by the NIAAA and NIDA institutes. I would like to know whether the new NIH institute will have a section funding grants on the medical consequences of drug and alcohol abuse. I think this is important since a program on drug/alcohol abuse has not fared well at other NIH institutes as they have traditionally been unsupportive of such research in populations with substance addiction.

It is important to study the epidemiology and etiology of drug and alcohol addiction/dependence and various intervention modalities. In my view, however, it is equally important to study the adverse health effects of drug and alcohol abuse. Without knowing the adverse health effects of these addictions it is meaningless to study all other aspects of drug abuse. Only research on adverse health effects of substance abuse will inform the public as to why not to abuse alcohol and drugs of abuse.

It is necessary to have a division or some other organizational entity clearly designated to deal with studies of the impact of drug and alcohol addiction on medical/health conditions and the spread of infectious diseases and other conditions that might impact on physiological systems, including role of nutrition in drug addiction and infectious diseases; morbidity, co-morbidity and mortality associated with drug use/abuse and /or infections; pathogenesis of drug abuse-associated HIV/AIDS and other co-occurring or opportunistic infectious disease, as well as others in this category.

Investigating the adverse health offects of drug and alcohol abuse is essential since it will inform the public as to why not to abuse alcohol and drugs of abuse.

 
142 04/24/2012 at 05:27:32 PM Self     My comments address issues associated with behavioral research in the addictions area.

Currently, the general model is to fund research that can result in the production of Evidenced-Based practices and protocols for their implementation (e.g., solution focused, motivational interviewing, cognitive-behavioral). One issue is the continued finding of lack of sustainability in the real world even if the setting administration is committed and good training and supervision is provided.

I believe this raises the issue of resistance to protocols that often lead to what I refer to as mechanical practice. I believe it would be helpful to fund efforts (my own included obviously) to develop models that integrate the best of specific findings without requiring individual rigid conformity to any one protocol. This would be an integrated approach that would in effect develop a science that frees artistry instead of one that limits it.

Associated with this would be another related area of research that explores the mechanisms of "mutual aid" within treatment groups. Mutual aid models can incorporate EBP practices without being bound to a specific protocol. Mutual aid processes can also be integrated into existing group EBP's. The emergence of our understanding of the power of group alliance, in addition to therapeutic alliance, is an area for exploration.

Finally, the exploration of the use of social media (e.g., Facebook)as a therapeutic tool should also be given attention. In addition to in-setting groups cyber groups can also create a system of support for clients struggling with addition issues including prevention and recovery.

The three areas identified above are:

1. The development of integrated approaches using evidenced-base practice model without strict adherence to one models' protocols.

2. Exploration of the dynamics of the mutual aid process in groups including leader interventions and how they affect the development of both the therapeutic alliance and the group alliance and their impact on treatment retention and other outcomes.

3. The use of social media as a tool for prevention and treatment. This would require developing tools for content and process analysis of social media interventions (at least one already exists).

The justifications for these suggestions were addressed in comment 1. Thank you for the opportunity to provide input.I would be glad to provide further information if requested.

Lawrence Shulman, MSW, Ed.D, Professor and Dean Emeritus of the University at Buffalo School of Social Work.

 
143 04/24/2012 at 09:20:09 PM Organization Social Development Research Group, University of Washington Seattle, WA Critical point 1. Maintain at least current funding levels. Although not necessarily conceptualized as such by the SMRB, Congress may see the merger as an opportunity for cutting total funding allocated to research in this area. Substance misuse, abuse, and dependence impose an enormous burden on the U.S. economy in terms of reduced worker productivity and costs associated with physical and mental health care, law enforcement, and criminal justice. Not only are these problems expensive, but they are widespread. Continued funding at current levels, or even increased funding, is vital to address these critical public health problems and reduce their impact on individuals and the U.S. as a whole. Studies of have shown that these investments often bring savings to the U.S. economy in the form of reduced social and health care costs and increased productivity.

Critical point 2. Prevention must remain a priority. Establishment of a new combined institute should be used as an opportunity to strengthen NIH’s prevention portfolio. Prevention has demonstrated significant impacts in reducing onset and progression of substance abuse and it is essential that NIH not lose this focus (cites). Prevention is a national priority in the Obama administration and recognized as critical to the nation’s health. A recent report (2009) from The Institute for Medicine calls for Continued research on both the efficacy of new prevention models and real-world effectiveness of proven prevention and wellness promotion intervention as well as adaptation of research-based programs to cul¬tural, linguistic, and socioeconomic subgroups. I believe that the new institute’s mission statement must include an emphasis on prevention. I strongly endorse that the new institute elevate prevention to a research branch with funding allocated to alcohol and drug abuse prevention research at least equal to, and ideally greater than, the sum of the current levels at NIAAA and NIDA. This branch should also work to focus on translational research of prevention programs into real world settings. Prevention programming is a primary driver of the national economic benefits of substance use research investments.

Critical point 3. Drug and alcohol use are social behaviors. The proposed strategic plan over-emphasizes biological science compared to social and behavioral science. Substance use and abuse, particularly of alcohol, usually occur in social situations. History, media, and social currents have made drug use a part of our national psyche. Both currently and historically, use of specific drugs has been linked to identification with particular social groups, movements, or philosophies. Research suggests that initiation of these behaviors is largely environmentally determined, and that socio-cultural environments (e.g., policy, peers, family) play pivotal roles in the initiation and, maintenance of, and desistence from drug use, abuse, and dependence. Certainly there is an interplay of environmental and biological influences in the development of addiction, however, to downplay the social, cultural, and psychological aspects of substance use disorder is a fundamental exclusion that will severely weaken efforts at prevention and treatment, and diminish the national economic contribution of work supported by the new institute.

Critical point 4. Integration with the NIH Roadmap. The new combined institute should have a clear plan for implementation of the NIH Roadmap for the Science of Behavior Change; for example, it could be a plan for how the behavioral sciences will be integrated into the biological and neuroscience portfolios.

Critical point 5. Interdisciplinary research is critical. Research on prevention and treatment of alcohol and drug abuse requires maintaining an interdisciplinary, multilevel perspective that takes into account comorbid disorders, such as mental health issues, and recognizes the role of social and environmental factors. It will be important as the two institutes combine that there is a strong commitment to interdisciplinary research.

Point of Clarification. What qualifies as “non-addiction research”? Does “non-addiction research” include such things as HIV sexual risk behavior, health promotion and positive youth development interventions (that may have a number of benefits, including reduced or delayed drug use), and research on use or misuse that does not meet criteria for abuse or dependence (e.g., binge drinking)? Do these research areas fit into the new Institute or will they be referred elsewhere?

   
144 04/25/2012 at 08:21:52 AM Self     I suggest consideration of the goals for tobacco dependence (consensus.nih.gov/2006/tobaccostatement.htm) outlined in the NIH State-of-the-Science Conference on Tobacco Use: Prevention, Cessation and Control

June 12–14, 2006 Bethesda, Maryland

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Conference Scope

The State-of-the-Science panel assessed the evidence on the following conference questions:

1. What are the effective population- and community-based interventions to prevent tobacco use in adolescents and young adults, including among diverse populations? 2.What are the effective strategies for increasing consumer demand for and use of proven, individually oriented cessation treatments, including among diverse populations? 3.What are the effective strategies for increasing the implementation of proven, population-level, tobacco-use cessation strategies, particularly by health care systems and communities? 4.What is the effect of smokeless tobacco product marketing and use on population harm from tobacco use? 5.What is the effectiveness of prevention and of cessation interventions in populations with co-occurring morbidities and risk behaviors? 6.What research is needed to make the most progress and greatest public health gains nationally and internationally?

   
145 04/25/2012 at 04:41:57 PM Self     As the plan for the new institute goes forward, it seems critically important to reinforce the importance within the new institute for the role and position currently held by Dr. Cora Lee Wetherington in ensuring that research on women's health and sex/gender differences is recognized and funded. It is too easy to overlook the value of this position as people are debating other issues. Yet, as demonstrated so well by Dr. Wetherington, a dedicated position/office for women's health/sex/gender investigation makes an enormous difference in the commitment of the institute to this area and to ensuring the generation of critical new empirical findings on the health of women and on gender differences in addictive behaviors that will greatly influence the public health.

I find it notable and disconcerting that the "preliminary list of potential scientific opportunities and public health needs that are not sufficiently addressed within the existing NIH structure," which the new institute would presumably remedy, does not include the study of women and gender differences. As indicated by multiple reports generated, for examplem through the IOM, this area of inquiry within addictive behaviors has been dramatically understudied and needs our attention.

 
146 04/25/2012 at 06:30:20 PM Self     The majority of American adults that drink alcohol are not alcoholic but rather moderate drinkers. The new institute must include the study of health benefits and risks associated with more moderate social and binge drinking.

The research portfolio of the new institute must include health promotion. Alcohol is unique in many ways with its health promoting effects at low doses (in the majority of the adult population) and dangerous effects with excessive use. Educational programs (and their evaluation) are critical for the youth and public at large.

The National Institute on Alcohol Abuse and Alcoholism has utilized a “systems biology” approach to its efforts addressing the impact of alcohol on the entire body and organ systems. This has served research well since alcohol has such a wide array of effects on the organism. There has been some suggestion that the new institute would not fund certain areas of alcohol research (prenatal alcohol exposure and end organ damage as examples), but instead send these to other institutes. This type of isolation would have devastating effects on these areas of alcohol research. It is critical that all aspects of alcohol research remain within this new institute. Fetal alcohol research, as an example, needs to be within an institute that focuses its research program on how alcohol affects not only brain but various organ systems, immune function, behavior, etc.

Since a major component of the new institute will have a focus on addiction, it is important that the many forms of addiction that may share underlying mechanisms be part of this new institute. This must therefore extend beyond alcohol and other drugs to include other addictions that have a tremendous cost to society including nicotine (smoking), gambling, overeating, shopping, and internet or gaming. A number of these are currently housed in other institutes and the logical if not necessary approach would be to transfer them to this new institute.

The majority of Americans that drink alcohol are not alcoholics, but rather more moderate drinkers. Binge drinking may fall into this category. Binge drinking is a dangerous and growing problem in the US, particularly among adolescents. It would seem imperative that the new institute includes the study of the social and biological risk factors associated with binge drinking. My currently funded research focuses on characterizing the neurobiological underpinnings of binge drinking. Such characterization will be critical to our understanding of the neurobiological effects of binge drinking, as well as the development of effect intervention and treatment strategies for this dangerous pattern of alcohol consumption. The establishment of a new institute that does not fund this type of work would be devastating to my research program.

There has been some suggestion about removing certain areas of alcohol research (like developmental alcohol exposure) to other institutes. This type of isolation would have devastating impacts. A number of my colleagues at Indiana University – Purdue University Indianapolis have active research programs investigating alcohol’s prenatal effects on brain development, and I am developing a new line of investigation along these same lines. Moreover, one of my current focuses is on alcohol sensitivity and intake during the critical developmental period of adolescence. It is critical that all aspects of alcohol research, including developmental alcohol research, remain within this new institute. Such a structure will be key if we are to better understand the social and biological impacts of developmental alcohol exposure, as well as identify intervention and treatment strategies for developmental alcohol exposure. Such work needs to reside within an institute that focuses its research program on how alcohol affects not only brain development, but various organ systems, immune function, behavior, etc. At present, it isn’t clear what institute would fund developmental alcohol research.

 
147 04/25/2012 at 06:43:38 PM Self     Increase understanding on how to reduce disparities in tobacco use and exposure to this addictive substance in minority, low socioeconomic status, and LGBT populations.

Increase effectiveness of evidence-based practices that reduce tobacco and other substance use for minority, low socioeconomic status, and LGBT populations.

Improve access and availability of community and clinical interventions/treatments to minority, low socioeconomic status, and LGBT populations.

Increase provider sensitivity and competence to deliver evidence-based practices to diverse cultural, linguistic, and geographically dispersed groups.

Increase opportunities for research training across diverse ethnic groups.

All of the above stated areas are important to address since populations who use/abuse substances, including tobacco, are disproportionately those who come from minority, low SES, and LGBT communities. Without specific foci, these areas are often not addressed as part of a research agenda. It is important to train new researchers from diverse populations to build a pipeline who can address these issues; its important to have competent providers to deliver interventions; and its important that what we know (our evidence-base) gets to the populations in need and that interventions are available and accessible to them.

 
148 04/26/2012 at 01:26:23 PM Self     The new Institute should focus broadly on the mechanisms, treatment, and consequences of substance use, abuse, and addiction. This should include individual and polysubstance use. As smoking remains a leading cause of death and illness in the US and tobacco is the leading addictive substance responsible for morbidity and mortality, nicotine dependence remains a high priority of continued NIH research funding.

In addition to the specific areas of interest outlined in the RFI, other topics of relevant importance are listed below. Each of these is particularly important to nicotine dependence, but is equally important to study for other addictions: ? Better understanding the mechanisms through which treatments work, including identifying the “active ingredients” of multi-component interventions. ? Understanding how to leverage health care systems to best meet the needs of smokers and other substance abusers. ? Identifying more cost-effective, population-based interventions which can serve as a first line of intervention. This is particularly for prominent substances of abuse such as nicotine and alcohol. ? Developing effective behavioral interventions that are targeted to specific sub-populations, based on psychiatric or other illness comorbidities (e.g., depression, HIV, and other chronic illnesses). ? Understanding how to leverage new information technologies to provide more cost-effective treatment and reach a broader population (e.g., smart phones, text messaging, secure messaging linked to electronic medical records, Internet-based programs, etc.).

In general, I believe it is critical that NIH support research designed to enhance our ability to develop and deliver more effective behavioral interventions for substance use, abuse, and addictions. Without this emphasis, efforts to curtail the economic and human toll of substance misuse will be hampered.

Additionally, I believe it is important to continue our investment in tobacco control. Tobacco is the leading addictive substance responsible for morbidity and mortality in the US and, as such, warrants particular emphasis in the new Institute.

 
149 04/26/2012 at 03:46:15 PM Self     • Prenatal Illicit Drug Use: 5% of pregnant women abuse illicit drug during pregnancy (Survey on Drug Use and Health, 2004). Women who use illicit drugs while pregnant are more likely to give birth early and have low weight infants that are at risk of neonatal abstinence syndrome and requiring intensive care; yet no psychosocial intervention has been efficacious to help pregnant women abstain from illicit drugs (Terplan & Lui, 2008). While a small percentage of pregnant women abuse illicit drug, the annual cost in the US to treat such neonatal problems as neonatal abstinence syndrome is approximately 1 billion dollars (Jefferson University Hospitals, 2010), indicating a clear need to develop an efficacious treatment for this population. • Prenatal Alcohol Use: Up to 35% of pregnant women report drinking at any time during pregnancy (Bobo et al., 2006). Excessive alcohol consumption during pregnancy is associated with increased risk for miscarriage, reduction in fetal growth and impaired neurodevelopment. Ten out of every 1000 births result in a child affected by fetal alcohol spectrum disorders (FASD), one of the leading causes of mental retardation, neurological and learning disorders and birth defects in the US (Osterman & Dyehouse, 2011). Prenatal alcohol exposure also increases the risk for development of young adult drinking at the age of 21 (Baer et al., 2003). Alcohol abuse costs the US 223.5 billion dollars a year (CDC, 2011), and FASD costs the US 631 million dollars per year (Miller et al., 2006b). Currently there is no efficacious psychosocial treatment for alcohol abusing pregnant women (Lui et al., 2008). • Prenatal Tobacco Use: It has been estimated that approximately 13% of pregnant women smoke during their pregnancy, resulting in about 820,000 pregnant smokers in any given year (http://www.americanpregnancy.org/main/statistics.html - retrieved January 19, 2012). Minority women and those with low incomes are disproportionately represented in this group (El-Khorazaty et al., 2007; Graham, 2009). It is well known that smoking increases risk for infertility, ectopic pregnancy, spontaneous abortion, placental abruption, and placenta previa (Cnattingius, 2004) in addition to increased risk for smoking-related illnesses generally (USDHHS, 2010). Smoking during pregnancy also has adverse effects on immediate birth outcomes including preterm delivery, low birth weight, and admission to the neonatal intensive care unit (Burns et al., 2008). The average cost of medical care for a premature or low birth-weight baby for its first year of life is about $49,000 (vs. $4,551 for a newborn without complications). In addition, the total annual tobacco-related cost in the US is 9.4 billion dollars. An incentive-based psychosocial intervention has been demonstrated to be the most safe and efficacious (Lumley et al., 2009), and this type of intervention needs to be disseminated in the community treating pregnant smokers.

• We identify treating pregnant smokers in the community settings as the most important for NIH to currently address. The reasons include that we already have a safe and efficacious psychosocial intervention ready to be disseminated in the community settings and also that the Affordable Care Act (ACA) of 2010 puts in place comprehensive health insurance reforms that includes prevention, mental health, and substance use disorder services (SEC. 1302) and that requires Medicaid coverage for pregnant women to access tobacco cessation pharmacotherapy and counseling (SEC. 4107), as part of the essential benefits package. In addition, prenatal smoking issues should not be studied through other national institutes such as those focusing on maternal and pediatric health and cancer due to smoking sharing many characteristics and outcomes that are common with other addictions (USDHHS, 2010).

 
150 04/29/2012 at 09:56:25 AM Organization University of British Columbia Vancouver It is imperative that FASD research continue to be included in NIH research. To exclude this research or commit it to separate agency would be equivalent to separating the mother from the fetus. FASD is a preventable disorder but only if the mother refrains from alcohol consumption. Although it is often stated that many cases of FASD are a result of a woman not knowing she was pregnant, the fact remains that somewhere in the order of 77% of those who give birth to a child with FASD will have a second child with the disorder as well. This is a clear indication that this individual very likely has a drinking problem and as such the mother is as important in the treatment strategy as the child.

Reorganization of addiction research that separates other disorders such as FASD would not only put tremendous financial strain on the research but would also potentially ignore a population of individuals that have increased susceptibility to addiction owing to their particular condition - namely FASD. The research on addiction must include individuals with an FASD or immune function as well as a wealth of other issues as a result of alcohol exposure should not be separated as the underlying issue - addiction - lays at the root of the disorders. Understanding the mechanism of alcohol-related illnesses will allow research to focus on treatment strategies and research that will benefit a ;much broader population and is ultimately linked to addiction research.

 
151 04/29/2012 at 03:28:03 PM Self     There is a critical need to understand the etiology of co-morbid psychiatric conditions in order to develop appropriate prevention and treatment strategies. Alcohol and drug addiction are frequently c-morbid with major mental illnesses such as anxiety and mood disorders.

There are currently very few treatments for individuals with co-morbid psychiatric conditions. Further, little is known about Pharmaco-kinetic and -dynamic properties of psychiatric medications in individuals that may be taking medications for multiple disorders. We need to identify common biological mechanisms that contribute to risk for co-morbidity in order to develop more selective and effective medications for alcohol and drug addiction co-morbid with psychiatric disease.

 
152 04/29/2012 at 07:14:18 PM Self     Given that fetal alcohol research is a relatively new field, it is imperative for its success that it remains in close association with the bigger field of alcohol research, currently managed by NIAAA. In particular, some of the observed neurobiological adaptations that occur in children (and animal models) following prenatal alcohol exposure are very similar to the changes that occur in the adult brain, which is one of the primary issues that NIAAA is currently focused on. Separation of fetal alcohol research from the alcohol field would be detrimental to its progress in finding novel interventions (pharmacological, educational, behavioral, etc.) that can help increase the quality of life for many individuals. Furthermore, with my previous experience with the alcohol field (as a graduate student and postdoctoral fellow studying effects of chronic alcohol and withdrawal) and now ready to begin my career as a new investigator in the fetal alcohol field, it has been extremely instrumental to have the network and support of NIAAA in advancing my career. I strongly feel that separating fetal alcohol research from substance abuse and addiction would severely impair my chances of becoming a successful investigator and make it more challenging for me to offer my ideas that will potentially help individuals who suffer from the consequences of prenatal alcohol exposure.

   
153 04/30/2012 at 08:45:12 AM Self     My major concern is the separation of fetal alcohol spectrum disorder (FASD) proposals from the main alcohol-related research.

FASD is a major health concern, and it is known that children with FASD are more vulnerable to develop addictions than those without FASD. Thus, if any etiology research remain within the new addiction institute, separating FASD research from other etiologies is a major problem and an illogical step.

 
154 04/30/2012 at 01:03:35 PM Self     25% of the women who drank before getting pregnant continue to drink during pregnancy. In most cases, the level of alcohol consumption does not reach that expected to result in frank expression of fetal alcohol spectrum disorder (FASD), but epidemiological and preclinical evidence is emerging to indicate that even a moderate amount of consumption during pregnancy could have profound and long-lasting effects on fetal brain development. I believe it is important that basic and clinical research on FASD and the effects of prenatal exposure to ethanol on the fetus in general be a major part of the proposed institute on substance abuse and addiction disorders.

Please see above.

 
155 04/30/2012 at 01:08:55 PM Self     *Targeting efforts to prevent substance abuse in adolescents and young-adults; *Understanding the implications of policy changes on substance use patterns and trajectories, especially in youth; and, *Furthering knowledge of tobacco use and addiction, including co-morbidity with other addiction and psychiatric disorders.

These three areas are particularly important to me. I am a graduate student investigating execution function, mental health, substance use and abuse in adolescents. We need more funding and research in youth prevention because it will result in more knowledge and less use of young people who will also be less likely to use and abuse substances as adults, which in turn will lessen the demands on the recovery and mental health system. Ripple effect. Prevention will ease the demands on everyone down the line. Prevention will result in not having to work with people with concurring mental disorders that have developed due to heavy substance abuse. Effective prevention would result in less funds needed for recovery programs and homes and instead directed to help the next generation have a far stronger and healthier start. To focus on prevention makes sense now and in the long run.

Another important area in youth substance use that needs to be addressed is the effect(s) of antidepressants and psychostimulants on the developing brain/neurons. There are many trials being done that compare different medications in youth - is this dangerous? Should we be comparing medications on developing brains when there appears to be a paucity of research about how their brains are affected by just one medication? We need more stringent policies for these studies, more regulating, and far more animal research should be conducted to see the effects of these medications on the adolescent brain. Antidepressants blunt the ability to feel emotion - in an adolescent, this can be detrimental especially because many of their decisions are emotion-based. Please provide funding and research in this area.

 
156 04/30/2012 at 03:06:55 PM Self     Issue #1: Funding A greater number of scientists and pre-doctoral candidates focus their research on alcohol more than any other drug of abuse. It would be a shame to see decreases in funding due to changes in policy and structure that could have downstream effects on the public, especially as to the impact of alcohol on society. Issue #2: Structure changes function Restructuring of a division in the government is bound to have long term implications on how many people go into the field of alcohol research. Researchers focusing on alcohol shouldn't compete with those focusing on cocaine, heroin, or other illegal drugs. Alcohol (and nicotine) are in a special category of legal yet highly detrimental drugs whose cognitive and physiological consequences are only understood by a small number of scientists. Restructuring will change function, and if anything, alcohol research needs to be expanded not constrained.

The NIH should consider how moving FASD research to NICHD will impact the amount of funding we receive, especially in the case of graduate students who are impacted through the amount of funds received via training grants. Moving FASD research into the arena of other drug studies may make sense, but alcohol impacts a greater number of people (both via abuse and research of the consequences of that abuse); therefore, re-appropriation of funds away from other drugs of addiction would be necessary if FASD was moved into a NICHD category.

 
157 04/30/2012 at 03:50:47 PM Organization Research Institute on Addictions Buffalo, NY I do not see an emphasis area for factors that lead to increased addiction propensity. For example, prenatal stress, drug or alcohol exposure is known to increase addiction propensity. The epigenetic factor for addiction should be a emphasis area because the use of drugs and alcohol is common during pregnancy. It is also conceivable that intervention strategies designed to targeet the prenatal or early postnatal stages can be beneficial to prevent addiction. This area should not be funded by other NIH Institutes.

We need to keep fetal alcohol spectrum disorders research under the proposed new Addiction Institute.

Fetal alcohol spectrum disorders is the major reason for mental retardation in the US. For years the researchers across different scientific displines have worked hard to understand the impact of prenatal alcohol exposure and prevention and treatment methods. In addition, FASD directly increases addiction risk later in life. Therefore, it is important to keep

 
158 04/30/2012 at 04:27:32 PM Organization University of Illinois at Chicago and Jesse Brown VA Medican Center Chicago, IL It is surprising to notice that Fetal Alcohol Spectrum Disorder (FASD) research will not be included in the interests of the proposed new National Institute of Substance Use and Addiction Disorders .

Several considerations needs to be made regarding the inclusion of FASD in the interests of the National Institute of Substance Use and Addiction Disorders : 1) FASD is a direct and devastating consequence of alcohol abuse and alcoholism in women. Separating FASD research from alcohol addiction research may have a negative impact in the pursuing of new strategies for the treatment and prevention of alcohol abuse and alcoholism in women. 2) FASD can be an important cause of addictive behavior as it has been shown that more than 40 % of individuals prenatally exposed to heavy alcohol develop alcohol and drug dependence in adolescence and/or adulthood (Streissguth et al., 1996). NIH has shown interest in researching the fetal origin of adult diseases; the dissociation of FASD research from alcohol and drug addiction, however, will hamper advancements in this direction. 3) While the effect of drugs in the developing adolescent brain will be an area of research pertinent to the new institute, research on the effects of drugs (and alcohol in particular, since from the Institute of Medicine 1996 Congress report we learn that: “of all the substances of abuse including heroin, cocaine, and marijuana, alcohol produces by far the most serious neurobehavioral effects in the fetus”) in the early (fetal) brain development will be directed to a different institute. This approach does not appear efficient in promoting advancements in brain development research and arbitrarily splits a highly interconnected area of research.

 
159 04/30/2012 at 04:59:34 PM Organization Community Treatment Program Caucus; NIDA/CTN National Membership We represent the 240 Community Treatment Programs in NIDA’s Clinical Trials Network. We have been treating individuals with alcohol and other drug abuse problems for many years and have a wealth of applied information that we believe would be of great assistance in the formation and structure of the new Institute. We are eager to play a meaningful role in the formation of the new Institute.

• We fully support the NIH commitment to excellent science, but wish to restore the balance between scientific rigor and relevance to real world problems. We think the gap has grown larger in the last decade, and we would like to increase NIDA’s commitment to bidirectionality. The NIDA CTN represents a remarkable opportunity for community treatment providers and scientists to work together to tackle the challenges faced in addiction treatment. This outstanding opportunity has not been fully realized and the new institute should renew the commitment to a bidirectional approach to improving treatment, using science as the vehicle.

• The current NIH emphasis on translational research reflects the recognition that there is too large a gap between science and practice. We think community treatment providers should be included in the formulation of the research questions and offer practical implementation considerations throughout the process. The CTN provides a robust infrastructure for this type of research and the historical embargo on conducting dissemination work within the CTN has led to a missed opportunity.

• Medications are tools, not solutions, in the treatment of SUDS. Diminishing emphasis on psychosocial interventions reflect a disregard for the real world problems of our patients and the need to address these in a comprehensive way. Behavioral interventions may work better than medications, or the combination of the two may work better than either alone. It is important to restore more balance to the research portfolio.

We think that close collaborations between researchers and community treatment providers is the best way to maximize the utilization of research findings to improve care. This is especially crucial as health care reform progresses. New questions arise daily. The research paradigm must be responsive to emerging concerns.

 
160 05/01/2012 at 10:29:21 AM Self     Please consider the impact of fetal alcohol exposure on problems later in life, for example propensity for addiction.

Please do not combine fetal alcohol research with the other areas

 
161 05/01/2012 at 11:01:02 AM Self     Attached is a description of content areas to be included within the new institute.

  I am the Director of a NIDA-funded P30 Center currently in its 15th year (Center for Drug Use and HIV Research, P30DA011041) and have conducted drug-use related research projects for over 25 years. Based on this experience, I agree with the decision at NIH to create an Institute focused on Addictions. However, in reviewing the RFI, and the Scientific Management Review Board Report on Substance Use, Abuse and Addiction Research at NIH (November 2010), it appears that many areas critical for addiction research, that should be included in the newly created Institute, have not been explicitly identified. I recommend that the following areas be included in the portfolio of NISUAD: - Socio-behavioral and epidemiologic research related to HIV and HCV – These infectious diseases have been shown to be highly related to substance use, both in their etiology, in their disease courses, and in the impact of treatment. Substantial gains in our knowledge about these infectious diseases related to substance use have been made through the attention brought by NIDA and NIAAA, and further progress will be facilitated if they remain under the umbrella of an addiction Institute. - Specific attention to multi-level socio-behavioral influences on substance use and addiction disorders, including individual, social, cultural and structural factors. The RFI included a list of potential research opportunities not sufficiently addressed within the existing NIH structure; these included primarily biomedical topics. It is critical to also address those topics that emerge from socio-behavioral and epidemiologic disciplines that have not been adequately addressed, and that should be placed under the purview of NISUAD. These include study of the multi-level influences on: initiating and maintaining addictive behaviors, as well as using this knowledge in the development and implementation of effective prevention and treatment approaches. Applying these research approaches to a broad range of addictive behaviors is likely to lead to innovative findings, with broad implications for prevention and treatment. - Need for transdisciplinary studies – there has been an increasing realization of the importance of conducting addictions research that draws expertise from multiple disciplines, including both the biomedical and the socio-behavioral sciences. These transdisciplinary studies can best be encouraged through their funding in a single agency, rather than partitioning these studies across different NIH Centers/Institutes. Thus, I recommend that a specific emphasis on are solicited from the field.
162 05/01/2012 at 01:24:45 PM Self University of Southern California Los Angeles, California I think two critical public needs the new NIH institute of Substance Use and Addiction Disorders has to address are: (1) developing effective alcohol/drug antidotes for the DUI (driving under the influence) problem; and (2) understanding the mechanisms by which moderate alcohol dringking combined with other leagal/illicit drugs (e.g. HCV/HIV drugs) of abuse potentiate risk for organ disorders/injuries.

(1) According to the statistics by DMV and/or the National Highway Traffic Safety Administration, DUI is a popular routine problem, even to decent people. One in three people will be involved in an alcohol-related crash in their lifetime, which kills innocent people. For instance, in 2009, 10,839 people died in drunk-driving crashes-one every 50 minutes. Drunk driving costs each adult almost $500 per year. That is $156 billion per year in this country. Alcohol-related emergency department visits but not in alcohol-related primary care visits have significantly increased since 1995. There are no direct ways to deal with this social and health problem. NIH must develop specific strategies to encourage researchers/scientists to tackle the DUI problem scientifically and save lives. That is to develop highly effective alcohol/drug antidotes to low blood alcohol quickly down to a safe level, which can be accomplished through using the same cutting edge technologies that have been used in developing the drugs. (2) Alcohol consumption is a millennium-old component of human civilization. Although alcohol abuse associates with a series of organ injuries (e.g., liver damage), the majority of adults in America that drink alcohol are not alcoholic but rather moderate drinkers. Moderate drinking does not often associate with apparent organ disorders. However, moderate alcohol drinking combined with legal or illicit drugs often causes un-predictable and synergistic damages to key organs such as liver and brain, which could happen to everyone given that modern people relies more and more on various drugs for quick recovery from illness. For instance, alcohol exerts high influence on medications with drugs for human immunodeficiency virus (HIV) or viral hepatitis (HCV and HBV), which not only impairs the therapy but also increases the incidence of liver cirrhosis and cancer unseen in moderate alcohol drinking or drug use alone. Therefore, the new NIH institute must include studies on interactive mechanisms and risks associated with more moderate social and binge drinking combined with legal or illicit drugs.

 
163 05/01/2012 at 02:35:35 PM Self     Research on Alcohol and Fetal Alcohol Associated disorders should not be simply melded in to institutes without being cognizant of the likely negative effect it will have on this area. The study of alcohol's actions both on the adult and on the developing nervous system represents unique challenges to investigators. The experimental designs and questions share little in common with other drugs of abuse. Most of the abused drugs have primary receptor targets and accepted sites of action. This is not so for alcohol. Alcohol researchers understand that alcohol can and does have multiple sites of action and this understanding is factored into our analytical approaches and desgins. Further, prenatal alcohol is not a matter of NISUDA since the fetus is not a drug seeking entity. It is more than likely that fetal alcohol research in this institute will be seen as a very poor cousin. The mission of fetal alcohol research is to understand the unique insult that alcohol represents to the developing nervous system. There is no real overlap between fetal alcohol research and the mission of a substance abuse and addicition disorders institute. Funding will disappear for this most vulnerable population.

How will you ensure that alcohol and FASD research will continue being an add on to an institute that shares none of the goals of FASD research and disrespects alcohol research? Merging institutes and forcing research into this or that pigeon hole almost guarantees is demise.

 
164 05/01/2012 at 04:05:30 PM Self   Charlottesville, VA   I am writing to express concern that the planned institute maintain a focus on HIV/AIDS within the context of alcohol and drug use. People at risk for HIV/AIDS in the U.S. and those living with HIV/AIDS commonly use and sometimes abuse drugs and alcohol, and the treatment of one condition complicates and interacts with treatment for the other. People with such comorbidities have complicated needs from both a prevention and a treatment perspective; these complications are best addressed by scientists with strong expertise in both. Maintaining an HIV/AIDS portfolio in the new institute will be crucial to adequately address the scientific issues that remain in order to optimize life and healthy years for those affected. Studying HIV and drug use together is especially important because we now understand that treatment is prevention. The scientific scope of the new institute should include prevention and treatment studies in the area of HIV/AIDS. Typically, these types of studies have not been done in NIAID, which funds more basic science for HIV/AIDS such as molecular and biological studies and pharmacotherapy development work. The staff at NIAID do not have the lengthy track record of knowing the literature and understanding what the field needs to move forward. The nuanced expertise of key NIDA and NIAAA program officials about the complicated intersections of HIV and substance use is not currently present in NIAID, and the unique needs of those living at this intersection are best served by scientists with sophisticated perspectives on addiction. I strongly encourage those who are shaping the scope of the science to be conducted at the new institute to consider carefully that a significant portfolio of HIV/AIDS research should remain at the new institute.

 
165 05/01/2012 at 08:48:39 PM Self     I am writing to request that, if a new institute is created for the oversight of addiction-related research, that research related to Fetal Alcohol Spectrum Disorders (FASDs) be included in this institute. The vast majority of women who consume alcohol during pregnancy do so a part of life-long pattern of drinking and addiction. Research on FASDs include studies on alcohol's actions on the pregnant mother which lead to secondary effects on the fetus (e.g., effects related to maternal stress responses) and are best considered in the context of maternal consumption and addictive behaviors. It is critical that all research on alcohol actions are maintained within the same institute.

   
166 05/01/2012 at 10:06:26 PM Self     I noticed that the documents related to the merged version of NIDA omitted any mention of HIV/AIDS. Considering the important relationship between substance (including ethanol) abuse and HIV transmission risk, I assume this was an oversight.

If this was not an oversight--and HIV was omitted by intent--then it is a very poorly conceived approach.

NIH should consider keeping a strong research focus into research that blends HIV and substance use. HIV transmission does not occur in a vacuum, and even in high risk populations, the impact of substance abuse is striking.

 
167 05/02/2012 at 09:43:01 AM Organization Association for Behavior Analysis International Kalamazoo, Michigan. Basic and translational behavioral science has contributed in substantial and enduring ways to our understanding of addiction. The formation of the National Institute of Substance Use and Addiction Disorders (NISUAD) presents an exceptional opportunity to expand upon the crucial role of behavioral science. NISUAD will be uniquely positioned to support basic behavioral research, and to influence its direction.

The discovery that drugs act as potent reinforcers by Charles Schuster (a former NIDA director), Roy Pickens, and Travis Thompson transformed addiction science and led to a range of evidence-based treatments that are still being disseminated across a multiplicity of settings. Basic research also gave birth to pre-clinical models to isolate and assess novel behavioral and pharmacotherapies for addiction.

Cutting-edge basic behavioral research continues on a range of topics in addiction. This work includes the influence of delay discounting on choice for drugs and other risky behavior, the role of associative processes in substance abuse and relapse, the importance of conditioned reinforcers in drug use, and the behavioral economics of substance abuse. Thus, behavioral research continues to transform our understanding, and it promises to lead to new strategies to prevent and treat addiction.

WE URGE THE NEW NISUAD TO PRESERVE A SIGNIFICANT ROLE FOR BASIC AND TRANSLATIONAL RESEARCH OF BEHAVIORAL PHENOMENA. In addition to the behavioral research described above, advances in neuroscience and genetics are increasingly being linked with basic behavioral phenomena. It is truly exciting when behavioral science and allied disciplines come together to form a deeper understanding of addiction. But these advances cannot occur without continued support for basic behavioral research. In any research portfolio, at some point the question will be asked about the behavioral significance of the phenomena under study. Answering this question will require basic behavioral research in animals and humans.

Critical issues that basic behavioral research can address include:

• THE ROLE OF CHOICE AND BEHAVIORAL REGULATION IN SUBSTANCE ABUSE. This includes the choice between drug use and other activities, self-control, delay discounting, modulation of incentive motivation, and response-inhibition in both animal models and in people.

• THE TRANSITION FROM TREATMENT TO COMMUNITY. The point at which an individual returns to the environment in which abuse occurred is a period of great vulnerability. We need to understand the basic processes of how such environments foster use and how to build resistance to these influences.

• THE ROLE OF ASSOCIATIVE PROCESSES, INCLUDING CONDITIONED REINFORCEMENT AND OCCASION-SETTING. These environmental factors contribute to the development of abuse, foster and enhance the impact of addictive substances and activities, and are critical determinants of relapse.

• THE DEVELOPMENT OF QUANTITATIVE MODELS OF DYSREGULATED BEHAVIOR. Such models provide formal content to otherwise ambiguous psychological constructs and thereby guide the identification of neural structures and functional relations that underlie addiction.

• THE ROLE OF ENVIRONMENTAL FACTORS IN RELAPSE. It would be difficult to overstate the importance of conditioning principles in relapse. We know that events paired with drug reinforcers occasion drug use and cravings but we have a poorer appreciation of how to exploit this understanding to program, for example, the generalization from treatment to community and domestic environments or to apply associative processes in predicting or preventing relapse.

• TRANSLATIONAL STUDIES TO IMPROVE TREATMENT. Direct application of behavioral economic principles can be found, for example, in the emergence of contingency management and other behaviorally based approaches to manage, treat, and prevent addictive disorders.

• CONTINUED SUPPORT FOR RESEARCH ON ADDICTIVE DISORDERS IN GENERAL. This includes gambling and other addictive disorders that do not involve drugs. It is our understanding that this support will continue, but we feel that this is so important that we wished to strongly endorse it.

By clearly articulating a role for basic behavioral research, NISUAD can become a leader in basic and translational behavioral science. Our understanding of conditioning processes advanced significantly because of the support of NIDA and NIAAA. With the formation of NISUAD these advances can continue to grow.

DESCRIPTION OF ABAI

This comment is submitted by the Association for Behavior Analysis International (ABAI), a scientific organization of over 6400 members who conduct basic and translational behavioral research with humans as well as nonhuman species. Since its founding in 1974, its membership has been focused on uncovering and applying basic principles of reinforcement and conditioning, principles that have been of enormous value in understanding addictive disorders.

1. INSTITUTIONALIZE A ROLE FOR BEHAVIORAL RESEARCH.

This simple step will sustain scientists involved in basic and translational studies. Here, we mean developing RFAs, RFPs and other funding opportunities for basic and translational behavioral research, and cultivating program officers and study sections with expertise in behavioral science. Without such an institutional commitment behavioral research will be in danger. In fact, the diminished support for basic behavioral research by NSF and NIMH is a serious threat to the sustainability of a field that has made important theoretical, methodological, and translational contributions to the investigation of addiction. This presents an opportunity for NISUAD to become a major influence. NIDA and NIAAA benefited enormously by the research conducted by behavioral scientists, and so will NISUAD if it supports basic research.

2. IDENTIFY BASIC AND TRANSLATIONAL BEHAVIORAL RESEARCH AS A PRIORITY.

This will improve our understanding of all stages of the addiction cycle and in the design of intervention strategies to break this cycle. The development of a substance abuse disorder, its prevention and treatment, and the sustainability of the benefits of treatment are all, in essence, behavioral problems. Any public health effort aimed at the treatment or prevention of substance abuse will include behavioral principles as a central component. Yet our understanding of these principles, and their translation, remains incomplete.

Text of attachment is the same as that of comment boxes.
168 05/02/2012 at 10:40:08 AM Self     Understanding polydrug addiction, and comorbidity with psychiatric disorders

Systems genetics is an important new approach to the identification and mechanistic characterization of the biological pathways underlying complex, multi-dimensional behaviors such as alcoholism and addiction. Many of the earliest methodological and resource developments were supported by NIAAA and NIDA. These methods have been a major avenue toward the model organism research, enabling the validation of behavioral models of alcoholism and addiction, translational and comparative studies of these traits, and an understanding of their relationship to other mental health related phenomena. Systems biology and systems genetics are enabled using model organisms including new advanced rodent populations that make such analyses readily tractable, high throughput analytics including sequence analysis and advanced, integrative computational mechanisms. The importance of recent advances in this area can not be overstated. These methods, once challenged by low precision and lengthy experiment times have now become quite precise and tractable.

A second critical area is in continued research support and infrastructural development in integrative bioinformatics. The needs of behavioral neuroscientists are unique and the complexity, depth and scope of investigation in neuroscience merits special consideration of reference and application ontologies for conditional analysis of the role of biological entities in neurobehavioral processes, anatomical atlases, translational and comparative genomics, and advanced modeling for data integration. None of this can happen without adequate financial and cultural support for data sharing, data repository construction and interoperable, user-friendly and stable interfaces for investigators with diverse research applications. The impact of such systems is to maximize return on research investment by enabling discoveries beyond those for which data were initially generated, and by reducing the time and effort for integration across findings through computation.

 
169 05/02/2012 at 10:44:50 AM Self Furman University Greenville I am aware of many of the arguments for and against this merger. I have received some small grant funding in the past from both NIAAA and NIDA as my interests are in addiction in general.

My primary concern is that any potential sharing of resources reflect the disproportionately high burden of alcohol use disorders on individuals, families, and communities.

It's irrational to let personalities or politics, rather than empirical evidence of costs, drive funding allocation.

Fair allocation of resources to investigations based on physical, mental and social burden rather than on what is deemed new, clever or likely to make a big splash in the press. I once heard alcohol described as a 'career inhibitor' because its mechanism of action is so messy. Yet, clearly, the costs are tremendous and so it is important that this drug have high priority for funding.

 
170 05/02/2012 at 10:47:59 AM Self     Most American adults who drink alcohol are not alcoholic but rather moderate drinkers. Therefore, I would hope that this new institute would include the study of health benefits and risks associated with more moderate social and binge drinking. This includes investigation of social factors that influence the initiation and maintenance of drinking habits.

   
171 05/02/2012 at 10:49:05 AM Self     Developing strategies to enhance stakeholder interest in developing medications to treat various addictions, including nicotine and alcohol: I believe that this is a critical issue on which the new institute should focus. Pharmacotherapy, which is the centerpiece of therapies for virtually all other psychiatric and medical disorders, has been relegated to a minor role in most addiction treatment. Efforts are needed to conduct proof-of-concept research that will promote involvement by industry in the development of safe and efficacious medications to treat alcohol and drug dependence.

Engaging the medical community in prevention and treatment of drug addiction and alcoholism: This too is critical insofar as most medical practitioners do not feel competent to recognize or intervene with addicted patients, which delays treatment and denies patients the benefits of early intervention. Encouraging patient recognition and utilization of effective substance abuse treatments: The focus on involving industry will only be successful if patients recognize the potential utility of available treatments. There currently exists a societal bias against medical treatment of addictions that will require thoughtful and science-based efforts to educate and interest patients and physicians in addiction treatments. Alleviating the translational bottleneck for treatments to move from the bench to the bedside to the community: There is, at present, little incentive to translate treatments. Thus, in the face of resistance borne of traditional views of recovery, translation is minimal. A concerted effort that incorporates both alcohol and drug addiction research is needed to improve this situation. Improving prevention efforts by developing a better understanding of the patterns and trajectories of drugs of abuse and their influence on brain development: Longitudinal studies that provide genetic, neuroimaging, and psychosocial data to address these issues are limited and the joint effort of alcohol and drug abuse researchers is needed to remedy this situation.

Targeting efforts to prevent substance abuse in adolescents and young-adults: Science-based policy is seriously lacking.

I believe that the following, related issues, are the most important to be addressed by NIH and will contribute to the achievement of the other goals:

Developing strategies to enhance stakeholder interest in developing medications to treat various addictions, including nicotine and alcohol

Engaging the medical community in prevention and treatment of drug addiction and alcoholism

Encouraging patient recognition and utilization of effective substance abuse treatments

Improving prevention efforts by developing a better understanding of the patterns and trajectories of drugs of abuse and their influence on brain development

 
172 05/02/2012 at 11:06:29 AM Self     Creative synergies may occur as this new institute is formed. I hope that the effects of drugs in combination (e.g., alcohol & nicotine, alcohol & energy drinks, alcohol & cocaine) may receive greater attention in the new institute. However, I am concerned that alcohol-related research will not receive the same level of funding that would have occurred had it been in its own institute.

As a scientist currently funded by NIAAA, I am concerned that the budget of the new institute be revenue-neutral across NIH. Estimates of the public health burden of substance use and abuse indicate that approximately 1/3 are alcohol-related. Research efforts should closely match the public health burden. Behavioral and social science research examining excessive alcohol consumption must continue if public health advances are made.

 
173 05/02/2012 at 11:13:46 AM Self     1. Should fetal alcohol spectrum disorders (FASD) research be excluded from the new institute?

2. What would be the financial cost of this structural re-organization?

3. What would be the impact of the re-organization on ongoing research programs, including those on FASD?

4. Should the scope of the new institute be broader than addiction?

· The majority of American adults that drink alcohol are not alcoholic but rather moderate drinkers. Therefore, this new institute must include the study of health benefits and risks associated with more moderate social and binge drinking. · For a new institute on substance use and addiction, the research portfolio must include health promotion. Alcohol is unique in many ways with its health promoting effects at low doses (in the majority of the adult population) and danger with excessive use. Educational programs (and their evaluation) are critical for the youth and public at large. · NIAAA has utilized a “systems biology” approach to its efforts addressing the impact of alcohol on the entire body and organ systems. This has served research well since alcohol has such a wide array of effects on the organism. There has been some suggestion about removing certain areas of alcohol research (prenatal alcohol exposure and end organ damage as examples) to other institutes. This type of isolation would have devastating effects on these areas of research. It is critical that all aspects of alcohol research remain within this new institute. Fetal alcohol research, as an example, needs to be within an institute that focuses its research program on how alcohol affects not only brain but various organ systems, immune function, behavior, etc.

 
174 05/02/2012 at 11:15:00 AM Self     Because estimates of public health burden indicate it to be about one-third alcohol-related (and one-third tobacco related plus one-third related to illicit and misused prescription drugs), it is essential that budgetary allocations to alcohol-research be maintained or increased if the new Institute is formed.

Additionally, because alcohol is a legal beverage, an agenda associated with illicit drugs may distract from the larger public health burden associated with alcohol use.

Importantly, the scientific directions for the new institute should not be based on the assumption of a common etiology/neuropathway for all the included disorders (e.g., see attached manuscript by Oscar-Berman & Marinkovic). Differences in drug action suggest many distinctive etiologies, processes, and consequences, along with multiple targets for effective treatments and medications.

Splitting research on the cause of a disease from its consequences most likely will slow progress, as will trying to develop approaches to ameliorate these disorders without reference to the factors that contribute to the disease process. Furthermore, the cause of these diseases goes beyond mere alcohol exposure, and includes complex social and family dynamics; separation of these lines of research into different institutes would defeat the very purpose of a new, consolidated, institute.

Moreover, behavioral, developmental, and social science research, along with epidemiology, prevention, treatment (medical and behavioral), and policy research, must be emphasized equally with bioscience in the new institute if public health advances are to be made; that is, the new institute should not be exclusively devoted to neuroscience.

PDF copy of article: “Alcohol: Effects on Neurobehavioral Functions and the Brain” by Marlene Oscar-Berman and Ksenija Marinkovic; published by Neuropsychology Review in September 2007 (vol. 17 no. 3)
175 05/02/2012 at 11:16:05 AM Self     The inclusion of research on all substances of abuse (i.e., alcohol, tobacco, illicit drugs, prescription drugs) under one institute will not only allow for more efficient conduct of important science that improves the nation's health, it will also allow for cross-pollination that may be somewhat stifled by housing these research areas across multiple research institutes. I am also writing to advocate that research areas which intersect with substance abuse (e.g., HIV, women's health, violence, health services, criminal justice and mental health) also be included in the portfolio of the new institute to better add to scientific knowledge about substance abuse. This would capitalize on the critical work already being done by NIDA and NIAAA and allow the new institute to have continued leadership in these fields.

I think the most vital issue to address is incorporating all substance abuse research into one institute, specifically for the reasons noted above (i.e., efficiency and cross-pollination).

 
176 05/02/2012 at 11:22:36 AM Self Center for Study of Addictions Philadelphia, PA 19104-6178 1. Progress in the Science of Addiction 2. Progress in treating patients successfully 3. Progress in teaching clinicians how to diagnose and treat all addictions

1. The field is currently separated artificially into alcohol and drugs. Based on my experience as a clinician, I realized that alcoholism was just another form of addiction and my patients did not segregate themselves as the NIH did. I founded in 1971 a treatment and research center for all addictions at Phila. VAMC and began studying alcohol and other drugs. Using animal models, we found that the endogenous opioid system was activated by alcohol and that blocking opioid receptors reduced alcohol reward. I got an IND in 1983 to test naltrexone in my alcohol patients and found that it was effective. There was great resistance in the "alcohol community" to reports that a drug for heroin also helped alcoholics. We pursued this to FDA approval and now another opioid antagonist is being used in Europe for alcohol, but the reaction of the alcohol field has delayed acceptance of an effective treatment. I teach and I treat patients more effectively by taking care of all addictions. I have received grants from both NIAAA and NIDA and research awards from both fields. The merger will help progress in research as well as treatment of patients.

 
177 05/02/2012 at 11:30:38 AM Self     See attachment.

  Criminal Justice Populations at Risk for HIV and Substance Abuse. There is substantial evidence that criminal justice populations are at disproportionately high risk for HIV infection from both injection drug use and unprotected sex. Furthermore, medication-assisted therapy, such as methadone, buprenorphine, and naltrexone, has been underutilized in the treatment of criminal justice populations. There are over six million individuals in the criminal justice system in the US. It is critical to study this population for the following reasons: 1) they have a fourfold involvement in drug use and other HIV risk behavior compared to the general population, 2) the high proportion of minority populations, 3) the relatively higher prevalence of HIV among women in this group, and 4) the high prevalence of many challenging co-morbid conditions and the many potential barriers to receiving HIV care in the community for this marginalized and stigmatized population. Finally, addressing HIV simultaneously with substance abuse is of high public health relevance because of the need to greatly improve access to treatment (substance abuse and HIV) for at-risk populations (those under criminal justice supervision) to stem the tide of HIV infection and drug dependence in the United States.
178 05/02/2012 at 11:32:02 AM Self     The majority of American adults that drink alcohol are not alcoholic but rather moderate drinkers. Therefore, this new institute must include the study of health benefits and risks associated with more moderate social and binge drinking.

For a new institute on substance use and addiction, the research portfolio must include health promotion. Alcohol is unique in many ways with its health promoting effects at low doses (in the majority of the adult population) and danger with excessive use. Educational programs (and their evaluation) are critical for the youth and public at large.

NIAAA has utilized a “systems biology” approach to its efforts addressing the impact of alcohol on the entire body and organ systems. This has served research well since alcohol has such a wide array of effects on the organism. There has been some suggestion about removing certain areas of alcohol research (prenatal alcohol exposure and end organ damage as examples) to other institutes. This type of isolation would have devastating effects on these areas of research. It is critical that all aspects of alcohol research remain within this new institute. Fetal alcohol research, as an example, needs to be within an institute that focuses its research program on how alcohol affects not only brain but various organ systems, immune function, behavior, etc.

2) Extensive experience in the alcohol field has shown that public health is best served by researching medical complications of alcohol use (FASD and Liver disease) in concert with the factors that contribute to excessive alcohol consumption. The increasing appreciation of the enormous impact of these downstream consequences by those studying consumption patterns, along with increasing support from NIAAA, led us to understand just how significant were the associated public health burdens. In particular, the systems biology approach encouraged by NIAAA has been extremely effective in addressing the impact of alcohol on organ systems. Splitting research on the cause of a disease from its consequences most likely will slow progress, as will trying to develop approaches to ameliorate these disorders without reference to the factors that contribute to the disease process. Furthermore, the cause of these diseases goes beyond mere alcohol exposure, and includes complex social and family dynamics; separation of these lines of research into different institutes would defeat the very purpose of a new, consolidated, institute. Prevention efforts hinge on public communications about these potential outcomes. These are the very synergies NIH seeks.

 
179 05/02/2012 at 11:53:17 AM Organization American Psychiatric Association Arlington, VA The American Psychiatric Association is pleased to submit comments regarding the proposed National Institute on Substance Use and Addiction Disorders (NISUAD). The American Psychiatric Association (APA) is a national medical specialty society whose physician members specialize in the diagnosis, treatment, prevention, and research of mental illnesses and substance use disorders. The APA is the national voice for modern psychiatry and represents over 36,000 members. The APA puts forward the following suggested additions to the research strategic plan for the proposed National Institute on Substance Use and Addiction Disorders (NISUAD). We recommend that NISUAD: 1. Longitudinally track the natural history of drug use/abuse & behavioral addictions (tobacco, alcohol, illicit drugs, gambling, etc.) in a large cohort that does not seek treatment starting in early adolescence. Issues of interest would include: progression of use, switches from one drug/behavior to another, natural recovery and relapse, which subset seeks treatment (why and when), interactions with co-occurring psychiatric disorders, and poly drug interactions. The study would also collect genetic data. Such a study would have major implications for treatment and public policy 2. Long-term outcomes for medication assisted treatment (for opioids & alcohol). Questions would be related to need for indefinite treatment, when to recommend taper or termination, how to identify patients who are good candidates for taper, etc. Such a study would look at treatment durations of 1 to 5 years 3. Improving education and training of healthcare professionals and the general public about addictive disorders 4. Biological, psychological, and social factors that promote resiliency and recovery in patients who are "successfully recovered" 5. Models of treatment of substance use disorders as part of population health management, including cost effectiveness and cost offset from other health care expenditures utilizing longer time windows than is typical for these studies 6. Measurement of quality of care across treatment providers and programs and assessing strategies for improvement, including methods for incentivizing improvement, financial or otherwise 7. Providing care outside of specialty care programs as in primary or specialty medical centers, schools, colleges, employee assistance programs and integration with mental health and addiction treatment settings 8. Comparative models of integration of substance use disorders early detection, screening, and treatment into general medical and primary care settings 9. Work with the FDA to address the criteria for approval of new medications especially with regard to the length of abstinence or improvement needed for approval as compared to the criteria for medication approval in the Psychotropic Division 10. Creation of a central bank of blood, genetic, and perhaps brain tissue, similar to what is done for Alzheimer's disease in order to share and examine biological footprints of addictive disorders 11. Where appropriate, treatment outcome studies should include measures of participation in self-help programs, such as Alcoholics Anonymous (AA) and Narcotic Anonymous (NA).

The APA is a long-time supporter of the critical research undertaken at both the National Institute on Alcoholism and Alcohol Abuse and the National Institute on Drug Abuse. We will continue to be a strong advocate for NIH’s much-needed resources to prevent, identify and treat substance use disorders and their impact on co-occurring mental illnesses. The APA stands ready to work with NIH as discussions on the proposed NISUAD move forward.

  May 2, 2012 The American Psychiatric Association is pleased to submit comments regarding the proposed National Institute on Substance Use and Addiction Disorders (NISUAD). The American Psychiatric Association (APA) is a national medical specialty society whose physician members specialize in the diagnosis, treatment, prevention, and research of mental illnesses and substance use disorders. The APA is the national voice for modern psychiatry and represents over 36,000 members. The APA puts forward the following suggested additions to the research strategic plan for the proposed National Institute on Substance Use and Addiction Disorders (NISUAD). We recommend that NISUAD: 1. Longitudinally track the natural history of drug use/abuse & behavioral addictions (tobacco, alcohol, illicit drugs, gambling, etc.) in a large cohort that does not seek treatment starting in early adolescence. Issues of interest would include: progression of use, switches from one drug/behavior to another, natural recovery and relapse, which subset seeks treatment (why and when), interactions with co-occurring psychiatric disorders, and poly drug interactions. The study would also collect genetic data. Such a study would have major implications for treatment and public policy 2. Long-term outcomes for medication assisted treatment (for opioids & alcohol). Questions would be related to need for indefinite treatment, when to recommend taper or termination, how to identify patients who are good candidates for taper, etc. Such a study would look at treatment durations of 1 to 5 years 3. Improving education and training of healthcare professionals and the general public about addictive disorders 4. Biological, psychological, and social factors that promote resiliency and recovery in patients who are "successfully recovered" 5. Models of treatment of substance use disorders as part of population health management, including cost effectiveness and cost offset from other health care expenditures utilizing longer time windows than is typical for these studies 6. Measurement of quality of care across treatment providers and programs and assessing strategies for improvement, including methods for incentivizing improvement, financial or otherwise 7. Providing care outside of specialty care programs as in primary or specialty medical centers, schools, colleges, employee assistance programs and integration with mental health and addiction treatment settings 8. Comparative models of integration of substance use disorders early detection, screening, and treatment into general medical and primary care settings 9. Work with the FDA to address the criteria for approval of new medications especially with regard to the length of abstinence or improvement needed for approval as compared to the criteria for medication approval in the Psychotropic Division 10. Creation of a central bank of blood, genetic, and perhaps brain tissue, similar to what is done for Alzheimer's disease in order to share and examine biological footprints of addictive disorders 11. Where appropriate, treatment outcome studies should include measures of participation in self-help programs, such as Alcoholics Anonymous (AA) and Narcotic Anonymous (NA). The APA is a long-time supporter of the critical research undertaken at both the National Institute on Alcoholism and Alcohol Abuse and the National Institute on Drug Abuse. We will continue to be a strong advocate for NIH’s much-needed resources to prevent, identify and treat substance use disorders and their impact on co-occurring mental illnesses. The APA stands ready to work with NIH as discussions on the proposed NISUAD move forward.
180 05/02/2012 at 12:07:20 PM Self     --Alcohol, in contrast to other substances, has health promoting effects at low/moderate levels. Therefore, health promotion should be part of the research portfolio. --Alcohol has an impact on many organ systems in the body and therefore splitting off some of these (such as prenatal exposure) would have serious negative consequences on these areas of research. It is of critical importance to retain all aspects of alcohol research in the new institute. --It has been clearly established by rigorous research that there are many related non-substance forms of addiction, including, among others, gambling and gaming, that should be part of the new institute, and not split off. --Tobacco use is highly comorbid with alcohol use, and therefore all research related to tobacco should be housed within the new institute, to better serve public health. In particular, prevention and treatment of tobacco use disorder should be included in the portfolio of the new institute, to maintain and promote research synergies. --the emphasis of the new institute should not solely focus on neuroscience, but rather include the full array of scientific disciplines (eg social science, epidemiology, medical and behavioral treatment, policy) to ensure continuing advances in public health.

   
181 05/02/2012 at 12:07:34 PM Self     Alcohol effects are different than the effects of other drugs of abuse, and combining the NIAAA and NIDA will necessarily reduce the emphasis on effects more prevalent or exclusive to alcohol. There has been some suggestion about removing certain areas of alcohol research (prenatal alcohol exposure and end organ damage as examples) to other institutes. This type of isolation would have devastating effects on these areas of research. Fetal alcohol research, as an example, needs to be within an institute that focuses its research program on how alcohol affects not only brain but various organ systems for a comprehensive and integrated understanding of this dreadful result of drinking by pregnant mothers. Withdrawal from alcohol use has hallmarks different from withdrawal from other drugs of abuse, symptoms that may be crucial for development and maintenance of alcoholism and that

The most serious issue will be the loss of integration of alcohol-related studies. The combining of NIAAA and NIDA will de-emphasize the whole-body actions of alcohol, and the interaction of the effects between brain and body.

 
182 05/02/2012 at 12:23:20 PM Organization Loyola University Chicago Alcohol Research Program Mywood, IL 60559 I am a Professor in the Department of Surgery and a member of a trauma research team at Loyola University Chicago Alcohol Research Program. Alcohol is major focus of our research. Since alcohol abuse remains the leading cause of traumatic injury and since it confounds post injury pathogenesis (e.g, end-organ/tissue injury) as well as the outcome from the injury, our studies are directed in elucidating the role of alcohol in post burn pathogenesis and end. Most of our funding comes from NIAAA, I would highly recommend on behalf of our group at Loyola and other groups working in this area elsewhere that alcohol, trauma and end-organ injury should remain a focus of the new institute as any disruption of funding in this area of research may severely hamper the progress in dealing with treatment of patients with alcohol and trauma.

Please see comment 1.

 
183 05/02/2012 at 12:28:55 PM Self     We greatly appreciate your assurance that the collective budget for the new institute will be “revenue-neutral” across NIH. Along with scientific planning, explicit budget planning should precede the standing-up of the new institute. Adjustments in priorities and allocations need to be made to better match the actual public health burden. Prevailing estimates of the public health burden indicate it to be about one-third alcohol-related,one-third tobacco related, and one-third related to illicit and misused prescription drugs (with an as yet unspecified portion to be allocated to other “to-be-determined” conditions---another area for discussion). Such adjustments are essential if research efforts are to come close to matching the public health burden, but will be politically difficult for a new institute administration whose fiscal base derives largely from current allocations as represented in the existing portfolio items.

Prevailing estimates of the public health burden indicate it to be about one-third alcohol-related,one-third tobacco related, and one-third related to illicit and misused prescription drugs (with an as yet unspecified portion to be allocated to other “to-be-determined” conditions---another area for discussion). Such adjustments are essential if research efforts are to come close to matching the public health burden, but will be politically difficult for a new institute administration whose fiscal base derives largely from current allocations as represented in the existing portfolio items.

 
184 05/02/2012 at 01:42:10 PM Self     The majority of American adults that drink alcohol are not alcoholic but rather moderate drinkers. Therefore, this new institute must include the study of health benefits and risks associated with more moderate social and binge drinking. Intimate partner violence, as well as other interpersonal violence is of particular concern in relation to alcohol use. Victimization is associated with subsequent alochol use and perpetration is associated with prior alcohol use. These issues must continue to be of importance in our alcohol research agenda beyond addiction.

For a new institute on substance use and addiction, the research portfolio must include health promotion. Alcohol is unique in many ways with its health promoting effects at low doses (in the majority of the adult population) and danger with excessive use. Educational programs (and their evaluation) are critical for the youth and public at large.

NIAAA has utilized a “systems biology” approach to its efforts addressing the impact of alcohol on the entire body and organ systems. This has served research well since alcohol has such a wide array of effects on the organism. There has been some suggestion about removing certain areas of alcohol research (prenatal alcohol exposure and end organ damage as examples) to other institutes. This type of isolation would have devastating effects on these areas of research. It is critical that all aspects of alcohol research remain within this new institute. Fetal alcohol research, as an example, needs to be within an institute that focuses its research program on how alcohol affects not only brain but various organ systems, immune function, behavior, etc.

Social issues, such as alcohol-related intimate partner violence, rape, and other interpersonal violence, as well as specific health-related issues, such as prenatal alcohol exposure are a critical part of our alcohol research agenda. Addressing addiction in isolation will not be inclusive of these issues. Violence in the home and violence on the street are major social issues that we cannot afford to ignore. In addition to the physical and mental health impact on victims themselves, victims of violence impact our medical and mental health systems.

 
185 05/02/2012 at 01:44:04 PM Self     1. In the alcohol field, we have adopted an approach that involves research from early risk assessment through prevention, to treatment, and to consideration of physical conditions that result from excessive drinking. Relatedly, research on the psychological, family, social, and biological contributors to problem drinking has indicated the importance of each area for understanding and treating this problem. This integrative approach has served our field very well. Etiology research consistently informs prevention and intervention research, as does research on physical sequelae of consumption. In recent years, our focus has become more developmental, and several interesting lines of research concern physical and neuronal consequences of adolescent consumption that, in fact, play a role in continued consumption and so become the object of prevention and intervention research. The level of synergy we have achieved across the whole “lifespan” of alcohol use is very real: it has led to groundbreaking collaborations and meaningful advances in treatment. I consider it a great model for the new Institute.

2. In my view, developmental, behavioral, social science, epidemiology, prevent, treatment, and policy research must have at least the same emphasis as does bioscience in the new Institute. The social science advances in understanding etiology, the development of effective prevention programs, and vastly improved treatment simply must continue. Within the traditional biological health sciences, psychologists and other behavioral professionals have become increasingly central. In part this is because causes of diseases are recognized as combinations of the behavioral and the biological, and in part because, in the end, any treatment required adherence/compliance, which is a behavioral matter.

3. The public health burden is roughly 1/3 due to alcohol, 1/3 due to tobacco, and 1/3 due to illegal drugs or misused prescription drugs. The new Institute has the opportunity to allocate resources in a way that is consistent with the public health burden. It is crucial that funds be allocated to reflect the nature of the burdens to society.

4. A crucial part of my research involves the identification of both common and distinct etiological factors across addictive behaviors: I focus primarily on alcohol, tobacco, and eating disorders. It has been my professional experience that scientists are often less aware of common etiological factors across disorders than they should be, with the result that, for example, tobacco researchers reinvent the wheel that had already been invented by alcohol researchers. The new Institute has the opportunity to facilitate growth in understanding each addictive behavior, by encouraging the kind of synergy across disorders as RSA has cultivated within the alcohol research world.

In my view, developmental, behavioral, social science, epidemiology, prevent, treatment, and policy research must have at least the same emphasis as does bioscience in the new Institute. The social science advances in understanding etiology, the development of effective prevention programs, and vastly improved treatment simply must continue. Within the traditional biological health sciences, psychologists and other behavioral professionals have become increasingly central. In part this is because causes of diseases are recognized as combinations of the behavioral and the biological, and in part because, in the end, any treatment required adherence/compliance, which is a behavioral matter.

The public health burden is roughly 1/3 due to alcohol, 1/3 due to tobacco, and 1/3 due to illegal drugs or misused prescription drugs. The new Institute has the opportunity to allocate resources in a way that is consistent with the public health burden. It is crucial that funds be allocated to reflect the nature of the burdens to society.

May 2, 2013 I am writing to provide my perspective on important issues in the development of the new Institute on Substance Use and Addictive Disorders. At present, my research is largely funded by NIAAA, with some funding from NIDA. I am a member of RSA. There are several things I hope are given full weight as the priorities of the new Institute are developed. 1. In the alcohol field, we have adopted an approach that involves research from early risk assessment through prevention, to treatment, and to consideration of physical conditions that result from excessive drinking. Relatedly, research on the psychological, family, social, and biological contributors to problem drinking has indicated the importance of each area for understanding and treating this problem. This integrative approach has served our field very well. Etiology research consistently informs prevention and intervention research, as does research on physical sequelae of consumption. In recent years, our focus has become more developmental, and several interesting lines of research concern physical and neuronal consequences of adolescent consumption that, in fact, play a role in continued consumption and so become the object of prevention and intervention research. The level of synergy we have achieved across the whole “lifespan” of alcohol use is very real: it has led to groundbreaking collaborations and meaningful advances in treatment. I consider it a great model for the new Institute. 2. In my view, developmental, behavioral, social science, epidemiology, prevent, treatment, and policy research must have at least the same emphasis as does bioscience in the new Institute. The social science advances in understanding etiology, the development of effective prevention programs, and vastly improved treatment simply must continue. Within the traditional biological health sciences, psychologists and other behavioral professionals have become increasingly central. In part this is because causes of diseases are recognized as combinations of the behavioral and the biological, and in part because, in the end, any treatment required adherence/compliance, which is a behavioral matter. 3. The public health burden is roughly 1/3 due to alcohol, 1/3 due to tobacco, and 1/3 due to illegal drugs or misused prescription drugs. The new Institute has the opportunity to allocate resources in a way that is consistent with the public health burden. It is crucial that funds be allocated to reflect the nature of the burdens to society. 4. A crucial part of my research involves the identification of both common and distinct etiological factors across addictive behaviors: I focus primarily on alcohol, tobacco, and eating disorders. It has been my professional experience that scientists are often less aware of common etiological factors across disorders than they should be, with the result that, for example, tobacco researchers reinvent the wheel that had already been invented by alcohol researchers. The new Institute has the opportunity to facilitate growth in understanding each addictive behavior, by encouraging the kind of synergy across disorders as RSA has cultivated within the alcohol research world. Thank you for providing this opportunity for feedback.
186 05/02/2012 at 02:24:07 PM Self     As an alcohol and drug research funded continuously throughout my career (more than 35 years) by NIDA and/or NIAAA, I feel that I am in an unbiased position to provide feedback on the merger and the new Institute on Substance Use and Addictive Disorders. Because I plan to retire soon, I will not personally gain anything from my suggestions. My research has clearly indicated some commonalities between alcohol and illicit drugs (e.g., many similar predictors of early onset in adolescence) and some clear distinctions (e.g., the nature of their associations with violence and their consequences for adult functioning). Therefore, it makes sense that some studies should be funded to focus on common bases for addiction but that others need to take into account the differential nature of alcohol and different drugs in terms of pharmacological effects, legal issues, social norms, and availability. Thus, my first and strongest recommendation is that you do not fold all alcohol research into a drug umbrella and that you ensure that there is as much or more money for both alcohol and drug research as has existed in the past. Given the especially high burden of alcohol use on society, from a public health perspective it is critical to increase the alcohol budget in relation to the drug budget. Furthermore, given the high comorbidity between alcohol and tobacco, it also makes sense, as recommended by the SMRB, that research on the prevention and treatment of nicotine addiction, as well onset and trajectories of cigarette smoking, be included in the new institute’s portfolio.

Another thing that has become clear over the decades I have studied alcohol and drug use is that a multidisciplinary approach that takes into account individual and environmental factors is critical to understand the nature and course of substance use disorders. There is a lot to be gained by examining multiple perspectives from behavioral and social science, genetics, neuroscience, epidemiology, prevention and treatment science, and policy research. Therefore, it is important to continue to fund research in all of these areas and not to focus only on neuroscience or biology.

Finally, it is clear that addiction can be prevented by modifying behavioral and environmental risk factors and enhancing protective factors. Therefore, the new institute must continue to support prevention research including etiology, development, implementation and dissemination of interventions, and evaluation of programs. One way to ensure continued funding of this research is to maintain a division dedicated to prevention. Equally important, of course, is the development and evaluation of new treatment approaches for those who develop addictive disorders. Thus, continued funding of both prevention and treatment belongs in the portfolio of an institute dedicated to studying addictive disorders.

Support research across multiple disciplines, including but not limited to behavioral and social science, genetics, neuroscience, epidemiology, prevention and treatment science, and policy research.

Increase funding for alcohol research independent of other drug use research.

Develop a Prevention Branch in the new institute.

Include research on the development of cigarette use and prevention and treatment of tobacco addiction in the new institute's portfolio.

 
187 05/02/2012 at 02:31:14 PM Self     Understanding the mechanisms by which alcohol and other drugs of abuse increase risk for certain diseases (e.g. HIV/AIDS), particularly when used in combination.

Committed addiction scientists have been working in HIV/AIDS from the start when NIDA's budget doubled and the AIDS budget increased at NIAAA. Scientists were able to reach vulnerable drug-using populations in the US and globally and demonstrate efficacy and effectiveness. Addressing mechanisms and behavior change related to HIV risk reduction fits within the planned merged Institute with scientists who have addiction expertise. This is essential in this research to compliment the full spectrum to understand biobehavioral, social and cultural and gender differences along with health disparities.

 
188 05/02/2012 at 02:34:51 PM Self     Focused funding program for studies of Fetal Alcohol Spectrum Disorder.

40,000 children born each year with damage resulting from the consumption of alcohol by the pregnant woman. An institute on Substance Use and Addiction Disorders may not address the need for a dedicated and focused funding program to support research and discovery in this area.

May 2, 2012 I am writing as an alcohol research scientist and educator who has dedicated the past 33 years of his work to the investigation of the resulting damage from the use of alcohol during pregnancy. I wish to express my concerns regarding the status of programmatic focus for science and discovery related to fetal alcohol research that is likely to be lost or severely limited in the re-organization of NIH institutes that will move the NIDA and NIAAA programs into a new institute on Substance Use and Addiction Disorders. According to the CDC, eleven percent of American women drink alcohol while pregnant and 1% of pregnant women will binge drink during the 3rd trimester of pregnancy. Thus, more than 40,000 babies each year are born having endured exposure to high levels of ethanol, consumed in a binge-like manner by their mothers during the third trimester of pregnancy. While we have begun to understand the types of damage produced by this pattern of ethanol exposure, classified as a component of fetal alcohol spectrum disorder (FASD), we know little about the mechanisms of that damage that would lead us to the interventions to mitigate or otherwise lessen the impact of FASD on the life of the individual. Women who drink during pregnancy do so for a variety of reasons and much of the alcohol consumed during pregnancy is not consumed by individuals who are addicted to the drug. It might seem reasonable that clearly communicating the reality of alcohol consumption on the developing fetus would have a significant impact and lead to the prevention of FASD. However, that is not the testimony of experience over the past 40 years. Our knowledge of the damage ethanol inflicts on the developing fetus has been known since the early 1970s. Nevertheless; the estimated prevalence of fetal damage due to alcohol exposure has remained essentially unchanged, at 1 per 100 live births. Thus, prevention efforts to date have not identified the most effective approach and science must continue to explore the relevant aspects of the consequent damage in order to be equipped with tools to assist those who ultimately are, and will be, afflicted. This is a difficult proposition for many reasons – perhaps most influential is our society’s ambivalence in regards to ethanol as a drug and alcohol as a beverage of accepted social value. I advocate the inclusion of a significant commitment of activities and grant funding to explore FASD science as a component of the Institute on Substance Use and Addiction Disorders. The absence of a significant percent of funds dedicated to this specific area will predictably lead to diminished activity and knowledge. Should this focus be “tasked out” to another institute there is clear concern for its ultimate demise or marginalization. I feel it is imperative that we not lose or diminish the already modest commitment that has supported progress in FASD research to date. Otherwise, the costs to society in raising the children born to mothers who consumed alcohol during pregnancy will continue as an unaddressed burden.
189 05/02/2012 at 03:19:36 PM Self University of Southern California Los Angeles, CA As alcohol-related liver research will be damaged by a proposal that abolishes NIAAA, NIAAA should be maintained. This merger could have a negative impact on the development of treatment for alcohol-related liver disease, such as liver cancer. The following ares will be affected, "understanding the mechanisms by which alcohol and other drugs of abuse increase risk for certain diseases (e.g. cancers), particularly when used in combination."

The following area is important "understanding the mechanisms by which alcohol and other drugs of abuse increase risk for certain diseases (e.g. cancers), particularly when used in combination, such as alcohol and viral infection/obesity" since it is very deadly cancer and almost no treatment is available.

 
190 05/02/2012 at 03:39:25 PM Self     Please see attached letter.

  May 2, 2012 I am a research scientist and educator who has focused for the past 29 years on the issues of the damage alcohol exposure has on the developing central nervous system. I wish to express my concerns on the upcoming re-organization of NIH institutes that will move the NIDA and NIAAA programs into a new institute on Substance Use and Addiction Disorders. My greatest concern is that the research initiatives related to fetal alcohol research will be separated from the larger, alcohol addiction field and hence the fetal alcohol research efforts will likely be lost or severely limited as a result of this re-organization. According to the CDC, eleven percent of American women drink alcohol while pregnant and 1% of pregnant women will binge drink during the 3rd trimester of pregnancy. This means that more than 40,000 babies are born each year who have endured high levels of ethanol, consumed in a binge-like manner by their mothers during the third trimester of pregnancy. We have begun to understand the types of damage produced by this pattern of ethanol exposure, classified as a component of fetal alcohol spectrum disorder (FASD). However we know little about the mechanisms of that damage that would lead us to the interventions to mitigate or otherwise lessen the impact of FASD on the life of the individual. One would reason that clearly communicating the reality of alcohol consumption on the developing fetus would have a significant impact and lead to prevention of FASD. But looking at the experience and history of the last 40 years (since fetal alcohol exposure was first defined), does not demonstrate that assumption. The truth is that the estimated prevalence of fetal damage due to alcohol exposure has remained essentially unchanged since the 1970s, affecting 1 per 100 live births. Thus, prevention efforts to date have not identified the most effective approach and science must continue to explore relevant aspects of the consequent damage in order to be equipped with tools to assist those who ultimately are, and will be, afflicted. I advocate the inclusion of a significant commitment of resources and grant funding to explore FASD science as a component of the National Institute of Substance Use and Addiction Disorders. The absence of a significant percent of funds dedicated to this specific area will predictably lead to diminished activity and knowledge. Should this focus be “tasked out” to another institute there is clear concern for its ultimate demise or marginalization. I, and my colleagues, feel that it is extremely important and imperative that we not lose or diminish the already modest commitment that has supported progress in FASD research to date. Otherwise, the costs to society in raising children born to mothers who consumed alcohol during pregnancy will continue as an unaddressed burden.
191 05/02/2012 at 03:49:39 PM Organization Roudebush VA Medical Center Indianapolis, IN   NIAAA has served a critical role in alcoholic liver diseases and it would be a great disservice to the veterans and Americans with alcoholic liver diseases to abolish NIAAA since broad interests/foci of new NIH institute is not likely to be able to meet their specific needs as NIAAA has done till now.

 
192 05/02/2012 at 04:09:56 PM Self     Critical Issue 1: Insufficient planning for consequence of reorganization. What will the new Institute do? Will all foci of research now covered by NIAAA and NIDA still be covered at the new Institute? If any such foci are lost in the process what institute will address them? Are new foci included?

Effects on the Public: the public may perceive that all addictions are alike, and adopt a least common denominator of concern to all.

Effects on the Scientists: Research on Alcoholism is, by comparison to research on other chemicals of abuse, broad and deep in its scope, addresses an illness adversely affecting more Americans than all other chemicals except nicotine (the current institutes collaborate on nicotine and alcohol quite effectively), underfunded by a substantial sum, and quite advanced in its attention to genetic and environmental influences and its systems approach to organ-system interaction. The scientific depth of perspective and interdisciplinary collaboration (valuable synergy) will be lost by the proposed homgenization.

INADEQUATE PLANNING (fuzzy, undocumented mission)

BUDGET (The approach so far will cost serious money).

SCOPE of research.

LOSS OF SYNERGY resulting from depth of perspective and interdisciplinary collaboration earned by one institute focusing on a ubiquitous illness for a long time.

 
193 05/02/2012 at 07:31:34 PM Organization Howard University Washington, DC "The majority of American adults that drink alcohol are not alcoholic but rather moderate drinkers. Therefore, this new institute must include the study of health benefits and risks associated with more moderate social and binge drinking."

This one area that has not been sufficiently explored in the USA. There are many misconceptions about alcohol drinking as well as alcohol drinking behaviors that hindered the productive research on the beneficial aspects of moderate alcohol on, for example, the cardiovascular system. Many clinical indicatives in Europe have shown that moderate alcohol, improves the survival rate after myocardial ischemia. Others point to the positive clinical evaluation of the cardiac function and stroke co-morbidity of moderate alcoholic versus non-alcoholic as well as versus heavy alcohol drinkers. It is time for NIAAA to take the lead into that direction and put emphasis on the basic and translational research that allows expansion of our knowledge base on the mechanisms related to the beneficial effects on health of moderate alcohol. It should be taken into consideration that we are definitely not advocating to encourage alcohol drinking patterns that leads to addiction or dysfunction, which are different from moderate alcohol consumption.

It is becoming more and more evident that moderate alcohol drinking has beneficial effects on the cardiovascular system as well as co-morbidity outcomes with patients suffering from myocardial ischemia, stroke and certain neurodegenerative diseases. This is an eye opener for other beneficial effects that are still to be discovered. Furthermore, our knowledge base is lacking the mechanisms through whcih modereate alcohol convey its beneficial effects on the health of the patients. This is most important for NIH to address due to (1) the collective and ripple effects and benefits it may have on co-morbidities, (2) the discovery of new alcohol-derived paradigms that help improve health and treatment approaches, (3) the preventive aspect towards disease progression, such as stroke, neurodegeneration, and myocardial ischemia.

 
194 05/02/2012 at 10:52:07 PM Self     It's very important to make sure that behavioral research (both basic research and intervention research) is maintained within the new Institute. I understand that biomedical research is being heavily emphasized at the NIH, but there are still many important contributions that behavioral research can make.

There are pros and cons for grouping alcohol will illicit drugs. Alcohol can be purchased legally and is by far the most commonly used substance in the US. Alcohol is consumed recreationally by many people who do not use other substances, and alcohol is one of the only substances that is actually recommended for use in moderation (e.g., drinking a glass of red wine per day may help to offset risks for heart disease). Grouping alcohol with other substances may obscure the important issues that are unique to alcohol.

 
195 05/03/2012 at 06:33:59 AM Self     I am the Principal Investigator of a NIDA Center of Excellence that was established in 1996 and a senior scientist in the drug abuse research field. I urge NIH to consider the following points when developing the plan for the new institute:

(1) Drug consumption, risky sex, overeating, and gambling are all behaviors. NIH must recognize that both biology AND behavior are important in the science of addiction, and increase the emphasis on behavioral and social science. (2) It is critical to maintain an emphasis on prevention research in the new institute. Prevention has been scientifically demonstrated to be both effective and cost-effective. The value and potential of prevention science has been carefully reviewed in the 2009 IOM report, Preventing Mental, Emotional, and Behavioral Disorders Among Young People. (3) It follows that it is critical to establish a prominent prevention research branch in the new institute, and to provide it with a budget that equals or exceeds the total resources currently devoted to prevention in the various institute branches that will be merged. (4) NIDA, NIAAA, and NCI have all funded research aimed at developing new quantitative methods, i.e., research design and statistical analysis, for behavioral research applications. This has helped move the field forward tremendously. The new institute must maintain this program.

   
196 05/03/2012 at 09:40:09 AM Organization Consumer Advocates for Smoke-free Alternatives Association Birmingham, AL Furthering knowledge of tobacco use and addiction, including co-morbidity with other addiction and psychiatric disorders.

Critical Issues:

Qualify the differences among addiction to smoking, tobacco, and nicotine. We need a better understanding of whether dependence on nicotine is a true addiction, or whether nicotine is being used for self-medication of underlying conditions.

Explore whether the practice of Tobacco Harm Reduction—replacing smoking with nicotine from less hazardous sources—will increase success rates for those with psychiatric and substance abuse disorders.

Evaluate where products fall on the risk continuum and convey this information to tobacco users, so that they can make informed choices.

The issues identified above are interrelated.

Gain a better understanding of dependency and/or addiction related to tobacco use: One critical issue that has not been addressed is to qualify the differences among addiction to smoking, tobacco, and nicotine. Some research suggests that smoking addiction is much more complex than chemical dependency on nicotine. In the first place, smoke may contain additional chemicals that make it more addictive than non-combusted tobacco and more addictive than nicotine itself. In the second place, there is reason to believe that people may become addicted to the motions of the act of smoking and to the visual manifestation of smoke.

Many people use nicotine when they are struggling to remain alert and attentive, or when they are striving for emotional equilibrium. We need a better understanding of whether dependence on nicotine is a true addiction or whether, when separated from other elements in smoke, nicotine is no more addictive than caffeine, which is often employed for similar purposes. We also need to take into account that some people use nicotine as self-medication for underlying conditions.

Nicotine consumption seems to plateau after users find a "level" that is comfortable for them--this is unlike "true addiction" that reinforces itself by constantly requiring the user to increase the dosage to achieve the desired euphoria that is rarely, if ever, associated with nicotine. Many people are able to temporarily quit smoking with NRT, but the success rate falls to less than 10% after just 6 months and continues to fall down to less than 2% after 20 months, well after treatment has ended. Since all indications are that all nicotine will have been metabolized and have left the body within 30 days, relapse after this time is another indicator that it is not a "true addiction" to nicotine, but far more likely to be treating an underlying cognitive deficit that benefits from natural neuro-stimulant alkaloids like nicotine or caffeine.

Increase success rates for those with co-morbid conditions: Selecting the most appropriate treatment is another critical issue because more than 40% of smokers have an active psychiatric or substance abuse disorder. Prescription drugs that target neuronal receptors may exacerbate psychiatric problems. Current and Lifetime Major Depressive Disorder are associated with a lower likelihood of quitting smoking and Current Major Depressive Disorder is associated with greater likelihood of smoking relapse. Nicotine has been shown to reduce symptoms of attention deficit and mood impairments. We need to explore whether the practice of Tobacco Harm Reduction—replacing smoking with nicotine from less hazardous sources—will increase success rates for those with psychiatric and substance abuse disorders.

Evaluate products for comparative risk: The Family Smoking Prevention and Tobacco Control Act has introduced the concept of modified exposure tobacco products, as well as modified risk products. We need to evaluate where products fall on the risk continuum and convey this information to tobacco users. Helping those with co-morbid conditions to transfer their dependence from smoking to less hazardous products may prove to be the most effective treatment method.

 
197 05/03/2012 at 11:33:07 AM Self     I am most appreciative that I have been given this opportunity to express my views regarding the proposed new Institute on Substance use and Addictive Disorders. I have had the benefit of funding from both NIDA and NIAAA over the 20 odd years that I have been actively engaged in research and writing grant applications. However, I believe that there are certain important issues that should be considered in the conceptualization and configuration of this new Institute. One highly significant consideration is what configuration would best serve the public health interest. The alcohol research community has built a strong and cohesive research portfolio that has benefitted from a collaborative, systems approach to understanding the cause of alcohol dependence in concert with its consequences. This includes research into complex social factors as well as genetic and neural factors. The consequences to peripheral organs cannot be separated from brain diseases and are as important a consideration as any other in developing treatments. I can see no benefit to separating any of these research initiatives from each other.

Another issue of considerable importance is the notion that there is a common etiology for all addictive disorders. I have experience researching multiple addictive drugs including ethanol, cocaine, methamphetamine, and morphine, among others. My research has focused on genetic factors that influence sensitivity to these various drugs of abuse and risk for dependence. My investigations clearly show that, although there is some overlap in brain circuitry, different genetic factors impact risk across drugs and the importance of particular biological processes varies as well. There are highly significant differences in drug actions within the brain, so it should not be surprising that there are distinct processes involved and that it is extremely unlikely to identify treatments that are highly effective for all addictive disorders. Support for this opinion is scientifically based. For example, there have been decades of focus on dopamine systems and evidence for the involvement of dopamine circuitry across many addictions, yet dopaminergic drugs have not been effective global treatments for addiction disorders.

Finally, there is the impression that the attention paid to research into alcohol-related problems has been overshadowed by that paid to research into problems associated with illicit drug use. This should not continue to be the case. Alcohol use poses a highly significant burden to society and should be appropriately integrated into the new Institute so that it receives at least equal if not greater attention as do illicit drugs. The health burden of alcohol use to society is greater than that of any of the illicit drugs.

   
198 05/03/2012 at 12:01:49 PM Organization American Society of Addiction Medicine Chevy Chase, MD May 3, 2012

Francis S. Collins, M.D., Ph.D Director National Institutes of Health 9000 Rockville Pike Bethesda, MD 20892

Dear Dr. Collins,

The American Society of Addiction Medicine (ASAM) is pleased to have the opportunity to offer input into the Scientific Strategic Plan for the proposed National Institute of Substance Use and Addiction Disorders (NISUAD); in particular, we hope our comments support the maintenance of research regarding the medical complications of addiction.

ASAM represents nearly 3000 physicians who specialize in the treatment of addiction; many of whom work in research or academic settings that rely on the addiction research outcomes and/or funding provided by the National Institute on Drug Abuse (NIDA) and the National Institute on Alcoholism and Alcohol Abuse (NIAAA). In fact, ASAM members in research and clinical practice alike have benefited from and implemented the advancements in addiction treatment-related science provided by NIDA and NIAAA. Furthermore, ASAM is grateful for the ongoing collaborations between these Institutes and ASAM to advance the science and practice of addiction medicine. We hope the following comments are useful to you as you consider this merger and the realignment of their respective portfolios.

It is our understanding that while the Scientific Strategic Plan will integrate various elements of NIDA’s and NIAAA’s research portfolios; other elements of these portfolios may be moved to other centers within the National Institutes of Health and/or eliminated altogether. ASAM is particularly concerned that the research and science regarding the medical complications of addiction like liver disease, fetal alcohol syndrome, and hepatitis, may be redistributed to the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Child Health and Human Development, or the National Institute of Allergy and Infectious Diseases, respectively, and lose the priority status they held within the addiction institutes. Moreover, these broader disease institutes may not be as sensitive to the co-morbid relationship of these disease states and addiction as are NIDA and NIAAA. Should this element of addiction research and associated funding fade within a reorganized NIH, addiction treatment providers, their patients and the public will suffer.

The members of the American Society of Addiction Medicine have been both beneficiaries and supporters of the life-changing research put forward by NIDA and NIAAA. We look forward to future collaborations with a new National Institute of Substance Use and Addiction Disorders that advances the current research portfolios of the NIDA and NIAAA and, consequently, the implementation of the NISUAD’s contributions in addiction treatment settings and training programs nationwide.

  May 3, 2012 The American Society of Addiction Medicine (ASAM) is pleased to have the opportunity to offer input into the Scientific Strategic Plan for the proposed National Institute of Substance Use and Addiction Disorders (NISUAD); in particular, we hope our comments support the maintenance of research regarding the medical complications of addiction. ASAM represents nearly 3000 physicians who specialize in the treatment of addiction; many of whom work in research or academic settings that rely on the addiction research outcomes and/or funding provided by the National Institute on Drug Abuse (NIDA) and the National Institute on Alcoholism and Alcohol Abuse (NIAAA). In fact, ASAM members in research and clinical practice alike have benefited from and implemented the advancements in addiction treatment-related science provided by NIDA and NIAAA. Furthermore, ASAM is grateful for the ongoing collaborations between these Institutes and ASAM to advance the science and practice of addiction medicine. We hope the following comments are useful to you as you consider this merger and the realignment of their respective portfolios. It is our understanding that while the Scientific Strategic Plan will integrate various elements of NIDA’s and NIAAA’s research portfolios; other elements of these portfolios may be moved to other centers within the National Institutes of Health and/or eliminated altogether. ASAM is particularly concerned that the research and science regarding the medical complications of addiction like liver disease, fetal alcohol syndrome, and hepatitis, may be redistributed to the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Child Health and Human Development, or the National Institute of Allergy and Infectious Diseases, respectively, and lose the priority status they held within the addiction institutes. Moreover, these broader disease institutes may not be as sensitive to the co-morbid relationship of these disease states and addiction as are NIDA and NIAAA. Should this element of addiction research and associated funding fade within a reorganized NIH, addiction treatment providers, their patients and the public will suffer. The members of the American Society of Addiction Medicine have been both beneficiaries and supporters of the life-changing research put forward by NIDA and NIAAA. We look forward to future collaborations with a new National Institute of Substance Use and Addiction Disorders that advances the current research portfolios of the NIDA and NIAAA and, consequently, the implementation of the NISUAD’s contributions in addiction treatment settings and training programs nationwide.
199 05/03/2012 at 12:23:23 PM Self     All of the areas are of importance, but none require folding NIAAA into NISUAD. Such arrangements that cut across institutes can be facilitated administratively. For example, Clinical Nutrition Research Units (of which I was one director for 20 years) cross from NIDDK into NCI and even NIAAA. Most of my points follow in comment 2.

The most important issue in this plan is abolition of NIAAA in favor of a laundry list of drug alcohol reactions. Alcohol is the most widely abused drug worldwide, and unlike most other drugs, has wide ranging multi-organ system diseases. Chronic alcoholism encompasses in particular fetal alcohol syndrome, neurologic, cardiac, nutritional, gastrointestinal, cancers, and hepatic diseases. Maintaining the focus within one institute has worked well for since inception of NIAAA, and this should not be abolished in favor of a narrow focus on drug interactions.

 
200 05/03/2012 at 01:09:03 PM Organization Friends Research Institute Baltimore, Maryland see below

see below

Thank you for the opportunity to comment on the creation of a single institute at NIH that is focused on the science necessary for the alleviation of addictions. I am writing from a fairly unique point of view. I directed the NIDA Medications Development Program from 1996 through 2008 and am familiar with the challenges and opportunities presented in addiction research. Thus, I would like to comment on the following four areas: MEDICATIONS DEVELOPMENT The development of medications for addictive disorders would be better served in one institute rather than two. The combination of the programs would recognize that a strategic, coordinated effort is needed to encourage the coordination of government, academia and industry to solve this most important health issue in society. A coordinated medications development program would be able to address the following: 1) patients with drug dependence disorders often have multiple drug dependencies, including alcohol and other drugs. In fact it’s really unusual to see patients with only one drug dependency; 2) patients with multiple drug dependencies may respond differently to medications; e.g., modafinil reduced cocaine use in those without a current alcohol dependence diagnosis but did not reduce use in patients who were cocaine and alcohol dependent (Anderson et al, Drug Alcohol Dependence 104:133-139, 2009); 3) there is an unmet need to develop medications for the treatment of cannabis, cocaine, phencyclidine, and methamphetamine dependencies; there is still a need to develop newer and better medications for the treatment of drug dependencies for which some treatments already exist: alcohol, nicotine, and opioids; 4) “Big Pharma” is moving away from central nervous system indications, including addictions. Although medications for treatment of addictions have never been a high priority target for “Big Pharma”, they are even less so now. A central focus of medications development for addictions would be better able to facilitate development with small to medium size industry partners. Combining the respective medications development portfolios of NIDA, NIAAA and any other medications development efforts assigned to the new institute would give the new medications program additional leverage to engage pharmaceutical stakeholders. 5) Combining the medications programs of the two institutes into one program will house individuals with a set of competencies that are not found in pharma; i.e, development of medications for addictions. I remember discussing a smoking cessation project with a pharmaceutical company that had 18,000 employees. One of the reasons that the company was reticent to collaborate on the project was that there was no one on the staff who knew anything about developing medications for smoking cessation. The expertise of the extramural scientists in the combined medications development program will be able to facilitate development with pharma for the whole panoply of addictive disorders. 6) Translation of discoveries in the combined basic and clinical neurosciences portfolios of NIDA and NIAAA to medications targets would be enhanced by the new institute. THE AIDS RESEARCH PORTFOLIO I think it is also critical that the AIDS research portfolios of NIDA and NIAAA be housed in the new institute. It has become appreciated that the transmission of HIV is not only seen in injection drug users but is also seen with non-injection drug and alcohol use. The AIDS research programs of these institutes are working to develop prevention and intervention strategies aimed at reducing the prevalence and spread of HIV. Studies of the behavioral aspects of HIV transmission, and its relationship to drug and alcohol use, belong in the new institute. Another critical aspect of the AIDS portfolio is the interaction of treatment for addictions medications with medications for the treatment of HIV disease. Researchers have done an excellent job of characterizing the pharmacodynamic and pharmacokinetic interactions between these classes of medications, giving clinicians crucial information on drug-drug interactions. This is another area that would be best located in the new institute. Similarly, the Hepatitis C portfolio of the two institutes should be located in the new institute. Studies of the behavioral transmission of Hepatitis C in drug using populations and the exacerbation of liver pathology by combined alcohol intake in Hepatitis C infected individuals are other areas that should go to the new institute. NON-DRUG ADDICTIONS The term “addiction” in Psychiatry has been confined to describing compulsive behavior patterns associated with problematic drug use. In more recent years, compulsive gambling, internet addiction, and addiction to food and sex have received serious consideration for classification as addictions. The portfolio of research on these behaviors should be assigned to the new institute. The neurobiology of these behaviors can be compared and contrasted to the neurobiology of drug addictions. This approach will enrich our understanding of these behaviors and likely result in new treatment approaches for these disorders. PRIORITIES FOR NIH I consider the AIDS portfolio and the medications development issues as the two most important to address in creation of the new institute. These two areas would likely constitute ~ 1/3 of the funding for the new institute. Thus, I think their assignment into the new institute is “mission critical”. Parsing parts of these programs into other NIH institutes will be a detriment to the advancement of the science and retard the development of better treatments for these disorders for American society. Thank you for the opportunity to comment on this important issue.
201 05/03/2012 at 02:00:04 PM Organization University of Texas at Austin Austin, TX An effort to determine the commonalities and interactions, as well as differences, among different classes of drugs (e.g., alcohol and psychostimulants) would greatly facilitate interactions and collaborations among researchers working on one class of drug.

An effort to understand how environmental factors (such as social status, dietary habit, exercise/ sport activities, other habits) influence the brain and the susceptibility to drug addiction and other addictive behaviors would not only help prevention but may also help developing ways to intervene with young developing brains at the initial stage of addiction.

An effort to pursue off-label usage of FDA-approved drugs for addiction would greatly benefit the public. It is important to note that epidemiological data may not be available for addiction (e.g., whether addicts taking antihypertensives have lower relapse rate) because addicts tend to be young and also not willing to pay attention to their health (blood pressure, blood glucose level, etc.) and seek medical service. Furthermore, pharmaceutical companies may not be interested if the patent has expired for that drug.

Investigating how pharmacotherapy interacts with psychotherapy would touch the core of drug addiction, which is driven by drug-induced learning and memory processes.

I would say encouraging the pursuit of off-label usage of FDA-approved drugs for addiction. I think it would be a very efficient usage of taxpayer's money.

 
202 05/03/2012 at 02:21:51 PM Organization Waggoner Center for Alcohol and Addiction Reserach Austin, TX A unified addiction research program would allow new approaches and understanding in several areas, which should be emphasis programs:

Promising new medications are emerging for alcohol dependence - are they effective for other dependencies? Genetics of alcohol action in humans and animals are rapidly emerging - do the same gene influence sensitivity or dependence on other drugs? An integrated systems biology approach is needed which requires study of all organs, not just brain. Organ damage for all drugs must be part of the new institute.

Research funding should reflect economic impact of the condition and nicotine and alcohol use must be the major emphasis of the new program.

Reorganization of addiction research at NIH must be guided by experts with a wide range of expertise in addiction, including a background in actions of the key drugs, nicotine and alcohol, and a deep appreciation of psychosocial aspects, organ damage, medication development and genetics.

 
203 05/03/2012 at 03:57:43 PM Self     Concerning the impact on the quality of biomedical research on alcoholism and, in particular, the unique aspects of alcohol relative to those of other drugs of abuse, by far my major concern is the lack of basic understanding of the pharmacology of alcohol by non-alcohol drug abuse researchers. With all due respect to my learned non-alcohol colleagues, there are fundamental differences in the pharmacology of alcohol and I have experienced over the past 25 years of work in the field numerous instances of outright ignorance of the basic science of alcohol by reviewers. First, alcohol does not interact on a strictly ligand-receptor basis as does any other major class of drug of abuse - save that of the abused inhalants. The interaction of alcohol with its numerous binding sites is not saturable, it is of very very low affinity and therefore does not exhibit the trademark pharmacological characteristics of other drug of abuse. As a result of such fundamental misconceptions by non-alcohol drug abuse researchers, I have experienced numerous instances in my career of scientifically-invalid comments. I should state I have been continuously funded by NIAAA since 1992 and I am absolutely mortified - not for myself - I am established and capable of weathering this huge error - but for young investigators being subjected, in this critically dollar-poor time, to reviews by individual who have virtually no real cogent understanding of alcohol actions.

Furthermore, there are fundamental differences in the nature of brain targets of alcohol relative to that other drugs. Alcohol is by far the most pleiotropic drug known to man. As of today, I can recount at least two dozen molecular targets through which pharmacological concentrations are known to directly interact. These include numerous ligand-gated ion channels, numerous G-protein coupled receptors, a variety of kinases, phosphatases, transcription factors, neuroimmune modulators and the list becomes even more extensive every month. It is only by concentrating one's career in this specific drug of abuse, can one adequately review and comment on the work of others.

When these two prior points are taken in combined consideration, I can insure the NIH that combining the portfolios of alcoholism with that of other drugs is a monumental mistake which will promulgate a huge disservice to both arenas. When one further considers that the dollar and medical costs due to alcohol are already woefully under-represented by biomedical research appropriations, I predict that such an administrative move would constitute the death knell for the basic alcohol research and fundamentally reverse the major advances made by myself and my colleagues over the past 20 years.

There is another issue I have as well - concerning the public welfare in general: the disintegration of an institute dedicated to ALL aspects of alcoholism and its abuse will result in serious negative repercussions to those aspects of alcoholism not directly related to brain mechanisms of addiction. For instance, prenatal and perinatal neurotoxicities are endemic to alcoholism and yet separating those components of biomedical research from those related solely to addiction will result in a rift between those very closely related disciplines. I know this for a fact since I first entered the field on a project related to synaptic plasticity deficits due to prenatal exposure and my discoveries directly impacted our understanding of ethanol-NMDA interactions due to direct brain exposure as in abuse. For my work, I received the RSA Young Investigator award. If the proposed unit structure existed then, I doubt that the basic research in the prenatal area would even funded - I am not aware for any adequate representation for funding non-addiction related alcohol effects - this concern applies not only to prenatal effects but also hepatic and other organ system toxicities and related effects of abuse.

Converse to this proposal, the NIH administration and Congress needs to re-visit concepts controlling the level of funds appropriated for alcoholism and its related disorders in comparison with those of drugs of abuse in general. Alcohol is by far responsible for the greatest medical and economic costs and yet the support for other drugs of abuse is much much greater. One major reason for this discrepancy is the remnant belief that alcoholism is a bad behavior of choice - nothing could be more further from the truth. Adopted twin studies long ago documented a genetic predisposition for the disease and yet funding remains low. It seems that Congress could recognize the reality of modern biomedical research and in such difficult times address the problems which need addressing the most. We are at the cusp on testing novel agents for alcoholism and my understanding NIDA has been quite unsuccessful in this regard. I beg Congress to intercede on the behalf of researchers who have dedicated their careers to addressing the true and major problem of substance abuse in our society - alcohol.

 
204 05/03/2012 at 04:47:39 PM Self     1. Abuse and dependence on alcohol and nicotine impose a much greater societal burden than illicit drugs in terms of economic cost and numbers of individuals affected. However, the current institute structure has invested substantially fewer dollars in research on alcohol and nicotine compared to research on illicit abused drugs (e.g., heroin, methamphetamine, cocaine). The new institute should correct this imbalance and devote a much greater proportion of its aggregate budget to research on alcohol and nicotine, including research on interactions between those drugs and illicit abused drugs.

2. Poly-drug abuse is common because most individuals abusing illicit drugs also use/abuse alcohol and/or nicotine. Thus, the new institute should strongly encourage research on how alcohol and nicotine contribute to likelihood of relapse to other substances.

3. Much greater emphasis must be placed on understanding genetic differences in the response to alcohol and other drugs and the way those differences contribute to abusive patterns of drug taking and dependence.

4. Animal model research that focuses on processes influencing the maintenance, elimination and relapse of alcohol and drug seeking/taking in animals that are clearly dependent must be encouraged. Many (most?) of the current models of “relapse” (reinstatement) do not involve dependent animals and their relevance to human alcoholism and drug addiction is questionable.

5. Research on the biomedical consequences of alcohol and drug addiction (e.g., liver disease, fetal alcohol syndrome) should NOT be conducted in institutes whose mission does not address research on the causes, treatment and prevention of addiction. These areas of research should be included in the new institute.

6. Greater emphasis should be placed on understanding the patterns of alcohol and drug use in adolescents and young-adults as well as on understanding the neuro-developmental processes that influence the likelihood of developing dependence disorders later in life.

7. Increased effort must be devoted to understanding and removing the barriers to treatment and encouraging health care providers to use treatments that have been found to improve patient outcomes, including medications.

1. Abuse and dependence on alcohol and nicotine impose a much greater societal burden than illicit drugs in terms of economic cost and numbers of individuals affected. However, the current institute structure has invested substantially fewer dollars in research on alcohol and nicotine compared to research on illicit abused drugs (e.g., heroin, methamphetamine, cocaine). The new institute should correct this imbalance and devote a much greater proportion of its aggregate budget to research on alcohol and nicotine, including research on interactions between those drugs and illicit abused drugs.

2. Poly-drug abuse is common because most individuals abusing illicit drugs also use/abuse alcohol and/or nicotine. Thus, the new institute should strongly encourage research on how alcohol and nicotine contribute to likelihood of relapse to other substances.

3. Much greater emphasis must be placed on understanding genetic differences in the response to alcohol and other drugs and the way those differences contribute to abusive patterns of drug taking and dependence.

4. Animal model research that focuses on processes influencing the maintenance, elimination and relapse of alcohol and drug seeking/taking in animals that are clearly dependent must be encouraged. Many (most?) of the current models of “relapse” (reinstatement) do not involve dependent animals and their relevance to human alcoholism and drug addiction is questionable.

5. Research on the biomedical consequences of alcohol and drug addiction (e.g., liver disease, fetal alcohol syndrome) should NOT be conducted in institutes whose mission does not address research on the causes, treatment and prevention of addiction. These areas of research should be included in the new institute.

6. Greater emphasis should be placed on understanding the patterns of alcohol and drug use in adolescents and young-adults as well as on understanding the neuro-developmental processes that influence the likelihood of developing dependence disorders later in life.

7. Increased effort must be devoted to understanding and removing the barriers to treatment and encouraging health care providers to use treatments that have been found to improve patient outcomes, including medications.

 
205 05/03/2012 at 05:12:53 PM Self Center for Study of Addictions Philadelphia, PA 19104-6178 1. Progress in the Science of Addiction 2. Progress in treating patients successfully 3. Progress in teaching clinicians how to diagnose and treat all addictions

1. The field is currently separated artificially into alcohol and drugs. Based on my experience as a clinician, I realized that alcoholism was just another form of addiction and my patients did not segregate themselves as the NIH did. I founded in 1971 a treatment and research center for all addictions at Phila. VAMC and began studying alcohol and other drugs. Using animal models, we found that the endogenous opioid system was activated by alcohol and that blocking opioid receptors reduced alcohol reward. I got an IND in 1983 to test naltrexone in my alcohol patients and found that it was effective. There was great resistance in the "alcohol community" to reports that a drug for heroin also helped alcoholics. We pursued this to FDA approval and now another opioid antagonist is being used in Europe for alcohol, but the reaction of the alcohol field has delayed acceptance of an effective treatment. I teach and I treat patients more effectively by taking care of all addictions. I have received grants from both NIAAA and NIDA and research awards from both fields. The merger will help progress in research as well as treatment of patients.

 
206 05/03/2012 at 08:45:46 PM Self     Addiction has its roots in development so I think a focus on developmental issues will be critical. WE still need to understand how drugs/alcohol affect developing brains and how the developing affects the propensity for addiction throughout life.

developmental effects drug interactions mechanisms that can be targeted for prevention/cure

 
207 05/04/2012 at 01:48:43 PM Self     I have two major concerns about the merger:

First, focusing the mission of the new center solely on addiction will restrict the funding rubric to CNS-related consequences of drug exposure. This would represent a true threat to scientific progress because peripheral physiology (endocrine reactions, dynamic organ system alterations, and other physiological processes) are critical moderators of brain function. Not only does peripheral physiology determine the CNS response to drugs of abuse, it may critically determine whether the individual is driven down the addictive path. This will be especially true for alcohol, as alcohol acts through a wide variety of direct and indirect cellular actions throughout the entire body.

Second, many of the premier researchers in this country have argued that addictive processes are in fact a developmental phenomenon. The past decade has seen a tremendous increase in studies demonstrating that the developmental epoch during which individuals are exposed to alcohol and other drugs of abuse is as critical in determining the outcome of drug exposure as the dose of the drug itself. Indeed, both pharmacokinetic and pharmacodynamic properties of the drug are powerfully impacted by stage of development (fetus, newborn, adolescence, adult, aged). To separate addictive processes from organismic development, therefore, would be a significant step in the wrong direction. Overall, I believe the entire dialogue about merging has generated exactly the type of cross-institution collaboration and generating funding ideas/new strategic goals that NIH had hoped to achieve with the merger. This, combine with a targeted series of program announcements and joint funding ventures within the existing NIAAA and NIDA agencies would probably achieve the desired objective without the major disruption to scientific momentum that already exists through NIAAA and NIDA.

   
208 05/04/2012 at 02:16:07 PM Self     Injecting drug use is an important risk behavior for HIV and hepatitis C virus (HCV) infection. In addition, non-injecting drug use (e.g. crack cocaine, methamphetamine) is also linked to high risk sexual behavior and increased risk of HIV, HCV and a variety of sexually transmitted infections (STIs). In addition to illicit drugs, alcohol high risk sexual practices that increase the risk of HIV and STI transmission and infection. Alcohol use is also linked to more rapid HCV progression to serious liver disease and death. Several studies have also cigarette smoking the progression of HCV disease.

HIV, HCV and STIs are all major public health problems that are linked to use of alcohol and other drugs. Accordingly, I am very concerned that HIV, HCV and STIs do not seem to be a focus area of the institute. The other NIH institutes do not seem to be well-suited for addressing issues related to the intersection of alcohol and other drug and HIV, HCV and STIs. If these public health problems are not among the priorities of the new institute, they are likely to be neglected and an important opportunity for reducing morbidity and mortality among alcohol and other drug users will be lost.

It is critical for the new institute to include infectious diseases (e.g. HIV, HCV, STIs) among its priorities. NIDA and NIAAA have played a leading role in addressing the intersection between alcohol and other drug use and HIV, HCV and STIs for many years. It is imperative that the new institute continue this work.

 
209 05/04/2012 at 04:03:37 PM Self     The new institute should make sure that its portfolio includes research that focuses on behavior.

The new institute should support research on disorders that are co-morbid with substance use, such as HIV.

The emphasis on prevention that currently exists in NIDA should be maintained at least at the current level in the new institute.

Research to advance quantitative methods has resulted in new approaches that have been very beneficial to the substance use research field. Such research should continue to be supported by the new institute.

As the advent of modern technology, the data collected in substance use researches become more and more complicated in terms of data structure, and become more and more difficult to handle in term of data size/volume. Thus, advanced quantitative methods will become more and more important and play critical roles for analyzing the BIGDATA collected in substance use and alcohol use researches.

Research to advance quantitative methods has resulted in new approaches that have been very beneficial to the substance use research field. Such research should continue to be supported by the new institute.

 
210 05/04/2012 at 04:21:16 PM Organization College on Problems of Drug Dependence (CPDD) Philadelphia, PA Please see attached letter

  COLLEGE ON PROBLEMS OF DRUG DEPENDENCE, INC. 2 May, 2012 We are pleased to respond to your request for expert input regarding the proposed research portfolio for the proposed National Institute on Substance Use and Addictive Disorders. As have many scientific societies, we encouraged our members to submit responses that highlight their particular areas of expertise. This document represents a compilation of key points that have been reviewed by the leadership of the College. It is not meant to be comprehensive, but does offer insight into the major themes that we believe should be represented in an institute with a mission to focus on the addictive nature of drugs. The College on Problems of Drug Dependence (CPDD) has been in existence since 1929 and is the longest standing group in the United States addressing problems of drug dependence and abuse. From 1929 until 1976, the CPDD was associated with the National Academy of Sciences, National Research Council. Since 1976, the organization has functioned as an independent body affiliated with other scientific and professional societies representing various disciplines concerned with problems of drug dependence and abuse. In 1991, the CPDD evolved into a membership organization with the new name of College on Problems of Drug Dependence. Currently, CPDD has over 900 members and ~1,400 attend our annual meeting, including scientists from over 50 countries. The organization serves as an interface among governmental, industrial and academic communities maintaining liaisons with regulatory and research agencies as well as educational, treatment, and prevention facilities in the drug abuse field. CPDD supports the notion that the portfolio of this (or any) Institute be based on the science and housed in a foundation that can best translate all of the needed resources needed to complete the Mission Statement of the Institute. A number of high profile methods including molecular, genetic and imaging approaches offer a unique and growing opportunity to accomplish the stated goals. The multidisciplinary nature of substance abuse mandates that in order to successfully advance the field, NISUAD will need to have the breadth and depth of many domains in order to effectively advance our knowledge in the area of detecting vulnerable populations, developing effective preventive strategies, creating and testing safe and reliable medications and behavioral therapies, integrating multiple treatment strategies, and be well positioned to explore the neurobiological basis of the substance abuse and then determine the mechanism of action of the treatments. In this spirit, the CPDD recommends that the budgets be assigned on the basis of the portfolio that becomes part of the Institute. The CPDD Recommendations for the Portfolio of the proposed new NIH Institute (tentatively called the National Institute on Substance Use and Addiction Disorders—NISUAD) include the following: 1. HIV/AIDS. The spread of HIV into a wider band of the population has been shown to be driven by individuals who engage in intravenous drug injection practices, including heroin, methamphetamine and cocaine. Major efforts to provide clean needles within the context of a drug abuse treatment program, offering medications (e.g., methadone/buprenorphine) and drug abuse prevention programs have had a significant impact on not only reducing the spread of AIDS, but on the cost of treating those who are infected. Several classes of abused substances including opioids, cannabinoids, cocaine and nicotine have been shown to alter replication of HIV and SIV in vitro and in vivo by direct effects on the virus and by altering functionality of chemokine co-receptors on target cells, or by altering levels of chemokine production. Historically, drug abusers have been excluded from clinical trials for new medications to treat HIV/AIDS. Thus, developing effective treatments for this important population remains a key component of a strategic plan for reducing the impact of HIV/AIDS. Epidemiologic studies, harm reduction strategies, and basic science approaches investigating how substance abuse and the individual drugs and alcohol contribute to HIV infection, should be part of the NISUAD portfolio. 2. Drug abuse and communicable diseases. The nature of the social and environmental conditions that support a drug abusing population also places these individuals in close proximity with one another such that communicable diseases like tuberculosis, hepatitis, pneumonia, and upper respiratory infections occur at a very high rate in the drug abusing population. Needle sharing contributes to transmission of infectious agents and can result in endocarditis and skin infections with staphylococci and streptococci. Furthermore, it is well established that many abused substances including nicotine, alcohol, opioids, cannabinoids, cocaine, and methamphetamine alter (mainly suppressing) basic immune functions of the body. Many of these substances have also been shown to sensitize to experimental infections with a variety of organisms, including those that are opportunistic organisms in patients with AIDS. Investigation of the mechanisms by which abused substances and withdrawal alter immune function and sensitize to infections should be part of the NISUAD portfolio. 3. In utero exposure to drugs of abuse. As noted above, the exposure to drugs of abuse presents a very special problem to especially vulnerable populations—the unborn fetus is perhaps the most vulnerable of all as they cannot just say “no” and walk away. Prenatal exposure to a known teratogen (alcohol) has been shown to have a widespread impact on the brain, ranging from subtle to extreme, depending on the total amount of exposure and when during the pregnancy the fetus was exposed. We still do not have the most effective and safe methods for treating drug abuse problems in pregnant women. The many functional abnormalities that occur are expressed as behavioral and cognitive problems. The proper management of the addicted fetus and newborn is best orchestrated by individuals who are well informed about the natural processes of the addictive properties of alcohol as well as tolerance, dependence and withdrawal. Furthermore, the unique relationship between a mother and her unborn child is made much more complicated when the mother’s needs do not necessarily match with her child. These are complex relationships that must be addressed very early in the pregnancy and involve a wide range of interventions that include pharmacological, psychosocial, economic and environmental factors. 4. Pain. Pain is the most frequently experienced symptom that leads patients to seek medical advice and treatment. Treatment of severe pain is extremely difficult and, in many cases, opiates are the only drugs that yield any relief. Studies involving pain and analgesia are conducted primarily by NIDA and because pain and addiction frequently occur together, this is another form of comorbid disease. Indeed, the discovery of the opioid receptors resulted from support by NIDA. That discovery also opened the whole field of neuropeptides. Opioids are of limited efficacy in the treatment of some types of pain and, in addition, can result in addiction and prescription drug abuse, two of the major public health problems we have today. The search for new and more effective analgesics that are devoid of addictive properties is of vital importance. Combinations of opioids with other drugs, such as cannabinoids, hold the promise of greater efficacy with fewer adverse effects. In addition, new evidence shows an interplay between products of the immune system, such as chemokines, with the endogenous opioid system in altering pain perception. Investigation of these interactions may elucidate how inflammation leads to opioid-resistant neuropathic pain, and is a research area with great potential. Given the history of the field and the potential to explore new approaches to increase the efficacy of opioid analgesia, NISUAD needs to maintain pain in its portfolio. 5. Developmental changes during early childhood exposure to drugs of abuse. Age-related improvements in higher-order cognitive domains such as executive functions are thought to be related to a marked, later reorganization (pruning) and refinement of the frontal lobe, and improved functional white matter (increased myelination) connectivity within and between brain cortical and subcortical brain regions. During this time there is also an increased propensity to seek out novel stimulation and engage in risk-taking behavior, perhaps due in part to immature cognitive and behavioral response inhibition abilities. Indeed, the addictive process is developmental in nature and may have a significant genetic or familial component to it. Developmental studies reveal that structural, functional, and neurochemical maturation in the healthy adolescent brain occur in brain regions and in cognitive domains that overlap with those observed to be most vulnerable to alcohol exposure. In addition to alcohol, tobacco, marihuana, opiates, stimulants can all have a profound impact on the neurobiological developmental processes that occur from the critical years of age 10- 21. Drugs of abuse have a unique impact on these processes that can affect the subsequent development of a drug abuse problem at an earlier age than if exposure was limited, and therefore the role that these drugs play in developmental processes should be part of the NISUAD portfolio. 6. Interaction of traditional drugs of abuse, tobacco, and alcohol. The fact that alcohol and tobacco are used in combination with so many different drugs (marihuana, opiates, stimulants, sedatives) confirms that this practice is a multi modal problem that requires a focus on not only the pharmacology of the individual drugs, but of the impact of their combinations and how they affect the physiology, incidence if side effects, and pharmacokinetic profile of the other drug[s] that are used in combination. In addition, there are a multitude of drugs that are relatively benign when taken alone, but can have significant negative effects when combined with alcohol. Many prescription and over the counter medications contain between 2.8 and 26.9% alcohol, making it even easier for drug addicted individuals to encounter significant amounts of alcohol. Indeed, abuse of these products has become an ever-increasing public health problem. Furthermore, these interactions can change in alcohol dependent individuals who chronically consume large amounts of alcohol. One of the challenges of treating the addictions is that polydrug abuse complicates the treatment plan and medications that work on a single drug of abuse might not work on individuals who are dependent on more than one drug. 7. Tobacco use and abuse. Cigarette smoking is the leading cause of preventable mortality and morbidity in the USA and contributes annually to almost half a million premature deaths. Smoking cessation is the obvious, but not so simple, solution to reducing multiple forms of cancer (and other serious health problems) in the United States. While it is clear that nicotine replacement therapy (NRT) and medications such as bupropion or varenicline are more effective than placebo, not all individuals respond to these treatments and the vast majority who stop smoking are prone to relapse. As such, continued research into the antecedents of tobacco use (e.g., cues that precipitate craving and relapse) and research to evaluate novel medications for nicotine dependence is critically needed. Directives that focus on the behavior of seeking out and using tobacco products are most effectively orchestrated when the addictive aspects of nicotine and the conditioned reinforcers of tobacco smoke are considered. An entirely different dimension to this problem is tobacco policy research that capitalizes on the known science of the effects of nicotine on biological systems in order to make informed decisions on how all nicotine-containing products should be regulated. Therefore, a comprehensive research program aimed at the full spectra of tobacco use and abuse should reside in the NISUAD portfolio. 8. Neurobiological substrates of reward-based learning, reinforcement, and their modulators. Drugs of abuse powerfully activate brain circuits that normally serve the natural rewards (e.g., food, sex, and social attachment). In a vulnerable subgroup of individuals, exposure to rewarding drugs of abuse leads to the compulsive pursuit of the drug, despite powerful negative consequences and despite attempts to stop. Even when addicted individuals manage to stop for a period, the likelihood of relapse – the return to compulsive pursuit of drug reward, is very high. The answers to fundamental questions for our field – Why do some individuals become addicted, but others do not? Why do some relapse rapidly, while others have prolonged recovery? How can we best prevent/treat addiction and relapse? -- depend heavily upon continued advances in basic research. Important research targets include the neurobiological substrates of reward (the positive hedonics of abused drugs), reinforcement (drug consequences that lead to the learning of drug habits) and the many modulators (context, genetics, and epigenetics) of these fundamental processes. A wide range of tools – to measure environmental influences, to image brain systems, to capture cellular signaling (e.g., neurotransmitter dynamics, drug/receptor dynamics, ion channel physiology), and to characterize gene expression -- will continue to be necessary for advancing progress toward individual biological markers of addiction/relapse vulnerability, for developing tailored interventions, and for predicting treatment-response. 9. Dual diagnosis. Individuals afflicted with a psychiatric disorder have an increased vulnerability to developing an addiction. While many individuals may initiate drug use in an attempt to “selfmedicate” their symptoms, the profound addictive properties of many of these drugs will take over and convert the use from “therapeutic” to destructive. Indeed, about 50% of the individuals who present in the mental health treatment system with a psychiatric disorder ultimately turn out to have an underlying drug addiction as well, and often to more than one drug. Conversely, about 50% of the individuals who present in the substance abuse treatment system with a substance abuse disorder have a mental illness. Thus, the mission of this Institute should be broad enough to encompass the special needs that are applied to the proper differential diagnosis and treatment development plan for individuals who are dually diagnosed. 10. Medication development. While we have approved medications for treating alcoholism, tobacco and opiate addiction, many individuals do not respond to these treatments and they are also prone to relapse even during treatment. It is critical that we continue efforts to identify novel medications for these addictions. Equally, if not more, pressing is that there are no approved medications for the vast majority of other drugs with additive properties (e.g., cocaine, methamphetamine and marihuana addiction). As the pharmaceutical industry continues to close CNS divisions and exit from developing addiction medications, the burden of discovering and applying novel strategies for the pharmacological management of the addictions will fall on NIH and the new Institute for addictive diseases. One promising strategy will be to revisit medications that have gained FDA approval for another indication. Many of these medications are traditionally used to treat neurological disorders such as epilepsy, depression, anxiety, nausea/vomiting, high blood pressure, etc. Ensuring that novel treatments are applied in a manner that optimizes their usefulness as addiction medications will be crucial for their successful development and as such should be highlighted in the NIASUD portfolio. 11. Non Substance-Related Addictions. Though for many decades (since the first DSM in 1952) addictions have been defined by the ingestion of a drug, recent scientific advances are encouraging a fundamental shift in the way we think about, and diagnose, addiction. The newer tools of imaging and genetics are leading the change in perspective. Imaging studies reveal similar brain vulnerabilities (e.g., low D2 receptor availability; poor frontal modulation of downstream reward circuitry) in “classical” drug addiction and in the compulsive pursuit of some non-substance rewards (gambling, food). Genetic studies point to shared heritability for substance and non-substance (e.g., compulsive gambling) addictions. Led by new research findings, the soon-to-be-published DSM-V will include compulsive gambling among the addictions, with the encouragement for continued data collection on other behaviors (e.g., compulsive internet game play, compulsive over-eating) that may eventually be recognized as “non-substance addictions”. We are at an extraordinary scientific juncture in our field – we need to carve new, data-driven, boundaries for the construct that defines our field. The research portfolio of the new institute should reflect this critical mission, helping us to parse pathology from the many pursuits (food, sex, gambling, internet gaming, shopping, exercise, etc.) that activate brain reward circuits. The re-carving of addiction promises a better fundamental understanding of these painful disorders, leading to novel, even “cross-cutting”, interventions with greatly improved efficacy. Finally, we believe that there should be a mechanism in place to reassess the portfolio in 3-5 years with the goal of ensuring that the research directives of the new Institute (as well as any others that were affected by reallocation of programmatic themes) are continuing to be met. One major concern is that while a reallocation of programs may make sense now, as these portfolios are moved around, they could land in Institutes that do not include such ventures in their long-term Strategic Plan. Thus, we could see certain areas of research fail to thrive in a few years after the reorganization. Thank you again for this opportunity to offer our thoughts on how to configure the research portfolio of this new Institute. We are pleased that this has been an open process and look forward to learning how our suggestions have melded with those of other organizations. As we stated last year in our official statement regarding the new Institute, CPDD remains well poised to offer any assistance that you or our task force may need in evaluating these important areas to consider as the new Institute begins to take shape. Please also consider CPDD as a resource for assistance in the search for the director of this new Institute.
211 05/04/2012 at 04:54:38 PM Self     I am an early-career researcher in the field of substance use, with a focus on how motivations and expectancies regarding alcohol and other drug use predict behavior. I am interested in intensive measurement designs that help us understand how behavior and consequences are related, and my work informs prevent efforts among adolescents and young adults. I graduated from Penn State in 2008, with pre-doctoral (F31) and post-doctoral (F32) support from NIAAA. My current research, as an Assistant Professor at the University of Michigan, is funded about equally by NIDA and NIAAA.

I feel that the new institute needs to include the following areas of research that are critical for promoting public health. 1) Behavioral and social science research, along with prevention and intervention work, must to supplement the focus on neuroscience. For example, work in epidemiology documents the scope of the problem, work in development sheds light on critical age periods for intervention, and work in prevention provides evidence for effective strategies. These areas of research are essential for addressing substance use among Americans. 2) The predictors and consequences of alcohol use (a legal substance) are different than predictors and consequences of illicit drugs, and this must be understood and acknowledged in the research agenda. 3) A focus on the associations between substance use and HIV is necessary. 4) Research to advance quantitative methods enhances the substantive research we are able to do, and this focus should continue in the new institute.

It is paramount to highlight social science research as part of the agenda of the new institute. Understanding human behavior is a critical part of intervening to prevent the negative consequences of substance use and addictions in our society.

 
212 05/04/2012 at 06:49:00 PM Self     my main concern about the merger is that it is very likely that liver complications from alcohol will be reduced in funding. this would be due to this topic not fitting in nida scope and having to compete with many other niddk priorities. this would be unfortunate because liver complications of alcohol are the major driver of alcohol related morbidity and mortality

my main concern about the merger is that it is very likely that liver complications from alcohol will be reduced in funding. this would be due to this topic not fitting in nida scope and having to compete with many other niddk priorities. this would be unfortunate because liver complications of alcohol are the major driver of alcohol related morbidity and mortality

 
213 05/04/2012 at 07:29:59 PM Self     The new institute should make sure that its portfolio includes research that focuses on behavior and prevention, and it should support research on disorders that are co-morbid with substance use, such as HIV.

Research to advance quantitative methods has resulted in new approaches that have been very beneficial to the substance use research field. Such research should continue to be supported by the new institute.

 
214 05/04/2012 at 08:28:23 PM Self     Alcohol related liver disesae is an under researched disease in the US and available treatment options are not completely effective. Alcohol related liver disesae is a significant cause of morbidity and mortality with 2nd most common indication for liver transplantation. Abolishing NIAAA and NIDA would seriously affect the research related to alcohol related liver disease ultimately affecting the public and the researchers.

With a high morbidity and mortality from alcohol related liver disease, NIH in my opinion should focus on the research related to alcoholic liver disease. Merging the NIAAA and NIDA with the NIDDK would seriously impact research related to alcoholic liver disease. I sincerely urge the NIH to readdress these issues and not abolish the NIAAA and NIDA institutes to merge with NIDDK.

 
215 05/05/2012 at 01:15:20 AM Organization Policy Solutions Lab Cambridge, MA 02141 There are a few areas worthy of consideration by NIH:

Policy Research. It is critical that the new institute take into account the importance of policy-relevant research. There is a paucity of current data on many policy interventions and NISUAD has an opportunity to dramatically change that reality. Too often, NIDA and NIAAA have hesitated at the chance to conduct true drug policy analysis, likely because this is not seen as "basic" science more typical of NIH institutes (notable exceptions are recent research into drugged driving and the impacts of "medical" marijuana). Given that drug abuse is a complex bio-behavioral disorder, sharing many -- but not all -- of the attributes of traditional diseases more typically the focus of NIH (like heart disease or cancer), NISAUD cannot afford to overlook this critical area. Practitioners in the field of prevention, treatment, and law enforcement need evaluations on their work in order to refine what they do and make necessary changes in policy, if required. No other entity in the government has the ability to conduct true drug policy analysis in a way that would be taken to scale. It is critical that NISAUD not ignore this area.

Prevention. Prevention is the most cost-effective, yet in many cases the least understood, intervention in the field of drug abuse. It is critical that NISAUD take a leadership role, as NIDA and NIAAA have in the past, in funding and seeing through prevention interventions that go beyond simple school-based programs and focus on environmental factors. Included here would be an increase in type 2 translational research, including studies of the adoption, implementation, and sustainability of tested and effective programs, policies, and practices in communities, services settings, and populations. This research would ensure that existing knowledge results in reductions in the incidence and prevalence of alcohol or drug abuse and addictions.

Drug-Related Crime. Unlike many of the diseases focused on at NIH, drug abuse fuels crime - through the psycho-physiological changes done as a result of drug taking to the market dynamics of illegal and quasi-legal substances. It is no longer possible to ignore this connection and NISAUD should work closely with the National Institute of Justice to evaluate criminal justice system interventions and bring the most successful ones to scale.

HIV/AIDS. Given the nexus between HIV/AIDS and drug use, abuse, and addiction, it is critical that NISAUD continue the work being done by NIDA and NIAAA on HIV/AIDS. This should be done in coordination with other federal entities (ONAP, CDC, OGAC/PEPFAR).

The four issues listed above - the expansion of policy-relevant research, the focus on prevention, criminal justice, and HIV/AIDS -- represent areas critical to the current picture of drug abuse today. If NISAUD were to expand focus on all of those subjects - and decide to work closely with sister organizations both in and outside of NIH (e.g. ONDCP, SAMHSA, ONAP, CDC, FDA, etc.), major progress on the national goals to reduce drug abuse and its consequences could be made.

 
216 05/05/2012 at 02:48:13 AM Self Carnegie Mellon University Pittsburgh PA The identified areas are all worthy, and would merit funding if budgets were unconstrained. However, the gaps in the portfolio are troubling.

It is said that NIH funds 85% of the world's research in the area, but that research informs perhaps 15% of the world's and the US's spending on drug control.

The great bulk of social costs of illegal drugs in the US are driven by cocaine/crack, heroin, and meth. People under criminal justice supervision (probation, parole, and pretrial release) consume the majority of all three of those substances. The centrality of criminality and the justice system are undeniable.

Furthermore, cost-of-illness studies find that crime-related costs (and also lost productivity) loom large, much larger than health-related costs other than lost productivity from premature death.

The nation's funding mismatch is not sustainable in the long term. No one in this budget climate is going to invest new billions to research drug-related crime, enforcement, markets, production & distribution systems, etc., so achieving balance means either cutting NIH budgets or expanding NIH's scope. Obviously the latter is preferable.

I think the new entity would be particularly vulnerable to a budget cutter's attack that it better serves addiction scientists than the public or the taxpayers if the NIDA culture were to prevail over the NIAAA culture in the new institute.

The good news is that so little is spent on research on justice-related issues that NIH could become a major player in that area with a modest share of its budget.

The "technology" with the greatest chance of making a profound difference in US drug problems is "testing with consequences" (HOPE, 24/7, etc.). Maybe NIH is funding work in that area of which I am unaware. If not, NIH could be left playing catch up.

Diverted pharmaceuticals kill more people than all other illegal drugs combined. NIH has not made that topic a priority.

The drug policy issue of the greatest interest to the largest number of voters pertain to marijuana availability (medical MJ, legalization, decriminalization, etc.). NIH shuns that topic.

There is much worry about translational research -- but not focused, as far as I know, on contingency management.

The explosion of violence in Mexico and Central America are among the most important developments in the field of illegal drugs over the last decade; NIH has nothing in particular to say about it.

There needs to be a balance between public health and "bench" science, and between community & societal level inquiries and those at the individual and cellular level. NIDA has not maintained that balance. I hope the new institute does.

 
217 05/05/2012 at 08:32:07 AM Self     The new institute should make sure that its portfolio includes research that focuses on behavior.

It is critical that the new institute include provision for health research on disorders that are comorbid with substance abuse such as mental health disorders as well as AIDS

The emphasis on prevention and clinical treatment that currently exists in NIDA should be maintained at least at the current level in the new institute.

Research to advance quantitative methods has resulted in new approaches that have been very beneficial to the substance use research field. Such research should continue to be supported by the new institute.

 
218 05/05/2012 at 01:49:30 PM Self San Diego State University San Diego, CA I appreciate the opportunity to share my input in regards to the mission and organization of the new Substance Use and Addiction Institute. I would like to encourage the inclusion of developmental exposure to alcohol and other drugs within the purview of this new Institute. First, understanding the mechanisms of action of these agents in the adult has been important in elucidating mechanisms during developmental exposure. For example, alcohol-related oxidative stress, NMDA receptor-mediated excitotoxicity, and impaired nutritional state (just to name a few), are damaging processes purported to occur with adult alcohol exposure. Many of these same processes contribute to the teratogenic effects of alcohol, and elucidation of these mechanisms has contributed to the identification of novel interventions to prevent and reduce fetal damage in the presence of such alcohol. Conversely, identification of alcohol’s actions on prenatal neurogenesis informed the investigation of its effects on neurogenesis in the adolescent and adult. These are just a few examples of how research on the effects of alcohol and drugs at various stages of development can inform one another. The elucidation of these drug processes across the lifespan, from the prenatal period, adolescence, to adulthood, informs the commonalities and unique characteristics of exposure at various developmental points which are critical to a comprehensive understanding of substance use and abuse. In addition to the commonalities in mechanism, prenatal exposure to alcohol and drugs also inherently involves both the exposed individual and the substance using/abusing pregnant woman. Prevention research and elucidation of maternal risk factors that influence vulnerability of the fetus depend greatly on understanding the relationship between maternal consumption and child outcome. Separation of these areas of inquiry across Institutes would dilute the ability link the substance abusing behavior of the mother and with the consequences, and separate prevention research from outcomes.

Finally, exposure to teratogenic agents prenatally results in life-long effects, some of which appear only later in life. For example, prenatal alcohol exposure leads to an increased propensity for alcohol and drug use during adolescence and adulthood, effects that are likely related to changes to CNS systems being investigated in the proposed Institute. Focusing on the teratogenic effects of maternal alcohol and drug abuse as a childhood disorder misses some of the devastating effects of prenatal exposure that transpire across the life-span.

In sum, I would argue that the synergies that would be lost by separating prenatal exposure to alcohol and drugs of abuse from the proposed Institute are antithetical to the goals of the Institute, which are to create and foster synergies that can lead improved public health related to substance use and abuse.

   
219 05/05/2012 at 08:59:03 PM Self     I am a psychiatrist and I have served at the Director of the Division of Alcohol and Drug Abuse at the University of Maryland and I am a NIDA funded researcher for more than a decade.

My clinical and research experience tells me that medical and psychiatric co-morbidities associated with addiction should be a part of the new institute’s research portfolio. Alcohol and drug use play a key role in the transmission of HIV and hepatitis. Drug injection has fueled the spread of HIV during the epidemic. Hepatitis C infection will eclipse HIV infection as a cause of morbidity and mortality and is highly prevalent in populations of drug injectors. Discovering effective approaches to identify and treat these infections among the drug addicted is of great significance to the public health. Furthermore, drug injectors have played an important role in the spread of HIV to the non-drug using population through sexual transmission. Thus, research regarding prevention strategies of sexual transmission is also critical to public health. Drug addicted patients with these and other medical co-morbidities are often unable to access effective medical care. Services research to identify and assess service delivery models for these conditions is also an important area that should remain in the new institute. This is particularly critical now in the era of health care reform and of cost constraints. Psychiatric illness is a second area of great importance to the addiction research portfolio. Psychiatric disorders are often mimicked by addiction and therefore research regarding differential diagnosis is of import. Depression, anxiety disorders, and post-traumatic stress disorder are prevalent among individuals seeking addiction treatment and effective approaches to treatment and service delivery are needed to improve patient outcomes. Individuals with severe and persistent mental illness, such as schizophrenia, often misuse substances creating adherence problems and illness exacerbation. The new institute should include clinical and services research to address psychiatric co-morbidity in its portfolio.

   
220 05/06/2012 at 10:19:20 AM Self     Critical areas to be included in the proposed new institute on addictions: DEVELOPMENTAL RESEARCH: Alcohol, drug, and food addictions are disorders with developmental roots, and hence developmental studies are crucial for elucidating processes leading to abuse and addiction. Critical developmental windows include the two primary developmental periods for exposure to alcohol, nicotine and illicit drugs: early in life via maternal exposure, and during adolescence – a time when youth often begin to experiment with alcohol, smoking, and to some extent use of illicit drugs as well. For food addictions, the critical developmental exposure period likely extends throughout the period between these two period as well. RESEARCH INVOLVING ALL ADDICTIONS, INCLUDING ALL RESEARCH PERTAINING TO TOBACCO, AS WELL AS OTHER ADDICTIVE BEHAVIORS. For the new proposed institute to be effective in developing synergies for the study of addiction, it is absolutely essential that it include the full realm of nicotine research, including prevention, disease consequences and pharmacology. Inclusion of other addictions (obesity; gambling; etc) is also important for any institute focused on determining similarities as well as important differences in the processes leading to addiction in its various forms. BEHAVIORAL RESEARCH AND ENVIRONMENTAL CONTRIBUTORS TO ADDICTION. Problems with addiction are reflected in behavior. It is at least as critical to understand the intricacies of this behavioral derailing -- and its environmental contributors -- as it is to dissect the cellular/molecular alterations associated with addictive processes. EFFECTS OF ALCOHOL/DRUGS ON ORGANS OTHER THAN THE BRAIN. The development of addiction is just not a process occurring in the brain, but involves the whole body. Important synergisms will be lost if the brain is artificially divorced from the rest of the body when studying addictive processes. SOCIAL SCIENCE, PREVENTION, TREATMENT, EPIDEMIOLOGY, AND PUBLIC POLICY RESEARCH. To improve prevention and treatment efforts, it is critical that the new institute not be focused merely on studies of the neuroscience of addiction, but to also emphasis work in these other areas. In so doing, it should be recognized that strategies for education, prevention and public policy efforts for legal addictions (alcohol; nicotine; food) will be substantially different than those associated with illegal drugs.

Particularly critical areas to be included in the proposed new institute on addictions: -Developmental Research (including both fetal and adolescent periods). -Research involving all addictions, including ALL research pertaining to tobacco, as well as other addictive behaviors. -Behavioral research and environmental contributors to addiction.

 
221 05/06/2012 at 02:04:21 PM Self     The new institute should make sure that its portfolio includes research that focuses on behavior and communication. Further, its portfolio should include negative social forces (e.g., Stigma) and unintended consequences (iatrogenic effects) in its studies.

The new institute should support research on conditions that are co-morbid with substance use, such as HIV, and mental health.

The emphasis on prevention that currently exists in NIDA should be maintained at least at the current level in the new institute.

Research to advance quantitative methods has resulted in new approaches that have benefited substance-use research. The new institute should continue to support studies in quantitative methods.

   
222 05/06/2012 at 09:09:52 PM Self     The effects of alcohol on the brain will be a central focus of any Institute on substance use, abuse, and addiction. Discussion on what portions of the NIAAA portfolio to include in this proposed Institute have suggested excluding research on alcohol's interactions with the brain during early development. Specifically, some have proposed that research on fetal alcohol spectrum disorders (FASD) be excluded from the new institute. For the reasons cited below, I believe that splitting alcohol brain research before and after an arbitrary moment in development would be harmful to the study of addiction and would set back the effort to prevent FASD, the most common preventable cause of developmental disability.

1. Susceptibility to addiction is greatest from early adolescence through the mid 20s, a time when the brain is still developing. The study of addiction depends crucially on understanding how alcohol affects the developing nervous system. Brain development begins during embryogenesis and does not cease until the third decade of life. Much of NIAAA's FASD portfolio focuses on the effects of alcohol on the developing nervous system. Alcohol interacts with many of the same molecular targets during prenatal and early postnatal brain development as it does in the developing adolescent and mature nervous systems. My own studies on the effects of alcohol on the L1 cell adhesion molecule illustrate this point. L1-mediated cell adhesion is inhibited by alcohol. L1 is critical for development; however, it is also expressed in adulthood, where it influences learning and memory. There is no scientific rationale for dividing the NIAAA brain research portfolio at any arbitrary point in the 3-decade timespan of human development. Therefore, all research on alcohol's effects on the developing nervous system should be coordinated and funded by a single institute.

2. Prenatal alcohol exposure permanently alters the structure and function of neurotransmitter pathways that mediate alcohol addiction. Children exposed to alcohol in utero are at increased risk for developing alcohol addiction. The comprehensive study of alcohol abuse and alcoholism requires the coordinated investigation of all factors that predispose to these disorders, including prenatal alcohol exposure. Therefore, preclinical and clinical studies of FASD should be an important part of the portfolio of an institute on addictions.

3. FASD is the single most important preventable cause of developmental disabilities. By far the most crucial strategy for preventing FASD is the prevention of drinking in women who are pregnant or trying to conceive. The defining face and brain abnormalities of fetal alcohol syndrome result from alcohol exposure during the third to fourth week of pregnancy, a time when most women do not know that they are pregnant. Hence, the prevention of FASD requires a concerted effort to reduce binge drinking in all women of childbearing age. Unfortunately, binge drinking is common, particularly in women in their late teens and early twenties. A broad array of clinical, psychosocial, and policy research has been directed at reducing drinking in this vulnerable population. This prevention research needs to be coordinated to address the specific challenge of reducing binge drinking in women of childbearing age. Therefore, preventing the major public health burden of FASD will depend critically on the inclusion of all FASD research within the portfolio of an institute on addictions.

Research on alcohol's effects on the nervous system should be a non-controversial component of the portfolio of an Institute on Substance Use, Abuse, and Addiction. The enormous public health and social burden of FASD results from alcohol's effects on the brain. FASD research is brain research. Public health and the study of addictions would be well served by including FASD research within the new Institute. In particular, FASD research addresses several components identified in the RFI's preliminary list of "potential scientific opportunities and public health needs that are not sufficiently addressed within the existing NIH structure":

1. Improving prevention efforts by developing a better understanding of the patterns and trajectories of drugs of abuse and their influence on brain development;

2. Engaging the medical community in prevention and treatment of drug addiction and alcoholism;

3. Targeting efforts to prevent substance abuse in adolescents and young-adults;

4. Understanding the implications of policy changes on substance use patterns and trajectories, especially in youth

 
223 05/06/2012 at 09:48:47 PM Self Yale University/VA Connecticut West Haven I am a psychiatrist researcher in the Yale Department of Psychiatry, and I direct the Substance Abuse firm at VA Connecticut. I have done research showing that people with HIV are less likely to take prescribed antiretroviral medication if they have recently used illicit drugs or alcohol, and described contingency management interventions that improve patients' viral loads more than control interventions do. Our group's research has shown the benefits of money management-based interventions in reducing cocaine use, and potentially reducing HIV risk-behaviors

I think the mission of the proposed National Institute on Substance Use and Addictive Disorders’ should include targeting the spread of HIV among substance users and reducing the spread of HIV among HIV-positive substance users by enhanced adherence to HIV-suppressing treatment. There are three main reasons to house these HIV-reduction missions in the new addiction agency:

1) Interventions to reduce risk behavior and reduce the spread of HIV require knowledge of substance-using populations, knowledge that will be consolidated within the National Institute on Substance Use and Addictive Disorders.

2) Substance using populations have distinct neurobiological, behavioral and psychological challenges that require interventions tailored to them. Interventions focused on more accessible populations may not be effective in substance users and fail to address this large population that harbors and/or spreads HIV.

3) The integration of HIV risk-reduction into addiction treatment has been facilitated by having HIV risk-reduction part of the mission of NIDA and NIAAA. This has manifested itself in the inclusion of risk-reduction components in standard treatments (e.g. CBT for cocaine use, opioid maintenance), and dissemination of HIV risk-reduction testing and interventions by NIDA and NIAAA. This synergy has been good for HIV risk-reduction and for public health in general.

It is not clear how the public health imperative of preventing the spread of HIV by and among drug users will be carried out if it is not housed in the Addictive Disorders’ agency. Making HIV risk-reduction the mission of another agency would divorce the mission from the population being targeted.

   
224 05/07/2012 at 08:04:37 AM Self     I am the Deputy Director of a NIDA-funded P30 Center currently in its 15th year (Center for Drug Use and HIV Research, P30DA011041) and have conducted drug-use related research projects for over 15 years. NIDA has played a critical role in the nation's critical and life-saving HIV/AIDS research program over the past 30 years. Indeed, HIV/AIDS and substance abuse are considered "twin epidemics." Several important areas pertaining to HIV/AIDS and addiction appear to be either missing or under-emphasized in the new plan to combine institutes. These include the important research on socio-behavioral and epidemiologic research related to HIV. Further, substance users are at grave risk for HCV, and an addiction institute seems an optimal place to support HCV-related research.

I would be very concerned if the new Institute did not support research on the relationships among HIV, HCV, and addiction. This, in my opinion, would have detrimental effects on our ability as researchers to address research questions under the National HIV/AIDS Strategy. Substance users are stigmatized and forgotten. Yet they are gravely over-represented among the populations of those living with and at risk for HIV (and HCV). The lack of inclusion of HIV/AIDS and HCV in the new Institute may have serious negative implications for the public health.

 
225 05/07/2012 at 10:06:29 AM Self     I have conducted research on HIV and drug abuse treatment within correctional settings for 22 years. In order for scientific knowledge to continue to advance, I believe strongly that it is critical for NIDA to continue providing leadership in the funding of HIV and alcohol/drug treatment. A change would likely result in a set back in scientific gain of several years.

Most important are clearly HIV, Drug Treatment in Correctional Settings, and Adolescents and Young Adults. Also important is the use and incorporation of technology into the treatment of clients.

 
226 05/07/2012 at 10:34:47 AM Organization U. of RI Kingston, RI I will be relatively brief. It is critically important for a new institute to continue to fund drug and alcohol research separately and in combination, to focus on treatment development and implementation (behavioral and biological), and to support drug and alcohol research that intersects with other areas (HIV, crime, mental health, diversity, youth and families, to name only a few). While these positions are not novel, I thought it might be important to state support for them.

I see the above as a single issue. No one area named above seems most important at this time.

 
227 05/07/2012 at 11:25:52 AM Self     I would urge you to consider seriously the recommendation put forth by the College on Problems of Drug Dependence (CPDD). As a member of CPDD (since 2004) I can attest to the careful thought that was applied to make that recommendation. As a young investigator, I would appreciate initiatives aimed at retaining talent in academic research as well.

   
228 05/07/2012 at 12:10:40 PM Self     FASD should be an important part of the portfolio of an institute on addictions.

1. Much of NIAAA's FASD portfolio focuses on the effects of alcohol on the developing nervous system. Alcohol interacts with many of the same molecular targets during prenatal and early postnatal brain development as it does in the developing adolescent and mature nervous systems. There is no scientific rationale for dividing the NIAAA brain research portfolio at any arbitrary point in the 3-decade timespan of human development. Therefore, all research on alcohol's effects on the developing nervous system should be coordinated and funded by a single institute.

2. Prenatal alcohol exposure permanently alters the structure and function of neurotransmitter pathways that mediate alcohol addiction. Children exposed to alcohol in utero are at increased risk for developing alcohol addiction. The comprehensive study of alcohol abuse and alcoholism requires the coordinated investigation of all factors that predispose to these disorders, including prenatal alcohol exposure. Therefore, preclinical and clinical studies of FASD should be an important part of the portfolio of an institute on addictions.

FASD should be an important part of the portfolio of an institute on addictions.

 
229 05/07/2012 at 12:45:39 PM Self   La Jolla I am writing to give my input on scientific opportunities and public health needs that should be included in the Scientific Strategic Plan for the new National Institute of Substance Use and Addiction Disorders per the NIH RFI NOT-OD-12-045 released February 8, 2012.

I am practicing physician specializing in addiction psychiatry with 30 years experience in the inpatient and outpatient treatment of addiction and dual psychiatric diagnosis disorders. I also work in a NIAAA funded Alcohol Research Center (PI George Koob) and as part of a research group (PI Cindy Ehlers) at The Scripps Research Institute in La Jolla, CA, which receives NIAAA and NIDA grant funding for projects investigating risk and protective factors for alcohol and drug use and addiction in Native American and Mexican American participants. I am a Co-PI in the Research Translation/Information Dissemination Component of The Scripps Research Institute Alcohol Research Center. One of the studies of the Translation Component is to assess a community outreach program to the immigrant Mexican American community in the border areas of San Diego County. I feel I have some useful experience in how valuable education/translational outreach can be in these communities.

I am in concurrence with the preliminary list of potential scientific opportunities and public health needs not sufficiently addressed within the current NIH structure, particularly those relating to substance use and use disorders in adolescents and young adults. Since substance use and addiction often begin in adolescence and young adulthood, assessing effective public policy and prevention strategies aimed at those age groups should be an important goal of the new institute.

To the strategic list, I would add the important scientific opportunity of genetic investigations in identifying risk factors, sites for potential psychopharmacologic intervention, and for monitoring treatment outcome in substance use and use disorders. The new institute should be on the forefront of investigating new genetic technologies, which will become increasingly important in all areas of medicine and public health. I believe that the use of basic science to understand risk factors, physiologic effects, and toxicity of alcohol and drugs should continue as the central aim of the new IC. An important challenge for the new IC, as I see it, will increasingly be that of translation of basic scientific advances not only to the bedside, but also to the community.

Translation to the community should involve sustained attention to the general U.S. population but also to involving minority communities in education and outreach and in the research enterprise itself. Community based participatory research should be a goal of the new IC not only with the aim of studying substance use and use disorders in minority communities but in training young minority researchers in the field.

As a rough rule, I believe that funding should be allocated in the new institute in a way that reflects the public health costs of substance use and addiction.

Thank you for this opportunity to contribute my thoughts on potential scientific opportunities and public health needs to be addressed in the strategic plan for the new institute.

I believe that all the issues identified in the preliminary list are important. In the Comment 1 box above, I have identified several additional issues that I think are worthy of consideration. Of these I think the use of new genetic technologies and minority community translation/education are the most important. Genetic technologies have the potential to offer new, powerful ways to understand the molecular basis of addiction and thereby revolutionize our approach to risk assessment, diagnosis, treatment, and prevention. Minority community translation/education is important because some minority communities bear a very heavy burden of substance use and use disorders and are greatly in need of improved treatment and prevention approaches.

 
230 05/07/2012 at 12:53:27 PM Self     Whether FASD research should be excluded from the new institute.

I am a psychologist and researcher that has been funded by NIAAA for most of my career. I am concerned that the formation of the new institute will be done in such as was as to exclude the current portfolio regarding fetal alcohol syndrome and related conditions. Given that this is my area of expertise, I feel comfortable that I am qualified to provide input on this matter.

The effects of prenatal alcohol exposure begin prenatally and are life long, they include long term physical, neurochemical, neuroanatomical, and psychological changes. These changes put the affected individual at risk for many secondary outcomes, including but not limited to their own substance use and abuse. This give FAS/FASD research a unique opportunity to identify individuals at risk for substance use very early in life. Early identification and intervention of people with FASD can reduce this risk. NIAAA has utilized a systems biology approach to alcohol and FAS/FASD is a model of this approach; prenatal alcohol exposure affects multiple organ systems, including the brain, both before and after birth. Thus, this continued approach must include the effects of alcohol on the fetus and later child development for the reasons stated.

Second, FAS is preventable if we intervene with women at risk for alcohol use in pregnancy. Removing the FAS/FASD portfolio in essence separates the child from the mother and the opportunity for intervention research may be lost.

For these and many other reasons, I urge you not to separate the FAS/FASD portfolio from the rest of the institute.

 
231 05/07/2012 at 12:55:38 PM Self     I am an Associate Professor in the Jane Addams College of Social Work at the University of Illinois at Chicago. I have been involved in research on substance abuse epidemiology and treatment for over 20 years, some of which has been funded by NIDA. I believe the plan to restructure NIDA and NIAAA into a single institute that will include all addictions is reasonable and will provide interesting and productive synergies that are not present within the current structure. Many of the preliminary scientific opportunities and health care needs described in response to the SMRB findings are well considered and will benefit from the proposed reorganization.

However, I also have several concerns about the proposed reorganization and research priorities that I would like to respectfully express:

First, most of the research priorities for improving treatment and prevention for addictions appear to have an exclusive medical/biological focus. There is very little emphasis on behavioral interventions and prevention. And yet, most of the available research indicates that even when effective pharmaceuticals have been developed to treat various mental health conditions such as depression and including addiction, they work best when accompanied by behavioral interventions. Additionally, despite considerable effort over the past 20 years and groundbreaking studies of the neurobiology of addictive conditions, the development of effective pharmaceutical treatments for many such conditions has remained elusive. In these instances, our best and still frontline treatments remain behavioral interventions. Accordingly, I believe the priorities should be amended to include a comparable emphasis on improving the science behind developing more effective behavioral interventions for addictions including prevention at the individual and community levels and studying the optimum way in which behavioral and medical interventions can best be combined.

Second, much of my own work has focused on studying conditions that commonly co-occur with substance misuse such as mental health disorders as well as chronic health conditions and infectious diseases. The link between HIV/AIDS and substance misuse is particularly well established. In this last regard NIDA has shown clear and effective leadership supporting much productive research since the beginnings of the AIDS epidemic. As a result of the considerable efforts at NIDA, effective and important prevention and treatment interventions have been developed to address HIV risk among substance abusers and we now have a very clear understanding of how these two issues intersect.

It is unclear under the reorganization plan, what will happen to this important portfolio of NIDA research studies. My broader concern is that the focus on co-occurring addictive disorders, while laudable, might come at the expense of a loss of focus on non-addiction disorders that commonly co-occur with substance misuse. This loss would be especially unfortunate given the recent trend in the medical and health care communities towards promoting primary care as a gateway for receiving health-related services for multiple conditions via mechanisms such as "medical homes". I believe we need to continue the strong tradition of NIDA-led studies on the co-occurrence of and treatment for addictions and other mental health and health conditions, particularly HIV/AIDS. Therefore, I strongly urge NIH to explicitly retain HIV/AIDS and co-occurring mental health and health conditions under the purview of the newly reorganized institute for addictions studies and to make such studies one of the identified priorities for the newly organized institute.

I believe the issue of co-occurring conditions, particularly HIV/AIDS and mental health conditions, and substance use disorders is most important for NIH to address in the proposed restructuring. The public health impact of this(these)issue(s) is(are) especially cogent and affect many. No other NIH institute would bring the same perspective as an institute focused on addictions.

 
232 05/07/2012 at 12:56:31 PM Self University of New Mexico Albuquerque Fetal Alcohol Spectrum Disorder should not be separated form the substance use, abuse, and addiction institute.Alcohol is a large part of our society and if the FASD field was to be split from the alcohol field I do not believe that FASD research would be valued as much by Institutes that do not fully understand the deleterious effects of alcohol especially during development.

Fetal alcohol exposure plays a important role in addiction and abuse later in life. The FASD field has shown the exposure to alcohol prenatally leads to an increase in alcohol intake in older animals possibly leading to substance abuse and addiction. Furthermore, this also emphasizes the long term alterations induced by alcohol on the developing brain.

 
233 05/07/2012 at 01:06:05 PM Self     For the existing area: • Understanding the mechanisms by which alcohol and other drugs of abuse increase risk for certain diseases (e.g. cancers), particularly when used in combination;

I recommend that this area should include language that specifically emphasizes study of HIV/AIDS as a “certain disease” in addition to cancers. Unique and significant associations with substance use and HIV/AIDS are noted in the United States. Two separate attributable risk analyses, using HIV seroconversion end-points within two independent cohort studies show that between 28% (Koblin, 2006) and 33% (Ostrow, 2009) of all HIV seroconversions among MSM can be attributed to non-injection substance use. Recent data from HPTN shows that among Black MSM (a group with high background HIV prevalence and incidence), alcohol use with 2 hours of a sexual event is a multivariate predictor of HIV transmission behavior (Penniman Dyer, 2012). There is a compelling and significant need for this combined institute to emphasize study of substance use (alcohol and other drugs, injection and non-injection) and its linkages to HIV/AIDS (both in terms of treatment and prevention), especially in groups of substance users who face multiple disparities due to poverty, race/ethnicity, and other forms of stigma and injustice.

An area that is needed for addition to this list is inclusion of development and evaluation of novel medication approaches to treating alcohol and other drug dependence.

This is an important area as pharma has little incentive to sponsor medication development for drug dependence. Drug dependent patients often are un- or under-insured. This situation limits the ability to sell drugs and make a profit for drugs that ultimately are shown efficacious for treating drug dependence. The area listed that emphasizes recruiting pharma to develop novel medications is important, but the lack of a market that could support profits sufficient to sustain such interests (in the same manner as drugs for other psychiatric conditions) presents obvious barriers for enthusiasm to companies that might otherwise consider drug development for substance dependence.

This situation puts government in the role of the position of last resort for guiding drug development for addictive disorders and emphasizes the need to increase investments in the area of encouraging companies to work in private-public partnerships to address treatment of addictions.

 
234 05/07/2012 at 01:18:38 PM Self     See attachment

See attachment

I greatly appreciate that you and NIH have solicited input from the scientific community to assist in planning the new Institute on Substance Use and Addictive Disorders. As you move forward with your strategic plan, I would ask you to consider the following points: 1) Because the causes and consequences of substance abuse are complex, they are best understood by bringing together scientists with diverse backgrounds. We will be most successful at addressing the issues related to substance abuse if we maintain a multidisciplinary emphasis. It is almost assured that an interplay between social, psychological and biological factors feed into the problems associated with substance abuse. By maintaining experts across divergent fields under a single umbrella, we will allow for synergies not possible in a more narrow approach. 2) Likewise, we must consider all aspects of the problem, with equal emphasis on cause and consequence. We must fully consider substance abuse from its predispositions through to the consequences of abuse, be it organ damage or fetal defects, such as FAS. This wholistic approach treats substance abuse as the multivariate problem that it is. Similar to my point above, by bringing together talented scientists from diverse backgrounds to study the far-reaching causes and consequences of substance abuse, synergies will develop that will advance the field more quickly then a narrow approach. I believe that NIAAA has been very successful at developing these synergies and would be an excellent model for the new Institute. 3) During budget planning, the Institute should take into account the actual health burden of substance abuse. Current estimates suggest that alcohol, tobacco and illicit/misused drugs each share 1/3 of the overall health burden. I thank you for providing me the opportunity to contribute to the planning of the new institute.
235 05/07/2012 at 01:22:28 PM Self     The greatest likelihood for addiction results from exposure during early adolescence through early 20's. Brain development begins during embryogenesis and continues through the 20s. Alcohol interacts with many of the same targets during adolescence as during development. There is no rationale for dividing research at an arbitrary developmental time point. Therefore, all research on alcohol's effects on the developing CNS should be coordinated and funded by a single institute.

FASD is the single most preventable cause of developmental disabilities. Often times significant damage to the developing fetus occur early in pregnancy before a woman knows that she is pregnant as often happens in binge drinking. One of the populations most at risk for the combination of binge drinking and unplanned pregnancies is teens and those in their early twenties. To prevent FASD requires a concerted effort to reduce binge drinking in women of childbearing age. A broad array of research has been and must continue to be directed at reducing binge drinking in this at-risk population. Thus, preventing FASD will depend critically on the inclusion of all FASD research in the protfolio of an institute on addiction.

 
236 05/07/2012 at 01:24:27 PM Self     Fetal Alcohol Spectrum Disorders (FASD) is a major public health problem even among the general population and is an integral part of addiction reserach and should remain within the mission of the proposed National Institute of Substance Use and Addiction Disorders. (1) Pregnant women who drink alcohol also usually consume other illicit drugs and tobacco, requiring a multi-faceted approach for therapeutic treatment. (2) The prevelance of substance-use disorders is higher in individuals with FASD than general population. (3) It is hypothesized that in utero alcohol consumption may cause neurobiological alterations that increase vulnerability to substance abuse. (3) FASD research can also not be seperated from adult alcohol research as they are inter-related; women in families that drink heavily continue to do so during pregnancy. (4) Animal models of FASD have not only shown increased alcohol consumption during adulthood but also vulnerabulity to subsequent life stressors, illness, later-life disorders, mental disorders, depression, and substance-use disorders. (5) Adult genotype differences may not only contribute to altered drinking patterns, but also impact the FASD outcome. 6) Many proposed FASD biomarkers are the same utilized for adult alcohol consumption and hence, development of a diagnostic platform/tool for FASD is intertwined with adult alcohol consumption biomarker research. (7) FASD is not merely a child health issue. It is an important women's health issue and alcohol has numerous effects on the maternal system that may lead to the pathogenesis of FASD. (8) Alcohol interacts with many of the same targets during brain development as it does in the adult brain.(9) Prevention of FASD is not only about alcohol; it involves multiple variables including exposure to violence, nutrition, use of other drugs, mother's overall health, mother's genetics, poverty, mother's stress level, racial discrimination etc. In summary, all research on alcohol's effects including FASD should be coordinated and funded by a single institute, specifically, the proposed National Institute of Substance Use and Addiction Disorders.

Fetal Alcohol Spectrum Disorders (FASD) is a major public health problem even among the general population and is an integral part of addiction reserach and should remain within the mission of the proposed National Institute of Substance Use and Addiction Disorders. (1) Pregnant women who drink alcohol also usually consume other illicit drugs and tobacco, requiring a multi-faceted approach for therapeutic treatment. (2) The prevelance of substance-use disorders is higher in individuals with FASD than general population. (3) It is hypothesized that in utero alcohol consumption may cause neurobiological alterations that increase vulnerability to substance abuse. (3) FASD research can also not be seperated from adult alcohol research as they are inter-related; women in families that drink heavily continue to do so during pregnancy. (4) Animal models of FASD have not only shown increased alcohol consumption during adulthood but also vulnerabulity to subsequent life stressors, illness, later-life disorders, mental disorders, depression, and substance-use disorders. (5) Adult genotype differences may not only contribute to altered drinking patterns, but also impact the FASD outcome. 6) Many proposed FASD biomarkers are the same utilized for adult alcohol consumption and hence, development of a diagnostic platform/tool for FASD is intertwined with adult alcohol consumption biomarker research. (7) FASD is not merely a child health issue. It is an important women's health issue and alcohol has numerous effects on the maternal system that may lead to the pathogenesis of FASD. (8) Alcohol interacts with many of the same targets during brain development as it does in the adult brain.(9) Prevention of FASD is not only about alcohol; it involves multiple variables including exposure to violence, nutrition, use of other drugs, mother's overall health, mother's genetics, poverty, mother's stress level, racial discrimination etc. In summary, all research on alcohol's effects including FASD should be coordinated and funded by a single institute, specifically, the proposed National Institute of Substance Use and Addiction Disorders.

 
237 05/07/2012 at 01:50:19 PM Self     It is important that research on FASD be a part of the proposed National Institute of Substance Use and Addiction Disorders, remaining in the same body that researches and funds substance use and addiction, rather than being separated out and placed within NICHD. Alcohol use during pregnancy affects both the mother and child and it is the substance use and/or addiction of the mother that can result in FASD in the child. Placing FASD research in NICHD, where the focus would be only on the child, leaves the woman out of the picture, ignoring crucial aspects of both etiology and treatment. FASD is a completely preventable developmental disability. Prevention of drinking in women who are pregnant or trying to conceive is the most direct strategy for preventing FASD. Targeting all women of reproductive age, however, is equally important because over half of all pregnancies in this country are not planned and much of the most damaging drinking during pregnancy occurs before many women are aware of their pregnancy. Binge and other heavy drinking is common in adolescents and young women and research directed at this population must be coordinated to address both the drinking and the effects of that drinking on the woman, the child and others within the family. It also is important to maintain a unified approach to FASD research given the increasing evidence that susceptibility to addiction is related to brain development, from the period in utero into young adulthood. Children exposed to alcohol in utero are at increased risk for developing alcohol addiction. The comprehensive study of alcohol abuse and alcoholism requires the coordinated investigation of all factors that predispose to these disorders, including prenatal alcohol exposure. There is no scientific rationale for dividing the NIAAA research portfolio at any arbitrary point in the timespan of human development. Therefore, all research on alcohol's effects on the developing nervous system should be coordinated and funded by a single institute. Preventing the major public health burden of FASD depends on the inclusion of all FASD research within the portfolio of an institute on addictions.

   
238 05/07/2012 at 01:50:49 PM Self     Fetal Alcohol Spectrum Disorders (FASD) should not be moved to NICHD and separated from the rest of alcohol research for the following reasons. 1. NIAAA FASD portfio focuses on alcohol and developing nervous system. Brain development begins during embryogenesis through the third decade of life. This research needs to be coordinated through a single institute across the lifespan. 2. Prenatal alcohol permanently alters the central nervous system and increases alcohol addiction risk in adulthood. Thus FASD should be part of the new institute of addiction if NIAAA is disbanded. 3. FASD is a preventable cause of developmental disabilities. Research on the prevention and treatment of FASD will be severely impacted if it is isolated from other research programs focused on how alcohol affects all organ systems. For these reasons, FASD research should be an integral part of the new institute's mission. There will be a severe impact and disruption of FASD research if moved to NICHD. FASD should be included within the scope of the new institute.

   
239 05/07/2012 at 01:54:19 PM Self     Maintaining research on developmental alcohol and substance abuse exposure in the same institute researching these substances in general.

Thank you for the opportunity to have input regarding the new proposed Substance Use, Abuse, and Addiction Institute. Of particular concern is the notion that developmental exposure to alcohol and other drugs might be moved to another existing institute, as I believe this will ultimately impede the progress of the science in the field. My research has focused on the effects of prenatal alcohol exposure on brain and behavior, using both animal model systems and clinical studies. This research has benefited significantly from collaborations and information gained from the greater alcohol research community. As an example, it is becoming clear that there are many similarities between neurological outcomes in those exposed prenatally to those that occur in adolescents who start drinking early in life. Similar changes are noted in specific brain structures and in white matter integrity. Collaborations between the Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD), a consortium established by NIAAA to study the effects of prenatal alcohol exposure and the Neurobiology of Adolescent Drinking in Adulthood consortium (NADIA), also funded by NIAAA to study the effects of adolescent alcohol exposure are poised to examine these relationships. There appears to be a continuum of effects that occur and separating the study of the prenatally exposed individual from those who start drinking early in life will make studying the basis of these changes along the lifespan just more difficult. The study in one institute of the consequences across the lifespan, from in utero exposure, to adolescence, to adulthood, and in the elderly can only enhance the science.

As an another example, it was clear from clinical case studies that genetic factors played a role in the etiology of fetal alcohol spectrum disorders (FASD), but what these factors were was unknown. Using animal model systems and rodents bred for differential sensitivity to alcohol, we were able to show how both metabolic influences and differences in functional tolerance impacted the outcome from prenatal alcohol exposure. The selected lines and the protocols used for these studies resulted from research unrelated to developmental alcohol exposure. For that matter, the protocols for the animal model systems that clearly demonstrated that alcohol was a teratogen were developed to study mechanisms of alcohol-induced liver and other organ toxicity, withdrawal, and tolerance. I am not implying that the research that we did would not have happened if I was not funded by the NIAAA, but it is clear that the research would have been slowed and hampered if I had not been exposed to those model systems through my involvement with the NIAAA. Furthermore, this research clearly showed that the maternal genotype was critically important in determining the outcome from prenatal alcohol exposure, yet moving developmental alcohol exposure to another institute would separate the connection between the mother and the offspring. Maternal drinking would be studied in one institute, while the consequences of that drinking would be studied in another. That makes little sense. I guess it could be argued that perhaps maternal drinking would also be studied in the institute where developmental alcohol exposure would move to, but that would disconnect the drinking of a woman who happened to be pregnant from the drinking of other women, which again makes no sense to me.

It is very clear that the developmental alcohol exposure field has benefited from the close contact with alcohol research in general. Much of what we learned about mechanisms responsible for alcohol-induced teratogenesis and prevention of FASD has resulted from close ties to the alcohol research community in general. Even relatively simple principles such as drink size and how this influences consumption and recall of that consumption, how to address asking women about their drinking, assessing the influence of being raised in a family where alcohol is used and abused, and the nutritional aspects of alcohol consumption that influences outcomes, all find their roots in the broader questions asked by alcohol researchers, not those only focusing on developmental exposure. Separating those interested in the outcomes from prenatal exposure from those studying broader issues related to alcohol use and abuse will only impede scientific progress.

As a final example, individuals exposed to alcohol in utero are at an increased risk for alcohol abuse latter in life. The role of genetics versus teratogenic influences is still unclear in this regard, but once again the research would be better served by keeping the research on developmental alcohol exposure in the same institute where alcohol use and abuse are studied in general.

I have been involved in the field of teratology since the mid 1970’s, and have studied other exposures besides alcohol. Within the NIH, the study of teratogens goes on in many institutes. Those causing oral-facial consequences are studied in NIDCR, yet many of these teratogens also have CNS consequences. The study of ADHD, which might be the closest analog to FASD in terms of behavioral outcomes, is primarily funded by NIMH. The study of autism goes on in multiple institutes, including NIMH, NICHD, NIDCD, and NIEHS. The study of environmental teratogens is done at NIEHS. Yet the proposal is to move research on the consequence of prenatal alcohol and drug exposure from an institute devoted to alcohol and substance use to an institute such as NICHD. The logic fails me, as I do not see the scientific benefit of separating the study of the agent from the consequences of exposure to that agent.

In summary, the current arrangement where research on FASD is funded by the same institute studying alcohol use and abuse in general simply makes the most sense in terms of scientific benefits and “bang for the buck.” The research and synergies that have been established by having this work funded primarily by the NIAAA have moved our knowledge about the consequences of prenatal alcohol exposure from next to nothing to where FASD is being considered for inclusion in the DSM in less than 40 years. The strides in this field have been tremendous and the current model of funding FASD research in the same institute studying the etiological cause of these disorders had been exemplary. I urge you for the sake of the public health to keep the current model.

 
240 05/07/2012 at 02:01:56 PM Self     I am responding to specific areas addressed by Dr. Tabak in his PowerPoint (PP) presentation at the April 2, 2012 webcast and during the subsequent question and answer period (Q/A) of the webcast.

1. NIH Staff: Public Health Opportunities (PP slide 10). The strategic plan for the new institute should reflect the awareness and commitment of the NIH to address the burden of illness in the general population associated with the use and addiction to alcohol, tobacco, illicit drugs and prescription drugs used without or beyond the limits of a prescription. Data were published recently by Grant, Dawson and Moss (2011). Importantly, among US adults 18 years of age and older, the estimated numbers of current users for alcohol, tobacco, and illicit drugs are 136, 57 and 12.2 million, respectively. For users of illicit drugs, cannabis accounts for 8.5 million or 70 percent of the total of 12.2 million. For abuse of prescription medications, it is 8.3 million. However, the estimated number of current addicted users of alcohol, tobacco and illicit drugs are 7.9, 26.5, and 1.2 million, respectively. The numbers clearly indicate that tobacco, heroin, cocaine and amphetamines are more addictive than are alcohol and other psychotropic substances. However, owing to the relatively low numbers of users in the general population, the numbers of illicit drug users are individually very low, with cannabis accounting for more than 50 percent (0.67 million) of the 1.2 million total.

2. Understanding the mechanisms by which alcohol and other drugs of abuse increase risk for certain diseases e.g. cancer (PP slide 8), I would like to point out that alcohol is unique among all drugs in that its metabolism and its immediate metabolic products directly lead to, not just are contributory, to certain end organ diseases. Most notable among these are alcohol addiction (brain), alcoholic liver disease (liver), fetal alcohol syndrome (fetus), and cancers of the upper aerodigestive tract. Alcohol is unique in that its pathway of metabolism, which accounts for more than 95 percent of its elimination from the body, is by way of its oxidation first to acetaldehyde, then to acetate and finally to carbon dioxide and water, using the metabolic pathways common to those for carbohydrates and fats in the generation of ATP and energy. Thus, alcohol consumption leads also to the generation of energy (98 Kcals per standard drink containing 14g ethanol), which is contributory (increasing the risk) for other diseases such as those associated with nutritional imbalance (including obesity) and those that have multiple identified and yet unidentified genetic and environmental/lifestyle risk factors. Alcohol is a sedative/hypnotic substance with low efficacy. Millimolar amounts are required for its CNS effects. By contrast, acetaldehyde is much more potent, with demonstrated reinforcing effects in micromolar concentrations. Acetate effectively preempts glucose metabolism in the brain and is incorporated directly into glutamate and glycine in the brain. It is possible that acetate can serve as the major source of energy in the brain of a chronic alcoholic; this is a novel research initiative worthy of exploration.

As provided in Dr. Tabak’s response to Sherry Deren (Q/A p12), knowing that “a substance has a direct impact on an end stage organ, you could make the argument that it would make sense (to keep it in the new institute) if that was unique to that specific agent.” In line with this thought process, I would urge keeping alcoholic liver disease, fetal alcohol spectrum disorders and upper aerodigestive cancers together with alcohol addiction in the new institute because of the unique direct impact of alcohol and its immediate metabolites on these disorders.

3. Pharmacokinetic and Pharmacodynamic Interactions Between Alcohol and Other Therapeutic Agents (PP slide 8). I wish to emphasize that is important to do so across the lifespan. Whereas alcohol and drugs do not change, the users and addicted users do. For example, the pharmacokinetics (absorption, distribution and metabolic rate) and the CNS pharmacodynamic effects of alcohol change with aging and exposure. The same is likely to be the case for other drugs and their interactions with alcohol.

4. Synergies with other NIH institutes raised by Mark Goldman (Q/A p2). An approach to synergies in strategic planning may be found in looking at the comorbidities of alcohol dependence/addiction. The highest comorbidity is nicotine addiction (34%) followed by antisocial personality disorder (29%), anxiety (19%) and mood disorders, especially major depression (17%) and drug use disorders (13%). Total rate of comorbidity is 60 percent. With these statistics, developed synergies with NIMH should be vigorously pursued.

In creating the new institute on substance use and addiction, the most important issue that NIH should address is this new opportunity to improve the health of the individual and the population at large. The new institute should develop a research portfolio that reflects understanding of the prevalence of burden of illness of the major substances of use, abuse and addiction. These can be clustered as follows: 1. Alcohol and tobacco 2. Cannabis and prescription meds 3. Other illicit drugs It is important to note that harm to self, others and society does not come only from addicted users, but also by use and misuse by the non-addicted population. A good example is binge drinking, which may be occasional as well as frequent in both our underage and adult populations. The economic cost of alcohol and illicit drugs is estimated to be about 200 billion dollars for each, with 71-73 percent being lost productivity for both. However, the lost productivity from drugs is mostly the result of incarceration, whereas for alcohol, lost productivity related to alcohol is due to more people who use alcohol and have lowered performance. These considerations pertain to the relevance and impact of the research that NIH supports. In strategic planning of the research portfolio, the budget should address these concerns and be commensurate with the burden of disease in the general population.

PDF copy of article: “Disaggregating the Burden of Substance Dependence in the United States” by Bridget F. Grant et al; published by Alcoholism: Clinical and Experimental Research in March 2011 (vol. 35 no. 3)
241 05/07/2012 at 02:04:31 PM Self University of New Mexico Albuquerque, NM I would like to use this opportunity to strongly urge consideration of inclusion of Fetal Alcohol Spectrum Disorders (FASDs), and prenatal drug exposure research more generally, within the scope of a new National Institute of Substance Use and Addiction Disorders (NISUAD). It is my belief that a shift in institute as part of an NIAAA and NIDA merger would be harmful, and that the potential negative impact would extend to the public and scientists alike. I will provide my opinions in regards to both affected groups, however, because the ultimate goals of research on FASDs are better identification, treatment, and prevention of FASDs I do not view the consequences for these groups as separate or unrelated.

The problem : FASDs are the leading cause of retardation in the world and costs and estimated $4 billon annually. Despite considerable efforts maternal drinking continues to occur at an alarming rate with full-blown Fetal Alcohol Syndrome representing approximately 0.6% of live births. More troubling is the estimated 10-20% of children exposed to lower, moderate levels of ethanol during fetal development. The effects of full-blown Fetal Alcohol Syndrome are clear based on dysmorphology evidence, however, the effects of lesser exposure are much more subtle but have a negative lifelong impact on health and behavior.

Impact on scientists: Unlike many developmental disorders, FASDs have a clear and known environmental cause related to drug abuse. For this reason alone inclusion of FASD research in NISUAD makes good sense because advances in our understanding of the consequences of fetal ethanol exposure can best proceed in the context of research on drug effects and addiction more generally. There are many other scientific benefits to inclusion of FASD research in the new institute. For example, among the major consequences of fetal ethanol exposure is an increased susceptibility to drug addiction in adolescence or later, which has been observed in animal models of FASDs as well. Further, advances in understanding of drug addiction and its consequences in adolescence or adulthood can benefit from information about the unique influence of drug exposure and abuse during these periods. An integrated approach that includes drug effects from the fetus throughout the life can provide such a framework, however, fragmenting these lines of across institutions with differing philosophies and emphases will necessarily reduce such integration. My fear is that moving FASD research, or any prenatal drug exposure work, to another institution would potentially harm not only this research but the potential scientific benefits such synergies provide. More generally, failure to include research on prenatal drug exposure, which is fundamentally an issue of maternal drug abuse, and to only focus narrowly on use and abuse on the individual in the new institute would, in my opinion, preclude opportunities to benefit from the commonalities inherent in these lines of investigation. In the long run I believe that this would do far more harm when weighed against the financial and scientific benefits associated with the more narrow focus outlined in the RFI. As a final point, it should also be recognized that many researchers who study prenatal drug exposure, including FASDs, also study drug use and effects at other time-points or in other models. The practical impact of fragmenting closely related lines of research across multiple institutes make inclusion of drug effects and abuse in one institute a much more attractive solution from purely scientific and practical perspectives.

Impact on the public : As a scientist, I believe that anything that is detrimental to the generation and/or communication of new knowledge is harmful. Thus, I do believe there is potential for negative impact on the public in relation to all of the substantive points I raised above. In this case, I believe failure to include prenatal drug and alcohol exposure within the scope of the new institute will harm these lines of work as well as those that have been highlighted in the RFI document. Ultimately this means that the public will be denied the benefits for treatments and prevention a broader scope would provide. When weighed against the potential benefits, both practical and philosophical, the gains simply do not sufficiently counter the losses. Finally, whatever the ultimate decision of the SMRB is it is very important to recognize the public health impact of prenatal drug effects and to ensure that research aimed at better understanding and treating the consequences of prenatal drug exposure are not negatively affected. The best prevention approaches are only modestly successful and even with improvement will never eliminate prenatal drug exposure, therefore, it is very important not to forget that the health and quality of life for individuals exposed to drugs prenatally will depend on discoveries made by scientists. I strongly urge NIH to protect funding for these important lines of investigation.

The most important aspects of my comments for NIH to address are 1) the inclusion of prenatal drug exposure within the scope of the new institute and 2) protection of funding for prenatal drug exposure research.

 
242 05/07/2012 at 02:05:15 PM Self     RE: Understanding the mechanisms by which alcohol and other drugs of abuse increase risk for certain diseases (e.g. cancers), particularly when used in combination;

I strongly suggest that this area should include language that specifically emphasizes study of HIV/AIDS. Approximately one-third of HIV seroconversions among MSM can be attributed to non-injection substance use.

   
243 05/07/2012 at 02:35:16 PM Self Medical College of Wisconsin Milwaukee, WI I would like to urge that the new combined institute specifically include in its mission and scientific prorities the study of substance use and addiction aspects of HIV/AIDS. Both NIDA and NIAAA have long had separate missions related to substance use and HIV, and both have individually supported critical research that studies and tests interventions to prevent HIV in substance using and addicted populations. This research area has had significant scientific and public health impact. Research related to HIV/AIDS and substance use remains a high public health priority, and uniquely falls within the scope of the new institute.

I urge the inclusion of research on substance use in relation to HIV/AIDS as s specific mission of the new institute.

Substance-abusing populations in the United States and elsewhere are disproportionately affected by HIV. Apart from transmission risk behavior associated with injection drug use, other forms of substance abuse (including alcohol and recreational drugs) are strongly associated with risk of contracting HIV infection. In addition to studying the basis for these associations, the development of interventions to prevent HIV transmission among substance-abusing populations remains a key scientific need in the field.

Apart from prevention, existing data amply demonstrate that substance-abusing persons with HIV infection are much less likely than non-substance-abusers to enter, remain, and adhere to antiretroviral therapy for HIV disease. The reasons for these patterns are understudied. Research that identifies the nature of these associations and intervenes with substance-abusive HIV-infected populations is essential to new public health efforts to reduce HIV transmission through improved treatment and viral suppression.

I urge the inclusion of HIV/AIDS-related research as a mission of the new institute.

 
244 05/07/2012 at 02:49:15 PM Self University of Arkansas for Medical Sciences   I have significant concern that the newly proposed institute focusing on addiction does not adequately consider other aspects of alcohol and drug abuse such as fetal alcohol spectrum disorders. In addition, NIDA and NIAAA have always taken a systems appoaoch to evaluate the effects of drugs on organ systems. It is expected that in the new plan that grants not focused on addiction will be removed to other institutes. This approach will not be effective. It is imperative that the effects of alcohol and other drugs of abuse on all organ systems be considered in the new institute and not only addiction.

   
245 05/07/2012 at 03:21:07 PM Self     The desire to frequently drink large quantities of alcohol is a hallmark of alcoholism. Numerous studies have observed a significant correlation between life-long quantity of alcohol consumed and detriment to the body, including the degree of brain atrophy and risk for alcoholism. Thus, control of high alcohol drinking is an important problem that requires greater understanding at all scientific levels. Commensurate with the need for a greater understanding of what controls high alcohol drinking, medications that mitigate the desire to drink large quantities of alcohol are much needed.

Novel anti-drinking medication development

 
246 05/07/2012 at 03:27:59 PM Organization AASLD Alexandria, VA Please see the attached document submitted on behalf of the American Association for the Study of Liver Diseases.

  On behalf of the American Association for the Study of Liver Diseases (AASLD), I would like to thank the National Institutes of Health for seeking input on the pending proposal to abolish two NIH institutes (NIAAA and NIDA), as well as other discrete programs within other institutes, and constitute a new institute with the working title of the National Institute of Substance Use and Addiction Disorders. As NIH is aware, AASLD representatives have testified against this course of action on four occasions before the Scientific Management Review Board (SMRB) and its working group established to investigate the issue due to our concern about the devastating impact this proposal will have on alcohol-related end-organ damage research. Nothing in this response should be construed to assume any revision in AASLD’s position on the question of whether this is a beneficial action. Our response is provided to assure that our views of the scientific issues involved are considered in the NIH’s deliberations. For your background, AASLD is the leading organization in the world of scientists and healthcare professionals committed to preventing and curing liver disease. AASLD was founded in 1950 by a small group of leading liver specialists to bring together those who had contributed to the field of hepatology. It has grown to an international society responsible for all aspects of hepatology, and our annual meeting, The Liver Meeting®, has grown in attendance from 12 to more than 7,000 physicians, surgeons, researchers, and allied health professionals from around the world. Liver disease is the tenth largest cause of death in the United States and alcohol contributes directly or indirectly to a large proportion of these deaths. We have responded below to those questions/issues on which the views of hepatologists can enhance the dialog. We have not addressed those issues that are outside our area of expertise. • Developing a compendium of the pharmacokinetic and pharmacodynamic interactions between alcohol and the therapeutics used to treat general medical and psychiatric conditions (e.g., hypertension, diabetes, epilepsy, depression); Liver toxicity is the major reason drugs in clinical development are withdrawn, yet underlying mechanisms are often obscure and predictors of toxicity risk are largely unknown. Any drug can cause liver injury in susceptible individuals and the potential role of alcohol in increasing susceptibility to drug-induced liver injury (DILI) for drugs prescribed to treat general medical and psychiatric conditions has not been entirely explored. It is well known that acetaminophen-induced liver injury (the single largest cause of liver failure) is greatly increased in individuals who chronically ingest an excess of alcohol. Given the epidemic of obesity and metabolic syndrome, investigation of the effect of alcohol on these conditions as well as on the effects of medication used in their therapy, should be a priority for advancement of medical practice and public health. • Encouraging research on the generation of novel metabolites resulting from the in situ interaction of alcohol with opiates, stimulants, hallucinogens, or inhalants (e.g., the production of cocaethylene when alcohol and cocaine are co-ingested) and their pharmacokinetic and pharmacodynamic properties and toxicity; Our response to this issue is the same as to the issue raised above. • Understanding the mechanisms by which alcohol and other drugs of abuse increase risk for certain diseases (e.g. cancers), particularly when used in combination; If one considers that HCV is mostly the result of “other” drug abuse, the combined effects of HCV infection and different degrees of alcohol consumption lead to a synergistic increase in the risk of developing cirrhosis and hepatocellular carcinoma. We do not know whether other psychoactive prescription drugs or drugs of abuse have other synergistic interactions to increase the risk of cancer, for example esophageal cancer, whose risk is related to alcohol metabolism in individuals with specific polymorphisms of alcohol dehydrogenase. Smoking is an additive risk factor for development of hepatocellular carcinoma in patients with chronic viral hepatitis or liver disease due to alcohol. There is also a marked increase in oropharyngeal cancers in patients with alcohol abuse who smoke. Another aspect that is not studied elsewhere is the multi-organ effects of alcohol within the same individual and the concept that injury in one organ will affect the function of others. There is increasing evidence for communication among various organs that could be altered by alcohol use. The “classical” example is the gut-liver interactions in alcohol-related liver disease but there is increasing evidence for communications between the brain and other organs such as the liver. These novel aspects of mechanisms by which alcohol affects the communication among different organs should be the target of new investigations. • Engaging the medical community in prevention and treatment of drug addiction and alcoholism; It is well recognized that patients with alcohol-related liver disease (alcoholic hepatitis, cirrhosis) may experience substantial improvement in their clinical condition, possibly avoiding death or liver transplantation, if they are able to abstain from alcohol. • Alleviating the translational bottleneck for treatments to move from the bench to the bedside to the community; This seems to be the specific reason for the creation of NCATS and is therefore addressed currently elsewhere in the NIH structure. We would not encourage duplication of services in these tight budget times. • Designing clinical trials that accurately reflect real-world conditions (e.g., greater inclusion of polydrug users); Many individuals with alcohol-related liver disease have limited access to health care, largely due to their socio-economic status. Community-based studies of treatment of alcohol-related liver disease should be encouraged to address this treatment disparity. • Understanding the implications of policy changes on substance use patterns and trajectories, especially in youth; and, It is our assumption that this question addresses issues like the drinking age, or decriminalization of marijuana. We believe strongly that such policy changes will affect not only the addiction component of alcohol use but also the end-organ effect on the liver. Furthermore, people can develop alcohol-related liver disease even in the absence of “addiction” and it is unknown whether the “addiction” behavioral component would be associated with more frequent or more severe liver disease. We would also emphasize the significant impact of binge drinking on long-term alcohol abuse risk. The lack of access to programs to address high-risk drinking behaviors early in life could increase the risk of alcohol-related liver disease and its complications. • Furthering knowledge of tobacco use and addiction, including co-morbidity with other addiction and psychiatric disorders. As noted above, there is a marked increase in oropharyngeal cancers in patients with alcohol abuse who smoke – nicotine being another ‘drug of addiction.’ Furthermore, smoking is an additive risk factor for development of hepatocellular carcinoma in patients with chronic viral hepatitis or liver disease due to alcohol. Again, on behalf of AASLD, I would like to thank the NIH for seeking input on the pending proposal to abolish two NIH institutes (NIAAA and NIDA), as well as other discrete programs within other institutes and constitute a new institute with the working title of the National Institute of Substance Use and Addiction Disorders. While our position on the policy remains unchanged, we appreciate the opportunity to provide scientific input as you consider next steps.
247 05/07/2012 at 04:11:10 PM Organization Social Development Research Group, University of Washington Seattle, WA Critical point 1. Maintain at least current funding levels. Although not necessarily conceptualized as such by the SMRB, Congress may see the merger as an opportunity for cutting total funding allocated to research in this area. Substance misuse, abuse, and dependence impose an enormous burden on the U.S. economy in terms of reduced worker productivity and costs associated with physical and mental health care, law enforcement, and criminal justice. Not only are these problems expensive, but they are widespread. Continued funding at current levels, or even increased funding, is vital to address these critical public health problems and reduce their impact on individuals and the U.S. as a whole. Studies of have shown that these investments often bring savings to the U.S. economy in the form of reduced social and health care costs and increased productivity.

Critical point 2. Prevention must remain a priority. Establishment of a new combined institute should be used as an opportunity to strengthen NIH’s prevention portfolio. Prevention has demonstrated significant impacts in reducing onset and progression of substance abuse and it is essential that NIH not lose this focus (cites). Prevention is a national priority in the Obama administration and recognized as critical to the nation’s health. A recent report (2009) from The Institute for Medicine calls for Continued research on both the efficacy of new prevention models and real-world effectiveness of proven prevention and wellness promotion intervention as well as adaptation of research-based programs to cul¬tural, linguistic, and socioeconomic subgroups. I believe that the new institute’s mission statement must include an emphasis on prevention. I strongly endorse that the new institute elevate prevention to a research branch with funding allocated to alcohol and drug abuse prevention research at least equal to, and ideally greater than, the sum of the current levels at NIAAA and NIDA. This branch should also work to focus on translational research of prevention programs into real world settings. Prevention programming is a primary driver of the national economic benefits of substance use research investments.

Critical point 3. Drug and alcohol use are social behaviors. The proposed strategic plan over-emphasizes biological science compared to social and behavioral science. Substance use and abuse, particularly of alcohol, usually occur in social situations. Both currently and historically, use of specific drugs has been linked to identification with particular social groups, movements, or philosophies. Research suggests that initiation of these behaviors is largely environmentally determined, and that socio-cultural environments (e.g., policy, peers, family) play pivotal roles in the initiation and maintenance of and desistence from drug use, abuse, and dependence. Certainly there is an interplay of environmental and biological influences in the development of addiction, however, to downplay the social, cultural, and psychological aspects of substance use disorder is a fundamental miss that will severely weaken efforts at prevention and treatment and diminish the national economic contribution of work supported by the new institute.

Critical point 4. Integration with the NIH Roadmap. The new combined institute should have a clear plan for implementation of the NIH Roadmap for the Science of Behavior Change, for example, it could be a plan for how the behavioral sciences will be integrated into the biological and neuroscience portfolios.

Critical point 5. Interdisciplinary research is critical. Research on prevention and treatment of alcohol and drug abuse requires maintaining an interdisciplinary, multilevel perspective that takes into account comorbid disorders, such as mental health issues, and recognizes the role of social and environmental factors. It will be important as the two institutes combine that there is a strong commitment to interdisciplinary research.

Point of Clarification – What qualifies as “non-addiction research,”? Does “non-addiction research” include such things as HIV sexual risk behavior, health promotion and positive youth development interventions (that may have a number of benefits, including reduced or delayed drug use), and research on use or misuse that does not meet criteria for abuse or dependence (e.g., binge drinking)? Do these research areas fit into the new Institute or will they be referred elsewhere?

To me, the issues of continued focus on prevention and continued emphasis on social and behavioral science are the most critical. Prevention research has tremendous potential for cost saving and for making concrete reductions in the prevalence of addiction and associated problems at the population level. A failure to recognize the social and psychological influences on addiction will derail scientific understanding of the processes that lead to addiction, how to treat it, and how to prevent it.

 
248 05/07/2012 at 04:15:43 PM Self     As a researcher focusing on the effects of prenatal alcohol exposure on the development and long-term outcomes for children identified with fetal alcohol effects, I raise a few points of discussion regarding why I think FASD research should remain with the addictions institute.

First, it is clear that individuals exposed prenatally to alcohol are at increased risk for developing addictions themselves. Therefore, FASD research should be seen as the beginning of a continuum of research to better develop methods of intervention to decrease addictions beginning at the youngest ages.

Second, fetal alcohol effects are the leading cause of developmental disorders and yet are inherently tied to the addictions of the mother. Therefore, it is clear that the best approach to limit this serious public health concern is to work directly with the mothers and women of child bearing age to reduce risky drinking. Therefore, it is critically important to link research developing effective interventions to reduce risky drinking with FASD research.

Third, individuals are most susceptible to developing addictions as adolescents and this important area of research may be fractionated by redirecting the child research NIAAA portfolio to be administered by the NICHD.

Finally, it is clear that in many, if not most cases, children born to individuals addicted to illicit substances are often exposed to multiple illicit substances. By separating the NIAAA child-related research from the addiction research, this will hamper the ability to fully understand the effects of multiple exposures on the development of the human nervous system and thereby hamper the ability to best address this growing concern.

Therefore, I think it is important for the NIH to consider addictions and their ramifications as a large complex problem, which includes the effects on their family, including their offspring. I am convinced that without a unified effort to understand the causes of addictions and furthering our efforts to develop effective interventions, substance abuse (including alcohol abuse) will continue to be the leading cause of developmental delay in children and lead to new generations of individuals at increased risk for developing addictions themselves.

 
249 05/07/2012 at 04:24:08 PM Self     For nearly 20 years I have been the Principle Investigator of NIAAA-funded research on Fetal Alcohol Spectrum Disorders (FASD). I am writing to voice my fervent opposition to separating FASD-related research from the rest of the portfolio of alcohol research. To keep my comments brief, I am offering just one among many arguments, and using my own research as an example of why FASD research is not separable scientifically from other alcohol research.

My research is focused on identifying how alcohol disrupts intracellular mechanisms that control the way neurons extend processes and form appropriate connections – functions that are critical for normal brain development, but also for plasticity associated with learning and memory and for responses to injury. Neuronal shape, and changing shape in response to activity or other extracellular cue, is a key determinant of various neuronal functions that are disrupted by alcohol. Signaling pathways that regulate cell movements and shape are comparable across many different cell types, and are thought to be similar regardless of whether the cell is in a fetus or a mature individual. Indeed, our research has demonstrated that alcohol affects key signaling molecules (e.g. calcium, small Rho GTPases) linking extracellular cues to the cytoskeleton – thereby disrupting the cellular machinery controlling cell movements. These same signaling molecules are sensitive to alcohol in mature neurons, where they control structural changes associated with learning and memory, as well as responses to injury. Even more broadly, what we are studying is likely to provide insight regarding alcohol effects on other biological events that are critically dependent on cellular movements, such as immune responses, wound repair and metastasis. I derive considerable inspiration for our research from alcohol researchers working in these other model systems. To summarize, it seems arbitrary and misguided to treat our research as somehow less closely aligned scientifically with alcohol research – based simply on the fact that our model system is neurons developing and extending processes – when the same alcohol-sensitive cellular mechanisms are utilized by mature neurons, immune cells or cancer cells. I am firmly convinced that to delineate the molecular targets of alcohol, and to use these insights to design new, more effective treatments for alcohol addiction, we must continue to foster coordination of scientific discovery across multiple model systems. I hope you will agree that this will be best achieved by maintaining scientific and financial oversight of FASD research in a single institute.

   
250 05/07/2012 at 04:48:44 PM Self     1) Should Fetal Alcohol Spectrum Disorders (FASD) be excluded from the new institute?

2) Should the scope of the new institute be broader than addiction?

1) FASD is the single most important preventable cause of developmental disabilities. By far the most important strategy for preventing FASD is the prevention of drinking in women who are pregnant or trying to conceive.

2) There has been some suggestion about removing certain areas of alcohol research (prenatal alcohol exposure and end organ damage as examples) to other institutes. This type of isolation would have devastating effects on these areas of research. It is critical that all aspects of alcohol research remain within this new institute. Fetal alcohol research, as an example, needs to be within an institute that focuses its research program on how alcohol affects not only brain but various organ systems, immune function, behavior, etc.

 
251 05/07/2012 at 05:22:41 PM Organization Children's Hospital of Los Angeles Los Angeles, California Prenatal alcohol exposure permanently alters the structure and function of neurotransmitter pathways that mediate alcohol addiction. Children exposed to alcohol in utero are at increased risk for developing alcohol addiction. The comprehensive study of alcohol abuse and alcoholism requires the coordinated investigation of all factors that predispose to these disorders, including prenatal alcohol exposure. Therefore, preclinical and clinical studies of FASD should be an important part of the portfolio of an institute on addictions.

FASD is the single most important preventable cause of developmental disabilities. By far the most important strategy for preventing FASD is the prevention of drinking in women who are pregnant or trying to conceive. The defining face and brain abnormalities of fetal alcohol syndrome result from alcohol exposure during the third to fourth week of pregnancy, a time when most women do not know that they are pregnant. Hence, the prevention of FASD requires a concerted effort to reduce binge drinking in all women of childbearing age. Unfortunately, binge drinking is common, particularly in women in their late teens and early twenties. A broad array of clinical, psychosocial, and policy research has been directed at reducing drinking in this vulnerable population. That research needs to be coordinated to address the specific challenge of reducing binge drinking in women of childbearing age. Therefore, preventing the major public health burden of FASD will depend critically on the inclusion of all FASD research within the portfolio of an institute on addictions.

Susceptibility to addiction is greatest from early adolescence through the mid 20s, a time when the brain is still developing. The study of addiction depends crucially on understanding how alcohol affects the developing nervous system. Brain development begins during embryogenesis and does not cease until the third decade of life. Much of NIAAA's FASD portfolio focuses on the effects of alcohol on the developing nervous system. Alcohol interacts with many of the same molecular targets during prenatal and early postnatal brain development as it does in the developing adolescent and mature nervous systems. There is no scientific rationale for dividing the NIAAA brain research portfolio at any arbitrary point in the 3-decade timespan of human development. Therefore, all research on alcohol's effects on the developing nervous system should be coordinated and funded by a single institute.

 
252 05/07/2012 at 06:02:12 PM Self     1. Should FASD research be excluded from the new institute?

2. What would be the impact of the re-organization on ongoing research programs, including those on FASD?

1) Absolutely not! FASD is the single most important preventable cause of developmental disabilities. By far the most important strategy for preventing FASD is the prevention of drinking in women who are pregnant or trying to conceive. Such an effort should be a primary objective of the NIH.

2) To lose traction on focused alcohol research, health issues, and treatment would be a travesty. The exclusion of FASD would be another loss for the under-served and under-treated.

 
253 05/07/2012 at 06:07:53 PM Self     1. This is to express my strong recommendation that during the merge of NIDA and NIAAA, the FASD research remains in the new Institute on Drugs and Addiction. There has been some suggestion about removing prenatal alcohol exposure and FASD research from the new the Proposed National Institute of Substance Use and Addiction Disorders (a merge of NIDA and NIAAA) to other institutes. FASD issues affect childbearing age women, their partners, newborns, children and adults with FASD and their families and FASD research is truly interdisciplinary and involves professionals from different medical fields. There is no other field or medical profession other than alcohol research that could combine these different aspects productively and efficiently. 2. For a new institute on substance use and addiction, the research portfolio must include health promotion. Alcohol is unique in many ways with its health promoting effects at low doses (in the majority of the adult population) and danger with excessive use. Educational programs (and their evaluation) are critical and are particularly important for the youth, women of childbearing age, health professionals, and public at large.

FASD research needs to be included in the research portfolio of the new institute on substance use, abuse, and addiction. FASD is a significant public health concern. It is estimated that FASD affects 10 out of 1,000 births, or 40,000 newborns per year and the cost of FAS in the U.S. is estimated to be at least $6 billion a year. The lifetime cost for each child with FAS > $2 million. Research is needed. We still do not understand the basic mechanisms of the alcohol effects that result in fetal alcohol disorders. We do not know the factors that increase or reduce the severity of the effects. Interventions for affected individuals and effective prevention efforts are needed urgently. FASD research has emerged from the extensive research on alcohol. The FASD field is truly interdisciplinary and professionals from a number of medical specialties have to work together to make progress in research, develop and test interventions and implement effective evidence-based prevention models. Researchers from basic sciences, genetics, epidemiology, pediatrics, psychology, allied health, neurology, physical and occupational therapy, primary care, OBGYN, and other medical professionals have been involved and are necessary to make progress and ensure quality of life for individuals and families and prevent this 100% preventable disease. All the disciplines are necessary and all have been brought together to work under the umbrella of alcohol research. FASD issues affect childbearing age women, their partners, newborns, children and adults with FASD and their families. There is no other field or medical profession other than alcohol research that could combine these different aspects productively and efficiently. Therefore, I strongly recommend that FASD research needs to be included in the research portfolio of the new institute on substance use, abuse, and addiction.

 
254 05/07/2012 at 06:16:42 PM Self     This is to express my strong recommendation that the research program on FASD remain in the new Institute on Drugs and Addiction. On first reflection, it appears that moving this research portfolio to another institute would be a logical move as FASD clearly effects the development of children. However, on further reflection, moving this research program away from direct involvement with the field of alcohol researchers has major drawbacks.

The major points to be made regarding the placement of FASD research are:

1. The research should remain in an agency that covers the development of the effects of the brain throughout the lifespan, not just the early development of the brain. 2. As research has shown that prenatal exposure to alcohol places children at increased risk for developing alcohol addiction, the research studies on FASD should be part of the portfolio of a comprehensive institute on addictions. 3. In order to present FASD, the single most preventable cause of developmental disabilities, a coordinated approach must focus on stopping women from drinking alcohol who are trying to get pregnant or who are pregnant. A broad range of clinical, psychosocial, and policy research has been conducted in the US and other countries focusing on reducing women’s drinking during pregnancy. This research with adults needs to be coordinated in a single Institute with a broad range of researchers working with adult addictions.

Our research at the University of Oklahoma Health Sciences Center has focused on preventing alcohol consumption by women in Russia; we have received excellent consultation and recommendations from the well-trained staff and consultants available through NIDA and NIAAA, adult focused research centers. It is my strong recommendation that the FASD research program continue to be housed in the Institute on addictions,

Thank you for your consideration of this recommendation.

 
255 05/07/2012 at 07:09:21 PM Self     Four ideas to consider

Preamble: The idea that a new Institute may combine several research areas that are currently in other Institutes, in order to consolidate efforts and reduce redundancy is an intriguing idea. However, knowing which research areas go “together” in an Institute on Substance Use Addiction Disorders is a bit like the story of the blind men’s idea of what constitutes an elephant, it really depends on from which side you are "feeling" it. It is of the utmost importance that the motivation to combine certain areas of research is based on sound scientific data and not politically motivated reasons. Creating a new Institute by dismantling several existing Institutes and reshuffling will cause 5 years of “adjustment disorders” to staff and grantees and nobody wants to go through this with little supportive data that it will result in a better finished product.

I would like to give examples of 4 scientific areas that need careful consideration in this process. And, I would further suggest that each of these 4 areas be considered for cross-Institute RFAs, as test cases, which would be a much more expedient, less costly, and less disruptive process than combining Institutes. Once the benefits that could arise out of these RFAs could be assessed then consideration of whether and what should go into a new Institute could be put on a more firm scientific footing.

1) Creative and innovative research does not come from a machine that has a monolithic idea behind it. One of the most highly and hotly debated issues is whether there is a common mechanism for addiction to all substances (including nicotine). This is very much an open question and while some research (i.e. elegant imaging and electrophysiological experiments of limbic forebrain dopamine) give evidence that this could be true there is also ample evidence that it is not. For instance, genetic studies aimed at identifying genes underlying substance use disorders have shown that genes for alcohol dependence, in particular, do not overlap with those for other drugs of abuse/addiction (see Ehlers et al., 2004), whereas other areas of the genome appear to harbor genes for dependence on many drugs including nicotine (and cancer/COPD risk) (see Saccone et al., 2010). Providing a forum for the genetic consortiums in each Institute to meet, present findings, and combine data will advance this field. We do not need a new Institute to do this.

2) Do the mechanisms underlying “addiction” extend to other activities such as eating, gambling and sex? This is an extension of the first idea but looks at it from a different viewpoint. Recent genetic evidence suggests that some of the genes underlying drug dependence (including nicotine) overlap with the areas of the genome that harbor genes for body mass index (see Ehlers and Wilhelmsen, 2007). A potentially exciting construct underlying this finding is that there may be a set of “consumption” genes that influences both eating and drug taking. This set of genes may also influence metabolism (e.g. so called “fat sparing” genes), obesity, and cardiovascular risk, and/or they may share environmental risk factors (see Denoth et al., 2011). Would it not be more expedient to put together an RFA directly addressing this overlap rather than suggesting a new Institute be formed to include drug abuse, diabetes, cardiovascular disease and obesity?

3) Investigating the toxic effects of substances, especially alcohol, sugar, and fats, is not only important for understanding morbidity and mortality but impacts directly on the “Addiction” process. Two of the most exciting ideas in “Addiction research” that have appeared have come from studies on the effects of alcohol on the liver, gut and fetus. First discovered by researchers investigating the mechanisms of how alcohol produces liver disease it was discovered that it does so by activating two mechanisms. First of all, it changes the permeability of the gut (e.g. “leaky gut” syndrome) allowing gut bacteria and their by-products to enter the liver, and potentially harm the liver (Thurman et al., 1999). Interestingly, at the same time, studies showed that gut microbes may shape the host metabolic and immune network activity and ultimately influence the development of obesity and diabetes (see Musso et al., 2011). Taken together these studies suggest that a mechanism that we thought was only related to liver toxicity may influence consumption and addiction. The second mechanism is the ability of alcohol to initiate a cascade that leads to inflammation. It further turns out that alcohol also causes inflammation in the fetus, pancreas, and in the brain of the addicted individual using the drug (Lindros and Jarvelainen, 2005). In fact recent investigations suggest that the effects of brain inflammation may be an integral part of the development of “Addiction” itself (see Crews and Vetreno, 2011). Therefore, studying the process of inflammation in many tissues of the body (brain, gut, liver, fetus, pancreas, and adipose tissue) may uncover a very important general process of pathology including addiction. Again an RFA addressing this issue could be organized across institutes addressing this overlap rather than suggesting a new Institute be formed to include addiction, diabetes, liver disease, fetal effects and obesity.

4) The co-morbidity (co-occurrence) of substance use and abuse with other forms of mental illness goes way beyond the fact that certain disorders are often seen to occur together. In fact, recent evidence suggests that the risk that underlies drug use and certain specific mental disorders may come from shared genetic traits. For instance, several recent studies have demonstrated that post-traumatic stress syndrome (PTSD) as well as exposure to assaultive trauma are heritable (see Stein et al., 2002) and at least 1 study has shown that this shared trait overlaps with risk for alcohol dependence (Sartor et al., 2011). This means that it is not just the simple idea that a person is exposed to trauma, gets PTSD and decides to “self medicate” by drinking and using drugs but rather they have a shared genetic liability to all co-occur in that individual. There are in fact several other examples of this process including such disorders as manic-depressive disorder and substance use and antisocial personality disorder and substance use (see Dick et al., 2010), autism and alcohol dependence (see Schumann et al., 2011) and gambling and substance use. This is yet another suggested area of overlap that could be addressed by an RFA between Institutes instead of forming a new Institute that would include much of mental illness as well as substance use and addiction.

To conclude, the reasons that a new Institute should be formed should be based on a sound scientific basis that can be tested and evaluated. Trying out several cross Institute initiatives is a way to “test the waters” using the scientific method. This process should be transparent and not be swayed by political agendas only important “within the beltway” as this process has the potential to disrupt thousands of individuals in both the intramural and extramural communities for what appears at present to be intangible benefits.

References Crews FT, Vetreno RP. Addiction, adolescence, and innate immune gene induction. Front Psychiatry 2011; 2:19. Denoth F, Siciliano V, Iozzo P, Fortunato L, Molinaro S. The association between overweight and illegal drug consumption in adolescents: is there an underlying influence of the sociocultural environment? PLoS ONE 2011; 6(11):e27358. Dick DM, Meyers J, Aliev F, Nurnberger J, Jr., Kramer J, Kuperman S et al. Evidence for genes on chromosome 2 contributing to alcohol dependence with conduct disorder and suicide attempts. Am J Med Genet B Neuropsychiatr Genet 2010; 153B(6):1179-1188. Ehlers CL, Gilder DA, Wall TL, Phillips E, Feiler H, Wilhelmsen KC. Genomic screen for loci associated with alcohol dependence in Mission Indians. Am J Med Genet B Neuropsychiatr Genet 2004; 129B(1):110-115. Ehlers CL, Wilhelmsen KC. Genomic screen for substance dependence and body mass index in Southwest California Indians. Genes Brain Behav 2007; 6(2):184-191. Lindros KO, Jarvelainen HA. Chronic systemic endotoxin exposure: an animal model in experimental hepatic encephalopathy. Metab Brain Dis 2005; 20(4):393-398. Musso G, Gambino R, Cassader M. Interactions between gut microbiota and host metabolism predisposing to obesity and diabetes. Annu Rev Med 2011; 62:361-380. Saccone NL, Culverhouse RC, Schwantes-An TH, Cannon DS, Chen X, Cichon S et al. Multiple independent loci at chromosome 15q25.1 affect smoking quantity: a meta-analysis and comparison with lung cancer and COPD. PLoS Genet 2010; 6(8). Sartor CE, McCutcheon VV, Pommer NE, Nelson EC, Grant JD, Duncan AE et al. Common genetic and environmental contributions to post-traumatic stress disorder and alcohol dependence in young women. Psychol Med 2011; 41(7):1497-1505. Schumann G, Coin LJ, Lourdusamy A, Charoen P, Berger KH, Stacey D et al. Genome-wide association and genetic functional studies identify autism susceptibility candidate 2 gene (AUTS2) in the regulation of alcohol consumption. Proc Natl Acad Sci U S A 2011; 108(17):7119-7124. Stein MB, Jang KL, Taylor S, Vernon PA, Livesley WJ. Genetic and environmental influences on trauma exposure and posttraumatic stress disorder symptoms: a twin study. Am J Psychiatry 2002; 159(10):1675-1681. Thurman RG, Bradford BU, Iimuro Y, Frankenberg MV, Knecht KT, Connor HD et al. Mechanisms of alcohol-induced hepatotoxicity: studies in rats. Front Biosci 1999; 4:e42-e46.

All 4 ideas are important please read them I took my time to think about and carefully write them.

 
256 05/07/2012 at 07:55:19 PM Organization The McShin Foundation Richmond Virginia Recovery is the solution to addiction.Recovery is best delivered by recovery people and recovery organizations not the criminal justice system or government agencies

fund recovery organizations directly and addiction will diminish.

 
257 05/07/2012 at 08:26:20 PM Self   Los Angeles I am concerned that HIV/AIDS is not included as a "certain disease." There has been ongoing research that has demonstrated the association between substance use and HIV/AIDS infection. These studies have included varying target populations including injection drug users as well as non-injection stimulant users, particularly men who have sex with men (MSM), who transmit HIV through sexual risks while using stimulants such as methamphetamine. Currently, those at highest risk for HIV infection are young MSM and substance-using MSM.

It is critical for NIH to address the study of substance use (injection and non-injection) and HIV infection among high-risk populations such as MSM and transgender women.

 
258 05/07/2012 at 08:30:06 PM Self     I strongly urge that you ensure that research on food addiction (or addiction-like properties of certain types of highly palatable food) be integrated and strongly supported within the new Institute. Obesity in the United States continues to worsen, with more than 40% of American adults forecast to be obese by 2030 and currently more than 2 out of every 3 adults currently overweight. Obesity is poised to surpass cigarette smoking imminently as the nation’s leading cause of preventable death. Disorders that involve binge eating also are strikingly increasing in prevalence. While obesity and eating disorders are clearly multifactorial in nature, increasing recent data indicate that addiction-like neuroadaptations in brain reward and brain stress systems may drive the escalation, maintenance, and relapse of overeating palatable food in our society. Understanding these neuroadaptive changes may have fundamental importance not only for combating this most pressing public health problem, but also, potentially for understanding addictive processes more generally. I urge the new Institute to value studies of addictive-like changes vis-à-vis obesity and the control of feeding high in its portfolio. The study of this aspect of obesity and eating disorders historically has not been targeted by the NIDDK and has only partly been addressed by NIDA previously. The new Institute represents a golden opportunity to tackle directly the motivating causes for this historic expansion of the nation’s appetite and waistline.

I also strongly urge that you ensure that substantial support for basic research on addictive processes, including work that embraces molecular, systems neuroscientific, pharmacological, physiological, and behavioral levels of analyses in animal models – has an important place at the new Institute.

Finally, I would like to echo sound input from the Research Society on Alcoholism that the new Institute should:

1) Reallocate its revenue-neutral budget to match the actual public health burden. Here, research on neuroadaptive-like changes associated with palatable foods high in sugar or fat should have a markedly increased budget relative to its current level. The remainder of the budget should be distributed approximately equally between 1) alcohol-related, 2) tobacco-related, and 3) illicit and misused prescription drug-related research. Such adjustments are essential if research efforts are to come close to matching the public health burden, even if they may be politically difficult for a new Institute administration whose fiscal base derives largely from current allocations as represented in the existing portfolio items.

2) Some consideration needs to be made as to whether medical complications that are viewed as derivatives of the substance abuse condition fall under the Institute’s jurisdiction (e.g.,for food, obesity, type II diabetes, gestational diabetes or overnutrition; for alcohol, fetal alcohol exposure or liver disease; etc.), Where another institute does not already currently exist explicitly to address the derivative medical condition (e.g., NIDDK for type 2 diabetes), then I feel that it is appropriate and most economical based on past experience that the new Institute be responsible for funding derivative conditions of the addiction.

3) The new Institute represents the perfect opportunity to address comorbidities of substance misuse, including the comorbidity between alcohol and tobacco use, for example. There has been debate, however, re: how other comorbidities should be addressed (e.g., post-traumatic stress disorder with substance abuse, for example). This is an important area that needs to be addressed given the nation’s recent experience with events anticipated to increase the incidence and prevalence of PTSD and comorbid drug/alcohol use disorders in the near future. I feel that Institute funding should be dedicated not only to polydrug comorbidities, but also to substance misuse disorders that are comorbid with other psychosocial conditions, even if those conditions individually (without comorbidity) might be addressed by other funding agencies (NIMH).

4) I think it is important that addictions to legal substances (e.g., alcohol, food, tobacco) or behaviors (e.g., gambling, computer use), not receive shortshrift at the expense of illicit substances (e.g., cocaine, methamphetamine) simply due to NIDA’s previous relationship with the Office of National Drug Control Policy because of their common interest in illicit drugs. The allocation of budget should, again, reflect the public health burden, and here, the public health burden of legal substances far surpasses that of illicit substances.

Increased support for research into "food addiction" (that is, addiction-like neuroadaptations in brain reward and brain stress systems) given that obesity is poised to surpass cigarette smoking as the nation's leading cause of preventable death. More than 2 our of every 3 American adults is already overweight, and more than 40% are forecast to obese by 2030.

May 3, 2012 Thank you for the solicitation of input from experts in the field of addiction research as planning goes forward for the new Institute on Substance Use and Addictive Disorders. My name is [redacted], and I am an Associate Professor at The Scripps Research Institute engaged in basic research on addictive processes. I strongly urge that you ensure that research on food addiction (or addiction-like properties of certain types of highly palatable food) be integrated and strongly supported within the new Institute. Obesity in the United States continues to worsen, with more than 40% of American adults forecast to be obese by 2030 and currently more than 2 out of every 3 adults currently overweight. Obesity is poised to surpass cigarette smoking imminently as the nation’s leading cause of preventable death. Disorders that involve binge eating also are strikingly increasing in prevalence. While obesity and eating disorders are clearly multifactorial in nature, increasing recent data indicate that addiction-like neuroadaptations in brain reward and brain stress systems may drive the escalation, maintenance, and relapse of overeating palatable food in our society. Understanding these neuroadaptive changes may have fundamental importance not only for combating this most pressing public health problem, but also, potentially for understanding addictive processes more generally. I urge the new Institute to value studies of addictive-like changes vis-à-vis obesity and the control of feeding high in its portfolio. The study of this aspect of obesity and eating disorders historically has not been targeted by the NIDDK and has only partly been addressed by NIDA previously. The new Institute represents a golden opportunity to tackle directly the motivating causes for this historic expansion of the nation’s appetite and waistline. I also strongly urge that you ensure that substantial support for basic research on addictive processes, including work that embraces molecular, systems neuroscientific, pharmacological, physiological, and behavioral levels of analyses in animal models – has an important place at the new Institute. Finally, I would like to echo sound input from the Research Society on Alcoholism that the new Institute should: 1) Reallocate its revenue-neutral budget to match the actual public health burden. Here, research on neuroadaptive-like changes associated with palatable foods high in sugar or fat should have a markedly increased budget relative to its current level. The remainder of the budget should be distributed approximately equally between 1) alcohol-related, 2) tobacco-related, and 3) illicit and misused prescription drug-related research. Such adjustments are essential if research efforts are to come close to matching the public health burden, even if they may be politically difficult for a new Institute administration whose fiscal base derives largely from current allocations as represented in the existing portfolio items. 2) Some consideration needs to be made as to whether medical complications that are viewed as derivatives of the substance abuse condition fall under the Institute’s jurisdiction (e.g.,for food, obesity, type II diabetes, gestational diabetes or overnutrition; for alcohol, fetal alcohol exposure or liver disease; etc.), Where another institute does not already currently exist explicitly to address the derivative medical condition (e.g., NIDDK for type 2 diabetes), then I feel that it is appropriate and most economical based on past experience that the new Institute be responsible for funding derivative conditions of the addiction. 3) The new Institute represents the perfect opportunity to address comorbidities of substance misuse, including the comorbidity between alcohol and tobacco use, for example. There has been debate, however, re: how other comorbidities should be addressed (e.g., post-traumatic stress disorder with substance abuse, for example). This is an important area that needs to be addressed given the nation’s recent experience with events anticipated to increase the incidence and prevalence of PTSD and comorbid drug/alcohol use disorders in the near future. I feel that Institute funding should be dedicated not only to polydrug comorbidities, but also to substance misuse disorders that are comorbid with other psychosocial conditions, even if those conditions individually (without comorbidity) might be addressed by other funding agencies (NIMH). 4) I think it is important that addictions to legal substances (e.g., alcohol, food, tobacco) or behaviors (e.g., gambling, computer use), not receive shortshrift at the expense of illicit substances (e.g., cocaine, methamphetamine) simply due to NIDA’s previous relationship with the Office of National Drug Control Policy because of their common interest in illicit drugs. The allocation of budget should, again, reflect the public health burden, and here, the public health burden of legal substances far surpasses that of illicit substances.
259 05/08/2012 at 12:37:43 AM Self   San Francisco, CA; New York, NY; Cheshire, CT

1) Encourage the development of new interventions for nonmedical staff to prevent and treat substance use, and to link substance users to appropriate treatment for HIV, hepatitis, sexually transmitted infections, and other infectious diseases. Over several decades NIDA and NIAAA researchers developed a series of substance abuse interventions, including relapse prevention, motivational interviewing, contingency management, and most recently Screening, Brief Intervention and Referral to Treatment (SBIRT). These interventions have been utilized primarily by non-medical staff who comprise the vast majority of the addiction workforce.

2) Promote the implementation and translation of behavioral addiction research to prevent substance abuse, HIV, hepatitis, sexually transmitted infections, and other infectious diseases. The science of implementation of addiction research has not extensively progressed and a number of evidence-based prevention, treatment programs have not yet reached the community. Advancing the science of behavioral implementing research to real work settings is crucial to address the growing epidemic of addiction and related consequences.

3) Encourage the development and implementation of addiction treatment and prevention approaches on co-morbidities (e.g., addiction, mental health, etc.) including depression, trauma and psychiatric disorders. Behavioral prevention and treatment on co-morbidities and their relationship to HIV and other infection diseases also require more attention.

4) Encourage research to support the study of transformation from an acute care model of addiction treatment for persons with severe substance use disorders (characterized by brief service durations and primary focus on achieving abstinence) to one of recovery management (RM). The latter is a framework for organizing services to promote sustained long-term recovery maintenance and includes promising practices relative to screening, assessment and level of care placement; service team composition and relationships; the locus of service delivery and shaping of post-treatment recovery environments, e.g. “recovery management check-ups” and holistic health. The RM model needs to be studied for its promise of more effective service outcomes, sound resource allocation, and controls in the rate of growth of healthcare costs. Such studies may also serve to identify contributors to late stage relapse, i.e. 5-10 and more years after achieving abstinence.

We are members of the current NIH Advisory Council on Drug Abuse (the NIDA Council) who are providing our assessment of areas of research that need to be included in the new Addiction Institute. We are providing these suggestions as individuals, not as members of the Council. As health service researchers or health care administrators we want to make sure that the following research areas take a high priority at the new Addiction Institute. Our general suggestion is that issues concerning health services research, psychosocial, and nonmedical issues need more attention. NIH RFI for new Institute: Response to: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-045.html May 7, 2012 We are members of the current NIH Advisory Council on Drug Abuse (the NIDA Council) who are providing our assessment of areas of research that need to be included in the new Addiction Institute. We are providing these suggestions as individuals, not as members of the Council. As health service researchers or health care administrators we want to make sure that the following research areas take a high priority at the new Addiction Institute. Our general suggestion is that issues concerning health services research, psychosocial, and nonmedical issues need more attention. Suggestions: 1) Encourage the development of new interventions for nonmedical staff to prevent and treat substance use, and to link substance users to appropriate treatment for HIV, hepatitis, sexually transmitted infections, and other infectious diseases. Over several decades NIDA and NIAAA researchers developed a series of substance abuse interventions, including relapse prevention, motivational interviewing, contingency management, and most recently Screening, Brief Intervention and Referral to Treatment (SBIRT). These interventions have been utilized primarily by non-medical staff who comprise the vast majority of the addiction workforce. 2) Promote the implementation and translation of behavioral addiction research to prevent substance abuse, HIV, hepatitis, sexually transmitted infections, and other infectious diseases. The science of implementation of addiction research has not extensively progressed and a number of evidence-based prevention, treatment programs have not yet reached the community. Advancing the science of behavioral implementing research to real work settings is crucial to address the growing epidemic of addiction and related consequences. 3) Encourage the development and implementation of addiction treatment and prevention approaches on co-morbidities (e.g., addiction, mental health, etc.) including depression, trauma and psychiatric disorders. Behavioral prevention and treatment on co-morbidities and their relationship to HIV and other infection diseases also require more attention. 4) Encourage research to support the study of transformation from an acute care model of addiction treatment for persons with severe substance use disorders (characterized by brief service durations and primary focus on achieving abstinence) to one of recovery management (RM). The latter is a framework for organizing services to promote sustained long-term recovery maintenance and includes promising practices relative to screening, assessment and level of care placement; service team composition and relationships; the locus of service delivery and shaping of post-treatment recovery environments, e.g. “recovery management check-ups” and holistic health. The RM model needs to be studied for its promise of more effective service outcomes, sound resource allocation, and controls in the rate of growth of healthcare costs. Such studies may also serve to identify contributors to late stage relapse, i.e. 5-10 and more years after achieving abstinence.
260 05/08/2012 at 07:48:48 AM Self     The presentation indicates on p. 10 ("NIH Staff: Public Health Opportunities") that a key opportunity is to:

"Engage the medical community in prevention and treatment of drug addiction and alcoholism."

This opportunity restates a 15 year old strategy that has been long on intent and short on administrative science. The strategy within the opportunity needs to be considered and articulated in much greater detail. An efficient, outcome driven durable business model must be established to accesibly deliver your findings. Consider a case in point--Naltrexone (oral and injectible)is strongly indicated for treatment of alcohol dependence, especially when combined with psycho-social supports. Less than 3% of the population receives the medicine. Given the movement of the PPACA, we have an opportunity to redefine the business model for delivery of the evidence basis you will develop. Please strongly consider giving some realistic support to research and modeling cutting edge delivery systems. Thank you for your consideration and attention.

   
261 05/08/2012 at 08:06:38 AM Organization SMART Recovery Mentor, OH We urge the NIH to turn its attention to undertaking a systematic, empirical investigation of recovery from addiction and include such an undertaking in its Scientific Strategic Plan. Recovery is much more than abstinence from the use of alcohol and other drugs and should be researched to understand and disseminate how people can and do get well. A recovery-oriented research agenda will provide the recovery community, policy makers, service systems, clinicians, funders and individuals and families still struggling with addiction long overdue information on effective strategies for finding new lives, free from addiction to alcohol and other drugs. Specifically, we recommend the following areas for investigation:

A). Pathways, Processes, Stages, and Styles of Long-term Recovery Research is needed to understand longitudinally the multiple pathways to long-term recovery. As a person goes along his or her recovery path, they experience a life filled or refilled with work, a place to live, relationships, and activities in the community. Research should examine how a person integrates recovery into an expanding quality of life and the stages that this process happens at with a community/environmental perspective. Factors to be examined should include health, quality of life, variety of self-help programs, and community service in long-term recovery.

We also need to understand what the factors are that contribute to initiating alcohol and drug use after a period of sustained recovery. How often do people start using again across the life cycle of recovery? Are there points of vulnerability associated with age, primary drug(s), recovery pathway, gender, race/ethnicity, sexual orientation, or presence of co-occurring medical/mental health disorders? Are there critical transition points from early recovery to sustained recovery and from recovery maintenance to enhanced quality of life in recovery that increased risk of relapse? Does the availability and use of peer and other recovery supports, recovery institutions such as recovery community centers, recovery schools, recovery-oriented employers, recovery residences, alcohol- and drug-free recreational activities, affect a person’s ability to sustain recovery for the long haul?

The impact of research in this area would be of great interest to the public and policymakers – it would demonstrate the reality and pathways to recovery to a public that is skeptical about the ability of loved ones, friends and co-workers to recover from addiction to alcohol and other drugs. Research that found that recovery from addiction was a contributing factor to lowering recidivism rates for people re-entering communities from incarceration could assist policymakers in making decisions about policy and funding priorities.

It should also be of great interest to scientists seeking to understand the management of this behavior – mainstreaming addiction recovery research with research on other manageable chronic health conditions and providing information about the solutions to a problem that has been well researched and documented.

B). Recovery patterns and experiences for specific groups of people including young people, women, and parents in recovery. This research area should be of great interest to policymakers as well as to the public and scientists. The earlier that a person identifies and embarks on his or her pathway to long-term recovery, the better in terms of personal health and wellbeing, family and community health. The costs of addiction are dramatically reduced as well; benefiting taxpayers and communities.

Using young people as an example, some of the questions that could be asked include: • What is the prevalence of recovery among young people; is it increasing, decreasing? • Are there predictable stages of recovery for young people? • Do the recovery rates of young people differ by gender, ethnicity, drug choice or other variables? • Does a family history of recovery affect a young person and/or other family members’ recovery? • Do young people whose families are affected by ongoing alcohol and other drug problems have better opportunities for sustained recovery if they sever family ties? • How can parents, other family members and significant people in a young person’s life best help him or her to initiate and sustain recovery over a lifetime? • What are the effects of post-treatment monitoring, recovery coaching and assertive linkage to communities of recovery on long-term recovery outcomes for young people? Are they different than for adults? For parents in recovery, some questions that could be asked include: • If a son or daughter is at increased risk of developing an alcohol or drug problem because they and one or both parents share a family history of such problems, do the children have less risk of developing problems if the parent is in long-term recovery? • If one or more children were to develop an alcohol or drug problem, are their prospects of recovery better because of the parents’ recovery? • What strategies of prevention and early intervention can specifically lower the risks of children of recovering parents developing alcohol and other drug problems at an early stage? What effect does the participation of a family member in specialty sector addiction treatment and/or recovery mutual aid groups have on the recovery prospects of other family members? • What changes should a person anticipate in early recovery in relationships with children and other family members? • What does it mean when parents who have lost custody or left their children during their active addiction seek to re-establish contact with their children? Will this harm or benefit the child and if so, when and how? • What evidence-based models are available for peer-based support for parents in recovery, e.g., parenting guides/sponsors?

C). Communities of Recovery. How does the level and degree of exposure to communities of recovery and recovery-oriented communities affect a person’s individual and family member recovery? Do community supports such as faith-based organizations, opportunities for community activities/advocacy strengthen recovery and affect community wellbeing? What is the impact of having multiple housing options available for people in early or long-term recovery available mean to building recovery-oriented communities? Are there specific activities, events or developmental issues that pose significant challenges to recovery and community health? If so, what works to support recovery and community health?

D). Recovery self-management. Growing numbers of people seeking addiction recovery are developing recovery plans that they modify over time to reflect their progress in reaching recovery goals. Does it make a difference if a person develops his or her own recovery plan in a community or clinical setting compared with the development of a treatment plan by a clinician?

E). Peer and other recovery supports. Non-clinical recovery support services are offering people seeking or in recovery new services based in the community. These services can be used alone, in combination with mutual aid and/or professional treatment. What are their effects on the person seeking recovery as well as the person providing the service?

F). Recovery support institutions and service roles. Over the last ten years a growing number of recovery community organizations have pioneered the development and delivery of peer recovery support services for people in or seeking recovery from addiction to alcohol or other drugs. These organizations provide services in a variety of diverse settings, including recovery community centers and recovery residences, as well as host of other settings outside of the recovery community including jails and prisons and medical settings. Peer recovery support services and organizations that provide them have been operating virtually unnoticed until the emergence of the health reform-related focus on prevention and wellness, an emphasis that highlights recovery-oriented systems of care and implementation planning.

These nonclinical services often assist individuals and families and include peer recovery coaching, recovery community centers, recovery residences, job readiness programs, financial management training, educational/ employment assistance, and telephone check-ups. These services are provided prior to, during, after or in lieu of treatment and other clinical services and support. The use of peer support is, by now, a common practice in many fields. While professionals treating chronic illnesses are often knowledgeable about peer services, there is still limited awareness among individuals and families. In today’s medical world, peer support is recognized as a valuable adjunct to professional medical and social interventions. Improved outcomes are particularly notable when peer support services are provided to people with chronic conditions that require long-term self-management. The peer recovery support services offered by recovery community organizations and others are supported by a long, well-documented, and replicated evidence-based tradition. Peer recovery support services hold promise as a vital link between systems that treat people with addiction in a clinical setting and the larger communities in which people seeking to achieve and sustain recovery live. Awareness of the existence of these various groups and supporting research is critical.

There is a robust body of research on the value and effectiveness of peer supports for a number of chronic health conditions such as diabetes, cancer, obesity, HIV/AIDS and mental illness. This research has identified the value of services delivered by peers at the community level and the usefulness of a wide variety of social and other supports.

There has been limited research on the effectiveness of addiction peer recovery support services, mostly focused on recovery residences (housing). While there is a good start on this research, there is very little research on other recovery support institutions such as recovery schools, recovery community organizations, recovery community centers, recovery industries or recovery ministries. And there is next to no research on the emerging peer and other recovery support service roles of recovery coach and peer recovery support specialist.

G). The Neurobiology of Recovery NIDA’s studies of the brain should also focus on brain resilience and recovery. To what extent and how does the brain heal? How does long-term recovery affect this process?

NIAAA’s studies of the health impact of alcohol dependence should also focus on the health impact of recovery from addiction. To what extent and how does health improve? How does long-term recovery affect this process?

Thank you for allowing for input into this important strategic plan.

The overarching issue of recovery is the most important for NIH to address. Recovery should be the explicitly stated goal of NIH research on addictions.

 
262 05/08/2012 at 09:17:05 AM Self   Fort Worth, Texas As an addiction researcher with a long-history of NIH support and service (i.e., consultant reviewer, member, chair of study sections and current member of the Behavioral and Social Science Approaches to Preventing HIV/AIDS Study Section, Center for Scientific Review—term 2012 to 2016), I see a major and critical omission in the list of potential scientific opportunities and public health needs that must be incorporated into the Scientific Strategic Plan for the proposed new National Institute on Substance Use and Addiction Disorders (NISUAD) as well as insufficient emphasis on another opportunity and need. The omission is—comorbidity of HIV/AIDS and sexually transmitted infections among persons with substance use disorders. The minimal emphasis is—comorbidity of mental health disorders among persons with substance use disorders.

These issues are major public health problems that are intertwined with addiction.

HIV/AIDS and drug abuse are inextricably linked and coalesce in virus transmission not only through injection drug use, but importantly through risky behaviors induced by the effects of drugs and alcohol which impair judgment and decision making. Individuals with substance use disorders are at risk of viral infections and if infected they may be contagious and transmit diseases to others. The public health and scientific benefits of including behavioral and services research related to HIV/AIDS and substance abuse as part of the Scientific Strategic Plan for NISUAD cannot be overstated. It is critical that contracting and transmitting HIV/AIDS be researched through the substance abuse/use perspective. HIV/AIDS and substance disorders are syndemic diseases, i.e., they interact and are not independent. Adherence to ART/HAART is a public health concern that must be considered within the aggregate of HIV/AIDS and addictive diseases and their synergistic interactions. Medication development and adherence issues in drug abusing populations are different than in other populations as witnessed by the historical exclusion of drug abusers from clinical trials for new HIV/AIDS medications. The best place and most scientifically appropriate home for behavioral and services research regarding HIV/AIDS among drug and alcohol abusers is within NISUAD, an Institute where the long term strategic plan includes a primary focus on substance use and addiction disorders.

Co-Occurring mental health disorders and drug abuse are also inextricable linked. In the U.S., our bifurcated system of services and funding for mental disorders and substance use disorders is replicated at the NIH in terms of separating the diseases into different institutes. While there is a need for this separation, there must be recognition that there is an intersection where individuals and public health needs must be addressed. About 50% of the individuals entering the substance abuse treatment system are also afflicted with a mental disorder, whereas approximately 50% of the individuals entering the mental health treatment system also have an addictive disorder. Each system is equipped to handle certain portions of the population with these co-occurring disorders. Typically, the mental health system treats clients “with severe and chronic mental illnesses” but is “not equipped to address the treatment of concurrent substance abuse disorders,” whereas “the substance abuse treatment system addresses all types of substance abuse disorders at all levels of severity; when necessary, many providers in this system are able to respond to mild to moderate forms of mood, anxiety, and personality disorders.” (U.S. Department of Health and Human Services, 2002, p. v). Thus, NISUAD and NIMH should continue their research ventures within the needs of individuals afflicted with co-occurring disorders, and the mission of NISUAD should be broad enough to encompass the public health needs of individuals with substance use and mild to moderate forms of mental disorders.

Recommendation. It is critical that the mission of, strategic plan for, and research portfolio of NISUAD include HIV/AIDS and Co-Occurring mental disorders.

Thank you for this opportunity to respond to this Request for Information and offer my thoughts on what should be included in the mission, strategic plan, and portfolio of the new Institute.

May 9,2012 As an addiction researcher with a long-history of NIH support and service (i.e., consultant reviewer, member, chair of study sections and current member of the Behavioral and Social Science Approaches to Preventing HIV/AIDS Study Section, Center for Scientific Review-term 2012 to 2016), I see a major and critical omission in the list of potential scientific opportunities and public health needs that must be incorporated into the Scientific Strategic Plan for the proposed new National Institute on Substance Use and Addiction Disorders (NISUAD) as well as insufficient emphasis on another opportunity and need. The omission is--comorbidity of HIV/AIDS and sexually transmitted infections among persons with substance use disorders. The minimal emphasis is--comorbidity of mental health disorders among persons with substance use disorders. These issues are major public health problems that are intertwined with addiction. HIV/AIDS and drug abuse are inextricably linked and coalesce in virus transmission not only through injection drug use, but importantly through risky behaviors induced by the effects of drugs and alcohol which impair judgment and decision making. Individuals with substance use disorders are at risk of viral infections and if infected they may be contagious and transmit diseases to others. The public health and scientific benefits of including behavioral and services research related to HIV/AIDS and substance abuse as part of the Scientific Strategic Plan for NISUAD cannot be overstated. It is critical that contracting and transmitting HIV / AIDS be researched through the substance abuse/use perspective. HIV/AIDS and substance disorders are syndemic diseases, i.e., they interact and are not independent. Adherence to ARTIHAART is a public health concern that must be considered within the aggregate of HIV/AIDS and addictive diseases and their synergistic interactions. Medication development and adherence issues in drug abusing populations are different than in other populations as witnessed by the historical exclusion of drug abusers from clinical trials for new HIV/AIDS medications. The best place and most scientifically appropriate home for behavioral and services research regarding HIV/AIDS among drug and alcohol abusers is within NISUAD, an Institute where the long term strategic plan includes a primary focus on substance use and addiction disorders. Co-Occurring mental health disorders and drug abuse are also inextricable linked. In the U.S., our bifurcated system of services and funding for mental disorders and substance use disorders is replicated at the NIH in terms of separating the diseases into different institutes. While there is a need for this separation, there must be recognition that there is an intersection where individuals and public health needs must be addressed. About 50% of the individuals entering the substance abuse treatment system are also afflicted with a mental disorder, whereas approximately 50% of the individuals entering the mental health treatment system also have an addictive disorder. Each system is equipped to handle certain portions of the population with these co-occurring disorders. Typically, the mental health system treats clients "with severe and chronic mental illnesses" but is "not equipped to address the treatment of concurrent substance abuse disorders," whereas "the substance abuse treatment system addresses all types of substance abuse disorders at all levels of severity; when necessary, many providers in this system are able to respond to mild to moderate forms of mood, anxiety, and personality disorders." (U.S. Department of Health and Human Services, 2002, p. v). Thus, NISUAD and NIMH should continue their research ventures within the needs of individuals afflicted with co-occurring disorders, and the mission of NISUAD should be broad enough to encompass the public health needs of individuals with substance use and mild to moderate forms of mental disorders. Recommendation. It is critical that the mission of, strategic plan for, and research portfolio of NISUAD include HIV/AIDS and Co-Occurring mental disorders. Thank you for this opportunity to respond to this Request for Information and offer my thoughts on what should be included in the mission, strategic plan, and portfolio of the new Institute.
263 05/08/2012 at 09:49:43 AM Self     Susceptibility to addiction is greatest from early adolescence through the mid 20s, a time when the brain is still developing. The study of addiction depends crucially on understanding how alcohol affects the developing nervous system. Brain development begins during embryogenesis and does not cease until the third decade of life. Much of NIAAA's FASD portfolio focuses on the effects of alcohol on the developing nervous system. Alcohol interacts with many of the same molecular targets during prenatal and early postnatal brain development as it does in the developing adolescent and mature nervous systems. There is no scientific rationale for dividing the NIAAA brain research portfolio at any arbitrary point in the 3-decade timespan of human development. Therefore, all research on alcohol's effects on the developing nervous system should be coordinated and funded by a single institute.

It would be a shame to loss what we have gained in regards to research on FASD. My family is counting on YOU to do the right thing and continue NIAAA funding for FASD research.We have recently brought togetehr a group of individuals with FASD who are aging and there is no research at this time to see what is happening to them. By moving teh research away from the mom, we will lose a great deal of information.

Prenatal alcohol exposure permanently alters the structure and function of neurotransmitter pathways that mediate alcohol addiction. Children exposed to alcohol in utero are at increased risk for developing alcohol addiction. The comprehensive study of alcohol abuse and alcoholism requires the coordinated investigation of all factors that predispose to these disorders, including prenatal alcohol exposure. Therefore, preclinical and clinical studies of FASD should be an important part of the portfolio of an institute on addictions. FASD is the single most important preventable cause of developmental disabilities. By far the most important strategy for preventing FASD is the prevention of drinking in women who are pregnant or trying to conceive. The defining face and brain abnormalities of fetal alcohol syndrome result from alcohol exposure during the third to fourth week of pregnancy, a time when most women do not know that they are pregnant. Hence, the prevention of FASD requires a concerted effort to reduce binge drinking in all women of childbearing age. Unfortunately, binge drinking is common, particularly in women in their late teens and early twenties. A broad array of clinical, psychosocial, and policy research has been directed at reducing drinking in this vulnerable population. That research needs to be coordinated to address the specific challenge of reducing binge drinking in women of childbearing age. Therefore, preventing the major public health burden of FASD will depend critically on the inclusion of all FASD research within the portfolio of an institute on addictions.

 
264 05/08/2012 at 11:12:39 AM Self     There are several reasons blow for keeping FASD research within a new institute on substance use, abuse, and addiction,

1. Susceptibility to addiction is greatest from early adolescence through the mid 20s, a time when the brain is still developing. The study of addiction depends crucially on understanding how alcohol affects the developing nervous system. Brain development begins during embryogenesis and does not cease until the third decade of life. Much of NIAAA's FASD portfolio focuses on the effects of alcohol on the developing nervous system. Alcohol interacts with many of the same molecular targets during prenatal and early postnatal brain development as it does in the developing adolescent and mature nervous systems. There is no scientific rationale for dividing the NIAAA brain research portfolio at any arbitrary point in the 3-decade timespan of human development. Therefore, all research on alcohol's effects on the developing nervous system should be coordinated and funded by a single institute.

2. Prenatal alcohol exposure permanently alters the structure and function of neurotransmitter pathways that mediate alcohol addiction. Children exposed to alcohol in utero are at increased risk for developing alcohol addiction. The comprehensive study of alcohol abuse and alcoholism requires the coordinated investigation of all factors that predispose to these disorders, including prenatal alcohol exposure. Therefore, preclinical and clinical studies of FASD should be an important part of the portfolio of an institute on addictions.

3. FASD is the single most important preventable cause of developmental disabilities. By far the most important strategy for preventing FASD is the prevention of drinking in women who are pregnant or trying to conceive. The defining face and brain abnormalities of fetal alcohol syndrome result from alcohol exposure during the third to fourth week of pregnancy, a time when most women do not know that they are pregnant. Hence, the prevention of FASD requires a concerted effort to reduce binge drinking in all women of childbearing age. Unfortunately, binge drinking is common, particularly in women in their late teens and early twenties. A broad array of clinical, psychosocial, and policy research has been directed at reducing drinking in this vulnerable population. That research needs to be coordinated to address the specific challenge of reducing binge drinking in women of childbearing age. Therefore, preventing the major public health burden of FASD will depend critically on the inclusion of all FASD research within the portfolio of an institute on addictions.

   
265 05/08/2012 at 11:31:06 AM Organization Recover Wyoming Cheyenne, WY The following areas for consideration to be included by the NIH research agenda are: A. Research on the development, support, and science behind long-term recovery from addiciton. B. Family issues surrounding recovery; family history, supporting young people and adolescents trying to get and stay in long-term recovery. C. Communities of Recovery - the effects of social connectedness on specific populations; the levels and degree to communities of recovery and recovery-oriented communities affect a person's individual and family member recovery? C. Peer and other recovery supports - specifically the effect of Peer-based Recovery Coaching based from non-treatment/clinical environments.

1. Science of Recovery. From personal experience, having been through 6 residential substance abuse treatment programs (ranging from 28 days in length to 6 months duration) all of which are a minute piece of my life into recovery for the entirety of my life, it is imperative that research lead the way to building the science of recovery. Lives are changed everyday through supportive recovery communities, and we need the data and rigorous research to back up what I already know to work.

 
266 05/08/2012 at 11:51:05 AM Self     Careful definition of what belongs to the scientific portfolio of the new institute based on consensus in the field. The latter should be surveyed as opposed to defined at the executive level.

Continued commitment to basic research as it is as important as translational and clinical research, since these are interdependent.

 
267 05/08/2012 at 11:53:43 AM Organization American Congress of Obstetricians and Gynecologists Washington, DC Understanding the mechanisms by which alcohol and other drugs of abuse increase risk for certain diseases (e.g. cancers), particularly when used in combination

Much work is currently being conducted by the NIAAA on Fetal Alcohol Spectrum Disorder (FASD), but more needs to be done. 20% of women continue to drink during pregnancy and approximately 40,000 babies are born each year with the disorder, making it the number one cause of preventable birth defects.

It is imperative that we better understand the link between maternal alcohol use and FASD. Currently, it is unclear whether FASD will fit within the definition of “addiction research” the new agency is tasked with conducting. The potential separation of research on alcohol use during pregnancy and FASD would be detrimental to the effort to fully understand the link between the two, and to conduct streamlined, synchronized research on preventing and treating FASD. When determining the shape of the Scientific Strategic Plan it is crucial that FASD research does not get “lost in the shuffle.” The configuration of the new institute, whose portfolio will arise from the strategic plan formulated with input from the scientific community, must make FASD research a high priority.

Improving prevention efforts by developing a better understanding of the patterns and trajectories of drugs of abuse and their influence on brain development

In determining the Scientific Strategic Plan, it is essential that NIH realize the important role it can play in curbing maternal alcohol abuse. There are several areas of research related to FASD and alcohol abuse during pregnancy that should garner much more attention, prevention being at the fore. Development of an accurate biological screen for binge drinking or exposure to alcohol during early pregnancy offers one opportunity where the return on investment could greatly improve our Nation’s health and curb the lifetime of complications that stem from FASD and alcohol use during pregnancy.

Engaging the medical community in prevention and treatment of drug addiction and alcoholism and encouraging patient recognition and utilization of effective substance abuse treatments

As a leader in public health efforts, the NIH should research and initiate an information-based campaign to address alcohol abuse during pregnancy. Facts on the complications caused by drinking during pregnancy need to be more effectively disseminated to many more women of reproductive age as well as a broad range of physicians who treat them. Public awareness through advertisements and Public Service Announcements, similar to the current campaign to curb tobacco use, offers a potential avenue to reach the many women who may not be receiving proper prenatal care. The Scientific Strategic Plan should incorporate the many public health opportunities to curb alcohol abuse during pregnancy.

The areas of the RFI that we commented on above are the three that we found most important.

Attachment #1: May 11, 2012 Re: NOT-OD-12-045 Request for Information (RFI): Input into the Scientific Strategic Plan for the proposed National Institute of Substance Use and Addiction Disorders On behalf of the American Congress of Obstetricians and Gynecologists (ACOG), representing 57,000 physicians and partners in women’s health, thank you for the opportunity to provide comments on the scientific strategic plan of the proposed National Institute of Substance Use and Addiction Disorders. In an effort to ensure a broad range of scientific, programmatic, and clinical perspectives, ACOG sought input from a broad cross-section of its membership to inform these comments. Obstetrician-gynecologists play a key role in screening, and providing both brief intervention and treatment referrals for alcohol use in pregnancy and at-risk alcohol use by women of reproductive age. ACOG relies heavily on research conducted by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) in developing clinical guidelines for its members. In addition, ACOG has partnered with the Department of Health and Human Services on a variety of patient education initiatives, and recently launched a new website called Women and Alcohol as a one-stop shop for providers on screening and treatment guidance. ACOG welcomes the opportunity to comment on the Scientific Strategic Plan. However, this response does not negate the concerns we have with combining alcohol and drug abuse research into one institute, and several of those concerns are reflected in our comments below: Understanding the mechanisms by which alcohol and other drugs of abuse increase risk for certain diseases (e.g. cancers), particularly when used in combination Much work is currently being conducted by the NIAAA on Fetal Alcohol Spectrum Disorder (FASD), but more needs to be done. 20% of women continue to drink during pregnancy and approximately 40,000 babies are born each year with the disorder, making it the number one cause of preventable birth defects. It is imperative that we better understand the link between maternal alcohol use and FASD. Currently, it is unclear whether FASD will fit within the definition of “addiction research” the new agency is tasked with conducting. The potential separation of research on alcohol use during pregnancy and FASD would be detrimental to the effort to fully understand the link between the two, and to conduct streamlined, synchronized research on preventing and treating FASD. When determining the shape of the Scientific Strategic Plan it is crucial that FASD research does not get “lost in the shuffle.” The configuration of the new institute, whose portfolio will arise from the strategic plan formulated with input from the scientific community, must make FASD research a high priority. Improving prevention efforts by developing a better understanding of the patterns and trajectories of drugs of abuse and their influence on brain development In determining the Scientific Strategic Plan, it is essential that NIH realize the important role it can play in curbing maternal alcohol abuse. There are several areas of research related to FASD and alcohol abuse during pregnancy that should garner much more attention, prevention being at the fore. Development of an accurate biological screen for binge drinking or exposure to alcohol during early pregnancy offers one opportunity where the return on investment could greatly improve our Nation’s health and curb the lifetime of complications that stem from FASD and alcohol use during pregnancy. Engaging the medical community in prevention and treatment of drug addiction and alcoholism and encouraging patient recognition and utilization of effective substance abuse treatments As a leader in public health efforts, the NIH should research and initiate an information-based campaign to address alcohol abuse during pregnancy. Facts on the complications caused by drinking during pregnancy need to be more effectively disseminated to many more women of reproductive age as well as to a broad range of physicians who treat them. Public awareness through advertisements and Public Service Announcements, similar to the current campaign to curb tobacco use, offers a potential avenue to reach the many women who may not be receiving proper prenatal care. The Scientific Strategic Plan should incorporate the many public health opportunities to curb alcohol abuse during pregnancy. Once again, thank you for the opportunity to comment on the Scientific Strategic Plan for the proposed National Institute of Substance Use and Addiction Disorders. We look forward to future opportunities of engagement in this process. For questions or any additional information, please contact [redacted]. Attachment #2: PDF copy of paper: “At-Risk Drinking and Alcohol Dependence: Obstetric and Gynecologic Implications” a committee opinion by The American College of Obstetricians and Gynecologists, published on August 2011 (no. 496) Attachment #3: PDF copy of publication: “Drinking and Reproductive Health: A Fetal Alcohol Spectrum Disorders Prevention Tool Kit” published by The American College of Obstetricians and Gynecologists
268 05/08/2012 at 11:54:02 AM Self     FASD is a critical issue deserving of funding and inclusion in the new institute.

The effects on the public of prenatal alcohol exposure are enormous. From increasing the chance of the offspring exhibiting increased propensity for alcohol use later in life to problems of ADHD and learning in general. The public interest in this research should be immense.

FASD research is a critical area of research deserving funding consideration. Alcohol use by the mother during pregnancy is estimated to be around 20% in the United States and has recently been reported to be as high as 30-40% in Italy. While only a small percent of babies are born with full blown FAS experience with alcohol in the womb is more insidious than one may first assume. As little as 3 drinks throughout the whole pregnancy significantly increase the risk of the child having problems with drinking in adolescence. The cost to society is in the billions of dollars due to alcohol related problems and even light drinking during pregnancy perpetuates these issues. Studying fetal exposure to alcohol and the effects it has on the brain as well as the behavior of the offspring is critical in finding ways to ameliorate this problem. The savings potential in both lives and money for society is almost incalculable. Considering that alcohol is one of a few legal drugs easily obtainable study of its effects should be a critical focus of NIH.

 
269 05/08/2012 at 12:07:22 PM Self     As a scientist who has spent my career studying the effects of addiction and substance misuse on women and their children, I am concerned regarding the disposition of research on fetal alcohol spectrum disorders when the new institutive on addictions is established. The support of NIAAA for research in this area has been the reason that we have come to understand that FASD is one of the major causes for developmental disabilities in the United States and worldwide. Without the support for the scientific evaluation the effects of alcohol abuse and alcoholism in this focused way, it is likely that this disability would have continued to be misunderstood and mislabeled. Understanding that maternal alcohol abuse leads to physical and behavioral deficits in infants and children and that the effects are persistent and pervasive has allowed generations of pregnant women to make informed choices about alcohol use and pregnancy and has undoubtedly prevented many children from suffering the effects of this teratogen. Previous experience regarding the attention to this important issue by other agencies within NIH, raises serious concerns regarding the degree to which effective attention is likely to be paid to this significant social and medical issue if FASD is no longer treated in association with the problem of alcohol abuse and alcoholism. It is suggested that FASD research will be subsumed by NICHD which has not demonstrated a great interest in this issue in the past and has not provided any plan for how this would be addressed in the future. It would be tragic if all the work and study that has informed this important field of study were to be lost as a result of the planned reorganization. If the impetus that has resulted in so much important scientific insight were lost, if adequate support is not available for existing and new science and scientists, it is possible that attention will be diverted from this important public health issue.

A second issue is that the relationship of prenatal exposure to later addiction and substance abuse, in general is, as yet, not understood. It is clear that alcohol exposed and affected individuals are more likely to become alcoholics and addicts themselves but the extent to which this is the result of genetic and social factors versus the impact of the prenatal exposure itself is not understood as yet.

 
270 05/08/2012 at 12:14:31 PM Organization UNC Bowles Center for Alcohol Studies Chapel Hill, NC 27599 The fetal, alcoholic liver disease and other drug induced tissue pathology portfolio‘s of NIAAA-NIDA should stay with the new institute because drug abuse-addiction prevention and therapy are essential for these pathologies necessitating their linkage to drug abuse-addiction institute efforts. Further, recent discoveries indicate systemic-brain and systemic maternal-fetal systems biology is an important component of drug induced pathology linking drug mechanisms to pathology. The synergy of common prevention-therapy-systems biology drug abuse efforts is greater than that of liver or fetal disease within other institutes.

A key to merger success will be staff involvement. The NIAAA has used an Enternal Advisory Board to review, encourange and empower staff on evaluation and prioritorization of initiatives that become the strategic plan adopted by council. Through a process involves staff preparation of materials promoting areas of interest. The materials are distributed to selected experts and all council members for review (study section like evaluation of staff proposal priorities). A group meeting that includes select experts on the topic, council members, as well as small and large group discussions of the merits of various proposals concludes with a consensus recommendation of priorities from the proposals. The discussions and priority setting help staff become involved and motivated for the new initiatives. This would be a useful way to integrate and involve staff from the 2 institutes and provide a basis for priority setting within the new institute.

 
271 05/08/2012 at 12:20:31 PM Self     Dear Officer:

I am a Professor in the Department of Surgery at Michigan State University. In the United States, alcohol abuse is one of the leading causes for traumatic injury and liver disease. Organ tissue injury caused by alcohol use and abuse is a major focus of our investigation. Our studies are to elucidate the adverse effect of alcohol on host immune defense, tissue injury repair, and tissue regeneration. Most of these important investigations are currently funded by NIAAA. I would strongly recommend on behalf of our program at Michigan State University and colleagues working in this field elsewhere that alcohol, trauma, host immune defense and end-organ injury should remain a major focus of the new institute as any disruption of funding in this area of research may severely hamper the progress in improving patient care for excessive alcohol consumption associated trauma and organ injury. As the Director of Surgical Research at Michigan State University, I have a serious concern about the merger of NIDA and NIAAA into an Institute focusing primarily on addiction and addictive behavior. As we all know that alcoholic beverage is the most frequently consumed beverage in the public social events. Binge drinking and the associated acute intoxication are responsible for most incidences of trauma and organ tissue injury. Approximately 50% of the adult trauma patients who are admitted to the hospital consumed alcohol prior to sustaining their injuries. Acute alcohol intoxication profoundly suppresses host immune defense, which increases the incidence of secondary bacterial infection. These particular health problems caused by binge drinking and acute alcohol intoxication are not necessarily associated with any addictive behavior. I strongly suggest that alcohol consumption and end-organ injury should remain a major focus of the new Institute.

   
272 05/08/2012 at 12:20:57 PM Self     It is vitally important that Fetal Alcohol Spectrum Disorders (FASD) research continue to be institutionally housed with the remainder of NIH-sponsored research on alcohol abuse and alcohol addictions. There are two primary reasons for this recommendation. First, neural development is a complex process that begins in the first trimester of human pregnancy and continues until the end of the third decade of life. Alcohol affects all stages of neural development. In many cases, alcohol targets similar neurobiological processes during fetal development as it does during adolescence and adulthood. Novel findings on how alcohol affects one stage of neurodevelopment can lead to important advances in understanding how alcohol affects other stages of neural development. Scientifically, it does not make sense to separate research on alcohol’s effects on neurodevelopment based on some arbitrary point within the first thirty years of life.

Second, there is a complex interplay between alcohol abuse / alcohol addiction and the long term effects of fetal alcohol exposure. Clearly, alcohol abuse and alcoholism during pregnancy are the greatest risk factors for FASD. Conversely, among the many adverse consequences of fetal alcohol exposure is an increased risk for developing patterns of behavior that lead to alcohol abuse and alcohol addiction. Better comprehension of how fetal alcohol exposure predisposes adolescents and young adults to alcohol abuse and addiction requires continued coordinated research and scientific communication between the FASD and the alcohol addiction research communities. Separating the FASD research portfolio from the remainder of the alcohol addictions research community will surely diminish progress towards a better understanding of these relationships and will diminish or delay the prospects of improved care and treatment for these complex disorders.

Thus, the portfolio of basic science, clinical and community-based research on FASD should be sustained as an important part of a single institution supporting research on the molecular mechanisms and long-term consequences of alcohol abuse and alcohol addiction.

   
273 05/08/2012 at 12:27:13 PM Self     I believe all of the areas identified in this notice are important for consideration by the NIH, however I do believe that very critical areas of research were omitted and therefore the list should be updated. Notably missing from the list is the significant issues regarding the intersection of substance use disorders and HIV infection / transmission . As a researcher who is trained in addiction medicine, internal medicine and infectious diseases , i am very aware of the importance of research that targets addiction medicine and communicable diseases such as HIV disease. In particular I work with the criminal justice system, where HIV disease is 3x more prevalent than in the community and alcohol use disorders and opioid dependence occurs in 50-75% of HIV infected patients within the CJS in the Northeast. Ten million prisoners and jail detainees are released to the community with 16% of them having HIV disease in the U.S. Relapse to alcohol and opioid use occurs in 85% within the first year after release and is associated with loss of retention in HIV care and psychiatric care as well as increased HIV-risk taking behaviors . Currently I have two R01s , one funded via NIDA and the other via NIAAA that specifically target preventing relapse to substance use for released HIV+ released CJS populations as means to improve retention in care and HIV treatment outcomes not only to improve individual well being but also to decrease transmission of HIV to the uninfected public. Please include specialists in HIV disease and especially with the Criminal justice setting in the new addiction medicine branch at NIH .

I believe it is critical therefore to include program officers and other specialists within the new addiction medicine branch with persons who have familiarity with the complexity of research involving HIV and substance use disorders.

PDF copy of article: “Public Health Implications for Adequate Transitional Care for HIV-Infected Prisoners: Five Essential Components” by Sandra A. Springer et al; published by Clinical Infectious Diseases in October 2011 (vol. 53 no. 8)
274 05/08/2012 at 12:49:18 PM Organization University of Chicago Chicago, IL 60637 I think gambling and impulse control disorders should be included. i would even think some eating disorders belong here.

merging NIDA and NIAAA is a great idea. I would also like to see them merged with NIMH, since i think there is actually no clear line between the three of them.

   
275 05/08/2012 at 01:25:52 PM Self Yale University New Haven, CT Effects on Public: 1) The effects on the public can be categorized as “things that won’t happen”. Therefore, the public will likely not notice any effect. The effects will take the form of public education and dissemination that no longer occurs or is diminished, translation of research into behavioral and pharmacologic treatments.

2) As troops return from over 10 years of war, with many suffering from PTSD, depression, TBI, and other problems that can promote alcohol misuse, there is a military problem that is becoming a public problem. Alcohol is a socially acceptable, legal form, yet debilitating and socially and physically destructive form of substance abuse for these soldiers who have served our country so well. If not NIAAA, who will find better ways to help those soldiers?

3) Unlike other drugs of abuse, alcohol has profound effects on the whole body, and the body’s processing of alcohol has an effect on the process of intoxication and damage, as do the diseases (liver, for example) that are caused by alcohol misuse. What the public is going to miss out on, never even see, is the benefit of NIAAA’s recognition that alcohol misuse has to be treated as a system-wide problem. The very design for the merged institute removes the issues of alcohol that are not currently seen as directly related to its addictive properties.

4) Something unusual about alcohol, in comparison to other substances, is that at moderate doses, it can have benefits for some people, while for others it poses risks of cancer or heart disease. It is a profound benefit to the public to understand those risks and benefits, and if the system-wide perspective of alcohol’s effects is eliminated from the institute, the probability of understanding the benefits of alcohol will be low. It will simply be very unlikely to have the right combination of people looking at the systems issue.

In summary, the primary effect on the public will be to lose education and understanding that are coming from a systems approach to alcohol. This kind of loss will probably go unnoticed by the public, because it is largely preventative and for benefits that do not exist yet.

Effects on Scientists: 1) The effects on scientists will be a reduced attention to alcohol research. One might say that the new institute will pay attention to alcohol, but the current size of the relative budgets of NIDA and NIAAA show that far greater interest is invested in drugs other than alcohol, even though the damage caused by alcohol is tremendous. Creating a new institute will not change the disparity of funding for alcohol research, and it will very likely make it worse, because alcohol research will no longer be a visible, separate entity.

2) As funding for alcohol research becomes more difficult, young scientists who are in their most creative years will be drawn or forced in directions away from alcohol research. One might, as a solution, propose training specific to alcohol research, but if funding after the training period is too sparse, they will do something else, instead. The population of new minds with new perspectives for treatment will slowly be reduced.

3) An additional loss will be from established scientists forced to abandon the field because of loss of funding. Yes, the ideal is that the new institute will fund alcohol research at least as much as it has been, but the fact of the loss of systems effects from the institute’s program means immediately that some work will end. As mature scientists leave the field, new ones grow less likely to find or encounter mentors to guide them in alcohol research, so the reduced number of young scientists will be less likely to find people to draw them to this area of work.

In summary, the effects on scientists will be to discourage the entry of new, creative people into the field of alcohol abuse. It will gradually eliminate more advanced researchers, compounding the problems of young researchers because of a lack of mentors. Alcohol research will almost certainly, in the long run be reduced by a loss of financial support and minds.

1) Public education: This is how research can most directly be translated into relevance that has an impact on people’s decisions and lives. Public dissemination, such as that now carried out through NIAAA’s work, is essential.

2) Continued funding, at least proportionate to what is currently spent on other drugs of abuse that have greater visibility but less societal and health impact than alcohol does. This position is important to maintain, or alcohol research will certainly suffer. Solving this issue will also maintain the ability to continue the flow of new, creative researchers into alcohol research to introduce new ideas and replace scientists who retire. Could a mandate be introduced that forces this to happen?

3) Systems-wide perspective on alcohol abuse. The interactions of the brain and other organs, from prenatal ages to senescence, should be maintained, because the public health impact derives from the effects on the entire body, and not just the brain.

4) The positives of the proposed reconstitution are, ideally, integration of perspectives of alcohol and other substances of abuse. Those can and should be encouraged under any circumstances, even without a unification of the institutes.

 
276 05/08/2012 at 01:36:43 PM Self     As the NIH moves towards creating an integrated substance abuse center, there are several critical issues that I as an alcohol researcher think should be emphasized.

Alcohol use disorders represent one of the leading sources of preventable deaths and are a huge economic and social burden, in part because alcohol is legal and prevalent. Tobacco smoking also exacts enormous costs for similar reasons, and in fact tobacco and alcohol research should be placed within the same institute because of the strong alcohol/tobacco comorbidity. One concern is that alcohol and tobacco research not be overlooked or downplayed simply because they are legal substances. Research into addiction for illegal drugs is very important, but funding support for different addictive substances should in part reflect their impact on the society we are trying to aid. Thus, it will be crucial to maintain sufficient funding for alcohol and tobacco to allow the novel discoveries that will facilitate development of new and effective treatments.

It is also critical that the new institute maintain research into social, policy, preventative, and therapeutic areas. Such work provides important direction for neuroscience and physiology research by defining the characteristics of the actual patient populations we wish to help. For example, social research can help define the pathological patterns of behavior in addicts, neuroscience can help elucidate the neural mechanisms that drive the problematic pathological behaviors, and novel therapies and interventions will be generated at the interface. The NIH seeks to promote research with synergy between different research areas, and this goal will be best served by maintaining a diverse research program including society and policy as well as systems biology.

The economic harms of excessive alcohol intake/smoking are related in part to damage to organs other than the CNS, and the pattern of intake is likely to have important consequences for downstream physiological damage. Thus, research on organs other than the brain should be retained within the same institute that studies the behavioral and neuroscience mechanisms that give rise to such patterns of intake.

Although there are similarities among addictions for different substances of abuse including alcohol, there are also many important differences. These range from the patient populations impacted to the different compensatory molecular and physiological changes. This is especially true for alcohol, which acts through many more target molecules relative to other addictive substances. Thus, medications under development to treat addiction may or may not be useful across different addictive substances. In fact, an appreciation of the similarities and differences between addiction to different substances will only enhance our overall ability to be therapeutically effective.

Thank you for your consideration.

   
277 05/08/2012 at 02:10:18 PM Self       We are writing concerning the issue of inclusion of fetal alcohol spectrum disorder (FASD) research in the new institute on substance use, abuse, and addiction. As basic science FASD researchers, we are acutely aware of the devastating, permanent, and costly effects of prenatal alcohol exposure. NIAAA-funded research has shown that while the brain is vulnerable to alcohol-induced damage at virtually every prenatal stage, some of the most severe brain damage can result from maternal alcohol use limited to such early stages of gestation that the majority of women would not yet be aware that they are pregnant. This, along with the fact that there remains an alarmingly high incidence of unplanned pregnancies in the US, and that alcohol consumption (including binge drinking) by women of childbearing age is pervasive, provides the basis for alcohol being the most prevalent cause of congenital mental disability in our country. The support that NIAAA has provided for both basic and clinical research regarding prenatal alcohol-induced birth defects has yielded a solid foundation for continued efforts to better define the relevant cellular mechanisms and pathogenesis. Since alcohol interacts with many of the same molecular targets during prenatal and early postnatal brain development as it does in the developing adolescent and mature nervous systems, the knowledge gained from study focused on each of these periods is complementary. Additionally, research on the underlying causes of alcohol abuse and alcoholism will have significant impacts in educating women and health-care providers on the prevention of FASD. In short, there is no scientific rationale for dividing the NIAAA brain research portfolio at any arbitrary point. Removal of the prenatal period as an area of study related to alcohol addiction, use, and abuse would jeopardize the rapid and continued progress that is needed in order to reduce, in a timely manner, the major adverse impact of FASD in our society.

 
278 05/08/2012 at 02:43:58 PM Self     There are many considerations critical to establishing an effective National Institute on Substance Use and Addictive Disorders that will improve research in these important areas. I hope that in addition to this round of written comments, the NIH will convene both scientific and public panels to discuss possible directions.

A key issue for the new institute is whether it will consider the problems of substance use and addictive disorders from a narrow or wide perspective. Focusing too narrowly on neuroscience of substances will set back efforts to address the wide panoply of problems that impact health and society. An important NIAAA strength, the integration of research at all levels, from molecular and cellular effects of ethanol through systems biology to both addiction and disease, and then to the impact on society and strategies for reducing negative impacts, should be a model for the new agency. In particular, the integration of alcohol-related diseases (including liver diseases, FASD and cancer) and the effects of alcohol on other diseases (including beneficial effects on cardiovascular disease) with the study of alcohol consumption sets a strong precedent for the new institute. If alcohol-related organ damage/disease is divorced from the institute that focuses on alcohol in all of its facets there is a significant risk that important issues will be neglected. Likewise, moving treatment, prevention and policy issues to a different agency may leave them orphaned.

In terms of the addictive properties of alcohol and drugs, it is clear that nicotine belongs with these other drugs. There are, in fact, more similarities between nicotine and alcohol than between alcohol and illicit drugs of abuse, including the high prevalence of exposure (drinking, smoking), high comorbidity, and the delicate policy issues that arise in confronting problems with legal substances. Funding of studies on alcohol and nicotine should be greatly increased, commensurate with their huge societal impact.

Comorbidities need more attention, both in the laboratory and in population and clinical studies. Too often, people with comorbid conditions (other drugs, other psychiatric or somatic illnesses) are excluded from studies on one drug or disease to simplify analysis, but that hinders studies of the patients that we are trying to help. Taking these complexities into account will increase the costs of individual studies, but increase their value even more.

1. Need for extensive discussions of priorities with scientists and clinicians in the fields; text input in response to this RFI is important but not sufficient. 2. Integration of studies at all levels, from neurobiology and behavior through organ damage and disease to prevention and treatment. 3. Attention to comorbidity. 4. Funding that matches the importance of the problems- alcohol research is underfunded relative to its immense societal impact.

 
279 05/08/2012 at 02:47:20 PM Self     Rather than focusing only on interactions with therapeutics or novel metabolites, a full analysis of the biological, metabolic and behavioral effects of alcohol-recreational drug and recreational drug-drug combinations needs to be undertaken. For example, here in Montgomery County, there are a substantial number of adolescents and young adults who drink alcohol and consume opiate drugs at the same time. If one goes to the literature, there is almost NO data on the interactions of opioids with alcohol despite widespread use. Will drinking hasten or attenuate the development of physical dependence on oxycontin? Will oxycontin increase the risk of alcohol withdrawal seizures? There are no data to guide the clinician in addressing these problems.

NIH supports biospecimen banks for most disorders. However, for alcohol and drug dependence disorders, well characterized brain specimens and/or biological fluids are difficult to find. This limitation has discouraged progress in the development of biochemical and "omic" biomarkers for these conditions since basic scientists have difficulty optaining testable material. Similarly, the new Institute should maintain patient registries, which include harmonized data fields that would permit "in silico" hypothesis testing.

 
280 05/08/2012 at 02:54:16 PM Self     A. The opportunity to consolidate the nation's addiction mission into a single institute is an exciting opportunity that could yield many benefits for the nation's mission of reducing the impact of addictive disorders.

B. However, I am extremely concerned that the addiction mission may not be effectively consolidated in the new institute. This concern has several components including:

1. If important components of the tobacco/nicotine addiction portfolio remain outside the proposed institute, the effort to consolidate addiction research (in this case, the most commonly abused drug) would be compromised.

2. It is extremely important to retain the study of the neurodevelopmental effects of abused substances (alcohol - fetal alcohol syndrome; nicotine - risk for ADHD; etc.) within the addiction institute. First, these neurodevelopmental effects are best understood within the context of the overall study of the effects of these substances on the brain. Second, the effort to prevent the neurodevelopmental consequences of addiction are going to reflect the combined effort to treat addiction in the mothers and mitigate the ill effects of these substances in the fetus. Third, addictions are neurodevelopmental disorders. It would introduce barriers to science to split off the antenatal period from the remainder of the research on the neurodevelopmental effects (particularly during childhood and adolescence) of abused substances.

3. I believe that it is similarly ill-advised to split off the medical consequences of addiction from the rest of addiction research. First, at the level of biology, the signaling mechanisms underlying the toxic effects of these drugs shares many features with the addiction-related effects of these drugs. There are scientific synergies associated with linking these areas of research. Second, the effort the prevent the medical consequences of addiction reflects the combined and united effort to prevent them (i.e., to prevent and treat addiction) and to treat the toxic effects of these substances in relevant tissues in the body. In some cases, the brain for example, the toxic effects likely contribute to the addiction process. The addiction institutes developed their medical portfolios (liver, heart, lung, HIV, etc.) because these areas were neglected by the "organ-based" institutes. These addiction institutes have become experts in this area over the past decades. It would seem that splitting off these areas of medical research would hamper rather than facilitate progress.

C. I am extremely concerned that the financial cost and the scientific and administrative disruption associated with creating the consolidated institute may outweigh the benefits of the consolidated institute. To this end, we have been assured that the budget of the new institute would not reflect a cut to the addiction research mission. However, I have not seen indications that there would be an infusion of funds to the new institute to cover the administrative costs of the consolidation. Thus, particularly at a time when funding seems so tight, there would seem to be reductions in addiction research funding related to the merger. In addition, there do not appear to be new resources set aside for the new emphasis on research on the abuse of multiple substances.

In summary, I am excited by the opportunities that would emerge from closer collaboration of NIDA, NIAAA, and other institutes in the service of reducing the impact of addiction. The creation of a consolidated addiction institute is certainly one path to achieve that end. However, it is extremely important that any steps toward consolidation protect the addiction research mission. As noted above, there are many aspects, both financial and scientific, that raise concern. I would support a consolidation plan that preserved the integrity of the addiction research mission along the lines that I outlined above. However, I would oppose a structural consolidation plan that was advanced at the cost of the nation's addiction mission, which is served ably currently by NIDA and NIAAA.

   
281 05/08/2012 at 03:42:09 PM Self     In accordance with NOT-OD-12-045, a new institute on substance use, abuse and addiction-related research will better enable recognition and development of scientific opportunities and assist in meeting public health needs. All non-addiction related activities are to be moved out of this new institute. FASD has been cited as one of the portfolios to be moved to NICHD rather than retaining it within this new institute, while studies of the alcohol-using/abusing/addicted mother would remain within the new institute. I maintain that neither scientific research/opportunities nor public health needs can be met by separating studies on the developing child from those on the mother, and thus isolating the fetal alcohol spectrum disorders (FASD) portfolio from the broader context of alcohol research. The following reasoning supports this view:

1. FASD is different from other neurodevelopmental disorders in that it is entirely preventable. Moreover, FASD does not occur in a vacuum. It is the direct result of maternal alcohol use, abuse and addiction, and cannot be understood in isolation, apart from the mother. The maternal-fetal system are interconnected, and the mechanisms underlying the numerous adverse effects of alcohol on physical, neurobiological, cognitive and behavioral outcomes of offspring can only be investigated and understood in the context of the maternal-fetal unit. Factors such as maternal and fetal genetics and gene x environment interactions, diet, drinking pattern and amount consumed, stress, health status, and physiological function are risk/resilience factors and will all influence fetal outcome. One needs both the alcohol exposure information and information about the mother in order to understand fetal outcome. Trying to understand effects and investigate mechanisms of prenatal alcohol exposure on the offspring in isolation from the mother is impossible, if key information on maternal history, factors involved in mediation of alcohol’s effects, and biomarker information are lost.

2. A Consensus Statement from a recent Consensus Conference on “Recognizing Alcohol-related neurodevelopmental disorder (ARND) in primary health care of children”, sponsored by the Interagency Coordinating Committee on Fetal Alcohol Spectrum Disorders, NIAAA, the CDC and the American Academy of Pediatrics, highlights this point. It was recommended that “For children, pediatric primary health care clinicians should obtain medical records about prenatal alcohol exposure and other potential risks from the birth mother’s obstetric caregiver. For children who are not living with their birth parents, clinicians should obtain any available records that may provide information about prenatal alcohol exposure or other relevant family history.” This statement represents a dramatic advance in thinking for pediatric primary health care clinicians, who have focused historically only on the child. If studies on the child and the mother are separated into different institutes, such an approach will be seriously undermined.

3. Research related to mechanisms underlying alcohol’s adverse effects and to the development of interventions for and treatments of both the mother and child will also be compromised by separating the mother and child into different institutes. This is true from both the basic science and public health perspective.

A prime example from the basic science perspective comes from the field of epigenetics, a key initiative in many institutes within NIH, including NIAAA. Increasing evidence suggests that investigation of possible epigenetic mechanisms as mediators of alcohol’s adverse effects on the fetus provides a promising approach for understanding the complex phenotypes associated with FASD, and the persistence of these characteristics into adulthood. Some of the strongest evidence for epigenetic processes comes from data suggesting that both preconception and preimplantation alcohol exposure, when the embryo is not yet implanted in the uterus and thus not yet connected to the maternal system, can cause adverse effects. Paternal alcohol consumption may be one route through which preconception effects of alcohol can occur, through DNA methylation of the sperm. In addition, numerous preconception and preimplantation effects of maternal alcohol consumption have been described. Epigenetic processes are likely involved in prenatal alcohol effects throughout gestation as well. A possible role for epigenetic mechanisms in intervention for FASD, including a focus on maternal dietary factors such as folate and choline, provides a novel approach to intervention. This research is all driven by a focus on the maternal-fetal-child and/or paternal-fetal-child units, and would likely be seriously compromised if research on the mother and research on the fetus/child are done in isolation from each other.

A prime example from the public health perspective concerns efforts to reduce drinking in women of child-bearing age. Under the aegis of NIAAA, a broad array of clinical, psychosocial and policy research has been directed at reducing drinking in this vulnerable population. Separating research on the mother and child into different institutes will seriously weaken the development of public health initiative aimed at reducing or eliminating drinking during pregnancy. From a public health perspective, for both prevention and intervention, one must target the health of Thus, preventing the major public health burden of FASD and developing a coherent public health strategy for FASD will depend critically on the inclusion of all FASD research within the portfolio of an institute on substance use, abuse and addiction. 4. The majority of American adults who drink alcohol are not alcoholic, but rather recreational or moderate drinkers. These individuals will likely not fall under the purview of the new addictions institute. Yet moderate levels of alcohol exposure, while not causing FAS, are known to have serious long-term adverse effects on fetal and child development, including numerous behavioral, cognitive, and physiological effects. Inclusion of FASD within the portfolio of the new institute will allow for targeting of these individuals in public health campaigns focused on prevention of FASD, and will allow for research related to all aspects of the adverse effects of prenatal exposure to alcohol.

5. Infants and children with FASD grow to adolescence and adulthood. Their developmental disabilities do not go away, and new problems often arise as they mature. Many of these individuals develop so-called “secondary disabilities” including depression and anxiety disorders, substance use/abuse/addiction problems, problems with the law, social problems, and other issues. Many of these individuals are never able to live independently. Moving the FASD portfolio into NICHD will exclude research on adults with FASD from consideration.

For all of these reasons, from both a scientific and public health perspective, it is the right decision to retain the FASD portfolio within the new substance use, abuse and addiction institute.

All of the issues cited above point to the fact that excluding the FASD portfolio from the new institute on substance use, abuse and addiction, while including issues regarding drinking during pregnancy, will serve neither the scientific nor the public good. It is impossible to separate research on the developing child from research on the mother. One needs information on the mother, including her alcohol use patterns and amounts,her diet, genetics and physiology, etc in order to understand fetal outcomes. The study of mechanisms underlying fetal alcohol effects, including possible epigenetic mechanisms, likewise requires treating the mother (and father) and child as an interrelated unit. Public health efforts to reduce drinking in women of childbearing age and to develop a coherent public health strategy for FASD require inclusion of the entire FASD portfolio within a single institute. One cannot target either the mother or the child in isolation. Moreover, children with FASD grow into adults with FASD. Moving the FASD portfolio to NICHD will exclude adults with FASD from both the research and the public health agendas.

 
282 05/08/2012 at 04:31:04 PM Self     My area of research in on the effect of excessive alcohol consumption on skeletal health. The skeleton sustains damage at all developmental stages from alcohol consumption, though this fact is largely overlooked by the general population. The continuing problem of adolescent binge drinking is especially relevant to the skeleton, because drinking during this period coincides with the period when young adults accrue their peak bone mass. Alcohol exposure is know to decrease the accrual of bone mass. Thus, the study of alcohol consumption on end organs such as the skeleton is of critical public health importance if we are to offset a major epidemic of alcohol-induced osteoporosis in coming decades.

The NIH must, in any reorganization of the NIAAA, retain the capabilities to review and fund applications addressing the effects of alcohol on end organ damage, as these effects may be more important to the overall public heath, than the addictive aspects of alcohol research.

 
283 05/08/2012 at 05:25:58 PM Self     This response is from the NIDA Comorbidity Interest Group (CIG). The CIG includes staff from all NIDA extramural Divisions with the mission of integrating new and ongoing research and working synergistically to promote a multidisciplinary perspective on the comorbidity of substance abuse with other psychiatric disorders. Substance use disorders (SUDs) are highly comorbid with other psychiatric disorders. Data show that persons diagnosed with psychiatric disorders are more than twice as likely to suffer also from a substance use disorder compared to the general population. The obverse is also true: persons diagnosed with SUDs are about twice as likely to suffer from other psychiatric disorders as are people without SUDs. Furthermore, in many instances, SUDs and other psychiatric disorders may share common genetic, environmental, and neurobiological risk factors. These patterns of comorbidity have significant implications for research leading to successful preventive and treatment interventions. For these reasons, the CIG strongly encourages that the Scientific Strategic Plan include scientific opportunities and attention to public health needs relevant to comorbidity. We strongly support two of the scientific opportunities already identified in the RFI, with the following additions: • Designing clinical trials that accurately reflect real-world conditions (e.g., greater inclusion of polydrug users). Comment: We suggest that to reflect real-world conditions more accurately, this point be expanded to promote greater inclusion of persons with comorbid substance abuse and other psychiatric disorders in clinical trials and laboratory studies. In addition, there is a critical need for research on specific treatment protocols for individuals with both SUDs and other psychiatric disorders, and on the challenges of identifying medications to treat persons with dual-diagnosis disorders. • Furthering knowledge of tobacco use and addiction, including comorbidity with other addiction and psychiatric disorders. Comment: We are pleased to see the recognition of tobacco use and addiction as strongly comorbid with other addictions and psychiatric disorders. We further recommend expanding this scientific opportunity to cover both the concurrent abuse of multiple addictive substances and the patterns of psychiatric comorbidity discussed above. In addition to these two research areas, we also suggest that the Scientific Strategic Plan include research on the etiology of the high prevalence of comorbidity between SUDs and other psychiatric disorders. Currently, there is insufficient understanding of the roles of psychiatric disorders in the genesis of SUDs, the contributions of SUDs to later psychiatric disorders, and the shared risk factors that may contribute to the development of comorbid conditions. Specifically, there are scientific opportunities for neurobiological, behavior, and genetic studies, and research on the interplay of these factors. Understanding the etiology of comorbidity will inform prevention and treatment of both substance use and other psychiatric disorders.

We think it is very important that NIH enhance research on the comorbidity of substance use and other psychiatric disorders for the reasons stated in the first paragraph of comment 1.

This response is from the NIDA Comorbidity Interest Group (CIG). The CIG includes staff from all NIDA extramural Divisions with the mission of integrating new and ongoing research and working synergistically to promote a multidisciplinary perspective on the comorbidity of substance abuse with other psychiatric disorders. Substance use disorders (SUDs) are highly comorbid with other psychiatric disorders. Data show that persons diagnosed with psychiatric disorders are more than twice as likely to suffer also from a substance use disorder compared to the general population. The obverse is also true: persons diagnosed with SUDs are about twice as likely to suffer from other psychiatric disorders as are people without SUDs. Furthermore, in many instances, SUDs and other psychiatric disorders may share common genetic, environmental, and neurobiological risk factors. These patterns of comorbidity have significant implications for research leading to successful preventive and treatment interventions. For these reasons, the CIG strongly encourages that the Scientific Strategic Plan include scientific opportunities and attention to public health needs relevant to comorbidity. We strongly support two of the scientific opportunities already identified in the RFI, with the following additions: • Designing clinical trials that accurately reflect real-world conditions (e.g., greater inclusion of polydrug users). Comment: We suggest that to reflect real-world conditions more accurately, this point be expanded to promote greater inclusion of persons with comorbid substance abuse and other psychiatric disorders in clinical trials and laboratory studies. In addition, there is a critical need for research on specific treatment protocols for individuals with both SUDs and other psychiatric disorders, and on the challenges of identifying medications to treat persons with dual-diagnosis disorders. • Furthering knowledge of tobacco use and addiction, including comorbidity with other addiction and psychiatric disorders. Comment: We are pleased to see the recognition of tobacco use and addiction as strongly comorbid with other addictions and psychiatric disorders. We further recommend expanding this scientific opportunity to cover both the concurrent abuse of multiple addictive substances and the patterns of psychiatric comorbidity discussed above. In addition to these two research areas, we also suggest that the Scientific Strategic Plan include research on the etiology of the high prevalence of comorbidity between SUDs and other psychiatric disorders. Currently, there is insufficient understanding of the roles of psychiatric disorders in the genesis of SUDs, the contributions of SUDs to later psychiatric disorders, and the shared risk factors that may contribute to the development of comorbid conditions. Specifically, there are scientific opportunities for neurobiological, behavior, and genetic studies, and research on the interplay of these factors. Understanding the etiology of comorbidity will inform prevention and treatment of both substance use and other psychiatric disorders.
284 05/08/2012 at 05:28:28 PM Self     The list of public health needs seems to underemphasize the need to understand the etiology of the development of substance abuse. This includes the identification of its biological and genetic underpinnings, contextual (environmental) risk and protective factors, the interaction of all these predisposing factors, and the contribution of comorbidity. The emphasis on treatment and prevention currently in the list of public health needs would seem likely to be better realized if complemented by work focused on developmental etiology, and how risk changes with development. For example, it will be difficult to understand how drug misuse influences brain development in youths without understanding whether there are deviations from normative brain development that predispose youth to initiate use and abuse substances, or whether predisposing brain factors interact with use in a manner that produces especially deleterious effects on brain development. Comorbidity associated with tobacco use is noted, but comorbidity is commonly observed across the different classes of drug use disorders, and this comorbidity renders difficult understanding effects specific to any one substance. Poor understanding of the effects of comorbidity is likely to undermine prevention and treatment efforts.

I've attempted to address the "why" behind my concern for lack of attention to the important issue of developmental etiology in Comment #1.

 
285 05/08/2012 at 05:45:36 PM Self     I endorse ABAI's response to this RFI. I transcribe the response below:

Basic and translational behavioral science has contributed in substantial and enduring ways to our understanding of addiction. The formation of the National Institute of Substance Use and Addiction Disorders (NISUAD) presents an exceptional opportunity to expand upon the crucial role of behavioral science. NISUAD will be uniquely positioned to support basic behavioral research, and to influence its direction. The discovery that drugs act as potent reinforcers by Charles Schuster (a former NIDA director), Roy Pickens, and Travis Thompson transformed addiction science and led to a range of evidence-based treatments that are still being disseminated across a multiplicity of settings. Basic research also gave birth to pre-clinical models to isolate and assess novel behavioral and pharmacotherapies for addiction. Cutting-edge basic behavioral research continues on a range of topics in addiction. This work includes the influence of delay discounting on choice for drugs and other risky behavior, the role of associative processes in substance abuse and relapse, the importance of conditioned reinforcers in drug use, and the behavioral economics of substance abuse. Thus, behavioral research continues to transform our understanding, and it promises to lead to new strategies to prevent and treat addiction. WE URGE THE NEW NISUAD TO PRESERVE A SIGNIFICANT ROLE FOR BASIC AND TRANSLATIONAL RESEARCH OF BEHAVIORAL PHENOMENA. In addition to the behavioral research described above, advances in neuroscience and genetics are increasingly being linked with basic behavioral phenomena. It is truly exciting when behavioral science and allied disciplines come together to form a deeper understanding of addiction. But these advances cannot occur without continued support for basic behavioral research. In any research portfolio, at some point the question will be asked about the behavioral significance of the phenomena under study. Answering this question will require basic behavioral research in animals and humans. Critical issues that basic behavioral research can address include: • THE ROLE OF CHOICE AND BEHAVIORAL REGULATION IN SUBSTANCE ABUSE. This includes the choice between drug use and other activities, self-control, delay discounting, modulation of incentive motivation, and response-inhibition in both animal models and in people.

• THE TRANSITION FROM TREATMENT TO COMMUNITY. The point at which an individual returns to the environment in which abuse occurred is a period of great vulnerability. We need to understand the basic processes of how such environments foster use and how to build resistance to these influences.

• THE ROLE OF ASSOCIATIVE PROCESSES, INCLUDING CONDITIONED REINFORCEMENT AND OCCASION-SETTING. These environmental factors contribute to the development of abuse, foster and enhance the impact of addictive substances and activities, and are critical determinants of relapse.

• THE DEVELOPMENT OF QUANTITATIVE MODELS OF DYSREGULATED BEHAVIOR. Such models provide formal content to otherwise ambiguous psychological constructs and thereby guide the identification of neural structures and functional relations that underlie addiction.

• THE ROLE OF ENVIRONMENTAL FACTORS IN RELAPSE. It would be difficult to overstate the importance of conditioning principles in relapse. We know that events paired with drug reinforcers occasion drug use and cravings but we have a poorer appreciation of how to exploit this understanding to program, for example, the generalization from treatment to community and domestic environments or to apply associative processes in predicting or preventing relapse.

• TRANSLATIONAL STUDIES TO IMPROVE TREATMENT. Direct application of behavioral economic principles can be found, for example, in the emergence of contingency management and other behaviorally based approaches to manage, treat, and prevent addictive disorders.

• CONTINUED SUPPORT FOR RESEARCH ON ADDICTIVE DISORDERS IN GENERAL. This includes gambling and other addictive disorders that do not involve drugs. It is our understanding that this support will continue, but we feel that this is so important that we wished to strongly endorse it.

By clearly articulating a role for basic behavioral research, NISUAD can become a leader in basic and translational behavioral science. Our understanding of conditioning processes advanced significantly because of the support of NIDA and NIAAA. With the formation of NISUAD these advances can continue to grow.

I endorse ABAI's response to this RFI. I transcribe the response below:

1. INSTITUTIONALIZE A ROLE FOR BEHAVIORAL RESEARCH.

This simple step will sustain scientists involved in basic and translational studies. Here, we mean developing RFAs, RFPs and other funding opportunities for basic and translational behavioral research, and cultivating program officers and study sections with expertise in behavioral science. Without such an institutional commitment behavioral research will be in danger. In fact, the diminished support for basic behavioral research by NSF and NIMH is a serious threat to the sustainability of a field that has made important theoretical, methodological, and translational contributions to the investigation of addiction. This presents an opportunity for NISUAD to become a major influence. NIDA and NIAAA benefited enormously by the research conducted by behavioral scientists, and so will NISUAD if it supports basic research.

2. IDENTIFY BASIC AND TRANSLATIONAL BEHAVIORAL RESEARCH AS A PRIORITY. This will improve our understanding of all stages of the addiction cycle and in the design of intervention strategies to break this cycle. The development of a substance abuse disorder, its prevention and treatment, and the sustainability of the benefits of treatment are all, in essence, behavioral problems. Any public health effort aimed at the treatment or prevention of substance abuse will include behavioral principles as a central component. Yet our understanding of these principles, and their translation, remains incomplete.

 
286 05/08/2012 at 06:20:18 PM Self     See uploaded comments.

  Although the proposed merger may well successfully draw together scientists in addiction and substance use, with the potential to benefit research in both alcohol and other substances, it is important to recognize key distinctions between the portfolios of the current NIAAA and NIDA, which reflect major differences in the manner in which alcohol and other drugs of abuse are encountered by the American populace. In my opinion, these differences must be paramount in developing a new research agenda for a combined institute. In sharp contrast to most drugs of addiction, alcohol is a legal and widely used substance, consumed by at least half of all Americans in any given month. It has a narrow but important dosing window in which it appears to have, at worst, no overall detrimental effect on health. As a result, NIAAA-sponsored research into the health effects of alcohol consumption - which span the entire gamut of human physiology and differ substantially between acute and chronic responses to drinking - has no clear parallel in research at NIDA. Put differently, as a primary care physician, I see no clear clinical reason to study the health effects of illegal drugs of abuse nor to determine what might put individuals at higher or lower risk for damage from them, because there is no situation in which they should be used; the legally mandated threshold of use is complete abstention. In contrast, there is urgent need for that type of research for alcohol consumption in adults. The health effects of alcohol consumption have been addressed in cell culture, animal models, human physiology studies, and long-term epidemiological cohorts, all of which have provided complementary insights into the pathways by which alcohol may injure human tissue, mechanisms to reduce injury, the varying dose-response curves for different illnesses, and potentially susceptible subgroups for whom even consumption within currently recommended limits is harmful. For example, research into the combined effects of hepatitis C virus and alcohol has spanned all of these domains and helped to drive clinical recommendations to minimize all alcohol use – even levels commonly considered nontoxic to hepatocytes – among individuals with chronic hepatitis C infection. No parallel exists for exposure to illegal drugs of abuse. A combined division on addictions must recognize the need for, and continue to fund, multidisciplinary work in these fields. It is likely that as many Americans consume alcohol as use all illegal drugs together, emphasizing the critical role that research on health effects of alcohol has on the health of the American public. Were the NIH to reduce its research investment in examining the health effects of alcohol consumption, we risk losing the opportunity to shape its use and ensure that harms are minimized and benefits, if they exist, are maximized. Any gains in efficiency in the study of addictions must be balanced with increased attention to the health effects of alcohol (and not simply alcohol in combination with other drugs, given the enormous burden of alcohol use among individuals who do not use other drugs). The current list of potential scientific opportunities and public health needs of a new institute does not adequately consider the short- and long-term health consequences of intake of potentially addictive substances because of its focus on complete abstention. Because complete abstention from alcohol is neither recommended nor realistic, this list therefore poses a real risk to future research, to the evidence needed for informed clinical guidelines for physicians, and to the health of the majority of Americans who consume alcohol.
287 05/08/2012 at 06:41:19 PM Self Clinical Psychologist Murrysville, Pa. 15668 While fears remain over the loss of specialization and of losing the always growing "library" of unique materials related to each substance and its use in specific populations, I do understand the finanical realities and even the potential positive opportunities that could become available through a new,unified Institute. With this unification however more responsibility must be assumed for both setting the direction of our science and in developing a comprehensive understanding of the illness. This sense, this "larger" role, should reflect both where the science exists today and where it needs to go tomorrow - if the Institute is to truly reflect the evolution of our science, understanding and practice.The RFI for the National Institute of Substance Use and Addiction Disorders falls short in assuming this larger opportunity in that it leaves out the understanding of the illness that can be found by researching and understanding how one gets and stays well from it. Today in America we have from 25-40 million (White, 2012) citizens in recovery, a new constituency that has much to offer in not only understanding the illness but its remission and continued recovery. To achieve this larger opportunity and to set the course of an even greater goal for the new Institute, I would recommend its name be the National Institute of Substance Use and Addiction Diseases and Recovery. Futher and more detailed justification is made in Comment 2.

NIH in its new Institute needs to address both the pathology and the "cure" to fully encompass the study of the illness. By doing so you expand from a science of pathology to a science whose illness and "cure" (euphemism)is informed equally by that pathology and by those who achieve progressive wellness, remission, initial and sustained recovery from it. Moreover this broader scope opens up the practicality of how science and research are used in the real world, developing and again informing our science of "adoption." How many are in recovery leads to a defintion of "recovery" and to measures of it which then leads practice change while empowering states and invested leaders with validating measures and outcomes, accountable financial analyses,alternative pathways to and community roles in recovery. In 2009, as Founder and head of the Instutute for Research, Education and Training in the Addictions (IRETA) I helped lead a national survey of researchers as to what key questions such a "science of recovery" would need. We also conducted a National Summit in Philadelphia where those questions were presented and as well as why we needed such a expansion to our science. Attachement 1 shares that thesis (pp.5-8) and those gathered key questions (pp.12-17). Since a lively dialogue has emerged from leaders as to a working (and evolutional) definition of "recovery", 34 states are now implimenting recovery focused care (e.g. in Pa. Recovery Oriented Methadone), six nations have written peer reviewed articles (see: Psychiatric Services, December, 2011)on the value of recovery focused care to both communities and individuals - and to the development and relevance of a new workforce to enhance it. The American Psychiatric Association has proclaimed "recovery focused care" to be "best practice" (Psychiatric Services, January, 2012)in MH; and in March and May(see attachement 2)this same journal argued for a "modernized" definition of the "medical model" that would include an understanding of clinical recovery, illness management and personal recovery in the revised definition. It was also advanced that these changes in MH are not the "antithesis" of the medical model but the modernization of it to reflect the changes that have occurred in the wider field of medicine and today's societal attitudes toward illness and the progress that comes by involving those with it and their communities in the solution. But where is our SU science in all this? Most recovery reseach is outside of NIH and those who want to study it often have a difficult time breaking through well worn and established pathways of more narrow topics and funding. Our science, and this new Institute, needs to evolve to this same modern view of understanding disease and wellness. Our science and research needs to broaden its view of the illness to support its fuller understanding and lived world application. Understanding the pathology of use, abuse and addiction within the enlightened contribuitions of research into remission,wellness, attained and sustained recovery brings the potential of a full, unifying science to the table.

Attachment #1: PDF copy of publication: “Building the Science of Recovery” compuled by Alexandre Laudet; published by Institute for Research, Education and Training in Addictions and Northeast Addiction Technology Transfer Center in January 2009 Attachment #2: PDF copy of letter to the editor: “A Medical Model for Today” by Michael T. Flaherty; published by Psychiatric Services in May 2012 (vol. 63 no. 5)
288 05/09/2012 at 10:52:12 AM Organization Scientific Advisory Board, National Center for Responsible Gaming Beverly, MA The NCRG is the largest private funder of peer-reviewed research on gambling and gambling disorders in the United States. The NCRG has funded 53 grants since 1996, including two Center of Excellence in Gambling Research grants. This funding, which totals $15 million, has resulted in more than 200 peer-reviewed publications. The purpose of this funding is to provide seed money for R01 type research. Without such support from NIH to support the primary studies, improved treatments and interventions for this disorder will not progress. The Scientific Advisory Board of the National Center on Responsible Gaming (NCRG) is recommending that research on gambling, problem gambling and pathological gambling be placed in the strategic plan for the proposed National Institute of Substance Use and Addiction Disorders. We base this on four main reasons.

First, the core symptoms of pathological gambling are conceptually similar to features of substance use disorders. According to the DSM-IV, “the essential feature of Pathological Gambling” is “persistent and recurrent maladaptive gambling behavior …that disrupts personal, family, or vocational pursuits” (APA, 2000). Symptoms include withdrawal when attempting to reduce or stop gambling; preoccupation with gambling; and need to gamble increasing amounts to achieve desired mood.

Second, there is an abundant amount of behavioral, epidemiological and neuroscience data that empirically support similarities between pathological gambling and substance use disorders. Examples: a) based on data from the National Comorbidity Survey Replication, the onset and persistence of pathological gambling is predicted by prior DSM-IV addiction-related disorders, including impulse-control and substance use disorders (Kessler et al., 2008); b) brain imaging studies and neurochemical tests have made a “strong case that [gambling] activates the reward system in much the same way that a drug does” (Holden, 2010); and c) pathological gamblers report cravings and other addiction-related behaviors and in response to gambling stimuli that are analogous to signs and symptoms displayed by individuals with a substance dependence disorder, (e.g., Potenza, Leung, Blumberg, 2003; Breiter, Aharon, Kahneman, Dale, & Shizgal, 2001).

Third, this body of research has persuaded the APA’s DSM-5 task force to reclassify pathological gambling as an addictive disorder. As noted by Professor Charles O'Brien, M.D., of the University of Pennsylvania, the chair of the addictions work group for DSM-V, the commonalities of pathological gambling with other addictive disorders warrant its inclusion with these disorders, including substance use disorders, in the revised DSM system.

Fourth, whereas pathological gambling is a relatively low base rate disorder In the United States (the prevalence of lifetime problem or “at-risk” gambling is 2% and lifetime pathological gambling is 0.6%; Kessler et al. 2008), conservative estimates of its prevalence is much higher in subpopulations, such as youth and minorities (Petry, 2004).

The Scientific Advisory Board has identified the following areas as priorities for the field: prevention and treatment of gambling disorders, especially brief interventions; the impact of Indian gaming; the progression from at-risk gambling to pathological gambling; gambling and minorities; and technology and gambling.

 
289 05/09/2012 at 10:57:41 AM Self     I consider it essential that the NIH continue to battle fetal alcohol exposure and the accompanying syndrome.

This is an important but preventable syndrome, and more research is needed to determine the appropriate social, environmental, and biological avenues for prevention.

 
290 05/09/2012 at 12:03:58 PM Organization Society for Women's Health Research Washington D.C. n/a

n/a

The Society for Women’s Health Research (SWHR) appreciates the opportunity to respond to the Request for Information (RFI) soliciting input into the Scientific Strategic Plan for the proposed National Institute of Substance Use and Addiction Disorders. This development of this Institute will result in a reorganization of substance use, abuse, and addiction-related research at the NIH. SWHR is the nation’s only nonprofit organization whose mission is to improve the health of all women through advocacy, education, and research. SWHR advocates for appropriate inclusion of women in all aspects of medical research; promotes the analysis of research data for sex-based differences; and informs women, health care providers, and policy makers about conditions affecting women exclusively, disproportionately, or differently than men. Sex-based biology, the study of biological and physiological differences between men and women, has revolutionized the way that the scientific community views the sexes and treats patients. The leadership at the National Institute on Drug Abuse (NIDA) has, historically been, and continues to be champions of sex difference research in the field of drug abuse and addiction disorders. SWHR has worked closely with NIDA to highlight these research discoveries over the last two decades. SWHR believes that NIDA’s commitment to the study of sex differences must continue to be a priority following the creation of the new Institute. SWHR strongly believes that the study of sex and gender differences will revolutionize personalized medical practice in the United States. It is imperative that the new Institute continue and expand upon NIDA’s extraordinary work in the field of sex and gender differences in substance abuse and addiction disorders. In order to coordinate and integrate sex differences research across the Institute, SWHR recommends that NIH creates an office of sex and gender research within this new Institute. This office should be fully staffed, funded and authorized to work in an interdisciplinary manner in the field of substance abuse and addiction disorders. NIDA currently has highly qualified staff that are experts in the field of sex and gender research, who can be drawn upon to seamlessly lead the newly created office within the Institute. As this area of research has implications for every condition within the realm of drug abuse and addiction disorders, the expertise of NIDA’s staff will enable the office to quickly provide leadership in integrating sex differences research into the Institute’s research portfolio. This new office must be provided grant making authority to enable it to work with other offices and centers across NIH. As NIH develops a new strategic plan for the Institute of Substance Use and Addiction Disorders, SWHR strongly recommends that it keep NIDA’s commitment to research into sex and gender differences by creating and supporting this new office. We are happy to provide input to the RFI relating to the development of this strategic plan and look forward to working with the new Institute to improve the health of all Americans, especially women, in the area of substance abuse and addiction disorders.
291 05/09/2012 at 01:20:46 PM Self     NIH policy on the portfolio of the new institute should be informed by experts in the field. The mission of the new institute should be developed by experts working in a transparent manner and the portfolio should reflect the institute's mission. Scientists and the public expect an open forum headed by leaders in the field. Irrespective of the mission, it is critical that a systems biology approach be employed in the scientific portfolio and that prevention plays a major role in the public policy aspects of the new institute.

Alcohol abuse and its myriad medical and social consequences must not be ignored or obscured under the topic of addiction. The two problems are often, though not always, distinct.

The proposed institute should reflect the public health burden of alcohol abuse, alcoholism, drug abuse and addictions. This is a great opportunity to apportion the NIH mission to public health needs.

Administrative reorganization should not detract from the progress of science. How can the NIH possibly undertake this administrative burden as we face sequestration of 8-10%. Please don't spend vital research monies on administrative reorganization. NIH should ask congress for a large budget increase to accomplish this reorganization in the best public interest.

 
292 05/09/2012 at 01:50:15 PM Self     As an overall outstanding document could serve as a template for strategic approaches for alcohol and other drugs of abuse, I highly recommend that you incorporate the NIAAA strategic plan in its entirety. Indeed, I think the life-span approach taken by this strategic plan can be easily adopted to all drugs of abuse or other stimuli that come to exert extreme control over behavior and compromise our public health. A link to this plan is : http://pubs.niaaa.nih.gov/publications/StrategicPlan/NIAAASTRATEGICPLAN.html

I would like to emphasize three other areas that I believe is worthy of consideration by NIH for emphasis by the proposed new institute:

1) Integrative Neuroscience “systems” approach in longitudinal studies of self-administration 2) The role of stress in alcohol addiction 3) Computational social neuroscience in pharmacotherapy development

Integrative Neuroscience “systems” approach in longitudinal studies of self-administration: Integrating information across research disciplines and across the life cycle of the addictive process is a very difficult task, but one that must be accomplished if we are to reap the full benefits of animal models. Integrating information from genetic, cellular, trans-synaptic, endocrine and behavioral approaches can be efficiently addressed with self-administration procedures and therefore could serve as an excellent platform to provide “systems” knowledge to addiction.

The role of stress in alcohol addiction: A sustained effort is needed to disentangle stress and its role as a leading risk factor in the third largest preventable death in the United States. A comprehensive approach and investigation of pituitary, adrenal, gonadal, hematological and hepatic sources of cytokines, neuroactive steroids and other endocrine stress factors appear to be involved in this co-morbidity. Our body of knowledge is far too underdeveloped in this area, thus my suggestion that alcohol remain as a single factor, rather than a co-factor with another drug, for further research in this area.

Computational social neuroscience in pharmacotherapy development: Social factors may be a large reason why potential pharmacotherapies show promise in animal models but fail to have efficacy when transferred to the clinical population. A concerted effort in computational social neuroscience is needed to identify social constraint on addictive behaviors, how the constraint is lost in the addiction process, and the interaction between pharmacotherapies and social outcomes in predicting the efficacy of establishing abstinence. Specifically, the development of computer engineering is needed to continuously capture and remotely annotate social behaviors to identify the dynamic behavior of individuals in a social group and their reciprocal interactions as well as integrate their pattern of drug use. Animals allow the degree of control necessary to develop these computer programs and to assess patterns of drug use and their consequences on a real-time basis.

May 9, 2012 I appreciate the opportunity to enter a response to the NIH request for information on the scientific strategy plan of a new institute on substance use and addiction disorders. I have devoted my entire scientific career to studying animal models of alcohol and drug abuse. I am particularly interested in the non human primate as a unique animal model for addiction research and in the environmental generation of excessive behavior. I am funded by the NIH and the NSF and currently serve on the NIAAA National Advisory Council. As an overall outstanding document could serve as a template for strategic approaches for alcohol and other drugs of abuse, I highly recommend that you incorporate the NIAAA strategic plan in its entirety. Indeed, I think the life--‐span approach taken by this strategic plan can be easily adopted to all drugs of abuse or other stimuli that come to exert extreme control over behavior and compromise our public health. A link to this plan is : http://pubs.niaaa.nih.gov/publications/StrategicPlan/NIAAASTRATEGICPLAN.html I would like to emphasize three other areas that I believe is worthy of consideration by NIH for emphasis by the proposed new institute: Integrative Neuroscience “systems” approach in longitudinal studies of self--‐administration: Integrating information across research disciplines and across the life cycle of the addictive process is a very difficult task, but one that must be accomplished if we are to reap the full benefits of animal models. Integrating information from genetic, cellular, trans--‐synaptic, endocrine and behavioral approaches can be efficiently addressed with self--‐administration procedures and therefore could serve as an excellent platform to provide “systems” knowledge to addiction. The role of stress in alcohol addiction: A sustained effort is needed to disentangle stress and its role as a leading risk factor in the third largest preventable death in the United States. A comprehensive approach and investigation of pituitary, adrenal, gonadal, hematological and hepatic sources of cytokines, neuroactive steroids and other endocrine stress factors appear to be involved in this co--‐morbidity. Our body of knowledge is far too underdeveloped in this area, thus my suggestion that alcohol remain as a single factor, rather than a co--‐factor with another drug, for further research in this area. Computational social neuroscience in pharmacotherapy development: Social factors may be a large reason why potential pharmacotherapies show promise in animal models but fail to have efficacy when transferred to the clinical population. A concerted effort in computational social neuroscience is needed to identify social constraint on addictive behaviors, how the constraint is lost in the addiction process, and the interaction between pharmacotherapies and social outcomes in predicting the efficacy of establishing abstinence. Specifically, the development of computer engineering is needed to continuously capture and remotely annotate social behaviors to identify the dynamic behavior of individuals in a social group and their reciprocal interactions as well as integrate their pattern of drug use. Animals allow the degree of control necessary to develop these computer programs and to assess patterns of drug use and their consequences on a real--‐time basis.
293 05/09/2012 at 02:53:48 PM Organization LifeSource Not-for-Profit Salt Lake City, UT I am writing to strongly urge the newly proposed National Institute of Substance Use and Addiction Disorders to fund continued research into the overlapping areas of pain and addiction. My request is driven by the need for greater scientific clarity into pain and its mechanisms and the need for newer, less addictive medications to treat pain.

  I am writing to strongly urge the newly proposed National Institute of Substance Use and Addiction Disorders to fund continued research into the overlapping areas of pain and addiction. My request is driven by the need for greater scientific clarity into pain and its mechanism and the need for newer, less addictive medications to treat pain. More than 100 million Americans suffer from chronic pain, according to the Institute of Medicine. Chronic pain affects more people than cancers, heart disease, and diabetes combined yet receives far less funding for research. In addition, the increase in the use of prescription opioids to treat pain has brought a significant public health problem in the form of substance abuse, addiction, and overdose deaths. The challenge is to understand pain better so as to treat it more effectively without the attendant public health risk posed by substance abuse. Patients who suffer from chronic pain and the doctors who treat them urgently need safer opioid and non-opioid alternatives to reduce the risk of abuse, addiction, overdose, and diversion to nonmedical use. Newer, safer therapies have shown promise but need further examination to determine their effectiveness in a variety of populations. Recent genetic finding show that the individuals vary in their medication needs and pain response, suggesting that further research into these areas could produce new methods of treatment based on genetic profiles. Research indicates that addiction and pain may utilize common pathways in the central-nervous system and feed each other. These are just a few of the promising areas that are ripe for future research. A dedication to funding quality research can yield great benefits. For example, in the War on Cancer, increased research has produced greater understanding of cancer biology and facilitated the development of improved treatments that are able to halt many cancers. Pain is similar in its complexity and the toll it takes on the public health. As such, it is deserving of the same commitment.
294 05/09/2012 at 03:36:23 PM Self     Addiction genetics: Please encourage responsible diversity in NISUAD

Addiction and abilities to quit are both likely to be driven by substantial genetic influences that contribute about half to individual differences in these phenotypes. Understanding the molecular genetic basis of these phenotypes therefore provides major work for the portfolio of NISUAD. It is not clear that any single approach will provide the optimal route to this understanding. Integration efforts should thus encourage pursuit of a number of independent approaches to this key aspect of addiction, should discourage concentration of control of this work and should provide institutional disincentives for organizational structures that act to limit responsible molecular genetic studies and analyses to single or few approaches.

1) History and several initial signs appear to point toward possible restriction of the diversity of human genetic approaches likely to be allowed or encouraged by NISUAD. These include the following:

There has been a longstanding large investment in a single extramural molecular genetics consortium by NIAAA (COGA) that has resulted in little diversity in extramurally-funded work on human genetics of alcoholism.

NIDA now funnels all extramural research with a molecular genetic component through a single unique prereview/postreview entity. An acting division chief chairs a committee and thus acts as a single de facto “decider” for any genetics research that can pass to the NIDA director and council. NIDA staff from other divisions believe that virtually no genetics work can be funded without approval of this individual, Dr Rutter.

Draft plans for NISUAD appear to call for a single intramural genetics “program”, raising the possibility that a single chief will function as effective “decider” for all intramural human genetics.

The human genetics opportunities for the NIDA intramural genetics program are currently sharply curtailed by administrative actions, reducing its ability to provide alternative (and apparently successful) approaches to complex genetics.

This lack of diversity has been accompanied by a very modest record of genetic accomplishments by linkage and GWAS approaches supported through COGA and the NIDA genetics extramural program.

2) There is now broad consensus that current consensus approaches to molecular genetics work poorly to identify many types of disease associated gene variants. Variants that display the “complex genetics” properties likely to be found in those that predispose to phenotypes of likely interest to NISUAD (including vulnerability to addiction, ability to quit and ability to respond to prevention strategies) have been poorly identified by current consensus approaches.

Features that make one current consensus approach (GWAS identification of single variants that provide Bonferroni-corrected levels of statistical significance) unlikely to succeed include: a) modest effect sizes of common variants for these common phenotypes; b) locus heterogeneity, and c) allelic heterogeneity. There are thus likely to be multiple variants at each of multiple genetic loci that contribute to each of these phenotypes, as well as others of interest re addiction. These features of genetic architecture are also likely to render resequencing data difficult to interpret.

Attempts to gain nominal power by aggregating samples from a variety of collection sites have provided evidence for large sample to sample variations. Principal components analyses of ARRA-funded dbGAP samples for addiction, for example, provide large components based on site of sample collection that are likely to mask many bona fide addiction related variants that are present at different frequencies with the differing genetic backgrounds sampled at different sites.

Consensus strategies for circumventing this problem include seeking rarer variants with greater effects in exome or genome-wide resequencing efforts, focus on variants that alter the “ADME” pharmacokinetic/pharmacodynamic properties of addictive substances, focus on variants in drug “receptors”, and renewed interest in candidate genes expressed in brain reward pathways modulated by addictive substances.

It is thus possible to focus large amounts of effort on single programs supporting resequencing of samples that have been studied in GWAS efforts, as suggested by recent NIDA RFAs, without addressing the underlying problems that lack of support for diversity in molecular genetic approaches and analyses has provided for the field.

3) The current state of science and general organizational principles both cry out for systematic support of a more diverse set of approaches to a) identification of the genes (and other chromosomal regions) that contain variants that contribute to individual differences in addiction, quitting, and prevention responses, b) understanding the ways in which these sequence differences change the brain or other organs, and c) understanding the ways in which these alterations alter addiction-relevant phenotypes.

This letter suggests that the results from Management Review committee integration process should provide a clear mandate for diversity, as well as appropriate scope, for genetics efforts of NISUAD.

In particular:

a) Centralized mandatory review channels in this field should be discouraged as NISUAD is established. Centralized programs should be informational, providing information for staff from all NISUAD branches and divisions about the range of possible useful practices as well as the dominant approaches. If there is any program established with de facto centralized mandatory funding approval authorities, it should be set up with strict sunsetting provisions (eg for 1 – 2 years at most).

b) Any “COGA-like” structure or centralized review process (such as the one currently maintained by NIDA) should not be encouraged, especially when its risks to diversity are at least as great as its benefits in providing scale. The risks for central NIDA review of extramural genetics by essentially, a single official (even a successful one) now appear to strongly outweigh the possible benefits of increased diversity in the NIDA genetics portfolio. The current central review process should be converted to a nonreview repository for information to aid other NIDA extramural program areas in optimizing their genetics portfolios, in ways that should include optimization of their diversity.

c) The diversity in human genetics approaches possible in the proposed Rockville and Baltimore campus intramural structure should be emphasized, with encouragement of better support for human genetics programs by established groups on both campuses and addition of staff. Sharing resources can be aided by establishment of incentives that do not mandate uniform approaches to human genetics of addiction-related phenotypes.

d) More laboratories and investigators should be encouraged to use genetic data, including transgenic animal models, to augment the translational utility of human molecular genetic results and increase the diversity of approaches to translating this data to improved understanding.

e) More clinical investigators should be encouraged to collect and use genetic data, to augment the possible T1 and T2 translation of these findings into other diverse areas relevant to addiction.

The founding of NISUAD provides an opportunity to break from the prior large influences exerted by relatively few investigators and administrators on centralized review of genetics protocols and concentration of resources in few samples and analytic approaches.

NISUAD’s promotion of diversity in its human genetic portfolio will be likely to pay substantial dividends. It is indeed ironic that genetics, a field that studies diversity, should need to be reminded of the benefits that diversity provides, especially in areas in which heavy concentration of resources in few hands have provided only modest benefits to date. The alternative, concentration of centralized control of genetic studies in few hands and further limitation of the diversity of approaches to the complex problems raised by addiction genetics, would appear not to allow NISUAD to optimally apply the power of human genetics for understanding addiction, its treatment and its prevention.

NISUAD’s promotion of diversity in its human genetic portfolio will be likely to pay substantial dividends. It is indeed ironic that genetics, a field that studies diversity, should need to be reminded of the benefits that diversity provides, especially in areas in which heavy concentration of resources in few hands have provided only modest benefits to date. The alternative, concentration of centralized control of genetic studies in few hands and further limitation of the diversity of approaches to the complex problems raised by addiction genetics, would appear not to allow NISUAD to optimally apply the power of human genetics for understanding addiction, its treatment and its prevention.

Text of attachment is the same as that of comment boxes.
295 05/09/2012 at 04:33:17 PM Self     The RFI guidelines makes no mentioned of alcohol and drug-impaired driving, which in terms of injury, death, damage and cost is easily among the most serious public health problems related to alcohol and drug use. The problem is complex and multifaceted, as must be the solutions. NIH is ideal agency to fund research focused on stemming the national tragedy that is impaired driving because it supports researcher-initiated efforts, innovation, and multimodal/multi-method solutions. The array of potential research area relevant to topic is extremely broad, including: the examination of major laws and policies, epidemiology studies of prevalence, primary predictors of impaired driving and impaired driving over the life cycle, the effect of therapy and medication on drunk-driving recidivism, the impact of judicial sanctions and programs on recidivism, evaluations of community programs and countermeasures, effective and efficient law enforcement strategies, the neurology of risk perception, impulsivity, and behavioral disinhibition, decision- making, information processing, and implicit cognition. There is tremendous opportunity for cross-domain, multi-disciplinary collaboration in this area. Further, the problem of impaired driving is one that the public understands and one for which prevention and research efforts the public supports.

There are other agencies that fund research on impaired driving prevention (namely the National Highway Traffic Safety Administration, or NHTSA). NHTSA sponsors some extremely important work in this area, but it is not sufficient for there to be real advancements in harm reduction. NIH support for impaired-driving research is essential because: (a) NHTSA does not support researcher-initiated projects, thus there is limited opportunity for innovation; (b) NHTSA requirements that research involving surveys first receives clearance from the Office of Management and Budget greatly reduces the type of research that can be conducted and the cost-efficiency of that research; and (c) NHTSA does not support peer-review publication of research results until government reports are approved; there is a large volume of relevant-research not made available to the scientific community because it is not identified as a priority by NHTSA.

In general, given that over half of the harm caused by alcohol and drugs is behavioral, there needs to be sufficient support for behavioral research in the area.

Funding priorities, at least to some degree, should reflect proportionately the actual public health threats that face of the country. When it comes to public health and alcohol, impaired driving presents the greatest potential harm. In the most recent comprehensive review conducted by the Center for Disease Control and Prevention (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5337a2.htm), alcohol-impaired driving caused more deaths than any other chronic or acute factor, surpassing even alcohol liver disease. It terms of years-of-potential-life-lost, alcohol-impaired driving by far surpasses any other alcohol-related cause. Importantly, these estimates attributed to alcohol-impaired driving are conservative in that they count only cases where drivers had blood alcohol concentrations in excess of the .08 g/dl illegal limit, although it is well-documented that impairment begins at considerably lower blood alcohol levels. Alcohol-impaired driving does not only effect drinkers, however; approximately 40% of people who die as the result of drinking drivers are passengers, other drivers and pedestrians who were not drinking, but fell victim to those who were. The cost to society associated with alcohol-impaired driving is nearly 4x the NIH annual budget - approximately $130 billion/year (Zaloshnja & Miller, 2009). Exacerbating this public-health problem is the understudied prevalence of drugged driving. The recent 2007 National Roadside Survey (NRS) found that more than 16.3% of weekend nighttime drivers tested positive for illegal, prescription, or over-the-counter medication (12.4% for illegal drugs) that might impair vehicle operation (Lacey et al., 2009), while a 2010 study of drivers in California revealed that cannabis-involved driving had increased since 2007 (Johnson et al., 2012). The potential for legalization of cannabis in California and decriminalization elsewhere portends a higher prevalence rates in future. This is problematic and presents a serious public health risk, as a growing body of literature suggests that illegal drugs (including cannabis) are associated with elevated crash risk (Huestis, 2002; Drummer, 1994; Drummer et al, 2004,; Grotenhermen et al., 2005; Mura et al., 2003; Ramaekers et al., 2004; Richer & Bergeron, 2008; Smiley, 1986, 1999).

Fortunately, the death, injury and damage caused by alcohol-impaired driving are all entirely preventable. From 1982 to 1997, the United States experienced a dramatic reduction in alcohol-related fatalities. Rates have been stable ever since, and in some places reverted upwards, but we can begin to reduce these numbers once again. The problem of impaired driving is surmountable. There are ways to cut into the tragic number of deaths and injuries caused by impaired driving. Rigorous multidisciplinary research that emphasizes the translation of scientific knowledge into real-world solutions is an essential step to realizing a future of safer highways and roads, and a healthier American public.

 
296 05/09/2012 at 04:53:43 PM Self     The strategic plan needs to include experimental medicine initiatives to indentify the potential molecular targets associated with compulsive self-administration of nicotine, alcohol, cocaine, methaphetamine, and opiates. Only through such efforts will we advance in developing therapuetics for addictive disorders.

Research priorities in the strategic plan ought to follow the public health impact of drugs of abuse. Thus, the strategic plan should emphasize research into tobacco and alcohol since as legal substances, they represent the greatest health risk to Americans, while use of illicit drugs (aside from cannabis) has a significantly lower prevalence and therefore lower impact on our public health.

 
297 05/09/2012 at 05:56:05 PM Self     I believe that the most important thing is that this new combined institute be at least revenue-neutral—that it be allocated the entire budget that NIAAA and NIDA are currently allocated combined, plus more to cover other addiction-related research that is currently spread throughout NIH. Due to the public health impact of addiction and related disorders, it is crucial that this area not experience funding cuts--and it would be even better if this new institute were allocated additional funding to facilitate cross-addition research, which this new institute is uniquely poised to sponsor.

I would like to highlight and extend a couple of the areas identified in the RFI that I believe are important in maximizing the effects of addiction research on public health. First, as noted in the RFI, funding efforts to prevent substance abuse in adolescents and young adults is obviously important. At the same time, additional basic research on the predictors of substance use and transitions to abuse and dependence among young people is necessary in order to make those prevention programs targeted to the most vulnerable youth and make them as effective as possible. Therefore, I would urge the new institute to also focus on this foundational research—the development of substance use and addiction in youth--in addition to actual prevention programs.

Second, comorbidity with other psychiatric disorders is mentioned in relation to tobacco use, but I would suggest that examinations of how other psychiatric disorders relate to the development, maintenance, and treatment efficacy of all addictive disorders is crucial for our understanding (and prevention and treatment) of addiction in general. We know that these comorbidities exist, yet our understanding of how other psychiatric disorders influence, or are influenced by, addictive disorders is in its infancy. It seems that increasing our understanding of this is crucial to successful prevention and intervention.

Finally, I believe that funding research on the genetics of addictive disorders, particularly gene-by-environment interactions, is likely to yield useful information that can be applied to the prevention and treatment of these disorders. Methodological advances in this area have facilitated sophisticated research that could yield significant advances in treatment and prevention efforts, and continuing on this path has the potential to have a significant impact.

I believe that focusing on learning about the development of addictive disorders among adolescents and young adults is crucial because we have the opportunity to prevent these disorders among this population. In addition, I believe that research on the comorbidity of addiction with other psychiatric disorders is crucial because in some cases, preventing or successfully treating one (the addiction or the psychiatric disorder) will reduce risk for the other, thereby reducing the burden of these disorders on individuals and on our nation’s health.

 
298 05/09/2012 at 05:58:53 PM Self     All comments offered in the attached document reflect my concerns about research and related funding. I believe that all these issues are important to ensure adequate continuity of ongoing research; maintain the stability to the field which will in turn optimize our ability to keep established researchers while also encouraging young investigators to enter our fields; and take steps to correct several deficiencies in the field for substance use disorders and related disorders research that have existed in the current NIH structure.

The most important comments are given in items 1-6 and include the need to maintain continuity, the opportunity to further enhance longitudinal research, the opportunity offered by the development of a new institute to expand findings from one related field into another, the importance of going beyond commonalities to also recognize unique aspects of specific substances and behaviors, and the need to recognize the broad range of research that should be included the new institute’s portfolio.

May 9, 2012 Re: Response to the RFI Requesting Input into the Scientific Strategic Plan for the Proposed National Institute for Substance Use and Addiction Disorders Reflecting my long tenure in the substance use disorders field, I highlight the following issues regarding the formation of the new NIH institute. My own background includes longitudinal studies of individuals at various levels of risk for alcohol and drug use disorders, the search for genes related to a range of characteristics that impact on substance problems, prevention efforts, the development of optimal treatments for these conditions, diagnostic issues, comorbidity between substance use disorders and psychiatric syndromes, as well as the development of optimal diagnostic criteria for substance-related problems. The issues I highlight are as follows: 1. The continuity of ongoing projects must not be lost. While the institute is new, substance use disorders related research has been going on for more than 70 years. Alcohol and drug research centers, as well as individual groups of investigators, have invested great amounts of time and public funds into their ongoing research. It is important that the ongoing projects be given appropriate consideration in both the development of the institute itself, as well as regarding the importance of their continued funding. If these projects are lost in the shuffle as the new institute begins, important progress and useful information can be inadvertently discarded. 2. The development of a new institute offers a unique opportunity to correct a longstanding structural problem in our field: the need for a mechanism to support longitudinal research. Prospective studies are challenging to do and important for our understanding of how risk factors for use, heavy intake, and associated problems develop. Thus, longitudinal research is essential to both genetic and psychosocial research in order to enhance our understanding of the disorders we treat while identifying important opportunities for prevention and early intervention. Despite the importance of these prospective investigations, there is no ongoing mechanism through which productive longitudinal research receives reviews by a longitudinal focused review committee, nor preferential funding when later stages of the work build upon earlier findings in the same population. The new institute should consider such a longitudinal research based review committee with appropriate funding for the continuation of these important projects. 3. The reorganization of alcohol and drug research also offers the opportunity for the new institute to develop Requests For Proposals to evaluate whether a finding related to one substance (e.g., gene variations that contribute to the development of alcohol use disorders) might also apply to predispositions toward a broader range of substance-related problems. Thus, staff of the new institute might be asked to annually review findings from sponsored research that might be appropriate for evaluation regarding a broader range of substance-related problems and additional relevant predispositions. 4. While there are many commonalities regarding predisposing factors (e.g., impulsivity), neurochemical and neurocognitive attributes (e.g., the dopamine-related reward system), and the clinical courses (e.g., the fluctuating nature of substance-related problems alternating with periods of abstinence and limited times of controlled use) across substances and related conditions, it is important for the new institute to recognize that there are unique attributes that apply to specific substances as well. For example, alterations in alcohol metabolizing enzymes impact mostly on the risk for alcohol use disorders, not substance problems in general, or gambling, or psychiatric disorders. Those mutations also produce a unique heightened vulnerability for specific alcohol-related outcomes such as pancreatitis, liver problems, and, perhaps, fetal alcohol effects without impacting on consequences of heavy use of other substances or related behaviors. Also, the low sensitivity to alcohol increases the risk for future heavy drinking and alcohol-related problems, but has little or no connection to impulsivity or to problems related to substances other than alcohol. There are likely to be similar vulnerabilities toward, or protective factors against, substance-related problems for other specific drug categories that relate to sensitivity toward that drug, specific receptor polymorphisms, and drug-specific adverse effects. Thus, an institute with a portfolio that reaches across substances of abuse and related conditions must carefully guard against ignoring factors that are more specifically related to individual types of substances or behaviors. 5. A mechanism must be developed to ensure that the portion of the research portfolio related to specific substances generally reflects the magnitude of the public health issues associated with that specific substance or behavior. While research on heroin, hallucinogens, inhalants, and a range of other substances are very important, the heavy public health burden associated with alcohol and nicotine must not be forgotten. While those of us in the field recognize that a rigid formula for allocation of financial resources to specific substances and related behaviors would not be appropriate, the institute’s research portfolio reviews need to keep in mind the magnitude of the problem being addressed. 6. While treatment-related research is important and was appropriately prominently emphasized in Dr. Tabak’s slides, it is important that the new institute also recognize the importance of genetic and environmental-based research focusing on causes of substance-related problems and associated behaviors, prevention protocols, research studying physical/psychiatric/psychosocial consequences of substance use disorders and related behaviors, and additional important issues highlighted above. It is important for administrators in the new institute to work toward a balanced portfolio where all potentially important research questions are addressed. 7. Regarding more focused issues, I offer thoughts on several additional items related to the development and structure of the new institute. These include: A. As I am sure the members of the relevant committees recognize, those of us in the field will not be able to offer the most useful suggestions until we have a greater understanding of the manner in which the research portfolio will be developed, and the probable level of funding to be received by the institute. B. For the new institute to function adequately, it is essential that all nicotine-related research be incorporated. Thank you for giving me the opportunity of offering these comments and suggestions. The comments raised here reflect my own thoughts and do not necessarily indicate opinions of any institution or organization to which I belong.
299 05/09/2012 at 06:15:37 PM Self     The majority of Americans spend the greatest segment of their adult life in the workplace. Many of these lives and the dependents associated with them are disrupted and ruined by inattention to substance use disorders that develop during employment careers. Research that maximizes the utility of the workplace as a setting for the identification and early intervention with employees affected by substance use disorders has been largely neglected by NIDA and NIAAA for nearly two decades. This neglect has occurred despite the prominence of a workplace research focus in the first two decades of NIAAA's existence. The workplace offers immense opportunities for primary prevention, early intervention, treatment without loss of employment, sustained followup and relapse prevention. None of these topics has an adequate research base to offer guidance for evidence-based interventions, esplaining in part the documented gap between the needs for treatment of substance use disorders and actual utilization of treatment. The new Institute should include a Branch or Division specifically devoted to the workplace as a setting for research and randomized clinical trials on effective prevention and intervention.

   
300 05/09/2012 at 06:20:41 PM Self University of North Dakota School of Medicine & Health Sciences Grand Forks, ND NIH director Dr. Francis S. Collins has identified a broadened vision of global health as one of the Institute’s top priority areas. He calls for research and training that goes beyond the traditional “big three” diseases (AIDS, TB, and malaria) to address a range of other serious health challenges that face lower-income countries worldwide. As one of these challenges, alcohol use and misuse considerably increase global morbidity, mortality, and social harms. Worldwide, the contribution of alcohol to the burden of disease and injury has been increasing; as measured in DALYs (disability-adjusted life-years), alcohol now ranks among the top four risks to health (WHO, 2009, 2010). International scientific collaborations are critically important for understanding the causes and consequences of alcohol and other substance abuse in diverse societies, and for translating new scientific knowledge into more effective approaches to prevention, treatment, and policy. As a scientist who has conducted NIAAA-funded multinational research to better understand the individual-level and societal-level predictors of alcohol use and misuse in 38 countries on 5 continents, I and my colleagues urge the new substance abuse and addiction institute to place a high priority on international collaborative research. Such research can produce new insights about biological and sociocultural risk factors for substance abuse and addiction in diverse cultural settings, build capacity for in-country substance abuse research in lower- and middle-income countries, and suggest culturally appropriate strategies for prevention and intervention that can benefit both “developing” and more developed countries worldwide.

World Health Organization (2009). Global health risks: Mortality and burden of disease attributable to selected major risks [Accessed: 2011-01-24. Archived by WebCite® at http://www.webcitation.org/5vzJ7a2NV]. Geneva: WHO.

World Health Organization (2010). Global strategy to reduce the harmful effects of alcohol. Geneva: WHO. http://www.who.int/substance_abuse/alcstratenglishfinal.pdf

   
301 05/09/2012 at 06:50:36 PM Organization University of Maine Orono, ME 04469 Fetal alcohol exposure and common consequences such as FASD represent an extraordinarily common condition in our Maine communities as well as throughout the world. In polydrug exposure, such as in the opiate-exposed samples we study, the role of maternal addiction is profound. For this reason, it is particularly compelling that the NIH keep the study of FASD in the addiction institute however configured. Prenatal alcohol exposure effects are the easiest of all of the polydrug exposures we observe to detect in neonatal and child outcomes with maternal opiate dependence.

Maternal addiction is responsible for the quality of the prenatal environment of the fetus. In fact, to characterize the expectations for the newborn in terms of physiological and neural functioning, it is fundamental to know as comprehensively as possible what kinds of exposures were experienced and when. This is no more true than in neonatal abstinence syndrome (NAS) associated with opiate exposure. In fact, NAS has been shown to be adversely affected by other co-morbid drug exposures (including psychiatric medications). Future work on the nature of prenatal exposures requires that the dyad (mother and baby) are studied together, particularly, as we try to understand the impact of prenatal exposures on postnatal outcomes including genetic risk for addiction, maternal competency, and pre-and postnatal brain development.

PDF copy of pre-publication version of article: “Epidemic of Prescription Opiate Abuse and Neonatal Abstinence” by Marie J. Hayes and Mark S. Brown; published by JAMA in May 2012 (vol. 307 no. 18)
302 05/09/2012 at 07:06:51 PM Organization Oregon Social Learning Center Eugene, OR 1. Prevention Research is Effective and Cost-Effective and Must Remain a Priority within the Scientific Strategic Plan of the New Institute. The most effective way to halt the manifestation of diseases and disorders is through prevention. Prevention of drug abuse, alcohol misuse, and other addictions differs from most other diseases and disorders in that, at the initiation stage, there is choice involved. NIDA and NIAAA have taken a proactive role in building the field of prevention science, creating a diverse portfolio that encompasses basic research, statistical methodology, efficacy trials, effectiveness research, systems research, and services research. Both Institutes have funded numerous trials that have shown that family-, school-, and community-based interventions can prevent the onset of drug and alcohol use and abuse and related problems. Basic research supported by both institutes has demonstrated that alcohol and drug abuse and addiction develop in a complex context of diverse psychological and behavioral problems. Prevention is therefore facilitated by interventions that modify one or more risk factors for these problems. The combination of basic and applied prevention science research in the current portfolios of NIDA and NIAAA is a model for addressing these risk factors comprehensively, based on the best research on trajectories leading to substance abuse, dependence, addiction, and comorbid disorders. This type of research must continue. Once problem behaviors and symptoms reach the point of being diagnosable disorders, the approach changes from prevention to treatment, many more resources must be expended to care for affected individuals, and public health costs increase

2. Establish a Prevention Research Branch. Establishment of a new combined institute should be used as an opportunity to build from and strengthen NIH’s prevention portfolio. This can most effectively occur when a branch of the institute is charged with this priority. We strongly endorse that the new institute include prevention explicitly in the mission and elevate prevention to a research branch with funding allocated to alcohol and drug abuse prevention research at least equal to, and ideally greater than, the sum of the current levels at NIAAA and NIDA.

3. Alleviate the Bottleneck for Treatments to Move from Bench to Bedside to Communities. To foster innovation and transformation in the next generation of prevention research, we recommend the expansion of Type 2 translational research, including studies of the adoption, implementation, and sustainability of tested and efficacious programs, policies, and practices in communities, services settings, and populations. This research would ensure that existing knowledge generated from basic research and randomized controlled trials results in reductions in the incidence and prevalence of alcohol and drug abuse and addiction and associated problems at a population level through implementation of effective programs in community settings.

4. Greater Emphasis on Environmental and Contextual Influences in the Scientific Strategic Plan. Recognizing the importance of biological science in understanding alcohol misuse or drug abuse and addictions, the current list of priorities underemphasizes the critical role of social and behavioral science in understanding and addressing these problems. Research funded by NIDA and NIAAA suggests a strong role of the environment on the initiation of drug and alcohol abuse and addiction behaviors, and that socio-cultural environments (e.g., policy, peers, family, communities) play pivotal roles in the initiation of, maintenance of, and desistence from drug use, abuse, and dependence. Certainly there is an interplay of environmental and biological influences in the development of addiction, however, to downplay the social, cultural, and psychological aspects of drug use is a fundamental miss that will severely weaken efforts at prevention and treatment. Continued emphasis on environmental and contextual influences in basic science and intervention research will ultimately help reduce the budget of substance use, abuse, and addiction-related disorders.

5. Pursue the Recommendations of the IOM Report. The report on prevention from the National Research Council and the Institute of Medicine (IOM) documents the substantial progress that has been made in prevention research since the IOM’s previous report on this topic in 1994. A substantial portion of the research cited in the new report was funded by NIDA. There are a number of recommendations from that committee that are important to pursue: (1) continuing the course of rigorous research both on specific and general risk factors and on protective factors that weaken or strengthen, respectively, age-appropriate competencies; (2) studying dissemination strategies; and (3) creating new research linkages with neuroscience.

  1. Prevention Research is Effective and Cost-Effective and Must Remain a Priority within the Scientific Strategic Plan of the New Institute. The most effective way to halt the manifestation of diseases and disorders is through prevention. Prevention of drug abuse, alcohol misuse, and other addictions differs from most other diseases and disorders in that, at the initiation stage, there is choice involved. NIDA and NIAAA have taken a proactive role in building the field of prevention science, creating a diverse portfolio that encompasses basic research, statistical methodology, efficacy trials, effectiveness research, systems research, and services research. Both Institutes have funded numerous trials that have shown that family-, school-, and community-based interventions can prevent the onset of drug and alcohol use and abuse and related problems. Basic research supported by both institutes has demonstrated that alcohol and drug abuse and addiction develop in a complex context of diverse psychological and behavioral problems. Prevention is therefore facilitated by interventions that modify one or more risk factors for these problems. The combination of basic and applied prevention science research in the current portfolios of NIDA and NIAAA is a model for addressing these risk factors comprehensively, based on the best research on trajectories leading to substance abuse, dependence, addiction, and comorbid disorders. This type of research must continue. Once problem behaviors and symptoms reach the point of being diagnosable disorders, the approach changes from prevention to treatment, many more resources must be expended to care for affected individuals, and public health costs increase 2. Establish a Prevention Research Branch. Establishment of a new combined institute should be used as an opportunity to build from and strengthen NIH’s prevention portfolio. This can most effectively occur when a branch of the institute is charged with this priority. We strongly endorse that the new institute include prevention explicitly in the mission and elevate prevention to a research branch with funding allocated to alcohol and drug abuse prevention research at least equal to, and ideally greater than, the sum of the current levels at NIAAA and NIDA. 3. Alleviate the Bottleneck for Treatments to Move from Bench to Bedside to Communities. To foster innovation and transformation in the next generation of prevention research, we recommend the expansion of Type 2 translational research, including studies of the adoption, implementation, and sustainability of tested and efficacious programs, policies, and practices in communities, services settings, and populations. This research would ensure that existing knowledge generated from basic research and randomized controlled trials results in reductions in the incidence and prevalence of alcohol and drug abuse and addiction and associated problems at a population level through implementation of effective programs in community settings. 4. Greater Emphasis on Environmental and Contextual Influences in the Scientific Strategic Plan. Recognizing the importance of biological science in understanding alcohol misuse or drug abuse and addictions, the current list of priorities underemphasizes the critical role of social and behavioral science in understanding and addressing these problems. Research funded by NIDA and NIAAA suggests a strong role of the environment on the initiation of drug and alcohol abuse and addiction behaviors, and that socio-cultural environments (e.g., policy, peers, family, communities) play pivotal roles in the initiation of, maintenance of, and desistence from drug use, abuse, and dependence. Certainly there is an interplay of environmental and biological influences in the development of addiction, however, to downplay the social, cultural, and psychological aspects of drug use is a fundamental miss that will severely weaken efforts at prevention and treatment. Continued emphasis on environmental and contextual influences in basic science and intervention research will ultimately help reduce the budget of substance use, abuse, and addiction-related disorders. 5. Pursue the Recommendations of the IOM Report. The report on prevention from the National Research Council and the Institute of Medicine (IOM) documents the substantial progress that has been made in prevention research since the IOM’s previous report on this topic in 1994. A substantial portion of the research cited in the new report was funded by NIDA. There are a number of recommendations from that committee that are important to pursue: (1) continuing the course of rigorous research both on specific and general risk factors and on protective factors that weaken or strengthen, respectively, age-appropriate competencies; (2) studying dissemination strategies; and (3) creating new research linkages with neuroscience.
303 05/09/2012 at 08:24:57 PM Organization Friends of Recovery New YOrk Albany, New York 1). For any of the areas identified in the notice and any other specific areas you believe are worthy of consideration by NIH, please identify the critical issues(s) and effect(s) on the public, on scientists, or both. The NIH and other federal agencies have invested millions and millions of dollars in taxpayer funds in developing an understanding of the neurobiology, prevalence, consequences and treatment of addiction to alcohol and other drugs. We urge the NIH to turn its attention to undertaking a systematic, empirical investigation of recovery from addiction and include such an undertaking in its Scientific Strategic Plan. Recovery is much more than abstinence from the use of alcohol and other drugs and should be researched to understand and disseminate how people can and do get well. With an estimated over 23 million Americans in recovery, we have been successful in raising the experiences of individuals, but have yet to build a science behind those stories. A recovery-oriented research agenda will provide the recovery community, policy makers, service systems, clinicians, funders and individuals and families still struggling with addiction long overdue information on effective strategies for finding new lives, free from addiction to alcohol and other drugs. Specifically, we recommend the following areas for investigation: A). Pathways, Processes, Stages, and Styles of Long-term Recovery Research is needed to understand longitudinally the multiple pathways to long-term recovery. As a person goes along his or her recovery path, they experience a life filled or refilled with work, a place to live, relationships, and activities in the community. Research should examine how a person integrates recovery into an expanding quality of life and the stages that this process happens at with a community/environmental perspective. Factors to be examined should include health, quality of life and community service in long-term recovery.

We also need to understand what the factors are that contribute to initiating alcohol and drug use after a period of sustained recovery. How often do people start using again across the life cycle of recovery? Are there points of vulnerability associated with age, primary drug(s), recovery pathway, gender, race/ethnicity, sexual orientation, or presence of co-occurring medical/mental health disorders? Are there critical transition points from early recovery to sustained recovery and from recovery maintenance to enhanced quality of life in recovery that increased risk of relapse? Does the availability and use of peer and other recovery supports, recovery institutions such as recovery community centers, recovery schools, recovery-oriented employers, recovery residences, alcohol- and drug-free recreational activities, affect a person’s ability to sustain recovery for the long haul?

The impact of research in this area would be of great interest to the public and policymakers – it would demonstrate the reality and pathways to recovery to a public that is skeptical about the ability of loved ones, friends and co-workers to recover from addiction to alcohol and other drugs. Research that found that recovery from addiction was a contributing factor to lowering recidivism rates for people re-entering communities from incarceration could assist policymakers in making decisions about policy and funding priorities.

It should also be of great interest to scientists seeking to understand the management of this chronic health condition – mainstreaming addiction recovery research with research on other manageable chronic health conditions and providing information about the solutions to a problem that has been well researched and documented.

B). Recovery patterns and experiences for specific groups of people including young people, women, and parents in recovery. This research area should be of great interest to policymakers as well as to the public and scientists. The earlier that a person identifies and embarks on his or her pathway to long-term recovery, the better in terms of personal health and wellbeing, family and community health. The costs of addiction are dramatically reduced as well; benefiting taxpayers and communities.

Using young people as an example, some of the questions that could be asked include: •What is the prevalence of recovery among young people; is it increasing, decreasing? •Are there predictable stages of recovery for young people? •Do the recovery rates of young people differ by gender, ethnicity, drug choice or other variables? •Does a family history of recovery affect a young person and/or other family members’ recovery? •Do young people whose families are affected by ongoing alcohol and other drug problems have better opportunities for sustained recovery if they sever family ties? •How can parents, other family members and significant people in a young person’s life best help him or her to initiate and sustain recovery over a lifetime? •What are the effects of post-treatment monitoring, recovery coaching and assertive linkage to communities of recovery on long-term recovery outcomes for young people? Are they different than for adults? For parents in recovery, some questions that could be asked include:•If a son or daughter is at increased risk of developing an alcohol or drug problem because they and one or both parents share a family history of such problems, do the children have less risk of developing problems if the parent is in long-term recovery? •If one or more children were to develop an alcohol or drug problem, are their prospects of recovery better because of the parents’ recovery? •What strategies of prevention and early intervention can specifically lower the risks of children of recovering parents developing alcohol and other drug problems at an early stage? What effect does the participation of a family member in specialty sector addiction treatment and/or recovery mutual aid groups have on the recovery prospects of other family members? •What changes should a person anticipate in early recovery in relationships with children and other family members? •What does it mean when parents who have lost custody or left their children during their active addiction seek to re-establish contact with their children? Will this harm or benefit the child and if so, when and how? •What evidence-based models are available for peer-based support for parents in recovery, e.g., parenting guides/sponsors?

C). Communities of Recovery. How does the level and degree of exposure to communities of recovery and recovery-oriented communities affect a person’s individual and family member recovery? Do community supports such as faith-based organizations, opportunities for community activities/advocacy strengthen recovery and affect community wellbeing? What is the impact of having multiple housing options available for people in early or long-term recovery available mean to building recovery-oriented communities? Are there specific activities, events or developmental issues that pose significant challenges to recovery and community health? If so, what works to support recovery and community health?

D). Recovery self-management. Growing numbers of people seeking addiction recovery are developing recovery plans that they modify over time to reflect their progress in reaching recovery goals. Does it make a difference if a person develops his or her own recovery plan in a community or clinical setting compared with the development of a treatment plan by a clinician?

E). Peer and other recovery supports. Non-clinical recovery support services are offering people seeking or in recovery new services based in the community. These services can be used alone, in combination with mutual aid and/or professional treatment. What are their effects on the person seeking recovery as well as the person providing the service?

F). Recovery support institutions and service roles. Over the last ten years a growing number of recovery community organizations have pioneered the development and delivery of peer recovery support services for people in or seeking recovery from addiction to alcohol or other drugs. These organizations provide services in a variety of diverse settings, including recovery community centers and recovery residences, as well as host of other settings outside of the recovery community including jails and prisons and medical settings. Peer recovery support services and organizations that provide them have been operating virtually unnoticed until the emergence of the health reform-related focus on prevention and wellness, an emphasis that highlights recovery-oriented systems of care and implementation planning.

These nonclinical services often assist individuals and families and include peer recovery coaching, recovery community centers, recovery residences, job readiness programs, financial management training, educational/ employment assistance, and telephone check-ups. These services are provided prior to, during, after or in lieu of treatment and other clinical services and support. The use of peer support is, by now, a common practice in many fields. While professionals treating chronic illnesses are often knowledgeable about peer services, there is still limited awareness among individuals and families. In today’s medical world, peer support is recognized as a valuable adjunct to professional medical and social interventions. Improved outcomes are particularly notable when peer support services are provided to people with chronic conditions that require long-term self-management. The peer recovery support services offered by recovery community organizations and others are supported by a long, well-documented, and replicated evidence-based tradition. Peer recovery support services hold promise as a vital link between systems that treat people with addiction in a clinical setting and the larger communities in which people seeking to achieve and sustain recovery live.

There is a robust body of research on the value and effectiveness of peer supports for a number of chronic health conditions such as diabetes, cancer, obesity, HIV/AIDS and mental illness. This research has identified the value of services delivered by peers at the community level and the usefulness of a wide variety of social and other supports.

There has been limited research on the effectiveness of addiction peer recovery support services, mostly focused on recovery residences (housing). While there is a good start on this research, there is very little research on other recovery support institutions such as recovery schools, recovery community organizations, recovery community centers, recovery industries or recovery ministries. And there is next to no research on the emerging peer and other recovery support service roles of recovery coach and peer recovery support specialist.

G). The Neurobiology of Recovery NIDA’s studies of the brain should also focus on brain resilience and recovery. To what extent and how does the brain heal? How does long-term recovery affect this process?

NIAAA’s studies of the health impact of alcohol dependence should also focus on the health impact of recovery from addiction. To what extent and how does health improve? How does long-term recovery affect this process?

Thank you for the opportunity to provide input to this important effort.

2). Please identify and explain which of the issues you identified are, in your opinion, the most important for NIH to address and why. The overarching issue of recovery is the most important for NIH to address. Recovery should be the explicitly stated goal of NIH research on addictions.

 
304 05/09/2012 at 09:39:54 PM Self     The newly proposed institute needs to design a comprehensive research approach that goes beyond the neuroscience of addiction and include research colleagues from the behavioral, developmental, and social sciences, epidemiology, prevention, treatment, and policy. The NIAAA is an exceptional model for this integrated kind of research approach.

The magnitude of the burden borne by the American public related to the use and abuse of alcohol, tobacco, and illegal and abused prescription drugs more than justifies the about equal representation of research efforts and the about equal distribution of research funds across these three major types of abused substances.

As chronic smoking is highly comorbid with both alcohol and illicit substance abuse, and as different types of substances are abused together to achieve a desired effect, polydrug use research has wider practical utility than past research forced into one corner or the other due to the separate existence of an alcohol and a drug institute. Practical utility and clinical relevance is increased by studying the clinical reality today – that is polydrug use - and should be a main research focus of the newly proposed institute. It is time for a newly formed institute to serve the type of patient that is actually seen in the clinic today.

Input into the Scientific Strategic Plan for the proposed National Institute of Substance Use and Addiction Disorders This message is to give feedback on the proposed National Institute of Substance Use and Addiction Disorders (NISUAD). I am a human brain imaging researcher at UC San Francisco and have been funded for close to 20 years by both NIAAA and NIDA to perform substance use research. My research experience is derived mainly from studying alcohol dependent individuals, chronic cigarette smokers, and those dependent on illegal drugs. My major observation I want to share in this context is that while there are many commonalities between these substance using populations, they are sufficiently different to warrant fundamentally different approaches to their treatments and to efforts geared at preventing harmful drug use. Such approaches and efforts would be best and most efficiently supported by an institute that has been designed from the get-go to be able to serve these different populations efficiently. Here are some of my suggestions on what the newly proposed institute should focus on: 1. The magnitude of the burden borne by the American public related to the use and abuse of alcohol, tobacco, and illegal and abused prescription drugs more than justifies the about equal representation of research efforts and the about equal distribution of research funds across these three major types of abused substances. 2. While it is the use of illegal and abused prescription drugs that are most often publicly associated with “addiction”, a major aspect of the societal harm and public health burden related to chronic alcohol consumption is from non-addictive use of alcohol (e.g., fetal alcohol spectrum disorders, fatal vehicle crashes, accidents, lost productivity, and homicides). The newly proposed institute needs to recognize this via a comprehensive research approach that goes beyond the neuroscience of addiction and includes research colleagues from the behavioral, developmental, and social sciences, epidemiology, prevention, treatment, and policy. The NIAAA is an exceptional model for this integrated kind of research approach, and the leadership of the newly proposed institute is well-advised not to abandon at least the framework for such complex research endeavor. 3. To see this model in action, simply come to a meeting of the Research Society on Alcoholism (RSA), which I and several thousand other alcohol researchers are members of. Activities of RSA are exemplary as it tries to unite under one roof practitioners and alcohol researchers from a multitude of disciplines, covering the basic sciences via social and treatment sciences to prevention research and drug policy. The meetings are refreshing and inspiring, giving the basic scientists a much-needed footing in the needs of the clinical communities and the policy makers a foundation in the realities of neurobiology. It is this society where researchers from very varied disciplines feel at home and interact easily to advance the type of research that I like the new institute to pursue for the betterment of our society as a whole. I am aware that RSA’s leadership has a critical role in consulting on the creation and design of the new institute and they have my full solidarity and support in that noble undertaking. 4. My NIAAA-funded research has pioneered neuroimaging and cognitive research on the effects of chronic smoking in alcohol dependent populations. This research has established smoking to have a significant synergistic effect on brain abnormalities in chronic alcohol users, with clear functional consequences for the individual and with important new implications for treatment of alcohol use disorders and smoking. Recent research also shows distinct effects of chronic smoking on the brain in polydrug abusers, which are different from those observed in alcohol dependence. As chronic smoking is highly comorbid with both alcohol and illicit substance abuse, and as different types of substances are abused together to achieve a desired effect, this kind of research has wider practical utility than past research forced into one corner or the other due to the separate existence of an alcohol and a drug institute. Practical utility and clinical relevance is increased by studying the clinical reality today – that is polydrug use - and should be a main research focus of the newly proposed institute. In other words, it makes no sense to me today to isolate tobacco research in a different corner of NIH than research on alcohol and other psychoactive substances and to continue the artificial and unrealistic classification of substance users into one who only uses alcohol and another only using an illicit drug. It is time that the newly formed institute serves the type of patient that is actually seen in the clinic today. Thank you for the opportunity to contribute information to the Scientific Strategic Plan to make this new institute the best it can be. I look forward to being kept in the loop regarding the major responses to this request.
305 05/09/2012 at 09:54:54 PM Self     I would like to suggest that research on Fetal Alcohol Spectrum Disorders (FASD) be included within the research portfolio of a new addiction institute. I think that it is both unwise and in the long run, a disservice to public health to artificially construct barriers between the causes and consequences of addiction.

In the case of FASD at least, the causes and consequences of addiction are increasingly known to overlap. Alcohol addiction has long been known to run in families. This is not just because children learn from the example set by their parents. FASD children often grow to become alcoholics and to abuse other drugs, even if they are raised in foster families. Animal studies also now show that animals that are exposed to ethanol during fetal life, exhibit a preference for ethanol in adulthood.

We are becoming aware that fetal experience predisposes the adult to disease, but we do not know the full extent of the problem. We do not understand how or why prenatal alcohol exposure predisposes individuals towards drug abuse. Does prenatal alcohol directly reprogram brain addiction circuits or does it program the endocrine system, or the immune system, or the hypothalamic circadian pacemaker, or the limbic circuitry, or learning and memory circuits, or……..? All of these factors and more could influence the development of addiction. The reality is that we know so little about the fetal basis of addiction that we can ill afford to cut off this avenue of research.

Finally, addiction (and alcoholism) has a multi-generational component. Alcoholism may run in families because of genetic factors. However, increasingly, experimental data suggests that epigenetics can account for the inter-generational passage of acquired traits. Epigenetics could influence the emergence of multi-generational addiction behaviors as well. A mother who drinks during pregnancy may influence the drug preference and addiction propensity of at least two generations (if not more) of offspring. The epigenetic contribution to addiction cannot be divorced from the developmental effects of alcohol abuse.

By separating cause from consequence, you run the risk of creating new silos where none exist. Some research into the developmental and inter-generational causes of addiction will simply not get done, because there will be no single agency with the responsibility to foster the growth of research in these areas. I therefore urge you to include both the causes and consequences of addiction within the portfolio of the new addiction institute.

It is important that FASD research be included within the portfolio of the new addiction institute. This is important because some research into the developmental and inter-generational causes of addiction will simply not get done, because there will be no single agency with the responsibility to foster the growth of research in these areas.

 
306 05/09/2012 at 10:26:34 PM Organization Community Connections, Inc. Princeton, WV Make Prevention a Priority Area As someone that is continually focused on how to solve substance abuse problems in a rural area, I urge you to make prevention research a priority area in the scientific strategic plan. Prevention focused funding and research must be a priority for the new institute. Prevention is proven to be the most cost-effective way to address the issue of substance abuse and addiction in our society. By review of our data, we know that by delaying the initiation of substance use, an individual is less like to become addicted in the future. In addition, a focus on prevention can also yield major economic dividends. The savings per dollar spent on substance abuse prevention can be substantial and range from $2.00 to $20.00 (Swisher, Scherer & Yin, 2004). In fact, Miller and Hendrie (2009) indicate that some prevention efforts result in cost-benefit ratios of more than 30:1. That is especially noticed in prevention based coalition strategies like the ones in place here in West Virginia. Investing in prevention yields savings and reduces economic and healthcare burdens (National Institute on Drug Abuse, 2007). Prevention research to continue our knowledge and practice of stopping use before it starts must be central to the new institute’s Scientific Strategic Plan. NIDA and NIAAA have invested heavily in prevention science and have focused efforts to understand the factors at the school, family and community levels that make substance more or less likely for a given population. This focus needs to continue at the new Institute and also be expanded in order to have the maximum impact on substance abuse in our country.

Expand the Research Focus on Policy/Environmental Strategies We encourage the new institute to continue the leadership NIAAA has taken to fund policy/environmental strategy research focusing on preventing alcohol abuse and related harms (e.g., research on alcohol taxes). Policies and environmental strategies are used to shift political, social and economic conditions that contribute to substance use and abuse. These are community-level interventions that aim to achieve population-level benefits for the entire community. More research is needed to continue to build the intervention base in this area. We also urge the institute to take a strong leadership position by funding a large portfolio of policy and environmental research on illicit drugs. There is a paucity of such research; however, there are many lessons to be learned from alcohol and tobacco research that would be important to test out in drug prevention. Practitioners critically need this information to guide their work.

Focus on Risk Factors Specific to Substance Abuse While there are shared risk factors for various problems, there are also some that are specific to substance abuse prevention that need to be attuned to in research and practice in order to have a population-level impact on alcohol and drugs. Particularly, we cannot lose a research focus on investigating additional strategies and interventions that impact the access and availability of alcohol and drugs. We must continue to focus research efforts on risk factors explicit to ATOD use/abuse. A sole focus on shared risk factors will miss out on important levers contributing to substance abuse in our communities.

Fund Participatory Research We also encourage the new institute to make more investments into studies using participatory methods. Community-based participatory research (CBPR) is a collaborative approach to research that engages community members such as Community Connections, and researchers as equal partners in all phases of the research process (Israel, Schulz, Parker, & Becker, 1998; Foster-Fishman, 2009). CBPR more appropriately responds to the needs of communities because it engages community members in defining the problem, selecting the solutions, controlling the implementation and owning the knowledge generation process. An understanding of the community context is imperative in solving local problems and the strategies and methods selected by the community are more likely to fit the local context (Foster-Fishman, 2009; Katz, 2004). Additionally CBPR supports Type II Translational Research by making research and action more culturally competent, relevant, and useful (Foster-Fishman, 2009). This approach to research answers questions that fit practitioner needs and take into consideration more of the factors and conditions in which interventions are implemented in real world setting; hence interventions that come out of CBPR studies are more likely to have buy-in and utility to the community.

Increase Community-Based Research Expertise on Review Panels The makeup of the review committees needs to be less clinically oriented for prevention grants. Prevention research, particularly those that are community-based, require review committees comprised of members who are experts on this type of research. Panel members should understand the particular challenges and benefits for research conducted in community settings, be familiar with collaborative/participatory methods and the benefits these approaches can add to research quality, and understand the usefulness and value of alternative methods to RCTs that may be more culturally competent, ethical and appropriate for certain settings and research questions. As someone that has served on multiple review committees, community based participation is essential to guiding others in understanding how communities truly incorporate others into solving the issues where it matters most…at the community level.

Support More Research on Comprehensive, Community-based Approaches to Substance Abuse Prevention Complex community health problems, like substance use and abuse, require comprehensive, collaborative solutions in order to achieve benefit for the entire community or targeted population. “As the field of prevention has matured, it has been recognized that any single strategy is unlikely to succeed and a reinforcing set of strategies has the greatest potential to reduce use” (Johnson et al., 2007, p. 229). Substance use and abuse is influenced at multiple levels and as such interventions must be broad-based, comprehensive and seek change at multiple levels (Bronfenbrenner, 1979; Sorensen, Emmons, Hunt & Johnston, 1998). The new Institute needs to focus research on these comprehensive, community-based approaches. In addition, research to guide practitioner use of these strategies and how to combine them in ways to achieve maximum benefit for the smallest cost are also needed. Additionally, while there is much focus on single interventions and their impact, more research is needed on the synergy that occurs when a comprehensive set of strategies working at multiple levels of influence are implemented.

Community Connections, Inc. believes that each of the above identified areas (Make Prevention a Priority Area; Expand the Research Focus on Policy/Environmental Strategies; Focus on Risk Factors Specific to Substance Abuse; Fund Participatory Research; Increase Community-Based Research Expertise on Review Panels; Support More Research on Comprehensive, Community-based Approaches to Substance Abuse Prevention) is critical to strengthening our collective understanding of the factors that make substance use and abuse less likely and less severe on a population-wide level in our communities. Without a collective approach, this problem will continue expansion and ultimately cause irreparable harm to our society long term.

Request for Information (RFI): Input into the Scientific Strategic Plan for the proposed National Institute of Substance Use and Addiction Disorders To Whom It May Concern: On behalf of Community Connections, Inc., the Family Resource Network for Mercer County, West Virginia, and our other partnerships such as the West Virginia Teen Court Association and the West Virginia CADCA (Community Anti-Drug Coalitions of America) Alliance (WVCADCA), I thank you for the opportunity to respond to NOT-OD-12-045 (Input into the Scientific Strategic Plan for the proposed National Institute of Substance Use and Addiction Disorders). As the proposed reorganization of substance use, abuse and addiction-related research at the NIH moves forward, I would like offer suggestions that would benefit the new Institute, the prevention science field, and also the substance abuse coalitions (like the ones that I work with on a regular basis) that work diligently to address substance abuse in their communities. Make Prevention a Priority Area As someone that is continually focused on how to solve substance abuse problems in a rural area, I urge you to make prevention research a priority area in the scientific strategic plan. Prevention focused funding and research must be a priority for the new institute. Prevention is proven to be the most cost-effective way to address the issue of substance abuse and addiction in our society. By review of our data, we know that by delaying the initiation of substance use, an individual is less like to become addicted in the future. In addition, a focus on prevention can also yield major economic dividends. The savings per dollar spent on substance abuse prevention can be substantial and range from $2.00 to $20.00 (Swisher, Scherer & Yin, 2004). In fact, Miller and Hendrie (2009) indicate that some prevention efforts result in cost-benefit ratios of more than 30:1. That is especially noticed in prevention based coalition strategies like the ones in place here in West Virginia. Investing in prevention yields savings and reduces economic and healthcare burdens (National Institute on Drug Abuse, 2007). Prevention research to continue our knowledge and practice of stopping use before it starts must be central to the new institute’s Scientific Strategic Plan. NIDA and NIAAA have invested heavily in prevention science and have focused efforts to understand the factors at the school, family and community levels that make substance more or less likely for a given population. This focus needs to continue at the new Institute and also be expanded in order to have the maximum impact on substance abuse in our country. Expand the Research Focus on Policy/Environmental Strategies We encourage the new institute to continue the leadership NIAAA has taken to fund policy/environmental strategy research focusing on preventing alcohol abuse and related harms (e.g., research on alcohol taxes). Policies and environmental strategies are used to shift political, social and economic conditions that contribute to substance use and abuse. These are community-level interventions that aim to achieve population-level benefits for the entire community. More research is needed to continue to build the intervention base in this area. We also urge the institute to take a strong leadership position by funding a large portfolio of policy and environmental research on illicit drugs. There is a paucity of such research; however, there are many lessons to be learned from alcohol and tobacco research that would be important to test out in drug prevention. Practitioners critically need this information to guide their work. Focus on Risk Factors Specific to Substance Abuse While there are shared risk factors for various problems, there are also some that are specific to substance abuse prevention that need to be attuned to in research and practice in order to have a population-level impact on alcohol and drugs. Particularly, we cannot lose a research focus on investigating additional strategies and interventions that impact the access and availability of alcohol and drugs. We must continue to focus research efforts on risk factors explicit to ATOD use/abuse. A sole focus on shared risk factors will miss out on important levers contributing to substance abuse in our communities. Fund Participatory Research We also encourage the new institute to make more investments into studies using participatory methods. Community-based participatory research (CBPR) is a collaborative approach to research that engages community members such as Community Connections, and researchers as equal partners in all phases of the research process (Israel, Schulz, Parker, & Becker, 1998; Foster-Fishman, 2009). CBPR more appropriately responds to the needs of communities because it engages community members in defining the problem, selecting the solutions, controlling the implementation and owning the knowledge generation process. An understanding of the community context is imperative in solving local problems and the strategies and methods selected by the community are more likely to fit the local context (Foster-Fishman, 2009; Katz, 2004). Additionally CBPR supports Type II Translational Research by making research and action more culturally competent, relevant, and useful (Foster-Fishman, 2009). This approach to research answers questions that fit practitioner needs and take into consideration more of the factors and conditions in which interventions are implemented in real world setting; hence interventions that come out of CBPR studies are more likely to have buy-in and utility to the community. Increase Community-Based Research Expertise on Review Panels The makeup of the review committees needs to be less clinically oriented for prevention grants. Prevention research, particularly those that are community-based, require review committees comprised of members who are experts on this type of research. Panel members should understand the particular challenges and benefits for research conducted in community settings, be familiar with collaborative/participatory methods and the benefits these approaches can add to research quality, and understand the usefulness and value of alternative methods to RCTs that may be more culturally competent, ethical and appropriate for certain settings and research questions. As someone that has served on multiple review committees, community based participation is essential to guiding others in understanding how communities truly incorporate others into solving the issues where it matters most…at the community level. Support More Research on Comprehensive, Community-based Approaches to Substance Abuse Prevention Complex community health problems, like substance use and abuse, require comprehensive, collaborative solutions in order to achieve benefit for the entire community or targeted population. “As the field of prevention has matured, it has been recognized that any single strategy is unlikely to succeed and a reinforcing set of strategies has the greatest potential to reduce use” (Johnson et al., 2007, p. 229). Substance use and abuse is influenced at multiple levels and as such interventions must be broad-based, comprehensive and seek change at multiple levels (Bronfenbrenner, 1979; Sorensen, Emmons, Hunt & Johnston, 1998). The new Institute needs to focus research on these comprehensive, community-based approaches. In addition, research to guide practitioner use of these strategies and how to combine them in ways to achieve maximum benefit for the smallest cost are also needed. Additionally, while there is much focus on single interventions and their impact, more research is needed on the synergy that occurs when a comprehensive set of strategies working at multiple levels of influence are implemented. From your description, the new Institute will offer the substance abuse field an opportunity to expand its reach, focus and effectiveness. Community Connections offers the above comments as a way to strengthen our collective understanding of the factors that make substance use and abuse less likely and less severe on a population-wide level in our communities.
307 05/09/2012 at 10:58:20 PM Self     Alcohol use and abuse peaks between early and late adolescence, a time when a number of neural alterations occur. The study of alcohol vulnerability strongly depends on the understanding of alcohol effects on the developing nervous system. Brain development begins during embryogenesis and does not cease until the third decade of life. Much of the current research focuses on the effects of alcohol on the developing nervous system, including prenatal alcohol exposure. Alcohol interacts with many of the same molecular targets during prenatal and early postnatal brain development as it does in the developing adolescent and mature nervous systems. Prenatal alcohol exposure produces permanent alterations in the neural systems that are implicated in alcohol use, abuse, and dependence. Individuals exposed to alcohol in utero are at increased risk for developing alcohol-related problems during adolescence. Therefore, an ontogenetic approach to the problem of alcohol's effects on the developing nervous system, including preclinical and clinical studies of the long-lasting effects of prenatal alcohol exposure, should be used.

Recent epidemiological studies confirm that humans exposed prenatally to moderate amounts of ethanol are at risk for alcohol abuse as adolescents and subsequently as adults. Data from the CDC show that more than ten percent of pregnant women drink alcohol, and approximately one in 100 babies is born with one of the Fetal Alcohol Spectrum Disorders (FASD). Alcohol effects on the developing brain, being life-long, produce motor, sensory, social, and learning deficits. Individuals with FASD are at greater risk for psychiatric disorders and illicit drug use. FASD is the single most important preventable cause of developmental disabilities. By far the most important strategy for preventing FASD is the prevention of drinking in women who are pregnant or trying to conceive. The defining face and brain abnormalities of fetal alcohol syndrome result from alcohol exposure during the third to fourth week of pregnancy, a time when most women do not know that they are pregnant. Therefore, the prevention of FASD requires a concerted effort to reduce binge drinking in all women of childbearing age. Unfortunately, binge drinking is common, particularly in women in their late teens and early twenties. A broad array of clinical, psychosocial, and policy research has been directed at reducing drinking in this vulnerable population. That research needs to be coordinated to address the specific challenge of reducing binge drinking in women of childbearing age. Current research of the effects of early alcohol exposure include not only prevention but also early life interventions, establishing and implementing novel and more effective diagnostic approaches, and systematic investigation of the mechanisms underlying the dramatic outcomes associated with early alcohol exposure. Therefore, preventing the major public health burden of FASD will depend critically on the inclusion of all prenatal alcohol research within the portfolio of an institute on addictions.

 
308 05/09/2012 at 11:58:31 PM Self     While it seems sensible to create a new institute to consolidate substance use, abuse, and addiction-related research in a single institute (a National Institute of Substance Use and Addiction Disorders), including “knowledge of tobacco use and addiction, including co-morbidity with other addiction and psychiatric disorders,” it is important that such a consolidation of tobacco addiction-related work not disrupt existing research programs on other aspects of tobacco use, including population-based tobacco control and tobacco treatment in the context of treating tobacco-induced disease (other than in the context of treating psychiatric disorders), currently under way in other Institutes, particularly the National Cancer Institute and the National Heart, Lung and Blood Institute.

While the fact that nicotine is addictive is the physiological reason that people continue smoking, it is important to recognize that development and treatment of this addiction is only one aspect of understanding and eventually eliminating tobacco-induced diseases. As the Surgeon General has noted, tobacco affects virtually every organ system in the body and it is crucial that tobacco-related research be distributed to all relevant NIH Institutes.

Most important, the policies and interventions that have driven most of this decline have been population-level interventions that have little to do with the fact that nicotine is addictive, the pharmacology of nicotine addiction, or the treatment of that addiction. Rather, this progress has been made under the broader agenda of cancer and heart and lung disease prevention and control by understanding the social determinants of smoking behavior, the effectiveness of population-based interventions (such as smokefree policies, tobacco taxation, media campaigns and smoking in the movies) as well as learning how to counter efforts by the tobacco industry to block implementation of effective interventions. These are all areas that the NCI Division of Cancer Control and Population Sciences, through its Tobacco Control Research Branch, have stimulated and supported for many years.

In addition, in recent years, the National Heart, Lung and Blood Institute has developed an interest in smoking treatment among hospitalized smokers and the effects of secondhand smoke on the cardiovascular system. The location of this work in NHLBI has been important for engaging the cardiovascular community in issues of smoking and tobacco treatment and prevention, something that has been sorely needed for a long time.

The relative importance of addiction (and related) research to dealing with the overall tobacco problem is illustrated by the volume of publications in different areas. Searching PubMed on 9 May 2012 yielded the following results:

(tobacco or smok*) and addiction: 5,390 papers (tobacco or smok*) and cancer: 44,009 papers (tobacco or smok*) and (heart or lung or blood): 84,991 papers

This broad distribution of work between relevant NIH Institutes should be maintained and encouraged.

It is also important to note that, while tobacco work is spread across NIH, there has been good cooperation between the existing institutes, particularly NCI and NIDA (where almost all addiction and nicotine treatment work is already located). Rather than trying to consolidate all or most tobacco research in the new institute, the kind of cross-institute collaboration that has already been so successful should be continued and rewarded.

I am co-director of the UCSF Helen Diller Family Comprehensive Cancer Center’s Tobacco Program. It has been a long fight to integrate tobacco control into the cancer center’s basic biological and clinical programs, but we are now making progress. Shifting the tobacco control research portfolio out of NCI will create the appearance and reality of NCI walking away from tobacco. Worse, it will and send a strong message that NCI does not think that tobacco control research is a priority for cancer control.

This reorganization of NIH comes at a particularly sensitive time for tobacco control, given the release last year of Secretary Kathleen Sibelius’ “Ending the Tobacco Epidemic: A Tobacco Control Strategic Action Plan for the US Department of Health and Human Services.” Even a cursory review of this document will reveal that the work funded by and conducted at NCI provides much of the scientific foundation for this plan. NCI should be taking credit for this important contribution, not trying to move it to another institute.

I am particularly concerned that the proposed reorganization of tobacco control research will create heightened opportunities for the tobacco industry to shut down the kind of research and training that has made such a strong contribution to reducing smoking prevalence and consumption together with a wide range of cancers and other diseases. Even absent frank political interference, a major reorganization will almost certainly disrupt NIH’s tobacco control funding and activities at this crucial time.

Rather than concentrating all or most tobacco control research in the addictions institute, NIH should work to integrate tobacco into the full range of its programs. Tobacco kills more people through heart and vascular disease than cancer, yet NHLBI has had a very limited presence in tobacco control research.

I have also attached a letters on this subject that Dr. Frank McCormick, director of our Cancer Center, and I sent NIH Director Collins on this subject last year addressing these points.

In addition, I draw your attention to the editorial published in 2011 by leaders of the American Cancer Society, American Heart Association, American Lung Association, Campaign for Tobacco Free Kids, Legacy Foundation and Partnership for Prevention (Tobacco Control 2011;20:175e177, doi:10.1136/tc.2011.043968) that concluded, “As major organisations concerned with reducing the burden of tobacco-induced diseases we strongly advise the task force and Director Collins to leave existing tobacco research at NCI, NHLBI and the Fogarty International Center, with some flexibility regarding the transfer of research that is wholly focused on the dependence-producing properties of tobacco. Indeed, rather than removing tobacco research from these (and other relevant) institutes, they should be encouraged to strengthen and expand their efforts to a level commensurate with the risks tobacco imposes and the central contribution that reducing smoking and tobacco use has been demonstrated to have reducing the burden of cancer, heart, lung and other diseases.”

This is a sensible recommendation from organizations that represent an important element of NIH’s organized constituency in general and regarding tobacco in particular. Please carefully consider the practical effect on the research community and the ability of NIH to make an ongoing contribution to implementing the Department’s new Strategic Plan and see that there are no disruptions to NIH’s contribution to reducing the burden of tobacco-caused cancer and other diseases.

Attachment #1: November 15, 2010 As director of the UCSF Helen Diller Family Comprehensive Cancer Center, I am writing to express concern about the proposal to move most of the tobacco control and prevention research from the National Cancer Institute to a new “addictions institute” created by merging the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAA). As you know, tobacco use is the leading preventable cause of cancer and much of the decline in the toll of cancer in recent decades has been due to population-level reductions in smoking. As a Comprehensive Cancer Center, we have worked hard to build our population sciences program in tobacco control and, after many years of struggling with this issue, are making important progress in integrating out tobacco control work with the other work of the Cancer Center in basic science and clinical trials. Moving this work out of NCI will send a strong message to Cancer Centers that NCI is not serious about or supportive of this important work. This issue is really separate from the question of whether NIDA and NIAA should be merged, and I view this question as outside my area of expertise and have no advice on that point. What I can tell you is that regardless of what you decide to do regarding that proposed merger, you should leave the population-level tobacco control work inside NCI. Attachment #2: November 17, 2010 I am writing you to express opposition to the proposal to move most tobacco control research out of the National Cancer Institute (and perhaps other NIH institutes) into the proposed “addictions” institute. This move makes no sense because smoking and tobacco use are the leading cause of preventable cancer deaths and because most of the drop in cancer in recent years has been due to reductions in smoking on a population level. Most important, the policies and interventions that have driven most of this decline have been population-level interventions that have little to do with the fact that nicotine is addictive, the pharmacology of nicotine addiction, or the treatment of that addiction