NOT-OD-01-047: FINDINGS OF SCIENTIFIC MISCONDUCT

Department of Health
and Human Services (HHS)
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FINDINGS OF SCIENTIFIC MISCONDUCT

Release Date:  June 27, 2001

NOTICE:  NOT-OD-01-047

Department of Health and Human Services

Notice is hereby given that the Office of Research Integrity (ORI) and the 
Assistant Secretary for Health have taken final action in the following case:

Kuie-Fu (Tom) Lin, D.V.M., Medical University of South Carolina (MUSC):  
Based on the report of an investigation conducted by MUSC and additional 
analysis conducted by ORI in its oversight review, the U.S. Public Health 
Service (PHS) found that Dr. Lin, a former graduate student, Department of 
Biochemistry and Molecular Biology at MUSC, engaged in scientific misconduct 
in research supported by the National Heart, Lung, and Blood Institute 
(NHLBI), National Institutes of Health (NIH), grants R01 HL29397,  Regulation 
and Function of Renal Kallikrein,  and R01 HL56686,  Gene Therapy in 
Experimental Hypertension and Renal Diseases. 

Specifically, PHS finds that Dr. Lin engaged in scientific misconduct by:

A.  Falsifying research on the expression and effect of the human atrial 
natriuretic peptide (ANP) gene in rats reported in Hypertension 26:847-853, 
1995.  Dr. Lin falsified data in the text on page 850 that described RT-PCR 
results shown in Figure 3 as obtained from multiple control and experimental 
rats, when only one rat was tested for each group.

B.  Falsifying research on the expression and effect of the human 
adrenomelullin gene in rats reported in Hypertension Research 20:269-277, 
1997.  Dr. Lin falsified data in:  (a) Figure 2 on page 272 by reusing Figure 
2 of the Hypertension paper cited in  A  above, and falsely relabeling it as 
being a test of ADM levels in experimental rats, (b) Table 1 on page 273 by 
stating concentrations of human ADM in experimental rat tissues without 
accounting for the high levels of endogenous cross-reactive rat ADM, and (c) 
Table 1 on page 273 by claiming that the levels of human ADM seen in rat 
tissues were obtained from four animals when the values were actually 
obtained from four serial dilutions of one sample.  The journal published an 
erratum at 22(3):229, 1999.

C.  Falsifying research on the expression and effect of the human ANP gene in 
rats reported in Human Gene Therapy 9:1429-1438, 1998.  Dr. Lin falsified 
data in: (a) Figure 3 on page 1431 by reusing Figure 2 of the Hypertension 
paper cited in  A  above, and falsely relabeling it as being based on the use 
of an adenovirus vector to deliver the ANP (gene rather than the use of 
 naked DNA  described in the earlier paper), (b) text on page 1433 that 
stated concentrations of human ANP in experimental rat tissues without 
accounting for the high levels of endogenous cross-reactive rat ANP, and (c) 
Table 2 by making an inappropriate calculation for the renal blood flow (RFB) 
of the  AdCMV-LacZ  group by altering data (from animals that should not have 
been included because their venous flow was greater than their arterial 
flow), to falsely produce an average RBF value that was significantly 
different from the group receiving the ANP vector.

All three of the questioned papers described gene therapy models in which the 
introduced gene lowered blood pressure in hypertensive or salt-sensitive 
rats.  Dr. Lin’s falsifications greatly enhanced the apparent expression and 
effects of the introduced ANP and ADM genes in the experimental rats.

Dr. Lin states that he made honest mistakes and deeply regrets his 
unintentional errors in data handling.

Dr. Lin has entered into a Voluntary Exclusion Agreement (Agreement) with PHS 
in which he has voluntarily agreed:

(1)  to exclude himself from any contracting or subcontracting with any 
agency of the United States Government and from eligibility for, or 
involvement in, nonprocurement transactions (e.g., grants and cooperative 
agreements) of the United States Government as defined in 45 C.F.R. Part 76 
(Debarment Regulations) for a period of three (3) years, beginning on June 
12, 2001,

(2)  to exclude himself from serving in any advisory capacity to PHS, 
including but not limited to service on any PHS advisory committee, board, 
and/or peer review committee for a period of three (3) years, beginning on 
June 12, 2001,

(3)  within 30 days of the effective date of the Agreement to submit letters 
of correction or retraction to:  (A) Hypertension 26:847-853, 1995: 
Requesting correction of the statement on page 850 to indicate that results 
on RT-PCR of tissue extracts were obtained with only one control and one 
experimental rat, rather than the four animals for each group claimed in the 
paper, (B) Hypertension Research 20:269-277, 1997:  Requesting retraction of 
Table 1, the notice to the journal should state that the values for human ADM 
in Table 1 were incorrect because they did not account for the high level of 
endogenous ADM detected in control tissues by the RIA, and that only a single 
rat was tested rather than the four animals claimed, and (C) Human Gene 
Therapy 9:1429-1438, 1998: Requesting retraction of Figure 2 and correction 
of Table 2 to indicate that the renal blood flow value for the  Ad.CMV-LacZ 
(4% NaC1)  rats was falsified.  The notice to the journal should state that 
Figure 2 was falsified because it was in large part a duplicate of a 
previously published figure and was falsified both because logit values were 
deliberately altered and because the results were obtained from experimental 
rats that were treated differently from those described in the paper.  This 
statement should also note that the first paragraph on page 1433 contained 
misleading concentrations of human ANP in experimental tissues because they 
failed to account for the high level of cross-reactive endogenous ANP 
observed by the RIA used in control tissues.

These correction and retraction requirements will remain on the ALERT System 
until Dr. Lin sends, and ORI receives, copies of these letters that are 
consistent with the above language.

INQUIRIES

For further information contact:

Director
Division of Investigative Oversight
Office of Research Integrity
5515 Security Lane, Suite 700
Rockville, MD  20852
Telephone:  301- 443-5330
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