NIH GUIDE, Volume 24, Number 25, July 14, 1995

P.T. 34


  Ethics/Values in Science & Technol 

  Grants Administration/Policy+ 

Department of Health and Human Services

Notice is hereby given that the Office of Research Integrity (ORI)

has completed an investigation and DOES NOT find scientific

misconduct in the following case:

David Plotkin, M.D., Memorial Cancer Research Foundation of Southern

California:  The Division of Research Investigations (DRI), Office of

Research Integrity (ORI), investigated allegations that clinical

trial data forms submitted from the Memorial Cancer Research

Foundation of Southern California (MCRF), Los Angeles, California,

contained falsified and fabricated information.  The data forms were

submitted to the Statistical Office of the National Surgical Adjuvant

Breast and Bowel Project (NSABP) located at the University of

Pittsburgh.  The NSABP project at MCRF received funding from the

National Cancer Institute (NCI), with Dr. David Plotkin as Principal


In mid April 1994, the Chicago Tribune obtained a copy of an April

1990 NSABP Audit Report that indicated there was a ~serious problem .

. . with respect to the accuracy of the data reported to the NSABP~

from the MCRF.  A Chicago Tribune reporter reviewed records on some

subjects entered on NSABP trials at MCRF and found apparent

discrepancies between reported data and medical records.  Much of the

questioned data was related to the B-06 clinical trial which compared

lumpectomy (with or without radiation therapy) to total mastectomy

for the treatment of breast cancer.

ORI reviewed records and data on 59 patients reported to NSABP

between 1973 and 1994 and did not find falsification, fabrication, or

deliberate misrepresentation on the part of Dr. Plotkin or his staff.

ORI found that many of the discrepancies originally identified by the

NSABP and the Chicago Tribune were the result of a review of

incomplete records, honest error on the part of one or more of the

participating parties, or differences in interpretations or judgments

of the facts.


For further information, contact:


Division of Research Investigations

Office of Research Integrity

5515 Security Lane, Suite 700

Rockville, MD  20852

Telephone:  (301) 443-5330


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