95-15397. Completion of Investigation

[Federal Register Volume 60, Number 121 (Friday, June 23, 1995)]
[Notices]
[Page 32684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15397]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary


Completion of Investigation

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: 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 
Investigator.
    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: Director, Division of Research 
Investigations, Office of Research Integrity, 301-443-5330.
Lyle W. Bivens,
Director, Office of Research Integrity.
[FR Doc. 95-15397 Filed 6-22-95; 8:45 am]
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