[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] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Completion of Investigation AGENCY: Office of the Secretary, HHS. ACTION: Notice. ----------------------------------------------------------------------- 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] BILLING CODE 4160-17-P