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Appendix: Chronology of the Controversy
- The University of Alabama Press
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Appendix Chronology of the Controversy Date Event 1958 NSABP founded 1967 Bernard Fisher becomes chair of NSABP; operations move to Pittsburgh 1977 B- 06 “lumpectomy”trial begins patient accrual 1980 Saint- Luc Hospital receives clinical trials grant; Roger Poisson named principal investigator 1985 NSABP publishes five- year B- 06 results comparing total mastectomy and lumpectomy in breast cancer treatment in NEJM 1986 President Ronald Reagan appoints Fisher to National Cancer Advisory Board 1989 NSABP publishes eight- year B- 06 results of randomized clinical trial comparing total mastectomy to lumpectomy in NEJM 1990 June NSABP investigators discover discrepancy reported in date of surgery on operative report of patient at Saint- Luc during a routine audit of data contributed by Dr. Roger Poisson, head of Cancer Research at Saint- Luc; they suggest a more thorough audit 170 Appendix September During the audit, the deputy director of NSABP’s Biostatistical Center finds several more anomalies and recommends a more extensive second audit 1991 January A three- person NSABP team visits Saint- Luc and finds more discrepancies in record keeping February The audit team notifies Fisher of Poisson’s data falsifications ; Poisson is dismissed from his position as principal investigator at Saint- Luc; Fisher and NSABP notify FDA, NCI, and OSI of Poisson’s discrepancies; Poisson admits to falsifying data in a faxed letter to Fisher March OSI’s Division of Research Integrity decides to conduct a formal investigation since misconduct has already occurred 1992 January NCI funding of Saint- Luc expires March NSABP assures NCI and ORI (successor organization to OSI) that there are no major changes to the published findings when Dr. Poisson’s data is eliminated from analysis; ORI reports there is general agreement on the need for reanalysis regardless December ORI finishes investigation determining that Poisson falsified 7 percent of data 1993 January NCI officials urge NSABP to finish reanalysis of all studies to which Poisson contributed patients as soon as possible; they offer expedited review for publication in Journal of the National Cancer Institute February ORI releases findings of their investigation to Poisson and NSABP March Poisson is debarred from receiving federal grants for eight years April ORI’s finding that Poisson was guilty of scientific misconduct is published in ORI newsletter; Poisson Chronology of the Controversy 171 resigns from all administrative positions at Saint- Luc June ORI findings in the investigation of Roger Poisson are published in the Federal Register 1994 March Chicago Tribune issues front- page report of Poisson’s falsifications, noting NSABP’s failure to publish reanalysis of the fourteen studies to which Poisson contributed; NCI discovers data discrepancy in second Montreal hospital; they request that Dr. Fisher be replaced at the NSABP; Congressman John Dingell calls hearings on the matter April Robert Herberman replaces Fisher at NSABP on an “interim basis”; Congressman Dingell holds first hearing of the Subcommittee on Oversight and Investigations to address NSABP breast cancer research misconduct May New England Journal of Medicine editors Marcia Angell and Jerome Kassirer publish an essay sharply criticizing Fisher, Poisson, and the NCI June NSABP submits draft of reanalysis to NCI; Dingell holds second hearing July Fisher files lawsuit against the University of Pittsburgh and the federal government for violation of due process August NSABP executive board joins Fisher in lawsuit against Pittsburgh September ORI begins investigation of scientific misconduct at Pittsburgh October Norman Wolmark replaces Fisher as chair of NSABP 1997 February ORI concludes Fisher and University of Pittsburgh are not guilty of scientific misconduct 172 Appendix August Fisher withdraws lawsuit from the university; the university apologizes, and Fisher is awarded $2.75 million in settlement from Pittsburgh with several hundred thousand dollars from NCI; Fisher is effectively cleared of “all wrongdoing” ...