The following are excerpts from a speech given by Bernard Fisher, MD, Distinguished Service Professor of Surgery, University of Pittsburgh, School of Medicine, at the American Society of Clinical Oncology's Fall 1994 Educational Conference in Atlanta, Georgia.
ABSTRACT: The following are excerpts from a speech given by Bernard Fisher, MD, Distinguished Service Professor of Surgery, University of Pittsburgh, School of Medicine, at the American Society of Clinical Oncology's Fall 1994 Educational Conference in Atlanta, Georgia.
"I have been involved with breast cancer research since 1958and was part of the group which founded NSABP [National SurgicalAdjuvant Breast and Bowel Project]. I have devoted my entire lifeto science, clinical trials, and efforts to help women . . . butnever have I felt such anxiety about what to say and do aboutthis presentation. . . .
"You're all familiar with l'affaire Poisson. . . . We'vebeen accused of delay in reporting falsifications to the NCI.Not true. Delay in publication of analysis and notification ofeditors and members of the NSABP. Not true. There was no--at thattime or now--due process to answer such charges. And there wereno rules to guide us. . . .
"If there was such a breach, then it involved the NCI, theNIH, and the ORI [Office of Research Integrity], who knew everythingthat we did and who could have stepped forward at any time andnotified patients and physicians about this whole affair.
"We were accused of publishing papers with data from St.Luc. The answer is yes, we did, because there are scientific andbiological justifications for doing so. The biostatisticians arethe ones who govern this kind of thing, since it relates to verysophisticated analytical procedures.
"We've been accused of delay in reporting deaths due to endometrialcancer. False. We've been accused of knowing about a problem offalsifications at another Canadian hospital for 6 months and notreporting it. False.
"I've been accused of holding an ICI [Imperial Chemical Industries,makers of tamoxifen] professorship at the University of Pittsburgh.False.
"NSABP meetings were said to be bacchanalian orgies withstrolling troubadours and fire eaters. False.
"There were some minor audit problems at the headquarters,which did not harm anybody and were readily fixable. The issue:Was this justification for deposing the chairman; stopping allclinical trials and special studies related to breast and colorectalcancer; preventing the implementation of new trials and new studies;delaying analysis of already available data; or putting the world'sleading breast cancer clinical trial group into disarray? Worstof all, was all of this justified in how it has affected womennow and for years to come? . . .
"It had been stated in the news media that NSABP data aretainted; it can't be trusted; it's falsified, and so on. I assureyou with all my strength that there was no massive plot of deception,no falsification by the NSABP. There was no subversion of information,which would have involved numerous headquarters, physicians, statisticians,and myself.
"I also condemn those who criticize our ethics. We do notconsider ourselves to be ethically defective. Consequently, anyinformation I have presented over the years stands as reported.
"A recent re-audit of the NSABP lumpectomy study (B-06) wascarried out by the NCI auditors who, for the most part, had noprior knowledge of this complex protocol. They visited some ofthe institutions that had put patients on the study between 1976and 1984, examined information that had been collected at thattime, and compared their findings with those originally reportedto the NSABP.
"This audit is now done. We should be here to praise thesefindings. Not one case of fraud was found, and there was no carelessnessin record-keeping. . . .
"To go back to a database of a different era, of a differenttime out of context of history . . . is to me a very chillingthing to be able to do. It's chilling because of the possibilityof changing history after the fact. . . . In the present situation,in the present climate, we can go back to any database that existsin this government or anywhere . . . and come up with a new setof answers out of context of the time. . . .
"This kind of thing questions the integrity of physicianswho participate in clinical trials. . . . To presume that thevast numbers of physicians who have participated in clinical trialshave a tendency to be dishonest is absolutely unthinkable. Inmy 40 years of experience, I know of no one in government or outwho has questioned or audited the quality of data in retrospectivestudies. . . .
"F. Scott Fitzgerald said, show me a hero and I'll show youa tragedy. The last 6 months have indeed been a tragedy. . . .I've learned how fear can influence the course of science."
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