WASHINGTON _ National Institutes of Health (NIH) director HaroldVarmus plans to appoint a blue ribbon commission to study howphysicians and investigators can be better trained to conduct clinicalresearch.The move was prompted by what he calls "the cloud that hasdescended on clinical research" as a result of misconduct in theNational Surgical Adjuvant Breast and Bowel Project (NSABP).NSABP, a large cancer study that involved a comparison betweenbreast-sparing therapy and mastectomy, was suspended in April afterinstances of data falsification became public."We at NIH are extremely concerned about what we see as a crisis ofconfidence in clinical research that should not have occurred at thisdepth," Varmus told an audience of scientists and educators on the finalday of a Convocation on Scientific Conduct at the National Academyof Sciences (NAS) here.The convocation, sponsored by NAS, the National Academy ofEngineering (NAE) and the Institute of Medicine (IOM), was plannedas a follow-up to a 1992 report on scientific conduct prepared by thesame three agencies. That report concluded that the prevalence ofmisconduct in science required explicit action to protect the integrity ofthe nation's scientists and research institutions and to addressallegations properly and promptly.Varmus said on Tuesday that his views on scientific conduct havechanged. "There was a time when I would have said, "Science is a self-correcting process, just leave us alone,' but now I recognize that theproblem of misconduct is real," he said. But Varmus and otherconvocation speakers differentiated between hard-core misconduct _defined as falsification or fabrication of data and plagiarism _ and themistakes of poorly trained and/or sloppy researchers.Gary Ellis, director of the NIH's Office for Protection from ResearchRisks, told BioWorld that the new NIH commission will attempt toanswer the question of how physicians can be trained to be goodresearchers. Ellis said that while a physician regards the treatment of anindividual patient as the supreme value in a given situation, aresearcher must have greater respect for the collection of data."A researcher is collecting data for the purpose of generalizingknowledge that might help many people in the future," said Ellis.He cited the case of an NSABP researcher who ignored entry criteria toenroll individual patients he thought he could help. But this infractionof data collection principles harmed more people than it may havehelped. For example, the NSABP, finding that lumpectomy andradiation were as effective in treating early forms of breast cancer aswas mastectomy, has guided therapy decisions for thousands of womenwith breast cancer. Once such a finding is tainted by improper datacollection, its value to society is lessened.Robert O'Neill, director of the Division of Biometrics at FDA's Centerfor Drug Evaluation and Research, said that recent cases of scientificmisconduct offer the research community an opportunity to reexamineits conduct. But he singled out industry-sponsored research, guided asit is by federal regulations, as exemplary."FDA regulations, with the force of criminal penalties behind them,provide a safety net for companies conducting clinical studies," heargued. "Pharmaceutical drug development probably has as muchoversight for assurance of quality research and data as any otherscientific endeavor in this country."`We Don't Want To Police Science'Publicized cases of misconduct often spur calls for increased oversightof clinical research but Varmus said that the NIH has struggled withthat issue. "Oversight is expensive, time-consuming and requirespersonnel who aren't always available. Misconduct is rare. It's adifficult problem to address with limited resources," he said. "We don'twant to police science."The 1992 NAS/NAE/IOM report revealed that between 1989 and 1991,more than 200 allegations of misconduct in science were reported toU.S. government offices. Of those cases, 30 have resulted in confirmedfindings of misconduct. In the same time period, the NIH awarded26,000 research grants.Yet each case of misconduct extracts a high price from the credibilityof all scientific endeavors. Although Varmus did not mention the PhaseII clinical trial of fialuridine (FIAU) that killed five people last year,the conduct of NIH investigators in that trial has been criticized by theFDA, some patients' families and lawmakers.Just last week, an NIH-commissioned panel of experts cleared NIHinvestigators of any negligence in running the trial, an action whichprompted charges of a "whitewash" from Rep. Edolphus Towns (D-N.Y.), who chairs a House subcommittee that will hold hearings on thematter later this summer.Highly publicized incidents such as the FIAU trial can have realconsequences for companies and investigators engaged in clinicalresearch. The FIAU trial caused the FDA to change its adverse eventreporting requirements, including increased requirements for collectionof laboratory data, cumulative vs. episodic reporting of adverse eventsand biannual instead of annual investigational new drug applicationupdates. The changes have already taken an indirect financial toll onthe biotechnology industry, according to one venture capitalist.Last month at a Biotechnology Industry Organization meeting inToronto, Peter Bick of Burr, Egan, Deleage & Co., of San Francisco,said that FIAU-inspired regulatory changes have made investing inbiotechnology companies less attractive due to increased drugdevelopment costs. n
-- Lisa Piercey Washington Editor
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