WASHINGTON _ The National Institutes of Health has proposednew rules for addressing conflicts of interest related to potentialfinancial gain among clinical research grantees.The rules, which were published in the Federal Register on June 28and are open for public comment until the end of August, wouldreplace existing toothless guidelines which do not even define themeaning of the phrase, conflict of interest, George Galasso, associatedirector for extramural affairs, NIH, told BioWorld.The push for stronger sanctions on conflict of interest dates back to1989, following a study in the New England Journal of Medicinewhich raved about a new drug, Galasso told BioWorld. "One of thefootnotes said that the research had been conducted with the support ofNIH, and by the way, 60 percent of the authors have stock in thecompany." (Galasso refused to name the drug, but BioWorld learnedelsewhere that it was tPA.)"[The authors] did the right thing by declaring [the stock ownership],"Galasso told BioWorld, "but a doc out in Iowa is going to say, `I'llwait until someone else tests it so I can be sure of the research.' That'snot a wise expenditure of taxpayer money."As a result, then-director of NIH, James Wyngaarden decided that theagency needed to clarify what it meant by conflict of interest. NIHproposed some stringent new guidelines, which received over 700mostly critical comment letters. Then-Secretary of Health and HumanServices Louis Sullivan ordered the proposed guidelines withdrawn,"Galasso said, adding that they went through numerous revisions."They are reasonable and necessary," Craig Venter, president anddirector of The Institute for Genomic Research, a not-for-profitresearch institution in Gaithersburg, Md., told BioWorld. "Obviouslyit would be a real conflict, for example, for me, as a major stockholderin Human Genome Sciences, to get a grant from NIH to do clinicaltrials on a drug they were producing," since Venter's stake in thecompany could bias his conduct of such a trial.Venter added that the new rules appeared to reflect carefulconsideration of the criticisms of the rules the agency had proposedearlier.Richard Rose, vice president for drug development at Cytel, in SanDiego, also reacted favorably. "We have very serious concerns aboutdoing research with people who have a financial bias," he toldBioWorld.In one case, said Rose, Cytel had to do without the services of one ofthe best outside researchers for a clinical trial on a drug for melanoma,because he worked so closely with the company both on the board ofdirectors, and as a consultant. That's the way it should be, Rose toldBioWorld."We are in an industry where the external perception of the value ofclinical research is an important driver and determines company valueon the Street," Rose told BioWorld. "People publish research, theanalysts tear them apart or praise them and it creates or destroys valuebased on perception."The new rules would require grantees to disclose "significant financialinterests" that could be affected by the research funded by the PublicHealth Service or proposed for funding. Significant financial interestsare defined as stock, or other equity, stock options, debt, security,capital holding, and salary or other remuneration. Intellectual propertyalso falls within the definition. Remuneration under $5,000 and equityin a company of less than five percent would be exempt from the rules.Interests in companies receiving Small Business Innovative Researchgrants from the Federal Government would also be exempt fromdisclosure rules. Few potential research grantees have more than 5percent equity in such companies, Claudia Blair, director of theInstitutional Affairs Office, NIH, told BioWorld.Grantee institutions would be required to carry out the rules, and todemonstrate to NIH that they have policies in place to do so.The rules would allow some flexibility in enforcement. Alternatives formanaging conflicts include public disclosure of financial interests,monitoring of research by independent reviewers, modification of theresearch plan, disqualification from participation in all or a portion ofthe funded research, divestiture of significant financial interests, orsevering relationships that have created the conflicts.As for sanctions, NIH could withdraw funding from the grantee, oreven from the entire institution. n
-- David Holzman Special To BioWorld Today
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