FDA Panel Members Considering COX-2 Inhibitor Have Financial Ties To Industry
April 17, 2007 – 10:44 am | posted in Pharma Industry, Primary CareThree members of an FDA advisory panel meeting on Thursday who will consider approval of Merck’s COX-2 inhibitor Arcoxia would not be allowed to vote under conflict-of-interest rules proposed by FDA in March, the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 4/12). FDA on March 21 announced proposed rules under which medical experts with more than a $50,000 financial interest in pharmaceutical companies could not serve on agency advisory committees that review their products or the products of their competitors. Under the rules, medical experts with less than a $50,000 financial interest could participate in discussions by advisory committees but could not vote on whether to recommend products. The $50,000 limit includes stock and consulting arrangements. Under current rules, medical experts with more than $100,000 or 15% or more of their net worth invested in pharmaceutical companies cannot serve on advisory committees. Medical experts must disclose smaller investments in pharmaceutical companies, but such investments do not prevent their participation on advisory committees. FDA officials said that the agency will accept public comments on the proposed rules for 60 days but did not announce when they would finalize the rules (Kaiser Daily Health Policy Report, 3/22). Panel members Robert Levine, a specialist in digestive system problems, disclosed that he owns Merck stock worth between $25,001 and $50,000; Kenneth Saag, an osteoporosis specialist, disclosed less than $50,000 per year in speaking and consulting fees from Merck on drug issues not related to Arcoxia and consulting fees from two competitors; and Dennis Turk, a pain specialist and designated chair of the meeting, disclosed that he receives fees of less than $10,000 annually from a competitor. Comments
Rep. Maurice Hinchey (D-N.Y.), who has sought stricter conflict-of-interest rules at FDA, said, “They know they should be eliminating these conflicts, but nevertheless, they continue to have people with conflicts on the panels,” adding, “That’s not going to encourage consumer confidence in these decisions, or, ultimately, in the product itself.” Merrill Goozner of the Center for Science in the Public Interest said, “This is one of the most controversial calls in medicine to come in a long time. You want two things on this committee: completely objective people and a sufficient number of people skilled in sifting through the data to evaluate the risk.” Peter Lurie, deputy director of Public Citizen’s Health Research Group, said that the Arcoxia advisory panel “is an ideal opportunity for the FDA to demonstrate its seriousness about the proposed rules and simply prevent these people from voting.” FDA spokesperson Kimberly Rawlings said that the agency is following its current conflict-of-interest rules because the new ones are not final. Saag said, “The pending deliberation by the advisory committee represents a drug approval issue of significant public health importance that requires careful deliberation by a multi-disciplinary group of experts.” The other two panel members were unavailable for comment (Los Angeles Times, 4/12).
American Public Media’s “Marketplace Morning Report” on Thursday reported on the market for COX-2 inhibitors and Merck’s application for FDA approval of Arcoxia (Palmer, “Marketplace Morning Report,” American Public Media, 4/12). Audio and a transcript of the segment are available online.
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