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Page: << Prev | 1 | 2 | 3 Controversy over FDA advisory board appointees has increased over the past few years, most notably over the approval and subsequent withdrawal of cox-2 inhibitor prescription painkillers.
According to a 2006 report in the New York Times, 10 of the 32 FDA advisory committee members who voted at that time to allow the continued sale in the United States of the three painkillers -- Bextra, Celebrex and Vioxx -- had previously acted as consultants for the drugs' manufacturers. If these members had not voted, the recommendations would have been for Bextra to be withdrawn and Vioxx to not be returned to the market, the Times said.
As it was, panel advisors with company ties voted overwhelmingly for Bextra to stay on the market and for Vioxx to return to pharmacy shelves. Celebrex would not have been affected.
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Both Bextra and Vioxx remain off U.S. drug store shelves, however. Vioxx was pulled in September 2004, after studies linked long-term use to cardiovascular trouble. Similar data prompted the withdrawal of Bextra from the market in April 2005. Celebrex remains available to consumers.
A study published last April in the Journal of the American Medical Association added more fuel to the debate. In that study, researchers examined agendas and transcripts from all FDA drug advisory committee meetings listed on the agency's Web site as taking place between Jan. 1, 2001, and Dec. 31, 2004.
A total of 221 meetings held by 16 advisory committees were included in the analysis. In almost three-quarters (73 percent) of the meetings, at least one committee member or voting consultant disclosed a conflict, yet only 1 percent of committee members disqualified themselves from participation, the study found.
Lurie said he is concerned that, even after Wednesday's announcement, nonvoting members will still have some impact on FDA panels. But he believes that their status as nonvoting members will also become a kind of stigma that the voting members will take into account, he said.
In addition, this change will make recruiting people without conflicts of interest more desirable, according to Lurie. "And that's as it should be," he said.
More information
For more information on FDA advisory committees, visit the U.S. Food and Drug Administration.
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