A agência Bloomberg que informa que a comissão que analisará o caso Avandia para o FDA é composta seis médicos com conflito de interesse em relação ao medicamento, conforme o texto da agência. O mesmo problema ocorreu na análise do Vioxx e Bextra pelo FDA.
July 16 (Bloomberg) -- Six doctors with financial ties to the pharmaceutical industry, including stock holdings or speaking fees, will be among members of a U.S. advisory panel on the use of a GlaxoSmithKline Plc diabetes medicine linked to heart risks.
The doctors will discuss the safety of the drug, Avandia, and similar treatments at a July 30 meeting convened by the Food and Drug Administration. As many as four of the six doctors with conflicts may vote on recommendations to the FDA, according to financial disclosure documents released by the agency. The agency wouldn't say how many members the committee will have. The FDA lets too many doctors with financial conflicts serve as advisers, lawmakers and consumer advocates say. Panelists with industry ties have backed drugs including Vioxx, the Merck & Co. painkiller that was withdrawn in 2004 after being linked to heart attacks and strokes. Legislation approved by the House last week would permit only one person with a financial conflict to vote on drug recommendations. ``They shouldn't appoint people with conflicts of interest,'' said Merrill Goozner, director of the Integrity in Science project at the Washington-based Center for Science in Public Interest, in an interview. ``The public perception of the evenhandedness of the process will be immeasurably enhanced if they appoint only people who do not have conflicts.'' To allow the doctors to participate in the Avandia review, the FDA is waiving rules that bar panelists with financial conflicts. Regulators, who routinely issue the waivers, say researchers often consult for drugmakers or have other ties and aren't swayed by those connections.
The doctors will discuss the safety of the drug, Avandia, and similar treatments at a July 30 meeting convened by the Food and Drug Administration. As many as four of the six doctors with conflicts may vote on recommendations to the FDA, according to financial disclosure documents released by the agency. The agency wouldn't say how many members the committee will have. The FDA lets too many doctors with financial conflicts serve as advisers, lawmakers and consumer advocates say. Panelists with industry ties have backed drugs including Vioxx, the Merck & Co. painkiller that was withdrawn in 2004 after being linked to heart attacks and strokes. Legislation approved by the House last week would permit only one person with a financial conflict to vote on drug recommendations. ``They shouldn't appoint people with conflicts of interest,'' said Merrill Goozner, director of the Integrity in Science project at the Washington-based Center for Science in Public Interest, in an interview. ``The public perception of the evenhandedness of the process will be immeasurably enhanced if they appoint only people who do not have conflicts.'' To allow the doctors to participate in the Avandia review, the FDA is waiving rules that bar panelists with financial conflicts. Regulators, who routinely issue the waivers, say researchers often consult for drugmakers or have other ties and aren't swayed by those connections.
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