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FDA Panel Members Indebted to Drug Companies

February 25, 2005

• FDA Toughens Advisory Committee Guidelines • Ex-FDA Chief Pleads Guilty to Conflict Of Interest Charges • FDA Promises More Transparency In Advisory Process • Study Finds Conflicts of Interest at FDA • Health Advocates Urge Reform of FDA Advisory Committees • Former Prozac Users Slam FDA • FDA Panel Members Indebted to Drug Companies

Ten of the 32 Food and Drug Administration (FDA) advisers who voted to continue marketing Vioxx, Bextra and Celebrex have been paid consultants for the drugs' manufacturers in recent years, The New York Times reported.

The Times said its calculations found that if the 10 advisors had not voted, the panel would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market.

The 10 advisors with industry ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx' return, the Times said.

Several of the panel members said that, in fact, the consulting funds had gone not to them but to their universities or institutions. Nevertheless, the issue of FDA advisors having ties to drug manufacturers has long been an issue.

The Times analysis found that 10 members of the advisory panel have worked in some capacity in recent years for Merck, Pfizer or Novartis, the three companies with the biggest stakes in the COX-2 safety debate. Merck makes Vioxx, Pfizer Celebrex and Bextra and Novartis is applying to sell Prexige, a similar COX-2 painkiller.

One of the panel members with no financial ties to any of the companies is Dr. Curt Furbery, an epidemiologist at Wake Forest University. He told the Times he was "uncomfortable with the Pifzer-friendly undertone" at the panel meetings.

"Fifty patients a day probably die from these drugs and who is speaking for them?" Furberg asked.

Merck withdrew the anti-inflammatory drug Vioxx from the market last year after it showed a twofold increase in serious cardiovascular events. Lawsuits rained down on the company and its stock price plummeted.

FDA scientist David Graham, who believes the drug caused more than 80,000 heart attacks and strokes in the United States since its 1999 launch, has said he was disappointed with the FDA panel's decision.

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