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Panelists in FDA Drug Vote Tied to Makers


Ten Members of FDA Advisory Panel Who Voted to Keep Drug on Market Had Ties to Makers, Report Shows


The Associated PressThe Associated Press

WASHINGTON Feb 25, 2005 — Ten members of the Food and Drug Administration advisory panel who voted that a group of powerful pain killers should continue to be sold had ties to the drug makers, an advocacy group says.

A study by the Center for Science in the Public Interest indicates that 10 of the 32 panel members had ties to either Pfizer Inc. or Merck & Co., ranging from consulting fees and speaking honoraria to research support.

The FDA issued a statement saying it screened members of the panel for conflicts of interest. "This transparent process requires the agency to carefully weigh any potential financial interest with the need for essential scientific expertise in order to protect and advance the public health," the agency said.

After three days of hearings on the drugs, known as Cox-2 inhibitors, the panel voted 31-1 to keep Pfizer's Celebrex on the market, 17-13 with 2 abstentions in favor of Pfizer's Bextra and 17-15 that Merck's Vioxx should be allowed back on sale.

Merck pulled Vioxx from the market Sept. 30 after heart problems were reported in some users. Similar questions were later raised about the other two drugs, prompting the FDA to call the advisory panel to look into the matter.

Since drug companies fund many studies it is not unusual for researchers to have ties to manufacturers, though some have questioned the practice.

The transcript, including the votes by the individual members of the panel, has not yet been posted by the FDA. However, a copy obtained by The Associated Press indicated that the 10 panel members in question voted 10-0 in favor of keeping Celebrex and Bextra available and 9-1 in favor of allowing Vioxx to be brought back onto the market.

Without those ballots the vote would have been 13-7 in favor of withdrawing Bextra and 14-8 to keep Vioxx off sale.

The industry ties of the panel members were first reported Friday by The New York Times.