Monday, February 28, 2005

Did FDA Cox 2 Panel have 10 Industry ringers on it?

Ten of the 32 U.S. advisers who supported future sales of pain relievers Celebrex, Bextra and Vioxx have consulted in recent years for the drug makers, according to a consumer group analysis of medical journals and other records.

Ten panelists were paid consultants for Pfizer or Merck, according to the consumer group Center for Science in the Public Interest (CSPI).

If those 10 panelists had not voted, the committee would have rejected future sales of Bextra and Vioxx. The Celebrex vote would not have changed because all but one member supported keeping that drug on the market.

The analysis sparked more congressional concerns over the FDA and its policing of drug safety.

"Tthe votes ... are now, justly or unjustly, tainted," said Iowa Republican Sen. Charles Grassley, chairman of the Senate Finance Committee.

The CSPI analysis, first reported by the New York Times, cited references from financial disclosures in medical journals and in public databases such as

Each of the 10 advisers with industry ties voted to keep Bextra on the market. Nine of them voted to let Vioxx be sold again. Merck withdrew Vioxx last September after a study linked the pain reliever to heart attacks and strokes.

If those 10 members had not cast their votes, the committee would have voted 13-7 to recommend that Bextra be withdrawn and 14-8 that Vioxx should not return to the market.

Comment: Is it any surprise in the least that the panel had 10 "professionals" who were paid by Merck for writing about it's products? Thank goodness a Republican was outraged about it.