Ten members of the Food and Drug Administration advisory panel who voted that a group of COX-2 inhibitors should continue to be sold had ties to the drug makers, a new analysis shows.
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 receiving research support from the companies.
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.
Celebrex, Bextra and Vioxx are part of a family of drugs called COX-2 inhibitors. The drugs were designed to ease pain as effectively as older, nonprescription drugs, while being easier on the stomach.
Most panel members felt all three drugs should have “black box” warnings — the strongest warnings used for prescription drugs — explaining their heart risks.
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, The New York Times reported its own analysis in Friday editions, indicating that the 10 individuals in question voted 9-1 in favor of allowing the drugs to be sold.
Without their votes, the Times said, the result would have been 12-8 to recommend withdrawing Bextra and 14-8 to keep Vioxx off the market.
