WASHINGTON — Ten members of the Food and Drug Administration advisory panel that voted to allow a group of powerful painkillers to be sold despite safety concerns had ties to the drug makers, an advocacy group says.
A study by the Center for Science in the Public Interest indicates that the members in question had ties to either Pfizer or Merck, ranging from consulting fees and speaking honoraria to research support. Documents show that, without their votes, the panel would have recommended that Pfizer's Bextra and Merck's Vioxx not be sold in the United States.
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 Bextra and 17-15 for Vioxx.
A copy of the transcript indicated that the 10 members in question voted unanimously in favor of keeping Celebrex and Bextra available and 9-1 in favor of allowing Vioxx to be brought back onto the market.
Merck pulled Vioxx from the market Sept. 30 after heart problems were reported in some users. Similar questions were raised later about the other two drugs, prompting the FDA to have the advisory panel look into the matter.
The industry ties of the panel members were first reported yesterday by The New York Times.
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.
Because drug companies fund many studies, it is not unusual for researchers to have ties to manufacturers, although some have questioned the practice.