Monday, April 11, 2005

Hidden Panel

"Was Painkiller Panel Stacked?" That question was posed by the headline of a CBS online report that took a close look at the FDA advisory panel that voted to allow the pain-killing drugs Vioxx, Celebrex and Bextra to stay on the market. So, WAS the panel stacked? Does Popeye love his spinach? In the alert "Hasty Pudding", we looked at some of the "finer" points of the advisory panel's decision. And now we're getting a revealing look at the panel itself. According to CBS News, 10 of the 32 panelists had financial ties to Pfizer (the maker of Celebrex and Bextra), Merck (the maker of Vioxx) or Novartis, a company that has submitted an application with the FDA for yet another brand in this class of drugs. The Novartis drug is called Prexige, and how that might be pronounced is anybody's guess. (With any luck we'll never find out.) CBS reports that the 10 "connected" panelists voted 9 to 1 in support of keeping Bextra on the market. They also voted 9 to 1 to allow sales of Vioxx even though Merck pulled Vioxx off the market last fall after a study showed that heart attack and stroke risk were doubled when taking the drug. If these 10 "experts" had not been drafted for the panel, neither Bextra nor Vioxx would have received enough votes to get the panel's thumbs up. Celebrex did better in the voting because, despite studies that have shown it to also increase heart attack risk in higher doses, the perception is that it's not as dangerous as Vioxx or Bextra. Nevertheless, sales of Celebrex have dipped. No surprise there really. But executives at Pfizer and Merck can't be too upset. After all, the panel didn't vote to pull the drugs altogether. And in the days since the lenient decision from the panel was announced, stock prices for Pfizer and Merck have been climbing. So everybody wins! Well, not everybody. The consumers of these drugs are surely wondering where the truth is among all the mixed signals. Curt Furberg, M.D., was one of the panel members who did not have any drug company ties. He told the New York Times that during deliberations, he didn't feel comfortable with "the Pfizer-friendly undertone" of the meetings. By Dr. Furberg's estimate, as many as 50 people each day may die as a result of taking these drugs. He posed this question to the Times, "Who is speaking for them?" The answer: David Graham, the associate science director of the FDA's Office of Drug Safety. In a controversial testimony before Congress last fall, Mr. Graham named several popular drugs that should be avoided because of safety concerns. Bextra was one of those drugs. Previously, Mr. Graham also presented evidence that Vioxx increased stroke and heart attack risk. But Mr. Graham says he encountered considerable resistance from FDA officials who didn't want him to publicize his findings. According to an Associated Press report, he told the Congressional committee that when safety questions arise regarding drugs already approved by the FDA, the agency responds with "denial, rejection and heat." And he could add to that list: stacked panels.


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