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Conflict of Interest Again

by Dr. Randy

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Two New York Times writers have blown the whistle on a government committee that voted to keep three controversial painkillers on the market. Vioxx, Celebrex, and Bextra will all be stocked on pharmacists’ shelves thanks to the vote of 32 advisers on the FDA advisory panel. Ten of those advisers have ties to the drug industry. According to the Times reporters, if those “10 advisers had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market. The 10 advisers with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx’s return.”

Only one committee member voted to withdraw Celebrex despite a recent study that connected the drug to life-threatening heart trouble. That study found that those who took 400-800 mg. of Celebrex a day were 2.5 times more likely to develop a major heart problem than those who took placebo. Vioxx was previously removed from the market after its association with heart attacks and strokes was finally revealed.

Data from clinical trials by Merck, the drug’s manufacturer showed that between
88,000 and 139,000 Americans probably have had heart attacks or strokes as a result of taking Vioxx, and that 30 to 40 percent probably died, according to David Graham, a highly placed FDA official. David J. Graham, associate director of the Office of Drug Safety, testified about the toxicity of Vioxx and several other drugs before a Senate panel. He suggested that Bextra, Crestor (the cholesterol-lowering drug), Accutane (acne), and Serevent (asthma) should all be restricted because they have dangerous side effects. Graham called the FDA’s handling of Merck & Co.’s Vioxx a profound regulatory failure. Graham also said that “the FDA as currently configured is incapable of protecting America against another Vioxx.” His statements in November 2004 proved to be prophetic. Vioxx, Celebrex, and Bextra have all been given a seal of approval from the FDA advisory panel.

Gardiner Harris and Alex Berenson, 10 voters on panel backing pain pills had industry ties, New York Times, Feb. 25, 2005.

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