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21: Delay in Recalling Vioxx Points to Problems in FDA Approval Process

By Jocelyn SelimJanuary 3, 2005 6:00 AM


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In September Merck & Co., one of the world’s largest pharmaceutical manufacturers, yanked its anti-inflammatory painkiller Vioxx, a drug used by millions of arthritis sufferers. The recall followed a report in September that the drug, first introduced in 1999, doubled the risk of heart attacks, strokes, and blood clots.

Critics subsequently charged that evidence of cardiovascular complications from Vioxx had been established four years ago, in a small company-funded study, but the results were glossed over in a report to the Food and Drug Administration. In the meantime, Merck spent $100 million a year on consumer advertising for the drug—more than Pepsi spent for its cola—and published more company-funded studies that obscured potentially deadly side effects.

John Abramson, a clinical instructor in primary care at Harvard Medical School and author of Overdo$ed America: The Broken Promise of American Medicine, argues that the delay in recalling Vioxx highlights problems with the entire process by which drugs are tested and approved: “You wouldn’t let a pro football team hire its own referees and then expect unbiased decisions, but that’s effectively what happens in the majority of studies required by the FDA. The odds are five times greater that a study sponsored by a drug company will support its own product than would a noncommercially funded study. To me, that says bias.”

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