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December 09, 2004
Can Money in Politics Kill You? This latest Ouch! from Public Campaign asks, can money in politics kill you? "A look at what has happened at the Food and Drug Administration (FDA) ever since the pharmaceutical industry started pushing to loosen the agency’s process for reviewing the safety of new drugs suggests the answer is yes." In our chapter on drug safety, we documented how pressure throughout the 1990s from the drugmakerspowered by tens of millions in targeted campaign contributions and hundreds of lobbyistsled the FDA to approve twice as many new medications in half the time they used to take, allowing several deadly drugs onto the market where they have since been linked to the deaths of over 1,000 patients... According to David Graham, the associate director of the FDA’s office of drug safety, between 88,000 and 139,000 Americans probably experienced heart attacks or strokes after taking Vioxx, and 30 to 40 percent probably died. That’s anywhere between 26,400 and 55,600 people whose lives were prematurely ended. Even if Graham’s estimate exaggerates the drug’s deadly effects by a factor of ten, that’s still a death toll that matches or exceeds those killed on September 11, 2001... Though questions about Vioxx first arose in 2000, a year after it was made available in the US, little action was taken by the FDA until recently because the drug industry had so successfully shifted the agency’s priorities. Under that pressure, Monday’s New York Times reported, the FDA had “slash[ed] its laboratories and network of independent drug safety experts in favor of hiring more people to approve drugs.” Back in 2001, Public Citizen’s Health Reform Group warned that problems with Vioxx were more prevalent than Merck admitted, and criticized the company for not doing long-term studies comparing it to older, more proven drugs. The consumer group put the drug on its “DO NOT USE” list. But the FDA only sent the company a warning letter for running ads for Vioxx that didn’t mention the fact that patients taking it had five times as many heart attacks as patients taking a different pain reliever, naproxen. Merck preferred to tout research by its own employees and paid consultants claiming that Vioxx was safe and by sponsoring talks at national medical meetings aimed at selling doctors on the drug’s value. The Times story shows that the FDA’s failure to police Vioxx’s dangers more thoroughly was part of a larger pattern of inattention. “Dozens of former and current FDA officials, outside scientists, and advocates for patients say that the agency’s efforts to monitor the ill effects of drugs that are on the market are a shadow of what they should be,” the Times’ Gardiner Harris reported...
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