Vioxx, Celebrex, Bextra Recall News

Tuesday, May 03, 2005

FDA incapable of drug safety in America

In an excellent article by Michael Scherer published on Mother Jones, one starts to get really worried about how dangerous the alliance between the FDA and the drug industry is. The article is really about Dr. David Graham who did his best to save American lives by speaking about the dangers of drugs like Vioxx, Celebrex, Bextra, Accutane, etc. But what the article really talks about how American lives are being risked so that the pharmaceutical firms can increase their profits.

Vioxx was recalled in September 2004 by Merck when it was no longer possible to hide the fact that Vioxx was killing people. Merck successfully hid the dangers for years but at that time the evidence was overwhelmingly against it. But in August of 2004, Dr. David Graham was asked to stay quiet by his bosses, particularly Dr. John Jenkins and Anne Trontrell, when he said that Vioxx was too dangerous to be sold in America. The agency soon approved Vioxx for children.

The FDA tried to discredit Dr. Graham and his work. Dr. Steven K. Galson, the acting director of the drug-evaluation division at the FDA, called Graham’s work as “junk science.” Then he sent an email to an editor at the The Lancet, a medical journal, arguing that his data was not reliable. The FDA’s acting commissioner, Dr. Lester Crawford, in a press release, criticized Graham for evading the agency’s “long-established peer review and clearance process.” Another official made calls to at least one Senate staffer, disparaging Graham personally and professionally. At this point Dr. Graham was already a celebrity and several senators intervened as he fought to keep his job. (Related article: Vioxx and Bextra recall expose the mess at the FDA)

In a testimony before Congress, Dr. Graham pointed out that tens of thousands of Americans are dead after taking Vioxx, though Merck still refuses to accept responsibility for even one death. This may be a good time for Americans to think how far they really want to take the idea of "small government." Since the FDA can not function without the money that comes from the drug industry, it is hard for the agency officials to monintor the very same people who write their paychecks. In a survey of FDA scientists by federal investigators, two-thirds of the scientists agreed that the FDA is not capable fo monitoring the safety of drugs in America. So it sounds rather ironical that the FDA makes such a big deal about importing prescription drugs from Canada and how dangerous they are.

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