Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, says that FDA denial of his group's petition to ban the weight loss drug Meridia is misguided.
In a statement on the Internet, Wolfe says: "For a drug such as Meridia to be approved or for it to stay on the market, there must be evidence that its benefits outweigh its risks. Evidence prior to its approval and more than 50 cardiovascular deaths, many in young people, since its approval confirm that its benefits do not outweigh its risks and that it should be removed from the market despite efforts by the FDA/Abbott duo to keep the drug alive."
The statement concludes: "Once again, the FDA is siding with a large drug company, much as the agency did several years ago with Merck concerning Vioxx, when it failed to demand a black box warning on that drug. How many more dangerously flawed decisions will the FDA make before the Congress repeals the Prescription Drug User Fee Act, which brings the agency ever closer to – and makes the agency less vigilant over – the companies that give it almost $200 million a year in funding?"
Posted by schwitz at August 18, 2005 10:22 AM | TrackBackThanks.
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