Friday, February 25, 2005

Conflict of interest in the FDA

So it looks like I was right. There were some previously undisclosed potential conflicts of interest relating to the FDA "endorsement" of the COX-2 inhibitors (Yahoo). Very problematic. If the government and academia doesn't get its act together, the public will have NO reason to trust research results.

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Blogger Gina W said...

Since the enactment of PDUFA, the FDA approval process has an inherent conflict of interest - pharmaceutical companies pay “user fees” to the FDA. A recent NEJM article indicates that such fees may come to approximately $300 million or 18 percent of the current total FDA budget (which would translate to a higher percentage of the drug evaluation budget).

Since studies are not very reliable predictors of the safety of a drug after it comes to market, a much better postmarketing surveillance system is urgently needed.

February 26, 2005 2:16 PM  

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