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.



Blogger GW 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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