FDA Avandia rules may driven by politics

by Anne Zieger on September 30, 2010

Pharmaceuticals

Is Avandia propped up by political pressure?

If the stats on its clinical risks are so negative, why is diabetes drug Avandia still on the U.S. market? Well, according to blogger John Mack, a pharma industry insider who keeps a close eye on these things, the answer may have more to do with politics than medicine.

As things stand, European regulators have completely banned the sale of Avandia.  Meanwhile, the FDA has merely put restrictions on the sale of the drug.

This is the position of powerful “drug chief” Janet Woodcock, who argues that the evidence against the drug’s safety wasn’t conclusive.  She has argued that since FDA scientists are bickering over Avandia’s safety, it’s not a good idea to ban it. Apparently, Commissioner Margaret Hamburg gave Woodcock and her supporters their way.

According to Mack, what we’re seeing here is Woodcock kissing up to the pharma industry, which is pouring buckets of money into the GOP to defeat Obama in 2012.  And if the GOP succeeds, it’s likely to help put Woodcock in the FDA’s top role.

The analysis makes sense to me, readers.  I wish I had the clinical training to know whether Avandia really is a major threat.

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