Avandia 2: Ethical Boogaloo?


GSK is coming under serious fire again from the FDA and Senate, who say the company resorted to scientific flimflammery to keep researchers quiet about Avandia's safety risks.

It seems like only yesterday Glaxo was fending off accusations that said its diabetes drug Avandia (rosiglitazone) led to an increased risk of cardiovascular problems. So don’t worry if the current Avandia brouhaha leaves you with an unshakable sense of déjà vu. This time, it was a Senate Finance Committee report that’s doing the damage.

But in fact it was two and a half years ago when FDA medical reviewer David Graham started calling for the drug’s removal from the market. GSK countered that it had been looking into potential safety issues throughout Avandia’s tenure on the market, and there were no conclusive studies linking the drug to increased incidence of heart attacks. The FDA slapped the drug with a black box warning and made GSK start another study of the potential link, and that seemed to be that. But apparently it wasn’t all “that.”

In a letter to FDA Commissioner Margaret Hamburg, committee chairman Sen. Max Baucus (D-MT) and ranking member Sen. Chuck Grassley (R-IA) wrote: “The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.”

And it only gets worse from there. The committee found that GSK execs “intimidated independent physicians,” used ghostwriters for academic studies, and misrepresented data from their own studies. There’s even a recording of a 2007 meeting between four GSK execs and Steven Nissen (Chair of Cardiovascular Medicine at the Cleveland Clinic) that supports those allegations. According to Nissen, the recording shows GSK was trying to bluff him into killing a journal article that would have negative consequences for the company.

The evidence seems pretty damning, but GSK is insists that those “intimidation” calls to researchers and their superiors were meant to merely establish communication channels and encourage collaboration. It denies any conscious effort to squelch particular studies. Furthermore, in a statement released February 20, the company alleges that the meta-analyses used in the Senate report are scientifically invalid, and the report itself relied on cherry-picking.

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