As usual with reports from Sens. Chuck Grassley and Max Baucus, the Avandia probe released over the weekend has opened a big can of worms. It's not that there's new data to look at, but that they've pulled back the curtain on Avandia, revealing troubling internal emails and reports at FDA and GlaxoSmithKline, which makes the drug.
But the curtain has been pulled back even farther now: Dr. Steven Nissen, who wrote that original study raising questions about Avandia's cardiovascular safety, has released an audiotape of a meeting he had with four Glaxo executives just before that study was published. Unbeknownst to him at the time, at least some of those executives had actually already read his work, because someone at the New England Journal of Medicine had leaked it to the company.
The taped meeting raises several questions, not the least of which is whether Glaxo was trying to persuade Nissen to quash his study. Why hasn't Glaxo done more to re-analyze the safety of Avandia, given that those executives promised Dr. Nissen almost three years ago that they would?
Now it's the job of FDA to untangle all those worms. And the agency must answer to critics who say it should have pulled Avandia off the market already, or at the very least should do so now while it and its expert advisors re-analyze the safety data. (FDA says it's proceeding as planned with its analysis.) Meanwhile, GlaxoSmithKline is vociferously defending itself, saying that there's no conclusive evidence linking the diabetes drug to increased heart attacks and strokes. And some are saying this sort of dust-up shows FDA needs more power to force drugmakers to do big outcomes trials. What do you think?