AvandiaGate: A Few Opening Remarks
3 CommentsBy Ed Silverman // June 6th, 2007 // 11:21 am
While viewing the Avandia hearing, you can peruse a few of the submitted statements. The hearing, by the way, started at around 10 am EST and, right now, Andy von Eschenbach, the FDA commish, is fielding questions.
Earlier, John Buse, a University of North Carolina endocrinologist who criticized Avandia, told the commmittee that Glaxo reps said to him in phone calls that “my actions were scurrilous enough to attempt to hold me liable for a loss in market capitalization.” He folded, though, and agreed to work with the drugmaker and signed a statement for distribution to investors.
Andy von Eschenbach, FDA commish;
Moncef Slaoui, Glaxo’s R&D chief;
Steve Nissen, Glaxo’s nemesis;
John Buse, the silenced critic;
Bruce Psaty, an FDA critic.
And this is the FDA medical review of Avandia from 1999.
Insider
Thanks for the link.
Excellent!
Hank
Yikes. Watched most of the “hearing,” although I’m not sure much “hearing” was going on. I am left wondering if rational discussion of these issues - not only Avandia, but FDA reform and the relationships between industry and research - is even possible. Maybe I haven’t watched enough of these “hearings” to develop the requisite immunity from hope.
From a purely “dramatic” point of view, Buse is no whistleblower, but the gray area in which he has found, and put, himself makes it more interesting as a human story. What I really wonder is this: How often do researchers genuinely “cave” under threats? In particular, junior people trying to establish themselves? And how typical is this sort of “vigorous scientific debate” (i.e., you owe us $4 billion)?
I have heard a lot of “war stories” from researchers, many pretty hair-raising. But still I wonder what is normative.
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