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Thursday, July 26, 2007

"Considerable Concern" at FDA About Avandia

Pharmalot has a good overview of the situation, though I question the wisdom of declaring it "AvandiaGate" at this stage. Addition: DrugWonks has an interesting excerpt from the Glaxo submission.

--BC

(As usual: I do a small amount of work for pharmaceutical clients.  I have not represented Glaxo, though I've had clients be co-defendants with them.)

http://lawprofessors.typepad.com/tortsprof/2007/07/considerable-co.html

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Comments

Hey Bill,

I've been referring to the mess as AvandiaGate since it broke, simply because of the confusion over the availability and accessibility of data. Seemed a bit murky at the time (no pun intended, really), and the headline just stuck. Maybe the next one will NissenGate. Who knows?

Cheers
ed

Posted by: ed | Jul 26, 2007 5:43:00 PM

Reasonable enough. I tend to think that "-gate" gets added to words rather quickly; in this case, even the editorial authors in the journal weren't ready to say you could reach conclusions from the data, which were themselves fairly murky.

Not intended as a slam on you, of course.

Posted by: Bill Childs | Jul 26, 2007 6:13:31 PM

For an interesting set of articles on the evolving Avandia issue and drug safety in general as well as the Patent Reform Bill of 2007, see http://blog.aesisgroup.com/.

Posted by: Ogan Gurel | Jul 27, 2007 10:56:41 AM

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