July 26, 2007
"Considerable Concern" at FDA About Avandia
(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.)
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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?
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