Today's hearing was supposed to be Steve Nissen and Henry Waxman's grand unveiling of a new master plan for FDA reform. Instead it was an embarassing examination of how Nissen's effort to explain away why he went to Congress (rather than the FDA) with a preliminary analysis of Avandia.
Now of the more zealous critics of the FDA are now left hanging out to dry by Nissen's own measured statements about not recommending that any doctor stop prescribing or not prescribe Avandia on the basis of his study. Of course to say that totally contradicts his claim that Avandia was "worse than 9/11" is an understatment. Too bad the head of GSK research didn't have the chance to take him head on. CMPI will try to offer him that opportunity as well as the researchers of the RECORD study.
That did not stop Bruce Psaty from waving the bloody shirt of safety at the hearings, though he was reduced to irrelevancy by the end.
One by one the safety extremists are marginalizing themselves. Dr. Nissen was alternately defensive, evasive and hesitant.
Now of the more zealous critics of the FDA are now left hanging out to dry by Nissen's own measured statements about not recommending that any doctor stop prescribing or not prescribe Avandia on the basis of his study. Of course to say that totally contradicts his claim that Avandia was "worse than 9/11" is an understatment. Too bad the head of GSK research didn't have the chance to take him head on. CMPI will try to offer him that opportunity as well as the researchers of the RECORD study.
That did not stop Bruce Psaty from waving the bloody shirt of safety at the hearings, though he was reduced to irrelevancy by the end.
One by one the safety extremists are marginalizing themselves. Dr. Nissen was alternately defensive, evasive and hesitant.
