Here's the Washington Times editorial page on the subject of Waxman and Nissen (along with Furberg and Psaty) as a defacto FDA:
"Dr. Nissen thus used his prominence and ties to Mr. Waxman and the media in order to engage in what one pundit has called drug safety vigilantism. So, while the media and Mr. Waxman have put Avandia, the FDA and drug companies on trial (once again) the real question is: Do we want Mr. Waxman and those he has anointed to usurp the authority of the FDA and scuttle proposed improvements to the current approach to regulation?
The Waxman-Nissen approach is clear: Come up with possible safety problems with questionable statistical approaches; share them with friendly members of Congress and editorialists who will use the findings to attack the FDA; hold hearings in order to put companies on the defensive and generate more lawsuits. "
Here's a link to the entire editorial:
http://washingtontimes.com/op-ed/20070605-092645-7468r.htm
"Dr. Nissen thus used his prominence and ties to Mr. Waxman and the media in order to engage in what one pundit has called drug safety vigilantism. So, while the media and Mr. Waxman have put Avandia, the FDA and drug companies on trial (once again) the real question is: Do we want Mr. Waxman and those he has anointed to usurp the authority of the FDA and scuttle proposed improvements to the current approach to regulation?
The Waxman-Nissen approach is clear: Come up with possible safety problems with questionable statistical approaches; share them with friendly members of Congress and editorialists who will use the findings to attack the FDA; hold hearings in order to put companies on the defensive and generate more lawsuits. "
Here's a link to the entire editorial:
http://washingtontimes.com/op-ed/20070605-092645-7468r.htm
