Here's USA Today crawling through the mud -- past Janet Woodcock who officially speaks for the FDA -- to talk to David Graham about Avandia:
"This is a warning that's not a warning," said Graham, speaking for himself. "The other thing that's missing is a statement that … there are other alternatives available that work as well as Avandia and don't have this cloud hanging over them."
So Graham wants the FDA to engage in comparative effectiveness which is clearly not it's statutory authority and for which there is no evidence anyways that could be slapped on a label. USA Today runs with this statement instead of the scientific one made by Dr. Woodcock based on the evidence.
No wonder patients are confused and afraid.
http://www.usatoday.com/news/health/2007-11-14-diabetes-heart_N.htm?loc=interstitialskip
"This is a warning that's not a warning," said Graham, speaking for himself. "The other thing that's missing is a statement that … there are other alternatives available that work as well as Avandia and don't have this cloud hanging over them."
So Graham wants the FDA to engage in comparative effectiveness which is clearly not it's statutory authority and for which there is no evidence anyways that could be slapped on a label. USA Today runs with this statement instead of the scientific one made by Dr. Woodcock based on the evidence.
No wonder patients are confused and afraid.
http://www.usatoday.com/news/health/2007-11-14-diabetes-heart_N.htm?loc=interstitialskip