BioCentury
ARTICLE | Politics, Policy & Law

Avandia and 9/11

June 4, 2007 7:00 AM UTC

This Wednesday's congressional hearing on GlaxoSmithKline plc's Avandia rosiglitazone will showcase escalating if not demagogue-like criticism of FDA's drug safety oversight, which has been given new life by cardiologist Steven Nissen's selective meta-analysis of small clinical trials that he downloaded from the Internet.

FDA previewed its defense last week, arguing it has acted responsibly in the face of inconclusive data, and GlaxoSmithKline attempted to refute Nissen's analysis. But neither made much headway as the media focused on reports of Avandia's shrinking market share and gave voice to comparisons between the drug and the 9/11 attacks. ...