Healthy Skepticism Library item: 11259

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Tanne JH.
FDA needs more funding, NEJM says, amid questions about antidiabetes drug
BMJ 2007 Aug 18; 335:(7615):322
http://www.bmj.com/cgi/content/full/335/7615/322

Abstract:

The US Food and Drug Administration needs more funding to do its job, say two articles in the New England Journal of Medicine (NEJM) related to reports of an increased cardiovascular risk associated with rosiglitazone (marketed as Avandia), used to treat type 2 diabetes.

Earlier this year the FDA placed its most serious “black box” warnings on rosiglitazone, which is made by GlaxoSmithKline, and pioglitazone (Actos), made by Takeda, saying that they increased the risk of congestive heart failure (BMJ 2007;334:1237 doi: 10.1136/bmj.39244.394456.DB).

Clifford Rosen, who chaired the FDA advisory committee that looked into the drug, has written a commentary in the NEJM (doi: 10.1056/NEJMp078167). “The basic plot of the rosiglitazone story quickly became obvious to the . . . committee: a new ‘wonder drug,’ approved prematurely and for the wrong reasons by a weakened and underfunded government agency subjected to pressure from industry, had . . .