Monday, July 30, 2007
The New York Times reports on the FDA's recent results from testing Avandia, a diabetes drug.
A federal drug safety official recommended during an advisory committee hearing today that Avandia, a controversial diabetes medicine made by GlaxoSmithKline, be withdrawn from the market because it increases heart risks.
Dr. David Graham noted in a written preview of his presentation that Avandia is no better at controlling blood sugar levels than similar diabetes medicines like Actos, made by Takeda. With a clear risk to the heart, and nothing to recommend it over other therapies, Avandia should be withdrawn, Dr. Graham argued in written remarks.
Dr. Graham is scheduled to speak to the committee later today. But it is not clear that the advisory committee, or indeed the Food and Drug Administration itself, will agree with Dr. Graham, a drug safety official at the F.D.A. who has a long history of arguing against the use or marketing of some widely-used drugs.
The committee may instead recommend that Avandia’s label include stronger warnings about its heart risks.
A committee vote is scheduled for later this afternoon.
Ezra Klein points to a recent article in the New Republic (subscribe free) by Arnold Relman detailing some of the operations of America's pharmaceutical companies. At least one commenter is critical of some of the research and notes that other industries do not face the same scrutiny that the pharmaceutical companies do.