February 20th, 2010
Senators and FDA Officials Attack Avandia
Larry Husten, PHD
A front page story in the New York Times reports that U.S. Senators and FDA officials are raising new questions about Avandia (rosiglitazone). A soon-to-be-released Senate report asks whether it is ethical to continue the ongoing 16,000 patient TIDE trial, while several FDA officials recommend that the drug should be removed from the market.
In response to the Times story, the US Senate posted the full 334 page staff report and an accompanying (and much shorter) press release. GlaxoSmithKline, the manufacturer of Avandia, rejected the attacks and issued its own press release.
(See the RECORD interim analysis on cardiovascular risk with rosiglitazone in NEJM from 2007, a related meta-analysis by Nissen and Wolski, and this summary of the research from Journal Watch General Medicine.)
One Response to “Senators and FDA Officials Attack Avandia”
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incredible story
This is an incredible glimpse of how a company defends a franchise rather than fully disclose their data and impressions. What can we do to address this type of behavior. I am really disappointed to see that the company tried to undermine and discredit and intimidate people who were stating concerns about safety — in many cases, the same concerns being expressed internally by company experts and advisors.