Did drugmaker GlaxoSmithKline conceal suicide risks for users of its antidepressant Paxil within the mountains of data it submitted to the FDA? That's a question Sen. Chuck Grassley (R-Iowa) would like to see answered, and in some detail. Grassley would like to find out who within Glaxo knew what, and when, about the medicine's possible link to increased suicidal behavior. In his correspondence with the FDA and HHS Secretary Michael Leavitt, Grassley notes that the U.K. recently concluded that the firm withheld safety information when submitting data for approval in Europe. Now, he wants to know whether Glaxo did the same in the U.S. In testimony on the Senate floor, Grassley noted that a report by one Harvard researcher contends that Glaxo probably knew about Paxil safety concerns all the way back in 1989, when it first asked the FDA for approval--and that it probably manipulated studies to diminish the perceived risk.
To learn more about Grassley's concerns:
- read this Wall Street Journal blog entry
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