The New York Times reports:
A leading diabetes doctor sent the Food and Drug Administration a letter seven years ago that warned of the heart risks of the drug Avandia. And in the next year, the F.D.A. reprimanded the drug’s maker for playing down safety concerns, according to documents from 2000 and 2001.The documents, found in a reporter’s search of the F.D.A.’s database, indicate that the agency had been warned of safety concerns with the Type 2 diabetes treatment Avandia, and that the drug’s maker, GlaxoSmithKline, was seeking to minimize Avandia’s risks, before some of the same cardiovascular concerns were brought to public attention on Monday in an article and an editorial in The New England Journal of Medicine. ...
In his letter to the agency, dated March 15, 2000, Dr. (John) Buse (incoming American Diabetes Association president) was highly critical of the drug maker’s marketing of Avandia, accusing the company of “pervasive and systemic” efforts to play down the drug’s risks and overstate its benefits.
In the Wall Street Journal, Buse is quoted as warning of "rampant abuse of clinical trial data" by then-maker SmithKline Beecham, saying the company "may have overstated the safety of the drug."
This is why I howl when I read stories from all over the country that seem to downplay long-term safety issues with new drug approvals - as with yesterday's glowing news all over the country about approval of Lybrel - a new oral contaceptive that promises to stop menstrual periods. Some newspapers (the Washington Post and the Minneapolis Star Tribune were two I saw) made this front page news. Many stories just flat failed to mention that many women dropped out of the Lybrel trials because of breakthrough bleeding or spotting. So, as some experts have pointed out, women may be trading scheduled bleeding for unscheduled bleeding. Perhaps we should ask those dropout women which they would rather have. There's a reason they dropped out. That didn't show up in much news coverage and that won't show up on Lybrel's labeling or TV ads.
How gullible we are. When will we learn?
Posted by schwitz at May 24, 2007 08:48 AM | TrackBack