Wednesday, May 23, 2007
Glaxo's Agreement to Disclose Publicly Clinical-Trial Results Lead to Finding of Avandia Risk
Article in the New York Times -- For Drug Makers, a Downside to Full Disclosure, by Barry Meier. Here's an excerpt:
When GlaxoSmithKline settled a lawsuit three years ago with the State of New York over the antidepressant medication Paxil, the company agreed to take an unusual step: publicly disclosing the results of its clinical trials for Paxil and other drugs.
The company, which was criticized at the time for failing to publicize all pediatric trials of Paxil, not just the positive ones, made good on its promise. The first posting on a new Web site was about 65 studies involving its popular diabetes drug, Avandia.
This week, GlaxoSmithKline learned what that greater disclosure could mean.
A cardiologist at the Cleveland Clinic, Dr. Steven Nissen, stumbled onto the Glaxo Web site while researching Avandia last April. He and a colleague quickly analyzed the data, and on Monday, The New England Journal of Medicine released its finding that Avandia posed a heightened cardiac risk.
“It was a treasure trove,” Dr. Nissen said about the Web site.