A question of disclosure
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 made good on its promise. The first data it posted on a new Web site: 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, Steven Nissen, stumbled onto the Glaxo Web site while researching Avandia last April. He and a colleague quickly analyzed the data, and Monday, the New England Journal of Medicine released its finding that Avandia posed a heightened cardiac risk.
The episode is likely to fuel efforts to require makers of drugs and medical devices to publicly disclose study results.