May 23, 2007GSK’s settlement of Paxil suit led to Avandia revelations
Most drug companies are very judicious about the scientific data they give out, emphasizing the positive and downplaying (if not hiding) the negative. So why would GlaxoSmithKline post the results of 65 studies that involved its popular diabetes drug Avandia? The data it contained was not altogether flattering.GSK took this unusual step due to the settlement terms of a 2003 lawsuit over Paxil, its antidepressant drug. The company agreed that it would henceforth publicly reveal the results of clinical trials—both for Paxil and for other drugs.
Widely criticized for hiding negative data about children taking Paxil, GSK followed through on its promise. Avandia was the subject of the first posting on a new website, and the company would soon learn what full disclosure meant.
Dr. Steven Nissen of the cardiology department at the Cleveland Clinic found the GSK website and realized its value. He and a colleague meta-analyzed the data, and their results were that Avandia posed an elevated risk for heart problems and heart attacks. The data and conclusions were recently published in the New England Journal of Medicine, and an accompanying editorial expressed agreement.
There were quick and strong repercussions. GSK, saying that Dr. Nissen’s methodology and his interpretation of the data were faulty, insisted Avandia is safe and effective. But officials at the Food and Drug Administration, recalling the Vioxx debacle, said they would convene a panel to decide what action to take on Avandia. Congress has considered requiring drug companies to reveal all such information. And GSK’s fortunes quickly dropped on Wall Street.