Schwitzer health news blog

Were the data on Paxil suicide risk cooked?

The Wall Street Journal reports:

GlaxoSmithKline PLC faces new questions about whether it deliberately misrepresented data on suicide risk for its antidepressant Paxil when it applied for the drug's approval to the U.S. Food and Drug Administration at an advisory committee meeting in 1991, a charge the company has denied.

A study by a Harvard psychiatry instructor, underwritten by plaintiffs' lawyers and previously kept under seal by a court order, says that Glaxo "improperly" counted patients taking placebos during clinical studies. From 1989 through 1991, Glaxo then submitted information to the FDA that indicated no major difference in risk of suicidal behavior, or suicidality, as doctors call it, between patients who took Paxil and those who took a placebo.

However, Glaxo's counting minimized the differences between suicidality rates in the Paxil and placebo groups, according to the report. For instance, the company counted placebo patients who had attempted or committed suicide before the study formally started, which enhanced the results for Paxil.

The real risk for suicidality from Paxil, says the report's author, Joseph Glenmullen, was eight times its risk for patients on placebo. "Glaxo was aware of this risk, and hid it," Dr. Glenmullen's report states. The drug was approved for sale in the U.S. in 1992. Dr. Glenmullen said, in an interview Thursday, that if Glaxo had given the agency the "correct" data in 1991, the FDA would likely have added warnings about the risk for suicidality when it approved Paxil.