02/28/2008 - National Legal News

A Republican senator is leading an inquiry into whether the manufacturer of the antidepressant Paxil withheld information about the risk of suicide associated with the drug for more than 15 years before warning the public.

In 2006, British drug maker GlaxoSmithKline added warnings to its prescription antidepressant Paxil to notify physicians and patients of an increased risk of suicidal behavior in adolescents. However, in a recent statement, Senator Charles Grassley of Iowa alleges that court documents from a dismissed lawsuit suggest that the manufacturer was aware of a risk of suicide as early as 1989.

In the documents, Dr. Joseph Glenmullen, a Harvard Medical School psychiatrist, alleges that GlaxoSmithKline mishandled the results of early Paxil studies that contained reports of patient suicides. After going over a substantial number of internal company documents, Dr. Glenmullen claimed that GlaxoSmithKline researchers included statistics on suicides and suicide attempts among a placebo group during a pre-trial phase of a study but did not do the same for a Paxil group, thereby making Paxil appear safer.

Glenmullen suggests that had GlaxoSmithKline accurately documented the suicide reports, the subsequent data would have shown that Paxil patients were at nearly an eight times greater risk of suicidal behavior.

GlaxoSmithKline maintains that it has always provided accurate suicide data to regulatory officials.