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Editor: Robert Binstock
Profession: Paxil Side Effect Attorney

Category: Paxil Suicide

According to court documents recently released to U.S. lawyers seeking damages for clients allegedly harmed by the antidepressant medication, Paxil, drug manufacturers may have know about an increased risk of suicide associated with the medication as far back as 1989. GlaxoSmithKline, the makers of Paxil, finally issued a warning for an increased risk of suicide in 2006. An analysis of early clinical trials for Paxil suggests that GSK employees included extra suicides in the placebo side of the trial to intentionally skew the results of the trial in favor of Paxil. The inappropriately included suicide data basically covered up the existence of an eight-fold increased risk of suicide.

Harvard University psychiatrist Joseph Glenmullen, who studied the papers for the lawyers, says it's "virtually impossible" that GSK simply misunderstood the data - a claim the company describes as "absolutely false".

Glenmullen's report rests on documents obtained by lawyers in Los Angeles, who are bringing around 30 cases against GSK linking suicides and suicide attempts to the use of Paxil. The report was under seal at a district court in Sacramento, California, until 18 January, when the judge agreed to make parts of it public.

The alleged conspiracy centers on a period known as the "washout" period, the time right before a clinical trial begins in which a patient stops taking most or all medication in an effort to gain a more accurate assessment of the drug that is being tested. Adverse reactions during this time frame cannot be included in trial results, as the drug being tested has not been introduced to the patient yet. Allegedly GSK deliberately included suicide related reactions during this period to the placebo or control group data, while omitting the same time period for the Paxil group, therefore creating a false appearance of a safer drug.

GlaxoSmithKline claims that the washout data was included in an effort to give a full representation of the trail data. A spokesperson for GSK, Mary Anne Rhyne, maintains that Paxil, even with the washout data still proved to be as safe as the placebo and has accused Glenmullen of incorrect analysis of the data.