Washout Or Whiteout? Paxil And Placebo Suicides

If the Ford Motor Company hid a defect in its product they would be hauled over the coals and sued by everyone and anyone who had ever had the misfortune to crash in one of their cars.

Why not Glaxo?

Unless of course, a ‘Don’t be naughty again’ type of letter sent to their CEO from the MHRA is that ‘hauling over the coals’?

Anyone with a decent amount of common sense here can see that they deliberately marketed a drug knowing that the suicide rate was abnormally high. This is not about ethics, surely this is about manslaughter?

If only the law were as simple huh?

Instead it takes years of legal wrangling between lawyers that ultimately ends up in a settlement with gagging orders placed on those who have endured unforeseen side effects from a drug that should never have been granted a license.

The company, in this case, GlaxoSmithKline offer a compensation payout - compensation that is in essence money they have earned from the sales of a defective drug. Money that could have… would have been better spent manufacturing a pill that actually carried no threat for the patient.

And still this drug is prescribed!

This from Pharmalot's Ed Silverman

Washout Or Wipeout? Paxil And Placebo Suicides

By Ed Silverman // June 16th, 2008

Last week, US Senator Chuck Grassley called for a probe into Glaxo and the FDA over their handling of the Paxil antidepressant. At issue are the long-standing allegations that the drugmaker knew about suicide risks in children for nearly 15 years but obscured evidence.

In demanding the probe, Grassley cited a report prepared by Joseph Glenmullen, a Harvard psychiatry professor, for litigation in federal court in California over Paxil side effects. The report was unsealed earlier this year, but was missing some pages. Last week, those pages became available and include a section that describes in some detail how Glaxo allegedly manipulated so-called placebo suicides.

These are deaths that occur among patients who are taken off other meds so they can participate in a trial. “The rationale from washing out all drugs is to prevent them from confounding the results of the study, so that all patients start out the study in similar conditions,” according to the Glenmullen report, which goes on to maintain Glaxo “improperly” minimized the differences between Paxil and placebo suicide data in order to obtain favorable results.

As a result, the actual suicide risk was eight times its risk for patients on placebo. “Glaxo was aware of this risk, and hid it,” the report states, as The Wall Street Journal noted over the weekend in a story that refers to the previously missing pages. Here is the full report and page 47 offers a summary of Glaxo’s efforts.

Related Links:

Glaxo Obscured Paxil Suicide Risks: Report
Grassley Probes Paxil Suicide Risks
Glaxo Escapes Prosecution Over Paxil In UK
What Negative Data? Paxil & Selective Reporting
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