Wednesday, February 27, 2008

Did GlaxoSmithKline trial data mask Paxil suicide risk?

Looks like the manufacturer of Paxil may have failed to disclose that an early Paxil found that the drug was associated with increased risk of suicide.As reported by New Scientist.

An inappropriate analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with paroxetine, a profitable antidepressant, for 15 years, suggest court documents (897kb, requires Acrobat Reader) released last month. Not until 2006 did GSK alert people to raised suicide risks associated with the drug, marketed as Paxil and Seroxat.

An analysis of internal GSK memos and reports, which were released to US lawyers seeking damages, suggests that the company had trial data demonstrating an eightfold increase in suicide risk as early as 1989. 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".
More info at the link.

Court documents can be downloaded here.

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