GSK ordered to hand over emails in Paxil suit

GlaxoSmithKline has been ordered to turn over emails exchanged with researchers studying birth defects associated with the antidepressant Paxil to a family suing the company. In the first of 600 or so lawsuits over Paxil, U.S. District Judge Nancy Gertner ruled "the plaintiffs are entitled to correspondence and documents between anyone at Slone and GSK about the study, its scope" and methodology, Bloomberg reports. GSK had sought to block the family from reviewing emails and other communications between company execs and researchers at Boston University's Slone Epidemiology Center.

The case was brought on behalf of William Seale, who died in 2004 allegedly due to heart defects caused by Paxil, which his mother had been taking. According to Bloomberg, the family contends that GSK knew of the risks and tried to pressure researchers to present the study's results so as to protect the company from lawsuits.

Gertner ordered researchers Allen Mitchell and Carol Louik to turn over their communications with the drugmaker, including exchanges with GSK execs just before the trial results were submitted to the New England Journal of Medicine. The judge stopped short of allowing the family access the raw trial data. Opening statements in the case begin today.

- here's the Bloomberg article [1]

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Glaxo promises a public airing of all trial data [3]
Judge reverses Paxil preemption ruling [4]
U.S. Paxil probe broadens [5]
Grassley asks FDA for Paxil review [6]