GSK set to face legal claims in the UK over anti-depressant
Saturday 05 June 2004
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The Legal woes facing GlaxoSmithKline over its best-selling anti-depressant, Seroxat, are set to spread to the UK where a campaigning solicitor is weeks away from launching a claim against the group, alleging the drug is "defective" and dangerous.
The Legal woes facing GlaxoSmithKline over its best-selling anti-depressant, Seroxat, are set to spread to the UK where a campaigning solicitor is weeks away from launching a claim against the group, alleging the drug is "defective" and dangerous.
The development comes in the week that Eliot Spitzer, New York state's combative Attorney General, launched a $250m lawsuit alleging GSK kept negative results of the drug trials secret.
Hugh James Solicitors, a Cardiff firm working on behalf of the UK's Seroxat Users Group, claims the drug is addictive and causes some users to become agitated, aggressive or suicidal. They say they are ready to send a "letter of claim" to GSK, demandingit surrenders Seroxat documents. A lawsuit is likely to be filed next year. Mark Harvey of Hugh James says he is working on behalf of 3,500 Seroxat users. "The evidence of suicide was compelling", he said.
GSK is strongly resisting the claims, saying the product is safe and effective. It is defending dozens of US class actions in which it is claimed the drug, sold there as Paxil, is addictive, and has received individual claims that it contributed to suicides.
A spokesman for GSK said: "Depression is a potentially deadly disease and Seroxat is an effective treatment that since launch has helped tens of millions of patients worldwide lead fuller and more productive lives."
Seroxat is taken by up to 800,000 patients in the UK. The medicines regulator, the MHRA, is investigating it and similar drugs to see if patient warnings need tightening.
Mr Harvey argued that Seroxat is "defective" under the Consumer Protection Act. "Drug companies ought to be studying their products better, and patients need better information. If the companies were more honest in describing the defects, then patients would be better able to decide whether they want to take the drug," he said.
Seroxat was banned for use by under-18s in the UK last year on fears it contributed to suicide among adolescents.
Mr Spitzer's lawsuit claims GSK suppressed or misrepresented a string of studies in the 1990s that suggested Seroxat was useless as a treatment for adolescents, and possibly dangerous. GSK says it was only when the studies were added together that they discovered a statistically significant increase in suicidal tendencies.
Jean-Pierre Garnier, GSK's chief executive, has moved to dismiss the central plank of Mr Spitzer's case - an internal memo which said the dissemination of trial data should be "managed" to "minimise any potential negative commercial impact". It was the work of a rogue "middle manager", he told Bloomberg. "You cannot accuse the company just on the basis of this one piece of information, because of one employee writing one memo among millions, millions of memos written by 120,000 employees every day," M. Garnier said.
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