American parents sue GSK over Seroxat
Monday September 6, 2004
Source: The Guardian
A lawsuit has been filed against GlaxoSmithKline in the United States seeking refunds for children and adolescents given the antidepressant, Seroxat, following claims that the firm suppressed data showing the drug did not work and increased suicidal tendencies in young people.
The class action suit follows an inquiry by New York state attorney general Eliot Spitzer that made similar accusations.
Last month GSK settled with Mr Spitzer for $2.5m (£1.4m), without admitting liability.
The amount surprised the industry because Mr Spitzer had originally said he wanted to recover all the money GSK had made from selling Seroxat - named Paxil in the US - which analysts have estimated at about £200m.
British regulators have advised doctors not to prescribe drugs like Seroxat for children and adolescents.
There are already several class actions against GSK regarding the withdrawal side-effects from Seroxat.
Paul Dahlberg, however, who is leading the case at law firm Meshbesher & Spence, said the lawsuit was the first class action intended to reclaim the money paid for the drug based on the alleged suppression of clinical trial data.
Mr Dahlberg is now representing at least 24 people who bought the drug for their children and is seeking to recruit the thousands of other Americans who have done so for the class action.
The writ alleges GSK hid the results of two clinical trials that showed the drug was no more effective than a placebo in treating depression. In one case, it says, the placebo was more effective than Seroxat. Instead, the lawsuit states, the mixed results from a separate study were published in a scientific journal and used to promote the drug.
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GSK has defended its process and Alastair Benbow, the firm's European medical director, wrote to the Lancet medical journal this year, giving details of presentations at scientific congresses at which the data was discussed.
"We have made this data available in various forms as is normal practice, that would be via articles in journals, presentations at scientific congresses and letters to doctors," a spokesman said. "We also went to regulatory authorities in May 2003 with all of the paediatric trial result data."
Additional information in the writ is an internal GSK memo, revealed this year, which said negative trial data should not be given to regulators and its dissemination should be managed "in order to minimise any potential negative commercial impact".
A spokesman for GSK said the individual's memo did not reflect company policy - as evidenced by the information it had published in the scientific community.
The drug was not officially sanctioned by US regulator the food and drug administration for use in under-18s. But doctors were allowed to use their own judgment, based on information letters sent by GSK. The lawsuit claims some of these letters omitted the negative information about the drug.
The class action lawsuit was filed in a Minnesota district court last month and is a federal case. The lead plaintiff, Nancy Gerdts, bought the drug for her 12-year-old son in August 2002 and is attempting to get her money back.
Because the law firm is still targeting the thousands of people who bought the drug, the amount the class action is seeking to recover is not yet known. Mr Dahlberg said he estimated the claim could be worth as much as $600m.
Class action lawsuits relating to drugs have been increasingly common in the US, particularly those involving serotonin reuptake inhibitors, which include Prozac and Seroxat