Guardian Unlimited | The Guardian | Glaxo faces drug fraud lawsuit
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Guardian Unlimited | The Guardian | Glaxo faces drug fraud lawsuit
An internal GSK document from 1998, cited in the lawsuit, said the company would have to "effectively manage the dissemination of these data in order to minimise any potential negative impact".
In the UK, public pressure led the drug regulator, the Medicines and Healthcare Regulatory Agency (MHRA) to set up a review of Seroxat and the other antidepressants in its class, which include Prozac.
GSK carried out trials of Seroxat on children from the late 1990s at the request of the American drug regulator, the Food and Drug Administration (FDA).
But the results were kept secret because they showed that the drug had no more effect than a placebo, while there were some worrying side-effects. Of those on Seroxat, 3.2% suffered mood changes including thoughts of suicide, attempted suicide and trying to harm themselves - compared to 1.5% on placebo.
A document revealed in the Guardian earlier this year showed that GSK was determined to bury the bad news as long ago as 1998. An internal strategy document proposed that GSK should not hand the data from two trials to the regulators.
To admit the drug did not work in children would be "commercially unacceptable . as this would undermine the profile of paroxetine (Seroxat/Paxil)".
The lawsuit says GSK submitted the unpublished results to regulators in 2002, four years after the first negative results appeared, when it hoped to win approval for the treatment of obsessive-compulsive disorder with Paxil.
The MHRA was finally given the full trial data on May 27 last year. Two weeks later it announced it was banning the use of Seroxat in children. Following further investigations by the expert group, every other drug in the SSRI (selective serotonin reuptake inhibitor) class except Prozac has also been banned from use in children.
Shortly after the British authorities took action, the Food and Drug
Administration (FDA) in the US also recommended that Paxil not be prescribed for children or adolescents but has so far stopped short of
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Guardian Unlimited | The Guardian | Glaxo faces drug fraud lawsuit
A GSK spokesman said the firm had not had a chance to examine the lawsuit in detail. But he denied there had been acover-up.
"We have acted responsibly in the conduct of clinical studies in paediatric patients and the dissemination of the results. The
paediatric studies have been made available to the FDA and
He said data had been published in medical journals and presented at
Special reportsSource: http://www.accutaneaction.com/press/glaxo.antidpressant.fraud.pdf
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