Sunday, 6 June 2004

Britain's largest pharmaceutical company, GlaxoSmithKline, is facing a civil lawsuit brought by US State attorney general Eliot Spitzer for allegedly concealing information that their antidepressant Paroxetine led to suicidal behaviour among children and teenagers during clinical trials.

The lawsuit claims that Glaxo suppressed the results from at least four seperate studies that showed that the drug acted at best as a mere placebo and at worst was harmful. At the same time the company was promoting the drug to American doctors boasting of its efficacy and safety.

And about time too. After my own misadventures with this accursed drug I am especially pleased that Glaxo are finally being taken to task over it. Glaxo's own trials proved that paroxetine performed no better than a placebo with depression among young people and in one study the placebos actually outperformed the drug. More worringly, in three of the trials suicidal behaviour among the young test subjects doubled as a result of taking the drug.

An internal Glaxo document circulated in 1998 stated that the company would have to "effectively manage the dissemination of these data in order to minimise any potential negative impact".

Results from trials performed by Glaxo on children at the behest of the US Food and Drug Administration (FDA) were subsequently withheld from the FDA because to admit the drug did not work in children would be "commercially unacceptable ... as this would undermine the profile of paroxetine (Seroxat/Paxil)".

In the UK the Medicines and Healthcare Regulatory Agency (MHRA) was finally given the results of these trials in May 2003 after Glaxo finally handed over the full results to the FDA in 2002 as part of their attempt to win approval for the treatment of obsessive-compulsive disorders with Paroxetine. This, coupled with several years of public pressure warning of the potentially harmful effects of Paroxetine (or Seroxat as it is known in the UK) finally convinced the MHRA to ban the use of Seroxat on children. After further studies the MHRA then banned the use of all SSRI (selective serotonin reuptake inhibitor) antidepressants on children with the sole exception of Prozac.

Mr Spitzer said: "By concealing critically important scientific studies on Paxil, GSK impaired doctors' ability to make the appropriate prescribing decision for their patients and may have jeopardised their health and safety."

David Healy, the consultant psychiatrist who first brought the safety of the SSRIs under scrutiny, said that the suppression of data applies to adult trials as well as those carried out in children. "The original data sent to the regulators for this drug showed an eight time greater rate of suicidal acts on paroxetine compared to placebo in adults." Yet the published data suggests there is no difference.

Glaxo, of course, deny a cover up: "We have acted responsibly in the conduct of clinical studies in pediatric patients and the dissemination of the results. The pediatric studies have been made available to the FDA and regulatory agencies worldwide."

Having suffered at the hands of Seroxat and having discovered that my experiences were not only widespread amongst others but also relatively tame compared to some, I am extremely happy to see Glaxo up against the wall on this one, especially if they knew how harmful their drug could be but put company profits before the safety of their customers.