The Guardian.
Link to actual article :-http://www.guardian.co.uk/business/2004/aug/27/mentalhealth.glaxosmithklinebusiness
Spitzer forces Glaxo to publish drug trials
David Teather in New York
guardian.co.uk, Friday 27 August 2004 09.28 BST
Article history
GlaxoSmithKline yesterday said it would publish all details of its clinical drug trials after being accused of concealing information that its leading antidepressant could be harmful to children.
The move is part of the settlement of a lawsuit filed by the New York state attorney general, Eliot Spitzer, in June that accused GSK of "repeated and persistent fraud".
The firm will also pay the relatively small sum of $2.5m (£1.4m) to settle the charges.
The lawsuit alleged that GSK suppressed the results of at least four different studies which showed the drug Paxil, known as Seroxat in Britain, was at best no more effective than a placebo and at worst was increasing suicidal behaviour among users. The results of a fifth test, showing mixed results, were released.
At the same time GSK was said to have been heavily promoting the drug to American doctors, boasting of its efficacy and safety.
The cover of a memo for sales representatives, cited in the suit, read: "Paxil demonstrates remarkable efficacy and safety in the treatment of adolescent depression."
Mr Spitzer said the settlement set a new standard for the pharmaceutical industry.
"This settlement holds GSK to a new standard of disclosure about studies concerning its drugs, a standard that helps to ensure that doctors and patients have access to all scientifically sound information so doctors can prescribe appropriate medication for their patients," he said.
GSK has already begun posting on the web clinical studies of the use of Paxil among adolescents and children. The company is planning to go further and will establish a "clinical trials register" that will contain summaries of results from all GSK-sponsored clinical studies of drugs conducted since the end of 2000, when Glaxo Wellcome and SmithKlineBeecham merged.
Each summary will be set out in standard form and include data regarding effectiveness, type and severity of side-effects and whether the goals or other components of the study were changed mid-stream.
Results of future studies must be posted within 10 months of the drug being first marketed, according to the terms of the agreement. It will advertise the clinical trials register in medical journals.
In a statement, GSK said it still believed the allegations were "unfounded" but agreed to pay the penalty to avoid "the high costs and time required to defend itself in protracted litigation". Mark Werner, GSK's senior vice-president for US legal operations, described the trials register as "a responsible step in ensuring transparency".
The prescription of antidepressants to children and adolescents has become a contentious issue due to reports of addiction or suicidal behaviour among users. Seroxat was banned for use by children and adolescents in Britain last June.
In a press release issued in Britain at the time, the firm admitted it had seen "a difference between [Seroxat] and placebo in terms of suicidal thinking or attempts particularly in adolescents".
The only antidepressant prescribed to children in Britain without a warning is Prozac, although studies suggest it has low success rates.
In 2002, more than 2m prescriptions for Paxil were written for American children and
adolescents to treat mood disorders and depression. That translated into $55m in sales.
In two of the studies, Paxil was no more effective than a placebo when treating depression in young people - in one study, the placebo, or dummy pill, actually outperformed Paxil. Most worryingly, the incidence of suicidal tendencies doubled among users in three of the tests.
