June 28, 2004

GlaxoSmithKline has undertaken to publish the results of all its clinical trials on the internet in a bid to rebuild its reputation in the face of allegations that it suppressed evidence of the dangers to children of its Seroxat antidepressant, societyguardian.co.uk has reported

The drug manufacturer denied the decision had come as a result of the legal action brought by New York attorney-general Eliot Spitzer, accusing GSK of "repeated and persistent fraud" in failing to make evidence of Seroxat's effects on children more widely available.

"The clear message is we are doing something that we think is in the best interests of patients and physicians. We believe this is a major step forward," said GSK's European medical director, Alastair Benbow. A spokesman also told societyguardian.co.uk: "We would not see this as a u-turn."

Seroxat - or Paxil, as it was known in the United States - was never licensed for use on children, but some doctors used their discretion to prescribe it "off-label". Regulators on both sides of the Atlantic effectively banned its use on children last year after a series of cases in which it was linked with an increase in suicidal behaviour.

Full trial results finally published two weeks ago by GSK included one study which showed that Seroxat worked no better than a placebo in treating depression in children. Another suggested there was a slightly higher tendency to think about or attempt suicide among patients taking the drug than in the placebo group.

All the trial results were disclosed to regulators in Britain and the US, but Mr Spitzer argues that GSK should have made more effort to inform doctors about the risks of prescribing the drug to children. The company continues to insist it has done nothing wrong.

See full society.guardian.co.uk article

See:
June 14: Regulatory body to warn some SSRI antidepressants can cause adults to become suicidal
June 7, 2004: Glaxo faces Seroxat fraud lawsuit - claims that firm suppressed results of studies showing Seroxat was no more effective than a placebo and even harmful.
April 4, 2004: GPs 'forced' to overprescribe antidepressants - survey shows 80% of doctors believe they are writing too many prescriptions for SSRIs
March 28: SSRI antidepressants must carry warnings that people might become suicidal while taking them - US drug regulator states

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