Glaxo climbdown over Seroxat trials

BATTERED by accusations of a cover up of clinical data, GlaxoSmithKline has agreed to release summaries of studies examining the safety and efficacy of a key anti-depression drug.

The pharmaceuticals giant will use its website to publish details of nine clinical trials of Seroxat given to children and adolescents.

GSK's climbdown follows last week's lawsuit by New York Attorney General Eliott Spitzer. He claims that GSK withheld information showing that Seroxat can prompt suicidal tendencies in some youngsters.

At best, the drug is little better than a placebo for non-adults, according to Spitzer's action.

He accused GSK of 'persistent fraud' and is seeking the return of all profits earned on Seroxat sales to children, as well as unspecified damages.

City analysts estimate damages at £200m - manageable for a company that made £6.3bn profits last year. But should Spitzer succeed, ensuing class action lawsuits from patients could cripple GSK. Seroxat earned £290m in the first quarter of this year.

GSK maintains that it has disclosed all relevant trial information to regulators. It insists that today's about face is simply an effort to ensure transparency.

'The data have been available to the healthcare world, which is the standard approach,' said a spokesman. However there appears to be 'a need for more clarity', he added.

In the UK, the Medicines and Healthcare Products Regulatory Agency has been investigating Seroxat for the past year.