GlaxoSmithKline refutes Panorama allegations that it distorted Seroxat trial results
GlaxoSmithKline has refuted allegations, brought by the BBC's Panorama programme this week, that it distorted trial results of Seroxat (paroxetine) to cover-up a link with suicide in teenagers.
“Secrets of the drug trials”, broadcast on Monday, reported
that GSK attempted to show Seroxat worked for depressed children despite
failed
clinical trials and that ghost writers employed by GSK influenced independent
academics.
In a statement, GSK said: “GSK utterly rejects any suggestion that
it has improperly withheld drug trial information.” It added that
no clinically meaningful increase in the rates of suicidal thinking or
attempted suicide was observed when trials were reviewed individually.
It was only when all the data became available at the end of the research
programme that an increased rate of suicidal thinking or attempted suicide
was revealed in those paediatric patients taking Seroxat. “GSK
brought this analysis to the attention of the regulatory authorities,
including in the UK,” it said. The company also refutes any suggestion
that Seroxat was promoted to UK doctors for use outside the terms of
the UK marketing authorisation.
In June 2003, following analysis of the combined data, the Department
of Health warned that paroxetine must not be used for the treatment of
children with depression because there is a risk that the drug
may cause suicidal behaviour in those under 18 years of age (PJ, 14 June 2003,
p813).
The Medicines and Healthcare products Regulatory Agency launched a criminal
investigation in October 2003 into whether GSK had breached medicines
regulations by withholding important safety data from its clinical trials
on Seroxat in children. No charges have yet been brought.
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