GSK drug poses suicide risk to young people, US lawyers allege

A leading pharmaceutical firm has being charged with fraud over
claims that it concealed data indicating that the antidepressant
paroxetine (Seroxat) poses a suicide risk to young people,
writes Craig Kenny.

New York State Attorney General Eliot Spitzer alleged that
GlaxoSmithKline suppressed the results of four paediatric studies
which suggested that the drug was no better than a placebo and
posed a possible increased risk of suicidal thinking. GSK denies
the allegation.

An internal memo from 1998 showed that GSK intended to
“manage the dissemination of data in order to minimise any
potential negative commercial impact”, Mr Spitzer said.

The data was only presented to regulators in 2002 when GSK sought a
new licence for the drug, the lawsuit says. The drug was banned for
under 18 use in the UK last  June by the Medicines and Healthcare
Regulatory Agency, but can still be prescribed to children in the
US.

Richard Brook, chief executive of the mental health charity Mind,
resigned from the MHRA last year alleging that it had covered up
evidence that Seroxat was being prescribed to adults at too high a
dose.

‘This issue again raises questions over whether
pharmaceutical companies are making data from research trials
available promptly, in full and in public to regulators to enable
them to do their job effectively,’ he said of the US
lawsuit.

‘Urgent action is now needed to review the role of the drug
regulators and their relationship with the pharmaceutical industry
to ensure that the drug regulatory framework puts patient safety
firmly ahead of commercial pressure and cost.’

A statement from GSK insisted that the company had made all studies
available to regulators worldwide. ‘The 1998 memo is
inconsistent with the facts and does not reflect the company
position,’ it said.