US Seroxat challenge prompts fresh calls for review of drugs regulation

The mental health charity Mind has repeated calls for a review of
the relationship between pharmaceutical firms and drug regulators
after a leading pharmaceutical firm was charged with fraud in the
US.

GlaxoSmithKline (GSK) maker of the antidepressant Seroxat has been
charged over claims that it concealed data indicating that the drug
poses a suicide risk to young people.

New York State attorney general Eliot Spitzer alleged that GSK
suppressed the results of four paediatric studies that suggested
Seroxat, also known as Paxil, was no better than a placebo and
posed a possible increased risk of suicidal thoughts.

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

According to the lawsuit, the data was only presented to regulators
in 2002 when GSK sought a new licence for the drug.

However, GSK insisted that it had made all its studies on the drug
available to regulators worldwide. “The 1998 memo is inconsistent
with the facts and does not reflect the company position,” it
said.

Seroxat was banned for use by under-18s in the UK last June by the
Medicines and Healthcare Regulatory Agency (MHRA), but can still be
prescribed to children in the US.

Mind chief executive Richard Brook said the US law suit “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”.

The charity believes that the MHRA relies too much on drug company
data, is secretive, too close to the industry and lacks consumer
input. It also said that pharmaceutical companies should have a
duty to report new data about the efficacy of drugs.

Brook resigned from the MHRA in March alleging that it had covered
up evidence that Seroxat was being prescribed to adults at too high
a dose.

He said: “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.”