http://www.guardian.co.uk/society/2008/mar/06/health.health
<http://www.guardian.co.uk/society/2008/mar/06/health.health>
Drug companies must cough up data after Seroxat results withheld
* David Batty <http://www.guardian.co.uk/profile/davidbatty> , Martin
Hodgson <http://www.guardian.co.uk/profile/martinhodgson> and Nicholas
Watt <http://www.guardian.co.uk/profile/nicholaswatt> *
guardian.co.uk <http://www.guardian.co.uk/> , * Thursday March 6
2008
* Article history
About this articleClose This article was first published on
guardian.co.uk <http://www.guardian.co.uk/> on Thursday March 06 2008.
It was last updated at 11:51 on March 06 2008.
The government today announced a significant tightening of the law
overseeing drug companies after an investigation found the
pharmaceutical giant GlaxoSmithKline (GSK) had held back evidence that a
controversial drug increased the likelihood of suicide among teenagers.
The public health minister, Dawn Primarolo, said new legislation will be
introduced by the end of the year to ensure drugs companies pass on
results of clinical trials as soon as the alarm is raised about one of
their medicines.
";Companies that conduct clinical trials should not compromise people's
health by withholding information," she said.
The move comes after a four-year investigation by the Medicines and
Healthcare Regulatory Authority (MHRA) into the way GSK withheld the
full results of its trials of the antidepressant Seroxat on children.
The trial data, which was finally handed to the MHRA in May 2003,
identified two problems of which the company had been aware as early as
1998: a higher risk of suicidal behaviour among under-18s using Seroxat
rather than a placebo, and that the drug was ineffective in dealing with
depressive illness among that age group.
Primarolo said GSK should have told the MHRA about the results earlier.
But GSK will not face criminal prosecution because present legislation
is insufficiently clear on whether and when drugs companies should
inform the regulator.
The new legislation will place a greater obligation on companies to
disclose the results of clinical trials.
In a written ministerial statement published today, Primarolo said: "The
process of investigation has revealed weaknesses in EU legislation as it
stood at the time, in terms of what safety information drugs companies
were legally obliged to provide to the regulators.
"I have therefore asked that immediate steps are taken, as follows: to
secure a strengthening of the law in this area, through changes to the
EU directive and, in the meantime, amending the law as it applies in the
UK; to make it clear to all pharmaceutical companies that,
notwithstanding the limitations that may exist in the law, they should
disclose any information they have that would have a bearing on the
protection of health. The MHRA is writing today both to GSK and to
pharmaceutical industry bodies to stress this point."
The MHRA investigation asked whether GSK had informed the regulatory
body in reasonable time about the Seroxat results. It showed that the
drug company had the information about the potentially suicidal effects
of the drug and concludes that GSK should have informed the MHRA
earlier. Nnonetheless it found that the company acted within the letter
of the law by withholding the data.
The chief executive of the MHRA, Professor Kent Woods, said: "I remain
concerned that GSK could and should have reported this information
earlier than it did. All companies have a responsibility to patients and
should report any adverse data signals to us as soon as they discover
them. This investigation has revealed important weaknesses in the drug
safety legislation in force at the time. We will take immediate steps to
ensure the law is strengthened further, so that there can be no doubt as
to companies' obligations to report safety issues."
Mental health charities condemned GSK for its failure to inform the
authorities promptly of the risks Seroxat posed to children.
The Mental Health Foundation's chief executive, Andrew McCulloch, said:
"It is totally unacceptable to hear that, when information can be made
available at speed, young people may have taken their own lives due to a
lack of transparency by a pharmaceutical company.
"The pharmaceutical industry has played a significant role in the
treatment of people with mental health problems over the years – it
has a duty to be transparent and rigorous; otherwise it is in danger of
losing the public's trust."
The failure to take stronger action against GSK will anger the many
critics of the regulatory body, who say it is not up to the job of
policing the pharmaceutical industry. Patients and some doctors have
been urging a tough line against GSK ever since the MHRA suddenly
announced, in June 2003, that doctors must not give Seroxat to children
and under-18s.
The agency said it was acting within two weeks of receiving the full set
of data from the Seroxat trials. Those statistics showed the drug was no
better than a placebo in alleviating depression in children and that
patients taking it were more likely to develop suicidal tendencies than
those on placebo. In one of the trials, 6.5% of children taking Seroxat
became suicidal compared with 1.1% in the placebo group.
A leaked internal document from GSK, dated to 1998, said the company
would have to "effectively manage the dissemination of these data in
order to minimise any potential negative impact".
In the US, GSK was sued by the New York state attorney general, settling
for a payment of $2.5m (£1.25m) and an agreement to publish all its
trial results - negative or positive - on a publicly available database.
Critics have called for big changes to the MHRA. In its report into the
influence of the pharmaceutical industry, the Commons health select
committee expressed concern that the regulatory body did not get all the
information it needed from manufacturers before it licensed drugs. It
called for a new regime of random audits of raw trial data collected by
companies and for more staff to be recruited.
GSK has always rejected allegations that it improperly withheld Seroxat
data. It said the drug had never been approved by EU or US regulators as
a medicine for under-18s and that the company had therefore never
marketed it for that age group. It also said its trial results had been
submitted to regulators and were presented publicly in journals and on
its website.
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