GlaxoSmithKline, the pharmaceutical giant, today announced plans to publish the results from clinical drugs trials on the internet.
The move follows legal action launched two weeks ago by Eliot Spitzer, the attorney general of New York, against Glaxo, claiming that the company suppressed findings from research trials which suggested that its Paxil anti-depressant was ineffective and unsafe in treating children. The costs of the case could run into millions of dollars for Glaxo.
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Mr Spitzer alledged that Glaxo had “engaged in repeated and persistent fraud by misrepresenting, concealing and otherwise failing to disclose” important information about the safety and efficacy of the drug.
An internal Glaxo memo which in 1998 recomended that the company “manage the dissemination of these data in order to minimise any potential negative commercial impact” has been highlighted in the case.
Paxil was once Glaxo’s top seller, with sales of $3.8 billion (£2bn) in 2002. The recent launch of cheaper generic copies has since reduced sales of the drug.
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Glaxo has denied the allegations, saying that the data was released in medical journals and at pharmaceutical conferences.
The GSK Clinical Trial Register, which Glaxo said has been under development for some time and was not created in response to the Spitzer lawsuit, will be accessible to the public.
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“The GSK Clinical Trial Register will be a major advance in providing online access to information to support patient care, facilitating access to study summaries by putting them on a single Internet site,” said Tadataka Yamada, Glaxo’s chairman of Research and Development.
“It is important to emphasise, however, that prescribing information approved by regulatory agencies must continue to guide appropriate use of our medicines,” he added.
Glaxo is also facing a potential criminal prosecution for allegedly failing to inform British health regulators about the suicide risks associated with Seroxat, the British brand name of Paxil.
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Officials at the Medicines and Healthcare Products Regulatory Agency (MHRA) launched an investigation into Glaxo because of concerns that Britain’s biggest pharmaceutical group had withheld important data from clinical trials into the suitability of Seroxat for treating children.
They claimed that the research showed that Seroxat could cause an increased risk of suicide and self-harm if prescribed to depressed teenagers.
The MHRA and the Committee on Safety of Medicines only received full details of the trials in May last year. Within two weeks, the MHRA announced a ban on giving Seroxat to children under 18 — the first regulator in the world to take such a step. Shortly afterwards, the US Food and Drug Administration issued similar, though less categorical, advice to doctors.