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GlaxoSmithKline to publish trial data online

Published on 24/06/04 at 06:10pm

GlaxoSmithKline has announced it is to make data from all of its trials available online in an effort to counter accusations that it withheld negative data on its antidepressant Seroxat/Paxil.

Pharmaceutical companies are currently not obliged to publish clinical trial data from its trials, including that used in submission to regulators, but recent years have seen growing calls for greater disclosure.

A new lawsuit filed in early June against the company by New York State Attorney General Eliot Spitzer has brought the issue to a head, with Mr Spitzer alleging that GSK committed "repeated and persistent fraud" by withholding data which showed Seroxat/Paxil did not help children, and suggested a possible increased risk of suicidal thinking and behaviour.

The Anglo-American company immediately rejected the accusations and two weeks ago said it would publish full safety and efficacy data on the drug, one of its biggest selling drugs.

The company has now unveiled plans for a full online clinical trial register for all trials that it sponsors, saying the initiative had been in planning long before the Spitzer lawsuit.

The website will provide summaries of trial protocols and corresponding results for GSK-sponsored trials of medicines that have already been launched, and will also provide references to publications cited in medical literature and promotions.

Dr Tadataka Yamada, chairman of GSK R&D said the website, which will be open to healthcare professionals and the public, would be a "major advance" in support of patient care, but added: "It is important to emphasise, however, that prescribing information approved by regulatory agencies must continue to guide appropriate use of our medicines."

Mr Yamada's remarks point to the responsibility of regulators such as the FDA and the UK's MHRA in monitoring prescribing of drugs and issuing guidance. In the UK, none of the antidepressant drugs in the SSRI class which includes Seroxat are licenced for use in children, but the authority's own investigation showed that 30-40,000 children and teenagers were being prescribed the drug off-label every year. The MHRA instructed doctors to stop prescribing the drugs to children except for fluoxetine (Prozac).

In March 2004 Richard Brook, chief executive of UK mental health charity MIND and a fierce critic of regulators and the industry resigned from the committee investigating SSRI drugs. He claimed the MHRA had been negligent in not acting earlier and said it had been in possession of the data for over a decade.

Meanwhile in the US, the American Medical Association has launched a campaign for the setting up of a single comprehensive clinical trials registry, asking institutional review boards (clinical trial ethics committees) to make registration in the database a condition of approval.

The initiative has already won the backing of US pharma giant Merck, putting pressure on other leading companies to make similar gestures towards greater openness.

An existing US government website, ClinicalTrials.gov could take on this role, currently listing trials of drugs for the most serious or life-threatening diseases.

Meanwhile, the International Committee of Medical Journal Editors have put forward their own similar proposal for registering trials before they are considered for publication in the leading journals.

Related articles:

GlaxoSmithKline 'misled doctors' over antidepressant safety, claims US state

Thursday, June 03, 2004

 

 

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