GSK opens up its trials to the world

Click to follow
The Independent Online

GlaxoSmithKline is to become the first pharmaceuticals company to publish the results of all its drug trials, following the furore over secret safety studies of its controversial anti-depressant Seroxat.

GlaxoSmithKline is to become the first pharmaceuticals company to publish the results of all its drug trials, following the furore over secret safety studies of its controversial anti-depressant Seroxat.

The UK's biggest drug-maker said it hoped "a new era of openness" would restore its reputation and that of the industry. The New York state attorney general, Eliot Spitzer, is suing GSK for fraud, claiming it suppressed studies showing that Seroxat - sold in the US as Paxil - increases suicidal thoughts among teenagers.

The new GSK Clinical Trials Register also presents a challenge to the pharmaceutical industry, which is facing growing pressure to make public all its studies. Positive trial results are much more likely to see the light of day than negative ones. The online register, to be built up over the coming months, will contain details of hundreds of trials, dozens of which have never been published before. It comes a week after GSK promised to publish the results of the nine studies of Seroxat in under-18s in full for the first time.

Alastair Benbow, European medical director at GSK, said the launch of the register had been planned for months and was not a specific response to Mr Spitzer's lawsuit. "The company's reputation has been under attack," Dr Benbow said. "We are dependant on patients to participate in clinical trial programmes and anything that threatens the reputation of the company or its products needs to be addressed.

"We are clearly making a major step forward, ensuring transparency at GSK and helping to restore the public's faith in medical research," he said.

GSK's register will contain summaries of the methodology and results for all GSK-sponsored trials of the medicines it has on the market. It will also have links to publications that have appeared in scientific journals and other communications with doctors. Only trials of yet-to-be approved medicines will be excluded for commercial reasons, but their launch will trigger the publication of all previous trials, including in areas where the drug proved to be ineffective.

The pharmaceutical industry has come under intense pressure on the issue of disclosing trial results, with doctors' and patients' groups on both sides of the Atlantic demanding a state-sponsored register to ensure that potentially important information on safety and effectiveness is not wasted. Last week, the respected medical journal, The Lancet, threw its weight behind the campaign and yesterday the New Jersey-based giant Merck became the first major drug-maker to indicate its support for such a scheme in the US.

Some fear that public disclosure could lead to unnecessary health scares and open up the industry to spurious lawsuits. Others worry that limited positive data from trials of existing drugs in new diseases might encourage doctors to prescribe the products for unapproved uses. GSK was insisting yesterday that prescribing information approved by regulatory agencies must continue to guide the appropriate use of its medicines.

Dr Benbow said GSK had chosen to publish summaries rather than every last detail of trials, but had "nothing to hide" and would publish all the key findings. "Regulators receive detailed information, thousands of pages, and interpretation of that level of detail is difficult and should be done by experts," he said.

Mark Clark, analyst at Deutsche Bank, said the trend towards full disclosure could not be resisted by the industry. "They are all going to fall into line because this is an industry issue, not a GSK issue. GSK, being under the cosh, are the just the first to make the move. In many ways it is surprising they haven't done it sooner, because we are firmly in a world of free information exchange."

Comments