GSK to publish clinical trial data for drugs

Pharmaceutical giant shocks medical world by opting to reveal findings of all tests on patients

Britain’s largest pharmaceutical company has stunned the medical world by announcing it would back a campaign to publish all clinical trial results to preserve the safety of medicines.

GlaxoSmithKline (GSK) announced the move eight months after it was hit with a record $3bn (£1.9bn) fine in the US last July, in part for withholding safety data about its best selling diabetes drug, Avandia.

In all, 26 drug companies – including eight of the 10 biggest global players – have racked up fines of more than $11bn (£7bn) in the last three years after having been found to have acted dishonestly.

The results of clinical trials, most of which are funded by the drug industry, are frequently withheld when they deliver disappointing results. This distorts the evidence base and raises doubts about the safety of medicines that are available on the market.

GSK said in a statement it would sign up to the campaign which is seeking the registration of all clinical trials, the reporting of all summary results and for full Clinical Study Results – the detailed findings – to be made public.

Campaign organisers who include Ben Goldacre, best-selling author of Bad Pharma, Fiona Godlee, editor of the British Medical Journal and Sir Iain Chalmers, co-founder of the Cochrane Library, said it was a “cartwheel moment.” Dr Goldacre said he had met Andrew Whitty, chief executive of GSK, last week.

“It was clear they have spent a lot of time thinking about these issues. While I will always wait for proof of the pudding I do not believe this is mere lip service,” Dr Goldacre said.

“There is no serious defence for withholding information about clinical trials from doctors and patients. It is simply unethical and it harms patients.”

Observers said GSK had occupied the moral high ground by its move and rival firms would likely follow suit.

The campaign has grown rapidly since publication of Bad Pharma four months ago, winning the backing of the Medical Research Council and the Wellcome Trust. The Commons Science and Technology Committee has announced an inquiry into missing trials.

The latest target of the campaigners is the Swiss multinational Roche, which has been accused by the British Medical Journal of sitting on trial data for its flu treatment, Tamiflu, which governments around the world have stockpiled against a possible pandemic at a cost of billions of pounds.

GSK also said it intends to publish details of trials for all approved  medicines dating back to its formation in 2000.

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