Drugs Giant Backs BMJ Calls for Full Disclosure of Trial Data: GSK Supports
Journal's call for complete transparency Test side-effects should be published, company says
Guardian (UK) - Nov. 01, 2012
Britain's leading drug company has declared its support for the British Medical Journal, which is campaigning for the pharmaceutical industry to openly publish all the data it has gathered on the side-effects and failures - as well as successes - of medicines during drug trials.
The BMJ said in an editorial that from January it will no longer publish research papers on drugs unless all the clinical data on what happened to the patients is made available to anyone who wants to see it.
GlaxoSmithKline, whose chief executive, Sir Andrew Witty, said in the Guardian three weeks ago that the company would let outsiders explore all the data on trials it holds, applauded the BMJ's move.
Patrick Vallance, GSK's president of pharmaceuticals research and development, said: "GSK fully supports the commitment made today by BMJ to drive greater transparency of clinical trial data. Moves like this should help medical research by allowing scientists to study the detailed results of clinical trials and increase understanding of current and new medicines. Ultimately this should improve patient care.
"At GSK we already post results from all our clinical trials, whether positive or negative, on our website. We also aim to publish these in peer-reviewed journals such as BMJ. Earlier this month, we announced plans to further increase openness and transparency by enabling researchers to access the detailed data that sit behind the results of our clinical trials."
The BMJ has been campaigning for greater openness from the industry, in particular over the flu drug Tamiflu, which has made manufacturer Roche billions of pounds, mostly from public funds. The drug was stockpiled by the UK and other governments during the flu pandemic. But the BMJ, in a joint investigation with the Cochrane Collaboration - a not-for-profit organisation that reviews trial data to assess the value of drugs and other medical interventions - says Roche has consistently failed to hand over data from most of its trials on Tamiflu to Cochrane.
In 2009, Cochrane published a report in the BMJ saying that eight out of the 10 randomised controlled trials that Roche used to demonstrate the effectiveness of the drug were never published. Cochrane researcher Tom Jefferson concluded that the evidence of its benefits could not therefore be relied on.
The Association of the British Pharmaceutical Industry said drug companies were moving towards transparency, but it would take time. "Clinical research, whether conducted by industry or academia, should be reported in such a way that it maximises benefit and minimises the risk for patients. All researchers want to see greater transparency and the industry has been working corroboratively in this area for many years.
"The pharmaceutical industry is a global one, encompassing
thousands of companies of all sizes. Change on this scale
inevitably takes time. Through trial registries such as
www.clinicaltrials.gov, and www.clinicaltrialsregister.eu, we are
moving in the right direction and driving best practice. We
recognise there is still some way to go, but the best way to
achieve lasting change is to work together with all relevant
stakeholders in the healthcare sector."
Posted: November 2012
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