GlaxoSmithKline says it welcomes the decision from the British Medical Journal to encourage researchers to publish all of their data.
As PharmaTimes Clinical News reported yesterday, from January next year the BMJ will only publish studies of drugs and medical devices – whether industry-funded or not – where there is a commitment “to make the relevant anonymised patient level data available on reasonable request”.
GSK said today that it supports this move. Patrick Vallance, president of pharmaceuticals R&D at the firm, 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.”
But this comes despite the firm being found withholding information about the safety of its diabetes drug Avandia, drawing criticism from both the BBC Panorama programme and the BMJ. The firm is accused of trying to bury negative data from Avandia’s RECORD study, which began in 2001 and was published in 2009.
Several emails between GSK executives in 2001 showed the company was willing to drop from the RECORD trials two negative studies showing a link between use of Avandia and cardiovascular events, as they would put the drug in a “negative light”.
Avandia was removed from several markets and restricted in others in 2010 after it emerged the drug could cause high levels of heart attack, heart failure and stroke in some patients.
Vallance also said that GSK “already posts results from all our clinical trials – whether positive or negative – on [the firm’s] website,” but this is something the firm must do, however, after it was found to be withholding important safety data on its antidepressant Seroxat in 2008.
Vallance added: “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.
“GSK’s ultimate goal is to see a broad system develop where the clinical research community can access data from trials conducted by different organisations. We want to work with others to make this happen.”
Allowing the full publication of all trial data has become a big campaign in certain circles, and is being led by the epidemiologist Dr Ben Goldacre, author of Bad Science and more recently Bad Pharma.
The BMJ’s editor Dr Fiona Godlee said she was moved to take this step after the Swiss cancer firm Roche continues to withhold important data about its influenza drug Tamiflu.