Saturday, April 27, 2013

GSK and Roche tell MPs that more clinical trial data should be published -BMJ

By Adrian O’Dowd

Two of the world’s largest drug companies have told MPs in parliament that they support a policy of publishing all clinical trial data.

A leading academic and clinician has, however, questioned their assertions and challenged them over how closely their promises would manifest into action.

MPs on the House of Commons Science and Technology Committee held an evidence session on 22 April for their inquiry into clinical trials. The inquiry is in the context of the European Commission’s proposal to revise the clinical trials directive that regulates trials in the United Kingdom and comes after concerns raised about transparency and disclosure of all trial data: drug companies are entitled to conduct numerous clinical trials on drugs but publish selectively.

MPs asked witnesses whether all clinical trials funded by drug companies were published.

James Shannon, chief medical officer at GlaxoSmithKline, giving evidence, said, “If a phase III trial or programme were to fail at any part of the process, and there was no evidence of efficacy, we would most likely not submit an application for a product licence.

“The clinical study reports in those cases would not necessarily be submitted to a regulator, because we are not applying for a product licence. However, all of those studies would be published in a peer reviewed journal.”

Ben Goldacre, a research fellow in epidemiology at the London School of Hygiene and Tropical Medicine and author of the book Bad Pharma, which highlighted the practice of drug companies choosing which trials to publish, also giving evidence, questioned that assertion.

“That may be true for GSK,” he said, “but I am not sure it would be universally true that trials which weren’t part of a marketing authorisation package would be made publicly available. Quite commonly, they’d be withheld.

“What we need to practise medicine in a safe and informed fashion is to have all the results of all the trials for all of the uses of all of the treatments that we are currently prescribing, and we don’t have that at the moment.”

Fellow witness William Burns, member of the board of directors at Roche, said, “This is a heavily regulated industry. What we’ve seen is an increasing requirement over recent years for more stakeholders to have more access to the data, and if society wants that to happen, then we have to respond. We believe this is a correct response to what society is looking for, but we should not underestimate that we should be working with the multiplicity of regulatory authorities.

“Probably the two companies sitting here are the first two out of the gate actually saying we will have a new policy going forward with greater disclosure than we’ve ever had in the past.”

Goldacre replied, “If we look at some of the biggest problems that have been spotted in the evidence base for medicines over the past few years . . . those problems were not spotted by regulators but by independent doctors and academics reviewing data that they had to fight to get hold of.

“In December 2009 Roche made a commitment to share all the clinical study reports on Tamiflu, and that promise has still not been paid out on.

“My concern is that Roche are making exactly the right kind of noises that we would like to hear about sharing clinical study reports, but in their specific interactions with the Cochrane [Collaboration] so far they have fallen well short of those aspirations.”

Shannon said, “We 100% agree with Dr Goldacre that the more eyes that are put on data, the better. That’s why GSK has taken the lead to commit to both patient level data transparency as well as clinical study reports.”

Burns added, “The same is true for Roche.”


Cite this as: BMJ 2013;346:f2639


The BMJ has been campaigning for fuller disclosure of trial data. See

No comments: