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Follow the Money; or, Why it Took an Accounts Committee to Decide Why Access to Clinical Trial Data Matters

Ginny Barbour, Medicine Editorial Director at PLOS, discusses a recently-published UK Government spending report on access to clinical trial information and the stockpiling of Tamiflu.

Yesterday the UK Parliament’s Public Accounts Committee, which monitors UK Government spending – focusing on “value-for-money criteria which are based on economy, effectiveness and efficiency” – published a rather amazing report; not just because of the topic of its enquiry but in particular its conclusions, which have implications well beyond the UK. The topic was “Access to clinical trial information and the stockpiling of Tamiflu”: the conclusions were that the money spent on Tamiflu was likely misspent, and moreover the lack of access to clinical trial data more widely is unacceptable.

Tamiflu was the drug which the UK stockpiled back in 2009 when the last influenza pandemic seemed to be coming, but much of which it subsequently had to destroy because of poor record keeping once the scare was over.

The cost of the Tamiflu that was destroyed was £74 million; what the committee now makes clear in public is that there was no good evidence that it worked anyway (“The case for stockpiling antiviral medicines at the current levels is based on judgement rather than evidence of their effectiveness during an influenza pandemic”) and what evidence there was, was largely hidden away from those who most needed to see it including doctors, academics (despite dogged pursuit by researchers from the Cochrane Collaboration and others), the general public and even the regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) the relevant UK Governmental agency. Thus there is a real question over the whole £424 million that was spent on stockpiling Tamiflu between 2006-07 and 2012-13.

On the issue of clinical trial data more generally the report is clear: noting that “None of the latest proposals from regulators or industry adequately addresses the issue of access to the results of trials from previous years on the medicines in use today”, a specific recommendation is that:

“The [UK] Department [of Health] should take action to ensure that the full methods and results are available to doctors and researchers for all trials on all uses of all treatments currently being prescribed, and should also ensure that there is clear and frequent audit of how much information is available and how much has been withheld.”

The Committee’s findings are a huge vindication of the AllTrials campaign which begun just a year ago and which calls for the registration and reporting of all trial results. There has been movement towards the easier issue of the prospective registration of new trials but access to data from older trials remains a problem.

Richard Bacon MP, member of the Committee of Public Accounts, said in  quote which succinctly sums up how unacceptable the current position is :

“The full results of clinical trials are being routinely and legally withheld from doctors and researchers by the manufacturers of medicines. This has ramifications for the whole of medicine. The ability of doctors, researchers and patients to make informed decisions about treatments is being undermined. Regulators and the industry have recently made proposals to open up access, but these do not cover the issue of access to the results of trials in the past which bear on the efficacy and safety of medicines in use today.”

Or, as the report’s summary says

“This longstanding regulatory and cultural failure impacts on all of medicine, and undermines the ability of clinicians, researchers and patients to make informed decisions about which treatment is best.”

AllTrials, a coalition spearheaded by Ben Goldacre (doctor and author of Bad Pharma), the charity Sense About Science, the BMJ, PLOS (where I am the Medicine Editorial Director) and a group of independent academics, was born out of real anger that the many backroom discussions on trials were simply going nowhere and there was a need to bring the issue of hidden data into the public view. The campaign has been successful in mobilizing academics and patients groups, has lobbied UK and European Parliamentarians and overall has been a key reason in the movement toward more transparency of a number of pharmaceutical companies.

It’s ironic in the end though that it may take a Committee whose job it is to look at spending to point out what Health Departments seems to have been willing to ignore – that hiding clinical trial data is tremendously damaging to society, at an individual, professional and yes, even a financial level.

Ben Goldacre sums it up thus:

“We cannot make informed decisions about which treatment is best, when vitally important information is routinely and legally kept secret. Future generations will look back at this absurd situation in the same way that we look back on mediaeval bloodletting.”

  1. An excellent report from the PAC. As a GP I would welcome their investigation of the value delivered by a number of the interventions we are being foist on us, in particular dementia screening where I would love Cochrane to have access to all the cognitive enhancer data and review their value.

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