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

"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 ..."