MPs have criticised the amount of money spent on stockpiling Roche’s Tamiflu, citing the lack of consensus over how well the antiviral actually works, and have called for much more transparency of trial data.
The UK Parliament’s Public Accounts Committee has published a report following its investigation into the Department of Health spending £424 million to stockpile Tamiflu (oseltamivir) for use in an influenza pandemic. The hard-hitting report notes that the PAC was “surprised and concerned to discover that information is routinely withheld from doctors and researchers about the methods and results of clinical trials on treatments currently prescribed in the UK”.
It adds that “this problem has been noted for many years in the professional academic literature, with many promises given, but without adequate action being taken by government, industry or professional bodies”. The committee adds 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”.
Richard Bacon MP, a member of the PAC, noted that the ability to make informed decisions about treatments is being undermined, citing research which suggests that the probability of completed trials being published is roughly 50%. Furthermore, trials “which gave a favourable verdict are about twice as likely to be published as trials giving unfavourable results”.
‘Extreme concern’
Noting the “extreme concern” of the committee, he added that the DoH Department and the Medicines and Healthcare products Regulatory Agency (MHRA) “must make sure, both prospectively and retrospectively, that clinical trials are registered and the full methods and results of all trials are available for independent wider scrutiny by doctors and researchers”. Mr Bacon also pointed out that there is “no routine sharing between the National Institute for Health and Care Excellence (NICE) and the MHRA of information provided by manufacturers during the process of licensing medicines”.
He concluded by noting that “the case for stockpiling antiviral medicines at the current level is based on judgement rather than on evidence of their effectiveness during an influenza pandemic”. The report highlights the fact that the DoH wrote off £74 million of Tamiflu “as a result of poor record-keeping” by the National Health Service, mainly concerning storage conditions.
The PAC report has been welcomed by groups who have been instrumental in the fight to improve access to data. Ben Goldacre, author of Bad Pharma and co-founder of AllTrials, said it is “a complete vindication” of the latter’s call for publication of all the results of all the trials on all the uses of all currently-prescribed treatments.
He added that “industry has claimed it is on the verge of delivering transparency for over two decades” and “while obfuscating and delaying, ever more results have been withheld”. Dr Goldacre noted that “some in industry now claim that results from even a decade ago may be lost and inaccessible. This is both implausible and unacceptable”.
Present situation ‘absurd’
He concluded by noting that “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”.
Fiona Godlee, editor-in-chief at the BMJ, wrote: “Congratulations to the PAC for fully comprehending how absurd and damaging the current situation is and for making these important recommendations”. She added that if the DoH does what the committee asks, “ensures access to the full methods and results for all trials on all treatments in current use, this will be a huge contribution to improved public health and patient care”.
Commenting on the report, Bina Rawal research, medical and innovation director at the Association of the British Pharmaceutical Industry, said “it is misleading to suggest that the pharmaceutical industry routinely withholds clinical trial data from doctors and researchers. She noted that in late 2013, an ABPI commissioned study was published in a peer-reviewed journal which highlighted “a positive trend of increasing levels of disclosure for industry-sponsored clinical trials”, with almost nine out of ten of all such studies disclosed by January 31, 2013.
Dr Rawal added that “we recognise that there is still work to be done and we are continuing on a journey to achieving greater clinical trial transparency”.
