But does it work?

The Public Accounts Committee of the British House of Commons has just released a report on access to clinical trial information, especially in the context of stockpiling the influenza anti-viral, Tamiflu, for use in future pandemics. Their summary says

The Department of Health (the Department) spent £424 million on stockpiling Tamiflu, an antiviral medicine used in the treatment of influenza, for use in a pandemic, but had to write off £74 million of its Tamiflu stockpile as a result of poor record-keeping by the NHS.

There is a lack of consensus over how well Tamiflu works, in particular whether it reduces complications and mortality. Discussions over this issue among professionals have been hampered because important information about clinical trials is routinely and legally withheld from doctors and researchers by manufacturers. 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. There are also concerns about the information made available to the National Institute for Health and Care Excellence (NICE) which assesses a medicine’s clinical and cost–effectiveness for use in the NHS.

The information from the clinical trials is, finally, being released: the director of the Cochrane Library says (at AllTrials)

The Cochrane Collaboration – who gained full access to all documents held by European regulators – discovered that many large trials on Tamiflu have not reported results and that for many more trials only partial information was available. Cochrane is now receiving full clinical study reports from Roche. This new information is being assessed by the twelve international researchers who make up the Cochrane Collaboration neuraminidase team, funded by the National Institute of Health Research. They are close to submitting the updated evidence for peer review. The findings will for the first time provide what the PAC calls for, ‘independent scrutiny of a medicine’s effectiveness.’ 

Tamiflu is one of the charismatic megafauna of the publication bias problem: it’s not that research into influenza is especially bad, it’s that this is one issue where it’s possible to make governments take notice.