Access to clinical trial information and the stockpiling of Tamiflu - thirty-fifth report of session 2013-14, report, together with formal minutes, oral and written evidence (Paperback)

The full results of clinical trials are being routinely and legally withheld from doctors and researchers by the manufacturers of medicines. 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. Research suggests that the probability of completed trials being published is roughly 50 per cent. And trials which gave a favourable verdict are about twice as likely to be published as trials giving unfavourable results. The Department and 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. There is also no routine sharing between NICE and the MHRA of information provided by manufacturers during the process of licensing medicines. There is still a lack of consensus over how well the antiviral medicine Tamiflu, stockpiled for use in an influenza pandemic, actually works. It is disturbing that regulators do not appear to have access to all the available information. Before spending money in future to maintain the stockpile the Department needs to review what level of coverage is appropriate. It should look at the level of stockpiling in other countries, bearing in mind that the patent for the medicine runs out in 2016.