Oct 24, 2014

On the road of information disclosure

As we discussed in previous entries of our Blog, clinical trial results are being routinely withheld from doctors, researchers and patients, which undermines the ability to make informed decisions about treatments, even if regulators and the industry have made proposals to open up access.

It is quite worrying that only 50% of completed trial results are published as is concluded by an influential parliamentary committee after making a public report which examined the Department of Health's decision to spend £ 424m on stockpiling the flu drug Tamiflu, before writing off £ 74m Because of poor record keeping.

Research also suggests that trials which gave a favorable verdict are about twice as likely to be published as trials giving unfavorable results and “this is of extreme concern to this committee” as Richard Bacon, a senior member, said. Dr Fiona Godlee, editor-in-chief of the British Medical Journal, told the MPs that the journal had published very clear summaries of systematic reviews of data on individual medicines or classes of medicines where, "when you add together the published and unpublished evidence, you get a very different picture of the quality and effectiveness of those drugs".

For Richard Bacon “The department [of health] and Medicines and Healthcare products Regulatory Agency [MHRA] must make sure that clinical trials are registered and the full methods and results of all trials are available for independent wider scrutiny by doctors and researchers." Bacon continues on to say that if this is not done in a prospectively and retrospectively way, it will 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.

The non-profit Cochrane Collaboration conducted a review of 20 existing studies about Tamiflu, and found that it did not reduce influenza-related lower respiratory tract complications but did induce nausea. Study is currently being completed through full clinical study reports from manufacturer Roche and should be used by government, the MHRA and the National Institute for Health and Care Excellence to review the drug's use.

Bacon added: "There is still a lack of consensus over how well the antiviral medicine Tamiflu, stockpiled for use in an influenza pandemic, actually works. The case for stockpiling antiviral medicines at the current level is based on judgment rather than on evidence of their effectiveness during an influenza pandemic”. He thinks that “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."

An MHRA spokesman said they would work with partners in the UK and in the EU to ensure greater transparency in the dissemination of clinical trials information.


Written by Dra. Belén Suárez Jiménez for The All Results Journals

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