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Ensuring safe and effective drugs: who can do what it takes?

Carl Heneghan
Last edited 12th January 2011

Today in the BMJ we have published on the current saga of ensuring the data and the problems we have found with the inconsistencies between what is published and what is in the Clinical study reports

In the last six months I have been working with a collabaration which includes Peter Doshi, Tom Jefferson Chrsi Del Mar, Matthew Thompson and a few other folk round the world. We have been busy returning to the problems with the evidence-base of Neuraminidase Inhibitors (e.g tamiflu) used extensively last year for swine flu and this year.

We met in Oxford in September to work out the methods for the analysis, this is what Tom Clarke of Channel 4 reported about the meeting at the time:

‘An international group of scientists has today raised further concerns about the lack of evidence supporting the safety and effectiveness of the blockbuster anti-flu drug Tamiflu.’

Our proposed new approach involves compiling a complete list of drug trials (published and unpublished) and requesting full clinical study reports. We have published a full protocol of what we are trying to do, prepared by the Acute Respiratory Infections Cochrane Review Group is available This will appear in issue 1, 2011 of the Cochrane Database of Systematic Reviews, due to be released on 19 January 2011.

"We do not yet know whether sound scrutiny is feasible with a journal's resources, but we intend to use the proposed review of neuraminidase inhibitors to attempt to quantify these tasks. We will be keeping a journal of our review with a resource tally, and proposing methods for in-depth scrutiny of a whole trial programme of a new drug. It is time the media, the Cochrane Collaboration, and any reader interested in knowing what they are prescribing or are being prescribed increase the pressure on policy makers. If you swallow a medication, you need to know how it works - for real."

We are therefore proposing a new approach that would allow in-depth scrutiny of the complete set of trial data for a new drug. As a result, Roche (oseltamivir’s manufacturer) publicly pledged to make full results for ten unpublished clinical trials available for scrutiny. Yet, to date, they have failed to fulfil this promise.

We are urging you as researchers, the public, and the media to work together to put pressure on industry to embrace the ethical responsibility to release data in the public interest. We are also calling on medical journals to require submission of the most detailed report available to allow independent scrutiny.

If you’ve got time we’d like you to comment on the protocol – the more feedback the better. Comments and feedback, should be send back to: cdelmar@bond.edu.au; jefferson.tom@gmail.com

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