BMJ editor urges Roche to fulfil promise to release Tamiflu
trial data
Journal launches open data campaign to compel greater
accountability in healthcare
In an open letter to company director, Professor Sir John
Bell, she says: "Billions of pounds of public money have been spent on
[Tamiflu] and yet the evidence on its effectiveness and safety remains hidden
from appropriate and necessary independent scrutiny."
The letter is published on the BMJ's website
(bmj.com/tamiflu ) alongside correspondence by the Cochrane team with Roche,
the US Centres for Disease Control (CDC) and the World Health Organisation
(WHO), as part of an open data campaign aimed at persuading Roche to give
doctors and patients access to the full data on Tamiflu.
Dr Godlee's letter follows recent reports that the European
Medicines Agency (EMA) has initiated infringement proceedings against Roche to
investigate deficiencies in safety reporting, including the processing of
around 80,000 reports on suspected adverse drug reactions.
Dr Godlee is also one of 28 signaturies to a letter
published in The Times today (thetimes.co.uk/letters) calling on drug companies
to "come clean" and make clinical trial data for all drugs in current
use available to healthcare professionals.
Pressure from politicians is also mounting. Last week, Sarah
Wollaston, a GP and Conservative MP, raised the issue of missing data in
Parliament, while Health Minister Norman Lamb has agreed to meet experts to
discuss the issue of access to clinical trial data.
In December 2009, Roche made a public promise to release
full clinical trial reports of its antiviral drug oseltamivir (Tamiflu) in
response to a major investigation by the BMJ and researchers Peter Doshi and
Tom Jefferson from the Cochrane Collaboration.
The investigation found no clear evidence that Tamiflu
prevents complications like pneumonia in healthy people. It also raised serious
concerns about access to drug data, the use of ghost writers in drug trials,
and the drug approval process.
Since the investigation, some further data have been
released to the Cochrane reviewers, but the full data set has still not been
provided.
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