lunes, 28 de enero de 2013

ROCHE esconde.../ "podría no curar sino matar" (cont)



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.



ROCHE esconde.../ "podría no curar sino matar"

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