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by Robert MacKay, Tuesday, December 11, 2012 | Categories: Tamiflu

The editor or the BMJ has written to the chairman of NICE requesting that they withdraw their recommendation on Tamiflu. While we support the open data campaign by the BMJ, we are not supportive of the NICE recommendation being withdrawn prior to the review of the data that have been withheld by Roche. It is our view that Roche must comply with its promise made back in 2009 to provide access to all data relating to oseltamivir, the active ingredient in Tamiflu. GSK, the manufacturer of Relenza, has already promised to make anonymised patient level data available to researchers. This level of access really should be the norm; it is actually outrageous that commercial organisations can withhold this sort of information from genuine interested parties such as academics, the medical profession and regulators such as NICE. Issuers of marketing authorisations can request this information but we understand that no request was made by the European Medicines Agency for these data. The recent infringement proceedings brought against Roche by the EMA would suggest that the company itself has not even properly evaluated the data gathered. We know from clinical practice that Tamiflu works but the profession and regulators need to know the full story.

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