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recommendation being withdrawn prior to the review of the data that have been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.