Tamiflu Efficacy, Safety in Doubt, Says BMJ
http://www.bmj.com/content/345/bmj.e7304
The BMJ is also intensifying its efforts to help resolve a three year battle to gain access to the full data on oseltamivir (Tamiflu). In 2009 the Cochrane respiratory group, led by Tom Jefferson, was commissioned by the UK government to update its systematic review of neuraminidase inhibitors. Despite a public promise to release “full study reports” (internal company reports) for each trial, each of which can run to thousands of pages,8 Roche has stonewalled, variously pleading patient or commercial confidentiality, or claiming that sufficient data have already been provided.9
In fact the Cochrane group has told the BMJ that about 60% of Roche’s data from phase III trials of oseltamivir have never been published. And although the European Medicines Agency (EMA) could have requested these data from Roche, it did not do so. This means that tax payers in the United Kingdom and around the world have spent billions of dollars stockpiling a drug for which no one except the manufacturer has seen the complete evidence base. Indeed the EMA’s unprecedented infringement proceedings launched against Roche last month suggest that even the manufacturer has never fully evaluated evidence it has collected on the drug’s adverse effects.10 What has Roche got to hide?
Two weeks ago in an attempt to break the deadlock, the BMJ wrote to one of the UK’s leading academics, John Bell, regius professor of medicine at Oxford University, who is a member of Roche’s board of directors. The letter is published this week.11 In a response not for publication, Bell said he has referred the matter to Roche and is awaiting a response./.../
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