Open letter to Roche about oseltamivir trial data.

Dear John I am writing to you in your capacity as a member of the board of Roche. As you may be aware, the BMJ has been working with the Cochrane Collaboration in its efforts to get Roche to release the raw data on the effects of oseltamivir (Tamiflu) so that Cochrane can properly fulfil the UK government’s commission for a systematic review of neuraminidase inhibitors based on clinical study reports. To remind you of the background to this, in 2009 the BMJ published the updated Cochrane review of neuraminidase inhibitors in healthy adults. This took the view that, since eight of the 10 randomised controlled trials on which effectiveness claims were based were never published and because the only two that had been published were funded by Roche and authored by Roche employees and external experts paid by Roche, the evidence could not be relied on. The BMJ also published an article summarising the Cochrane team’s efforts to obtain the data from these randomised controlled trials and a feature investigation exploring the underlying issues. 3 After these articles were published, we and the Cochrane Collaboration received public assurances from Roche that the data from these 10 trials would be made available to physicians and scientists. Although some further data have been released to the Cochrane reviewers, the data that were promised (“full study reports”) have not been made available. Below is a table showing which “modules” (sections) of the 10 trials Roche has so far refused to make available.⇓ Also attached is a graphic, taken from a single study report, which explains the kind of content contained in each module of a full study report. This gives an indication of what can be expected in the modules that Roche has as yet not provided. Example of content of each of the five modules of a full study report