This page displays the following correspondence:
- BMJ editor in chief Fiona Godlee's October 2012 letter to Roche board member John Bell, plus a follow-up email sent on December 6, reminding him he had yet to respond
- Cochrane Collaboration researcher Tom Jefferson's emails to Roche about the missing data, dating back to September 2009
- A reactive statement issued by Roche to the media about the BMJ's Tamiflu open data campaign. On 8 November Peter Doshi, Tom Jefferson and colleagues wrote to Roche saying it contained misleading statements
- Roche's letter to Professor Chris Del Mar, in his capacity as a Cochrane Collaboration editor. The letter announces the establishment of an advisory board to look at the Tamiflu data. Also included is the Cochrane Collaboration's response, sent on 26 November
Background
In September 2009 Jefferson first asked Roche for the unpublished dataset used in a Roche supported analysis, published in 2003.
Jefferson needed the data by the following month to update the Cochrane Collaboration’s review on neuraminidase inhibitors in healthy adults.
Jefferson’s October deadline passed. Two months later the Cochrane review, published in the BMJ,[3] said that because eight of the 10 randomised controlled trials on which effectiveness claims were based were never published, the evidence could not be relied on.
The review concluded: "Paucity of good data has undermined previous findings for oseltamivir’s prevention of complications from influenza. Independent randomised trials to resolve these uncertainties are needed.
An accompanying BMJ investigation and analysis article described how Cochrane’s attempt to reproduce an analysis underpinning the use of oseltamivir in pandemic flu hit a brick wall.
In December 2009 Roche promised to make full study reports on the 10 trials available to doctors and scientists.
In October 2012 BMJ editor in chief Fiona Godlee reminded the company, in a letter to board member John Bell, that Roche had still not made the full clinical study reports available.