The BMJ's  open data campaign  aims to achieve appropriate and necessary independent scrutiny of data from clinical trials. Working with others, we seek to highlight the problems caused by lack of access to data, and we welcome any suggestions on how to take things further.

The Tamiflu story

Our first open data campaign initiative relates to a public promise Roche made in 2009 to release full clinical trial reports in response to an investigation by the BMJ and Cochrane collaborators Peter Doshi and Tom Jefferson. [1][2][3][4]

The bottom line:

• WHO recommends Tamiflu, but has not vetted the Tamiflu data.
• EMA approved Tamiflu, but did not review the full Tamiflu dataset.
• CDC and ECDC encourage the use and stockpiling of Tamiflu, but did not vet the Tamiflu data.
• The majority of Roche's Phase III treatment trials remain unpublished over a decade after completion.
• In Dec 2009, Roche publicly promised independent scientists access to "full study reports" for selected Tamiflu trials, but to date the company has not made even one full report available.

Releasing the trial reports would allow independent academics to answer questions about this globally stockpiled drug. To date, the full data set has not been provided.

This page links to others listing open correspondence with Roche, and the various bodies around the world which licence or recommend drugs. This open correspondence of letters offers readers the chance to witness attempts to compel greater accountability and responsibility in public health decision making and policy. The BMJ plans to launch other campaigns linked to its investigations in the future. Find out more about the background to Tamiflu and open data by reading this feature and accompanying editorial.

What's new

• The MUGAS meeting has taken place, where questions about the quality of the data collected in Tamiflu trials was questioned. Trish Groves, BMJ deputy editor, took part in that meeting and has written a BMJ blog which describes the output.

  Now the team behind MUGAS, including some of the original investigators of Tamiflu sponsored by Roche, will undertake a meta-analysis of both published and unpublished data. Concurrently, the Cochrane Neuraminidase Review Group have gained access to unpublished trials, and will be updating their own analysis previously published in the BMJ.

• See correspondence with the European Medicines Agency
• See the Cochrane Collaboration's complaint to the European Ombudsman
• Tom Jefferson writes to Rt Hon Margaret Hodge MP, Chair of the UK Parliament's Public Accounts Committee to describe his disquiet over the comments made by the regulator and Chief Medical Officer during the committee's recent hearing

References:

1. 1. Smith, J: Roche point-by-point response from Roche to BMJ questions (BMJ 2009;339:b5374)
2. 2. Cohen D. Complications: tracking down the data on oseltamivir (BMJ 2009 Dec 8;339:b5387)
3. 3. Doshi, P: Neuraminidase inhibitors - the story behind the Cochrane review (BMJ 2009;339:b5164)
4. 4. Jefferson T, Jones M, Doshi P, Del Mar C: Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis (BMJ 2009;339:b5106)