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.
The bottom line:
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.
By October 2013 the Cochrane reviewers had received the full Clinical Study Reports for 107 studies from the European Medicines Agency (EMA), GlaxoSmithKline and Roche.
The Cochrane review was published in April 2014, both on the Cochrane Library and in shortened version as two separate reviews (one per compound) in the BMJ.
Editor's Choice: The missing data that cost $20bn.
Analysis. Oseltamivir: the real world data.
Analysis: Multisystem failure: the story of anti-influenza drugs.
Feature: Tamiflu: “a nice little earner”.
In addition to the reviews and the correspondence in this web section, the Cochrane and editorial teams have made available the complete sets of 107 full clinical study reports on Dryad and the complete set of peer reviewers’ comments from 2009, making this probably the best documented and most transparent review ever undertaken and certainly the first one to use a full regulatory dataset
1. Smith, J: Roche point-by-point response from Roche to BMJ questions (BMJ 2009;339:b5374)
2. Cohen D. Complications: tracking down the data on oseltamivir (BMJ 2009 Dec 8;339:b5387)
3. Doshi, P: Neuraminidase inhibitors - the story behind the Cochrane review (BMJ 2009;339:b5164)
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)
We have created an interactive timeline that shows articles about Tamiflu which were published in the BMJ, between 2003 and 2012.
We have so far included the major influenza outbreaks, and will continue to add other external events.