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
Tamiflu (oseltamivir) is a neuraminidase inhibitor, developed by Roche, for the treatment of seasonal and pandemic influenza. Yet for the first time a comprehensive review of the data, by independent researchers, has shown that the claims for Tamiflu’s effectiveness have been overestimated, and that harms have been underreported.
Here is the audio of a recent press conference where researchers and The BMJ's editors describe the findings of that research, and the systematic regulatory failures those findings expose.
Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments
Zanamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments
Multisystem failure: the story of anti-influenza drugs
Oseltamivir: the real world data
The Tamiflu trials
Neuraminidase inhibitors for influenza
Cochrane review questions effectiveness of neuraminidase inhibitors
The ability of the independent researchers, the Cochrane’s Acute Respiratory Infections Group, to analyse the dataset is the endpoint of a 5 year campaign by them, and The BMJ, to obtain access to the full data set held by Roche.
Here was document that campaign.
We are also committed to increasing transparency, so are making the full CSR dataset used by the Cochrane Collaboration in its latest analysis online - doi:10.5061/dryad.77471. We are also making the peer review history of the research papers available to external scrutiny, via links from the relevant article pages.
Tamiflu – a history of data availability
Developed in the 1990s, and licenced by the US Food and Drug Administration (FDA) in 1999; it was during the 2009 H1N1 pandemic influenza outbreak that attention was drawn to the drug, as governments around the world began to stockpile billions of dollars worth of Tamiflu.
During the development of Tamiflu, 84 clinical trials were carried out by Roche, but as the Cochrane’s Acute Respiratory Infections Group discovered, much of the data from those trials was never seen by the governmental agencies who made the decision to stockpile Tamiflu, let alone independent researchers who were attempting to meta-analyse the data
The timeline of key events
Below is an interactive timeline of events, showing the key points in the decision making process, links to articles articles, and access to the data.
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.