BMJ wants raw data for all drug trials to be shared

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

Under the headline “We want raw data, now,” BMJ editor Fiona Godlee recounts the story of how BMJ had to pressure a drug company into releasing full study reports verifying their claims as to the effectiveness of oseltamivir (Tamiflu).

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Tamiflu. Photo by Richard Sunderland via Flickr.

Godlee says that researchers updating their Cochrane review of the drug “failed to verify claims, based on an analysis of 10 drug company trials, that oseltamivir reduced the risk of complications in healthy adults with influenza. These claims have formed a key part of decisions to stockpile the drug and make it widely available.”

Only after Roche was questioned by the BMJ and Channel 4 News did the manufacturer commit to making “full study reports” available. Godlee says that some questions remain, including how patients were recruited and why some neuropsychiatric adverse events were not reported.

Godlee argues that “it can’t be right that the public should have to rely on detective work by academics and journalists to patch together the evidence for such a widely prescribed drug,” saying that “Individual patient data from all trials of drugs should be readily available for scientific scrutiny.”

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