Tag Archives: pharma

BMJ wants raw data for all drug trials to be shared

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).

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.”

Archive offers drug industry documents online

In correspondence earlier this month, Kim Klausner, of the University of California, San Francisco Library and Center for Knowledge Management, suggested that reporters should be aware of the Drug Industry Document Archive.

Klausner, the industry documents digital library manager, sent a complete guide to what’s available, the history of DIDA and lots of examples of how reporters and others have used DIDA that is available on HealthJournalism.org.

The archive, available to anyone with access to the Internet, contains about 2,500 pharmaceutical industry documents submitted by “lawyers representing people who file law suits against drug companies and Congressional committees investigating the pharmaceutical industry,” according to Klausner.

William Heisel of the Antidote blog is doing a series of posts that show how the archive can be used to research stories. Heisel’s example uses depositions from a case against Wyeth over side effects of its hormone replacement therapy drugs.