To prepare for influenza H1N1 outbreaks, governments across the globe are forking over billions of dollars to Roche Holding to stockpile Tamiflu (oseltamivir), whose original clinical trials showed only mild benefits in fighting seasonal flu. One of the major marketing claims for the drug is that it reduces hospitalization for pneumonia and lower respiratory tract infections, which sometimes accompany severe flu cases.

Today, a new Cochrane Collaboration analysis and British television investigation, jointly published in the British Medical Journal, casts doubt on the evidence behind the pneumonia claim. The reviewers, led by Tom Jefferson, who is also skeptical about the efficacy of the flu vaccine, had demanded Roche turn over the data behind the 10 clinical trials supporting the pneunonia claim, all of which were funded by Roche and only two of which had appeared in the medical literature (and were ghost-written by a medical communications company hired by Roche, according to whistleblowers inside the company). Roche provided limited datasets, leading the Cochrane group to give a vote of no confidence in the claim, just as the Food and Drug Administration and Great Britain's National Institute for Clinical Excellence had done before them.

After being confronted by BMJ and the journalists, Roche promised to post the complete datasets behind the trials on a password-protected website. "In being less then forthcoming with the raw data, Roche has done nothing wrong by current standards and even less by standards of 10 years ago," an accompanying editorial concludes. "It has done exactly what the current system allows."

Far more needs to be done to open the vaults on clinical data, concluded the BMJ editorial:

As well as timely release of summary data once a trial is completed, as required by the FDA Amendments Act, governments should mandate ready access to the raw data behind any analyses used to license and market a drug. They also need to establish mechanisms for dealing with the legacy of unreleased data on drugs already on the market.