An influential review that is due out tomorrow will not contain up-to-date efficacy information about Tamiflu, the widely used influenza drug sold by Roche, because researchers at the Cochrane Collaboration say they were stymied by the drugmaker in their efforts to fully assess the medication, according to reports.
Iain Chalmers, one of the founders of the Cochrane Collaboration, a non-profit group dedicated to analyzing medical evidence, last week told a conference on research integrity in London that a review of influenza treatments will state that Roche would not comply with requests to provide additional data, Nature writes.
“We have invested millions of pounds on stockpiling Tamiflu on the basis of a paper that presented the results of 12 trials, only two of which have been published. The investigation… shows Roche refused to provide data to evaluate these trials. Investigators got some data through the European Medicines Agency, but this doesn’t answer all of the questions they have,” he tells The Independent. “It is a disgrace that Roche have not provided this data.”
This is not the first time that the Cochrane scientists have tangled with Roche. An earlier review about Tamiflu and the Relenza drug made by GlaxoSmithKline was withdrawn in 2010, as the researchers made clear in two different pieces in BMJ in which they complained about unpublished studies the drugmaker would not release (see this and this).
Tom Jefferson, the lead author of the study, tells The Independent he was concerned that the European Medicines Agency, which approved Tamiflu, only saw some trial results and the FDA is believed not to have reviewed the largest ever trial of Tamiflu when the med was being considered for approval.
A Roche spokesperson tells the newspaper that full clinical study data was made available to regulators for review as part of the approval process, and that all completed Roche-sponsored studies on safety and efficacy were available as peer-reviewed publications or in summary form. The Cochrane researchers were also given access to 3,200 pages of detailed information. “Roche stands behind the robustness and integrity of our data supporting the efficacy and safety of Tamiflu,” Roche says.
We will see what tomorrow brings, yes?