Authors from the influential Cochrane Collaboration for medical-evidence reviews are once again accusing a leading pharma company of failing to provide vital evidence on the efficacy of flu drugs.
Iain Chalmers, one of the founders of the international Cochrane Collaboration, told a conference on research integrity in London that a review of treatments for influenza out on 18 January will state that Roche would not comply with requests to provide additional data on its drug Tamiflu.
The Cochrane Collaboration has experts assess all of the research on specific medical treatments and is often referred to as a ‘gold standard’ of medical evidence. Its reviewers tasked with assessing influenza drugs have had a long-running spat with Roche.
A previous Cochrane review on Tamiflu and a rival drug manufactured by GlaxoSmithKline (GSK) was withdrawn in 2010, on the grounds that “the results are now out-of-date and we realise that the information therein (which has the potential for being used for policy decisions) could be used inappropriately”.
In an article published last year in the British Medical Journal (BMJ), some of the authors of that review detailed problems obtaining data from Roche. And some of the same researchers also reported problems with Roche back in 2009.
They then wrote, in a meta-analysis of the evidence for the BMJ, that when they were preparing their 2009 update of the Cochrane review, the company was “not able to unconditionally provide the information as quickly as we needed it to update this review”.
In their 2011 article they note that only two of ten manufacturer trials on Tamiflu have been published, although a meta-analysis of all ten has been published.
Members of the group are now asserting that, whereas GSK provided all data requested for the latest review, Roche “refused to provide more than portions” of the data.
Roche has consistently denied any wrongdoing. A statement released by the company today said that it had provided the Cochrane group with access to 3,200 pages of “very detailed information enabling their questions to be answered”.
“Roche has made full clinical study data available to health authorities around the world for their review as part of the licensing process,” said the company. “Roche stands behind the robustness and integrity of our data supporting the efficacy and safety of Tamiflu.”