After a battle lasting more than three years, Roche has finally given in to a campaign from the BMJ and the Cochrane Collaboration to hand over its Tamiflu data.
In a statement the BMJ said that it “is at last being granted access” to 74 Roche-sponsored trials of the influenza drug Tamiflu (oseltamivir) after originally asking for the data in 2009.
Both the BMJ and the Collaboration argue that many of the trials have not been made available for public scrutiny and are concerned it may not be efficacious, even though the governments around the world have spent billions of pounds on stockpiling the medicine.
The BMJ said that in an email to the Cochrane researchers on 2 April, Roche said they would provide “each CSR [clinical study report]” over the next few months. The reports, however, will be edited by Roche “to ensure patient confidentiality and to protect legitimate commercial interests”.
Sile Lane, director of campaigns at Sense about Science, one of the founding members of the AllTrials register, says: “It shouldn’t have taken the researchers years of persistence and publicity to get [access to] these Tamiflu results.”
The BMJ said this was “all” of the data, but both the Cochrane Collaboration and Bad Pharma author Dr Ben Goldacre have voiced their concerns that this may not be the case.
Both said that they are concerned that data redaction and other problems may make analysis and interpretation “impossible” and point out that Roche has previously promised access to data, but not followed through.
The long path for data
In December 2009, Roche gave the Cochrane group access to one part of ten Tamiflu trials - far from the full set of 74.
Carl Heneghan, one of the Cochrane reviewers, said the group was told by Roche that “you have all the detail you need to undertake a review and so we have decided not to supply any more detailed information”. He adds the fact that the 74 studies are now being released “undermines these original statements”.
In March 2013, just after the PharmaTimes debate on this very issue Roche, which attended the debate and expressed their wish to do more with transparency, said they had appointed various third parties to review the data on Tamiflu, identify any gaps and invited the Cochrane Collaboration to participate.
The so-called Multiparty Group for Advice on Science (MUGAS) will be organised by the European Scientific Working Group on Influenza Funded by an unrestricted grant from Roche. The group is due to meet on 18 June.
The Cochrane collaboration has, however, asked for further clarification before deciding whether they will accept the invitation. They are also concerned that three of four key MUGAS partners are in fact advisors to Roche.
Tom Jefferson, one of the Cochrane reviewers, said: “The roles of public health bodies, researchers, governments, experts and the media in promoting [Tamiflu] need to come under public scrutiny”.
He added: “The last three years have shown that industry key opinion leaders have contributed in preventing access to the full trial dataset and obscuring accountability for decisions made”.
Professor Osterhaus, one of the key members of MUGAS and a Roche scientific advisor, told the Cochrane group that their concerns were “misplaced” and that some Cochrane groups openly declare their collaboration with industry, “knowing that transparent cooperation […] is a powerful tool to move things forward”.
He suggest that they stop wasting “precious energy to this pointless discussion about scientific integrity and instead engage in a constructive collaboration to address urgent health issues”.