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Drug giant agrees to release all Tamiflu trial data

Roche agrees to release 74 trials data after three-year battle

Adrian O'Dowd

Friday, 05 April 2013

The drug giant Roche has agreed to release data on all of its 74 clinical trials of the influenza drug oseltamivir (Tamiflu) after three years of debate.

The BMJ, which has been running an ‘open data’ campaign revealed that Roche has agreed that it will grant access to the Cochrane Collaboration for all 74 Roche-sponsored trials of Tamiflu. 

In an email to the Cochrane researchers on 2 April, Roche said it would provide “each CSR [clinical study report]” over the next few months and the reports would be edited by Roche “to ensure patient confidentiality and to protect legitimate commercial interests”.

The Cochrane group has welcomed the move, but said it was concerned that data redaction and other problems could make analysis and interpretation impossible.

The company promised three years ago to make key trial data on Tamiflu available for independent assessment, but since then the Cochrane Collaboration has still not gained full access to the data.

In December 2009, Roche gave the Cochrane group access to just one part of 10 Tamiflu trials.

Carl Heneghan, one of the Cochrane reviewers, told the BMJ that the group was told by Roche: “You have all the detail you need to undertake a review and so we have decided not to supply any more detailed information” but he added that the fact the 74 studies were now being released undermined those original statements.

Last month, Roche said it had appointed various third parties to review the data on Tamiflu, identify any gaps and invited the Cochrane Collaboration to participate.

A 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 and the group is due to meet on 18 June.

The Cochrane collaboration has, however, asked for further clarification before deciding whether it will accept the invitation.

Tom Jefferson, an independent epidemiologist and one of the Cochrane reviewers, said: “The roles of public health bodies, researchers, governments, experts and the media in promoting oseltamivir need to come under public scrutiny.

“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”.

A spokesperson for Roche said: “I can confirm that in line with our transparency policy, we have reached out to the Cochrane Collaboration to provide them with all 74 clinical study reports.”

Sile Lane, director of campaigns at Sense about Science, said: “It shouldn’t have taken the researchers years of persistence and publicity to get [access to] these Tamiflu results.”

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