Tamiflu correspondence with Roche

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Background

In September 2009 Jefferson first asked Roche for the unpublished dataset used in a Roche supported analysis, published in 2003.

Jefferson needed the data by the following month to update the Cochrane Collaboration’s review on neuraminidase inhibitors in healthy adults.

Jefferson’s October deadline passed. Two months later the Cochrane review, published in the BMJ,[3] said that because eight of the 10 randomised controlled trials on which effectiveness claims were based were never published, the evidence could not be relied on.

The review concluded: "Paucity of good data has undermined previous findings for oseltamivir’s prevention of complications from influenza. Independent randomised trials to resolve these uncertainties are needed.

An accompanying BMJ investigation and analysis article described how Cochrane’s attempt to reproduce an analysis underpinning the use of oseltamivir in pandemic flu hit a brick wall.

In December 2009 Roche promised to make full study reports on the 10 trials available to doctors and scientists.

In October 2012 BMJ editor in chief Fiona Godlee reminded the company, in a letter to board member John Bell, that Roche had still not made the full clinical study reports available.

Displaying 1-10 out of 24 published

redacted correspondence

Competing interests: None declared

Tom Jefferson, Researcher

Cochrane Acute Respiratory Infections Group, Italy

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redacted correspondance

Competing interests: Manufactures Tamiflu

Don MacLean, Life Cycle Leader - Tamiflu

Roche, London

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Jefferson requests that Roche publish the large Tamiflu trial M76001 completed in 1999 and correct the published record of the WV15799 trial.

Competing interests: None declared

Tom Jefferson, Researcher

Cochrane Acute Respiratory Infections Group, Italy

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17 April 2013


Competing interests: Authors of Cochrane review of neuraminidase inhibitors (A159)

Peter Doshi, postdoctoral fellow

Mark Jones, Rokuro Hama, Tom Jefferson, Chris Del Mar, Matthew Thompson, Carl Heneghan

Johns Hopkins University, Baltimore, MD 21205

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16 April 2013

David De Pooter responds to Tom Jefferson et al.

Competing interests: None declared

David De Pooter, ESWI management

European Scientific Working group on Influenza, Belgium

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10 April 2013

Tom Jefferson replies to the MUGAS invitation, and enquires about the " unsolved scientific issues" to which Prof. Osterhaus alludes.

Competing interests: None declared

Tom Jefferson, Researcher

Cochrane Acute Respiratory Infections Group, Italy

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MUGAS reply to the points raised in Chris Del Mar's email from 22nd March 2013

Competing interests: None declared

David De Pooter, ESWI management

European Scientists Fighting Influenze, Belgium

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Each CSR will consist of around 2,000 - 3,000 pages, therefore Roche propose to stagger the delivery of these CSRs over the next few months.

This is concurrent with the offer by MUGAS for collaboration with the Cochrane NI review group (below), but represents a separate agreement by Roche to open up their data to external scrutiny.

Competing interests: Employed by Roche

Don MacLean, Life Cycle Leader - Tamiflu

Roche, London

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28 March 2013

Chris Del Mar replied to David De Pooter

Competing interests: None declared

Chris Del Mar, Professor of primary care research and Coordinating Editor of the Cochrane Acute Respiratory Infections Group

Bond University, Queensland, Australia

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Cochrane respond to Don MacLean's invitation to meet with Roche regarding clinical trial data for Tamiflu.

Competing interests: None declared

Peter Doshi, Researcher

Tom Jefferson, Chris Del Mar, Mark Jones, Rokuro Hama, Carl Heneghan

Cochrane Collaboration, worldwide

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