Correspondence with the European Medicines Agency

Correspondence sent from Tom Jefferson to the European Medicines Agency on 3 December 2012.

Displaying 1-6 out of 6 published

Tom Jefferson and Peter Doshi appeal the EMA's decision not to release data.

Competing interests: None declared

Tom Jefferson, Researcher

Peter Doshi

Cochrane Neuraminidase Inhibitors Review Group, Rome, Italy

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The EMA's decision on Tom Jefferson's request for data.

Competing interests: None declared

David Mackay, Head of Unit, Veterinary Medicines and Product Data Management

European Medicines Agency, London

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EMA responds to Jefferson's email dated 12th of February 2013

Competing interests: assessed tamiflu for regulatory purposes

European Medicines Agency, european drug regulator

Europe, London

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Tom Jefferson responds to the letter from the EMA (below). He believes it shows that they are not comfortable taking a strong position with respect to Tamiflu's effect on risk of complications, though it does not appear that they have carried out their own analysis to confirm the fact, and are accepting Roche's analysis at face value. This reply requests more documentation regarding this from the EMA.

They do however state unambiguously that Roche's clinical trial does not show that Tamiflu reduces transmission as has been claimed in the past.

Competing interests: None declared

Tom Jefferson, Coordinator

Cochrane Vaccines Field, Rome

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The EMA responds to Jefferson's query.

Competing interests: None declared

Guido Rasi, Chairman

European Medicines Agency, London

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In the letter, Jefferson explains that the points the Cochrane Collaboration would like to discuss are the effects of Tamiflu both in the treatment and post exposure prophylaxis (PEP) of influenza as well as the drug’s mode of action.

Competing interests: None declared

Tom Jefferson, Researcher

The Cochrane Collaboration, Rome

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