Correspondence with the European Medicines Agency


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

 

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

Competing interests: No competing interests

15 July 2013
Tom Jefferson
Researcher
Peter Doshi
Cochrane Neuraminidase Inhibitors Review Group
Rome, Italy
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31

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

Competing interests: No competing interests

15 July 2013
David Mackay
Head of Unit, Veterinary Medicines and Product Data Management
European Medicines Agency
London
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23

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

Competing interests: assessed tamiflu for regulatory purposes

05 March 2013
European Medicines Agency
european drug regulator
Europe
London
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43

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: No competing interests

19 February 2013
Tom Jefferson
Coordinator
Cochrane Vaccines Field
Rome
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36

The EMA responds to Jefferson's query.

Competing interests: No competing interests

18 February 2013
Guido Rasi
Chairman
European Medicines Agency
London
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35

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: No competing interests

03 December 2012
Tom Jefferson
Researcher
The Cochrane Collaboration
Rome
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85