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Professor Sir Alasdair Breckenridge CBE Medicines and Healthcare products Regulatory Agency Market Towers, 1 Nine Elms Lane London SW8 5NQ
4 May 2004
Dear Sir Alasdair,
The MHRA posted on its website this morning a Question & Answer document which included inter alia the following statement:
Havent there been recent criticisms of the Yellow Card Scheme in the media, particularly with regard to the issue of SSRIs and suicidal thoughts and self-harm?
An article recently published by Mr Charles Medawar and Dr Andrew Herxheimer - A comparison of drug reaction reports from professionals and users, relating to the risk of dependence and suicidal behaviour, expressed concerns about the miscoding of reactions reported through the Yellow Card Scheme and about proper follow up of reports. The criticisms of the coding and follow up of reports are unfounded. MHRA has robust procedures in place to ensure that reports of adverse reactions are accurately coded and where necessary, further information is obtained from the reporter.
This statement is clearly defamatory, but I assume you are prepared to defend it, and Im now writing to ask you to provide the evidence on which you rely:
1. Please supply me with a copy of any analysis or analyses of our paper that was/were carried out by or on behalf of the MHRA, on which this assessment of our work is based, indicating the date(s) on which such analyses were done.
2. Please explain why the MHRA made no effort to contact either me or Dr Herxheimer, to draw our attention to your concern that our criticisms were unfounded, and to invite us to respond and/or correct any unfounded inferences and assertions.
3. Please say whether the MHRA made any effort to communicate with the International Journal of Risk & Safety in Medicine, with a view to publishing either some refutation of our paper, and/or to giving evidence of the effective working of the robust procedures to which your Q&A document refers.
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