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Professor Sir Alasdair Breckenridge CBE
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

29 September 2004


Dear Sir Alasdair,

Further to our conversation yesterday, I am writing to you in connection with the MHRA’s assessment of the paper Andrew Herxheimer and I published late last year in the International Journal of Risk & Safety in Medicine (2003, 16, 3-17). The title of this paper is, incidentally, wrongly cited on the MHRA website: the title is "A comparison of adverse drug reaction reports from professionals and users, relating to risk of dependence and suicidal behaviour with paroxetine". I refer specifically to the following text, posted on the MHRA website since 4 May:

Haven’t 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.

I have made repeated requests to see the evidence on which the MHRA has alleged that our "criticisms of the coding and follow up of reports are unfounded". In the nine months since publication of our paper, the MHRA has provided no evidence to explain or justify this claim. Yesterday, you again proposed a meeting to discuss the matter, and again I made clear that I would want to meet to discuss the issue only after I had had an opportunity to review the evidence on which the MHRA’s allegation is based. I have already explained why: you made public your assessment of our work; now you should make public the evidence on which that assessment was based. The imperative to publish seems all the greater for an Agency with prominent responsibilities for public health that claims science- and evidence-based credentials.

To break this deadlock, and in the interests of intellectual hygiene and transparency more generally, I am now making a formal request under the Code of Practice of Access to Government Information: please supply copies of all disclosable documentation specifically relating to the allegation that our published findings were unfounded, including all appraisals and analyses of the evidence in our paper, and all notes, memoranda and communications relating thereto.

To forestall the possibility that the Agency further delays in responding substantively to what is surely a reasonable request (i.e. by suggesting it would cost too much or take too long to provide the requested documents), I wish to make a further, separate request under the Code, as follows: please supply copies of any readily available document, prepared before 5 May 2004, on which the Agency relies and/or relied to reach the conclusion that our published criticisms were unfounded.

In relation to both of the above requests, I should also like to forestall any response along the lines of "Medawar and Herxheimer didn’t see the full Yellow Card information." In response to a specific request I made about the contents of the ASPPs we were sent, the MHRA (Sarah Walk) confirmed on 6 August 2003, that we had been sent all information received by the Agency, both from the original report and any follow-up.

"Q7 – The ASPP will include all information received in relation to that report – whether the information was provided in the initial report, sent unprompted by the reporter, or in response to a request for follow up. The ASPP does not necessarily state whether information was provided in the initial report or on follow up although in some circumstances there will be a comment to the effect that certain information was provided on follow up.

Q8 – The truncation of text was purely a mechanical problem. There was no other editing of the text before it was sent."

It might help to reduce tension at our joint speaking engagement in Bournemouth next week, if you were to communicate by return that you would expect to meet at least the second of these requests within the usual maximum of 20 working days. I think I’ve already had to wait far too long for an honest answer to a straight question, which is quite centrally related to the issues to be discussed on Panorama, this Sunday.

I look forward to hearing from you.

Yours sincerely,

Yours sincerely,
Charles Medawar