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

18 June 2004


Dear Sir Alasdair,

I’m replying to your belated response to my letters of 4 May and 8 June. I note that you take personal responsibility for the allegation that our "criticisms of the coding and follow up of reports are unfounded", and that this statement is still on the MHRA website. Your letter failed to explain why you did not contact either Dr. Herxheimer or me at any stage after the publication of our paper, nor why you made no response or representations to the International Journal of Risk and Safety in Medicine. Six months have elapsed since publication and you have not produced a shred of evidence to justify your assessment of our work.

Taking into account the very different roles you and I have played in the unfolding of this regulatory fiasco, I have to concede your point about defamation. When it comes to SSRI antidepressants, the credibility of the MHRA is such that I would be very hard put to claim personal loss or distress: it would be like trying to persuade a court that I had suffered terribly after a flogging with a wet lettuce leaf.

I object to the Agency’s ‘opinion’ because, by denouncing our work, you seriously misrepresent the risks of paroxetine and the MHRA’s ability to contain them. The MHRA hasn’t the evidence to substantiate this ‘opinion’, but passes it off as a sober and considered judgment about the safety of paroxetine, and the competence of the authorities and the value of the systems they rely on. But the facts are ugly and there is more to come, and the Agency’s own motives do not bear examination. My opinions are at least evidence-based. See Medicines out of Control? I think I’ve made a very reasonable case for suggesting you might resign, and your letter removes the remaining doubts I had.

I would not be at all happy to join in the discussion you propose at the end of your letter, before seeing your written and detailed assessment of how the MHRA actually dealt with the coding and follow-up of the sample of paroxetine Yellow Cards that Dr Herxheimer and I examined. I feel sure that we accurately described how the MHRA analysed the paroxetine Yellow Cards. To accept any proposal to talk before you produce good evidence to the contrary would be to yield to an offer that seems evasive and condescending.

Yours sincerely,
Charles Medawar