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Mr Roy Alder, Head of Executive Support
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

29 September 1998

Dear Mr Alder,

Thank you for your 8 September reply to my letter of 21 August, i.e. the follow up to your reply of 17 August to my letter of 29 June.

1. Thank you for telling me that the organisation that requested confidentiality was not the CSM. Your letter was a potent reminder they had no absolutely no need to.

2. Thank you for sending me the one-page statement from the Post-Licensing Division about The Antidepressant Web. In previous correspondence, I have used the word "incompetence" more tentatively than I would be inclined to on this occasion - for reasons I will elaborate elsewhere. As a representation of the issues discussed in my paper, it was trivial; it seemed more of an invitation to discount the risks there appear to be. I expect to be writing to the Post Licensing Division; I do not think this is one for you.

3. When I was in short pants, I can remember seeing WWII films in which heroic British officers, when interrogated by the enemy, would steadfastly refuse to impart more information than "name, rank and number". But this is not war and that was many years ago. The refusal to disclose any information about, or arising from, such an important discussion involving the whole UK drug control system is pretty stunning. It makes me think we are heading for the courts.

4. You would have noticed that Graham Dukes is editor of the IJRSM, the learned journal in which The Antidepressant Web was first published. When he was Vice-Chairman of the Dutch equivalent of the MCA, in 1979, Dukes wrote a characteristically brilliant Side Effects of Drugs Essay, which vividly explained the need for regulators to be able to think in peace. I am certain he is right, but there is a price to be paid to for it: public confidence and the reasonable expectation that the regulators are going to do a good, thorough job. In both respects, the MCA/CSM's account seems deeply in the red.

One problem with all this secrecy is that it obscures the extent to which the CSM/MCA may be tackling genuine uncertainties, as opposed to wriggling and spinning its way out of trouble and taking unreasonable advantage of the ignorance and inertia on its side. My reading of this whole correspondence makes me feel like Chief Deckchair Attendant on RMS Titanic. The combination of bull and guff, with ritual secretion of everything of substance, leads me to think that the Man on the Clapham Omnibus might be very well-advised to jump off at the next stop.

5. You brush aside almost an injunction to disclose expert advice, on the grounds that the MCA/CSM are engaged in a systematic process of policy formulation in the meeting of 26 March. I think not: they were engaged in a review of a local drug safety problem, albeit of great systemic significance. The Post-Licensing Division's paper of 19 December spells this out: "The aim of this review is to clarify the issue of withdrawal reactions associated with SSRIs and to ensure that the information contained in the product information for doctors for doctors and patients is adequate". The meeting played some part in that review.

Please will you therefore reconsider the refusal to disclose, also taking into account the tail end of the relevant sentence in the Guidance on Interpretation at 2.23, which was omitted from your letter. The Guidance discusses possible damage to internal candour specifically in the context of disclosure "invariably and in full". I never asked for this and, unless the MCA/CSM are completely at sea, your refusal to disclose any information about their meeting has to go far beyond any legitimate need to avoid putting "pressure on key advisers to avoid expressing differences of view".

6. This blanket refusal, based also on the MCA/CSM's unique and peculiarly self-serving view of the public interest, otherwise provides a vivid example of the need for good Freedom of Information law - a prospect now dismally receding. If the MCA/CSM can use the existing Code of Practice to completely thwart a request such as this, nothing less than law will do.

7. I was also disappointed that your letter concluded with the stock paragraph which invites unhappy bunnies to refer to Dr Jones. In my letter of 21 August, I specifically mentioned that such a course did not seem appropriate because of the possible conflict of interest for Dr Jones. If you aren't prepared to reconsider your refusal, and feel I should have to jump through a few more hoops en route to the PCA, perhaps you could suggest a better route to independent internal review. Thank you for your attention; I look forward to hearing from you.

Yours sincerely,
Charles Medawar

Ref: M.N.G. Dukes: The van der Kroef syndrome (Side effects of drugs essay 1979) in M.N.G. Dukes (Ed), Side Effects of Drugs Annual 4, Amsterdam: Exerpta Medica, 1980, v-ix.


Contents page
List of correspondence with MCA/CSM