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

10 November 1998

Dear Mr Alder,

Thank you for your letter of 4 November, but it was not easy to construe as an answer to the main questions in my letter of 27 September. I certainly didn't expect you to agree that the CSM evades public accountability, but thank you for considering the point. It's not that I was trying to twist the messenger's arm or mind; just wanted to say what I thought the message meant.

Your letter explicates a procedure for either imparting information, or refusing to, which may or may not appeal to the PCA, but I felt it missed the point. The net effect of the arrangements you explained - however smooth and fair they may seem - is to reinforce the CSM's policy of total non-disclosure in the face of sticky questions. This is hard to accept. Is it even ethical for a committee of doctors to respond to serious, reasoned and well-documented allegations of incompetence, just by claming up? Can such a policy be compatible with natural justice and honest science? We both know that, as individuals, CSM members are decent and admirable people but, collectively, they are something else. To put it gently, they are not much of an advertisement for standards in public life, and it doesn't become the MCA to abet them.

1. The record shows that, until a few months ago - several years after the introduction of the Code - it had not occurred to anyone your end that the CSM was exempt from its requirements. What you now describe as "the correct approach" and "current practice" seems to be a stop-gap procedure designed mainly to contain the embarrassment of letting the CSM have its cake and eat it. Your letter does not address fundamental contradictions in the present arrangements. How can an "independent" body like the CSM be spoken for only by an executive agency? When the CSM is exempt from the Code, how can it be proper to use its provisions to argue nothing should be disclosed? Indeed, what is the CSM up to and what is it really for? These are not questions for the executive. No matter that the Agency holds their papers; these are questions for the CSM itself.

2. Your letter seeks to dignify the impacted public relations of the CSM, explaining that it is "bound" by section 118 of the Medicines Act - as if it had no discretion in the matter, no option but to clam up when difficult questions arise. This isn't true and is a long way off what you wrote on 30 April: "The CSM is considering the Government's proposals for freedom of information, and is perfectly entitled to formulate its own views on how the principles of FOI can be taken forward in relation to its duties." I am most concerned about the CSM's refusal to respond in the light of the questions raised in my letter of 10 June. Legal constraints do not stop them answering, period. The only thing to be said for their non-response is that it signals some recognition that there is much to be concerned and embarrassed about.

3. Your letter assures me, on the one hand, that the CSM is open and accountable. On the other hand, it says you are certain that I "echo the views" of many CSM members who want things to be more open. This seems very inconsistent, if amusingly implausible. It is hardly persuasive to argue the CSM is open and accountable when none of its more enlightened members seem able to speak for themselves. Collectively, they have made no impact on the kind of secrecy that the outgoing Chairman (personally) was complaining about over ten years ago. Loved the irony, but to insinuate that I am a slouch on disclosure compared with many members of the CSM, might have seemed highly defamatory had it not first blown my mind.

4. You defer to Parliament, as you must. I enjoy the luxury of not having to accept the polite fictions that make government ministers accountable as the Licensing Authority, and that point to the sovereignty of parliament, but I will refrain from ribald or seditious comment. Suffice to say that Mr Dobson is not my idea of a Competent Authority - nor his, I'm sure. I also find it hard to feel enthusiastic about the effectiveness of parliamentary scrutiny, when there has never been a public enquiry into the risks of medicines and how to reduce them.

I cannot reasonably ask you to respond to this letter, but I would welcome it if you decided to. I look forward to receiving a reply to my letter of 30 September, in due course.

Yours sincerely,
Charles Medawar

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