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Professor M D Rawlins
Chairman, Committee on Safety of Medicines
Market Towers, 1 Nine Elms Lane
London SW8 5NQ 14 May 1998

Dear Mike,

Thank you for your letter of 8 May. You should stop worrying about what you imagine I appear to be saying. I do chose my words carefully and wish you would concentrate on them. I note your views on innuendo in the light of the mysterious "volumes" of meaning you attach to what you see as my failure to make a referral to the Committee on Standards in Public Life. The prospect of delighting you by making a referral is certainly an incentive to write to the Committee, but I did clearly explain why I hadn't: "my mind is not closed to the idea that the CSM did all that might reasonably be expected of it to avoid conflicts of interest."

You deny that the CSM might have motives "other than those of the public interest" when it offers advice on licensing matters. My immediate reaction, disbelief, gave way to the realisation that probably what you meant was that the CSM upholds the law. I don't doubt this, nor do I have any problem in accepting that the CSM characteristically comprises an excellent team, who work very hard and do their level best, and who would be shocked by the Poggiolini affair (though I do wonder how many were surprised) .

On the other hand, it would be naive to suppose that CSM members gave no thought to personal convenience or advantage (eg career development, political honours) and I believe the law is seriously inadequate. Moreover, what I understand by "the public interest" comes much closer to notions of benefit to the public, and refers to policies and activities carried on with informed consent. Here we part company. You will never persuade me to entrust the determination of the public interest on drug safety issues to a committee monopolised by doctors, buried in secrecy, close to the industry but very frosty towards consumers, when members may have conflicts of interest, walk a tightrope of temptations, and then make decisions on matters of life and death.

I think there may be another misunderstanding which distances us, and perhaps I should have made my purpose clearer - though it should make no difference to way in which Code requests are handled. When I make a request for disclosure, I have two distinct interests in mind - one relating to the substantive issue, the other to do with establishing how much of the CSM's business is conducted in secret, and how justifiable this seems to be. I am, if you like, taking baseline measurements, with a view to better informing the developing debate about the nature of secrecy, the extent of abuse, and the need to eliminate it.

When I made a formal Code request asking for disclosure of extracts from the CSM's register of members' interests, I was probably more concerned with the question of accountability - though I did think it reasonable to ask you to substantiate the claims you made at the King's Fund Centre debate, about the excellence and apparent infallibility of the CSM's procedures. Now you tell me that the CSM discussed my request and has decided nothing should be disclosed, not even the reasons for the refusal. Could it be that you are procedurally all at sea? Is the CSM mandated to handle Code requests and, if this is what it did, should I not have been informed of the reasons why the request was refused? I have now asked the MCA to consider this request; but I am not at all happy about this two month delay. In the meantime, please will you arrange for me to be sent a copy of the relevant minute from the CSM meeing, treating this as a formal request under the Code.

I welcomed your comments on the Montgomery & Dunbar paper because at least they clarify why you are confused. I shall write to you about this, at length, in due course.

On the question of the relationship between withdrawal and dependence, I am enclosing a copy of my 7 May letter to Dr Jones. The attachment will remind you what dependence meant, just a few years ago, in the days when common sense and understandings prevailed.

You are right to suggest there is a dialogue of the deaf about the paper by Price et al. I still believe it should be withdrawn and it alarms me that you suggest I am some kind of idiot to think so.

I did see the Haddad et al editorial, and responded with a letter to the BMJ. I don't know if they'll publish it. A copy is enclosed. I note these authors are completely independent of the CSM/MCA, but believe they failed to disclose a significant association with the manufacturers of Prozac.

I defer to your better understanding of the research grant process, but was not thinking of this when I said "companies also play a major part in deciding who gets to the top". I had other issues in mind - for example, whose names get around? Whose opinions get most published and quoted? Who gets invited to conferences? Who sits on committees which recommend drugs? Who picks the participants at consensus meetings where decisions are made about what should be treated and how? Who wins prizes and awards? Who get chairs endowed for them? Who flies First or Club class to fine locations? Who gets funding, commissions and fees?

In the light of what you say in your last paragraph, please would you let me know, again as a formal Code request:  [a] whether or not the CSM/MCA have considered within the last six months the need to revise data sheet warnings about withdrawal reactions with SSRIs; [b] if so, whether or not you are satisfied with them as they stand; and [c] if not, whether you have some substantial revision in mind? Discounting the possibility of any dereliction of duty, perhaps it would be appropriate not to be quite so monumentally overbearing in future correspondence. I find it quite engaging (and accept your criticism of my intemperance) but, given the authority of your office, the tone of your remarks might just cause some people, Ministers even, to believe there is not the slightest justification for my enquiries and concerns.

Yours sincerely,

Charles Medawar



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