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

Dear Mike,

Thank you for your letter of 1 July. I appreciate this is a long correspondence and that it has taken up hours of your time, not that I can agree that you and your colleagues have provided much by way of information and explanation. If you spent more than a few minutes on your last letter, I imagine it was in contemplation of better routes to longer grass, since you addressed none of the questions I raised in my letters of 14 May and 10 June. If you now want to bow out, I fear it is not for the reasons you give, but because the arguments on offer range from unconvincing to hollow.

I'm not sure what you mean when you say the correspondence "is substantially greater than that currently displayed on your website". I try to post everything of interest, though not simple acknowledgements, cover notes etc. If I've made a mistake and failed to post something important, there is a simple remedy: just let me know what I have missed and I'll attend to it right away.

You keep urging me to make a formal complaint to the Committee on Standards in Public Life. Yes, as I wrote to Dr Jones, last year, I would have liked to have been able to get an independent adjudication - but unfortunately the CSPL has a full programme and no powers to investigate individual cases, so this is not an option. In any case, once I make a referral to a third party, it risks giving the MCA/CSM the complete justification for claming up altogether. They wouldn't want 'to prejudice matters that were the subject of an independent enquiry', etc. You know the form.

I therefore cannot meet your request for an outline complaint to the CPSL - though I can tell you that, if I were making one, it would now be mainly directed at your refusal to respond to any question in my 10 June letter. To me this represents the antithesis of Openness and failures in Accountability and Leadership, as the Committee defines them. It is not fair to suggest that you would have "to rehearse the arguments yet again". This was the first time such questions had arisen.

My questions (10 June) related specifically to the reasons you gave (8 May) for claiming that Montgomery & Dunbar (1993) had presented good evidence and reached reliable conclusions. I came back with abundant evidence to show that you and the CSM need to think again on this - and my questions asked if you would do so. For all their wider implications, my questions specifically relate to your judgement, authority and leadership. Therefore it does not seem acceptable to try to deflect them to the MCA.

Incidentally, I doubt if your refusal would do too well even under the ABPI Code of marketing practice. This requires that "substantiation for any information, claim or comparison must be provided without delay …" and that "information and claims about side effects must reflect available evidence or be capable of substantiation by clinical experience", and even "It must not be stated that a product has no … risks of addiction."

I hope this clarifies your understanding of my concerns and will encourage you to now to send a straightforward reply.

Yours sincerely,
Charles Medawar



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List of MCA/CSM Correspondence