Coleg Meddygaeth Prifysgol Cymru University of Wales College of Medicine
Adran Meddygaeth Seicolegol / Department of Psychological Medicine
Adran Cymru y Gogledd / North Wales Department
Pennaeth Adran / Head of Department
Yr Athro /Professor Michael J. Owen
Bangor
Dr. D. Healy (Cyfarwyddwr)

Dear Dr Raine,   

I thought I'd sent you a letter on 19 June 2001 but not having received an acknowledgement of its receipt I've begun to doubt whether it went or not. I would of course be most interested in any answer to the questions raised in the letter.

I wonder if I could ask some further questions also. Given the fact that there are moves to harmonise European labelling at the moment, and given that the wording you proposed to SmithKline Beecham, Glaxo and Lilly was presumably in harmony with what you perceive to be the requirements of the harmonisation programme and given that the companies refuse to accept the proposed wording and indeed have significantly changed it, I would have thought that the issue would need to be raised at a European level. I wonder therefore if I could, in addition to the minutes from any CSMIMCA consideration of these issues, which I have previously asked you for, I could ask you to forward minutes relevant to any consideration of these issues you have had in the European context - that is minutes from either internal MCA meetings or with the European regulators.

A further question arises from the CSM Current Problems Bulletin number 21 from 1988. In this you warned of the ability of Benzodiazepines to precipitate suicide and aggressive reactions. This is a confident and unambiguous warning. However in the fight of current debate about what problems the SSRIs may cause I have to note that it the 1988 warning has been placed there without the benefit of clinical trial or other epidemiological data. I, of course, think that your approach then was appropriate. But I have to note that it is inconsistent with your approach now. Can I ask you how you think this potentially embarrassing inconsistency should be addressed?              

Yours sincerely

David Healy MD FRCPsych

Director, North Wales Department of Psychological Medicine

Uned Hergest, Ysbyty Gwynedd, Bangor, Gwynedd LL27 2PW

Ffôn: (01248) 384452 Ffacs: (01248) 371397

Hergest Unit, Gwynedd Hospital, Bangor, Gwynedd LL27 2PW

Tel: (01248) 384452 Fax: (01248) 311397

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