Coleg Meddygaeth Prifysgol Cymru

University of Wales College of Medicine

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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)

 

Dr Keith Jones, Director 5 July 2000
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
LONDON SW8 5NQ

Dear Dr Jones,

It's now over three months since I wrote to you enclosing details of a healthy volunteer study that had been conducted in North Wales and requesting details of any other healthy volunteer studies that might have been submitted to you in the course of development work on other SSRIs.

I realise my request places you in an extraordinarily tricky position but equally I am faced with something of a dilemma.

My dilemma is this. Given our study and the existence of other studies of which I'm aware which have shown a much higher rate of akathisia/agitation in healthy volunteers on SSRIs, I am absolutely sure that Ethical Committees would not permit further studies of SSRIs in healthy volunteers to take place without clear warnings and close monitoring. Even were an Ethical Committee prepared to sanction such a study, the insurers who indemnify these studies for University Departments might well refuse to do so even in the presence of clear warnings and close monitoring. I would imagine if either you or I worked for such an insurance agency this is quite possibly the line we would take.

Yet the SSRIs are available in this country and for the most part are being prescribed to individuals who have stress reactions of various sorts - individuals who come close to healthy volunteers in many respects. They are being prescribed without warning and without monitoring even in children.

I can see almost any move you might make in this area has far reaching implications. I on the other hand have little option but to makes move if only because of the healthy volunteer studies that may be in train or being contemplated around the country. At some point someone is bound to ask me what the MCA are doing about all this. Perhaps you'd like to tell me.

Yours sincerely,

David Healy MD FRCPsych
Director, North Wales Department of Psychological Medicine

 

Uned Hergest, Ysbyty Gwynedd, Bangor, Gwynedd LL27 2PW
Ffn: (01248) 384452 Ffacs: (01248) 371397
Hergest Unit, Gwynedd Hospital, Bangor, Gwynedd LL27 2PW
Tel: (01248) 384452 Fax: (01248) 311397

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