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                               /Philip Hunt 3 April 2000
Medicines Control Agency                           /Department of Health
Market Towers, 1 Nine Elms Lane              /Richmond House, 79 Whitehall
LONDON SW8 5NQ                                    /London SW1A 2NS

Dear Dr Jones/Lord Hunt,

RE: DANGERS OF ADVERSE REACTIONS TO SSRI'S           [Go to previous correspondence]

Some time back I submitted to you a draft of some developments during a randomised Placebo Control Trial in Healthy Volunteers that we undertook in this department. I have since been deposed in a legal case in the United States and in the course of that deposition it has become clear to me that it is a matter of considerable legal importance whether you have had any remotely similar reports filed with you since the development programmes of various SSRIs started in the early 1980s.

By remotely similar reports I mean studies in which any of the SSRIs were given to healthy volunteers and reactions ranging from anxiety and agitation through to other psychic disturbances emerged and were reported to you.

A further issue emerges if you have such reports on file. Clearly the approach that I would have taken to our ethical committee in North Wales when undertaking the studies that I undertook would have been completely different had such information been available to me. If you have information other than our particular study there are implications for any other healthy volunteer studies that may at present be undertaken within the United Kingdom or indeed world-wide.

This is a particularly acute issue for me at present as I have been approached some months back by a television programme within the United Kingdom due to air later this year which will consider some of the ethical and scientific issues surrounding healthy volunteers studies or self experimentation. This is an area where clearly I could unwittingly do considerable harm albeit with the best possible intentions. I would appreciate some response therefore from you on these questions and indeed even more than a response - some guidance would be helpful. As I believe I have indicated before I would be happy to meet up to show my hand more fully on some of these issues and to get the benefit of the experience of considering issues such as this within your agency.

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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