Coleg Meddygaeth Prifysgol Cymru

University of Wales College of Medicine

hergest.bmp (2190 bytes)
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
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
LONDON SW8 5NQ 12 February 2001

Dear Dr Jones,

Further to my letter of 3rd August 2000 to which you replied that you had indeed seen a copy of the Pfizer Healthy Volunteer Study that had led to me writing to you in the first instance, I wonder if I could ask whether you had at that point or have now seen the full version of that study. I ask because I am aware that there are several summaries of this study. You could conceivably have seen a summary and still be concerned about the pattern of serious adverse events that you noted.

My question can be rephrased as follows: How many pages was the version of the Hindmarch study you had in front of you as of August 2000? I hope this doesn't seem too trivial a question to ask.

Following your suggestion that I meet with Dr Raine, you may be aware that I have done so. It is not clear to me however that we have agreed on any way to move the issues that concerned me forward. That being the case should the issues come up in public, I at present would feel warranted to indicate that I have discussed my concerns with the MCA and they have not offered me any information that would allay those concerns.

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

This letter was acknowledged by the MCA on 12 February: "Dr Jones is out of the office at present, but will be shown your letter on his return, whereupon a full response will be coordinated and sent to you accordingly"

CLICK HERE TO READ ON
Or HERE for full index of this correspondence

Contents page
What's New?