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) |
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"
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