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 June Raine, Director of
Post-Licensing Division, MCA
Market Towers, 1 Nine Elms Lane
LONDON SW8 5NQ 16 November 2001

Dear Dr Raine,                      

Our Ref: DH/JT

I wrote to you almost half a year ago on issues to do with suicidality and SSRIs as well as physical dependence on SSRIs. I followed up the original letter a month later enquiring about the review of healthy volunteer studies that the MCA/CSM were scheduled to undertake in July of this year.

I haven’t had a reply to either letter. I am still interested in your response to the issues raised in both letters. I would also be interested to see a copy of the minutes dealing with the meeting in which the healthy volunteer work was considered.

I enclose with this letter an article that contains details that must be of some concern to you. It appears that the categorisation of suicide and suicide attempts in their clinical trials by some of the pharmaceutical companies as placebo suicides and suicide attempts is incorrect. Some of these occurred during the washout period of clinical trials. When a correction is made for that the current database of clinical trials submitted to you and to the FDA in application for licenses for the most recently licensed set of antidepressants shows that they collectively raise suicide risks statistically significantly. The increased risk is statistically significant for paroxetine on its own.

As you will see from the enclosed article there is a great deal of other data which fits in with this finding.

I would be grateful for the comments of the MCA on the implications of the data collected in this article and indeed the comments of any expert reviewers you may care to show this article to.

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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