|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|
|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 havent 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|
|Ffôn: (01248) 384452 Ffacs: (01248) 371397|
|Hergest Unit, Gwynedd Hospital, Bangor, Gwynedd LL27 2PW|
|Tel: (01248) 384452 Fax: (01248) 311397|
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