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 19 January 2000
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
LONDON SW8 5NQ

Dear Dr Jones,

Many thanks for your letter of the 7th of January 2000. In your letter you mention that it must be emphasised that only a relatively few patients are exposed to a medicine in clinical trials before it is marketed. I accept this of course. However I believe that there is a large amount of unpublished randomised control trial data from these relatively few patients that confirms rather conclusively that fluoxetine and other SSRIs compared with placebo raise rates of suicide attempts.

I have no idea how the MCA stands as regards unpublished data on suicide attempts. You may be interested to know that the FDA has recently required all companies to submit data on just this issue for currently marketed antidepressants. Given that this data is being prepared anyway It might be worth your while to consider requesting the companies to forward it to you also.

If you do proceed down this route, I would be very happy, if you wished, to inform you as to whether the data that I know that exists and is currently unpublished features among the data that will have been submitted to you.

Quite aside from unpublished and unsubmitted data however there is a published meta-analysis by Pierre Fabre of their drug Milnacipran currently under scrutiny by the MCA in which I believe you will find that SSRIs have a significantly elevated rate of suicide attempts compared to either Milnacipran or TCAs.

You then raise the point about the warning on Prozac. I think this is quite inadequate. There are published clinical studies of children with OCD becoming suicidal on Prozac. This suicidality does not stem from a depressive disorder.

Furthermore on this point I enclose a first draft of a study that I have been involved in with colleagues. This is currently submitted for publication. I would hope you would keep the contents confidential but as you will see it is quite clear from this healthy volunteer study that within two weeks of going on Sertraline two of our healthy volunteers became seriously and significantly suicidal. This is not a suicidality that was inherent in any depression that they had. None of our volunteers were depressed or ill in any way.

It seems to me that this study significantly changes the terms of the debate. By the time you have received this letter I will have presented the data at the Institute of Psychiatry. I will shortly be presenting the material as well in the Department of Psychiatry in Oxford.

There is another issue that my letter to you raised which you don't appear to have addressed in your response. This is the issue of legal jeopardy. You note that I have suggested that there are ways to collect the data of adverse reactions with investigational compounds that may improve the informational content of trials. This is one thing. It's something however that is only required in one sense if companies treat the data coming out randomised control trials the way Lilly and other SSRI companies have been treating the data that have come out of their randomised control trials. The fact that data on adverse effects that have occurred has not been recorded has been used to argue that the effects themselves did not happen. As I understand it this means therefore that the patients who went through these clinical trial programmes, in a rather precise use of the term, have put both themselves and all the rest of us in a state of legal jeopardy. I would be most interested in your thoughts on this particular matter and ideas about how it can be remedied.

This is a matter that I will be working as hard as I can to raise the public profile of in weeks and months to come. If you have any thoughts on the issue I would be very grateful to receive them as it may influence the approach I take when raising the issues.

On this issue as well as on the issues raised by the enclosed study I would hope to hear from you in the near future.

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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