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)

 

Miss Sarah Wark, Senior Scientific Assessor 8 May 2000
Post-Licensing Division, Medicines Control Agency
Market Towers, 1 Nine Elms Lane
LONDON SW8 5NQ

Dear Dr Wark,

Many thanks for your letter. I'm not clear whether you've answered my question or not.

Let me expand slightly. The issue is not simply the adequacy of coding of side-effects. There are a range of related issues. For example, you may include terms such as emotional indifference and suicidal ideation in MedDRA but if the coding of side-effects is done by spontaneous reporting methods then the likelihood of significant side-effects being picked up is greatly reduced. Second at present, on the basis of clinical trials that are not designed to detect for example phenomena such as suicidal ideation or akathisia the lawyers for companies producing SSRIs are putting pressure on judges to dismiss cases that do not demonstrate by randomised control trial methods a twofold increase in the relative risk on the SSRI compared to placebo.

Given that this is the case, I have in publications recently, one of which has gone to the Chairman of every ethical committee in the country (the Bulletin of Medical Ethics and IJRSM papers enclosed ) suggested that ethics committees and indeed patients consider their position as regards clinical trials, even to the extent of not permitting participation in the case of ethics committees and not actually participating in the case of patients. I've done so on the basis that it seems that participation in trials of this sort, when companies are prepared to use the data in this way does constitute legal jeopardy.

It's possible that no one will pay any heed to me. It's possible that no one will pay any heed to anything that I've written. At this point in time unless advised to the contrary by yourself and the MCA that a state of legal jeopardy does not apply in these circumstances, I would envisage when interviewed on radio or potentially television on some of these issues over the next few weeks giving similar advice.

Should anyone of those who might participate in clinical trials or those who grant ethical permission for the trials to take place begin to pay heed to what I'm saying, there could be substantial implications for the pharmaceutical industry base in this country. In the circumstances, if the point I'm making is incorrect I would as I've mentioned before greatly appreciate being informed exactly why it is incorrect. Your letter of May the 4th does not allay my fears or provide explanations as to what points I'm making might be incorrect.

As regards MedDRA, clearly having a dictionary which includes the terms suicidal ideation, akathisia, emotional indifference and disinhibition is a step forward. I wonder could I ask you when this came into force. Could I also ask you whether pharmaceutical companies are obliged to use it. I understand there were dictionaries with terms like suicidal ideation available to Eli Lilly to use in their clinical trials of Prozac but they did not use these dictionaries. The same I suspect is true of Pfizer and other SSRI producing companies.

Finally you mention that it is in the interest of companies to ensure that all adverse effects of their drugs are labelled. This is only the case in situations where they are at any risk of losing legal actions. Otherwise sales can be maximised in situations where adverse effects can be concealed. You may be interested to know that one of the isomers of Prozac was patented some time back and at present the patent is jointly owned by Eli Lilly and others. The patent application mentions that the isomer is less. likely to cause akathisia and suicidal ideation that the parent compound causes. The induction of suicidal ideation is not something that you will currently find in the label for Prozac or indeed for any of the other SSRIs. This is hard to reconcile with a state of affairs where a company can take out a patent on a compound on the basis that the parent compound (Prozac) does cause these problems which does not appear your label and stands to make millions if not billions of dollars as a consequence. (I have attached extracts of this patent)

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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