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)

 

Sarah Wark, Senior Scientific Coordinator
Medicines Control Agency          
Market Towers, 1 Nine Elms Lane    
LONDON SW8 5NQ    30 June 2000

Dear Dr Wark 

Many thanks for your letter. Apologies for the confusion that I appear to have caused. You do however appear to have got hold of the wrong end of the stick. Perhaps this has been because my efforts to try and explain the problem-have fallen down somewhat, owing in part to the fact that the issues appear to me to be blindingly simply and to involve legal jeopardy.

The state of legal jeopardy that I'm referring to is not one that applies to any participant in a clinical trial. The legal jeopardy applies to you and me or to anyone who takes potentially any pill at all but certainly something like an SSRI.

The jeopardy arises from the fact that should you or I suffer an adverse event from an SSRI that the company in question will claim that their drug could not have caused the problem by virtue of the fact that the clinical trials they ran didn't record the particular problem that we may be concerned to take an action about.

Clearly in some instances clinical trials will not record adverse events - ones that occur at a frequency of say 1 in 10,000 for example. In this case, companies would not be able to use their clinical trials basis to argue the point one way or the other. However in the case of side-effects that occur much more frequently that should have been picked up in clinical trials, where it is clear these events almost certainly did occur in the clinical trials but were not coded for, the use of this clinical trial data by companies then to argue that you or I did not suffer the adverse event in question is potentially problematic.

It's particularly problematic in our current era of evidence based medicine when the usual methods of determining cause and effect have been suspended in favour of the supposed evidence that comes from the supposed gold standard method for determining cause and effects - the randomised control trial.

As regards whether this type of argument is currently being used by companies in legal proceedings at present, I can tell you that it certainly is.

From your letters I have no indication to date that it would be incorrect for me to advise patients against participation in clinical trials generally on the basis that they may be putting their relatives and families in a state of legal jeopardy. It appears that I should even be able to say that I've consulted on this matter with the MCA who have not indicated that there is anything essentially incorrect about the argument that I'm making. The only difference between us at present appears to be my awareness of the fact that clinical trial participation has de facto resulted in states of legal jeopardy for a large number of people whereas you seem aware of the theoretical risk rather than an actual hazard.

As previously I would invite you to correct this interpretation if it appears to be incorrect in any way. I appreciate however that there may be difficulties for you in making any clear pronouncement in this area.

Many thanks for the clarification that MedDRA was not used in clinical trials during the development of the SSRIs or indeed has not been used to date.

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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