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)

 

Alan Milburn, Secretary of State for Health 7 December 2001
Department of Health
Richmond House, 79 Whitehall
London SW1A 2NS

Dear  Mr Milburn

Our Ref: DH/JT

RE: ADVERSE EFFECTS AND PRESCRIPTION ONLY STATUS

I’m copying this letter to Dr Keith Jones of the MCA as I suspect you will wish some input from the MCA on this point and copying him in on the letter may expedite the process. There would seem very little point in writing to Dr Keith Jones on his own as any letters that I have written to the MCA recently have not been answered.

As a historian of psychopharmacology I have been particularly interested in the question of prescription only status of psychotropic and other drugs. My understanding is that one of the primary reasons for prescription only status is so that physicians, who it is thought will be in a better position to quarry out information about the hazards of drugs, than you for instance would be, when it comes to treating you, will quarry out such hazards and will factor such issues into account when deciding on what medication to give you for whichever complaint you should present with.

In a recent series of articles in the Archives of General Psychiatry and the American Journal of Psychiatry, a research group in Michigan have presented data from the published literature and from trials submitted to the FDA on both antidepressants and antipsychotics and the numbers of suicides in those trials both on new antidepressants and new antipsychotics as well as older antidepressants and older antipsychotics and on placebo.

As an aside companies have it would appear in some instances coded as placebo suicides and suicidal acts, suicides and suicidal acts that did not happen on placebo. I have written to the MCA, alerting them to this but have received no response from them on the significance of this, which I believe is methodologically indefensible.

But to come to the main point, as you will see from the enclosed table of studies on antipsychotics in the case of Lilly’s Olanzapine and AstraZeneca’s Quetiapine the data published by Khan et al show gaps for suicide attempts. In order to determine what the risks of treatment might be, it is very important for a clinician such as me to have these gaps filled in. The companies have the data. There is however no way to access this data within the public domain. The scientific literature apparently does not contain the answers. The only way to access the data is through the companies. As I understand the legal basis for prescription only arrangements, there is a moral and probably a legal requirement on companies to supply this data if a request is made for it.

I have written to AstraZeneca and to Eli Lilly. The responses from both companies were initially unsatisfactory. Follow-up letters in the case of Eli Lilly have produced the attached response where you see they state frankly that they will not supply the data.

In an era when evidence based medicine is so trumpeted, it is difficult to know how to handle this lack of important evidence. I’m writing to ask you if you could clarify whether there is any obligation on companies to provide such data. If not I wonder whether you would feel it appropriate to inform clinicians around the UK generally that there may be significant data on all medications that is being withheld from them?

I would appreciate a response at your earliest convenience.

Yours sincerely,

David Healy MD FRCPsych
Director, North Wales Department of Psychological Medicine   (Honorary Consultant Psychiatrist)

CC Dr Keith Jones, MCA

Table 1

Drug Patient No Suicides Suicide Attempts
Risperidone 2,607 9 43
Comparator 621 1 5
Placebo 195 0 1
Olanzapine 2,500 12 ?
Comparator 810 2 ?
Placebo 236 1 ?
Quetiapine 2,523 1 ?
Comparator 426 0 2
Placebo 206 0 0

Khan A, Khan SR, Leventhal RM, Brown WA (2001). Symptom reduction and suicide risk among patients treated with placebo in antipsychotic clinical trials: an analysis of the Food and Drug Administration Database. American J Psychiatry 158, 1449-1454.

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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