Social Audit Ltd

P O Box 111 London NW1 8XG

Telephone/Fax 44 (0)171 586 7771

Dear Mr Hinchcliffe,

I am writing to ask if your Committee might consider the need for an inquiry into the adequacy of present arrangements for ensuring the safety of (users of) medicines. The immediate reason for requesting this is spelled out in the enclosed paper, to be published this week in the International Journal of Risk and Safety in Medicine. The paper gives evidence of an impending health problem, likely to arouse considerable public concern, not least because of the questions its raises about the role of the Medicines Control Agency and Committee on Safety of Medicines.

Briefly, I believe the MCA/CSM are deluding themselves and misleading others in claiming that tranquillisers like ValiumÒ are drugs of dependence, though antidepressants like Prozac® not. While relying on research of dubious scientific quality to support their view that all's well, the MCA/CSM are sitting on compelling evidence that drugs like Prozac® are quite as 'addictive' as tranquillisers such as Valium®, if not more so. The present situation seems to parallel closely the position in the early 1980s when the authorities mistakenly claimed that barbiturate sedatives were drugs of dependence, but benzodiazepine tranquillisers not; this caused suffering and waste, and involved the previous government in costly litigation lasting for years.

Though this paper specifically discusses the effectiveness and safety of drug treatments for depression, it also raises some very basic questions about the effectiveness of the UK drug control system. The present system is founded on law now 30 years old. In the meantime, there has never been a public inquiry into the safety of medicines, notwithstanding a succession of problems with some individual products and unacceptably high levels of iatrogenic disease. I believe the cost to the NHS of ill-health caused by drug treatments would approximate the total cost of the national drugs bill, and the evidence suggests much of it is avoidable.

After several months of essentially fruitless negotiation with the MCA/CSM, I have written to the Secretary of State for Health to suggest the need for a fundamental review of the present medicines control system. In short, I believe that regulatory failure is intimately related to lack of openness, absence of effective public participation and conflicts of interest; these agencies need public trust but I fear they neither command nor deserve it.

Rather than take on these inherited problems, I hope that the Health Secretary will be persuaded of the need for a fundamental review. However, he will no doubt also receive much advice against; therefore it might be very helpful if the Committee were to make its own position clear. In any debate which might follow publication of this paper, the need for an independent authoritative voice will be paramount, and your Committee might have a decisive part to play in promoting media and public understanding about the relationships between drug benefits, risks and costs.

You should know that I shall, in the near future, be posting this paper and all correspondence arising on the Internet. For reasons indicated in my letter to Mr. Dobson, I hope this would encourage rather than deter a response.

I would be very grateful if you would consider asking your staff/advisers to evaluate the evidence in this paper, and would be happy to provide any further information you or they might require. Thank you very much for your attention and I look forward to hearing from you in due course.

Yours sincerely,

Charles Medawar

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