Social Audit Ltd

P O Box 111 London NW1 8XG

Telephone/Fax 44 (0)171 586 7771

Dear Dr. Clarke,

I am writing to you in anticipation of your forthcoming White Paper on Freedom of Information, also in connection with your review of the operation of QUANGOS. As the attached letter explains, the government has inherited what may well emerge as a difficult health problem, which appears to involve a serious failure by the medicines control authorities. In the enclosed paper, to be published this week in the International Journal of Risk and Safety in Medicine, I set out the reasons for thinking that the Medicines Control Agency and Committee on Safety of Medicines have failed, and that this is intimately related to their 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.

The problems described in this paper appear all the more significant in virtually duplicating errors made by the medicines control authorities in the early 1980s. That mistake resulted from an almost perverse analysis of the available data and led to significant health problems, also involving government in protracted and costly litigation. The circumstances are outlined in the enclosed book, Power and Dependence (1992), and the position today, in relation to antidepressants, appears substantially the same. There seems to me compelling evidence that such problems might have been avoided, but for the rigidly top-down organisation of the medicines' control system and if the authorities had closely observed what the Nolan Committee identified as "The Seven Principles of Public Life".

Your Department will no doubt come under great pressure in the near future to exempt the control of medicines from mainstream proposals relating to freedom of information. I hope you will find evidence in the enclosed papers that will help you to successfully resist it. Please let me know if I can provide any further information. In the meantime, many thanks for your consideration.

Yours sincerely,

Charles Medawar

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