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Professor Kent Woods, Chief Executive,
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

10 June 2005


Dear ProfessorWoods,

Thank you for your letter of 29 April, responding to my letter of 19 April 2005 and our complaint about the regulation of SSRI antidepressants by the MHRA/MCA and CSM. I regret and apologise for the delay in replying: family matters supervened.

I hope you didn’t think that my silence meant that your letter had made its mark. Your overbearing tone mainly suggested that the Agency was re-positioning itself, public relations-wise - presumably gearing up to "refute" paragraph 376 and more of the House of Commons Health Committee report.

Your letter seemed notable mainly for its failure to acknowledge any aspect of the Agency’s work that might have been improved. Two-thirds of all antidepressants are prescribed for ‘mild’ depression - when there is minimal evidence they are effective, but substantial evidence of harm. This has been the case for a decade or more, but the MHRA and CSM still deny any responsibility for curbing it. Blimey. To suggest that the regulators do their bit by controlling misleading advertisements seems, at best, very na´ve.

Why is the Agency so paralysed? My reading is to do with deep, sometimes quite natural, conflicts – between politics and science; trade and health; ‘clinical freedom’ and effective prescribing; hope and reason; secrecy and transparency, promotion and information; the stock market and social capital; community and personal values, meaning well and doing good, and reputation and disgrace.

From the late 1980s through 2004, the regulators concealed evidence that antidepressants were only modestly effective and shouldn’t generally be prescribed for people with mild depression, and look at the size and shape of the market now. No wonder the MHRA so vehemently objects to the proposal that it now bolts the stable door. Coming clean would acknowledge weakness in the foundations of the regulatory system – except that to do so would at least signal the commitment to a fresh start. I would support nothing less.

If you honestly think that I’m imagining the problem, and if you really feel half as bullish as your letter suggests, I suggest we debate these issues in person, and in public. I’d be happy to have a solemn, evidence-based and properly mediated debate, anywhere. Interested? I shall telephone your office in the next week or two to see how things stand. Please leave a message for me, if you aren’t able to take the call.

Yours sincerely,
Charles Medawar