Social Audit Ltd
P O Box 111 London NW1 8XG
Telephone/Fax 44 (0)171 586 7771


Dr. Keith Jones, Chief Executive Officer
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

3 December 1998

Dear Keith,

Tomorrow is the first anniversary of print publication of The Antidepressant Web. Notwithstanding what the MCA was saying in public, this time last year you were telling me about the MCA's serious commitment to disclosure and accountability. You promised a thorough review of the issues and risks, and assured me that remedies, if needed, would be found. It's been a long year.

I am still waiting to hear if there ever was a review and, if so, what it amounted to - and the role of the CSM remains a complete mystery. The main response from them was the blustering decision to disclose nothing - especially not about the key issues I raised in my letter to Professor Rawlins of 10 June. If you have been following our website review of the four recently published papers relating to SSRI withdrawal, you will realise how explosively these issues have now surfaced again.

In my letter of 22 November, I specifically mentioned the findings reported by Rosenbaum, Fava et al., (1998). They show the CSM/MCA has been underestimating the risks of SSRI withdrawal reactions by around 100,000% - hence the need to withdraw the paper by Price et al., (1996). However, by properly recording what actually happens to people in the week after withdrawal from paroxetine, they also thoroughly discredit the CSM/MCA's justifications for relying on the work of Montgomery & Dunbar (1993). Obviously, they reached very mistaken conclusions. As their study underpinned the data sheet claim that paroxetine efficacy is maintained for at least a year, I should also now like to make an urgent request that this statement be withdrawn.

The evidence in these four trials also points to a serious problem with fluoxetine. I fear that that what these trials really show is that fluoxetine withdrawal symptoms are just better disguised - with all that implies. Would you not now accept this, and do the MCA/CSM have any plans for risk and damage limitation?

The catalogue of evidence that has accumulated on our website otherwise points to a drug safety control system that barely acknowledges the personal and social burdens of drug injury, and lacks any coherent strategy for reducing it. The system seems cumbersome, disintegrated and outmoded; far out of touch with the public, hardly competent in its risk and safety assessments; steeped in self-interest; over-exposed to commercial influence and pressures, intensely secretive and accountable to no competent authority. It has to be a pretty hopeless system when so many honourable individuals get into this sort of collective mess. There is a job here for Parliament to be sure.

What with the New Year ahoy, and Professor Breckenridge about to take over, I have been wondering about the turning over of new leaves. Might this be the moment for some positive initiative? If not, how might things be one year from now, on the eve of the new milennium? You will appreciate that maintaining a siege is almost a formality when the besieged are determined to stay deep in their bunkers, or keep digging in their holes.

Yours sincerely,
Charles Medawar


Contents page
List of correspondence with MCA/CSM