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


M. Patrick Deboyser, Head of Pharmaceutical
Products and Cosmetics Unit,
DG-III, European Commission
Rue de La Loi 200
Brussels, Belgium 1049

18 January 2000

Dear M. Deboyser,

You may remember we corresponded about the safety of antidepressant drugs in late 1998. I was prompted to write to you again after a fruitless 45-minute search on the EMEA website, seeking further information about the report in SCRIP (January 5th/7th, 2000, p.3) which began as follows: "The safety working party of EMEA's CPMP is currently examining all SSRI antidepressant products, following reports of physiological dependency in animals"

Would you be kind enough to identify a web source, or to refer me to someone, who could give me further information about this? I was intrigued by the published report for several reasons. In particular, I wondered why there should be this response to reports from animal studies when physiological dependency is already clear from reports of neonatal withdrawal following maternal use of SSRI and other antidepressants?

I would be grateful for any information you could give on this - also on one other topic on which I've searched at length without results. I understand the EU/EMEA is currently considering proposals relating to direct-to-consumer (DTC) advertising. If so, I would welcome information about the terms of any enquiry also, if possible, an opportunity to submit evidence. You may be interested to know that I recently made a formal complaint about a misleading professional advertisement for the product (detrusitol) which was also linked to the UK's first DTC advertisement, and that I have just been informed by the Prescription Medicines Code of Practice Authority that this has been upheld.

Many thanks for your attention; I look forward to hearing from you.

Yours sincerely,
Charles Medawar


Neither this letter, nor a follow up, received any response, but


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