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


Professor Rolf Bass
Head of Human Medicines Evaluation Unit
European Medicines Evaluation Agency
7 Westferry Circus, Canary Wharf

24 July 1998

Dear Professor Bass,

Thank you for your faxed letter dated 20 July, received yesterday.

I was interested in your comments, but would be grateful if you could now respond to the questions I asked at the end of my last letter. Please could you let me know [a] specifically which Commission office is dealing with the CPMP recommendation for the new SPC warning about withdrawal reactions; and [b] whether there exists any form of appeal or review mechanism that I might use to challenge the recommendation made. I think there is very strong prima facie evidence to suggest that the authorities have been incompetent in this matter and I naturally wish to pursue it.

You are quite right to point out that what I said about the perceptions of "the average doctor or patient" was pure conjecture on my part, and I agree that the text makes no reference to withdrawal symptoms being either rare or mild. However, it seems a pedantic observation, and you are mistaken in thinking the points [a] to [j] made in the note, SSRIs, EMEA and the CPMP, are matters of personal opinion. There is substantial evidence for all of them and I would be happy to supply it if you doubt this.

I hope you will be able to let me know in the near future about the opportunities available to me for challenging the CPMP decision.

Yours sincerely,

Charles Medawar


Contents page
Correspondence with government