|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|
|LONDON E14 4HB||
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
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