Social Audit Ltd
P O Box 111 London NW1 8XG
Telephone/Fax 44 (0)171 586 7771
Dr S.M. Wood, Director
Post-Licensing Division
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

27 January 1998

Dear Dr Wood,

Thank you for your letter of 23rd January. It was delayed in the post, probably because of typing errors in our address and post code.

Your letter suggests that I requested you to approach SmithKline Beecham to ask if they would agree to release of data. I can assure you I would never have done so, and was astonished when you did. My experience of that Company indicated to me there was not the slightest chance they would agree. I naively thought that you were writing to Company pretty much as a courtesy to explain that you needed to answer intelligibly the question I put to Dr Price in my letter of 23rd October. I asked him to explain the contradiction between [a] the MCA's belief that withdrawal reactions from SSRIs were very rare; and yet [b] far from being very rare, they were conspicuous enough in clinical trials to justify a warning.

I was so surprised when I learned you had approached SKB, I immediately faxed the news to Maurice Frankel at the Campaign for Freedom of Information, with a covering note saying that this looked like progress. I can now see I was wrong to be so optimistic. I had supposed that the MCA wished to respond and was writing to Company pretty much as a matter of courtesy to explain its intentions. My interpretation at the time was that the MCA would consider that it was its duty to demonstrate that its assessments were not as absurd and as partial as they might appear. This would have made disclosure possible under the terms of s.118 (1b) of the Medicines Act, 1968. The prohibition is removed if "the disclosure was made in the performance of (his) duty".

Your letter signalled to me that you approached the manufacturers, in effect, to ask to ask their permission to disclose, very probably in the expectation they would refuse, and perhaps even hoping they would do so, since this would exempt you from addressing my question. However, this may be harsh and signals can be misleading. In any case, I would prefer to be proved wrong.

To help establish the facts, please would you let me know whether the MCA requested the license holder to disclose on this occasion by letter or otherwise, and please may I have a copy of the letter(s) or record(s) in which the MCA made this request. It would be quite acceptable to obliterate any commercially confidential data and this would, I think, by-pass any legal restriction on disclosure. The requirement in s.118 relates to information "obtained by or furnished to …", but my request relates only to information "furnished by" the MCA.

I have decided to appeal against the decision not to disclose and will, as you suggest, write to Dr Jones about this.

Yours sincerely,

Charles Medawar


Contents page
List of MCA/CSM Correspondence