PAROXETINE (SEROXAT) REQUEST FOR INFORMATION UNDER THE CODE

Thank you for your letter of 13^th February, and for sending me a copy of the letter the MCA wrote to SmithKline Beecham.

I think there has been some misunderstanding on the question of the MCA's approach to SKB, and I apologise for contributing to it. The problem for me was the statement in your letter of 23 January: "We sought the views of the company on your request", and I do think it rather ambiguous, though not enough for me to moan about. Anyway, thank you for clarifying what happened and why.

However, as I said in my letter of 28^th January to Dr Jones, my complaint is not that the company refused to disclose, on the grounds that the information "was commercially confidential and would give an advantage to competitors" - but that the MCA "saw no reason not to accept this view". I find this very worrying, and it might be helpful to mention two reasons why.

The first is to do with recent correspondence with Professor Michael Rawlins. This arose because, in 1987, he wrote me a letter including the following statement:

"Much of what you (and I) would seek would require repeal of section 118 of the Medicines Act which is the section concerned with secrecy. A small part of individual [license] applications might be regarded as commercially confidential but the major proportion could, with little loss to anyone, be made publicly available. Similarly, I see no objection to Committee's papers being publicly available".

This seemed very important at the time. Although it was clearly a personal view, it was also the considered opinion of a senior member of the CSM, and I have quoted it more than once - albeit with attribution only to an unnamed member of the CSM. However, as Professor Rawlins has been Chairman of the CSM for the past five years, and because virtually nothing has changed, it seems all the more important now. Therefore I recently wrote to him to ask whether he still held that view and, if so, if I might attribute it. He has now confirmed that it is and I can. See correspondence enclosed.

This brings me to my second point. All my instincts suggest that the information I requested falls well within the category identified by Professor Rawlins as data which could "with little loss to anyone, be made publicly available", and that this was one of those "circumstances where commercial sensitivity is not a sufficient justification for non-disclosure" (Guidance Notes 13.14). The data I asked for has to be about as innocuous as these things ever get: anyone with an interest in the issue knows (or should) that there's a real problem with paroxetine withdrawal symptoms, so what harm could be done by disclosing that a few people in the pre-marketing clinical trials experienced them? What on earth might be disclosed that would be so damaging to the company's interests that the MCA should decide, "in the public interest", that it saw no reason to disagree with the company's view?

I will not trouble you with any of the several answers rolling around my mind, other than to say they are all pretty alarming. I hope it will already be clear enough why I am pursuing this matter as a formal complaint - and therefore why I am also copying this letter to Dr Jones and to Ms Davidson who will be dealing with it.

By way of adding substance to my apology, and demonstrating grateful acceptance of yours (re our address etc), I am happy to confirm I would not expect you to answer this letter.

Yours sincerely,

Charles Medawar           

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