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Mrs Heather Simmonds, Director
Prescription Medicines Code of Practice Authority
12 Whitehall
London SW1A 2DY 1 February 2003

Dear Mrs Simmonds,

Case AUTH/1318/5/02 Safety of Seroxat (paroxetine)

Thank you for your letter of 29 January. I have now been able to consult my colleagues, Drs Healy and Herxheimer and Ms Winyard. We have all now read your response carefully and with interest and are unanimous in our view:

1. We would be grateful if the decision not to publish details of the interests declared by Appeal Board members might be reviewed by the Chairman, Nicholas Browne QC. In any case, could you please send us a copy of the minutes of the meeting? This request for review is based on the following: [a] we had no notice of the declarations of interest made and precious little time to consider the position as each declaration was briefly reviewed; [b] We have no written record of the interests disclosed and our request to record proceedings, or bring a stenographer, was refused; and [c] if disclosure of interests at the meeting was appropriate, the same would surely be true in relation to the detailed publication of the proceedings, if only in the interests of justice being seen to be done.

2. Yes, the original complaint concerned what Mr Chandler had said – but in defending his remarks, GlaxoSmithKline provided a company brief (Reactive Key Messages and Issues) to indicate what he should have been saying. We had never seen these documents before but, once we had, we gained a much clearer understanding of what Mr Chandler had been quoted as saying, and why. This was reflected in our letter of Appeal (1 August 2002) where we alleged that the company brief was itself false and misleading and in breach of Code requirements, in several respects. This assertion was and is basic to our complaint – just as denying it was and is basic to the company’s defence – and by declining to consider these allegations, the Appeal Board has upheld the company’s defence by default. This does not seem fair either to us, or to Mr Chandler – especially in view of the uncertainty about the words he actually used. Yes, Mr Chandler did seem to have gone a bit beyond the message in the Reactive Key Messages and Issues document – but the essence of what he communicated seems quite consistent with the company briefing. Implicitly, you seem to be suggesting that, if we object to what was said in the briefing document, then we should bring a further, separate complaint to the Authority. Is this the course you would recommend? Wouldn’t this amount to a colossal waste of time and resources – given the opportunity the Appeal Board had to deal with the key issues on this occasion?

Our remarks about the limitations of self-regulation in this case were not intended to suggest that existing alternatives were preferable – but the point is rather academic, because other regulatory mechanisms do not invite people to believe that pharmaceutical companies can be relied on to present information that conforms to high ethical standards, being reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation, and so on. I hope this clarifies our position and we look forward to hearing from you.

Yours sincerely,
Charles Medawar
                                            cc: Dr David Healy, Andrew Herxheimer, Anne Winyard


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