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Our Ref: HJS/jr

29 January 2003

Mr Charles Medawar
Director, Social Audit Ltd
PO Box 111
London              NW1 8XE

Dear Mr Medawar

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

Thank you for your letter of 22 January regarding the report of the above case.

Responding to your points:

I Paragraph 4.4 of the Constitution and Procedure requires members of the Code of Practice Appeal Board to declare interests prior to the consideration of a case. The Chairman of the Appeal Board, Mr Nicholas Browne, QC, then determines whether it is appropriate for that member to remain for the consideration of that case. Declarations of interest are made known to the parties present and they are given the chance to comment upon them. Declarations of interest are recorded in the minutes of the Appeal Board meeting but are not recorded in the published reports for cases. I will not be amending the case report in this regard. If you do not accept my decision then you can request that the matter be referred to Mr Nicholas Browne QC for his decision which is final (Paragraph 13.3 of the Constitution and Procedure refers).

2 The complaint concerned what Mr Chandler had said. The Appeal Board ruled breaches of the Code in this regard. You state that in your view Mr Chandler was simply putting a gloss on the messages conveyed in the GlaxoSmithKline briefing document. This implies that he was going beyond the written briefing document. The Appeal Board has not ducked the issues raised in your letter of 1 August 2002. The Appeal Board has ruled upon the complaint as set out in your letter of 20 May 2002. As with all companies ruled in breach of the Code, GlaxoSmithKline UK Limited has provided the requisite undertaking and assurance to avoid a sImilar breach of the Code in the future. GlaxoSmithKline must ensure that all documentation and verbal information provided complies with this undertaking.

GlaxoSmithKline was ruled in breach of the Code and I fail to see how taking all the factors into account you consider the Appeal Board’s conclusions to be a sorry reflection on the state of self regulation as it affects the safe use of medicines. The evidence in the case was limited as part of it related to unrecorded conversations between Mr Chandler and a journalist. The Appeal Board based its ruling on the balance of probabilities. It might be argued that mechanisms other than self regulation would not have found against the company on the available evidence.

Yours sincerely

Heather Simmonds (Mrs)

Director Heather Simmonds 020 7747 1438
Secretary Etta Logan 020 7747 1405
Deputy Secretary Jane Landles 020 7747 1415


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