|Social Audit Ltd|
|P O Box 111 London NW1 8XG|
|Telephone/Fax 44 (0)20 7586 7771|
|Heather Simmonds, Director|
|Prescription Medicines Code of Practice Authority|
|London SW1A 2DY||22 January 2003|
Dear Mrs Simmonds,
Case AUTH/1318/5/02 Safety of Seroxat (paroxetine)
Thank you for sending the Appeal Boards statement. I have now consulted my colleagues, Dr Healy, Dr Herxheimer and Ms Winyard, and we are all agreed on the following points.
1. At the start of the hearing, the Chairman identified several members of the Appeal Board who had declared possible conflicts of interest. We were also informed that GSKs representative at the hearing, Dr Alastair Benbow, was a former member of the Appeal Board. We believe that reference to this preliminary exchange should be included in the official report, identifying each of the members concerned and the interest(s) that each declared.
2. While we welcome the decision that Mr Chandlers statements about Seroxat (paroxetine) were inaccurate and inappropriate, we also consider he has been made a scapegoat. For the Appeal Board to have concluded that a GSK employee with the rank of "Director, UK Corporate Media" was unilaterally speaking out of line seems almost perverse. In our view, Mr Chandler was simply putting a gloss on the messages conveyed in the GSK briefing document (Reactive Key Messages and Issues) as, in the real world, he might be expected to do. Those messages are inconsistent with established facts and evidence and good common sense, not to mention the Summary of Product Characteristics, as Clause 3.2 requires. The Appeal Board has completely ducked the issues raised in our letter of 1st August 2002, relating to these concerns. We are unanimous in this view, but sad to record it. We appreciated the opportunity to put our case to the Appeal Board, but honestly believe these conclusions to be a sorry reflection on the state of self-regulation by the pharmaceutical industry as it affects the safe use of medicines.
Charles Medawar and: Dr David Healy, Dr Andrew Herxheimer, Anne Winyard
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