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

I refer to your letters of 22 January and 1 February regarding the report of the above case.

I As requested I referred your letters to the Chairman of the Code of Practice Appeal Board, Mr Nicholas Browne QC; this was in accordance with Paragraph 13.3 of the Constitution and Procedure.

Mr Browne’s view was that declarations of interest were procedural matters which were always recorded in the minutes of the meeting but which were not included in the published case report. Mr Browne saw no reason to depart from this practice and decided that the case report would not be amended. The Chairman’s decision is final as stated in Paragraph 13.3 of the Constitution and Procedure.

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The Constitution and Procedure for the Prescription Medicines Code of Practice Authority does not provide for the Authority to supply copies of the Code of Practice Appeal Board minutes to the parties. The published case report is the public record of the proceedings. Case reports are very detailed and are virtually a complete reproduction of the Code of Practice Panel’s minutes. For cases that go on to appeal, the case report also includes virtually a complete reproduction of the Appeal Board minutes.

Declarations of interest are required by Paragraph 4.4 of the Constitution and Procedure. Parties involved in appeals are sent a list of Appeal Board members in advance of the meeting. Members of the Appeal Board declare their interests at the start of an appeal hearing and the Chairman then decides whether a member can remain for the consideration of the case. Declarations of interest are revealed to the parties before the appeal commences as happened in Case AUTH/1318/5/02. You made no objection to the declarations of interest nor did you state that you required further time to consider them.

For your records the declarations of interest were:

Mr Conacher, Ms Pezzack and Mr Williams as their companies marketed products in the same therapy area. Dr Rowsell as she had been involved in the phase IV trials with Seroxat and had at one time worked for SmithKline Beecham. Mrs Baker, as President of the European Federation of Neurological Associations, had received educational grants from GlaxoSmithKline working directly with Dr Benbow. Mrs Baker also declared she had worked with you.

The Chairman also advised you that Dr Benbow of GlaxoSmithKline had previously been a member of the Appeal Board.

As previously explained, GlaxoSmithKline has provided the requisite undertaking and assurance to avoid a similar breach of the Code in the future. A form of undertaking and assurance relates not only to the material the subject of the complaint but also to any other similar material. GlaxoSmithKline has undertaken to ensure that all relevant documentation is withdrawn and that future documentation and verbal information provided including internal briefing documents complies with this undertaking.

I therefore do not agree with your view that by declining to consider your specific allegations, raised on appeal, about the GlaxoSmithKline briefing document the Appeal Board has upheld the company’s defence by default. The company was ruled in breach of the Code.

It is a matter for Social Audit to decide whether it wishes to submit a formal complaint about the GlaxoSmithKline briefing document. The Appeal Board could not make specific rulings about the GlaxoSmithKline briefing document and it would have been inappropriate to do so. The Appeal Board ruled a breach on the complaint before it. The GlaxoSmithKline briefing document was a part of the background material but it was not the subject of the complaint.

With regard to your comments about self regulation, the ABPI Code of Practice for the Pharmaceutical Industry sets out the requirements and provides a robust mechanism to deal with complaints some of which are ruled not to be in breach of the Code. The publication of detailed case reports ensures transparency and acts as a sanction for companies ruled in breach.