Social Audit Ltd
P O Box 111 London NW1 8XG
Telephone/Fax 44 (0)171 586 7771
socialaudit@gn.apc.org   http://www.socialaudit.org.uk

 

Mrs J Macdonald, Head
Product Information and Advertising
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

18 July 2000

Dear Mrs Macdonald,

Thank you for your letter of 12 July, responding to our complaint of 23 March about the advertisement for Seroxat (paroxetine).

Mr Alder has yet to reply to my letter of 14 February, in which I asked about the procedures and resources the MCA uses to ensure compliance with the advertising regulations, and your letter gave no indication of the steps you had taken in this particular case. However, reading between the lines, this is how it seems to me.

1. The MCA responded to our complaint by writing to SmithKline Beecham (SKB) to ask for their comments.

2. The company was unable to support the headline claim, "Lifts mood quicker than fluoxetine", on the basis of the two references given in the advertisement. So they send the MCA ten more references, carefully selected to support their claim.

3. The MCA examines this evidence and, weak as it is, concludes that "the overall balance of evidence is in favour of the claim".

What worries me is the thought that the MCA considers that "the overall balance of evidence" can be assessed simply by looking at the evidence SKB provided in favour of the claim. That would clearly be improper, since there is much evidence (including negative results) to suggest that the headline claim exaggerates the properties of the drug and fails to encourage rational drug use. Hence the following request under the Code of Practice on Access to Government Information: please supply, in the fullest possible detail [a] copies of all communications to and from the license holder in connection with this complaint; and [b] any other information, facts and analyses that would help to explain the basis on which the MCA concluded that the overall balance of evidence is in favour of the headline claim.

Thank you for your attention; I look forward to hearing from you.

Yours sincerely,
Charles Medawar

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List of correspondence with MCA/CSM