Dr Nageen Hashmi Scientific Assessor, Advertising Post-Licensing Division
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ	30 June 2006

 

Dear Dr Hashmi,

RE: EFEXOR & EFEXOR XL (venlafaxine): PL 00011/0223-0224 & 00011/0199-0201 Advertisement in BMJ of 16 April 2005

Thank you for your letter of 27 June, responding to my 2^nd June enquiry about publication of the corrective statement for Efexor.

At least I am not blind as a bat and my query turns out to have nothing to do with the numbering of pages containing advertisements. The facts are that the corrective statement was published only in the ‘General Practice’ edition of the BMJ and not in the ‘Clinical Research’ edition - in spite of the fact that the offending advertisement filled the whole outside back cover of the "Clinical Research" edition of that journal.

Thank you for sending the relevant papers I requested. In annex 5 in this documentation, it states: "A corrective statement is a statement published by an advertiser in the same publication where the advertisement that was considered to be in breach of the Advertising Regulations was originally published. It is of similar size to the originally published advertisement …" In short, the corrective statement should have been published in the "Clinical Research" edition of the BMJ and should have been given much greater prominence.

Why didn’t this happen? My reading is that Wyeth pulled a fast and slippery one and the MHRA missed a trick. See the 8 November 2005 email to you and two colleagues from Wyeth’s Legal Director, Mr Ben Holgate. His email states, "As discussed, I confirm that publication of the statement is now organised for the HSJ and BMJ (GP edition)".

So the question is: did the MHRA agree with Wyeth that the corrective statement should not be published in the Clinical Research edition of the BMJ, as your rules required, and if so, why? If not, what representations will you now be making to the company and what restitution will the MHRA seek?

Sincerely, 
Charles Medawar

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