|Social Audit Ltd|
|P O Box 111 London NW1 8XG|
|Telephone/Fax 44 (0)171 586 7771|
|[email protected] http://www.socialaudit.org.uk|
|Mrs. Elizabeth Hopkins, Post Licensing Division|
|Medicines Control Agency|
|Market Towers, 1 Nine Elms Lane|
|London SW8 5NQ||
22 January 2000
Dear Mrs Hopkins,Mrs Thyer wrote to me on 9 December last year to say that our complaint about an advertisement for Efexor XL has been referred to you, and I look forward to your response. I am now referring a complaint about an advertisement for Cipramil (citalopram); the enclosed copy is a two-page spread from the British Medical Journal of 13 November 1999.
The illustration is of young man holding a bunch of flowers and on his knees. He is seriously elated: the citalopram appears to have worked so well that someone close to the photographer has accepted his proposal of marriage. It seems quite depressing that doctors are inspired by this sort of thing, but I wouldn't want to make an issue of it.
My main concern is about the advertised claims. The first, "Cipramil delivers ahead of fluoxetine", is based on data positively dredged from a paper by Patris et al (1996). The claim generalises from two partial, specific and apparently unrepresentative findings - that citalopram delivers "significantly faster early effect than fluoxetine" and "significantly faster full response than fluoxetine". I will spare you a critique of the trial, as the paper (enclosed) pretty much speaks for itself: "The results of this study demonstrated that citalopram and fluoxetine were both efficacious at a dose of 20mg daily and that they were equally effective". Indeed, the authors note that four out five other comparative studies with citalopram failed to support their finding of an early onset of action with citalopram.
Secondly, the advertisement claims that "Cipramil delivers when fluoxetine doesnt" - an allusion to data from a poster presentation at the 1999 meeting of the American Psychiatric Association. This proposes that "patients who failed to respond to fluoxetine showed a good response to Cipramil". I haven't seen the poster; suffice it to say that this is another sweeping generalisation, given a prominence that has to be out of all proportion to the specific and limited data on which it is based.
It seems to me the advertisers are claiming important clinical advantages for this product that go far beyond the license terms. Therefore I am writing to ask if the MCA is satisfied that this advertisement is "not inconsistent with the particulars contained in the Data Sheet" [Medicines Act, s. 96 (3) (b)], and not "likely to mislead as to the nature or quality or effects" of this drug [s. 93 (7) (b)]? If the MCA is not satisfied, what steps will be taken to enforce these provisions of the Act?
Thank you for your attention; I look forward to hearing from you.
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