The Pharmaceutical Journal
Vol 270 No 7239 p334-335
8 March 2003

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Letters to the Editor

Marketing

What about publicising results that are unfavourable?

From Mr D. S. Reece, MRPharmS

I am sure Dr Kate Lloyd of Pfizer (PJ, 1 March, p302) will correct me if I am mistaken, but I do not recall any advertisement in the medical press focusing on the recommendation that, after an interim analysis by an independent data review committee, the doxazosin treatment arm of the ALLHAT trial¹ was halted.

David Reece
Hyde, Cheshire

The role of the PMCPA explained

From Mrs H. Simmonds

The Prescription Medicines Code of Practice Authority (PMCPA) was established by the Association of the British Pharmaceutical Industry to deal with all matters relating to the Code of Practice for the Pharmaceutical Industry — at arm's length from the ABPI itself. The code covers the promotion of medicines for prescribing to health professionals. It reflects and extends beyond United Kingdom legal requirements.

With regard to Jonathan Mason's article "Is the marketing of pharmaceuticals a matter of style over substance?" (PJ, 22 February, p264), pharmaceutical companies are a source of useful information for health professionals and promotional material has to be "evidence-based". The article states that "evidence to support claims ... is not always robust". The code requires that material is accurate, balanced, fair, objective and unambiguous and based on an up-to-date evaluation of all the evidence and reflects that evidence clearly. Material must not mislead either directly or by implication. Claims do not always have to be referenced but they must always be capable of substantiation and such substantiation, which may include additional references to any cited in the promotional material, must be provided without delay at the request of a health professional. Companies are allowed to refer to data on file but the relevant part of this must be provided on request. It is not necessarily unacceptable for advertising to refer to effects on surrogate markers provided that the medicine is promoted in accordance with its marketing authorisation.

Mr Mason refers to advertisements referring to guidance from the National Institute for Clinical Excellence. Companies must be clear about what NICE guidance actually states. Mr Mason's first example (the advertising of a COX-2 selective inhibitor) appears to be based on a case ruled in breach of the code although this is not mentioned. As with all cases, a full report on this case was published by the PMCPA and is available on request.

Mr Mason's second example (the advertising of Avandia) also appears to be based on a case under the code wherein no breach was ruled. The report will be published shortly. Occasionally, NICE recommendations for the use of a product are narrower than the relevant marketing authorisation but companies are none the less at liberty under the code (and UK law) to promote the authorised indications. Conversely, if NICE were to recommend the use of a product in a way that was inconsistent with its marketing authorisation, a company would not be able to advertise that fact because this would be a breach of the code. Sponsored articles and supplements are often subject to the code. In the event of a complaint about such material the extent and nature of any pharmaceutical company involvement would be a factor to consider in deciding whether the code applied.

Mr Mason suggests ways of "standing up to marketing" but fails to point out that consideration should also be given to submitting a complaint to the PMCPA for consideration under the code.

Pharmaceutical companies advertising to UK health professionals devote considerable resources to ensure that promotional activities comply with the code and any complaint is regarded as a serious matter with sanctions being applied against a company ruled in breach of the code.

With regard to Peter Burrill's letter about the advertising of Istin by Pfizer Ltd (PJ, 1 March, p302), this will be treated as a complaint under the code. This is in accordance with our usual practice with regard to public criticisms of the activities of companies.

Heather Simmonds
Director,
Prescription Medicines Code of Practice Authority

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