Bayer contraceptive advert breaches Code of Practice
pharmafile | May 27, 2011 | News story | Medical Communications | ABPI Code of Practice, Bayer, Multaq, Sanofi, Yasmin
Bayer Healthcare has been singled out for “particular censure” by the PMCPA, the body which regulates the ABPI Code of Practice.
Multiple breaches of the Code arose from Bayer’s “misleading” advertisement for its oral contraceptive Yasmin (ethinylestradiol and drospirenone), which suggested the drug could be used to treat a variety of other symptoms.
The PMCPA ruled a breach of clause 2 of the Code – the most serious offence, which means that Bayer has caused “discredit to, and reduction of confidence in, the industry”.
An anonymous GP complained that the advert’s claim “Yasmin has also been shown to have a beneficial effect vs baseline on acne, fluid retention, hirsutism and premenstrual symptoms” was misleading.
Acne and fluid retention actually appeared on the same ad as possible side effects of taking the drug – as did the statement: “Yasmin is not licensed as a treatment for acne, hirsutism, fluid retention or premenstrual symptoms”.
However, the panel felt this disclaimer did not offset the impression that Yasmin could be used for more than its authorised indications, and some of the data referred to in the advert was non-comparative.
The ad’s strapline “Contraception and more” would encourage readers to consider prescribing Yasmin “for more than just its oral contraceptive efficacy – i.e. its positive effects on acne, fluid retention, hirsutism and premenstrual symptoms”, the panel said.
Any additional clinical benefits should be referred to within the context of the licensed indication and not be presented “such as to imply that they were the reason, per se, to prescribe”, the PMCPA added in its judgment.
There was no evidence to show that patient safety – a touchstone for clause 2 rulings – had been adversely affected. But the PMCPA said to imply possible clinical uses that were not licensed was a serious matter.
The advert was also judged to fall foul of clause 3.2, which states that the promotion of a medicine must be in accordance with the terms of its marketing authorisation.
The PMCPA rules a further breach of 7.2, which deals with information, claims and comparisons in promotional material.
The Code explicitly states that adverts “must not mislead either directly or by implication, by distortion, exaggeration or undue emphasis”.
Finally, Bayer was also judged to have ignored clause 7.9, which suggests that “information and claims about side effects must reflect available evidence or be capable of substantiation by clinical experience”. The PMCPA thought the advert had underplayed the side effects of Yasmin.
Sanofi in breach for promotional report
In another case, Sanofi has also had its knuckles rapped – albeit in a less serious breach of the Code.
It contravened clause 12.1, which says that promotional material and activities must not be disguised, through its sponsoring of a “special report” on atrial fibrillation in a November issue of Health Service Journal (HSJ).
The PMCPA felt that the piece was not independent sponsored editorial – which is acceptable – because Sanofi had, through its communications agency, influenced the scope and content of the special report and facilitated contact with experts.
A doctor complained that Sanofi’s medicine dronedarone (Multaq) was “favourably mentioned several times” and that the layout of the sponsored copy was extremely similar to that of the HSJ, making it hard to see that Sanofi had paid for the piece.
The PMCPA agreed that this was, in effect, disguised promotional material for dronedarone.
Adam Hill
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