Bayer contraceptive advert breaches Code of Practice
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 Bayers “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 adverts 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 ads 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. Adam Hill
Anonymous General Practitioner v Bayer
An anonymous and non-contactable general practitioner alleged that a journal advertisement for the oral contraceptive Yasmin (ethinylestradiol and drospirenone) issued by Bayer Healthcare, was misleading and could put patients at unnecessary risk.
A bullet point stated that Yasmin had been shown to have a beneficial effect vs baseline on acne, fluid retention, hirsutism and premenstrual symptoms. The complainant was concerned that the advertisement read as if it were asking him to prescribe Yasmin in these conditions and noted that at least three of them were listed as adverse events in the Yasmin summary of product characteristics (SPC).
The detailed submission from Bayer is given below.
The Panel noted that the headline claim Yasmin. Its for more women than you might imagine was immediately followed by claims in much smaller type, the first two of which were that Yasmin was an effective and well-tolerated contraceptive and that 95% of users reported overall satisfaction. The claim at issue followed: Yasmin has also been shown to have a beneficial effect vs baseline on acne5
- , fluid retention6*, hirsutism7* and premenstrual symptoms8*. This was followed by the claim Yasmin is licensed for oral contraception beneath which, in a smaller type size again, was the explanation *Acne and fluid retention may be uncommon side effects of COC combined oral contraceptive use. Yasmin is not licensed as a treatment for acne, hirsutism, fluid retention or premenstrual symptoms. ^A non-comparative study. The product logo to the right of the claim at issue included the strapline Contraception and more.
The Panel noted that there was a difference between promoting a medicine for its licensed indication and promoting additional clinical benefits. Whilst the Panel considered that it was not unacceptable to refer to a medicines additional clinical benefits, such benefits must be referred to within the context of the licensed indication and not presented such as to imply that they were the reason, per se, to prescribe. Statements to the contrary were unlikely to negate an otherwise misleading impression. The Panel considered that overall the claim that Yasmin was for more women than you might imagine and the strapline Contraception and more would encourage readers to consider prescribing Yasmin for more than just its oral contraceptive efficacy ie its positive effects on acne, fluid retention, hirsutism and premenstrual symptoms.
The acne claim was referenced to a study whichdemonstrated the non inferiority of Yasmin compared with Dianette (which was licensed for severe acne refractory to prolonged oral antibiotic therapy). The fluid retention claim was referenced to a non comparative prospective study which showed an improvement in abdominal bloating and breast tenderness. The claim for a beneficial effect on premenstrual symptoms was referenced to an in-house literature search in which thirteen studies were identified, five of which included an active or placebo comparator. All showed a positive trend on one or more premenstrual symptoms with Yasmin. Many showed statistically significant results. Conversely, the Panel noted that depressive mood, changes in libido and fluid retention were listed on the SPC as possible adverse reactions.
The Panel noted that the advertisement stated that acne and fluid retention may be uncommon side effects of COC use (emphasis added). The Yasmin SPC stated that both effects had been reported during use with Yasmin. The Panel considered that the advertisement underplayed the side-effects of Yasmin. A breach of the Code was ruled.
The Panel noted Bayers submission regarding the adverse reactions in the SPC and that these included treatment emergent adverse events irrespective of whether they were thought to be caused by the medicine. The Panel considered that the advertisement promoted clinical effects of Yasmin which were not licensed indications and the converse of which were listed as adverse reactions in the SPC. In the Panels view the advertisement encouraged prescribers to consider these features as a reason to prescribe Yasmin. Further, some of the data referred to in the advertisement was non comparative. The Panel considered that overall the advertisement was misleading and inconsistent with the SPC. Breaches of the Code were ruled.
The Panel noted that prejudicing patient safety was an activity likely to be ruled in breach of Clause 2. The Panel noted that there was no evidence to show that patient safety had been adversely affected but considered that to imply possible clinical uses that were not licensed, such that a counter claim was considered necessary, was a serious matter. Further, citing possible clinical advantages the opposite of which were listed in the SPC as potential side effects was of serious concern. The Panel did not consider that the statement Acne and fluid retention may be uncommon side effects of COC use negated the impression otherwise given. A breach of Clause 2 was ruled.