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Product: Health & Beauty – Pharmaceutical
Advertiser: Pfizer Healthcare Ireland
ASAI Code 7th Edition: 2.4(c), 3.3, 4.1, 4.4
A television advertisement opens with a close up of a bedside locker. On the locker is an alarm clock, a glass of water, a photo frame, a lamp and a packet of Nexium control. A man gets up out of the bed and walks towards a wardrobe. He opens the doors to the wardrobe and walks into the wardrobe between the clothes. The man emerges out the other side of the wardrobe fully dressed into an office where he is met by a man who hands him a cup of coffee. A woman approaches him holding out a computer tablet for him to look at. He then turns and walks up a stairs and the scene changes to reveal him at the top of a stairs in a market. The man walks across the market and as a cyclist approaches him, he takes an item from the basket on the front of the bicycle. He then turns and walks under a curtain to emerge into a restaurant kitchen taking a dish from a waiter and putting it on a table where people are sitting, taking some of the food as he leaves. He then walks back towards an open wardrobe where clothes are shown hanging, entering through the middle of the clothes emerging the other side back into his bedroom, dressed in his dressing gown and sitting on his bed.
The voiceover stated “Since switching to Nexium Control, I’m protected around the clock from heartburn. So my day just flows. a coffee to start the day. work goes smoothly and lunch on the go..... is go, and evenings are there to enjoy with friends. Nexium Control can help your day flow uninterrupted by heartburn. just one pill a day can give you 24-hour protection to target zero heartburn. -Take control with Nexium Control. Talk to your pharmacist.”
On screen footnote text during the advertisement stated:
“Suitable for people experiencing heartburn. Do not use for longer than 2 weeks. Nexium Control 2mg gastro resistant tablets and hard capsules. Contains Esomeprazole. Always read the leaflet.”
At the end of the advertisement, a Nexium Control package is on a bale and beside it the following on screen text:
“1 pill a day
for 24 hour protection
target zero heartburn
Talk to your pharmacist”
The complainant considered that the advertisement was attempting to normalise the use of proton pump inhibitors as it implied that it was acceptable and normal to take medication on a daily basis and regularly. While the complainant noted that the advertisement had stated that the medication should only be taken for two weeks, they considered that the advertising was misleading, irresponsible and was trivialising the use of the medication.
The advertisers stated that their product, Nexium Control, was granted a non-prescription marketing authorisation across Europe by the European Medicines Authority (EMA) in August 2013. They said that during the non-prescription licence application at EMA, the benefit risk of the product was evaluated to ensure that the product could be safely supplied without prescription. They said that the benefit risk was found to be positive and so a licence was granted which established that the risks could be managed via routine pharmacovigilance processes and via routine risk minimisation measures. They said that the assessment and the finalised risk management plan for the product addressed and resolved the following type of risks;
• Direct danger due to ADRs which are serious, severe or frequent in certain patient groups;
• Indirect danger – symptomatic treatment may mask an underlying condition which requires medical attention;
• Incorrect self-diagnosis – ensure condition can be easily recognised and treated appropriately; and
• Risk of misuse/Incorrect use
They provided the Executive with a copy of the cartons and the patient information leaflets and advised that the outer cartons of the product very clearly made reference to the following, which were specifically added to ensure that the product was used for short term treatment;
• For short-term treatment of reflux symptoms (heartburn, acid regurgitation) in adults, aged 18 or over.
• If your symptoms worsen or do not improve after taking this medicine for 14 days in a row, contact your doctor.
• Read the package leaflet before use.
The also said that the patient information leaflet contained more information, including advising patients to talk to their doctor if they were aged over 55 and had new or recently changed reflux symptoms or needed to take a non-prescription indigestion or heartburn remedy treatment every day. The leaflet also included guidance on how patients should take the product, specifically calling out that the product should only be taken for “up to 14 days” and that if the symptoms get worse or don’t go away, to consult a doctor. In view of this they considered that the product itself contained sufficient advice on the treatment length and clearly informed consumers to seek medical advice if symptoms persisted or were longstanding, hence mitigating the risk of inappropriate long-term use. They also stated that the product was a pharmacy only medicine that was kept behind the pharmacy counter where each supply was made under the direct supervision of the responsible pharmacists who would provide further guidance to consumers.
In regard to the television advertisement itself, the advertisers said that the key information within the advertisement and the concepts relating to them all focused on the typical activities of a single day – 1 pill per day, for 24 hour protection, target zero heartburn, don’t let heartburn ruin your day and to help your day flow uninterrupted by heartburn.
They said that the advertising displayed the essential information legally required for medicines, including a clear direction to always read the leaflet and clearly stated “do not use for longer than 2 weeks” together with “talk to your pharmacist”. They said that the advertisement had been reviewed by Clearcast and was found to meet their requirements, including the length of time that the superimposed text should remain on the screen, in this case a minimum of 8.2 seconds, whereas they had kept the text “do not use for longer than 2 weeks” on screen for over 10 seconds.
They did not consider that the advertisement advocated irresponsible medicine usage, nor encouraged the consumer to act in a way outside of the marketing authorisation for the product.
The Complaints Committee considered the detail of the complaint and the advertisers’ response, including the detailed information that was provided to consumers in the product packaging and labelling.
The Committee, however, considered that the depiction of the daily activities in association with the voiceover text which stated “Since switching to Nexium Control I’m protected round the clock from heartburn…” and “Just one pill a day can give you 24 hour protection to target zero heartburn”, implied that the product could be taken without restriction. They noted that the superimposed text had stated “Do not use for longer than 2 weeks”, however, they did not consider that this statement had been given sufficient prominence in order to balance the impression given in the visuals and voiceover, particularly as no reference was made in the voiceover to the fact that the product, a medicine, should only be taken short term and as the superimposed text had not been shown on screen for the entire duration of the advertisement. The Committee also noted that the text “1 pill a day” that appeared on screen at the end of the advertisement had not been qualified or linked to any qualifying text on screen. In the absence of this information, the Committee considered that the advertising was in breach of Sections 3.3, 4.1 and 4.4 of the Code.
The advertisement must not reappear in its current form.