Background
Summary of Council decision:
Two issues were investigated, both of which were Not upheld.
Ad description
A TV ad for GlaxoSmithKline’s Nexium Control, an over-the-counter heartburn relief medicine, seen in December 2021, featured a shot of a man waking up next to a packet of Nexium on his bedside table. The ad then followed the man through various everyday activities: drinking a coffee in an office environment, grabbing lunch at a market and delivering food to a table of friends, before returning back to bed. The accompanying voice-over stated, “Nexium Control helps protect me around the clock from heartburn, so my day just flows. A coffee to start the day, work goes smoothly. Lunch on the go is go. And evenings are there to enjoy with friends. Nexium Control could help your day flow uninterrupted by heartburn. Just one pill a day could give you 24-hour protection for zero heartburn. Take control with Nexium Control.” Small, on-screen text displayed during the ad stated “Suitable for people experiencing heartburn. Nexium Control 20mg gastro resistant tablets and hard capsules. Contains Esomeprazole. Do not use for more than 14 consecutive days. Always read the leaflet”. The ad’s final shot displayed a packet of the medicine which featured text stating “7 tablets”, “One tablet daily” and “Lasts 24 hours” accompanied by on-screen text stating “1 Pill A DAY, FOR 24 HOUR PROTECTION. FOR ZERO HEARTBURN, TRUST THE UK’s No.1* For 24hr heartburn protection”.
Issue
The complainant, a GP, challenged whether the ad was irresponsible and potentially harmful because it:
1. discouraged essential treatment for conditions for which medical supervision should be sought, and encouraged use of the medicine that did not conform to the use indicated by the MHRA; and
2. encouraged unhealthy behaviours that might cause frequent heartburn and increase risk of serious health conditions.
Response
1. GlaxoSmithKline Consumer Healthcare UK Trading Ltd t/a GlaxoSmithKline said that Nexium Control 20 mg capsules were approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for sale at retail outlets without the intervention of a healthcare professional. Prior to the medicine being given this legal status in the UK, the European Medicines Agency (EMA) had authorised its sale as a non-prescription medicine under the supervision of a pharmacist. The EMA did so on the basis that Nexium Control’s safety and efficacy for the short-term treatment of reflux symptoms were both well established. The MHRA then allowed the medicine’s sale without the intervention of a pharmacist after consideration of whether Nexium’s wider availability would lead to any incremental risk, compared to other products already on the market.
GlaxoSmithKline said that Nexium Control’s current classification reflected that each regulatory body was satisfied that risks associated with the medicine’s misuse could be adequately managed via routine measures such as text on its packaging and in the patient information leaflet (PIL). In line with this, text on Nexium’s packaging and in the PIL instructed patients to consult a doctor if they did not experience symptom relief within 2 weeks of continuous treatment.
GlaxoSmithKline also highlighted that the ad’s on-screen text “Do not use for more than 14 consecutive days. Always read the leaflet” was consistent with information given on the MHRA’s Summary of Product Characteristics (SPC) for Nexium, including that “the duration of the treatment is up to 2 weeks. Once complete relief of symptoms has occurred, treatment should be discontinued”. They believed those warnings would ensure that patients understood the medicine was indicated as a short-term treatment only and would seek medical supervision if they required it.
They referred to advice on the NHS website that stated “Lots of people get heartburn from time to time. There’s often no obvious reason why”. They also told us that the NHS classified short-term acid reflux symptoms as suitable for self-treatment and that prescription treatments for those symptoms would not usually be offered in primary care. They therefore believed that the ad did not discourage patients from seeking essential medical supervision.
They said that the Proprietary Association of Great Britain (PAGB – the consumer healthcare UK trade association) had approved the ad, noting that the ad’s events occurred across a single day, and that it made no reference to the persistence or frequency of the man’s symptoms. The PAGB told us that they considered those elements did not suggest the man had been using the medicine for a prolonged period of time.
Clearcast stated that they did not believe the ad went so far as to suggest that Nexium Control could serve as a long-term preventative medicine. The ad’s on-screen text made the 14-day timeframe for self-treatment clear and the instruction to consult the information leaflet upon purchase would ensure that patients would use the medication in a way that conformed to its licence.
2. GlaxoSmithKline told us that their intention was for the ad to depict everyday activities common to many consumers across the UK. For example, the man was seen drinking a morning coffee, grabbing a takeaway lunch, and eating an evening meal with friends. They did not believe that any of those activities were unhealthy or over-indulgent.
They noted that acid reflux symptoms are not always caused by unhealthy behaviours and were frequently observed in patients who led typically healthy lifestyles. They acknowledged that some lifestyle factors including the consumption of caffeinated or alcoholic drinks, certain foods, being overweight, smoking and stress were known to influence patients’ experience of acid reflux symptoms. However, they believed that none of the activities depicted in the ad were significant risk factors for acid reflux symptoms.
Clearcast did not provide any additional comments on this point.
The PAGB supported GlaxoSmithKline’s response on this point.
Assessment
1. Not upheld
The ASA noted that Nexium Control was licenced only as a short-term treatment for acid reflux symptoms and that ads for the medicine were required to conform to the use indicated on that licence.
We sought an informal view from the MHRA, who said that ads for medicines indicated for short-term treatment should not encourage long-term use of the product. They told us that the SPC stated a maximum of two weeks of continuous treatment to ensure that patients sought medical supervision if their symptoms got worse, failed to improve or if other ‘red flag’ symptoms suggestive of a more serious condition were also present. They were satisfied that the on-screen text “Do not use for more than 14 consecutive days” was consistent with Nexium’s SPC.
We considered that viewers would understand from the voice-over and the accompanying scenes showing the man waking up, in the office, at lunch and dinner, and then returning to bed, that the ad depicted events occurring across a single day. We considered that the overall phrasing of the voice-over, and the presence of a packet of the medication on the protagonist’s bedside table at the start of the ad, implied that the product could be taken daily. The statement in the voice-over and in on-screen text which appeared at the end of the ad that “1 pill a day could give you 24-hour protection for zero heartburn …” emphasised that, as well as communicating the duration of action of one pill.
The ad did not refer to the frequency or severity of the man’s heartburn symptoms, nor the duration for which he had been using Nexium Control to alleviate them. We considered the voice-over and accompanying scenes did not suggest that the medicine was being used on a long-term basis, but rather that viewers would interpret it to be showing examples of situations throughout a busy day when the man might have experienced short-term heartburn symptoms and take Nexium Control to alleviate them.
We noted that the on-screen text which included the statement “Do not use for more than 14 consecutive days. Always read the leaflet” was displayed throughout the ad’s opening shots. We considered it was sufficiently prominent to ensure that viewers would read it and that it adequately communicated that the medicine should not be used for more than two weeks consecutively. It also directed viewers to the PIL. We considered that viewers would interpret the ad in the context of that information. We therefore concluded that viewers would understand that Nexium Control could be used daily, but that it should not be used for more than 14 days consecutively. We understood that message conformed to the SPC.
We therefore considered that the ad did not discourage essential treatment for conditions for which medical supervision should be sought or encourage use of the medicine that did not conform to that indicated by the MHRA. We concluded that it did not breach the Code.
On that point we investigated the ad under BCAP Code rules 11.3 11.3 Advertisements must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional (see rule 11.9). That does not prevent advertising for spectacles, contact lenses or hearing aids. and 11.19 11.19 Medicines must have a licence from the MHRA, the VMD or under the auspices of the EMA before they are advertised. Advertisements for medicinal products must conform with the licence. Advertisements must not suggest that a product is "special" or "different" because it has been granted a licence from the MHRA. For the avoidance of doubt, by conforming with the product's indicated use, an advertisement would not breach rule 11.3 11.3 Advertisements must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional (see rule 11.9). That does not prevent advertising for spectacles, contact lenses or hearing aids. (Medicines, medical devices, treatments, and health), but did not find it in breach.
2. Not upheld
The ASA understood that certain unhealthy lifestyle factors including eating large amounts of fatty, fried or acidic foods, excessive alcohol or caffeine consumption, and smoking were known to be underlying causes of some patients’ heartburn symptoms and could increase patients’ risk of serious health conditions. The NHS advised patients experiencing heartburn to tackle their symptoms, not only by seeking the alleviation offered by suitable medicines, but with the preventative measure of making healthy lifestyle changes (for example, reducing alcohol consumption).
The man depicted in the ad drank a single cup of coffee and the food shown during the ad appeared to be healthy and balanced. The ad gave the impression of a busy “on the go” day but the man was not shown doing anything, such as smoking, drinking alcohol or overeating, that would typically be viewed as unhealthy or overly likely to trigger acid reflux symptoms. We considered there was also no implication that the man generally had an unhealthy lifestyle. We therefore considered the ad would not be understood by viewers as showing him using the medicine to alleviate symptoms that were preventable with healthy lifestyle changes. As such, we concluded that the ad did not encourage viewers to engage in unhealthy behaviours that might cause frequent reflux symptoms or increase their risk of serious medical conditions. We therefore concluded that the ad did not breach the Code.
On that point, we investigated the ad under BCAP Code rules 1.2 1.2 Advertisements must be prepared with a sense of responsibility to the audience and to society. (Social responsibility) and 4.4 4.4 Advertisements must not include material that is likely to condone or encourage behaviour that prejudices health or safety. (Harm and offence), but did not find it in breach.
Action
No further action necessary.
