A TV ad for Pfizer’s Nexium Control heartburn relief product, seen in August 2018, featured a woman in various situations looking uncomfortable and holding her chest. A female voice-over stated, “I remember having frequent heartburn. I was always reaching for short-term relief, over and over. But when my heartburn kept waking me up, I took control.” A male voice-over stated, “Nexium Control. Just one pill a day could give you 24-hour protection and zero heartburn.” The female voice-over continued, “Now I’m protected. What a difference.” Small. on-screen text displayed during the ad. stated “20mg Gastro-resistant tablets and hard capsules. Contains Esomeprazole. Always read the leaflet”.
Two complainants, who understood that frequent heartburn was a symptom of health conditions for which medical supervision should be sought, challenged whether the ad was irresponsible and potentially harmful because it could discourage viewers from doing so.
Pfizer Ltd said that Nexium Control was first authorised as a non-prescription medicine for use across Europe by the European Medicines Authority (EMA) in 2013. As part of its consideration of the licence application, the EMA assessed the benefit risk of the product to ensure it could be safely supplied without prescription. That included an assessment of risks including whether the product provided symptomatic treatment which could mask an underlying condition which required medical attention, the risk of incorrect self-diagnosis, and the risk of misuse or incorrect use of the product. Following that assessment the EMA granted a licence which established that the risks of the product could be managed via routine processes and measures such as the use of text in the “summary of product characteristics” (SPC) and the product labelling and information leaflet. In the UK the product was allowed to be sold without prescription, but under the supervision of a pharmacist.
Pfizer then submitted an application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Nexium Control to be made available without the intervention of a pharmacist. The MHRA assessed whether there was any incremental risk in allowing that, compared to products already on the market. Pfizer explained that their application specifically addressed the risk of the product masking underlying diseases such as stomach ulcers and cancers. They provided a copy of the MHRA’s report and copies of the product packaging and patient information leaflets for Nexium Control tablets and capsules.
The MHRA report noted some diseases that included symptoms of heartburn and acid regurgitation which might be masked by use of the product, but further noted that those conditions were usually associated with other symptoms which would alert a patient to visit their doctor. The report highlighted that the product labelling and information warned that if symptoms worsened or did not improve after 14 days of use a doctor should be contacted, and listed several additional, easily recognisable ‘red flag’ symptoms for which patients should contact a doctor. The report stated that the risk of missing an underlying more serious condition was no greater for the active ingredient in Nexium Control than with any other treatment for heartburn currently available. Pfizer said that the MHRA therefore considered that the product labelling and patient information adequately minimised the risk of missing the underlying cause of the problems.
Pfizer highlighted that, following the usual post-reclassification procedure, the MHRA pre-vetted advertising for the product for a period of time. While the MHRA had not specifically pre-vetted the ad about which the ASA had received a complaint, Pfizer said the key information within the ad and the concepts relating to it were in line with what was originally approved by the MHRA. They added that the TV ad in question had been approved by the industry body Proprietary Association of Great Britain (PAGB).
Pfizer said that through the depiction of the women in the different scenarios in which heartburn might be experienced, and the voice-over’s reference to her “frequent” heartburn and “reaching for short-term relief, over and over”, the ad was intended to show a frequent heartburn sufferer who often had to reach for short-term relief, during a short period of time, because the products she had been using only lasted for up to four hours; and that she found that inconvenient. In particular, the woman’s trigger for seeking alternative treatment was that her heartburn kept waking her up at night because the products she was taking did not last long enough, and that inconvenience was the ‘final straw’ for her. Those elements were used to emphasise that, in contrast, Nexium Control provided 24-hour protection from heartburn with only one pill per day.
Pfizer said that night-time heartburn did not represent an escalation or worsening of symptoms which should lead people to consult a doctor; it was a normal symptom of heartburn because lying down could exacerbate symptoms and it was not listed in the SPC as a ‘red flag’ symptom. The ad also specifically referenced that the woman had “frequent” heartburn (which was defined as someone who experienced it two or more times per week) rather than that she had “persistent” heartburn (which signified heartburn that was ongoing and non-treatable). Additionally, there was no indication in the ad that the woman was suffering from heartburn for longer than two weeks or that she was experiencing heartburn all the time. Rather, the ad showed scenarios which illustrated the usual triggers of heartburn and there was no reference to the passage of a long period of time.
Pfizer also highlighted that the TV ad showed the essential information legally required for medicines, including a clear direction to always read the leaflet. They said the ad did not advocate irresponsible medicine usage, or encourage the consumer to act in a way outside of the marketing authorisation and SPC of the product. It did not discourage individuals from seeking treatment. On purchase of the product there were clear warnings that the product should not be used for more than 14 days and that consumers should consult a pharmacist or doctor if the product did not work or if symptoms change. The patient information leaflet also referenced a wide range of ‘red flag symptoms’ for which consumers should consult an appropriate healthcare professional.
Clearcast supported Pfizer’s response and believed that the claims in the ad were justified because the voice-over specifically talked about the woman suffering from heartburn and looking for a specific product to help relieve those symptoms associated with heartburn. The ad included on-screen text which stated “always read the label”, which made clear that consumers should read those instructions when purchasing the product.
The ASA understood that heartburn could be a symptom of serious underlying conditions including stomach ulcers and cancers, which were conditions for which medical supervision should be sought. We acknowledged that heartburn could also be a symptom of less serious conditions such as gastro-oesophageal reflux. Nexium Control was licensed to provide short-term treatment (up to 14 days) of reflux symptoms, such as heartburn and acid regurgitation, in adults. Ads for the medicine must conform to that indication.
We sought an informal view from the MHRA, who said that ads for medicines indicated for short-term treatment should not suggest long-term use or use of the product for continuous treatment of symptoms. They were concerned that the ad appeared to suggest that the woman had had persistent heartburn over a long period and that it had increased in severity over time. They considered that was not consistent with the SPC for the product, because the indication was for short-term treatment and stated that “patients should be instructed to consult a doctor if … they have been on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks”. They said the effect of that would be that viewers with persistent heartburn would not seek medical advice promptly in circumstances where they should do so.
The ad’s voice-over stated, “I remember having frequent heartburn. I was always reaching for short-term relief, over and over. But when my heartburn kept waking me up, I took control”. We acknowledged the visuals in the ad did not specifically show that the woman had been experiencing heartburn over a long period of time. However, we considered that the cumulative effect of showing the different scenarios along with the character’s references to “frequent heartburn”, “reaching for short-term relief, over and over” and “when my heartburn kept waking me up” implied that she had experienced frequent and continued heartburn over a long period of time, and that while other products had provided short-term relief they were no longer effective in relieving her symptoms, at which point she sought alternative treatment. We considered that the same elements in the ad also implied that the character had experienced a worsening of her symptoms over time. We further considered that because of the way those elements were presented viewers were unlikely to make a distinction between “frequent” and “persistent” heartburn.
In the context of the remainder of the voice-over we considered the implication was that Nexium Control was suitable to be used to relieve heartburn which had been experienced over a long period of time and which had become progressively worse, and where other products had failed to relieve symptoms in the short-term. We considered the on-screen text “Always read the leaflet” did not alleviate that impression.
Because of that implication we considered viewers who were experiencing persistent heartburn, including those whose heartburn had become more severe, and whose symptoms could be the result of a serious condition, would be less likely to promptly seek medical advice about their symptoms. We acknowledged that information was provided on the product packaging and in the patient information leaflet which made clear that those who were experiencing long-term symptoms, symptoms which became more severe, or additional symptoms, should seek medical advice. However, it was also required that ads for the product must be consistent with the SPC.
We concluded that the ad discouraged essential treatment for conditions for which medical supervision should be sought and therefore breached the Code.
The ad breached BCAP Code rules 1.2 1.2 Advertisements must be prepared with a sense of responsibility to the audience and to society. (Social responsibility), 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) and 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).
The ad must not be broadcast again in its current form. We told Pfizer Ltd to ensure that future ads did not discourage essential treatment for conditions for which medical supervision should be sought, including by implying that Nexium Control was suitable for long-term relief of heartburn.