Two ads for the Aerosure Medic device:
a. A national press ad, seen in the Sunday Express on 26 November 2017 was headed, “Enjoy a breath of fresh air”. Text, in the style of an article, described how the device worked and how it could benefit people with different types of breathing problems. A blue box titled “SCIENTIFICALLY-TESTED TO REDUCE BREATHLESSNESS**” featured text stating, “In a recent clinical study in 23 people with COPD at University Hospitals of Leicester (NHS trust), daily use of Aerosure over an 8 week period resulted in a significant improvement in breathlessness.” In the small print at the bottom of the page text stated, “**ISRCTN Clinical Trial Registry number 81979106”.
Another box featured text that stated, “AEROSURE is a CE marked medical device intended to reduce breathlessness in patients with COPD (Chronic Obstructive Pulmonary Disease). It is also suitable for use in the following patient groups … Asthma … Chronic Bronchitis … Emphysema …”. The ad featured a number of testimonials from users who were described as having COPD.
b. A TV ad, seen on 15 December 2017, featured a voice-over that stated, “Are you huffing and puffing due to COPD, or feeling out of breath? See if you could breathe easier today with Aerosure Medic Breathe Easy device. Drug free, using clinically tested breathing therapy. Aerosure could help to reduce breathlessness and help you breathe easier. Find out from your pharmacy how Aerosure Medic is suitable for people diagnosed with COPD. It's time to get the relief you deserve. And breathe easier”. At the beginning of the ad a man was featured who was breathless while gardening, and a woman was shown out of breath while climbing some stairs. The man was then shown using the device. At the end of the ad he appeared blowing out candles on a cake without breathing difficulties and laughing. On-screen text stated, “Suitable for people diagnosed with COPD. Use in conjunction with professional support. Always read the label”.
Two complainants challenged whether the claims that the Aerosure Medic device was “SCIENTIFICALLY-TESTED TO REDUCE BREATHLESSNESS” and “using clinically tested breathing therapy” were misleading and could be substantiated.
Actegy Ltd stated that the medical device claims being challenged by the ASA were founded on the device’s intended purposes governed by the Medical Devices Directive (MDD), which sought to a degree to harmonise the regime for the marketing of medical devices throughout the EU. The indications were based on product-specific evidence as well as equivalent device evidence.
They said the Aerosure Clinical Evaluation Report (CER) clearly demonstrated how the devices were equivalent. The CER had been approved by a senior, UK-based respiratory expert, who understood the device characteristics and physiological effects, and the MDD that governed the evidence which supported the Aerosure intended purposes/ medical claims. Actegy provided the CER and three studies in support of their claims. One of the studies used Aerosure Medic as the intervention device. Actegy contended that the study responded to weaknesses in the evidence that had been identified during a previous ASA investigation on an ad for the same Aerosure Medic device. They said that all medical device intended purposes, for which the CER provided claim support, were supported by a body of evidence rather than a single published paper. The paper was not on its own, provided as substantiation for the intended purposes of, or claims made about, the device. For those reasons, they believed that the study was of sufficient quality to support equivalence of Aerosure Medic to the Inspiratory Muscle Training (IMT) devices discussed within the CER. They believed that this was in line with the CAP Guidance on the level of substantiation expected in health, beauty and slimming claims.
Actegy Ltd referred to a previous ASA ruling on an ad for the same Aerosure Medic device, in which the ASA had taken expert advice. They said that on the basis of the evidence provided at that time, the expert had accepted that IMT in general had beneficial effects, and this was reflected in the ASA ruling.
Given the evidence for IMT in general, Actegy believed that it was not misleading to state “using clinically tested breathing therapy”, as they did not think that this implied that the device itself had been clinically tested. That notwithstanding, they believed that they had now provided sufficient evidence to show that the device had been clinically tested. Actegy said that “scientifically tested” was a lower claim than “clinically tested”. Furthermore, that claim was presented in a press ad where people had time to read and consider the full text, which included details of the study on which the claim was based.
In relation to ad (b), Clearcast stated that the script and supporting data had been passed to their consultant, who was satisfied with the claims.
The ASA noted that the product appeared to meet the requirements of the MDD but understood that the MDD did not harmonise EU law relating the advertising of medical devices, which was subject to Directive 2005/29/EC on unfair business to consumer commercial practices (including advertising) generally (UCPD). That meant that advertisers must still meet the requirements of the CAP Code, which reflects the provisions of UCPD. Under the CAP and BCAP Codes, medical claims could be made for CE-marked medical devices provided they complied with other requirements of the Codes, including those relating to substantiation. We understood that the Aerosure Medic was classified as Class I medical device. Class I medical devices were generally CE-marked on a self-declaration basis. CE certification in itself did not constitute evidence for medical efficacy claims, and advertisers needed to ensure that they held evidence for such claims.
Ad (a), presented in the style of an article, discussed how the Aerosure Medic device worked, the distress and struggles caused by breathlessness in day-to-day life, and the potential benefits of the Aerosure Medic device for users who experienced problems with breathlessness due to different causes. For example, text stated, “Take a deep breath and get your life back on track. Breathing problems are the cause of so much day-to-day distress but now there is a drug-free way to help yourself … Aerosure is a simple device that has the power to make a difference … The breathing muscles are strengthened - both in and out - to help reduce breathlessness. Aerosure not only makes things better in that area, it also improves respiratory fitness in the longer term … Aerosure has been scientifically tested and shown to help with Chronic Obstructive Pulmonary Disease (COPD), a collective name for chronic bronchitis and emphysema. It’s also suitable for conditions such as asthma, cystic fibrosis and bronchiectasis. It can particularly be a boon for those who are feeling at their worst after years of smoking. But there are also benefits in other areas, particularly for those who find that the mental stress of being afraid to carry out everyday tasks is a gruelling as their physical effects. Being out of breath can affect everyday life in so many ways - like the sheer terror of knowing that you cannot even pop to the shops without fear of an incident. Not only can Aerosure help you breathe easier, it can also help you sleep easier, as shortness of breath becomes more manageable … Aerosure can help you manage your shortness of breath”.
A box toward the bottom of the page stated, “SCIENTIFICALLY-TESTED TO REDUCE BREATHLESSNESS** In a recent clinical study in 23 people with COPD at University Hospitals of Leicester (NHS trust), daily use of Aerosure over an 8 week period resulted in a significant improvement in breathlessness”. The asterisks linked to small print that stated the clinical trial registry number. Testimonials from individuals with COPD described how the Aerosure Medic device had reduced their breathing problems. For example, “Lionel, 66, of Holloway, north London, has COPD from 27 years of being around diesel fumes as a London bus driver. He was always breathless but now he does not wheeze at night and has the energy to play with his grandchildren … Graham Biggs of Waterlooville, Hampshire, was in the Navy and involved in construction, including boilers lined with asbestos. He also suffers from COPD ... ‘After two weeks using Aerosure I couldn’t believe the filth that came off my lungs. Years ago I used to do lots of long walks - now I can do them again’ … ”.
The ASA noted Actegy’s view that “scientifically tested” was a weaker claim than “clinically tested” and did not require the same standard of evidence. However, we considered that the general audience at which the ad was aimed were likely to understand “SCIENTIFICALLY-TESTED TO REDUCE BREATHLESSNESS” not only to mean that the device had been tested under scientific conditions, but as a claim that the device was proven to be effective in reducing breathlessness, particularly in the overall context of the ad which made numerous strong claims about how it could help with breathing problems. The device was also referred to as being “suitable” for those with asthma, cystic fibrosis and bronchiectasis, which in the context of the ad was likely to be understood as an efficacy claim.
We considered consumers would understand that the device was effective in reducing breathlessness generally, including in people suffering from COPD (which included chronic bronchitis and emphysema), asthma, cystic fibrosis and bronchiectasis. The additional information provided in the ad about the study and IMT more generally was unlikely to alter consumers’ impression that the device could effectively treat breathlessness, including among those suffering from the specific conditions named in the ad.
Ad (b) featured a voice-over that stated, “Are you huffing and puffing … or feeling out of breath? See if you could breathe easier today with Aerosure Medic Breathe Easy device. Drug free, using clinically tested breathing therapy. Aerosure could help to reduce breathlessness and help you breathe easier … It's time to get the relief you deserve. And breathe easier”. It depicted actors whose breathing problems appeared reduced after using the device. Overall, we considered consumers were likely to understand from the ad that the device could reduce breathlessness.
We noted Actegy’s argument that “using clinically tested breathing therapy” referred to IMT therapy in general. However, we considered that consumers were unlikely to appreciate this distinction, and were more likely to understand from the claims in the ad that the Aerosure Medic device could effectively treat breathlessness, including in people with COPD.
We took expert advice on the evidence Actegy had provided, and it was assessed on the basis of the available scientific knowledge. We understood that the Aerosure Medic device contained an oscillator that briefly and repetitively interrupted breathing creating an overall increase in resistance and in vibration. It was claimed that this provided a form of IMT.
In relation to COPD, the CER was similar to that provided to the ASA in a previous investigation, with the addition of several further studies. We understood from our expert that the CER was a reasonable summary of the available literature at the time the ads were seen in November and December 2017.
We also assessed the additional studies submitted by Actegy with assistance from our expert. The first, which was referenced in ad (a), was a feasibility study on 23 participants with COPD using the Aerosure Medic device with the aims of assessing recruitment and dropout rates, device adherence, possible outcome measures, and necessary sample size in a larger clinical effectiveness study. It was not designed to test the efficacy of the device. There was no blinding or control group. Statistically significant improvements were noted in muscle strength and one indirect measure of breathlessness. The authors noted the small sample size of the study and potential for bias or placebo effect, concluding that it was not possible to make any comment on clinical effectiveness. A further study of 16 COPD patients compared the effects of a different IMT device with respiratory muscle exercise. The study had a crossover design that left open the possibility that “hangover” effects from the first intervention might have influenced the second. There was no blinding. Both interventions increased chest expansion and walking distance, though this was accompanied by falling oxygen saturation, suggesting there was no fundamental difference in their functional capacity. There were no significant differences in breathlessness. In the third study, ten participants used a different IMT device and ten acted as a control group. The study was not blinded. There were no improvements in maximum exercise capacity, but there was an improvement in submaximal exercise duration. There was an improvement in breathlessness, but it was not statistically significant.
We accepted that there was a body of evidence that allowed the scientific conclusion that IMT could under some circumstances improve breathlessness in patients with COPD. However, we understood that the evidence was not clear-cut and depended on the combined assessment of a number of small studies, many of which were methodologically weak due to the lack of allocation concealment and participant blinding. The studies submitted included a variety of IMT techniques and devices, and it was unclear as to whether or not the results were generalizable from one product to another.
We considered that the evidence in support of the role of IMT in general could not be taken to support the effectiveness of the Aerosure Medic device specifically. The full body of evidence submitted, including one study on the Aerosure Medic device itself, did not meet the standard required to substantiate the claims in both ads that the device was effective in reducing breathlessness generally, including in people suffering from COPD. Furthermore, we had not been provided with evidence of the effectiveness of the Aerosure Medic device for reducing breathlessness in people with asthma, cystic fibrosis or bronchiectasis, as implied by ad (a).
Taking into account the full body of evidence provided by Actegy we considered that the claims “SCIENTIFICALLY-TESTED TO REDUCE BREATHLESSNESS” and “using clinically tested breathing therapy”, as consumers were likely to understand them in the context of the ads ‒ that is, that the Aerosure Medic device was effective to reduce breathlessness, including in people with COPD, asthma, cystic fibrosis or bronchiectasis ‒ had not been substantiated. We therefore concluded that ads (a) and (b) were misleading and breached the Codes.
Ad (a) breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products). Ad (b) breached BCAP Code rules 3.1 (Misleading advertising), 3.9 (Substantiation) and 11.2 (Medicines, medical devices, treatments and health).
The ads must not appear again in the forms complained about. We told Actegy Ltd not to state or imply that the Aerosure Medic device was effective to treat breathlessness, including in people with COPD, asthma, cystic fibrosis or bronchiectasis, unless they could demonstrate such claims were supported by evidence of an adequate standard that tested the device itself and was relevant to the target audience and specific claims made in the ad. For example, they must not use the claims “SCIENTIFICALLY-TESTED TO REDUCE BREATHLESSNESS”, “using clinically tested breathing therapy”, or claims similar to them, or claim the device was suitable for use by patients with COPD, asthma, cystic fibrosis, bronchiectasis or other medical conditions involving breathlessness.