Ad description
A national press ad, seen on 28 Dec 2019 and 10 January 2020, and a TV ad seen in December 2019 for Actegy Ltd’s Aerosure device:
a. The press ad featured the headline claim “MEDICAL BREAKTHROUGH: COUGHING WEARING YOU OUT? COUGH LESS WITH DRUG-FREE AEROSURE. Clinically proven to – Reduce coughing – Reduce a tight-chest [sic] associated with breathlessness – Strengthen breathing muscles”. The ad also featured the prominent claim “Is your cough driving you crazy? Act today! Aerosure is now clinically proven to Reduce Coughing”. Further text stated “Clinically Proven in NHS. In a recent Clinical Trial of 96 COPD patients, smokers and ex-smokers, at an NHS hospital, daily use of Aerosure over an 8 week period result in a significant reduction in a tight chest associated with breathlessness and a significant reduction in coughing”.
b. The TV ad featured images of people struggling to breathe followed by an animated image of a face using the Aerosure device. On-screen text stated “Clinically Proven”. The ad then featured a man inhaling alongside on-screen claims “Reduce Coughing”, “reduce a tight chest associated with shortness of breath” and “suitable for people diagnosed with COPD”. The voice-over said, “Coughing. Ever smoked? Revitive Aerosure is a drug-free, clinically-proven medical device that could help reduce coughing and reduce a tight chest associated with shortness of breath. Aerosure is suitable for people diagnosed with COPD.”
Issue
Two complainants challenged whether the claims “clinically proven”, “clinically proven to Reduce Coughing”, “reduce a tight chest associated with shortness of breath” and “suitable for people diagnosed with COPD” were misleading and could be substantiated.Response
Actegy Ltd submitted a new randomised controlled trial on 94 patients diagnosed with COPD (Chronic obstructive pulmonary disease). They said the study demonstrated that the device was clinically proven to reduce coughing and a tight chest associated with shortness of breath. They also highlighted that 75% of Amazon users gave the product a four- or five-star customer rating, while only 18% gave it a one- or two-star rating.
Actegy said that the Aerosure device was a Class I medical device registered as suitable for people with COPD with the MHRA, who were the UK’s competent authority for medical devices. They said the claim “suitable for people diagnosed with COPD” reflected the device registration.
Clearcast showed that they had received expert advice on the study, which they argued showed that it substantiated the claims in ad (b).
Assessment
Upheld
The ASA noted that the product appeared to meet the requirements of the Medical Device Directive (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 (Unfair commercial practices directive - UCPD). That meant that advertisers must still meet the requirements of the CAP Code, which reflected 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 does not constitute evidence for medical efficacy claims, and advertisers need to ensure that they hold evidence for such claims.
We considered consumers were likely to understand from the claims “clinically proven to reduce coughing” and “reduce a tight chest, associated with breathlessness” in ads (a) and (b) to mean that the Aerosure device was proven to significantly reduce coughing and the feeling of a tight chest when short of breath. We considered that the term “clinically proven” would be understood by consumers to mean that the medical device had been demonstrated, through a clinical trial, to be effective at reducing those symptoms. We considered consumers would understand the claim “suitable for people diagnosed with COPD” to mean that the device was effective at reducing chest tightness associated with shortness of breath and coughing commonly experienced by those with COPD.
We had previously investigated similar claims that the device was effective at reducing breathlessness and improving respiratory fitness, and found that those claims were misleading as Actegy did not have adequate substantiation. Actegy had since provided an additional study which they believed substantiated the claims made in the ad. We took expert advice on that study.
The study was a randomised controlled trial of 96 patients who had mild to moderate symptoms of COPD. Patients were first assessed against a 20-item Chronic Respiratory Disease Questionnaire (CRQ) - a test of health-related quality of life designed for patients with chest disease. There was no statistically significant difference between the outcomes for the treatment group (patients using the Aerosure device) and the control group (using an inactive sham device). The study was accordingly not adequate evidence of the efficacy of the device.Patients were secondly assessed against an 8-item COPD Assessment Test (CAT) designed specifically to measure the impact of COPD. There was no statistically significant difference in the outcomes between the treatment and control groups, and neither group reported a clinically significant improvement.Patients were further assessed against the Leicester Cough Questionnaire and Hospital Anxiety and Depression Score, but there was again no statistically significant difference in the outcomes between the treatment and control groups, while no clinically significant improvement was established.
A further Multidimensional Dyspnea (MDP) questionnaire found no significant difference between the treatment and control groups for the direct measure of breathlessness or the subjective assessment of breathlessness and emotional response.
The Amazon customer reviews were the subjective views of individuals and were not sufficient evidence to support efficacy claims.
We considered that the evidence showed no improvement in breathlessness, coughing or breathing-related disability (including due to COPD) attributable to the Aerosure device. We therefore concluded that the claims “clinically proven to Reduce Coughing”, “clinically proven to reduce a tight chest associated with shortness of breath”, “suitable for people diagnosed with COPD” and associated claims had not been substantiated and were therefore misleading.
Ad (a) breached CAP Code (Edition 12) rules
3.1
3.1
Advertisements must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Advertisements must not falsely imply that the advertiser is acting as a consumer or for purposes outside its trade, business, craft or profession. Advertisements must make clear their commercial intent, if that is not obvious from the context.
(Substantiation) and
12.1
12.1
Radio Central Copy Clearance – Radio broadcasters must ensure advertisements subject to this Section are centrally cleared.
(Medicines, medical devices, health-related products and beauty products).
Ad (b) breached BCAP rules
3.1
3.1
Advertisements must not materially mislead or be likely to do so.
(Misleading advertising),
3.9
3.9
Broadcasters must hold documentary evidence to prove claims that the audience is likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation) and
12.1
12.1
Radio Central Copy Clearance – Radio broadcasters must ensure advertisements subject to this Section are centrally cleared.
(Medicines, medical devices, treatments and health).
Action
The ads must not appear again in the forms complained about. We told Actegy Ltd to remove the claims “clinically proven to … reduce coughing”, “clinically proven to … reduce a tight chest associated with shortness of breath”, and not to use claims had the same, or a similar meaning in future, unless they held adequate evidence to support their claims. We also told them not to imply the product would be efficacious in reducing those same symptoms in people diagnosed with COPD, including by stating the device was suitable for those with COPD in a context that implied alleviation of symptoms.
