Background
Summary of Council decision:
Four issues were investigated, all of which were Upheld.
Ad description
Claims on the website www.aerosure-medic.com, seen in April 2014, for a respiratory device, included claims of efficacy for the device on the home page and web pages headed “Benefits of Aerosure” and “How Aerosure Works”.
Issue
The complainant challenged whether the following claims for the device were misleading and could be substantiated:
1. “Clinically tested technology”;
2. “may help to reduce breathlessness”, “Reduce shortness of breath and relieve breathlessness with regular use”, “Breathe Easier” and “with regular use ... may result in reduced breathlessness”;
3. “Increase respiratory fitness with regular use”, “... improve respiratory fitness” and “with regular use improves respiratory fitness”; and
4. “may help to ... improve mucus clearance”, “Improve mucus and phlegm clearance” and “Mucus Relief”.
Response
Actegy Ltd t/a Aerosure Medic (Actegy) said the Aerosure Medic device could be operated at two different frequencies. At 25 Hz (the ‘Breathe Easier’ mode) it could be used as an inspiratory muscle training (IMT) device, and at 15 Hz (the ‘Mucus Relief’ mode) it could be used to generate oscillatory positive expiratory pressure (OPEP) to aid mucus clearance.
They said the Aerosure Medic device had formerly been known as the “YouBreathe”, and that this device had been tested in three trials, which they provided in support of the claims. They also provided a ‘Clinical Evaluation Report’ (CER) which was compiled to address the requirement for clinical evidence of safety and performance as part of the CE-marking process for the Aerosure Medic device. They said the CER established the equivalence of the Aerosure Medic device to other IMT and OPEP devices and then undertook systematic reviews of the medical literature examining the effects of those similar devices. They believed the CER established that the benefits of IMT and OPEP devices and techniques were not specific to any one technology or protocol and therefore that any beneficial effects identified by those studies could be extrapolated to the Aerosure Medic device.
1. Actegy said the claim referred to the fact that the Aerosure Medic device had been tested in well-designed trials on humans. They referenced the three studies conducted on the device in support of the claim.
Two studies measured the effects of the device compared with an alternative form of flow-resistive breathing and with resting breathing. The first study, of 12 participants, measured the effects of taking ten breaths. The second study, of ten participants, measured the effects of taking 30 breaths.
The third study examined the effects of using the device in its 25 Hz Breathe Easier mode on 20 subjects (the ‘Aerosure Medic group’), against a group of 15 using a device which delivered an alternative form of flow-resistive breathing (the ‘alternative IMT’ group), over a five-week period. Actegy said the Aerosure Medic device and the alternative IMT device appeared identical during use, and participants were unaware of the sham intervention. They considered the use of the two groups enabled the investigation of any placebo effect the Aerosure Medic device might cause, as well as allowing for a comparison between the Aerosure Medic and an alternative form of IMT. They felt the results from the study demonstrated that both the Aerosure device and the alternative IMT device led to benefits in terms of inspiratory muscle strength and performance, and reductions in breathlessness.
They said both devices had flow-resistive loads which were appropriate for use in clinical populations and which had been shown to be beneficial for breathlessness. The results were comparable to the results from other studies which used similar and alternate forms of IMT. They referred back to the CER and provided two additional reports of studies on IMT devices. Actegy considered it was not essential for the five-week study to include a placebo group (i.e. a group which would have used a device identical to the Aerosure Medic device but which did not provide any resistance to breathing), due to the body of evidence described in the CER.
2. Actegy said the CER established the clinical equivalence of Aerosure Medic with other IMT devices, and included a systematic review of medical literature which examined the effects of IMT for the relief of breathlessness in patients with a variety of chronic medical conditions where breathlessness was a prominent feature, and the effects of IMT in healthy volunteers and athletes.
Actegy said the CER identified 12 clinical trials which showed that IMT produced clinically significant beneficial effects on breathlessness in patients with chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure (six in relation to COPD and three each in relation to asthma and chronic heart failure). The CER also identified eight clinical trials which showed clinical improvements of IMT for breathlessness in healthy volunteers and athletes, one of which was the five-week trial conducted using Aerosure Medic’s Breathe Easier mode. Actegy said one of the main findings of that trial was that five weeks of high frequency oscillation (HFAO) training using the device caused a significant reduction in breathlessness during an inspiratory resistive loaded challenge in healthy volunteers.
3. Actegy said the CER also reviewed medical literature relating to the effects of IMT for improvements in respiratory fitness in patients with a variety of chronic medical conditions where breathlessness was a prominent feature, and in healthy volunteers and/or athletes.
They said the CER found 19 clinical trials which demonstrated that IMT produced clinically significant beneficial effects on respiratory fitness in patients with cystic fibrosis, COPD, asthma and chronic heart failure (four in relation to cystic fibrosis, seven in relation to COPD, three in relation to asthma, and five in relation to chronic heart failure). They said another 22 clinical trials showed improvements in respiratory fitness associated with the use of IMT in healthy volunteers and/or athletes. Three of those trials were those which related specifically to the Aerosure Medic device, as provided separately to the ASA. Actegy said the main findings of those three clinical trials found that HFAO using the Aerosure Medic device resulted in modulation of ventilation consistent with improved respiratory performance.
4. Actegy said the CER had also undertaken a systematic review of medical literature examining the effects of OPEP for mucus clearance in patients with cystic fibrosis and bronchiectasis. They said the CER identified three studies that demonstrated that OPEP produced clinically significant benefits for mucus clearance at least comparable to chest physiotherapy, and one study that demonstrated benefits superior to chest physiotherapy, in patients with cystic fibrosis. It identified another four studies which demonstrated that OPEP produced clinically significant benefits for mucus clearance at least comparable to chest physiotherapy in patients with bronchiectasis.
Assessment
1. Upheld
The claim “Clinically tested technology” appeared in the ad close to the claim “the only drug free respiratory device that has 2 functions designed to help relieve breathlessness and clear mucus”, and on the same page as other claims relating to the efficacy of the device for breathlessness, respiratory fitness and mucus clearance. In that context the ASA considered it likely that consumers would understand the claim to mean that trials had been conducted on the Aerosure Medic in a clinically controlled environment, and that those trials constituted clinical evidence which supported the claims that the device could relieve breathlessness and improve mucus clearance and respiratory fitness.
We took expert advice. We noted the studies which measured the effects of the device after ten and 30 breaths investigated physiological responses to the device but were not clinical studies measuring whether there was a beneficial effect to the treatment. We therefore considered those studies were not adequate to support the claim “Clinically tested technology”.
With regard to the final, five-week study which involved 35 participants, we noted that although there was some form of pseudorandomisation in the allocation of the Aerosure Medic-treated and sham groups, they were not matched for all relevant parameters, which resulted in the treated group having poorer starting values for several parameters than the sham group. The Aerosure Medic-treated group improved more than the sham group but we understood that this might have been a reflection of the differences between the two groups rather than because of the effects of the Aerosure Medic device.
The study made 32 lung measurements at the beginning and end of the five-week period. The average results for those 32 measures showed, for the treatment group, an improvement in six measures and deterioration in none, and for the sham group an improvement in ten measures but a deterioration in two measures. We understood that whilst the study reported that the treated subjects reported less breathlessness when breathing against a resistance at the end of the study, the effect was not clearly substantially different from that found in the sham group. The study also did not include a placebo group to allow for the effects of increasing familiarity with the test procedures or a training effect of making repeated measurements, and so the cause of the improvements was not clear. We considered that while the study demonstrated that the Aerosure Medic was not inferior to the device delivering the sham form of IMT, it did not demonstrate superiority over it and it did not clearly demonstrate efficacy of either device.
We acknowledged that the study did test the beneficial effects of the treatment. However, we considered that the study was not sufficiently robust in either its methodology or its findings to support claims of efficacy for the device in its Breathe Easier mode, which related to breathlessness and respiratory fitness.
We concluded we had not seen evidence adequate to support the claim that the Aerosure Medic was “Clinically tested technology” in its Breathe Easier mode. Additionally, we noted Actegy had not submitted any clinical studies which tested the device’s efficacy in relation to mucus clearance. We concluded the claim “Clinically tested technology” had not been substantiated and was therefore misleading.
On this point, the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are 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
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health-related products and beauty products).
2. & 3. Upheld
We considered consumers would understand the claims “Breathe Easier” and “Reduce shortness of breath and relieve breathlessness with regular use” to mean that using the Aerosure Medic device on a regular basis would reduce breathlessness. We considered the claims “may help to reduce breathlessness” and “with regular use … may result in reduced breathlessness” to mean that using the Aerosure Medic device, on a regular basis, was likely to reduce breathlessness. We also considered that, in the context of the ad’s references to the symptoms of respiratory conditions, the claims “Increase respiratory fitness with regular use”, “… improve respiratory fitness” and “with regular use improves respiratory fitness” would also be interpreted to mean that regular use of the device would reduce breathlessness.
We considered that, while consumers might have slightly lower expectations of a claim that a device “may” have a particular effect they would understand that medical interventions were not guaranteed to work, and the introduction of qualifying terms such as “may” would not change their expectation that such a claim would be substantiated by methodologically robust and relevant evidence which demonstrated that the device had a clinically significant effect for the majority of users.
Actegy had provided three clinical studies in relation to the efficacy of the Aerosure Medic device. As referenced at Point 1, we considered the two studies which related to the short-term physiological effects of using the Aerosure Medic device for ten or 30 breaths were not sufficiently robust to support claims of the device’s efficacy through regular use. We also considered that, while the five-week study demonstrated that the Aerosure Medic was not inferior to the alternative IMT device (the sham) it did not clearly demonstrate efficacy of either device and therefore, as referenced above, we considered it was not sufficiently robust to support claims of efficacy for the Aerosure Medic.
We noted Actegy considered that evidence relating generally to IMT devices and techniques, as referenced in the CER, substantiated claims relating to the effectiveness of the Aerosure Medic device. We considered the CER was a reasonable review of the literature and accepted its position that IMT devices in general had beneficial effects, but noted that there was a division of opinion amongst reviewers of studies into the efficacy of IMT. While there was a reasonable body of opinion that accepted the efficacy of IMT devices in general, other reviewers expressed doubt about the clinical significance of the effects of IMT.
We understood the rationale for the efficacy of the Aerosure Medic device in particular was that there was some evidence that vibration helped to condition muscles generally. The vibration delivered to the muscles involved with breathing might provide a particularly effecting form of IMT. However, we noted Actegy had not provided evidence which specifically supported that rationale. We further considered that, notwithstanding that the CER found that IMT devices in general had beneficial effects, in the absence of robust evidence relating specifically to the efficacy of the Aerosure Medic as an IMT device, we had not seen evidence which demonstrated that the results of clinical studies relating to other devices and techniques could be directly extrapolated as evidence for claims about the efficacy of the Aerosure Medic device for breathlessness and respiratory fitness. We concluded the claims in the ad had not been substantiated and were therefore misleading.
On these points, the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are 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
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health-related products and beauty products).
4. Upheld
We considered consumers would understand the claim “may help to ... improve mucus clearance” to mean that the Aerosure Medic was likely to improve mucus clearance, and the claims “Improve mucus and phlegm clearance” and “Mucus Relief” to mean that using the Aerosure Medic device would improve mucus and phlegm clearance. As referenced above, we considered that claims that the device “may” have a particular effect would nonetheless need to be substantiated by methodologically robust evidence which demonstrated that the device had a clinically significant effect for the majority of users.
We understood that there was a variety of airway clearance techniques aimed to facilitate the expectoration of sputum, including devices that caused vibration in the lungs such as the Aerosure Medic. The evidence generally, however, for the benefits of such techniques was limited and did not indicate that any particular technique was superior to any other.
No studies had been conducted on the effectiveness of the Aerosure Medic device with regard to mucus clearance. The claims were solely based on extrapolating the results of evidence relating to other OPEP devices to the Aerosure Medic device. We understood the amplitude of oscillations of an OPEP device was likely to be important in determining its mucus-clearing effect. We noted the amplitude of oscillation of the Aerosure Medic device was at the lower end of the range for other devices referenced in the CER, but that additional information provided by Actegy indicated that in practice there was likely to be substantial overlap with other devices. We understood that on that basis, the Aerosure Medic was likely to be as effective as other OPEP devices, but we noted the evidence did not directly demonstrate that this was the case. We considered that, notwithstanding that the Aerosure Medic was likely to be as effective as other OPEP devices, in the absence of robust evidence relating specifically to the Aerosure Medic as an OPEP device, we had not seen evidence which demonstrated that the results of clinical studies relating to other OPEP devices and techniques could be directly extrapolated as evidence for claims about the efficacy of the Aerosure Medic device for mucus and phlegm clearance.
We concluded the claims in the ad had not been substantiated and were therefore misleading.
On this point, the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are 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
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health-related products and beauty products).
Action
The ad must not appear again in the form complained about. We told Actegy they should not make claims that the Aerosure Medic device was clinically tested, that it could reduce breathlessness and improve respiratory fitness or that it could improve mucus and phlegm clearance.
