Ad description
A magazine ad by Neuronix for a medical device, NeuroAd, seen on 27 July 2017, featured the headline claim "A New Treatment for Alzheimer's Disease". Further text stated "The NeuroAd System of Neuronix. The first medical device developed for the treatment of mild to moderate Alzheimer's disease. NeuroAD is a unique combination of two well-known clinical treatments: repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Training. Under the heading “Patient Benefits”, text stated “… while not every patient will experience the same results, benefits may include: improved memory, mood and overall daily living. Better language, name and face recognition. Greater independence and social interaction. Noticeable improvements in attention and focus”.
Issue
The complainant challenged whether the claims that NeuroAd could treat Alzheimer's disease were misleading and could be substantiated.
Response
Neuronix Medical Ltd t/a Neuronix submitted certification which showed that the NeuroAD System was CE approved by a European Notified Body, and had been approved for treatment of cognitive decline conditions, in particular mild to moderate stages of Alzheimer’s disease. Neuronix submitted a range of published and unpublished papers in support of the claims in the ad. The papers included three randomised controlled trials, three case series studies and two poster presentations on controlled clinical trials. They also submitted a presentation that summarised a multi-centre randomised controlled trial that had been submitted to the US Food and Drug Administration.
Assessment
Upheld
The ASA considered consumers would understand from the ad that the NeuroAD device had been proven to treat Alzheimer’s disease and provide the listed benefits of “improved memory, mood and overall daily living”, “better language, name and face recognition”, “greater independence and social interaction” and “noticeable improvements in attention and focus” to people with Alzheimer’s disease. While we acknowledged that the ad included the qualifications “not every patient will experience the same results” and stated that the device “may” provide those benefits, we considered that the overriding impression of the ad was nevertheless that the device had been proven to generally provide those benefits to people with Alzheimer’s disease.
We acknowledged that the certificate from the European Notified Body was sufficient to demonstrate that NeuroAD was a Class IIa medical device which conformed with the Medical Devices Directive 93/42/EEC. However, a CE certification did not constitute evidence for the purposes of rule
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.
of the CAP Code, which required advertisers to hold documentary evidence to support efficacy claims.
We took expert advice. We understood that the NeuroAD system used a combination of transcranial magnetic stimulation and cognitive exercises tailored to individuals, and given in one-hour sessions, five days per week for six weeks. Transcranial magnetic stimulation was a non-invasive technique which used an electromagnetic coil held against the scalp to create an electric field in the brain to stimulate neurons. Cognitive training involved guided practice on a set of standard tasks designed to reflect particular cognitive functions such as memory and attention.
We assessed the evidence submitted by Neuronix. Three of the studies were randomised controlled trials, and we acknowledged that each of those studies was well conducted with strong structures. They were all double-blinded with placebo controls and had appropriate inclusion and exclusion criteria. However, the sample sizes in each case were small such that the results could not be viewed as reliable unless the reported treatment effects were particularly large. Two of the studies with treatment group samples sizes of seven and ten respectively reported statistically significant results. However, the results were only marginally statistically significant in the first study. In the second study, we noted most of the improvements occurred after the end of the treatment, and we considered that given the small sample size, there was a significant possibility that the improvements were due to chance as opposed to a continuation of the physiological process after the treatment. We further noted that the study authors had explicitly stated that the possibility of drawing general conclusions was limited due to the small sample size, and that a multi-centre trial was necessary to make conclusions about the clinical relevance of the findings. We considered that while the findings of those two studies were encouraging and provided some evidence in support of the claim, the studies were not sufficient in themselves to substantiate the claim that NeuroAD could treat Alzheimer’s disease.
In the third randomised control trial, no statistically significant difference was demonstrated between the final outcomes of the test group and the control group. While the study had reported a statistically significant difference between symptoms of Alzheimer’s disease at the beginning and end of the study, we considered that was not appropriate when there was a control group available for direct comparison. In addition, the study had adjusted for age, gender and education between the two groups, which we considered was inappropriate and left the study susceptible to bias when the treatment allocation was already randomised. We therefore considered that the study did not provide adequate evidence that NeuroAD could treat Alzheimer’s disease.
Three of the further studies submitted by Neuronix were case series studies on eight, ten and thirty patients respectively. We considered that because the studies had no control group or any form of comparison, and given the relatively small sample sizes, they could not be used as evidence.
Neuronix also submitted two poster presentations which reported on the findings of controlled clinical trials. The sample sizes were small with only six patients taking the treatment in each case. In both studies it appeared that there was no process of randomisation in the assignment of patients to the treatment and control groups, meaning that the studies were susceptible to selection bias. In one study, there was also no reference to the blinding of the assessors, which further increased the risk of bias. In the other study, the results primarily compared symptoms of Alzheimer’s disease before and after the treatment, with little evidence provided of a difference between the treatment group and the control group. We considered that the evidence in both studies was insufficient to support the claims that the device could treat Alzheimer’s disease.
We understood that a full study had been submitted to the US Food and Drug Administration in support of their application for marketing clearance in the US. However, the full study had not been submitted to us, and instead Neuronix has provided a brief presentation which summarised the study. The presentation indicated that the study had used a substantial sample size of 131 patients, had appropriately used a placebo control group and double-blinding, and that the inclusion and exclusion criteria were both relevant. However, there were a number of inconsistences and omissions in the data presented. We were further concerned that a number of patients appeared to have been excluded from the study after the randomisation process, and were not included in the analysis. We considered that post-randomisation exclusions undermined the principle of “intention to treat”, restricting the ability to statistically test the results and rendering the results unpredictable. Furthermore, the presentation did not provide any discussion or analysis of a reported imbalance between the treatment group and the control group in the patients’ symptoms of Alzheimer’s disease at the beginning of the study. For those reasons, we considered that the information provided was insufficient to draw conclusions about the validity and reliability of the study.
In conclusion, we acknowledged that two of the randomised controlled trials submitted by Neuronix provided some evidence in support of the claims in the ad, and it was possible that in future more substantial evidence would be produced to demonstrate the device’s effectiveness in treating those with Alzheimer’s disease. However, we considered that the current evidence base was insufficient to support the claims that the medical device treated Alzheimer’s disease or produced the potential benefits of the device listed in the ad. As such, we concluded that the claims had not been substantiated, and the ad was therefore misleading.
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 its current form. We told Neuronix not to claim that the NeuroAD device could treat Alzheimer’s disease or any symptoms of Alzheimer’s disease, unless they held adequate evidence.
