Background
Summary of council decision:
Three issues were investigated, all of which were Upheld.
Ad description
A website for the Gupta Programme, www.guptaprogramme.com, seen on 27 September 2017, advertised a treatment programme developed by Ashok Gupta for a range of conditions, through a “FREE Video Course on how to Recover”, followed by attending “In-Person Weekend Workshops” training, a “Home Study DVD Course”, and/or group “Coaching Webinars”. The website included text stating the programme was “a powerful revolutionary new treatment” with “incredible healing effects” for illnesses such as “Fibromyalgia”, “Chronic Fatigue Syndrome (CFS) or ME” and “Electrical Sensitivities”. It also said, “… these conditions are caused by abnormalities in the brain, especially a brain structure called the ‘Insula’ & the ‘Amygdala’” and the programme “is a way of re-wiring the brain’s responses to bring back health and vitality”. The website included various “Success Stories”, offered “a one year money back guarantee” and included a “Disclaimer” stating “this website is purely for informational purposes only, and is not a substitute for medical diagnosis, treatment or advice”.
Issue
The complainant challenged whether the claims that the Gupta Programme could treat the following conditions were misleading and could be substantiated:
1. “Fibromyalgia”;
2. “Chronic Fatigue Syndrome (CFS) or ME”; and
3. “Electrical Sensitivities”
Response
1. & 2. Harley Street Solutions Ltd t/a Gupta Amygdala Retraining (Harley Street Solutions) said that they had conducted clinical trials on their treatment protocol and believed they could substantiate that it could be used to support people with fibromyalgia, CFS or ME. They provided two published studies and a draft manuscript for a third study in support of those claims. With regard to the draft manuscript study, Harley Street Solutions said their treatment programmes included mindfulness tools and techniques as a standard part of their amygdala and insula retraining.
3. Harley Street Solutions said that ‘electrical sensitivities’ was not a recognized medical condition and therefore their claim to be able to treat it could not be in breach of any rules.
Assessment
1. & 2. Upheld
The ASA considered that consumers would understand from the claims in the ad that the Gupta Programme could treat “Fibromyalgia”, “Chronic Fatigue Syndrome (CFS) or ME”. The ad made reference to both attending workshops and a “Home Study DVD Course” and consumers would therefore understand the claims to relate to both methods of treatment. Harley Street Solutions had provided two published studies and a draft manuscript relating to a third study. We therefore considered whether the body of evidence submitted was sufficient to substantiate claims to treat those medical conditions.
The draft manuscript was of a Spanish randomised controlled trial examining the efficacy of mindfulness alongside amygdala and insula retraining in the treatment of fibromyalgia. We noted Harley Street Solutions stated that their amygdala and insula retraining included mindfulness techniques; however, the descriptions of the programmes on the website did not state that mindfulness training was a core part of that treatment. We also noted the study had not been published or subject to peer review. Additionally, the study appeared to involve weekly two-hour group sessions with a therapist and daily homework assignments, followed by three monthly sessions. The treatment delivery did not replicate exactly the advertised method of treatment in the ad of a two-day workshop with three follow-up webinars with Ashok Gupta (1.5 hours), or a home study DVD course followed by 12 weekly webinars. There were 64 participants in total and 22 in the relevant group, of whom 19 completed the study. The study noted the limitations of the fairly small sample size and that this meant they were not able to control for the possible influences of the individual therapist in each group. For those reasons, we did not consider the trial substantiated that the advertised therapy could treat fibromyalgia.
The second study related to both fibromyalgia and CFS. It had been published in a peer reviewed journal which focused primarily on complementary medicine. The single-blinded study compared the efficacy of amygdala retraining alongside ‘standard care’ with ‘standard care’ alone, and so the results would not be able to show the efficacy of amygdala retraining alone. ‘Standard care’ consisted of a 1.5 day course involving cognitive behavioral therapy (CBT) and graded exercise therapy (GET). Over half of participants did not complete the study – of the original 44 participants, 21 completed it, and only seven from the amygdala retraining group did so. This meant that the outcomes for the participants who did not complete it were not accounted for in the results, which was a significant limitation. Although the study reported statistically significant effects in some of the 16 different outcome measures used, given its limitations we did not consider that the study substantiated that the advertised therapy could treat fibromyalgia or CFS.
The third study related to CFS only and was an internal clinical audit published in a peer reviewed journal with a focus on complementary medicine. As a clinical audit it was therefore not controlled, randomised or blinded. The paper was authored by the Director of Harley Street Solutions and described the outcomes of 33 patients who had been recruited onto a one-year programme, 27 of whom completed it. Whilst 93% participants reported improvement we considered that the limitations of such an internal clinical audit meant it did not substantiate that the advertised therapy could treat CFS.
Taking account of the evidence as a whole, we did not consider that it was sufficient to substantiate that the Gupta Programme could treat “Fibromyalgia”, “Chronic Fatigue Syndrome (CFS) or ME” and we therefore concluded that the claims were 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).
3. Upheld
We acknowledged that “Electrical Sensitivities” was not a generally recognised medical diagnosis. However, we also understood that some people did suffer from real symptoms which they attributed to electromagnetic hypersensitivity (EHS), and we considered that the reference to “Electrical Sensitivities” in the ad implied that the Gupta Programme could treat those symptoms. Because we were not provided with any evidence to substantiate that claim we concluded that it was 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 its current form. We told Harley Street Solutions Ltd not to state or imply that the Gupta Programme could treat “Fibromyalgia”, “Chronic Fatigue Syndrome (CFS) or ME” or “Electrical Sensitivities”. We told them to ensure that they held substantiation for any similar claims relating to medical conditions or symptoms.
