Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
A Facebook post on The Cognitive Health Coach’s page, seen on 23 October 2022, stated, “Independent trial where 74% of patients with Alzheimer’s stabilised or improved. If you’d like to know how you can benefit, how you can reverse the symptoms of Alzheimer’s, how you can get your loved one back, get in touch for your free guide”. Below was a URL of their website. Further text stated, “#alzheimers #dementia #brainhealth #thecognitivehealthcoach”. Further text stated, “ReCODE Protocol Results” with an image of a pie chart and text that stated, “51% Improved 23% Stabilised 26% Decreased.”
Issue
1. The complainant, who worked in medical publishing, challenged whether the claims regarding the efficacy of the “ReCODE Protocol” in treating the symptoms of Alzheimers were misleading and could be substantiated.
2. The ASA challenged whether the ad discouraged essential treatment for a condition for which medical supervision should be sought.
Response
1. Parkwood Learning Ltd t/a The Cognitive Health Coach provided to the ASA the trial paper for the ReCODE Protocol study referred to in the ad, which had been published in the Journal of Alzheimer’s Disease in 2022. They said the trial presented a case for Alzheimer’s as a multi-cause disease that could only be treated with a precision medicine approach. They said they would send a potential client a summary of the trial and that the Facebook post also included a link to the same information so that consumers could conduct their own research.
The Cognitive Health Coach said they only ever referred to prevention or reversing of Alzheimer’s symptoms, they accepted there was, as yet, no cure, but they maintained that reversal of symptoms was achievable on the Protocol.
They said the Lancet medical journal and Alzheimer’s charities acknowledged that the prevention of around 40% of dementias was possible with simple lifestyle modifications and that the NHS also referred to similar advice. However, they said those lifestyle modifications were not as targeted as the Protocol which used extensive testing to establish the root causes, which is why they referred to only 40% of dementias and “prevention”. They said that if the Protocol were a drug, there would be more published trials and more medical evidence. That was because drug trials were predicated on testing a drug (or a blend of drugs) versus a placebo in double blind trials, but it was very difficult to complete a double blind, randomised trial of a precision medicine protocol. The ReCODE Protocol included many lifestyle changes, as well as supplements, which were bespoke to each patient and would be impossible to compare to a placebo.
2. The Cognitive Health Coach said they agreed that any patient with Alzheimer’s needed to be under appropriate medical supervision. As a health coach, they helped people to implement lifestyle changes directed by UK doctors with additional qualifications in Functional Medicine or with a provider of the ReCODE Protocol. Any client they worked with would immediately be referred to and meet with such a practitioner for whom they would complete comprehensive medical history forms, receive appropriate testing and an explanation of the bespoke protocol they were prescribed, and the root causes established by the tests. They would remain under medical supervision throughout the implementation of the Protocol and would also complete cognitive testing at the beginning and after six months to enable assessment of personal improvements. The Cognitive Health Coach said it was never their intention to discourage anyone from seeking medical advice.
Assessment
1.Upheld
The ASA considered consumers were likely to interpret the claim “Independent trial where 74% of patients with Alzheimer’s stabilised or improved” to mean that the ReCODE Protocol had improved or stabilised Alzheimer’s symptoms in three-quarters of the people on whom the trial had been conducted and would understand that it could, therefore, treat Alzheimer’s disease. The ad also stated, “If you’d like to know how you can benefit, how you can reverse the symptoms of Alzheimer’s, how you can get your loved one back, get in touch for your free guide”. We considered those statements would be understood to mean that people could reverse their symptoms and be cured of the disease, so that they could be taken back to their pre-Alzheimer’s state. That impression was further reinforced by the statement “how you can get your loved one back”, which we considered suggested that even someone in the advanced stages of Alzheimer’s could be brought back from that stage of cognitive decline. We therefore expected any evidence to substantiate the claims to relate to patients in the advanced stages of the disease.
Although the ad also stated, “ReCODE Protocol Results” and “51% Improved 23% Stabilised 26% Decreased”, which we considered indicated that the Protocol could improve, slow down or stabilise symptoms in 74% of patients, that did not override the impression given by the other claims in the ad that the Protocol could cure or reverse the symptoms of Alzheimer’s, even in patients in the advanced stages of the disease.
We understood that there were certain risk factors which affected the likelihood of someone developing Alzheimer’s and that some of those could be avoided or reduced by making lifestyle changes. We acknowledged from the NHS website that certain medicines could slow the progression of symptoms or temporarily improve them. However, we understood, also from the NHS website, that there was currently no cure for the disease.
We considered that the ad made breakthrough claims that would require a high level of evidence to substantiate them.
We therefore expected to see a substantive body of evidence, in the form of rigorous trials conducted on people with advanced Alzheimer’s symptoms.
We would normally expect that to include at least one adequately controlled experimental human study. We did not consider before and after studies, with little or no control to be sufficient to substantiate new claims relating to physiological action in humans.
The study provided was a pilot study carried out on 25 patients aged between 45 and 76 who had early-stage dementia or mild cognitive impairment. The patients were treated for nine months with a personalised precision medicine protocol and their cognition was assessed at zero, three, six and nine months using various measures. The results showed improvements across outcome measures, some of which were statistically significant. However, there were limitations with the study. In particular, the cohort was small and did not represent a racially diverse group, it did not include patients with intermediate stage or advanced Alzheimer’s disease, and it did not control for other factors that might have led to the improvements recorded. Furthermore, because cerebrospinal fluid had not been taken and analysed, it was uncertain whether the patients had Alzheimer’s disease-associated pathology. Finally, it was unclear whether the protocol used in the study was identical to the ReCODE protocol referred to in the ad, and whilst the results showed an improvement in symptoms, it did not show that cognitive decline could be reversed and/or the disease cured. The study also noted that a larger, randomised controlled trial was needed.
For those reasons, we considered that the study was not adequate substantiation for the claims.
Because we had not seen adequate evidence to prove the efficacy of the ReCODE Protocol for treating, curing or reversing advanced symptoms of Alzheimer’s disease, we concluded that the claims had not been substantiated and the ad was misleading.
On that point, the ad breached CAP Code rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).
2. Upheld
The CAP Code stated that marketers must not discourage essential treatment for conditions for which medical supervision should be sought. Advertisers must not offer specific advice on diagnosis of or treatment for such conditions, unless that advice, diagnosis or treatment was conducted under the supervision of a suitably qualified medical professional.
We considered that claims related to reversing the symptoms of Alzheimer’s and “how you can get your loved one back” would be interpreted to mean that the Protocol could treat symptoms of Alzheimer’s. We considered Alzheimer’s disease was a condition for which medical supervision should be sought, and therefore advice, diagnosis or treatment should be conducted under the supervision of a suitably-qualified health professional.
We understood that medically trained doctors, who had additional qualifications in providing the ReCODE Protocol, would be involved with the treatment of patients. However, the Cognitive Health Coach, who assisted with lifestyle changes was the first direct contact for consumers and we had not seen evidence that she was a suitably qualified health professional.
We also considered that accurate and timely diagnosis was important for treating Alzheimer’s disease and the references in the ad to reversing symptoms could discourage consumers from seeking essential treatment promptly under the supervision of a suitably qualified health professional. For those reasons, we concluded that the ad breached the Code.
On that point, the ad breached CAP Code (Edition 12) rule 12.2 (Medicines, medical devices, health-related products and beauty products).
Action
The ad must not appear again in its current form. We told Parkwood Learning Ltd t/a The Cognitive Health Coach to ensure that they did not make claims to treat, cure or reverse the symptoms of Alzheimer’s disease unless they held adequate evidence that substantiated those claims. We also told them not to make claims that discouraged essential treatment for conditions for which medical supervision should be sought.
