Background
Summary of Council decision:
Four issues were investigated of which two were Upheld and two were Not upheld.
Ad description
The website www.lightningprocess.com, for a complementary therapy course known as the Lightning Process, included a landing page that displayed links titled "CFS/ME", "FM/Chronic Pain", "Multiple Sclerosis", "IBS/Digestive issues", "Food/Chemical Intolerances", "Eating Disorders", "Addiction", "Depression", "Phobias/Anxiety/Stress", "Low Self Esteem" and "OCD". Each link directed readers to a page headed "The Phil Parker Lightning Process for [relevant condition]" which featured information including a link to a "Find A Practitioner" page.
The "CFS/ME" page of the website included the statements "Our survey found that 81.3 %* of clients report that they no longer have the issues they came with by day three of the LP course" and "The Lightning Process is working with the NHS on a feasibility study, please click here for further details, and for other research information click here".
The Frequently Asked Questions (FAQ) page stated "Q. Is it similar to any other therapy? A: No, the Lightning Process is a training programme and although it is designed with an expert knowledge of osteopathy, NLP and life coaching, it's not the same as these or any other approaches. The Lightning Process is completely unique ... Q. Why isn't the Lightning Process available on the NHS? A: We have discussed the role of the Lightning Process in the NHS with a number of NHS consultants, and have taken their advice that for the time being its three day format and the particular way it looks at language and health, it's best catered for in a non medical setting. We are looking at ways, including our work with research groups, to make the LP available on the NHS for the future".
Issue
Hampshire Trading Standards challenged whether:
1. the CFS/ME page, and in particular the claim "Our survey found that 81.3%* of clients report that they no longer have the issues they came with by day three of the LP course", misleadingly implied that the Lightning Process could treat or cure CFS/ME;
2. the claim on the FAQ page that "The Lightning Process is completely unique" could be substantiated; and
3. the references to the NHS on the website misleadingly implied that the Lightning Process had been endorsed by the NHS.
4. The ASA challenged whether the pages dedicated to each of the conditions listed on the landing page misleadingly implied that the Lightning Process could treat or cure those conditions.
Response
Phil Parker Group Ltd (Phil Parker Group) said Phil Parker was a statutory registered osteopath, psychotherapist and hypnotherapist and that he was therefore suitably qualified to work with people who suffered from the conditions mentioned. They stated that every Lightning Process (LP) practitioner had been personally trained by Phil Parker and his faculty and that they were all clinical hypnotherapists qualified to work with a range of psycho-therapeutic processes.
They stated that the LP was a training programme which looked at how individuals could influence their own health and wellbeing. They believed the website made it clear that LP was a non-medical training programme and therefore not a cure or a treatment. They were of the strong opinion that the Code rules on medical treatments should not be applied to the LP, because it did not market or define itself as a medical or health product. They did not believe validation of the effectiveness of a training programme required the same evidence base as medicines or medical treatments. They nevertheless provided evidence which they believed demonstrated that the LP could assist those who suffered from various conditions. They provided a copy of their own "LP Outcome Measures Research" and "LP Snapshot Survey" and abstracts of a number of other studies which they believed were relevant to the application of LP for the conditions listed on the website.
1. Phil Parker Group said many of their clients considered themselves free of ME after doing the LP course and had been signed off as healthy by their doctor since completing it.
They said no biochemical marker could be identified as a measure of change for people with CFS/ME and that self-reporting questionnaires were therefore among the most generally accepted ways of documenting change. They said a pilot study conducted with the International Centre For Wellness Research and the LP Outcome Measures Research demonstrated that the LP was an appropriate method for teaching people the tools to assist them with their CFS/ME. They also provided details of surveys conducted by the ME association, the Brighton and Sussex Medical School and the Sussex & Kent CFS/ME Society as well as their own Snapshot Survey. They pointed out that they had included a disclaimer linked to the Snapshot Survey results which stated "Our Snapshot Feedback Survey has been designed as a tool to collect data from clients as to whether they feel they have gained any benefit from attending the Lightning Process course. Although the data was collected from over 1000 people, the results are naturally subjective. Lightning Process practitioners are not medically trained and are therefore relying on client information about their diagnoses, symptoms and issues that they bring to the course".
2. Phil Parker Group said the LP had been designed solely by Phil Parker. They said he had no direct knowledge of cognitive behavioural therapy (CBT) or graded exercise therapy (GET) but that they believed GET encouraged a pacing approach to generally increasing the patient's exercise capacity, which was completely unlike the LP, which was not an exercise therapy.
They stated that CBT was a very broad field with very few accepted standard prescribed approaches, whereas the LP was a standardised training programme which meant a visit to a practitioner anywhere in the world should result in receiving the same training, material, tools and coaching. They said one of the core CBT approaches was a conscious evaluation, engagement and self-analysis of how the individual had been thinking about something; a recognition of how that might not have been the best way of thinking about it and a consideration of other ways of thinking. They explained that this was very unlike the LP approach which worked in training the individual to recognise any unhelpful ways of thinking; to disengage, avoid self-analysis and immersion in those ways of thinking and instead utilise a set of specific and standardised LP questions and physical movements to create new approaches to situations.
3. Phil Parker Group said the first reference to the NHS on the website was in relation to the feasibility study that they had undertaken with a specialist CFS/ME service for children based at the Royal National Hospital for Rheumatic Diseases, which was an NHS hospital. They said the only other reference to the NHS was in the answer to the FAQ "Why isn't the Lightning Process available on the NHS?" They did not believe any information on the website contained an express or implied claim that LP had been endorsed by the NHS but said they were prepared to remove the reference to attempting to make the LP available on the NHS in future from the FAQ page.
4. Phil Parker Group reiterated their view that, because LP was a training programme, it could not cure anything. They said the website did nothing more than accurately and responsibly offer general information about conditions that the LP might be of some use for.
They said the statement on their website that read "We have seen a number of people with all the different types of MS reporting impressive results when using the LP" was accurate and that they had documented results from a proof of concepts study carried out in conjunction with the Multiple Sclerosis Resource Centre (MSRC), as well as their LP Outcome Measures Study and individual testimonials. They said the studies supported the fact that LP was an appropriate and documented approach to teaching people tools to assist them to some degree with their MS. They also stated that the evidence provided in relation to LP and ME/CFS formed part of an evidence base that showed brain training approaches could influence the key systems that needed support in people with MS.
They said there was overwhelming evidence that brain-training approaches were suitable for IBS/Digestive issues and food intolerances. They provided several abstracts of studies which looked at the role of hypnotherapy in the treatment of people with IBS. They believed those showed that hypnotherapy had a positive impact on the symptoms of IBS and that the LP, which trained participants in self-hypnosis and other brain training techniques, was therefore an appropriate approach to teaching people tools to assist them to some degree with their IBS. They believed that the research mentioned in relation to ME/CFS showed the effect of brain training techniques on the function of the immune system and supported the idea that the mind could dampen heightened immune responses such as chemical sensitivities.
They provided links to two studies which looked at the application of hypnosis in the treatment of anorexia, which they believed supported the claim that LP was an appropriate and documented approach to teaching people tools to assist them to some degree with their eating disorders. They provided an abstract of a study which documented techniques of brain training in supporting ex-addicts in recovery and they said the positive outcomes from the LP Outcome Measures Research supported the use of LP for addiction. They also provided an abstract of a study that investigated the comparative effectiveness of hypnosis and CBT on depression and they believed the study and the results of their own Snapshot Survey supported the fact that the LP was an appropriate and documented approach to teaching people tools to assist them to some degree with their depression.
They stated that a number of the conditions referred to on the landing page, including anxiety, stress, phobias, OCD, low self-esteem and FM/chronic pain were accepted as being within the remit of psychosomatic practitioners. They reiterated that all LP practitioners were clinically trained hypnotherapists and could therefore refer to those conditions, so long as there was no promise of cure. They added that many of those conditions had also been shown to be affected positively by the LP Outcome Measures Study.
Assessment
The ASA noted that Phil Parker Group referred to LP as a training programme rather than a therapy and that none of the pages of the website expressly stated that LP could cure a specific medical condition. However, we noted that each page of the website stated "Welcome to this site, I do hope these pages [or "which I hope"] will answer some of your questions about [medical condition] and the Lightning Process (LP)". We noted that each page included a disclaimer that stated "Due to the nature of the [Lightning Process] training we cannot guarantee results as everyone is different, however we have received a considerable amount of positive feedback from clients with the varied symptoms that many people with [medical condition] can experience" and that the pages for CFS/ME, IBS/digestive issues, food and chemical intolerances, depression, FM/chronic pain, phobias/anxiety/stress and OCD included an introduction to a customer testimonial which explained the positive experience those customers had with the LP.
We considered that references to the LP and its potential benefit for those who suffered from the named medical conditions constituted objective claims for medical efficacy and that the Code rules specific to medical treatments were therefore applicable. Because neither CAP nor the ASA had previously seen evidence that the LP could be effective in treating the medical conditions listed, we considered that a high level body of relevant evidence was needed to prove the claims.
1. Upheld
We considered that visitors to the website were likely to understand from the statements such as "I hope these pages will answer some of your questions about this illness [CFS/ME] and about the Lightning Process (LP)", "Our survey found that 81.3%* of clients report that they no longer have the issues they came with by day three of the LP course" and "Due to the nature of the training the Lightning Process cannot guarantee results as everyone is different, however we have received a considerable amount of positive feedback from clients with the varied symptoms that many people with chronic health issues experience" that the symptoms of their CFS/ME were likely to be gone by the end of the three-day LP course and that they would have gained the knowledge to help them prevent those symptoms returning (with support from time to time from their LP practitioner).
Although we acknowledged that self-assessment questionnaires were commonly used to assess outcome measures in trials relating to CFS/ME, we noted that the LP Outcome Measures Study was not controlled and had been designed only to provide preliminary outcome measures which could be used to support an application for funding for a larger-scale randomised control trial (RCT).
Although we had not seen the full study, we understood that the pilot study conducted with the International Centre For Wellness Research reported positive results from a sample of 17 participants. However, we understood that the study was not controlled and had concluded that further investigation was necessary, with a larger sample size with wider inclusion criteria.
We had seen only a summary of the LP Snapshot Survey. We had no reason to doubt the accuracy of the reporting. However, we noted that participants need only have been self-diagnosed to participate in what was a self-assessment survey which was not controlled. Similarly, we noted that the trials conducted by the ME Association, the Brighton and Sussex Medical School and the Sussex & Kent CFS/ME Society reported positive results but were self-assessment studies and had not been controlled. We considered that those studies and surveys did not constitute a suitably robust body of evidence to demonstrate the effectiveness of the LP in the treatment of CFS/ME. Because of that, we concluded that the CFS/ME page of the website was likely to mislead.
On this point, the website 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. Not upheld
We understood that GET and CBT were the two treatments for CFS/ME used within the NHS. We understood that GET was a structured exercise programme that aimed to increase gradually how long a person could carry out a physical activity. We understood that the LP involved only low intensity physical movements, the purpose of which were not to expand the body's capacity for exercise, and we considered that it therefore differed significantly from GET.
Although we considered that there appeared to be similarities between CBT and the LP, in that both attempted to provide people with new ways of thinking about the issues presented by their illness, we noted LP incorporated elements of hypnosis and meditation, as well as low intensity physical movement, and we considered that it therefore differed sufficiently from CBT to be regarded as "unique".
On this point, we investigated the website under CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising) and 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), but did not find it in breach.
3. Not upheld
We noted that the NHS was referred to on the FAQ page of the website, where an explanation was offered as to why LP was not available on the NHS. Although we considered that the FAQ page implied that it was for practical reasons rather than reasons of documented medical effectiveness that the LP was not available on the NHS, we did not consider that it implied the LP had been endorsed by the NHS.
Although we noted that the LP was working with only one NHS hospital on a study intended to determine whether it was possible to recruit young people with CFS/ME into a study to compare specialist medical treatment with specialist medical treatment plus the LP, we noted that the website provided a prominent link to further information and we therefore concluded that the reference to the feasibility study did not imply that the LP had been endorsed by the NHS.
On this point, we investigated the website under CAP Code (Edition 12) rule 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising), but did not find it in breach.
4. Upheld
We considered that visitors to the website would interpret the customer testimonials, the results quoted from the LP Snapshot Survey and the other claims made for the LP on the MS, IBS/digestive issues, food and chemical intolerances, eating disorders, addiction, depression, FM/chronic pain, phobias/anxiety/stress, low self-esteem and OCD pages of the website to mean that the LP could be effective in treating those conditions.
We noted that the LP Outcome Measures Study showed a positive impact of the LP for those who suffered with MS, addiction, depression, FM/chronic pain, anxiety, low self-esteem, OCD and conditions classed as "Other/Unknown". However, as we noted at point 1 above, we did not consider that study to be strong evidence of the effectiveness of the LP.
We noted that the other study we had seen that looked specifically at the effectiveness of the LP in treating MS was also not a controlled clinical trial. The majority of the study abstracts we received looked at the performance of treatment methods other than the LP for different conditions and we had not seen an extrapolation by an appropriate expert of the findings from those studies that demonstrated they could be relevant in support of the claims for the LP, which was identified as a unique process which, while drawing from elements of osteopathy and hypnotherapy, did not hypnotise participants or involve any physical manipulation. In the absence of adequately controlled trials relating specifically to the impact of the LP in the treatment of people with MS, IBS/digestive issues, food and chemical intolerances, eating disorders, addictions, depression, FM/chronic pain, phobias/anxiety/stress, low self-esteem and OCD, we considered that the website was likely to mislead consumers regarding the benefits of the LP in the treatment of people with those conditions.
In addition to the fact that we had not seen robust evidence in support of the efficacy claims, we noted that the CAP Code stated that ads should not contain references to medical conditions for which medical supervision should be sought because of the risk that it might discourage readers from seeking essential treatment for those conditions. We noted that the ad made reference to conditions including MS, eating disorders, addiction, depression and OCD and we acknowledged that depression and OCD were generally regarded as conditions capable of being treated under the supervision of suitably qualified psychosomatic practitioners. We understood that Phil Parker was a registered hypnotherapist, osteopath and psychotherapist, however, we noted that the website was intended to direct prospective customers to find their local LP practitioner. We noted that LP practitioners need only be trained in hypnotherapy and could therefore practice without having attained the necessary qualifications to treat those conditions.
Because Phil Parker Group had not supplied evidence to show that the LP could treat MS, eating disorders, addiction, depression and OCD and because reference to them could discourage readers from seeking essential treatment under the supervision of a suitably qualified health professional for them, we concluded that the claims were misleading for that reason also.
On this point, the website 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.
and
12.2
12.2
Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see 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.
).
Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
(Medicines, medical devices, health-related products and beauty products).
Action
The claims on the website should not appear again in their current form. We told Phil Parker Group to ensure they did not make medical claims for the LP unless they were supported with robust evidence. We also told them not to refer to conditions for which advice should be sought from suitably qualified health professionals.
