Proof Positive?

The SMILE trial is set against the background of an approach known as ‘biopsychosocial’. In the context of ME/CFS, this approach presupposes that the initial trigger of illness (e.g. viral) is no longer present and that the ongoing symptoms are a result of unhelpful beliefs by the patients that they have a chronic physical illness and consequent physical deconditioning, brought on by the patient’s fear that activity will harm them.

The following quote, from a conference on the biopsychosocial movement in 2002,
appears predictive of the denial of the right of  parents
and child participants to informed consent to take part in the SMILE trial.

“Rather than start with the physicians, which might be quite a difficult task,
we could make a start with youngster in schools. 
My experience is that they are much easier to educate. 
The only barrier is the parents.
Once we have the child on our side we are in a very good position”.

Professor Trudie Chalder, 2002.

Extract from Proof Positive?  30th August 2005
http://www.meactionuk.org.uk/PROOF_POSITIVE.htm

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SMILE trial: Summary of Concerns

A trial of The Phil Parker Lightning Process on children newly diagnosed with ‘CFS/ME’ (Chronic Fatigue Syndrome/Myalgic Encephalopathy or Myalgic Encephalomyelitis) 

A small online focus group formed in October 2010 to share various concerns after the SMILE trial passed approval by the South-West 2 Research Ethics Committee in September 2010.  The group included psychologists, educators, former clients of the Lightning Process, patients and parents of children with ME/CFS.  Correspondence with the South-West 2 Research Ethics Committee, National Research Ethics Service, General Medical Council, and Clinical Medical Officer was posted here for reference, and the site is now in the process of being updated (February 2016).

One of the main concerns was that SMILE was processed as a feasibility study, rather than as a clinical trial of a previously untested intervention, when in fact, the trial participants were required to undergo the intervention as an integral part of the feasibility study. The feasibility study went ahead, and results were published on 5th December 2013. Meanwhile, two further favourable opinions were provided by the South West 2 Local Research Ethics Committee on on 31 May 2011 and 6 September 2012 for amendments to study documents and protocol, seemingly to convert the study to a full clinical trial. This trial was completed and publication of the paper was expected by the end of 2015.

Comparing specialist medical care with specialist medical care plus the Lightning Process® for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial). Study Protocol – http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-444

The following summary relates to the July 2010 trial protocol and process of ethics
approval for the SMILE trial as a feasibility study in 2010.

SMILE (Specialist Medical Intervention and Lightning Evaluation)
Assessing the feasibility and acceptability of comparing the Lightning Process with  specialist medical care for Chronic Fatigue Syndrome or Myalgic Encephalopathy (CFS/ME) – pilot Randomised Controlled Trial.

“The protocol for this experiment using a novel and unpredictable psychotropic process on vulnerable children should leave nothing to the imagination.” ‘frown at SMILE’, 2010.

Main Issues of Concern

1.  There was no sound justification for conducting this research on
children before its safety and effectiveness had been assessed in adults.

2.  The Lightning Process is advertised as a non-medical tool and the
LP practitioners are not medically qualified, yet the PI claimed that
this was a study of treatment for ME/CFS.

3.  In Q2 of the study application form, the lead researcher (Dr. Esther Crawley)
did not declare this to be a clinical trial, yet the children were to undergo the
Lightning Process as part of the feasibility study.

4.  Dr. Esther Crawley claimed that it was necessary to assess
the safety and effectiveness of the Lightning Process, yet in QA22, she replied,
“We do not believe there are any risks of being part of this study.”
Minutes of the SW ethics committee meeting (10) show that Dr. Esther Crawley was
aware there are risks to patients from doing the Lightning Process.

5. The trial participants were denied their right to give informed consent
to take part in the research, in breach of the Declaration of Helsinki.

6. Child Protection concerns regarding risk to the trial participants mental and physical health; and the Lightning Process research collaborators were trading in breach of Advertising & Trading regulations.

SUMMARY OF CONCERNS RAISED BY ‘frown at SMILE’ in 2010

Failure to –
• process SMILE as a clinical trial
• meet official guidelines for research in children
• take account of existing (and new) research on children with ME/CFS
• justify why the research should be done
• disclose risks (psychological and physical) of the LP intervention
• protect the safety of trial participants
• informed consent in breach of the Declaration of Helsinki
• declare financial incentive for trial participants
• declare conflicts of interest of key investigators/collaborators in the study
• ensure impartiality of ‘Independent Advisory Group’

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ASA Ruling on Phil Parker Group Ltd. March 2013

Re. Phil Parker Group Ltd
River Plate House
7–11 Finsbury Circus
London
EC2M 7DH
Date: 27 March 2013
Media: Internet (on own site)
Sector: Health and beauty
Complaint Ref: A12-210374
Complaint Upheld
https://www.asa.org.uk/Rulings/Adjudications/2013/3/Phil-Parker-Group-Ltd/SHP_ADJ_210374.aspx#.Vr4DMfkrLIU

Ad
The website http://www.lightningprocess.co.uk, visited on 9 October 2012, was headed “Lightning Process – Phil Parker’s Personal View”. Text stated “This is my personal site (for the official one click here) all about the Lightning Process’ development and my journey with it from a small clinic in North London to it being practiced across the world. In it you’ll find stories of those who inspired me with how they used the mind body connection to get over ME/CFS, MS, Depression, Anxiety, Chronic Pain and Eating Disorders and much more”.

Issue
Hampshire Trading Standards challenged whether the references to “ME/CFS, MS, Depression, Anxiety, Chronic Pain and Eating Disorders” misleadingly implied that the Lightning Process could treat or cure those conditions.

CAP Code (Edition 12)
12.112.23.13.7
Response
Phil Parker Group Ltd said the site was not owned by them but by Phil Parker personally and that nothing was being sold from the site, which was only for discussion and opinions. They said it did not include links to Lightning Process practitioners and their websites, did not provide information about how to take the training with either Phil or the team, did not use the corporate branding and logos which were used on their commercial sites and did not link to the shop where their products were available. They said the site had no commercial intent and was not a marketing communication within the remit of the Code.

They said there was an incredible amount of information about the Lightning Process on the internet, some of which was accurate and some of which was not, and that Phil Parker wanted to provide people with correct information about it. They considered it reasonable that Phil Parker, who had designed the Lightning Process and had qualifications relevant to the treatment of CFS/ME, was allowed to share his views on the Lightning Process in relation to CFS/ME, and other conditions, on his personal website. They said that to prevent Phil Parker discussing his opinions about the Lightning Process on the site would infringe upon his freedom of speech. Nevertheless, the challenged claims were removed from the site in February 2013.

Assessment
Upheld

The ASA noted that Phil Parker Group did not believe that the Code applied to Phil Parker’s “personal” website. The Introduction to the UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing (the Code) stated that the Code applied to “Advertisements and other marketing communications by or from companies, organisations or sole traders on their own websites, or in other non-paid-for space online under their control, that are directly connected with the supply or transfer of goods, services, opportunities and gifts, or which consist of direct solicitations of donations as part of their own fund-raising activities”.

We noted that the website’s URL was “www.lightningprocess.co.uk”; that there was an active link to the official Lightning Process website (www.lightningprocess.com); that the official Lightning Process website was headed “Phil Parker Lightning Process® – the mind-body connection training”; and that the content of the website was almost exclusively about the Lightning Process. We considered that Phil Parker was inextricably linked with the Lightning Process brand and that the content on the website would, as far as it related to the Lightning Process, be understood by consumers as a promotion by Phil Parker of his commercial proposition, in which he had a financial interest. We therefore considered that that content was directly connected to the supply of goods and services and was subject to the Code.

We noted that the home page of the website referred to Phil Parker’s “journey” with the Lightning Process and to the stories that consumers would find within the site about those who had used the “mind body connection” to “get over ME/CFS, MS, Depression, Anxiety, Chronic Pain and Eating Disorders and much more”. We considered that visitors to the website would infer from the home page that the Lightning Process could be effective in treating each of the conditions listed.

We had previously considered a complaint about the official Lightning Process website which made claims about the use of the Lightning Process in the treatment of various medical conditions, including ME/CFS, MS, depression, anxiety, chronic pain and eating disorders. In our adjudication we concluded that we had not seen a suitably robust body of evidence to demonstrate the efficacy of the Lightning Process in the treatment of any of those conditions. We also concluded that references to medical conditions, for which medical supervision should be sought, including MS, depression and eating disorders, had breached the Code, because of the risk that they might discourage readers from seeking essential treatment for those conditions. Phil Parker Group had said Phil Parker was a registered hypnotherapist, osteopath and psychotherapist and, while we noted that he might be qualified to treat conditions such as depression, we also noted that the official Lightning Process website (which was linked to from the home page of the “personal” site) was intended to direct prospective customers to find their local Lightning Process practitioner, who need not be similarly qualified.

Because we considered that the website was subject to the Code, and because we had not seen evidence to show that the Lightning Process could treat ME/CFS, MS, depression, anxiety, chronic pain and eating disorders, we concluded that the website was likely to mislead consumers regarding the benefits of the Lightning Process in the treatment of people with those conditions. Furthermore, because the mention of MS, depression and eating disorders could discourage readers from seeking essential treatment under the supervision of a suitably qualified health professional, we concluded that the reference to them was misleading for that reason also.

The website breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 and 12.2 (Medicines, medical devices, health-related products and beauty products).

Action
The claims must not appear again in their current form. We welcomed the decision to remove the claims. We told Phil Parker Group not to make claims on websites within their control that were directly connected with the supply of their goods and services if those claims could not be supported with robust evidence. We also told them not to refer to conditions for which advice should be sought from suitably qualified health professionals.

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ASA Ruling on Phil Parker Group Ltd. August 2012

A complaint was submitted to the Advertsising Standards Authority by Hampshire Trading Standards. To summarise, the ASA upheld that:
1. The claims with respect to treatment of ME/CFS, in particular the 81.3% claims of success, were misleading and that LP is a medical therapy with respect to the law and not a training program.  *This finding validates various concerns raised by organisations and individuals concerning the SMILE study as detailed in the frown at SMILE site.*

2. The claims with respect to MS, IBS/digestive issues, food and chemical intolerances, eating disorders, addiction, depression, FM/chronic pain, phobias/anxiety/stress, low self-esteem and OCD, are both misleading and should not appear again as they could prevent people from seeking proper treatment from appropriately medically qualified practitioners for those conditions.

The website breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 and 12.2 (Medicines, medical devices, health-related products and beauty products).

The full adjudication as published on 22.8.2012.

ASA Adjudication on Phil Parker Group Ltd
Phil Parker Group Ltd
River Plate House
7–11 Finsbury Circus
London
EC2M 7DH

Date:22 August 2012

Media:Internet (on own site)
Sector:Health and beauty
Number of complaints:1
Complaint Ref:A11-158035

Background
Summary of Council decision:

Four issues were investigated of which two were Upheld and two were Not upheld.

Ad
The website http://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.

CAP Code (Edition 12)
12.112.23.13.7
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 (Misleading advertising), 3.7 (Substantiation) and 12.1 (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 (Misleading advertising) and 3.7 (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 (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 (Misleading advertising), 3.7 (Substantiation) and 12.1 and 12.2 (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.

http://asa.org.uk/ASA-action/Adjudications/2012/8/Phil-Parker-Group-Ltd/SHP_ADJ_158035.aspx

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The Curious Case of the SMILE Research Collaborators

The Advertising Standards Authority Adjudication re: Alastair Gibson’s unsubstantiated claims about The Phil Parker Lightning Process in a sponsored link to his “Withinspiration” website dated June 2010.

Alastair Gibson is named by Dr. Crawley on th NHS REC form as one of the two Lightning Process practitioners involved with SMILE and Alastair Gibson announced that he was one of the two on his Withinspiration website in March 2010, the other being Phil Parker.

In her letter of 4th February 2011, which she requested be publicised, Joan Kirkbride of the National Research Ethics Service, wrote:

Mr Parker has confirmed that the complaint that was investigated by the Advertising Standards Authority (ASA) did not concern him but rather an entity called “WithInspiration” with whom he has no financial, employment or other interest. It is a private business managed by a registered Lightning Process Practitioner and he had no ability to influence the day to day management or marketing of this business.”

This is plainly and indisputably untrue – Mrs. Joan Kirbride, Dr. Janet Wisely, and now Sarndrah Horsfield, Acting CEO of the National Patient Safety – all now know that the NRES has publicised information that is not only misleading but plain false, yet they have nothing whatsoever to rectify that situation by correcting this misinformation and telling the public the truth of the matter.

In a further letter of 4th March 2011, Mrs. Kirkbride wrote:

The application form which details the involvement of parties in the study is available on the University of Bristol website but I would confirm that Mr Gibson is not providing any research intervention with the children.”

It would be interesting to know at what point and for what reason it was decided that Mr. Gibson would be providing any intervention with the children, and to know what his role in the research is.

There was no acknowledgement of the lie by omission that Withinspiration belongs to Alasatir Gibson or the direct lie that Phil Parker “has no financial, employment or other interest” or “influence” in his business, and Mrs. Kirkbride wrote:

NRES does not intend to issue any further apology and the statement provided is correct that the SW 2 REC was provided with incorrect information“.

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SMILE in BMJ June 2011

We had hoped that the GMC Case Examiners would not feel coerced or unduly influenced by the slur cast on them in article published in the BMJ on 22nd June (as well as on patients, parents and professionals raising objections to the SMILE study and Dr. Crawley’s conduct) and would  feel able to remain impartial with respect to the legitimate, factual and evidence-based complaints against Dr. Crawley in this instance.

From GMC 6th July 2011

I refer to the above matter and write further to your emails date 7 June
and 6 July 2011.

In respect of your email dated 7 June 2011, I can confirm that prior to
making their decision the Case Examiners considered all the information
you put forward and that their decision was based on this.

They have also considered your email of today’s date. There is no new
material contained within this email. The article you cite is a feature
by a freelance journalist and is not a scientific paper, it contains
anecdotal material and opinion.

In view of the fact that all the information was considered, there are
no grounds for the Case Examiners decision to be reviewed. The fact that
you do not agree with their decision is insufficient grounds for the
matter to be considered further.

If you have any questions please do not hesitate to contact me.

Yours sincerely,
Investigations Officer
Standards and Fitness to Practise Directorate

Direct Dial : 0161 923 6432
Direct Fax : 0161 923 6578

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Complaint to General Medical Council May 2011

To GMC 6th May 2011

I wish to report Dr. Esther Crawley for matters relating to
research-related fraud and misconduct that cast serious doubt over her
fitness to practice and which I believe are serious enough to warrant
investigation by the GMC.

I understand that you are already looking into complaints about Dr.
Crawley’s professional conduct under the above reference number.
Please find attached my complaint and please let me know if you
require any further information from me on the matter.

Reply from GMC

Thank you for your email, your comments will be considered by the case
examiners in due course. If you have any supporting evidence I would be
grateful if you could forward it to me at your earliest convenience.

Kind regards

Yours sincerely

Investigations Officer
Standards and Fitness to Practise Directorate

To GMC 16th May 2011

Thank you for your reply and I apologise for the delay in responding.
Please let me know if you have any further queries.
Supporting evidence –

1.  SMILE misled REC child-adult ME.
2.  SMILE failed to justify
3.  SMILE illegal trading LP

4.  SMILE promise therapeutic gain
5.  SMILE child protection
6.  SMILE risks PEM
7.  SMILE risks patient evidence

To GMC 20th May 2011

Re: Further evidence in support of the complaint that Dr. Crawley failed to justify why the Lightning Process intervention should be used in research on children before first testing it with adults (supporting evidence document numbered 2).  While the SMILE pilot study has not been funded by the MRC, I believe this extract to be of particular relevance as it refers specifically to research in children with CFS/ME.

MEDICAL RESEARCH COUNCIL
MRC CFS/ME RESEARCH ADVISORY GROUP
CFS/ME RESEARCH STRATEGY
02 May 2003

41. In addition to these symptomatic issues, CFS/ME can affect a wide
age range, which brings additional complexities to undertaking
research. The understanding of the aetiology and outcome for children
with CFS/ME is, at present, an area that appears to be
under-researched. It is likely that interventions developed for an
adult may need significant modification before they could be evaluated
in children.
There are particular ethical dimensions to children participating in
research which must be considered in great depth by researchers, and
the rights of the child must remain paramount. Whilst acknowledging
the importance of research with children, the MRC CFS/ME Research
Advisory Group endorses the generally accepted principle that for
ethical reasons research involving children should be undertaken only
when there are good reasons why such studies could not be done in
adults (McIntosh et al., 2000).”
ion/idcplg?IdcService=GET_FILE&dID=8392&dDocName=MRC001895&allowInterrupt=1

The case examiners may already be aware of this, otherwise I hope it is of help.

Reply from GMC 26th May 2011
https://frownatsmile.wordpress.com/2011/07/31/gmc-says-case-closed/

From complainant’s reply 6th June 2011

The case examiners demonstrated that some of the complaints may be easily upheld, and other areas of complaint have not been addressed in full.

“The Case Examiners have reviewed all the documents provided by the complainants and Dr Crawley and cannot find any evidence from peer-reviewed randomised controlled trails that demonstrates similarities/differences of CFS/ME in adults and children or that supports the efficacy or otherwise of LP.”  General Medical Council 6th June 2011

The above finding by the GMC Case Examiners confirms that Dr. Esther Crawley failed to justify why this research should be done on children before adults. 

The GMC response did not address the matter of Dr. Crawley’s use of paediatric patients in collaboration with illegal traders – Phil Parker and The Phil Parker Group of Lightning Process practitioners – including directing patients and research participants to share confidential medical information on the LP application form; or the matter of coercion to participate in research as the participants are the chief investigator’s own patients recruited at her specialist clinic at the point of diagnosis and as the information they are required to read about the intervention comprises promotional sales material.

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Complaint to National Patient Safety Agency – May 2011

To: Chief Executive of NPSA

Date: 3rd May 2011

Re: Complaint

Ref. 10/H0206/32 submission date 24.05.2010

Assessing the feasibility and acceptability of comparing the Lightning Process with specialist medical care for Chronic Fatigue Syndrome or Myalgic Encephalopathy (CFS/ME) pilot Randomized Controlled Trial. (SMILE)

I wish to submit a formal complaint about the conduct of the SW 2 Regional Ethics Committee and the National Research Ethics Service in their handling of the above study application. I would like to make it clear that my complaint is not intended as an appeal against an REC decision – I am aware that there is no appeal process for third parties against REC decisions. Please also note that my complaint is in no way vexatious in intention. I have no personal or professional relationship with the researchers and no vested interest in this study. The purpose of my correspondence with the REC – which commenced in October 2010, after ethics approval had been granted – has been with a view to bringing to the REC’s attention new information that I believe warrants a review of their favourable opinion. I was pleased that the REC did conduct a review, but they failed to address the fundamental issues raised by that new information, and they have subsequently failed to take into account further new information, which seriously compromises the validity of the study and more importantly, compromises the rights and welfare of the research participants and their parents. I use “parents” to indicate the adults with personal responsibility for the patients. My concerns relate to the rights, safety, dignity and well-being of the paediatric patient participants and their parents and to the professional conduct of the National Patient Safety Agency, which I believe has breached its stated remit in the context of this study application. I believe I also have both a right and a duty to report concerns that criminal offences may have been committed and that the spirit of the law and regulations may not have been upheld. Please be aware that my complaint and any response received may be placed in the public domain in the public interest.

Areas of complaint

. Conduct of the Chief Investigator (CI), which I believe the REC did not use Standard Operating Procedures (SOPs) to deal with, and which may amount to research-related fraud and misconduct.

. Conduct of the REC in handling the original study application and the review of its opinion.

. Conduct of the NRES once the matter had been referred on.

Summary of specific concerns

  1. Failure to declare or treat this as an application for approval of a clinical trial.
  2. Failure to disclose risks and material information to the REC and study participants.
  3. The REC relied too heavily on the views and opinions of the CI, which are in contradiction of medical and scientific evidence provided to the REC by concerned parties.
  4. The REC failed to take sufficient account of the lack of impartiality of the care organisation supporting the study and of the External Advisory Group.
  5. The reasons given by the CI why children should be used as test subjects for this intervention before first testing it on adults are unsubstantiated and contradicted by existing scientific evidence.
  6. The reasons given by the CI to justify this research were not evidence-based.
  7. Reasons why the research could not be justified were evidence-based yet were dismissed as largely matters of opinion.
  8. Patients’/parents’ right to give informed consent to participate in the study has been undermined by the following:

8.1 The study participants are the patients of the CI, recruited by her at her specialist NHS clinic at the point of initial diagnosis, which is likely to positively and prejudicially influence the primary outcome of the study – recruitment and retention.

8.2 Non-disclosure of risk to participants in the study proposal.

8.3 Non-evidence-based declaration of risk as slight following ethics review.

8.4 Non-disclosure that the information regarding the success rate of the intervention and regarding the underlying causes of ME/CFS (and other diseases) in the advertising of the intervention cannot be relied on as it is unsubstantiated, and given that patients’/parents are specifically advised in the study protocol to read such information – this inevitably makes promise of therapeutic gain even if therapeutic gain is not promised directly in the patient information leaflets. Therefore, participants are subject to coercion in breach of the Declaration of Helsinki and their human and civil rights.

8.5 Financial incentive to participate given that the LP costs upwards of £620. With no risk declared initially, and then only “slight” risk declared after ethical review, and with claims of such high success rates in the advertising material that they have been directed to read, incentive to patients/parents to try a product that is already on the market, in addition to the standard care they would normally receive, is inevitably high, particularly for less wealthy families.

8.6 Non-disclosure that practitioners administering the intervention are currently breaking the law by breaching Consumer Regulations and are under surveillance by the Trading Standards Service and the Advertising Standards Authority.

9. Given that the Phil Parker Group is in beach of consumer regulations and under surveillance by Trading Standards for false and misleading claims, aggressive selling and illegal marketingpractices, the effect of exposure to advertising of the product under evaluation on the study outcomes. If the intervention were a drug in a blinded trial, exposure to such aggressive sales techniques in the product’s advertising would be likely to increase the placebo effect in the control group. As a psychotropic intervention in a non-blinded trial, such expectations of recovery as promised from the advertising are likely to influence the paediatric patient’s belief that they are recovered, and their inclination to say they feel better when they may not. No biomedical tests are being used to assess the impact of the intervention – only subjective measurements using questionnaires focussing on the patients’ moods and feelings – even though it is claimed that the intervention affects the patient’s physiology and is being tested as a treatment. This not only compromises the scientific value of the study but increases the risks of psychological and physical harm to the participants.

10. The dignity, safety and well-being of a vulnerable group of minors are being put at an indefensible degree of risk by the DH/NHS/NPSA by entrusting their care to practitioners who are not medically or clinically qualified and are breaking the law.

11. As a result of the above, criminal offences may have been and may be currently being committed.

Full  NPSA Complaint  in pdf

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AYME Petition – covering letter

For the attention of The Association of Young People with ME:
Board of Trustees
Chief Executive
President
Copies sent to:

Re: Petition: AYME – Denounce PACE and SMILE

I would like to inform you of the growing concerns many sufferers and advocates have over the way AYME conducts itself and influences the lives of young people with ME. The enclosed petition was drawn up in reaction to the response made by AYME to the PACE trial publication and to its ongoing support of the clinical trial on children known as SMILE. The petition ran from to 12th May I understand that another petition has already been delivered to AYME in response to AYME’s comments on the results of the PACE trial: “AYME does not represent the ME community and its actions have now become harmful to ME sufferers” 

Young people are particularly vulnerable and open to coercion, especially by adults and those in authority. As the largest charity for children and young people with ME, AYME has a lot of influence and therefore a great deal of responsibility. It is very difficult for children to speak up against the ideas and beliefs held by those in privileged positions and who maintain specialist roles such as AYME’s medical advisers and board of trustees. It is also notable that the size, scope and public face of AYME, including the emphasis on community and friendship, leads parents to believe wholeheartedly that AYME deeply cares for the well being of all its members and puts that well being before all other interests. Parents put their trust in AYME and the advice AYME gives, they are led to believe that these techniques work and are not harmful and their children go on to fully believe this also. It is cruel to allow children to believe they will get better if they only try hard enough and use graded exercise techniques and it is AYME’s responsibility to ensure that children and young people with ME are not put in such a position.

Your support of the PACE publication and the clinical trial on children known as SMILE gives undue credence to the psychosocial model of ME and undermines its true physical nature. It allows public opinion to remain in the dark ages of “yuppie flu” while psychiatrists monopolise funding for ME and none goes to biomedical research into aetiology and treatment. We respectfully suggest you take a more scientific and responsible approach and seek to acquire a true ME specialist medical advisor(s) in place of Dr Esther Crawley – exuberant supporter of CBT and GET – and Dr Derek Proudlove, Child Psychiatrist. This would better serve your charity, which is quickly losing all credibility, as well as your members who deserve far better than this. AYME would truly serve its members’ interests by following the example set by The Young ME Sufferers Trust – a charity for children and young people with ME charity that fulfils its obligation to those it exists to support.

Please consider this a formal complaint presented to you by the 380 co-signatories and the 677 users of Facebook who showed their agreement by clicking “like” on the petition; among them, AYME service users, ex-members of AYME and concerned members of the public. We look forward to your response, which will be placed in the public domain.

Yours sincerely,

Please send any correspondence to:

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GMC says case closed May 2011

From GMC 26th May 2011

I refer to our previous correspondence regarding your complaint about Dr Esther Crawley.

We have now completed our enquiries into your complaint and both a medical and a non-medical case examiner have considered the case. Case examiners are senior GMC staff, appointed to make decisions on cases.   

The case examiners have now reviewed your complaint and the additional information we collected through our enquiries. They have decided to conclude your complaint with no further action. 

The case examiners found as follows: 

The complaint alleges that Dr Esther Crawley, an honorary consultant paediatrician, was dishonest in her application for ethics approval of her research project, Assessing the feasibility and acceptability of comparing the Lightning Process®with specialist medical care for Chronic Fatigue Syndrome or Myalgic Encephalopathy (CFS/ME) – pilot Randomised Controlled Trial.”

The Lightning Process® (LP) is a commercially marketed course aimed at people with symptoms of CFS or ME.  LP is a non medical intervention based on the model that body and mind interactions affect health.  LP strategies are taught to self-referred patients with the aim that they can learn to alter these interactions in ways that have a positive impact on their health state.   Dr Crawley’s research project is clearly stated to be a feasibility study only:  Its overall aim is “to study the feasibility and acceptability of conducting a randomized controlled trial (RCT) to investigate the effectiveness and cost effectiveness of Specialist Medical Care compared to Specialist Medical Care plus the Lightning Process in treating CFS/ME in children”.  The stated study rationale is as follows: 

This is important because over 250 children a year receive the Lightning Process for CFS/ME and there are currently no reported studies investigating the effectiveness or complications of the Lightning Process in children. As with all interventions, proper evaluation is necessary. 

Before doing an RCT we need to know whether recruitment is possible and acceptable to families. We need to understand more about the differences and similarities between both interventions in terms of process, design, and setting. In addition, we need to develop appropriate outcome measures for any trial and test the feasibility and acceptability of investigating the health economic consequences of each intervention.” 

The bundle includes a copy of Dr Crawley’s NHS REC (Research Ethics Committee) application (including the information sheets for prospective participants and their parents); an extract from minutes of a 2 December 2010 meeting of South West Research Ethics Committee (SWREC) to consider objections to this study which has been forwarded from the National Research Ethics Service (NRES); Dr Crawley’s Rule 4 response to the complaint. 

The Case Examiners are asked to consider all of the evidence in this case and to establish if there is a realistic prospect of proving that Dr Crawley‘s fitness to practise is impaired to a degree that would justify action being taken on her registration status. This is known as the realistic prospect test. 

The specific allegations are listed and considered below: 

Dr Crawley knowingly provided false information in an application for research ethics approval 

Both complainants allege that Dr Crawley misled SWREC by giving factually incorrect information and failing to disclose information relevant to gaining ethical consent.   

a)  Mr X alleges that, in order to circumvent the regulation preventing research involving children that could reasonably be done with adult subjects, Dr Crawley stated in her REC application: “CFS/ME is different in children and adults with different risk factors, course and outcome. It is therefore not possible to complete a study in adults and extrapolate the results to children.”  Mr X argues that Dr Crawley would have been aware of the LP company’s claims that roughly the same percentage of children and adults with CFS/ME has a positive response to the LP device.  Mr X appears to regard the LP company’s claims as scientific evidence that calls into question Dr Crawley’s rationale for conducting research involving children as subjects. 

The Case Examiners have reviewed all the documents provided by the complainants and Dr Crawley and cannot find any evidence from peer-reviewed randomised controlled trails that demonstrates similarities/differences of CFS/ME in adults and children or that supports the efficacy or otherwise of LP.  They note that SWREC considered Dr Crawley’s rationale to be legitimate.  

b)  Ms Y alleges that Crawley failed to provide evidence to justify the research; failed to declare the study as a clinical trial; failed to disclose risks to participants; put participants at unjustifiable risk; undermined patients’ parent’s rights to give informed consent. 

The Case Examiners have reviewed the REC application (including the patient information sheets) and are satisfied that none of these allegations is supported on an evidential basis.  They also point out that the core duty of RECs is to satisfy themselves on these matters and that SWREC has no concerns. 

The realistic prospect test is not met in relation to this allegation. 

Dr Crawley allowed a study researcher to induce patients to volunteer as study participants on the promise of therapeutic benefit 

Mr X alleges that Dr Crawley permitted Mr Philip Parker, designer and developer of LP, to recruit children to her study by making unsubstantiated claims about the efficacy of LP. 

The Case Examiners have reviewed the documents provided by the complainant and cannot find any evidence that Mr Parker, or any claims that he may or may not have made about LP, had any influence on the design or proposed conduct of Dr Crawley’s feasibility study.  Recruitment and consent procedures are clearly described and do not involve Mr Parker or any LP practitioners 

The Case Examiners make the observation that any action which may have been taken by the Advertising Standards Authority (ASA) in respect of persons making unsubstantiated claims about the benefits of LP has no bearing on the feasibility study being conducted by Dr Crawley.  They note that SWREC satisfied itself on this matter when it re-reviewed Dr Crawley’s REC application in the wake of complaints from Mr X and others. 

The realistic prospect test is not met in relation to this allegation. 

Dr Crawley had a financial interest in the organisation marketing LP 

Dr Crawley did not declare in her ethics approval application that she had conflicts of interest 

The complainant did not provide any evidence to substantiate these allegations.  The SWREC minutes show that it was satisfied that Dr Crawley did not have any conflicts of interest.  The realistic prospect test is not met in relation to this allegation. 

The Case Examiners are satisfied that Dr Crawley’s REC application was appropriately scrutinised and approved by SWREC and then fully re-reviewed by SWREC in the light of objections received by NRES.  They note that SWREC upheld the decision to give ethics approval to this research project, with only minimal changes to the Patient Information Sheets.  The Case Examiners conclude that there is no merit in these complaints.  The case can be closed with no further action.”

I hope that I have been able to explain clearly our reasons for concluding this case.  Please contact me on my direct dial number if you have any questions. 

Yours sincerely

Investigations Officer

Fitness to Practise Directorate

Direct Dial: 0161 923 6432

Fax No: 0161 923 6401

From complainant’s reply 6th June 2011 – 

The case examiners demonstrated that some of the complaints may be easily upheld, and other areas of complaint have not been addressed in full.

“The Case Examiners have reviewed all the documents provided by the complainants and Dr Crawley and cannot find any evidence from peer-reviewed randomised controlled trails that demonstrates similarities/differences of CFS/ME in adults and children or that supports the efficacy or otherwise of LP.”  This finding confirms that Dr. Esther Crawley failed to justify why this research should be done on children before adults. 

The GMC response did not address the matter of Dr. Crawley’s use of paediatric patients in collaboration with illegal traders – Phil Parker and The Phil Parker Group of Lightning Process practitioners – including directing patients and research participants to share confidential medical information on the LP application form; or the matter of coercion to participate in research as the participants are the chief investigator’s own patients recruited at her specialist clinic at the point of diagnosis and as the information they are required to read about the intervention comprises promotional sales material.

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