Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)
Shortlink: http://wp.me/p5foE-2Vt
Poll: Do you think it is ethical to undertake a pilot study looking at the feasibility of recruiting children aged 8 to 18 with CFS and ME into a randomised controlled trial (RCT) comparing Lightning Process and specialist medical care when no rigorous RCTs into the application of LP in adults have been undertaken?
Register your opinion here: http://tinyurl.com/LightningProcessPilotStudyPoll
An ASA Adjudication against “Withinspiration” came to my attention, today, via the Co-Cure mailing list:
ASA Adjudication on Withinspiration
Withinspiration
Date:
16 June 2010
Media:
Internet (sponsored search)
Sector:
Health and beauty
Number of complaints:
1
Complaint Ref:
123134
Ad
An internet sponsored link stated “Chronic Fatigue Recovery. End the cycle of ME/CFS: Get Well! with The Lightning Process”.
Issue
The complainant challenged whether the claim “Chronic Fatigue Recovery. End the cycle of ME/CFS” could be substantiated.
CAP Code
3.150.150.3
Response
Withinspiration said they had personal experiences of improvement in medical conditions, such as myalgic encephalomyelitis (M.E), as a result of using the lightning process. They argued that the lightning process, created by Phil Parker, had received a number of celebrity endorsements and positive press articles, which they believed were a testament to the effectiveness of the treatment. Although Withinspiration said they held no scientific evidence to support the claims, they said that trials were due to commence in 2010.
Assessment
Upheld
The ASA understood that the lightning process was a three-day course that sought to teach individuals a range of techniques, such as life coaching and neuro-linguistic programming skills, to improve physical and mental well being, particularly amongst those with chronic fatigue syndrome (CFS) or ME.
We were concerned that Withinspiration did not hold robust evidence to support their claims that the lightning process was an effective treatment for CFS or ME. We therefore reminded them of their obligations under the CAP Code to hold appropriate evidence to substantiate claims prior to publication. Because we had not seen any evidence to demonstrate the efficacy of the lightning process for treating the advertised conditions, we concluded that the claims had not been proven and were therefore misleading.
The ad breached CAP Code clauses 3.1 (Substantiation), and 50.1 (Health and beauty products and therapies).
Action
The ad must not appear again in its current form. We told Withinspiration to ensure they held substantiation before making similar efficacy claims for the lightning process
Adjudication of the ASA Council (Non-broadcast)
Bournemouth Lightning Process instructor/trainer/coach, Alastair Gibson, had already identified himself, on his Withinspiration website, as “one of the two practitioners working with the NHS” in connection with the Dr Esther Crawley led pilot study. At 29 March, Mr Gibson’s website had carried this information:
http://www.withinspiration.co.uk/index.php
“Breaking News – NHS and Lightning Process research collaboration.
“A new pilot study involving the Lightning Process and the NHS has been awarded £164,000 for research into the treatment of CFS/ME in children and adolescents. Alastair Gibson is one of the two practitioners working with the NHS and the young people in this exciting research study. Find out more…”
http://www.withinspiration.co.uk/lightning_process_NHS_research.php
This statement no longer appears on his website. It is unclear whether Mr Gibson retains an involvement with this proposed pilot study.
RNHRD NHS FT Bath and University of Bristol pilot study
On 2 March, the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust, also known as the Min, and the University of Bristol announced a research study looking into “interventions and treatment options for Chronic Fatigue Syndrome” [1].
Funding of £164,000 from the Linbury Trust and the Ashden Trust has been awarded to the research team led by Dr Esther Crawley, Consultant Paediatrician, Royal National Hospital for Rheumatic Diseases, Bath, the CFS Clinical Lead for Bath NHSFT and a Senior Lecturer, University of Bristol.
“The study will involve in depth interviews with the patients and their parents, and the primary outcome measure will be school attendance after six-months. It is hoped that over 90 children aged between eight and 18 and their families will be involved in the study. They will be recruited after assessment by the specialist team at the Min. The study will begin in September 2010.”
Press Release: Research study to investigate a chronic childhood condition
Open PDF here: Media Release – 2 March 2010
Open PDF media article here: Chronic fatigue syndrome study Mineral Water Hospital
Dr Esther Crawley
Dr Crawley, FRCPCH, PhD, is a Senior Lecturer at the University of Bristol, a Consultant Paediatrician and clinical lead for the Bath CFS service. Dr Crawley’s specialist CFS service for children and adolescents is reported to be the largest regional paediatric service in the UK and also provides services nationally.
Dr Crawley had been a member of the NICE CFS/ME Guideline Development Group and gives presentations around the NICE guideline CG53 and the CFS/ME Clinical and Research Network.
Dr Crawley had chaired the CFS/ME Clinical Research Network Collaborative (CCRNC), now reformed under the new name “BACME”, for which Dr Crawley continues as chair.
Dr Crawley is a member of the MRC’s “CFS/ME Expert Panel”.
In the last couple of years, Dr Crawley’s research team has been awarded considerable sums of funding for CFS studies and Chronic Fatigue studies in children – including a £873,579 NIHR Clinician Scientist Fellowship award, last year. She has also received funding from patient organisation, Action for M.E. (£49,650).
Grants awarded to Dr Crawley during 2007-09 here: http://www.bristol.ac.uk/ccah/grants/
The Lightning Process
The Lightning Process is controversial and untrialled. It is marketed by the Phil Parker organisation not as a therapy or a treatment but as a “training program” delivered by “instructors” or “practitioners” or “coaches”.
Instructors are trained and licensed by the Phil Parker organisation and are not accountable to any regulatory professional body. If individuals have complaints about a practitioner or about the Lightning Process, itself, which cannot be resolved directly with the practitioner or through the Phil Parker complaints procedure, their only recourse is Trading Standards.
Some practitioners may already be established therapists in CAM or psychotherapy fields but have trained with the Phil Parker organisation to also offer the Lightning Process to their clients. But many Lightning Process practitioners are individuals who have undergone the process for some condition or other, then paid to train with the Phil Parker organisation to become “Licensed Lightning Process Practitioners”, themselves, and will have had no previous background in therapies or life coaching.
In early 2007, the ME Association published their position on the Lightning Process which included the following statement:
“The Lightning Process is a new and very speculative form of treatment that has not been assessed in a proper clinical trial. So while we are providing information about it, it is not a form of treatment that we are able to endorse. We recommend caution when considering this approach.” [2]
In March 2007, Action for M.E. published an article featuring several negative patient experiences of undergoing the Lightning Process [3].
Data from two large patient surveys carried out by Action for M.E./AYME (published 2008) and by the ME Association (published May 2010) show similar levels of worsening of symptoms in CFS and ME patients following the three day “training program”, or of no improvement at all (AfME/AYME: Worse:16%, No change: 31%; MEA: Slightly worse 7.9%; Much worse 12.9%: No change: 34.7%) [4].
GOSH gives a platform to Phil Parker
At the July 2009 meeting of the Countess of Mar’s Forward-ME group, patient reps discussed their concerns that Phil Parker was being given a platform at a University College London workshop, held in conjunction with Great Ormond Street Hospital (GOSH), for medical and allied health professionals working with children and young people with ME and CFS at which Mr Parker would be promoting the Lightning Process [5].
CFS clinical lead and paediatrician, Dr Esther Crawley, who was presenting at this Forward-ME group meeting, was invited to participate in discussions around the GOSH workshop, the Lightning Process in general and its application in children, in particular. According to the minutes of the July meeting, Mary Jane Willows, CEO AYME, was tasked with approaching the workshop organisers to discuss ME patient organisation concerns. The outcome of this initiative was not recorded in the minutes of the next meeting of the Forward-ME group.
No RCTs
To date, no rigorous, randomised controlled trials into the safety, acceptability, short and long-term effects of the Lightning Process have been carried out in adults with ME and CFS. There is no reliable, independent published data on the safety of the application of the Lightning Process.
Patients and carers were astounded to learn, in early March, that a Bristol/Bath research team led by an NHS consultant paediatrician intends to undertake a pilot study to investigate whether it is possible to recruit children as young as eight with CFS and ME into an RCT comparing the Lightning Process with specialist medical care.
The press release, issued on 2 March, announced:
“The team will carry out a pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process® and specialist medical care. This will be the first study of its kind in this area, and the team hopes to establish a basis for a larger scale multicentre research project.”
The study has the involvement of Phil Parker and is expected to start in September 2010.
Research using vulnerable patient groups
The MRC produces specific guidelines for research involving children. The document MRC Medical Research Involving Children (Nov 2004, revised Aug 2007)” is clear:
“4.1 Does the research need to be carried out with children? Research involving children should only be carried out if it cannot feasibly be carried out on adults.” [6]
Not only is it feasible to carry out research into the application of the Lightning Process using adults with ME and CFS, many feel it is unethical not to do so first.
There are considerable concerns that an NHS paediatric CFS unit should be planning a study involving children as young as eight when no rigorous, RCTs have first been undertaken into the safety, acceptability, long and short-term effects of the application of this very controversial “process”.
Request for information under Freedom of Information Act
It is proving very difficult to obtain any information about the design, methods and objectives of this research study.
In response to a request for information under the Freedom of Information Act (fulfilled 17 June), the University of Bristol Information Office is withholding the names of Lightning Process practitioners who have an involvement with the study under Clause 22(1)(a).
They are also withholding the names of the ethics committee(s) reviewing the application for ethics approval.
University of Bristol has confirmed that the study (for which the funding was secured last November) is still going through the ethics approval procedure.
All other information and documents requested is currently being denied [7].
Open PDF Request for information under FOI and responses: FOI – Lightning Study Chapman 17.06.10
To virtually all questions the response has been:
“This information is intended for future publication when the study protocol and other related documents are published online. It is therefore exempt from disclosure under section 22(1)(a) of the Freedom of Information Act.
“The study is currently going through the ethics approval procedure and this information is expected to be published around August / September 2010. We cannot see that there is any public interest in disclosing this information before that time.”
But it is a matter of considerable public interest that an NHS Trust seeks to use children as young as eight as guinea pigs. I am intending to request an internal review of the decision not to make available any information about the design and methods for this study, at this stage.
What does the Lightning Process involve?
The Lightning Process website describes the process as being derived from neuro linguistic programming (NLP), osteopathy and life-coaching [8].
One account included this description of the “process”:
Personal account of Lightning Process technique as applied to patient with ME
“I had an acute onset and went from a hardworking person to bedbound overnight. In a desperate attempt to recover I decided to try LP after reading stories of severely affected M.E. patients who had recovered. It all sounded so convincing and after a phone consultation with a LP coach I felt very positive I was doing the right thing. I borrowed the money from my parents, £880.00 as I had long lost my job, and went for it.
There were 3 other m.e. patients at the same course none of these people nor myself recovered. The course was over 3 days from 10am-2pm with a break at lunchtime for tea and biscuits. We were told not to discuss the content of the course with each other during the breaks. We learned the ‘affirmation’ and stood on the floor on paper circles with key words written on them.
Here is the big secret of what we had to say while standing on paper circles -
WHEN YOU FEEL A SYMPTOM
SHOUT- STOP! (stand on the paper STOP)
SAY- I HAVE A CHOICE ( stand on the paper CHOICE)
SAY- YOU CAN CHOOSE THE PIT OR THE LIFE YOU LOVE ( you then stand on the LIFE YOU LOVE circle)
SAY- I CHOOSE THE LIFE I LOVE
SAY- WELL DONE, YOU ARE A FANTASTIC GENIOUS, YOU ARE ON TRACK! I AM WITH YOU EVERY STEP OF THE
WAY (you are being your own coach here)
ASK YOURSELF – WHAT DO I WANT?
ANSWER YOURSELF- I WANT ENERGY AND HAPPYNESS LIKE (you say something that means energy etc. to you)
ASK YOURSELF- HOW WILL I GET THIS?
TELL YOURSELF- BY STOPPING EVERY NEGATIVE THOUGHT
EVERY NEGATIVE EMOTION
AND DOING THE LIGHTNING PROCESS.
There are a few more short affirmations and that’s it you are cured of M.E. We all DID leave on the third day full of hope and newly found confidence and told that no-matter how we felt in the future ALWAYS SAY WERE WERE CURED OR THE PROCESS WILL NOT WORK !!!! These coaches are very good at their job but I can assure you they can not cure you of M.E. Think about it PAPER CIRCLES AND AFFIRMATIONS. The four of us all were ‘high’ for a few weeks or months and did indeed do more than usual but sadly all relapsed.” [9]
The application process
Potential applicants for Lightning Process sessions must first complete an application form where they agree to undertake certain commitments and to sign up to certain beliefs, including that they are “ready” to benefit from the programme [10]. Practitioners may further “assess”, via a telephone interview, an applicant’s “readiness” to participate and benefit from the “process” but also “assess” whether the applicant has any previous or current medical or psychological conditions which would render them “unsuitable” for undertaking the “process”. Practitioners are not medically qualified.
Sample application form here: LP application form or here: http://www.changeworksforyou.com/applicationform.htm
Parents are expected to sign up to these beliefs and commitments on behalf of applicants under the age of 18, irrespective of whether the child or young person might be considered competent to understand the expectations of the practitioners delivering the courses or of understanding the implications of the “belief system” they are being asked to commit to and the tasks they will be expected to follow over the course of the three days of sessions and following completion of the sessions, which also includes a workbook through which affirmations are reinforced.
The patient experience – “living the life you love”
Lightning Process practitioners are charging from £560 to £880 for three sessions which may last 3 to 5 hours per day, held on three consecutive days, and usually in a group setting.
“Trainees” have reported that they are encouraged to ignore their symptoms of malaise and discomfort and at the end of the day’s session to undertake an activity which they would not normally undertake.
“Trainees” have reported that they were instructed to believe that they are “doing illness” not that they have illness. From one young woman’s personal account:
“The first thing was to take responsibility for our illness. I had to stop saying I had M.E. Instead I have to say I am ‘doing M.E’, I wasn’t tired, I was ‘doing tired and doing muscle aches’. The implication being if I am doing it I can stop doing it.” [9]
So “trainees” are expected to agree that they are “ready” to undertake and to benefit from the program when they sign up to it; that they will commit to understanding and carrying out the instructions properly and that they will work hard at putting the “process” into practice in order that they can “live the life they love”.
Is the burden of “failure” then placed on the patient and not on the ability of the “process”, itself, to “cure”, “resolve” or “substantially improve” whatever medical condition, psychological condition or “life-style issue” the process has been purchased for because the individual was not after all “ready” to undergo the “process”; or that they had not properly understood what was expected of them during the sessions; or that they had failed to carry out the instructions properly or that they had not worked had enough at putting the “process” into practice?
Here’s another account by a CFS patient who also reports on the experience of a “trainee” with Multiple Sclerosis and more accounts here [9].
A letter to the media, here, from a dissatisfied former “trainee”: Lightning process for ME didn’t work for me
No data
There are considerable concerns for the physiological and psychological impact of exposing young children and teenagers with CFS and ME to this type of program and some of these issues are raised within my FOI request, in questions 23 thru 26 a) to l). No responses were provided to any of these questions.
With no data from research into adults, how can the research team determine that overall the likely benefits of the research outweigh any risks to child participants or that undergoing the training program would not be detrimental to a child’s current health status and psychological well-being, as a patient diagnosed with CFS or ME?
Concerns raised include:
• there is no scientific evidence for the Lightning Process on which to base informed consent;
• children and their parents may not fully understand what is expected of them;
• children may feel pressured to conform to the beliefs of the practitioners or to say that they feel better in order to please the researchers and practitioners;
• children might feel pressured to get well and to make too rapid a return to school
• invalidation of the patients’ experience of illness and symptoms;
• the dangers of teaching a child to ignore and override sensations of illness and post exertional malaise;
• the program may be physiologically and psychologically damaging to the child and may impact negatively on the family dynamics if a child were unable to complete the program and withdrew early from the study, or if the child failed to gain benefit from the program, or experienced exacerbation of symptoms during or following the program, or were to experience significant set-back or relapse or if an apparent improvement or resolution of symptoms and disability proved to be short-lived.
With no data from RCTs on the safety and acceptability of the Lightning Process in adults with ME and CFS, how are parents able to give informed consent for their children to participate?
The University of Bristol would provide no rationale for undertaking a pilot study in children when rigorous, randomised controlled trials (RCTs)trials have yet to be undertaken and results published on the application of the Lightning Process in adults with CFS or ME.
There are also concerns that this pilot study in children might serve to legitimise referrals outside the NHS and influence potential future commissioning of the Lightning Process within NHS Trusts. There is evidence that some medical specialities are already referring patients to Lightning Process practitioners, for example, for chronic pain and for CFS, despite no rigorous RCTs having been undertaken into its safety and long-term effects and despite there being no regulatory professional body to protect these patients when accessing private sector providers.
As a clinician, Dr Crawley sees children and young people with a wide range of fatigue – from fatigue relating to other conditions, for example, following head injury, to chronic fatigue, Chronic Fatigue Syndrome and severe ME, where children may be bedbound [13] [14].
Because information is being withheld, it has not been possible to establish which research criteria are to be used. There are concerns that if improvement were shown in those mildly affected with fatigue that the process might be applied inappropriately to children with moderate to severe CFS and ME.
What else is the Lightning Process being used for?
Some Lightning Process practitioners are claiming success with patients with other diseases and conditions, like Multiple Sclerosis (MS), diabetes and some neurological diseases.
One Suffolk Lightning Process practitioner (The Rowan Centre) is currently making the following claims on its website:
http://www.simpsonandfawdry.com/lightning-process.html
What does the Lightning Process work for ?
“People using the Lightning Process™ have recovered from, or experienced significant improvement with the following issues and conditions
“ME, chronic fatigue syndrome, PVFS, adrenal fatigue
acute and chronic pain, back pain, fibromyalgia, rheumatoid arthritis, migraine, injury
PMT, perimenopausal symptoms and menopause
clinical depression, bipolar disorder, anxiety and panic attacks, OCD and PTSD
low self-esteem, confidence issues
hay fever, asthma and allergies
candida, interstitial cystitis, urinary infections, bladder and bowel problems
IBS, coeliac disease, crohns disease, food intolerances and allergies
blood pressure, cardiac arrhythmia, type 2 diabetes, restless leg syndrome, hyper / hypo thyroidism
insomnia and sleep disorders
autistic spectrum disorder, dyspraxia, ADHD
lymes disease, glandular fever, epstein barr virus
weight and food issues, anorexia and eating disorders
multiple sclerosis, cerebral palsy, parkinsonian tremor, motor neurone disease”
Timeline
Funding for the pilot had been secured by November, last year. £44,000 over three years (09/10, 10/11, 11/12) has been awarded by the Ashden Trust; £120,000 by the Linbury Trust.
An ethics committee decision is anticipated in August/September. The study is due to start in September.
Patient organisation positions
*AYME (Association of Young People with ME) has published no position statement, but in an article in the May 2010 edition of “LINK”, AYME describes the pilot as “an interesting piece of research”.
*Dr Esther Crawley is a Medical Consultant to AYME.
*Action for M.E. published this position statement on its Facebook Wall but not on its main website:
“Action for M.E. sees no reason to oppose this pilot study.
As was made clear when it was announced, the research at this stage is simply a pilot designed to see if it would be possible to set up a trial that can independently assess the Lightning process against specialised medical care.
It is a fact that many parents are already taking their children to LP practitioners and so there are urgent questions that need to be addressed in order to assure the safety of those children. Dr Crawley’s initiative aspires to find a way of answering some of those questions.”
*Sir Peter Spencer, CEO of Bristol based, Action for M.E., is a non-executive director of the Royal National Hospital for Rheumatic Diseases, Bath – Dr Esther Crawley’s employer.
ME Association: No position statement issued
The Young ME Sufferers Trust: No position statement issued
The 25% ME Group: No position statement issued
Invest in ME published a position statement in its March/April 2010 Newsletter:
Lightning Process – The Falsehood of Magical Medicine
“…Not only is this a waste of scarce resources but children aged 8-18 are to be used to perform this study. There are many stories of the damage this series of courses can do to patients – a business enterprise which is unregulated, has no valid research into the “theory” behind it which really warrants funding of it (certainly not in preference to the funding of biomedical research into ME) and for which anyone can seemingly attend a few courses and set up a business, with no medical training…
…If this training programme really needs research then why not start with adults who can give informed consent – and why not test it on a well known patient group with clear biomarkers such as diabetics or MS patients to see if these patients stop “doing” diabetes or MS after three days of training. Why are ME patients always the target for therapy businesses? If there is funding available for research into ME then why not direct it to biomedical research…”
Full statement here: http://www.investinme.org/IIME%20Newsletter%20Mar%2010.htm
Discussion:
There are a number of current threads on Lightning Process, in general, and this pilot study in particular on Phoenix Rising Forums:
April 2010 “Dr Frivoldi, MD” blog article by Cort Johnson
http://www.forums.aboutmecfs.org/blog.php?b=364
Article: An MD on the Lightning Process
http://www.forums.aboutmecfs.org/showthread.php?4687-Article-An-MD-on-the-Lightning-Process
Lightning Process to be Evaluated in Research Study on Children
http://www.forums.aboutmecfs.org/showthread.php?3538-Lightning-Process-to-be-Evaluated-in-Research-Study-on-Children
My son & i are giving the lightning process a go on this week
http://www.forums.aboutmecfs.org/showthread.php?3827-My-son-amp-i-are-giving-the-lightning-process-a-go-on-this-week
See also:
Action for M.E. 2007 article:
http://www.afme.org.uk/res/img/resources/IA%2059%20lightning%20process.pdf
The March 2007 edition of Action for M.E.’s magazine InterAction published this article:
InterAction 59 March 2007
LP: the light at the end of the tunnel or just another flash in the pan?
“The Lightning Process (LP) has attracted national press coverage but alongside the hype and talk of miraculous recovery, InterAction received reports of relapse and failure, and decided to find out more.”
References:
[1] Press Release, University of Bristol, 2 March 2010:
http://www.bristol.ac.uk/news/2010/6866.html
Media article: Chronic fatigue syndrome study Mineral Water Hospital
[2] ME Association position statement on Lightning Process, February 2007
[3] Action for M.E. article on Lightning Process, InterAction magazine, March 2007:
http://www.afme.org.uk/res/img/resources/IA%2059%20lightning%20process.pdf
[4] Patient Survey 2008, Action for M.E. and AYME:
http://www.afme.org.uk/res/img/resources/Survey%20Summary%20Report%202008.pdf
Patient Survey May 2010, ME Association:
http://www.meassociation.org.uk/images/stories/2010_survey_report_lo-res.pdf
[5] Minutes, Forward-ME meeting, House of Lords, 8 July 2009:
http://www.forward-me.org.uk/8th%20July%202009.htm
[6] MRC Guidelines Medical Research Involving Children (Nov 2004, revised Aug 2007):
http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430
[7] Request for information under FOI and FOI Office responses:
FOI – Lightning Study Chapman 17.06.10
[8] Lightning Process website
http://www.lightningprocess.com/
[9] LP Doesn’t Work for ME: Personal accounts from LP “trainees”:
http://www.sayer.abel.co.uk/LP.html
Letter: Lightning process for ME didn’t work for me:
http://www.thisisnorthdevon.co.uk/news/Lightning-process-didn-t-work/article-613394-detail/article.html
Personal account of Lightning Process technique as applied to patient with ME:
http://www.forums.aboutmecfs.org/showthread.php?4687-Article-An-MD-on-the-Lightning-Process&p=77679&viewfull=1#post77679
Personal account of Lightning Process as applied to patients with ME and MS:
http://forums.randi.org/showpost.php?p=4293368&postcount=1
[10] Sample Lightning Process application form:
http://www.changeworksforyou.com/applicationform.htm
[11] ASA adjudication against “Withinspiration”, June 2010:
http://www.asa.org.uk/Complaints-and-ASA-action/Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx
[12] Withinspiration “NHS and Lightning Process research collaboration”:
http://www.withinspiration.co.uk/lightning_process_NHS_research.php
[13] Radio 4 Case Notes: Dr Crawley on CFS clinic approach, November 2007
http://www.bbc.co.uk/radio4/science/casenotes_tr_20071106.shtml
[14] RNHRD Bath Chronic Fatigue Syndrome/ME Service for Children & Young People
http://www.rnhrd.nhs.uk/departments/chronic_fatigue_syndrome_children.htm
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