FOI and Bristol Pilot study: Lightning Process and children 8 to 18
A version of this post was published on Co-Cure on 3 May and will also be available on ME agenda site.
Bristol Pilot study: Lightning Process and children 8 to 18 and Freedom of Information request:
"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." [1]
On 3 March, the University of Bristol issued a press release announcing a pilot study on Lightning Process and children [2]. The study is due to start in September 2010.
The study is expected to recruit 90 children with "CFS/ME" between the ages of 8 and 18. The primary outcome measure will be school attendance after six months.
Funding of 164,000 has been awarded by the Linbury Trust and the Ashden Trust and the research team is led by Dr Esther Crawley.
Dr Crawley, FRCPCH, PhD, is Consultant Senior Lecturer in the University of Bristol's Centre for Child and Adolescent Health and a Consultant Paediatrician at the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust (RNHRD NHS FT).
Dr Crawley chairs the CFS/ME Clinical Research Network Collaborative (CCRNC) and is Medical Adviser to the children and young person's patient organisation, AYME.
The research team will carry out a pilot project
"to investigate whether it is possible to look at two different approaches to the intervention and treatment of Chronic Fatigue Syndrome/ME (CFS/ME) in Children."
This pilot project and any study resulting out of it should not receive research ethics approval.
The MRC produces specific guidelines for research involving vulnerable patient groups. The document "MRC Medical Research Involving Children" [3] 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."
No rigorous controlled studies have been carried out on Lightning Process in adults. To date, not a single study into the application of LP has been published.
At the July 2009 meeting of the Countess of Mar's "Forward-ME" group, the Lightning Process had been tabled on the Agenda [4]:
"5. Lightning Process:
"Charles Shepherd had been made aware of a meeting which was to take place at University College London in conjunction with Great Ormond Street Hospital which appeared to promote the Lightning Process for patients with CFS/ME. As Dr Crawley knew something about the subject, she was asked to remain and to contribute to the discussion. Of particular concern was the promotion of the programme to vulnerable clinicians who had just started to practice. After some discussion about the pros and cons of the programme, it was agreed that Mary-Jane Willows would talk to the organisers on behalf of Forward-ME highlighting our concerns."
The outcome of this Forward-ME group initiative has not been reported on.
Action for M.E. Chief Executive, Sir Peter Spencer, is a non executive director of the RNHRD. Asked for a position statement, Action for M.E. has said:
"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." [5]
But in 2008, Action for M.E. and the children's organisation AYME published results of a joint patient survey [6]. Of the people who reported their experience of the Lightning Process, 53% stated they had improved, 31% reported no difference and 16% reported an adverse outcome.
Figures from an ME Association survey in 2009 reported 45% improvement but 21% said they had been made "worse" or "much worse".
In 2007, Action for M.E. had published this article in the March edition of its magazine, InterAction [7]:
"LP: the light at the end of the tunnel or just another flash in the pan?"
http://www.afme.org.uk/res/img/resources/IA 59 lightning process.pdf
"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."
To date, the ME Association and The Young ME Sufferers Trust have remained silent on their position on LP and this planned pilot study.
What is the Lightning Process claimed to be effective for?
The website [8] says:
"Over the years we've discovered that it's such a powerful process that it seems to be very effective in areas where people feel stuck. Due to the nature of the training we can't guarantee results as every individual is different, however we have had considerable success in helping people with chronic health issues.
"This includes, but is not limited to
"Addiction
Anxiety & Panic attacks
Chronic back and neck pain and headaches
Depression
Eating issues
Eczema
Fear of failure
Fibromyalgia
IBS and Digestive problems
Insomnia
Low self esteem, self-doubt, guilt and even self-hatred
M.E. (Myalgic Encephalopathy)/Chronic Fatigue Syndrome
M.S (Multiple Sclerosis)
Obsessive compulsive disorder
Smoking
Stage fright and presentation fears
Stress & Struggle
"And it's also effective for enhancing
"Relationships
Discovering what you really want
Interview performance
Confidence
Sleep"
Some prospective "trainees" report that they had been led to understand the "training" should work for everyone
if they are
"ready" to undertake the process and if they
"carry out the instructions properly".
When applying for "training" sessions, prospective "trainees" are asked to sign up to a set of beliefs and undertakings that are shockingly manipulative [8]. Read a sample application form, here:
http://www.changeworksforyou.com/applicationform.htm
No child should be exposed to this.
What data has been used in order to establish that overall the likely benefits of this research outweigh any risks to children with "CFS/ME"?
How will it be determined that undergoing the "process" will not be detrimental to the child's psychological well-being or impact negatively on the family dynamic if the child fails to gain benefit from the program, or if the child were to experience set-back or significant relapse during or following the program, or if an apparent improvement or resolution of their symptoms and disability were short-lived?
What are the ethical issues of applying psychology and NLP techniques to children and young people with CFS/ME (and it is proposed to include children as young as eight) which invalidates their experience of the illness and motivates them to ignore their symptoms and their post exertional malaise because they are
"doing M.E."
Accounts by those with misgivings about LP and its failure to "cure" them, how the "process" is applied during "Seminars" and "Training" sessions and concerns about how some "Trainers/Coaches" have reacted to complaints from clients are beginning to seep into the public domain [1].
Despite considerable controversy surrounding this unregulated "Training Program"; despite no rigorous controlled studies having been carried out with adults and with no data on its safety and efficacy, this study plans to recruit children with "CFS/ME" as young as eight.
It is unconscionable that this pilot study should go ahead; unconscionable that apart from Invest in ME, no UK national ME organisation has publicly opposed this study.
On 16 April, I submitted a request for information under FOIA in relation to this Dr Crawley led pilot study. A full copy can be accessed here: http://tinyurl.com/FOIrequestLP1
[1] LP Doesn't Work for ME: Personal accounts from LP "trainees"
http://www.sayer.abel.co.uk/LP.html
Contributions to:
john23@sayer.abel.co.uk
Letter: Lightning process for ME didn't work for me
http://www.thisisnorthdevon.co.uk/n...idn-t-work/article-613394-detail/article.html
[2] Press Release: University of Bristol, 3 March 2007
http://www.bristol.ac.uk/news/2010/6866.html
[3] MRC Medical Research Involving Children (Nov 2004, revised Aug 2007)
http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430
[4] Minutes: Forward-ME meeting, House of Lords, 8 July 2009
http://www.forward-me.org.uk/8th July 2009.htm
[5] Position statement: Action for M.E., April 2010
http://www.facebook.com/actionforme
[6] Patient Survey 2008, Action for M.E. and AYME
http://www.afme.org.uk/res/img/resources/Survey Summary Report 2008.pdf
[7] Article: InterAction 59, March 2007
http://www.afme.org.uk/res/img/resources/IA 59 lightning process.pdf
[8] Lightning Process website
http://www.lightningprocess.com/what-does-it-work-for.aspx
[9] Sample Lightning Process application form
http://www.changeworksforyou.com/applicationform.htm
Suzy Chapman
http://meagenda.wordpress.com