Category: Dr Esther Crawley

Scientific trial involving children and the Lightning Process is unethical, says joint statement issued by two national ME charities

Joint Press Release and statement issued today by the ME Association and The Young ME Sufferers Trust

Shortlink: http://wp.me/p5foE-2YW

Update @ 11 August

On 4 August, the ME Association released a list of recipients of the press release issued earlier that day jointly with the Young ME Sufferers Trust.  The list is media recipients is appended beneath the press release.

 

ME agenda welcomes this very strong opposition statement from the ME Association and The Young ME Sufferers Trust.  The iniative to liaise with Trading Standards is also welcomed.

The  joint press release says:

“If any trial is to be held, it should first be on adults, who can give informed consent.”

My own position is that to undertake RCTs on any patient group would be giving credence to the Lightning Process as having potential as a treatment for ME and would also legitimise it, ethically, as a potential treatment. I would not want to see any RCTs into the application of the Lightning Process, whether undertaken with ME patients, MS patients or for any other medical disease, condition or syndrome.

 

For background to this issue see ME agenda 5 July report:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)

 

From the ME Association

http://tinyurl.com/MEA-TYMESTrust-LP-Statement

Scientific trial involving children and the Lightning Process is unethical, says joint statement issued by two national ME charities

Wednesday, 04 August 2010 17:15

A plan to recruit children with ME/Chronic Fatigue Syndrome to a scientific trial comparing the efficacy of an unproven psychologically-based training programme with specialist medical care is “unethical”, say two of Britain’s leading ME/CFS charities – The ME Association and the Young ME Sufferers Trust.

In a joint statement issued today (4 August 2010), the two charities say:

We are issuing this joint statement due to widespread public concern, together with our own serious reservations, about a forthcoming study of the psychologically-based Lightning Process on children.

The pilot study, scheduled to start in September, will look at the feasibility of recruiting children aged eight to 18 with ME/CFS into a randomised controlled trial (RCT) comparing the Lightning Process with specialist medical care.

It is planned that over 90 children aged between eight and eighteen and their families will be involved in the study.

The Medical Research Council (MRC) produces specific guidelines for research involving vulnerable patient groups.

The document ‘MRC Medical Research Involving Children’ is quite clear on this issue. It poses the question: ‘Does the research need to be carried out with children?’ In answer, the MRC states: ‘Research involving children should only be carried out if it cannot feasibly be carried out on adults.’

The ME Association and The Young ME Sufferers Trust do not believe that it is ethically right to use children in trialling an unproven and controversial process such as the Lightning Process.

A survey of 4,217 people carried out by the ME Association on the management of ME/CFS found that over a fifth of those who had tried the Lightning Process were made worse (7.9% slightly worse,12.9% much worse). If any trial is to be held, it should first be on adults, who can give informed consent. No rigorous RCTs into the application of the Lightning Process have ever been undertaken.

Despite many years of scientific research there is still no single diagnostic test for ME/CFS, nor is there a curative treatment. The theory upon which the Lightning Process is based, together with its claim that the prolonged nature of the illness is caused by ‘the adrenaline, nor-adrenaline and cortisol loop’ is not scientifically proven. Moreover, the Advertising Standards Authority recently ruled that an advertisement in an internet sponsored link containing claims of its effectiveness by a Lightning Process practitioner should be removed. We understand that the practitioner will be involved in this study and we find this concerning.

The Trading Standards departments of two local authorities have also taken action over therapeutic claims by Lightning Process practitioners following referrals by Dr. Charles Shepherd of the ME Association. The Lightning Process calls itself a training programme, not a medical treatment, combining concepts from Neuro-Linguistic Programming, Life Coaching and Osteopathy. It claims to be effective for ME/CFS and psychological problems such as anxiety, stress, depression, guilt, low self esteem. Any evidence for this effectiveness on ME/CFS is purely anecdotal. ME has long been classified by the World Health Organisation as a neurological illness, not a psychological condition.

We cannot approve of a study involving children as young as eight when no rigorous trials have first been undertaken into the safety, acceptability, long and short-term effects of the application of this controversial and unregulated ‘process’ with adults.

Furthermore, we have serious concerns about the primary outcome measure, which is school attendance after six months. Children have a legal right to ‘suitable education’ for their particular needs, which may or may not include school attendance.

The statutory guidance ‘Access to Education for Children and Young People with Medical Needs’ explains that whilst it is desirable for children to be educated in school, other forms of education must be provided for those who need it. The Chief Medical Officer’s Working Group Report on CFS/ME (DOH 2002) stated that most children with ME will need education in their homes at some time, potentially for a considerable period. In 2009 the Education White Paper ‘Back on Track : A strategy for modernising alternative provision for young people’ included virtual education. Chapter 7, ‘Learning from the best and supporting innovation’, spoke of ‘e-learning and virtual provision, particularly for pupils who cannot attend school due to health needs.’ Accessible education is also provided for in disability discrimination law.

If school attendance is the primary outcome measure of this study, families involved may then feel pressurised into avoiding alternative forms of education which would benefit their children and to which they are legally entitled.

For all these reasons, it is our considered opinion that this study of the Lightning Process in children is unethical and should be abandoned.

NOTES TO EDITORS

References:

‘£164,000 awarded for new research into the treatment of a chronic childhood condition’.

Press release issued by The Royal National Hospital for Rheumatic Diseases, which can be found at their press release page:

http://www.rnhrd.nhs.uk/index_sub_menus/news/news_menu.htm

Advertising Standards Authority ruling:

http://www.asa.org.uk/Complaints-and-ASA-action/Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx

 

MEA and TYMES Trust 4 August 10 press release recipients

(NB: this may not be a comprehensive list)

The press release has gone out to

The Times news desk
David Rose, health reporter, The Times
The Independent news desk
Steve Connor, science editor, The Independent
Jeremy Laurence, health editor, The Independent
Sunday Times news desk
Daily Telegraph news desk
Sunday Telegraph news desk
The Lancet news desk
BMJ news desk
Daily Star, news desk
The Sun, news desk
Daily Mail, news desk
Daily Mail, health editor
Fergus Walsh, BBC health correspondent
Western Morning News, newsdesk
Bristol Evening Post, news desk
Western Daily Press, news desk
Buckingham Advertiser
Bucks Herald
You and Yours, Radio 4
Today programme, Radio 4
Panorama, BBC 1
Dispatches, C4
Disability Now
Evening Gazette Colchester
Channel 4 news
Breakfast, BBC 1
GMTV news desk
Randeep Ramesh, health reporter, The Guardian (Sarah Boseley is on holiday til August 9)
The Guardian, news desk
Osteopathy magazine
East Anglian Daily Times, news desk
Daily Express, news desk
Daily Express, health editor
Private Eye, news desk
Anna Winkles, health reporter, BBC Online
Press Association, health editor
All Together Now magazine
Bath Chronicle
News of the World
Tom Moore, health editor, Sky News, and his news desk.
Stacey Poole, the ME-aware health editor at Meridian, ITV station for south of England.
Emailed Times Ed Supplement, highlighting educational aspects of the release and suggesting they speak with Jane Colby.

BRAME Statement about the Lightning Process

BRAME Statement about the Lightning Process

Shortlink: http://wp.me/p5foE-2Zv

According to information received, today, the MEA and Tymes Trust will issue a joint statement later today opposing “unethical” proposed study of Lightning Process effect on children with ME.

BRAME has provided me with the following statement in response to the Bath/Bristol pilot study on Lightning Process for children aged 8 to 18 which does not yet have ethics approval.

Text below or open Word document here: BRAME Lightning Process Statement August 2010

For background to this issue: http://wp.me/p5foE-2Vt

BRAME Statement about the Lightning Process

We (BRAME) have grave concerns about lightening therapy and have voiced these concerns at many meetings, including with the Forward ME group when it was discussed there, and we will continue to do so.

BRAME has always worked/campaigned for ME to be recognised as a neurological illness, as classified by WHO, and have constantly worked to create a greater awareness and understanding of ME, for the complex and debilitating illness we all know it to be, and the impact it has on all those living with ME.

We (BRAME) have also been working hard, for the past 4 years, to try and get a national policy for ME adopted within the NHS, along with the use of the Canadian Clinical Guidelines on ME/CFS, and Canadian Clinical Diagnostic Criteria, to urgently address the paucity of biomedical services for people with ME within the NHS, and to address the national inequality of care. We have consistently raised this with PCTs, SHAs, the All Party Parliamentary Group on ME, various Ministers of Health, and even to Prime Ministers, at Number 10 itself, and within our responses to consultation documents.

Tanya was also patient representative on the CMO Working Group on ME/CFS and the NICE Guideline Development Group on ME/CFS, her response to these can be found on the BRAME website.

When we write to people who want information on BRAME and ME, we always state that:

“If any future health care professional is sceptical about ME, you could politely remind them that:

 Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS) are classified as neurological illnesses by WHO (ICD10:G93.3).

This WHO classification of ME and CFS is recognised by the Department of Health.

ME/CFS is included in the National Service Framework for Long Term Neurological Conditions.

ME/CFS is recognised as a neurological illness by the Royal College of General Practitioners with a Read Code of F286 (F denotes diseases of the nervous system).

The Canadian Clinical Guidelines on ME/CFS (2003) give consensus diagnostic and management advice which are accepted around the world.

The first 4 main points were reconfirmed by the Health Minister Ann Keen, at the APPG on ME meeting  on 22 January 2008, and by Lord Darzi, in his response to a formal question posed to him by our patron the Countess of Mar, in the House of Lords on 2 June 2008.”

We have also worked with the DWP for many years, raising the problems many people with ME have with the benefit system, and have campaigned for improved benefits, and on behalf of carers, and have been quoted in the government’s recently published white paper on Welfare Reform. We are extremely concerned over the proposals of the new coalition government on changes to benefits and the Work Capability Assessment and migration of people from IB, SDA and IS to the new ESA. We are also concerned over the proposed new medical assessment for those on DLA.

We have written to all the new Ministers but the responses we have received have not been encouraging. We will have to see if the new APPG on ME can be effective in supporting us by raising our grave concerns with the relevant Ministers. Sadly we lost in the election our own, very supportive, MP, Tony Wright, who was responsible for forming the APPG on ME in 1998, and was an officer of the group from 1998 to 2010.

We will continue to raise our concerns about the lightning process, and the need for a national policy on ME calling for biomedical services led by a specialist in ME of consultant level, to be set up nationwide based on the Canadian Guidelines/Diagnosis as set out in the BRAME Guide to Diagnosing, Managing and Caring for people who are Severely/Very Severely Affected by ME.

Tanya Harrison
Chairperson – BRAME
August 2010

http://www.brame.org/

Invest in ME Decline BACME Invitation

Invest in ME Decline BACME Invitation

Shortlink: http://wp.me/p5foE-2Z2

Invest in ME has issued a statement around its decision to decline an invitation to become a member of BACME (British Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis).

For Invest in ME’s position statement on the proposed Bath/Bristol pilot study to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process and specialist medical care in CFS/ME in children as young as eight, go here Invest in ME March 2010 Newsletter.

 

Invest in ME Decline BACME Invitation

Invest in ME recently received an invitation from the British Association for Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (BACME) inviting us to apply to become an executive member of that organisation.

BACME is chaired by consultant paediatrician Dr Esther Crawley – who was recently awarded a grant to do a clinical trial on the Lightning process (funded with £164,000 from the Linbury Trust and the Ashden Trust) – a business which assumes that no matter what is causing an ME patient’s illness it will help cure a patient from them.

With cases of people with ME being made worse from this business the recent Norwegian film by Paal Winsents (“Make Me Well”) illustrates the danger of people with no medical training attempting to treat a neurological illness such as ME. A telling quote from a LP practitioner in that film says it all –

“…. It does not matter how it started. Sometimes people had a bacterial infection, sometimes people had a viral infection. It does not matter how it started. The Lightning Process works equally well”.

Such uninformed, non-clinical and dangerous statements being used by people promoting businesses without any medical training, at a time when the need for more funding for biomedical research into ME and the evidence to support that funding requirement is overwhelming, is symptomatic of the problems on a non-strategic, non-biomedical approach to diagnosing and treating people with ME. Meanwhile ME patients and their families have to witness this absurd waste of money.

Dr. Crawley’s views on ME aren’t those of Invest in ME’s and we have serious concerns about her position as chair of an organisation such as this.

The Assistant Chair of BACME is Alison Wearden, who is Reader in Psychology at the University of Manchester, Chair Elect of British Psychological Society’s Division of Health Psychology and Associate Editor of British Journal of Health Psychology and whose studies include “Illness cognitions and diabetes – how the beliefs which patients hold about their diabetes impact on their attempts to manage it, their adjustment and well-being”. Wearden was head of the FINE trials (click here) – a waste of taxpayers’ money which resulted in nothing of value for people with ME.

BACME has a constitution to which members have to sign up. In this constitution, which BACME requires its members to support, it includes the following-

2.2 Objectives

2.2.1 To champion evidence-based approaches to the treatment of CFS/ME, such as those provided in the NICE guidelines

2.2.4 To support the delivery of services and to enable services to maintain standards of care in the treatment of CFS/ME as set out in the NICE guidelines

4. The Executive

4.1.4 The BACME Executive will invite no more than four people drawn from National UK CFS/ME organisations which explicitly support the aims and constitution of the organisation to sit on the Executive committee as either observers or members

Invest in ME rejected the NICE Guidelines and therefore cannot agree to endorse a constitution which lists among other things the above objectives.

Invest in ME endorse the critique set out by Twisk FNM, Maes M. in their review of CBT/GET in which they state

“So, it can be concluded that the efficacy claim for CBT/GET is false. But what is more important, is the fact that numerous studies support the thesis that exertion, and thus GET, can physically harm the majority of the ME/CFS patients.

This assertion is confirmed by the outcomes of two large patient surveys in the UK and Norway, and two smaller surveys in Scotland and the Netherlands.”

(A review on Cognitive Behavorial Therapy (CBT) and Graded Exercise Therapy (GET) in Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS): CBT/GET is not only ineffective and not evidence based, but also potentially harmful for many patients with ME/CFS. Neuro Endocrinol Lett. 2009 Aug 26;30(3):284-299.) click here

The NICE guidelines need complete revision* as their current version is far from evidence-based.

The NICE guidelines have been shown to be ineffectual, biased, unusable, with ME patients eventually taking NICE to a judicial review.

For an organisation to support NICE, and require members to abide by them, let alone “champion” them illustrates a flawed and damaging basis for any claim to represent people with ME and their families. Such an organisation is likely to continue to force a continuing approach of going round in circles, obfuscating the true requirements for ME patients and achieving little of real value for people with ME and their families.

With BACME maintaining its present structure, current chairman and constitution then Invest in ME will decline any offer to apply for membership of this organisation.

It would be unethical of Invest in ME to sign up to such a constitution and Invest in ME’s aim remains to find ways other than those set out in the NICE guidelines to treat patients diagnosed with ME according to the Canadian Clinical Consensus guidelines.

Further Reading: (links provided by Invest in ME)

Magical Medicine: How to Make a Disease Disappear – click here

Lightning Process – The Falsehood of Magical Medicine – IiME Newsletter March 2010 – click here

Can the MRC PACE Trial be justified? – click here

Wessely’s Way: Rhetoric or reason? – click here

Invest in ME – Communications with the UK Chief Medical Officer – click here

Lightning Process pilot for ME and CFS children: Funding letters

Lightning Process pilot for ME and CFS children: Funding letters

Shortlink: http://wp.me/p5foE-2XZ

Press Release issued 2 March 2010: Research study to investigate a chronic childhood condition 

For background to this issue see ME agenda 5 July report:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)

The University of Bristol Information Office is withholding virtually all information known to have been requested to date under Clause 22(1)(a) of the Freedom of Information Act.

Currently, no information on the study design, methods, objectives, recruitment process and research criteria for this proposed pilot study is available for public scrutiny.

The study is due to commence in September.

The University has confirmed that the research study, for which funding was secured last November, is still going through the ethics approval procedure but is withholding the names of the research ethics committee(s) considering the application for ethics approval.

Funding for the pilot has been awarded by the Linbury Trust and the Ashden Trust.  Some funding related documents have been made available to members of the public in response to requests for specific information.

To virtually all questions submitted under FOIA, the University Information Office’s response has been the same:

“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.”

Some limited documentation has been provided to two members of the public:

Document 1:

4 November 2009  |  Linbury Trust to Dr Esther Crawley  |  Open PDF:  Funding Linbury Trust 04.11.09

Note: The grant is conditional on the project commencing no later than October 2010.

Document 2:

24 November 2009  |  Ashden Trust to Dr Esther Crawley 

Note: At least part of the total grant is being paid out over three years: 2009/10, 2010/11, 2011/12.

Document 3:

8 March 2010  |  Linbury Trust to Dr Esther Crawley

 

University of Bristol internal review

A request for an internal review of the responses received on 17 June 2010 from the University of Bristol was submitted yesterday, 22 July.  A copy of the complaint will be published in the next post.

A question of ethics; Juvenile Treatment – Testing and LP – CBT/GET ethics

A question of ethics; Juvenile Treatment – Testing and LP – CBT/GET ethics – two views

Shortlink: http://wp.me/p5foE-2XM

“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]

20 July 2010

Published with kind permission of Karl Krysko.

A version of this commentary was published earlier today, on the Co-Cure Listserv mailing list.

Juvenile Treatment -Testing and LP-CBT/GET ethics

Recent attention has been drawn to the question of ethics in attempting a Lightning Process (LP) pilot study on children and juveniles suffering from ME. It is right to question such. The very nature and history of this pseudo-treatment approach should dictate against even entertaining the thought, yet alone dabbling in its dangerous claims.

It is obvious that some individuals in the LP, if they are lucky, do not actually have ME in the first place, while others who do, in fact, and show some ‘improvement’ are simply drawing on margins of redundancy for extra energy expenditure that patients automatically and unconsciously build into their cautious use of activity generally. The un-lucky ones, however, encouraged and lured with promises of ‘cure’ in the LP trespass these self-protection margins, and face precipitating a serious relapse.

The basic therapeutic ‘rationale’ for the LP has been around for many years during which time its foundations, essentially Neuro Linguistic Programming (NLP) and Affirmation therapy, have had plenty of time (and patient financing) to establish their scientific and medical validity. This they have failed to do long term.

Practitioners such as Leonard Orr, of ‘re-birthing’ fame, and others in the early 1980s motivated their newly diagnosed and pathetically desperate HIV patients, for example, to go jogging along the beaches of California (where else!) while affirming repeatedly to TV cameras, and all, that they were no longer ill, did not have a life threatening medical condition, and were in fact in perfect health. This claim they were directed to assert most emphatically, and especially so – no matter how unwell they felt or became, as if the ‘magic’ of insisting this to be the case could somehow make it so.

Then as now, patients were charged most handsomely for this treatment approach. Many such individuals back then, before the era of medical understanding and proper treatments for the AIDS virus, went to their early death still chanting and ‘affirming’ their pathetic mantras, in total denial. The modern versions of this nonsense, and it has various forms even among some charismatic ‘healing’ religions, just goes to show how difficult it is to kill off a good money making racket.

But the current discussion has missed one similar and important parallel to the question of ethics in treating and testing child victims of ME with the LP. The proposal has recently been made in Wales that the NHS should be petitioned for an essentially CBT and GET-GAT treatment service for ME youngsters, alongside the already existing services for adults here in the Principality.

But notice how the facts and ethics of the LP and CBT/GET link unmistakably:

Just as CBT thinking really began to replace the old ‘taking and insight therapy’ and catharsis types of approach to behavioural-psychological based problems, at the same time Affirmations and NLP appeared on the scene.

As with the LP, and after all this time since, the scientific and medical validity of CBT and de-conditioning therapy for ME is also lacking, despite early robust efforts, here for example, by the Welsh ME/CFS Service (with several others conducted in the UK at the time) over five years between 1999 and 2004 to establish its value, using the best methodological, statistical and University (Bangor) facilities available. After some attempted spin-up, those poor results were later sat on.

Like the LP also, the CBT approach obviates the patients’ instincts and intuitions concerning their health situation, as well as the views of their carers, friends and family. The patient in both paradigms has to denounce what they know they know, experience, and have learned about their illness and coping in order to, supposedly, get better. And both regimes thereby effectively downgrade or refute the genuine seriousness, gravity and clinical authenticity of ME.

Like the LP, CBT/GAT also make promises that cannot be substantiated or upheld, clearly so for our badly compromised patients; one nine year GP-diagnosed, for example, severely effected and bedridden ME patient near Flintshire north Wales, was told by her ME Clinic that she would be well and functioning within the year, if she maintained the methods propagated at their eight day training course. Meantime, similar attempts were made to overturn her longstanding ME diagnosis with her GP. Lightning Process patients are made equivalent promises, and are similarly encouraged to anathematise their ‘ME title and patient ‘role’.

Most seriously and least obviously, both the LP and CBT/GAT approaches irresponsibly reject, ignore, are indifferent to, or deny the existence of (already) serious ongoing molecular and organic damage that will be exacerbated over time by inappropriate, incremented, upward gradations of kinetic load, in the name and claim of ‘improvement.’ The compounding of this molecular damage could have mortal consequences for many ME patients, at least over the long-term and wherein, temporally, this therapy is exactly designed to operate.

In their most recent and comprehensive Review of the Research to date, for example, Twisk and Maes (2009 – 10) refer in this regard to forms of bio-chemical long-term damage that CBT and methods like Graded Activity/Exercise for ME patients could produce, stating that the therapy ‘is not only ineffective and not evidence based, but also potentially harmful for many patients with ME.’

The question of ethics, of placing ME children in the direct oncoming hit-path of a Lightning Process treatment and assessment – in a ‘test to destruction’ fashion – potentially a consequence in the short or long term – is therefore as unethical as doing so in its other latest crack-pot analogue recently announced here in the Principality as ‘a new campaign’; for yet another, this time specifically child and juvenile, CBT/GAT Service for Wales.

Rejecting the Lightning Process and its flawed manifestations down the decades, it is for the same parallel reasons here given between the two treatments, that we also reject and will actively campaign against such an irresponsible, scientifically indefensible and, yes, unethical NHS development for our young ME victims living here in North Wales.

Karl Krysko  BA (hons), BSc.

 

Although Ms Jacqui Footman signs herself, in this Co-Cure opinion piece, as a “Mother and Information Officer, South Molton ME Support Group”, Ms Footman fails to disclose a conflict of interest.

Ms Footman is a provider of EFT and similar therapies and advertises her business in the magazines of national patient organisations.

Advert from an ME Association magazine – ME Essential

“Jacqui’s EFT practice combines aspects of counselling, life-coaching, NLP and psychotherapies such as CBT and solution-focussed therapy with the powerful new energy-psychology technique EFT, which involves tapping acupuncture points to bring about dramatic personal change and healing. EFT is available by phone.

“Jacqui Footman BA (Hon), PGCE, Member National Council of Psychotherapists, Practitioner of Emotional Freedom Techniques (EFT), NLP, EMDR, WHEE, EmoTrance and Reiki. Registered (General Regulatory Council for Complimentary Therapies). Trained by Dr Myhill to support her ME/CFS treatment programme. Info Officer, South Molton ME Support Group with extensive experience of ME/CFS at many levels.”

Published on the Co-Cure Listserv mailing list  |  20 July 2010

From Jacqui Footman

[CO-CURE] NOT, MED, ACT: A question of ethics

Speaking of ethics, my question – is it ethical to attempt to deny 90 children/young people the opportunity to have their young lives back? or to try to persuade others to rescind that opportunity?

My 12-year-old was diagnosed with ME 3 months after glandular fever. The diagnosis was confirmed by our two UK best-known paediatricians in the field, Drs Speight and Crawley. She definitely had ME/CFS. She went from active swimmer and gymnast to wheelchair. She missed a year of school. Out of desperation with an NHS strict activity management approach which was driving her to distraction and starting to cause her to feel miserable she reached out to Lightning Process(LP) … and was back to enjoying an active life within weeks.

The LP Practitioner she saw has worked with many teenagers and has 100% success rate with teenagers so far.

Because of the obvious change when my daughter did LP, notably that she immediately went from so often looking deathly pale to having a constant healthy rosy complexion, someone in our local ME support group who had been bedbound for 10 years since being made dreadfully worse with CBT/GET decided there must be something to LP and it must have some sort of capacity to directly affect the physiology. She mustered the courage to try LP herself and the same practitioner went to her house to do it with her as she wasn’t well enough to get to a LP course. She was walking round her garden by the third day of the LP course and has gone from strength to strength since. That was over a year ago. She has just won a design competition and is to start the high profile design course in Oxford for which she won the fees in September this year. She has a life again after 17 years of existence in a bed. She had ME/CFS too, no question.

LP is nothing like the NHS CBT/GET/GAT treatments. I’ve detailed knowledge of both. LP bears no relationship to the deconditioning theories etc upon which CBT treatments have been based.

When LP first came out I was sceptical. After this personal experience and observation I don’t hesitate to recommend this LP Practitioner who once had ME/CFS herself and has a brilliant understanding of what people need to get well and gives all the support and follow-up needed. Although I don’t recommend LP per se without qualification. I do believe there should be further research. LP seems to work best with young people.

Jacqui Footman
Mother and
Information Officer, South Molton ME Support Group
info@mecfssupportdevon.org.uk
(please note, long and negative anti-LP emails will not be answered, so save your energy)

Related material:

Press Release issued 2 March 2010: Research study to investigate a chronic childhood condition
 

For background to this issue see ME agenda 5 July report:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)

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 

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

Unethical Bristol/Bath Lightning Process ME/CFS children pilot study

eBMJ: Unethical Bristol/Bath Lightning Process –  ME/CFS children pilot study

Shortlink: http://wp.me/p5foE-2XC

The following response was submitted to eBMJ Rapid Responses on 15 July, and is currently unpublished.  A copy also appears on the ONE CLICK website.

Re: Failure to appreciate pain is a symptom not a diagnosis is what leads to bad medicine

Suzy Chapman,
Carer
Dorset

15 July 2010

Send response to journal:
Re: Re: Failure to appreciate pain is a symptom not a diagnosis is what leads to bad medicine

In his response “Failure to appreciate pain is a symptom not a diagnosis is what leads to bad medicine”, Dr Munglani, Consultant in Pain Medicine, West Suffolk Hospital, recommends the Lightning Process [1].

The Lightning Process is a three-day course said to be based on neuro-linguistic programming (NLP) and life coaching. It is marketed not as a therapy or a treatment but as a “training program”. It is unregulated and its practitioners are trained and “licensed” by the Phil Parker organisation. Many of those who train to become Lightning Process instructors are former “trainees”, themselves.

I note that Dr Munglani has a provided a number of personal testimonials for the pages of the website of a Suffolk Lightning Process centre [2].

The website states that there are now NHS and private consultants, GPs and occupational therapists referring patients to the centre, and that NHS clinicians have attended as observers of the work carried out there. Visitors to the site are encouraged to contact an OT at the James Paget University Hospital pain clinic or OTs at the Norfolk and Suffolk ME/CFS service, for which contact details are given.

On one of its web pages is the following:

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”

On 16 June, the Advertising Standards Authority (ASA) published an adjudication against a Bournemouth company following its upholding of a complaint about a Lightning Process advertisement [3].

The ASA records their concerns that “the company 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 company was advised to ensure “they held substantiation before making similar efficacy claims for the lightning process”.

The Advertising Standards Authority’s remit does not extend to website content. But I hope that Dr Munglani, who provides personal testimonials for the Suffolk centre, has satisfied himself that this centre is able to provide robust evidence to substantiate its claims that people using the Lightning Process, said to be based on neuro-linguistic programming (NLP) and life coaching, have “recovered from, or experienced significant improvement” from diseases and conditions which, in addition to ME and chronic fatigue syndrome, include urinary infections, coeliac disease, crohns disease, blood pressure, cardiac arrhythmia, type 2 diabetes, hyper/hypo thyroidism, autistic spectrum disorder, dyspraxia, ADHD, lymes disease, glandular fever, epstein barr virus, multiple sclerosis, cerebral palsy, parkinsonian tremor and motor neurone disease.

This is a very topical issue because in March, the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust, also known as the Min, and the University of Bristol announced a pilot study looking into interventions and treatment options for Chronic Fatigue Syndrome [4].

Funding of £164,000 from the Linbury Trust and the Ashden Trust has been awarded to a research team led by Dr Esther Crawley, Consultant Paediatrician, Royal National Hospital for Rheumatic Diseases, Bath, CFS Clinical Lead for Bath NHS FT and a Senior Lecturer, University of Bristol.

The pilot study, scheduled to start in September, will look at the feasibility of recruiting children aged 8 to 18 with CFS and ME into a randomised controlled trial (RCT) comparing the Lightning Process and specialist medical care. The study has the involvement of Phil Parker and colleagues.

“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 Medical Research Council (MRC) produces specific guidelines for research involving vulnerable patient groups. The document “MRC Medical Research Involving Children” 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.” [5]

No rigorous RCTs into the application of the Lightning Process in adults with CFS and ME have been undertaken.

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%) [6].

With no robust data from the application of Lightning Process in adults, how can the research team determine that overall the likely benefits of the research outweigh any risks to child participants and 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?

There are considerable concerns that an NHS paediatric CFS unit should be planning a study involving children as young as eight when no rigorous trials have first been undertaken into the safety, acceptability, long and short-term effects of the application of this controversial and unregulated “process”.

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 unethical not to do so first.

References

[1] Failure to appreciate pain is a symptom not a diagnosis is what leads to bad medicine: Rajesh Munglani, 8 March 2010:
http://www.bmj.com/cgi/eletters/340/jan06_2/b5683#232414

[2] The Rowan Centre, Suffolk:
http://www.simpsonandfawdry.com/about-simpson-and-fawdry.htm

[3] Advertising Standards Authority Adjudication, 16 June 2010:
http://www.asa.org.uk/Complaints-and-ASA-action/Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx

[4] Media Release, University of Bristol, 2 March 2010:
http://www.bristol.ac.uk/news/2010/6866.html

[5] MRC Medical Research Involving Children (Nov 2004, revised Aug 2007):
http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430

[6] 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

Competing interests: None declared

Related material:

Press Release issued 2 March 2010: Research study to investigate a chronic childhood condition
 

For background to this issue see ME agenda 5 July report:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)

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 

Is it ethical to undertake a pilot looking at feasibility of recruiting children 8 to 18 with CFS and ME into an RCT comparing Lightning Process and specialist medical care when no rigorous RCTs into the application of LP in adults have been undertaken?

Shortlink: http://wp.me/p5foE-2W3  or  http://tinyurl.com/LightningProcessPilotStudyPoll

Update @ 5 August

Poll now closed

Thank you to everyone who registered their opinion.

For background to this issue see ME agenda Post 5 July 2010:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)  

Poll: Is it 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 the Lightning Process and specialist medical care when no rigorous RCTs into the application of the Lightning Process in adults with CFS and ME have been undertaken?

 

ME Association: Advertising Standards Authority upholds a complaint against a Lightning Process practitioner

ME Association: Advertising Standards Authority upholds a complaint against a Lightning Process practitioner

Shortlink: http://wp.me/p5foE-2VD

Update @ 7 July

Phil Parker’s Lightning Process site at http://www.lightningprocess.com/ is down this morning and the Lightning Process pages of his http://www.philparker.org/Home/ site are also unavailable.

 

Read ASA Adjudication on Withinspiration or for full text see previous post

Today, the ME Association reported on the ASA adjudication.

From the News pages of the ME Association

Tuesday, 06 July 2010

ASA Ruling 

A complaint that an internet sponsored link carried an unsubstantiated claim that the Lightning Process can make people with ME/CFS well again has been upheld by the Advertising Standards Authority (ASA).

In a decision announced on 16 June 2010, the ASA ordered the company “Withinspiration” to drop an advertisement which claimed: “Chronic Fatigue Recovery. End the cycle of ME/CFS: Get Well! with The Lightning Process.”

The ASA ruling says: “The ad must not appear again in its current form. We told Withinspiration to ensure they held substantiation before making similar efficacy claiming for the lighting process [sic]”.

The complainant wasn’t named in the ruling but the ASA said the company had told them that they had personal experiences of improvement in medical conditions such as ME, as a result of using The Lightning Process. The process had received a number of celebrity endorsements and positive press reaction, which were testament to its effectiveness.

Although Withinspiration said they held no scientific evidence to support the claims, they said that trials were due to begin in 2010.

 Upholding the claim, the ASA wrote:

“The ad breached CAP Code clauses 3.1 (Substantiation), and 50.1 (Health and beauty products and therapies).”

“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.”

◦ No similar claims appear on the Withinspiration website today. The site promotes the work of Alastair Gibson – “one of the most experienced international advanced Lighting Process practitioners”. It gives a contact phone number for the Bournemouth area.

Ed: Note that 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 and the young people” in 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 the proposed pilot study, announced by the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust and University of Bristol in March.

In response to a request for information under FOIA, 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) of the Freedom of Information Act.

The study, scheduled to start in September, is still going through the ethics approval procedure.  Funding for the pilot had been secured in November 2009.

The names of the ethics committee(s) reviewing the application are also being withheld by University of Bristol. 

 

Related material:

Press Release issued 2 March 2010: Research study to investigate a chronic childhood condition
 

For background to this issue see ME agenda 5 July report:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)

 

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