Category: AfME, Action for M.E.

Chutzpah – he’s got it in spades! (Lightning Process and scientific research)

Chutzpah – he’s got it in spades! (Lightning Process and scientific research)

Shortlink: http://wp.me/p5foE-38M

The Phil Parker Lightning Process site announces they are shortly to launch “a public opinion survey designed to raise awareness about current research into the physical nature of this disease”  –  a “Campaign to increase awareness of ME/CFS as a physical illness” with the promise of more information to follow.

 

Mr Parker’s scientific ability to step inside people’s bodies:

This is the man about whom it is claimed…

http://www.healinghawk.com/prospectushealing.htm  

…Phil Parker is already known to many as an inspirational teacher, therapist, healer and author. His personal healing journey began when, whilst working with his patients as an osteopath. He discovered that their bodies would suddenly tell him important bits of information about them and their past, which to his surprise turned out to be factually correct! He further developed this ability to step into other people’s bodies over the years to assist them in their healing with amazing results. After working as a healer for 20 years, Phil Parker has developed a powerful and magical program to help you unlock your natural healing abilities. If you feel drawn to these courses then you are probably ready to join…

That entire course prospectus is worth a skim.
 
 

Mr Parker’s scientific opinion on the Lightning Process and XMRV:

Slide presentation:  xmrv cfs | 8:30 mins

17 slides, no audio

http://www.youtube.com/watch?v=R8GCp00KC78

thephilparker | 27 October 2009
Phil Parker, designer of the Lightning Process discusses the latest research into the xmrv virus and cfs

@ Slides 13 and 14

How this relates to the Lightning Process

• If we assume that on average:

– 67% of the cases of CFS clients that are seen with the LP have the XMRV virus,

– And according to our findings 85% of these people recover their health in the 3 days of the LP programme

LP and XMRV

• The LP must be assisting these people to deal effectively with that infection in some way (we would hypothesise it is a resumption of good immune and neurological function)

 

Mr Parker’s promotion of the “Lightning” as a “Dynamic New NLP Pattern Seminar” and “Self Coaching Strategy”, in 2002:

Yahoo! Groups   hypnosis-hypnotherapy-UK

Tue Apr 23, 2002 3:34 pm

http://health.groups.yahoo.com/group/hypnosis-hypnotherapy-UK/message/3888

Dynamic New NLP pattern seminar

The London College of Holistic Medicine

Presents

The Lightning Self Coaching Strategy

A seminar training you in the latest developments in the fields of NLP and Coaching

Led by Phil Parker Do Dip E Hyp NLP CMPNLP MBIH

and Phil Swallow DCHNLP CMPNLP

Sunday June 16th 10am-5pm Central London,UK

This is a rare opportunity to discover some NEW NLP patterns;

these are as a result of Phil’s latest research and are simply not available anywhere else.

Do you want to build on your current skills and master a simple, effective, rapid and lasting strategy for helping you and your clients to learn how to:

Make changes in issues which have troubled them for years

Breakthrough old areas of stuckness

Stop old negative thought patterns

Develop a more supportive and affirming relationship with themselves

Stop victim behaviour, inaction, lack of responsibility and sulking

Stop abusive patterns like smoking, overeating

Stop worry, anxiety, panic attacks

Get over depression

Become more proactive and less dependent on professional support

Coaching and self coaching.

Most of us are now familiar with concepts of coaching, and recognise the value of this supportive and focused way to address the issues of your life.

Self coaching takes these core coaching concepts even further, rapidly developing the clients own abilities to take charge of the choices they make in their lives, to create solutions to unfamiliar situations, to nurture and support themselves, and focus their lives in the directions they really want to. This detailed course trains you so that you can apply the key steps of this process to teach and coach your clients to mastery in the Lightning Self Coaching Strategy.

You will learn how to use the following Key Steps

Explain to clients how their current negative patterns work; and help them to discover how changing them will produce amazing results

The Lightening Self Coaching process

Testing and fine tuning

Making it stick

Pre-course requirements.

To ensure the course is appropriately targeted, you meet one of the following eligibility criteria

A: a NLP practitioner

B: a Hypnotherapist

C: have a clinically based training, e.g. doctor, nurse, osteopath, acupuncturist etc.

D: have a coaching training

E: had a personal interview with course leader

You will get the most from the course by reading Phil Parker’s groundbreaking handbook on self coaching, The Ten Questions. Available at http://www.philparker.org

Course fee: £120 (please make cheques payable to Phil Parker and mail to LCHM 170 Weston Park London N8 9PN UK)

Early bookers discount; be sure of your place, save yourself £20 and make the admin easier for us by booking before May 1st 2002 and your course fee will only be £100

Clients comments after using the Lightning Self Coaching Strategy.

I’m not quite sure how you’ve help me do this but, but I do not recall feeling so good for decades; the rollercoaster of anxiety and stress that I used to have a season ticket to has just gone away. Thanks so much for teaching me what I wished I’d learnt years ago.

I’ve been the Queen of yo-yo dieting for years. I’ve seen everyone, and I mean everyone, from Nutritionists to fitness trainers to astrologers. Nothing has made any long term impact until I started this process with Phil. Now I’ve been eating normally for 3 months, and not even snacking when the stress starts to build up.

I feel like a genius!

I believed I had a milk allergy causing all my digestive problems, but it seems I was mistaken, not only can I now eat what I like and feel fine, but I’ve also reduced the stress is my life to almost zero, just in three sessions. I can’t believe how good I feel, and how easy it was, and how I never knew any of this work before now.

Warning: There is a strong possibility that your current clients could stop needing to see you as often as they used to and that they will begin refer you more new clients than you can handle.

Reserve your place by mailing a cheque made payable to P Parker to

LCHM,170 Weston Park, London N8 9PN.

For further details call 020 83149800

Please note

Once you have committed to taking a place on the course fees can not be refunded unless we have to cancel the event.

—————————————–

the secret is out

How much more will you be able to achieve once you’ve discovered THE TEN QUESTIONS ?

Order your copy of Phil Parker’s new book now, and re-design your future today.

Click now www.philparker.org/order.htm to find out more

 

Mr Parker’s scientific opinion on whether medical professionals can assess whether you are “ready” to undertake the scientific Lightning Process:

From the FAQ: Can my doctor assess me for readiness?

If your doctor or health care specialist is trained as a Lightning Process Practitioner then of course they can assess you for readiness to take the programme. If they are not trained in the programme they will not have the requisite skills or knowledge base about this very specialised field to assess you.

A large part of the training for LP practitioners is to train them to appropriately assess potential trainees for their suitability for the process, as it is essential to ensure, as far as is possible, that only those who are ready to get benefits from the training program are enrolled in the training.

 

Mr Parker’s scientific method of resolving CFS and ME, as recounted by a disappointed Lightning Process “trainee”:

Phoenix Rising forum thread

[…]

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. 

 

…and if the Lightning Process doesn’t scientifically fix CFS and ME, well there’s plenty more it can sort, according to the sites of some Lightning Process practitioners:

What does it work for?

People using the Lightning Process® have also recovered from, or experienced significant improvement with the following conditions: –

Fibromyalgia
Chronic Fatigue Syndrome
Post Viral Fatigue
Asthma
Rheumatoid Arthritis
Hayfever
Depression
Dyspraxia
Bipolar Disorder
Ocd
Anxiety And Panic Attacks
Insomnia
Cerebral Palsy
Low Self Esteem
Parkinsons Tremors
Motor Neurone Disease
Hyper And Hypo Thyroidism
Chronic Aches And Pains
Ibs
Lyme Disease
Anger Issues
Food Intolerances
Coeliac Disease
Ptsd
Candida
Allergies
Type 2 Diabetes
Interstitial Cystitis
Migraines
Noise And Light Sensitivity
And Many More

Using the Lightning Process® has proven effective for clearing ALL the debilitating physical and mind based symptoms of ME, chronic fatigue syndrome, and post viral syndrome.

Some of the symptoms that people have cleared are listed here…

Addictions, adrenal problems, allergies and intolerances, anxiety, balance problems, bloating, blurry vision, brain fog, candida, chemical sensitivity, compulsive behaviours, concentration problems, confusion, constipation, depression, diarrhoea, dizziness, electrical pulsing sensations, excessive sleeping, exhaustion, fatigue, fear, feeling detached or disconnected, fever and chills, flu-like symptoms, frequent coughs and colds, fybromyalgia, hallucinations, head pain or pressure, heartburn, indigestion, insomnia and other sleep disturbances, irritability, irritable bowel syndrome, itching and rashes, itchy eyes, joint pain, light sensitivity, loss of vision, malaise, memory loss, migraines, muscle pain, nausea, noise sensitivity, oedema, panic attacks, painful and/or swollen glands, pins and needles, restless leg syndrome, runny nose, sensitivity to electrical fields/computers/mobiles etc, shaking, shooting pains, skin sensitivity, stomach pain, sun burn sensation, swelling, temperature control problems, thrush, thyroid problems, unrefreshing sleep, vertigo and similar sensations, vomiting, water retention, watering eyes, weakness…

 

Lightning Process practioner, Alastair Gibson* who is part of the research team collaborating in the Dr Esther Crawley NHS Bath/University of Bristol pilot study into the application of Lightning Process in children, due to start recruiting this month, can also provide you with relief and enhancement:

*In June, Mr Gibson was subject to an Advertising Standards Authority ruling in relation to claims made in an advertisement about the efficacy of the Lightning Process for CFS and ME.

Relief from:

Addictions
Anger management
Children’s Anxieties
Sadness
Grief and Loss
Negative Memories
Procrastination
Stomach Problems
Weight Issues Allergies
Stress
Chronic Fatigue Syndrome
Fears and Phobias inc:
Public Speaking
Spiders
Heights
Flying

Relationship Issues

Anxiety and Panic
Compulsions and Obsessions
Guilt
Headaches
Limiting Beliefs
Pain Management
Stuckness

And many more…..

Enhancement of:

Abundance
Emotional Control
Relationships
Self Image
Creativity & Productivity Concentration
Healing
Relaxation
Work and School Performance
And many more…..

Confidence
Life Direction
Self-Esteem
Sports Performance

March 2011 can’t come soon enough.

Landmark agreement extends ASA’s digital remit

SMILE – Specialist Medical Intervention and Lightning Evaluation documents

SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME)

Shortlink: http://wp.me/p5foE-37x

See also previous ME agenda post:

“Unethical” Lightning Process pilot study in children receives ethics approval

Update: Key documents

3] SMILE Research Protocol

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/smprotv6final.pdf

Open here: smprotv6final

29] Research Ethics  Application Form

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/recfrmrfs.pdf

Open here: recfrmrfs

University of Bristol website

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smile.html  

Source: Protocol document

 

SMILE – Specialist Medical Intervention and Lightning Evaluation

What is SMILE?

SMILE is a feasibility study to see whether it is possible to recruit young people into a study to compare specialist medical treatment with specialist medical treatment plus the Lightning Process for young people with chronic fatigue syndrome or ME (CFS/ME).

The study will also look at how we should measure outcomes and the health economic impact on the families of young people with CFS/ME.

Young people will be observed completing the questionnaires that we use to look at how unwell they are before they see us and what happens to them after an intervention. We will also talk to young people and their parents to understand what they think about the questionnaires and to determine the most acceptable and sensitive ones to use. This study is the first to work out which questionnaires we should be using to understand outcome in paediatric CFS/ME.

Frequently Asked Questions

Why is research in children needed?

Over 250 children a year already attend Lightning Process training. It is important that people know whether it is safe and effective or not. We need high quality research to answer these questions. If SMILE can recruit enough people to participate in the study then further research could look at whether it is helpful or not.

Should research be done in children before adults?

Children have the right to research particularly in illnesses which are different to adults. CFS/ME in children has a different outcome to adults and the treatment is different therefore research in adults cannot be extrapolated to children.

How will the safety of those involved in SMILE be monitored?

The safety and wellbeing of people involved in any research project, not just the SMILE project, is of the utmost importance. There is an Independent Advisory Group to oversee, and monitor this research. All participants will be carefully monitored and regularly reviewed in the specialist CFS/ME service. Young people taking part can opt out of the trial at any point.

How can we take part in the study?

Young people are eligible if they are between 12 and 18 years of age, have CFS/ME and are from the region covered by the Bath/Bristol specialist CFS/ME service. Young people are recruited at assessment so you will not be eligible if you have already been seen by the service.

What ethical review has SMILE received?

The study has been scrutinised by the South West 2 Research Ethics Committee whose role it is to ensure that research is safe and ethically sound. The ethics committee have looked in detail at the study design, and all associated documentation and suggested improvements to the readability and accessibility of the patient information leaflets and consent forms which have been adopted.

The SMILE study is compliant with Good Clinical Practice Guidelines, Research Governance Framework, Medical Research Council guidelines, Royal College of Paediatrics and Child Health guidelines for the conduct of trials and has been approved by an ethics committee.

Further information about this research project can be found in the following documents:

Smile Study Documents

[Ed: I have numbered these documents for ease of reference – they are not numbered on the University of  Bristol website.]

Note: some of the documents on this page are in PDF format. In order to view a PDF you will need Adobe Acrobat Reader

1] SMILE Information sheet for teenagers August 2010 [pdf (150kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/infoshtteensv4aug10.pdf

Open here: infoshtteensv4aug10

2] SMILE Information sheet for parents September 2010 [pdf (147kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/infoshtprntsv7sept10.pdf

Open here: infoshtprntsv7sept10

3] SMILE Protocol Final July 2010 [pdf (170kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/smprotv6final.pdf

Open here: smprotv6final

4] SMILE Under 16 assent to contact July 2010 [pdf (109kb)

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/u16asscv4july10.pdf

Open here: u16asscv4july10

5] SMILE 16 to 18 consent to contact July 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/16to18confinaljuly10.pdf

Open here: 16to18confinaljuly10

6] SMILE Parental consent to contact 10 May 2010 [pdf (111kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/parconsv310may10.pdf

Open here: parconsv310may10

7] SMILE Under 16 assent to study July 2010 [pdf (112kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/u16assv4july10.pdf

Open here: u16asscv4july10

8] SMILE 16 to 18 consent to study July 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/16to18constjuly10final.pdf

Open here:  16to18constjuly10final

9] SMILE Parental consent to study 10 May 2010 [pdf (113kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/parconssv310may10.pdf

Open here: parconssv310may10

10] SMILE teenager consent/assent to teenager interview August 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/tcontinvv5aug10.pdf

Open here: tcontinvv5aug10

11] SMILE Parental consent to child interview 10 May 2010 [pdf (111kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/parconcinv10may10.pdf

Open here: parconcinv10may10

12] SMILE Parental consent to parental interview 10 May 2010 [pdf (109kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/parconinvv310may10.pdf

Open here: parconinvv310may10

13] SMILE Consent to record intervention for participants, parents and those delivering interventions July 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/conrecintjuly10final.pdf

Open here: conrecintjuly10final

14] SMILE Lightning process assessment form July 2010 [pdf (159kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/lipcassfrmv2july10.pdf

Open here: lipcassfrmv2july10

15] SMILE letter to GP 10 May 2010 [pdf (49kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/letgpv110may10.pdf

Open here: letgpv110may10

16] SMILE WPAI [pdf (135kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/wpai.pdf

Open here: wpai

17] SMILE Health resource use questionnaire 10 May 2010 [pdf (232kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/healthresuseq.pdf

Open here: healthresuseq

18] SMILE SF-36 [pdf (165kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/smilesf36.pdf

Open here: smilesf36

19] SMILE Interview topic guide 10 May 10 [pdf (178kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/topgdev210may10.pdf

 Open here: topgdev210may10

Correspondence with Ethics Documents

20] Initial covering letter to NREC 20th May 2010 [pdf (75kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/covlet20may10.pdf

Open here: covlet20may10

21] NREC Letter 14th June 2010 [pdf (108kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/let14jun.pdf

Open here: let14jun

22] NREC Letter 19th July 2010 [pdf (272kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/let19july.pdf

Open here: let19july

23] Covering letter in reply to NREC 28th July 2010 [pdf (159kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/letrep28july.pdf

Open here: letrep28july

24] NREC Letter 13th August 2010 [pdf (72kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/let13aug.pdf

Open here: let13aug

25] Letter re meeting notes in reply to NREC 19th August 2010 [pdf (45kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/letmetn19aug.pdf

Open here: letmetn19aug

26] Second covering letter reply to NREC 20th August 2010 [pdf (109kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/seclet20aug10.pdf

Open here: seclet20aug10

27] Letter in reply to NREC 13th September 2010 [pdf ( 80kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/let13sep.pdf

Open here: let13sep

28] NREC Approval letter 14th September 2010 [pdf (213kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/applet14sep10.pdf

Open here: applet14sep10

29] REC Form [pdf (353kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/recfrmrfs.pdf

Open here: recfrmrfs

“Unethical” Lightning Process pilot study in children receives ethics approval

“Unethical” Lightning Process pilot study in children receives ethics approval

Shortlink: http://wp.me/p5foE-36W

Update on the Dr Esther Crawley led Royal National Hospital for Rheumatic Diseases (RNHRD) NHS FT, Bath/University of Bristol Lightning Process pilot study for children aged 8 to 18 (now 12 to 18)[1].

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

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

For joint ME charity opposition statement and press release see:

Joint Press Release and statement: ME Association and The Young ME Sufferers Trust

Source: Protocol document

“Unethical”

A pilot study on the controversial Lightning Process using children as young as eight has received the go ahead from a South West Region Research Ethics Committee (REC), despite widespread public concern and condemnation by two UK national patient organisations.

In August, ME patient charities, The ME Association and The Young ME Sufferers Trust, issued a joint press release describing the study as “unethical” and calling for it to be abandoned [2].

The organisations said:

“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 [3].

“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…

“…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.”

Today, information received from University of Bristol Information Rights Officer, Matthew Morrison, confirms that the pilot study has now been granted ethics approval. Recruitment to the study, which is being funded by the Linbury Trust and the Ashden Trust, was scheduled to start in September.

 

What has been published?

A large number of documents are published today on the University of Bristol website.

Information on accessing the research protocol and other published material can be found in the next post.

SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and  ME)

Shortlink: http://wp.me/p5foE-37x

 

Advertising Standards Authority (ASA) ruling

In June, ME agenda reported that Alastair Gibson, who had previously identified himself as one of two Lightning Process coaches involved with the NHS study, was the subject of an Advertising Standards Authority (ASA) ruling [10].

The ASA upheld a complaint about unsubstantiated claims made for the efficacy of the Lightning Process in ME and CFS in an advertisement for Mr Gibson’s “Withinspiration” company.

At least one Lightning Process company has made changes to the wording on its website following the ME Association’s discussions with Trading Standards.

Currently, the ASA’s remit does not extend to website content but from May 2011, the ASA will broaden its remit and will be able to consider complaints about:

Advertisers’ own marketing communications on their own websites and;

Marketing communications in other non-paid-for space under their control, such as social networking sites like Facebook and Twitter.

On 1 September, the Advertising Standards Authority issued a news release setting out its extended remit: 

Landmark agreement extends ASA’s digital remit (Lightning Process pilot study in children)

 

Department of Health responses

Concerns about the pilot study have been taken up with Earl Howe (Parliamentary Under-Secretary of State for Quality). Earl Howe is a Patron to The Young ME Sufferers Trust. An unsatisfactory response was received from Bill Davidson, Research Governance Manager, Department of Health, on 30 August, who responded on behalf of Earl Howe.

In July, Annette Brooke, MP, Mid Dorset & North Poole forwarded my concerns and documents to the Rt Hon Andrew Lansley MP, Secretary of State for Health, Department of Health. Paul Burstow MP, Minister of State for Care Services, responded briefly on behalf of the Secretary of State for Health, on 12 August.

Mrs Brooke is Vice-chair of the newly reformed APPG on ME (Acting chair, David Amiss, MP).

The ME Association had also written to the Department of Health requesting that their joint press release be forwarded to the ethics committee reviewing the application. The DoH refused to do so – a decision which the ME Association considered unacceptable.

The name of the South West Research Ethics Committee, which had met to review the application on 8 July, was identified on 27 August in a response to my request for information under the Freedom of Information Act. The contact details for this regional RE committee chair have been passed to the ME Association.

The South West Regional Manager for the National Research Ethics Service (NRES) confirmed to me, in May, that there is apparently no process through which REC decisions might be challenged by the public.

 

References:    

[1] Press Release, University of Bristol, 2 March 2010
Media article

[2] Joint Press Release and statement: ME Association and The Young ME Sufferers Trust

[3] MRC Guidelines Medical Research Involving Children (Nov 2004, revised Aug 2007)   

[4] Request for information under FOI and FOI Office responses  

[5] Action for M.E. article on Lightning Process, InterAction magazine, March 2007   

[6] Patient Survey 2008, Action for M.E. and AYME   

Patient Survey May 2010, ME Association  

[7] LP Doesn’t Work for ME: Personal accounts from LP “trainees”

Letter: Lightning process for ME didn’t work for me

Personal account of Lightning Process technique as applied to patient with ME

Personal account of Lightning Process as applied to patients with ME and MS  

[8] Sample Lightning Process application form

[9] ASA adjudication against “Withinspiration” 

[10] RNHRD Bath Chronic Fatigue Syndrome/ME Service for Children & Young People

[11] Lightning Process website

An open AGM and some questions for Action for M.E. (Lightning Process)

An open AGM and some questions for Action for M.E. (Lightning Process)

Shortlink: http://wp.me/p5foE-36C

On Page 4 of the Autumn issue of Action for M.E.’s InterAction magazine, CEO, Sir Peter Spencer, announces changes to the way in which the organisation operates.

Sir Peter writes, “In another significant change, inspired by your Board wishing to create greater transparency and demonstrate their accountability, our Trustees have voted to invite members to attend Action for M.E.’s annual general meeting (AGM). The first opportunity is Thursday 21 October in London and an application form for attendance is enclosed with this magazine.

“Additionally, the Board will be introducing procedures that will give all our Supporting Members voting rights regarding the appointment of Trustees and the Chair from 2011.”

How this change of policy will operate in practice remains to be seen but I would like to thank those who have lobbied long and hard for years for the right to attend AGMs, for voting rights and the right to participate in what I hope will be a democratic trustee election process.

I maintain a membership of Action for M.E. not because I support their policies or the way in which they operate but because, as a site owner, I need to know what the organisation is involving itself in and with whom, and what its policies and positions are.

There is to be a question and answer session with the board members (the Trustees/Directors) at the AGM.

Were I to attend this first open AGM, scheduled for October, I would want to raise the following:

There has been considerable public and patient group opposition to the Lightning Process pilot study for children aged 8 to 18 proposed by the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust, Bath (the “Min”) and the University of Bristol.

This pilot study, led by Dr Esther Crawley, with funding from the Linbury Trust and the Ashden Trust, is still pending approval by a South West Region Research Ethics Committee.

The application was submitted on 14 June. The REC meeting to consider the application took place on 8 July.

Although funding for the study had been secured last November and a press release published in early March, at 6 September, the study is said to be “still at the final stage of the ethics procedure”.

The ME Association and the Young ME Sufferers Trust issued a joint press release on 4 August, describing the proposed study as “unethical” and calling for it to be abandoned.

To date, no rigorous controlled trials have been undertaken using an adult patient cohort into the safety, acceptability, long and short-term effects of the application of the Lightning Process.

No rationale has been provided by the research team for piloting first with children and there has been virtually no information made available about the study design, objectives, interventions, criteria, recruitment process etc, for public scrutiny.

At the end of March, in response to a request for a position statement, Action for M.E. said it saw “no reason to oppose this pilot study.”

On 24 August, in response to a request that Action for M.E. set out what information it had used to inform its position on whether to support this study and what its understanding is of what the children in this proposed study would be exposed to, Sir Peter wrote:

“…Action for M.E. has not seen the research protocol for this proposal and has no detailed knowledge of the way in which this trial would be conducted if approved.”

They don’t know. They’ve bought into a pig in a poke.

Four days earlier, Action for M.E. had issued a second position statement in which the organisation wrote:

“As long as the ethics committee gives its approval, the charity supports proposals to investigate whether it is possible to set up a controlled trial to look at the Lightning Process and how it compares with current treatments for M.E./CFS in children.”

But how much does this South West Region REC actually know about the Lightning Process?

What information have the researchers placed before this committee?

With no robust data from RCTs into the application of Lightning Process in adults, how is the research team and the Research Ethics Committee considering this application in a position to determine that overall the likely benefits of this proposal outweigh any risks to child participants or that undergoing the training program would not be detrimental to their health and psychological well-being, as patients with ME and CFS?

So I should want to ask how Action for M.E. justifies sidestepping responsibility for safeguarding children as young as eight under these circumstances?

I’d also raise the following:

On Page 14 of this Autumn edition of InterAction, is a quarter page advertisement for the Phil Parker Lightning Process at the “Swallows Retreat”, in Henfield.

On Page 32, a quarter page ad for the “Rowan Centre” who until recently had been claiming on their website:

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”

Their advertisement reads “We offer a training programme with on-going support to help people improve their symptoms. The teaching is based on neuroscience and cell biology and shows you how to affect your immune system using techniques derived from NLP processes, brain rehearsal and brief meditation techniques.”

On Page 22, a half page ad for The Lightning Process with Alastair Gibson.

In June, Mr Gibson’s “Withinspiration” Lightning Process company had been subject to an Advertising Standards Authority adjudication following a complaint about unsubstantiated claims [1].

In March, Mr Gibson (who in September will be offering Lightning Process sessions in Bristol) had identified himself on his website as “…one of the two practitioners working with the NHS and the young people in this exciting research study”.

I am sure there will be many questions raised at this Action for M.E. open AGM next month.

I append a copy of the article “New benefits for our members” by Sir Peter Spencer.

 References

[1] ASA adjudication against “Withinspiration”, June 2010

[2] Background to this Lightning Process pilot issue

———————–

InterAction 73 Autumn 2010

New benefits for our members

Action for M.E. is transforming how it operates so that we can reach more people with M.E. and work more effectively on your behalf. Sir Peter Spencer explains.

We really do appreciate the expertise that people with M.E. share with us. Over the past three years we have greatly increased our efforts to consult so that we can better represent your views on a wide range of important matters. However, Action for M.E. can still do more to empower members to become an even stronger collective catalyst for change.

Today, the most efficient and cost-effective way of reaching more people with M.E. is through the internet. That’s why we are creating an entirely new website, the Online M.E. Centre.

As well as multi-media communication channels, new members-only forums will be available as safe havens, where people with M.E. can reach others who understand exactly what they’re going through. We know that 50% of people with M.E. are not in contact with anyone else with the illness. We have ample evidence that putting people in touch can really help them face and share the distressing problems of isolation caused by loss of social contact and not being understood by family and friends.

Membership

From September this year, anyone renewing or joining Action for M.E. for the first time will be able to choose the features and benefits they want from their membership package. You can join or renew online, by telephone or by post.

There will also be greater flexibility by giving members a personal choice about how much they feel able to contribute through their membership donation, either by a monthly direct debit or on an annual or lifelong basis. Exceptionally, those facing extreme financial hardship may be eligible for a payment waiver. The sustainability of our new membership arrangements will be made possible through the generosity of those more fortunate who are willing to give more to enable the most vulnerable to remain part of our movement; an essential point that I want to re-emphasise.

We greatly value you as members mainly for your presence and for contributing your expertise and moral support. You are much more than a vital source of revenue. The higher our numbers grow, the stronger our voice and the greater our credibility and authority in lobbying the Government for action.

Some of our supporters do not have M.E. themselves. Many of these provide extremely generous financial donations and free expertise because they care so much about those who have the illness. We need much larger numbers of all types of member and, because all members are essentially supporting our charity, we’ve adopted the term ‘Supporting Member’ to describe all categories of personal membership. Professional membership for individuals and organisations will also be available, allowing better access to relevant information about how to support people with M.E.

AGM and trustees

In another significant change, inspired by your Board wishing to create greater transparency and demonstrate their accountability, our Trustees have voted to invite members to attend Action for M.E.’s annual general meeting (AGM). The first opportunity is Thursday 21 October in London and an application form for attendance is enclosed with this magazine.

Additionally, the Board will be introducing procedures that will give all our Supporting Members voting rights regarding the appointment of Trustees and the Chair from 2011.

This is a crucial and exciting year for Action for M.E. I hope you agree that the developments I’ve described will ensure that we continue to meet your high expectations.

I know that many people with M.E. do not use the internet. So want to reassure you: Action for M.E. will of course continue to provide printed information through InterAction and our information booklets. We will also be providing enhanced telephone support line services from October.

Source: InterAction 73 Autumn 2010 http://www.afme.org.uk

Landmark agreement extends ASA’s digital remit (Lightning Process pilot study in children)

Landmark agreement extends ASA’s digital remit (Lightning Process pilot study in children)

Shortlink: http://wp.me/p5foE-35z

It is of considerable public concern that Dr Esther Crawley has sought to obtain the advice, guidance and involvement of a Lightning Process practitioner who, in June, was subject to an Advertising Standards Authority ruling in relation to claims made in an advertisement about the efficacy of the Lightning Process for CFS and ME [1].

In July, in this background posting, I reported that Bournemouth Lightning Process instructor, Alastair Gibson, had already identified himself, on the “Withinspiration website”, as “one of the two practitioners working with the NHS and the young people” in the Dr Crawley led pilot study into Lightning Process for children aged 8 to 18 [2].

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.”

That statement no longer appears on his website and it is unclear whether Mr Gibson retains an involvement with this proposed pilot study.

At 27 August, according to the University of Bristol’s FOI officer, the study had yet to obtain ethics approval. A research protocol and other information was supposed to have been published on the University of Bristol’s website by the end of August – regardless of whether the study gained approval [3].

This material has failed to appear.

The Old Bailey Online site is a fully searchable collection of 197,745 criminal trials held at London’s central criminal court:

In the 1700s, Old Bailey court reports included advertisements and this one caught my eye:

Old Bailey Proceedings, 27th February 1712

“All Melancholy, Hysterical and Hypochondriacal Distempers, which variously affect the Mind with strange Fears, and dismal Apprehensions, Paintings, and Sinkings of the Spirits, great Hurries, Restlesness and Disquietment (little understood, and seldom cured by any common Means) also Pains and Giddiness of the Head, Risings to the Throat, Sick-fits, Tremblings, Oppressions of the Heart, or any other Disorders caus’d by Vapours, are successfully cured (with God’s Blessing) by a Physician well experienc’d therein, and of more than 20 Years Practice in those deplorable Cases; who also cures all kind of Fits, tho’ strange and violent, if curable; which he informs on sight of their Water. Living next door to Shadwell Coffee-House in Upper-Shadwell, near London; where those that have occasion, and live remote, may direct their Letters, and they shall be speedily answer’d, or attended on, if desired.”

Well little changes, because in 2010, the sites of some Lightning Process practitioners are still making the following claims:

What does it work for?

“People using the Lightning Process® have also recovered from, or experienced significant improvement with the following conditions: –

“Fibromyalgia
Chronic Fatigue Syndrome
Post Viral Fatigue
Asthma
Rheumatoid Arthritis
Hayfever
Depression
Dyspraxia
Bipolar Disorder
Ocd
Anxiety And Panic Attacks
Insomnia
Cerebral Palsy
Low Self Esteem
Parkinsons Tremors
Motor Neurone Disease
Hyper And Hypo Thyroidism
Chronic Aches And Pains
Ibs
Lyme Disease
Anger Issues
Food Intolerances
Coeliac Disease
Ptsd
Candida
Allergies
Type 2 Diabetes
Interstitial Cystitis
Migraines
Noise And Light Sensitivity
And Many More”

“Using the Lightning Process® has proven effective for clearing ALL the debilitating physical and mind based symptoms of ME, chronic fatigue syndrome, and post viral syndrome.

“Some of the symptoms that people have cleared are listed here…

“Addictions, adrenal problems, allergies and intolerances, anxiety, balance problems, bloating, blurry vision, brain fog, candida, chemical sensitivity, compulsive behaviours, concentration problems, confusion, constipation, depression, diarrhoea, dizziness, electrical pulsing sensations, excessive sleeping, exhaustion, fatigue, fear, feeling detached or disconnected, fever and chills, flu-like symptoms, frequent coughs and colds, fybromyalgia, hallucinations, head pain or pressure, heartburn, indigestion, insomnia and other sleep disturbances, irritability, irritable bowel syndrome, itching and rashes, itchy eyes, joint pain, light sensitivity, loss of vision, malaise, memory loss, migraines, muscle pain, nausea, noise sensitivity, oedema, panic attacks, painful and/or swollen glands, pins and needles, restless leg syndrome, runny nose, sensitivity to electrical fields/computers/mobiles etc, shaking, shooting pains, skin sensitivity, stomach pain, sun burn sensation, swelling, temperature control problems, thrush, thyroid problems, unrefreshing sleep, vertigo and similar sensations, vomiting, water retention, watering eyes, weakness…..and probably many more

“We advise you to consult your GP, have the necessary tests and obtain a diagnosis before applying for the Lightning Process® training programme”

The Phil Parker Lightning Process website and the sites of some Lightning Process practitioners have a “FAQ” page which includes the following:

Can my doctor assess me for readiness?

“If your doctor or health care specialist is trained as a Lightning Process Practitioner then of course they can assess you for readiness to take the programme. If they are not trained in the programme they will not have the requisite skills or knowledge base about this very specialised field to assess you.

“A large part of the training for LP practitioners is to train them to appropriately assess potential trainees for their suitability for the process, as it is essential to ensure, as far as is possible, that only those who are ready to get benefits from the training program are enrolled in the training.”

So, according to Mr Parker, your doctor is not capable of assessing patients for “readiness” to undertake the Lightning Process.

How and by whom are the potential child participants in the RNHRD NHS FT Bath/University of Bristol pilot study going to be assessed for “readiness” and suitability to undertake the “training”?

We don’t know, because the University of Bristol is withholding virtually all information requested by me under Clause 22(1)(a) of the FOI Act.

 
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.

Currently, the Advertising Standards Authority’s remit does not extend to website content. But this is to change in March 2011.

The Advertising Standards Authority has issued this news release today:

Landmark agreement extends ASA’s digital remit

http://asa.org.uk/Media-Centre/2010/ASA-digital-remit-extension.aspx

1 September 2010

The digital remit of the Advertising Standards Authority (ASA) is to be extended significantly to deliver more comprehensive consumer protection online.

The ASA’s present remit online includes ads in paid-for space and sales promotions wherever they appear. But from next year, the rules in the UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing (the CAP Code) will apply in full to marketing communications online, including the rules relating to misleading advertising, social responsibility and the protection of children. The remit will apply to all sectors and all businesses and organisations regardless of size.

The Committee of Advertising Practice (CAP), the body responsible for writing the CAP Code, has decided to extend the digital remit of the ASA in response to a formal recommendation from a wide cross-section of UK industry. CAP has today published a document detailing the new remit and sanctions.

( Open PDF here: CAP Digital Remit Extension[1] )

In summary:

The new remit will ensure the same high standards as in other media and will cover:

Advertisers’ own marketing communications on their own websites and;

Marketing communications in other non-paid-for space under their control, such as social networking sites like Facebook and Twitter.

Journalistic and editorial content and material related to causes and ideas – except those that are direct solicitations of donations for fund-raising – are excluded from the remit.

Sanctions
In addition to the ASA’s present sanctions, which already achieve a high level of compliance, CAP member bodies have agreed new sanctions to apply to the extended remit such as:

Removal of paid-for search advertising – ads that link to the page hosting the non-compliant marketing communication may be removed with the agreement of the search engines.

• ASA paid-for search advertisements – the ASA could place advertisements online highlighting an advertiser’s continued non-compliance.

Funding
The industry has agreed to apply the standard 0.1% levy on paid-for advertisements appearing on internet search engines through media and search agencies. This is an extension of the existing funding mechanism in other media that pays for the ASA and it will be supplemented initially with seed capital from Google.

Implementation
The remit will come into force on 1 March 2011 after a six month period of grace to allow the ASA and CAP to conduct training work to raise awareness and educate business on the requirements of the CAP Code, particularly amongst those who may not previously have been subject to ASA regulation. Website owners and agencies are urged to sign up to CAP Services to receive guidance and training to help ensure their sites comply with the new rules
before 1 March 2011.

ASA Chairman Lord Chris Smith said, “This significant extension of the ASA’s remit has the protection of children and consumers at its heart. We have received over 4,500 complaints since 2008 about marketing communications on websites that we couldn’t deal with, but from 1 March anyone who has a concern about a marketing communication online will be able to turn to the ASA.”

CAP Chairman Andrew Brown said, “Extending the online remit of the ASA has been a top priority for UK industry  over the last couple of years. Our aim has been to extend further in the online world the principles that are already well established in our system, namely those of effective consumer protection and fair competition.”

[Ends]

[1] ASA adjudication against “Withinspiration”, June 2010:
http://www.asa.org.uk/Complaints-and-ASA-action/Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx

[2] Background to this issue:
Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)
http://wp.me/p5foE-2Vt

[3] Update on ethics approval for the Dr Esther Crawley led RNHRD NHS FT Bath/University of Bristol Lightning Process pilot study for children aged 8 to 18:
http://wp.me/p5foE-341

Update on ethics approval: Dr Esther Crawley Bath/Bristol Lightning Process pilot study for children 8 to 18

Update on ethics approval for the Dr Esther Crawley led RNHRD NHS FT Bath/University of Bristol Lightning Process pilot study for children aged 8 to 18

Shortlink: http://wp.me/p5foE-341

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

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

For joint ME charity opposition statement and press release see:

Joint Press Release and statement: ME Association and The Young ME Sufferers Trust

I was advised by the University of Bristol Director of Legal Services on 17 August that

“The Information Rights Officer has been assured by the leader of this project that the information requested will be published on the University’s website by the end of this month. The published information will include the research protocol and related material, including information about the ethics approval process.”

“May I therefore suggest that you await publication of the information and then come back to the Information Rights Officer if there are any aspects of your original request which you consider have not been fulfilled through publication.”

On 26 August, I was advised by the University’s Information Rights Officer that:

“The study is at the final stage of the ethics proposal. The information will be published regardless.”

 

On 3 August, I had submitted a request for information to the National Research Ethics Service (NRES) under the Freedom of Information Act around the application for ethics approval and application timeline.

This was fulfilled yesterday, 27 August.

I received the following responses provided by the FOI Manager, NHS South West. Responses are highlighted in blue:

27 August 2010

Royal National Hospital for Rheumatic Diseases NHS Foundation Trust and the University of Bristol

Funders: £164,000 awarded by Linbury Trust and the Ashden Trust

Lead researcher: Dr Esther Crawley, Consultant Paediatrician, Royal National Hospital for Rheumatic Diseases, Bath, Senior Lecturer, University of Bristol.

Study: Pilot project 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. Project to incorporate study on health economic cost of CFS/ME in children.

Ethics Approval:

1] Any reference numbers attached to the application for ethics approval: 10/H0206/32

2] Names of Research Ethics Committee(s) responsible for reviewing application: [A South West region Research Ethics Committee is identified]

Status of application for ethics approval:

3] Date application received: 14 June 2010

Has a Research Ethics Committee already met to consider this application? Yes

On what date did this meeting take place? 08 July 2010

Was an unfavourable ethical opinion or a favourable ethical opinion given? A decision is awaited on the ethical opinion.

If an unfavourable opinion, has the applicant re-submitted, submitted modifications or appealed, and on what date were these received? Not applicable

Were any clarifications requested? This information is exempt under Section 22 of the Act (information intended for future publication) as it will be published by the University of Bristol in the foreseeable future.

Was a modified application submitted to a different REC and if so, which REC? No

If an appeal was submitted was the application reviewed by a different REC and if so, which REC? Not applicable

What was the outcome of any re-submission, modification or appeal and on what date was the Principal Investigator/lead researcher applicant notified of the outcome? Not applicable

If a favourable opinion, on what date was the Principal Investigator/lead researcher/applicant notified? Not applicable

If the application has yet to be considered, which Research Ethics Committee is responsible for considering this application and on what date is the committee expected to meet to consider the application? Not applicable

By what date is the Principal Investigator/lead researcher/applicant expected to be notified of the opinion? This date is not yet known.

Please provide copies of applications for research ethics approval for the study, including any accompanying documentation that forms part of the application, for example, questionnaires, interview protocol.

Please provide copies of any ethical opinions already handed down, with any requests for resubmissions, modifications, requests for clarifications.

This information is exempted under Section 22 (information intended for future publication) as the University of Bristol plans to publish this information in the foreseeable future.  

I am advised that I have the right to complain about this response by reference to the complaints procedure of the South West Strategic Health Authority in which case I should write to the Chief Executive at NHS South West, South West House, Blackbrook Park Avenue, Taunton, Somerset TA1 2PX. That if I remain dissatisfied with the decision of the Authority following my complaint, I may write to the Information Commissioner, whose address is:
Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF.

 

Related information:

REC Application flowchart

 REC Application Researcher Training Pack

 FOI request 16 May 2010 to University of Bristol, fulfilled 17 June

Background to this issue

ME Association and The Young ME Sufferers Trust joint Press Release, 4 August 10

Archive for all Lightning Process posts on ME agenda

Questions for Action for M.E. (Lightning Process pilot study in children)

Questions for Action for M.E. (proposed Lightning Process pilot study in children with CFS and ME aged 8 to 18)

Shortlink: http://wp.me/p5foE-31X

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

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

For joint ME charity opposition statement and press release see:

Joint Press Release and statement: ME Association and The Young ME Sufferers Trust

Update @ 24 August

I have received a response from Sir Peter Spencer, this afternoon.

Sir Peter writes that [Action for M.E.’s] position derives from their detailed reading of the MRC Ethics Guide for medical research involving children and from their understanding of the role of any ethics committee in satisfying itself that appropriate independent arrangements are in place to ensure patient safety.

That Action for M.E. has not seen the research protocol for this proposal and has no detailed knowledge of the way in which this trial would be conducted if approved.

That [Action for M.E.] does, of course, want to see research into LP in adults too – but as children are already seeing LP practitioners, before the process has been subject to research published in respected peer-reviewed journals, [they] can see a case for investigating if it is feasible within the Ethics Guide to set up a controlled trial.

 

I have written, today, to Action for M.E. requesting clarification of what information they have relied on when formulating their position on this controversial RNHRD NHS FT, Bath/University of Bristol Lightning Process pilot study.

Action for M.E. has now issued two position statements on this proposed Lightning Process pilot study for children.

Although funding for the study had been secured last November and a press release published in early March, by 17 June, the research team were still waiting on an ethics committee decision.

According to information posted on Action for M.E.’s Facebook site on 23 August, the project’s lead researcher, Dr Esther Crawley, has apparently confirmed that the pilot is still waiting to receive ethics approval.

University of Bristol Information Rights Officer and the Director of Legal Services had already confirmed to me (on 10 and 17 August) that the project lead had given assurances that “information requested will be published on the University’s website by the end of this month” and that “the published information will include the research protocol and related material, including  information about the ethics approval process”.

It appears then that Dr Crawley is very confident her project will be approved.

The University FOI office has told me that I will be notified when the material is published. 

A request for information and documents relating to the application for approval and the approval process timeline is due for fulfilment on or before 31 August.  Information requested of the National Research Ethics Service can be read in this posting:

Freedom of Information requests: South West Strategic Health Authority and National Research Ethics Service

To: Policy Officer; Heather Walker, Communications Manager; Sir Peter Spencer, CEO

Sent: Monday, August 23, 2010 4:18 PM
Subject: Query on position statements

This is a query in relation to Action for M.E.’s two published position statements on the proposed Lightning Process pilot study for children.

It was reported, back in March, by the regional Bristol newspaper:

http://www.thisisbath.co.uk/news/Money-Min-children-s-study/article-1885785-detail/article.html

“Money for Min children’s study
Thursday, March 04, 2010, 15:29

“A project looking into a chronic childhood condition has been given a £164,000 boost.

[…]

“The team will be carrying out a three-day trial using the Phil Parker Lightning Process, which is designed to teach people a new set of techniques for improving life and health.

“The system is derived from osteopathy, neuro-linguistic programming and life coaching.

“Its creator, osteopath Phil Parker said: “We are thrilled to have the opportunity to collaborate on this exciting and groundbreaking research with Dr Crawley and her team.”

———

As you are aware, the University of Bristol’s FOI office is withholding virtually all information and documents under FOIA Clause 22(1)(a). Some limited documents relating to the funders have been made available.

When the University of Bristol issued its press release published on 2 March 2010 announcing the Lightning Process pilot study, the study had not, at that point, obtained ethics approval.

At 17 June, the University FOI Office confirmed that the study was still going through the ethics approval procedure and that information requested was expected to be published around August/September 2010.

I am recently advised by the FOI Office that Dr Crawley has assured them that information around the study and the research protocol is now planned to be published by the end of August. It is unconfirmed, but this suggests that the study may now have received approval.

So there is very little information in the public domain about the study design and methods.

The only information that is currently publicly available is:

1] The press release announcing the study on 2 March:
http://www.rnhrd.nhs.uk/index_sub_menus/news/documents/FINALRNHRDCFS_ME_fundingfeb10.pdf

2] The media article in “This is Bath” (URL above).

3] An article in the May issue of AYME’s Link Newsletter (a copy can be provided but no URL).

4] The information that Alastair Gibson is one of two LP practitioners involved with the NHS study (was on his website in March but has since been removed).

The “This is Bath” article states:

“The team will be carrying out a three-day trial using the Phil Parker Lightning Process, which is designed to teach people a new set of techniques for improving life and health.”

In five months, this has not been corrected by the lead researcher if this information is misleading.

The press release states that the primary outcome measure will be “school attendance after six-months”.

It seems unlikely, then, that the pilot participants and their families are going to be subjected solely to the application of “in-depth interviews”.

To date, there is virtually no information in the public domain about the proposed study design and methods and the research protocol is not expected to be published until the end of this month.

a) What is Action for M.E.’s understanding of what will be applied to the children during the life of the pilot study and by whom?

Where has it obtained the information on which it has based its decision to support this pilot study and to support any decision by the ethics committee(s) to grant a “favourable opinion”, ie, to approve the application?

b) Would Action for M.E. please set out what information it has relied upon in order to inform its position on this pilot and whether the organisation has made any approaches to the researchers or to any other body to obtain information about the proposed study over and above the press release, and what was the outcome of any approaches made?

Sincerely,

Suzy Chapman
_____________________

http://dxrevisionwatch.wordpress.com
https://meagenda.wordpress.com
http://twitter.com/MEagenda
http://www.facebook.com/MEagenda

Action for M.E. and Lightning Process research on children – An opinion: Peter Kemp

Action for M.E. and Lightning Process research on children – An opinion: Peter Kemp

Shortlink: http://wp.me/p5foE-31S

From Peter Kemp

21 August 2010

AfME stated on their facebook page (http://wp.me/p5foE-31M ) on 20th August, 2010:

“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.”

This gobbledegook does not explain or justify AfME’s support for LP experimentation on children.

Are the children in some kind of danger as AfME’s statement implies? If so then LP practitioners should urgently be prevented from tampering with the vulnerable minds of sick children until LP is properly researched. But this does not appear to be AfME’s intention.

Or are AfME suggesting that because some children are already LP subjects this somehow makes it ok to experiment with LP on children in formal research?

If ethics theorists took this approach then codes and guidelines intended to protect children might simply say – ‘if the parents think it’s ok, then children can be experimented on’.

Guidelines don’t say that. They say that adults should always be experimented on first if it is possible to do so. With LP it is perfectly feasible to try it on adults first, “in order to assure the safety of those children”.

AfME seem to be resting on a cop-out to justify their support of experimenting on children’s minds:

“Before any research is approved, an ethics committee scrutinises the proposals to ensure that the rules about research involving children are satisfied. The committee also ensures that proper safety systems are in place and include safety monitoring by an independent committee.”

Ethics is an evolving area of human values. Almost no ethical statement, code or guideline survives more than a few years before weaknesses are found that must be addressed with updated versions. To take a position similar to – ‘if an ethics committee says it’s ok then we agree’ – is capitulating all responsibility to defend the rights and interests of children with M.E. The only thing that any ethics committee can be relied upon to do, is to try and figure out if a particular research project is safe and legal within the limits of current knowledge and human frailty.

AfME are supposed to be an ‘M.E.’ charity. Are they unaware that many people, including many doctors, do not understand M.E.?

Ethics committees are comprised of people who might have no more knowledge of the seriousness of M.E. than those who believe M.E. is simply ‘fatigue’. I can easily envisage an ethics committee approving LP research because of such misconceptions.

If AfME believed, as do others, that M.E. is a serious neurological/immunological illness I think they would join with the credible M.E. patient organizations and individuals who are opposed to children being experimented on with LP. Adults can make their own informed choice – so experiment on them first.

Peter Kemp

Action for M.E. issues second position statement on Lightning Process pilot in children 8 to 18

Action for M.E. issues second position statement on Lightning Process pilot in children 8 to 18

Shortlink: http://wp.me/p5foE-31M

Action for M.E. Second position statement

20 August 2010

Issued via Action for M.E. Facebook Wall

Action for M.E. is very concerned that the Lightning Process is being given to children in the UK without having been formally evaluated for effectiveness and safety.

Although the MRC ethics guide says that research involving children should only be carried out if it cannot feasibly be carried out on adults, there are exceptions eg. studies which aim to increase understanding of child health or shed light on a disease, its natural history and possibilities of prevention.

Before any research is approved, an ethics committee scrutinises the proposals to ensure that the rules about research involving children are satisfied. The committee also ensures that proper safety systems are in place and include safety monitoring by an independent committee.

As long as the ethics committee gives its approval, the charity supports proposals to investigate whether it is possible to set up a controlled trial to look at the Lightning Process and how it compares with current treatments for M.E./CFS in children.

Dr Esther Crawley is a Consultant Paediatrician specialising in CFS/M.E. and a leading researcher in the field. Together with Dr Margaret May and Dr Alan Emond, Dr Crawley has recently published new research on phenotypes of CFS/M.E. in children in the journal Archives of Disease in Childhood.

They showed that there appear to be three different phenotypes: musculoskeletal (the main symptoms being muscle and joint pain), migraine and sore throat. None of the phenotypes were associated with age or length of illness suggesting that they did not merely reflect deconditioning. The lack of association with symptoms of depression or anxiety (with the exception of the migraine phenotype) also suggests that they are unlikely to reflect mood disorders.

At the end of March, Action for M.E.* had 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, NHS Foundation Trust – Dr Esther Crawley’s employer.

25% ME Group position statement on Lightning Process pilot study in children 8 to 18

25% ME Group position statement on Lightning Process pilot study in children 8 to 18

Shortlink: http://wp.me/p5foE-31F

Today, the 25% ME Group has issued a position statement on the Dr Esther Crawley led RNHRD NHS FT Bath / University of Bristol proposed pilot study into the feasibility of recruiting to a randomised controlled trial (RCT)comparing the Lightning Process with specialist medical care.

The Medical Advisors to the 25% ME Group are Dr Byron Hyde (Canada) and former UK NHS paediatrician, Dr Nigel Speight.

Whilst I welcome the issuing of this statement, it should be noted that the press release announcing the pilot study was issued over five and a half months ago.

According to information provided by University of Bristol Information Rights Officer and their Director of Legal Sevices, information on the study and the research protocol is anticipated to be published on the University of Bristol website by the end of this month. 

This suggests that ethics approval for the pilot study may now have been obtained.

It is not known whether the 25% ME Group has or intends to make representations to any individual, institutions, organisations or bodies.

The document is heavily formatted and I will be posting a copy of the text, later.  In the meantime a Word version of the group’s statement can be opened here:

25% ME Group LP Research Position Statement 20.08.10