Letter to SW2 Ethics Committee October 2010

9th Oct 2010

FAO Mr. Richard Ashby, Chair, South-West 2 Research Ethics Committee

Dear Mr. Ashby,

Re: Dr. Crawley’s Study of the Lightning Process with Children with CFS/ME

“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.”

I am writing with reference to the study of the Lightning Process with children and young people with CFS/ME. My concern is that approval was granted by the ethics committee on the basis of substantive omissions of fact and information in the study proposal concerning The Lightning Process itself and the premise on which it is based, and also concerning research evidence relating to the pathology of the illness that the children to be recruited to the study suffer from. My concern is that the ethics committee would not have had all the evidence available to it at the time to be able to come to an informed decision regarding ethics approval for this study.

1. ME/CFS

Myalgic Encephalomyeltis (ME) is classified as a disease of the nervous system (neurological) and can be found at WHO ICD-10 G.93.3 as Post-Viral Fatigue Syndrome (PVFS): Benign Myalgic Encephalomyelitis. Chronic Fatigue Syndrome was a term invented in the 1980s to describe a cluster of symptoms for which there was no identifiable cause. This term was then used interchangeably with ME, so to avoid confusion, the WHO annexed CFS to PVFS:ME in 2004, so that CFS is also classified as a neurological condition. As a member of WHO, the UK government is in full agreement with this classification, which can be verified by the Department of Health.

2. REASONS GIVEN FOR WHY THE STUDY SHOULD BE CONDUCTED

The most obvious objection to the study is that any research should not be carried out with children if it can feasibly be conducted with adults first, and that the reason given for why ethics approval should be granted in this case was not based on a balanced evaluation of the empirical evidence. Dr. Crawley stated in her application for ethics approval that,

“CFS/ME is different in children and adults with different risk factors, course and outcome. It is therefore not possible to complete a study in adults and extrapolate the results to children. At the moment, over 250 children currently use the Lightning Process as an intervention for CFS/ME. It is important to evaluate this intervention in children.”

All the biomedical research carried out to date shows the pathology of ME/CFS to be the same in adults as in children. The most recent example of this is UK research published in September 2010 that shows evidence of persistent viral infection in children with M.E, which is consistent with the same results found in adults with ME in 2005. It is my belief that this evidence was not available to the ethics committee at the time of its decision.

Biochemical and Vascular Aspects of Paediatric Chronic Fatigue Syndrome:
http://bit.ly/1QBdBoG

As these recent research findings post-date Dr. Crawley’s original application for ethics approval for this study, presumably they would not have been available as evidence of potential risks and harm to the children concerned. I accept that these findings may be contrary to Dr. Crawley’s own ideas about ME/CFS, and that they are contrary to the hypothesis on which the Lightning Process is based, but I believe that to ignore the body of existing biomedical research evidence as well as this new and emerging research is an unacceptable omission of relevant facts that presents a one-sided approach to the management of this condition in children, and that to embark upon a programme that is not a medical treatment, and has yet to be trialled with adults, is unethical.

“There are currently no reported studies investigating the effectiveness or side effects of the Lightning Process in children. As with all interventions, proper evaluation is necessary if it is to brought into mainstream practice”
The use of the word “if” strongly implies that it IS intended to be brought into mainstream practice and that the aim of this study is to achieve that end. It is extraordinary that Dr. Crawley should feel that proper evaluation of what is in effect, a life-coaching programme, takes higher priority than evaluating the use of prescription medications or specific supplements, therapies or techniques that have been tried and tested for symptom management, immune support and so on, or why it should take priority over biomedical research into the pathology of the illness that could lead to a cure.

Contrary to engaging in a study of that product on children, Dr. Crawley and the charity to which she is medical adviser (AYME) should be advising parents against trying out the programme on their children until biomedical research supports the hypothesis on which it is based, and until a suitable controlled trial has been conducted on adults.

3. POTENTIAL RISKS

“For all studies, describe any potential adverse effects, pain, discomfort, distress, intrusion, inconvenience or changes to lifestyle. Only describe risks or burdens that could occur as a result of participation in the research. Say what steps would be taken to minimise risks and burdens as far as possible.” Dr. Crawley states: “We do not believe there are any risks of being part of this study.”

This is described as a feasibility study but in reality, the children and young people recruited will undergo the 3 day training programme. Alastair Gibson is not medically qualified and The Lightning Process is not a medical treatment nor even a therapy. It is a product, in the form of a training programme, designed to train children to ignore their symptoms and to deny that they are ill.

Given that ME/CFS is a neurological condition and that the symptoms of ME/CFS (if correctly diagnosed) are organic, not psychosomatic, and that symptoms are signals by the body that something is wrong, it makes sense that telling children to ignore and deny their symptoms is a totally unethical and potentially dangerous thing to do. In addition, given the emerging biomedical research on children and adults with ME/CFS, training children to ignore their symptoms and pushing through, even when one feels unwell, as they are trained to do on the Lightning Process, is a very unsafe thing to advise until the pathology of this disease is fully understood.

Moreover, the emphasis in the information about The Lightning Process that the success of the programme is up to the participant may well cause a child mental harm in the form of feelings of failure, guilt, of letting their parents down and of dismay that they are not recovered as promised and so on and I believe this to be unethical.

While Dr. Crawley is excluding severely ill children from this study, she is recruiting children at the point of assessment. This is a condition that is known to be variable (and relapsing and remitting) with risk of deterioration or relapse if the patient over-stretches themselves in the early stages, which they may well do with the Lightning Process, and the potential for deterioration in the child’s condition is not worth the risk, so to do so is surely unethical.

Presumably, Dr. Crawley’s belief that the study present no risks to the participants is based on her unsubstantiated and contentious belief that ME/CFS presents differently in adults than in children, as the risks to adults who have paid to undertake the Lightning Process are well-known among the ME charities and people with ME themselves.

There is also a good deal of adverse personal experience of The Lightning Process by people, including children, with ME reported on the internet and elsewhere. This is a highly controversial training programme and I feel this should have been disclosed in the study proposal. It is surprising and alarming that, as a leading paediatrician in this specialist field, Dr. Crawley is unaware of the potential risks of the Lightning Process, given that she is about to trial it with vulnerable children.

“A6-2 “CONSENT – The research nurses will explain the study design, the uncertainties about intervention, the known advantages/disadvantages of the interventions, the options available outside the RCT ..”
What are these known advantages/disadvantages? They are not specified and information given by Alastair Gibson about the Lightning Process gives no indication of any disadvantages.

4. RECRUITMENT OF SUBJECTS TO 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.”

I believe it to be unethical to recruit children for participation in such a controversial programme at the point of initial assessment of ME/CFS, prior to any opportunity for the parents or the young people themselves to research ME/CFS itself or to make an informed decision about whether to participate or allow their children to participate in the study.

5. OUTCOME MEASURES

“A57. What is the primary outcome measure for the study?
The feasibility and acceptability of doing an RCT will be assessed using the percentage recruited of those eligible for recruitment and the percentage who complete each intervention out of those randomised to each arm.”

This feasibility study is obviously designed for a positive result. If the participants are to be recruited at the point of assessment, before parents or young people have had a chance to absorb the implications of diagnosis, or research either the illness or the Lightning Process properly, then the percentage recruited is likely to be high, as it is being offered by a specialist doctor at a specialist clinic and, if the programme takes only 3 days, of course it is highly likely to be completed.

“A58. What are the secondary outcome measures?(if any)
1. The primary outcome from the interventions will be school attendance at 6 months
2. Secondary outcome measures for the interventions will be school attendance at 6 weeks, 3 months and 12 months;
the SF36 (physical function) at 6 weeks, 3 months, 6 months and 12 months and pain visual analogue scale at 6 months.”

“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”.

“A.11 (secondary research objectives) ..1. Investigate appropriate patient reported outcome measures for the RCT including evaluating existing measures of school attendance, mood, fatigue and function”

As ME/CFS is a physical (neurological) disease, these outcomes should include objective biomedical assessments. School attendance should not be used as an outcome measure for illness or disability as it is, of course, possible for children to attend school if they are either ill or disabled to varying degrees. Surely, school attendance is a social outcome measure, and not necessarily an indicator of health. Moreover, the prognosis for recovery from ME/CFS is improved if the patient is allowed complete rest in the early stages of illness onset. How can this occur if early return to school is to be used as an outcome measure for these newly-diagnosed children? Why the emphasis on mood and fatigue when children with ME have medical problems that require proper investigation and medical intervention?

6. TREATMENTS FOR CHILDREN WITH ME/CFS

A.12 “there is a limited evidence base for the treatment for children with CFS/ME”

This is because services for children with ME/CFS are wrongly placed under the auspices of mental health and are offered cognitive behaviour therapy (CBT) and graded exercise therapy (GET) as, what Dr. Crawley describes as “specialist medical intervention”. Given that ME/CFS is the same disease as that contracted by adults, and given that CBT and GET have been shown to be ineffective as interventions for adults with ME/CFS (FINE trial) and given that the MRC has funded no biomedical research into the disease in adults, let alone children, this limited evidence base is unsurprising and is no justification for trialling yet another non-medical intervention on children.

“RISKS BURDENS AND BENEFITS ….. we do no know whether one treatment is better than another for this patient cohort”

The Lightning Process is NOT a treatment. Alastair Gibson states on his website that The Lightning Process addresses the underlying cause of ME. As the cause for the ongoing symptoms of ME/CFS remains as yet unknown or unconfirmed, this is an unsubstantiated hypothesis and so surely it is unethical to trial this programme with children before it has been tested on adults.

7. MONITORING OF THE STUDY
“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.”
Dr. Crawley leads the CFS/ME paediatric service and the Chief Executive of the charity to which she is medical adviser, AYME, will be on the External Advisory Group, so the independence of this monitoring and review process is highly questionable.

8. THE ADVERTISING STANDARDS AUTHORITY ADJUDICATION ON ALASTAIR GIBSON’S ADVERTISING OF THE PHIL PARKER LIGHTNING PROCESS

“In addition to the specialist Medical Care detailed above, young people and their parents will be asked to read the information about the Lightning Process on the website or using information sheets.”

Children in the study and their parents are advised to read the Lightning Process website, which means they will be exposed to content that is misleading through a number of unsubstantiated claims, significant omissions of fact, and statements that are factually incorrect, and is thereby inappropriate and offensive to anyone who genuinely sick and disabled by ME/CFS.

I wonder whether the Ethics Committee was aware that The Advertising Standards Authority ruled in June 2010 that a sponsored link to Alastair Gibson’s Withinspiration website should be removed. The ASA stated:

“We were concerned that Withinspiration did not hold robust evidence to support their claims that the lightning process was an effective treatment for CFS or ME. We therefore reminded them of their obligations under the CAP Code to hold appropriate evidence to substantiate claims prior to publication. Because we had not seen any evidence to demonstrate the efficacy of the lightning process for treating the advertised conditions, we concluded that the claims had not been proven and were therefore misleading. The ad must not appear again in its current form. We told Withinspiration to ensure they held substantiation before making similar efficacy claims for the lightning process. The ad breached CAP Code clauses 3.1 (Substantiation), and 50.1 (Health and beauty products and therapies).”

The full ASA Adjudication on Withinspiration:
http://www.asa.org.uk/Complaints-and-ASAaction/
Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx

Website content currently falls outside the remit of the ASA but their remit has been extended with effect from 1st March, by which time, Alastair Gibson’s website will be in breach of several CAP codes. Additionally, Alastair Gibson is breaching Office of Fair Trading guidance by falsely claiming that his product is able to cure illnesses and dysfunction (ME/CFS).

9. MIS-LEADING INFORMATION FOR PARENTS AND YOUNG PEOPLE ABOUT THE LIGHTNING PROCESS AND ME/CFS

I wonder if the Ethics Committee read Alastair Gibson’s website, “Withinspiration”, and his advertising of The Lightning Process.

www.withinspiration.co.uk

Alastair Gibson is offering, The Lightning Process training programme, to children with a serious neurological condition without being medically qualified to do so. He is basing his rationale for the efficacy of his product on erroneous claims about the cause of the medical condition; claiming that a scientific researcher endorses his product without providing evidence of this, and omitting to cite any of the large body of research that supports alternative hypotheses about the cause of the medical condition. In spite of stating on the website that, “ME/CFS ME is a genuine physical illness with disturbances of the immunological, endocrinal and neurological systems”, every other reference to ME/CFS on the site links it with psychological problems and life-style issues. As sales advertising, it is also mis-leading, making unsubstantiated claims about the efficacy of The Lightning Process.

This combines to give grossly misleading and distorted information about ME/CFS and about The Lightning Process that is likely to affect the parents’ or young person’s agreement to participate in the trial, as they cannot be expected to analyse a large body of scientific evidence, and will trust the information on Alastair Gibson’s website as he is working with their CFS/ME specialist, Dr. Crawley. This is surely unethical.

10. Further examples of unsubstantiated and exaggerated claims for the Lightning Process and misinformation about ME/CFS on Alastair Gibson’s website that is likely to influence parents’ and young peoples’ decision to participate in the study may be found in the attached pdf file.

Thank-you for your consideration of these very serious concerns. I hope that the above information would have led the Ethics Committee to reach a different decision.

I look forward to your reply.

Yours sincerely,

(Patient Advocate)

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