Church Times letters, 26 November 2010 – Dr Esther Crawley responds to Professor Robin Gill

November 30, 2010

From the Church Times letters page, 26 November 2010

Original letter by Professor Robin Gill

Professor Gill's article on the SMILE study

From Dr Esther Crawley

Sir, — On 8 October, you published an article about a feasibility randomised controlled trial investigating interventions for CFS/ME in teenagers — the SMILE study. This article appeared two weeks after all study documentation was made publicly available, and we are disappointed that the author, Professor Robin Gill, made no attempt to contact the study team to verify his assertions before publication, particularly given the nature and strength of the assertions made.

We agree with Professor Gill that there is limited evidence on the effectiveness of the Lightning Process in treating CFS/ME. Despite this, approximately 250 children a year pay for and attend Lightning Process interventions. It is precisely for this reason that we listened to children and their families who have asked for improved evidence, and are conducting research that will enable them to make informed decisions about their care.

The SMILE project is not “comparing the effectiveness of the Lightning Process with that of conventional medical care”. Participants in this study will receive either specialist medical care or specialist medical care plus the Lightning Process. The purpose of the study is to assess the feasibility of recruitment to a full trial — it is not designed to compare outcomes of care.

In this article, Professor Gill argues that children or non-competent adults should be involved only when competent and consenting adults have been fully tested first or where this is impossible, and he quotes from the guidance issued by the Medical Research Council (MRC) and the General Medical Council (GMC). There are, however, other quotations he could have selected, such as the MRC’s lengthy advice about when research into medical care for children is important (pages 7-8) and ethical (page 13), and similar statements from the GMC.

Our protocol makes it clear that CFS/ME in children is not sufficiently close to CFS/ME in adults to mean that research in adults could be extrapolated to children. The Royal College of Paediatrics and Child Health states: “Research involving children is important for the benefit of all children and should be supported, encouraged and conducted in an ethical manner.”

Professor Gill ends by stating: “The coercion of children is not an ethically acceptable option.” We absolutely agree with this, and deeply resent the implication that our study involves such coercion. This view was encouraged by the cartoon used to illustrate the article, which we find abhorrent and unacceptable.

All the children and families participating in the SMILE study provide fully informed consent/assent by means of a rigorous, recorded procedure that has been reviewed and given a favourable opinion by a research ethics committee. No child is coerced to join the study, and participants can withdraw at any time.

on behalf of the SMILE Study Group
School of Social and Community Medicine
University of Bristol
Hampton House
Cotham Hill
Bristol BS6 6JS

The Editor apologises for any offence caused by the cartoon, and for any misrepresentation of the research it might have suggested.

3 thoughts on “Church Times letters, 26 November 2010 – Dr Esther Crawley responds to Professor Robin Gill”

  1. I got ME as a child, there is no difference now that I am an adult. So how does the need for research involving children take precedence? And how can anyone taking part in this experiment be able to provide informed consent if they do not know the dangers of the Lightning Process, if it has never been tested on adults. Simply you are putting your children at risk if you agree to this experiment. Instead you should insist on adults first, and before that biomedical research funding.

    How can Crawley work with those who claim that the Lightning process has an affect on XMRV? Because that is what Phil Parker says.

  2. “Our protocol makes it clear that CFS/ME in children is not sufficiently close to CFS/ME in adults to mean that research in adults could be extrapolated to children.”

    Their protocol?

    How about ‘x-study has shown’? Some vague undisclosed protocol has no place being used as a factual citation.

    It’s amusing how they get angry and yet complete neglect substance.

  3. As a person with ME since 1986, now 80% recovered thanks to systematic and determined energy conservation; also qualified in NLP since 1990, and a UKCP-Accredited NLPt psychotherapist for the past 20 years, I am in a strong position to comment on this. The fundamental diagnostic criteria for ME is post-exertional malaise – muscular exertion (and cognitive exertion) makes it worse. Complete rest, followed by adapting ones life-style to conserve exertion gives the best prognosis (I was back at work, full-time, while still very ill, thanks to use of volunteer drivers/wheelchair pushers, always keeping my head supported, learning to write reports on a PC while lying down with the keyboard on my lap, spending days in bed arranging meetings by phone, and having a job that consisted of attending meetings and writing reports, allowing me to work from home to my own timescale.) NLP was useful – for example, as my father had died of a heart attack, and I shared his Type A drive, I coded having to lie down for five years as a preventative of early death from a heart attack. I coded people who thought I was just pretending as people to keep out of my life. I coded the embarrassment of having to sit down and lean against a wall if someone was keeping me standing as their problem, not mine. But – NLP used as it is in the Lightning Process – urging people not to believe they are ill, and to keep exercising even when they are suffering – puts it in the same class as CBT/GET, and will result in harm. Let me use the analogy of how I used to feel when going swimming – the endorphin high from using muscles encouraged me to keep on beyond what I should have. I would feel great – but always got sick in the next few days. A year or so ago I listened to advice from my chiropracter to start riding my bike. I rode my bike to work for a couple of weeks – really pleased, felt marvellous. This was followed by my becoming more ill than I had been for years, and taking months to recover to my former level. NLP can be very powerful in lifting mood, feeling positive, believing you can move the earth – so people will feel very positive about it, do things they thought they couldn’t do – be recorded as recovering – but weeks or months on, they are very likely to suffer a severe relapse, possibly long-term or permanent. So it really is dangerous.
    The approach to exercise taken by the people at Workwell is much more sophisticated, involving resting up to the point where minimal exercise is not harmful, carefully monitoring the patient’s state to ensure that exertion stays within the level that would cause exacerbation. (Davenport TE, S. S. (2014, January). Conceptual Model for Physical Therapist Management of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis. Physical Therapy, 602-614.) If such careful monitoring is not available, Jason et al (Jason LA, B. M.-H. (2013, January 14). Energy conservation/envelope theory interventions. Fatigue: Biomedicine, Health & Behavior, 1(1-2), 27-42.) have done research indicating that patients who consistently keep their activity levels below their perceived energy levels do improve. NLP can help if patients can learn to code ‘resting’ as ‘a weapon in the fight to get better’, use of a wheelchair and other aids as ‘tools’ for getting better, and limits on physical activity as ‘opportunities to learn skills such as relaxation and meditation’. But patients should NEVER be advised to ignore their symptoms and persist in exertion when it is making them feel terrible, that is a formula for descending into more extreme levels of this illness. Lost Voices from a hidden illness, (Invest in ME. (2010). Lost Voices from a hidden illness (2nd Edition ed.). (N. Boulton, Ed.) Wild Conversations Press), the narratives of people severely ill, includes many accounts of moderate levels of illness becoming severe following this ‘pushing past’, whether because of personal determination, or as a result of adhering to a program of GET.
    In sum, I agree with those who believe that this particular research program may, and is likely to result in harm to the participants.

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