NHS pilot study looking at the feasibility of recruiting children 8 to 18 into an RCT comparing the Lightning Process and specialist medical care (Poll Closed)

  • Yes, I consider this ethical
    15.13%
    51 votes

     
  • No, I do not consider this ethical
    84.57%
    285 votes

     
  • No opinion either way
    0%
    0 votes

     
  • Don't ask me, I'm an ME charity
    0.3%
    1 vote

     

Posted 9 years.

30 Comments

  • Suzy Chapman - 9 years ago

    @ Pat Did your contact say who investigated their concerns and what the outcome was? Or did they seek a legal opinion? They are welcome to contact me via my website Contact form.

  • Pat - 9 years ago

    I got an e-mail today from somebody in Spain who said they got LP investigated and it satisfied the criteria as a sect for which one could be charged in court (manipulation, financial embezlment, use of hypnosis without patient's permission, etc). I don't think one should be allowed brainwash children.

  • cyndy - 9 years ago

    We avoided the Lightning Process for a long while because of all of the negative comments we read on ME web sites. My daughter had confirmed diagnosed ME. She was ill in hospital unable to do anything for herself. We finally read one positive comment about LP and two and a half years ago we took a chance and arranged for her to do the three days training. Thank goodness we did. Life is so very very different now.

  • Lisa - 9 years ago

    If ME CFS proves to be a virus (in every case) I wonder how many ME/CFS viral people will chose the lightning process to fix their internal cellular structure. If you watch new ME trailers -after XMRV exposed - none of the psychobabblers were willing to comment. Now that would be great if the process can cure a virus. I'll stick with what I know about RNA and DNA .

    You may feel better because you have acceptance of your condition -I mean after all isn't that better than being half dead and completely ignored? Would the process work to cure a virus? Falsely maybe. Prolong needing treatment. It is gloomier to not have the means to cure yourself but the sideshow might do that for you? The risk is not worth it- just a diversion to make people not panic. I find it hilarious to put people with this in school in 6 mths. is that the goal of the therapist and do they have school age children who might share a classroom with these CURED children. I hear everyday how ME/CFS people just need to push harder. You are wrong. My kids a fighter and I hope that everyone reading this will just have half of his strength. Experiment on someone who can give consent. Graded exercise-did that caused my son's newly acquired heart problem? Please exercise with caution-the people cheering you on NOW probably won't be there when you confront them for having you partake in experimental science that worsened your condition.

  • Lisa Baldwin - 9 years ago

    We all want our children better - sometimes we will do anything to help them. www.bringingryanhome.com is about when the ENTIRE establishment gets it wrong. Let me know if once this process causes a heart condition who is going to be liable. Get a life people. Are you the parent of a sick child - don't really belive they are sick? Shame on you - We have a similar program for RSD in US . They force you to exercise until you overcome your issues. If I had subjected my son to that- no matter how much I wanted him better - he'd be dead today. Maybe a better educational tool would be educating the public so that parents don't feel the brunt of the blame when their children are sick-with underfunded conditions that deserve better medical research . It's not rocket science. If your kid is back in school in 6 mths- he doesn't have ME/CFS anyway-at least not the severity . I am sure many kids are misdiagnosed but I wouldn't want to have to play doctor and decide and if you are the parent behind this therapy I believe you also believe that we can cure AIDS with talk/exercise therapy. Please learn something from our experience. Ryan's mom.

  • Suzy Chapman - 9 years ago

    @ Lyn Please see:

    http://wp.me/p5foE-2Vt
    http://wp.me/p5foE-2XC
    http://wp.me/p5foE-2Yy

    Also ME Joint Press Release and statement issued today by the ME Association and The Young ME Sufferers Trust:
    http://wp.me/p5foE-2YW

  • lyn - 9 years ago

    All these negative comments about LP is so sad, I know of a delightful young women of 24 who suffered from ME from the age of 7, she heard of LP a few years ago but was put off the process at that time by the various ME associations and then last year she decided she would take the 3 day course, she is now well, has her own business and enjoying life.

    What she is upset about is that she didn't have a child hood, she doesn't know what its like to be a teenager, and whilst LP was not around when she was 7 its was when she was 14, but what is more important is that it is available now, so many many kids have already benefited from LP why should we say to others "you have to stay ill until there is a pill to get you well" why can't we give all these kids a childhood and allow them to be teenagers.

    As for the ridiculous comments about LP being a cult, I thought with a cult you were hooked into it for ever, and you were not encouraged to enjoy your life any way you wanted too. What is it that some of theses people that have written negative comments are afraid of? are they ill themselves and for what ever reason need to stay that way. As I mentioned at the beginning of this comment it really saddens me.

    Why is the NHS doing this research, its simple to many people both children and adults have completely recovered using LP they just can't ignore the results any longer.

  • Suzy Chapman - 9 years ago

    Having reached over 300 votes, I closed the Poll yesterday, but the comment facility remains accessible. Thank you to everyone who took the time to register their opinion. There is no premoderation of comments and commenters are responsible for the content of their comments. If your comment does not appear immediately, please check that all required fields are completed or try again. I have no control over the formatting of comments, so please be aware that no paragraph spacing is retained.

  • Suzy Chapman - 9 years ago

    General Medical Council. 0-18 years: guidance for all doctors
    http://www.gmc-uk.org/static/documents/content/GMC_0-18_0911.pdf

    Department of Health, Research Governance Framework for Health and Social Care
    http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4108962

    Research Governance Framework for Health and Social Care Second edition, 2005 - Annex

    Royal College of Paediatrics and Child Health: Ethics Advisory Committee
    http://www.rcpch.ac.uk/doc.aspx?id_Resource=2222

    http://www.mrc.ac.uk/consumption/idcplg?IdcService=GET_FILE&dID=11512&dDocName=MRC002430&allowInterrupt=1
    Medical Research Council MRC Ethics Guide 2004, Medical research involving children
    (revised on the 24 August 2007)

  • v99 - 9 years ago

    The LP process has never been tested. The 85% is therefore no better than a rumor. It is not a drug, but it needs to have the same rules appplied to it that a drug would receive, after all it can be just as dangerous. Especially when you apply such a therapy without measuring the effect on the patients biology. Testing this on children is ethically wrong, there is no other way to look at it. It would be tantamount to child abuse to let this study proceed.

    As for everyone having the same disease, they of course do not. CFS is not one disease.

  • Chris - 9 years ago

    So, 51 people think that this is ethical (contrary to universal medic ethics) and there are several very well scripted supportive comments, in contrast to those who appear to be struggling cognitively, probably because they have ME, and who see the dangers in trialling this 'talk therapy' on children with a neuroimmune disease (some because they have tried it themselves and been made worse by it). Either 51 people clicked the wrong button or they have lost their moral compass. Or they are simply LP 'trolls'. Or all three. I was going to explain, medically, how the LP's pushing of people past their physical limits is particularly dangerous to young people. But I don't suppose the LP zealots want to know about US empirical evidence going back 15 years that demonstrates the permament cardiomyopathic damage caused to children with ME just by making them stand. Or the prosecution in the US of a guardian who forced a highly orthostatically intolerant teenager to climb stairs and subsequently collapse with heart failure. I don't need to explain this to those who do have concerns about this trial because they're the ones who probably live with this phenomenon every day, either in themselves or in their children, and whose common sense tells them that ignoring the body's signals will damage it further. The LP tells people that they are 'doing ME' rather than 'having ME'. Perhaps those who 'do ME' can be helped by the LP. But if one child who 'has ME' (i.e. a neuroimmune disease which is increasingly being linked to a retrovirus) develops a sub-endocardial MI as a result of this trial, then it will not only have been unethical but negligent and immoral.

  • polly - 9 years ago

    Hmm 85% Sucess rate hey would you like to give a link to the study which has produced those figures ? Oh thats the problem there hasnt been a study has there .Anyone can pluck a figure out of thin air but without legitimate study to back it up it is worthless.

    If any study should be done , it should be done on adults first not children , thats the whole point of this debate . I very much doubt that an independently run research program would produce a 85% sucess rate .

    Why do you think the Advertising Standards Authority recently ruled that an advertisement in an internet sponsored link containing claims of its effectiveness by a Lightning Process practitioner should be removed.

  • John Garcia - 9 years ago

    It is highly unethical to use this kind of psycho-babble on any child, let alone a sick child. Adults who attend LP meetings are told that if they do not get better it is their own fault! Imagine the psychological devastation this could wreak on a child's mental health if they are brainwashed into believing that their illness is their *own* fault. These people are criminal and should be prosecuted for peddling such dangerous snake-oil. Where are the laws protecting the sick and the vulnerable???

  • Jen - 9 years ago

    I can understand how people may be concerned about the trial being conducted on children - but the fact that their families are allowing this as well as the NHS allowing it, plus the whole 85% success thing is enough for me to think it is reasonable. My best friend has a very sick daughter not with M.E but another physical condition that has left her unable to walk and having to have 5 operations this year alone. In her words she said, "Jen, if there was anything that had an 85% success rate that could possibly help her, I would do it. It's better than her suffering like this..in fact I'd feel bad keeping her from a treatment that might give her chance.."

    So there we go. Everyone has their opinion about this, but at the end of the day it is the parents of the children that allow this, and I am supporting their decisions for their children.

    Sure there are people the LP doesn't work for. But that goes with anything! Graded exercise can make people much much worse but it's available on the NHS!? In fact doctors recommend it as the first port of call for treatment? What is that about?

  • Jo - 9 years ago

    Having got well using the Lightning Process myself, I suggested it to a friend whose 14 year old daughter was missing lots of school and life due to CFS. She is now fully well and off her medication which did not help at all. The impact of her recovery has been enormous, she is now doing what girls of her age love to do, with her friends and family. Her sisters no longer have to tip toe around the house, but can have fun with the whole family. I think it is unethical to suggest children wait any longer for a chance of getting their life back. This emotive talk of brainwashing is scare mongering, unethical rubbish. It is certainly unethical for children to be prescribed medication that cannot not improve their symptoms. This is a drug free intervention that gives children, adults, their families and carers their life back.

  • Helen - 9 years ago

    This is an interesting debate. I have read all the comments. Why is it that everytime someone writes something positive about the Lightning Process that person is very pointedly reminded that the poll is about ethics not results however when someone writes something negative no one seems to remind them. I find this bias against Lightnng Process in the ME/CFS support forum unethical in that it never provides a balanced view. Could it be that people who do get well are too frightened to keep in contact with their old associations for fear of being abused. I certainly know of cases where people have been told that they obviously were never ill in the 1st place once they have got well using it. Im sorry it hasn't worked for everybody but if you read their website it doesn't claim to work for everybody but it certainly does have a very high suceess rate like nothing else does for this debilitating illness. I feel certain that should that research grant be able to be transfered to an adult group then there would be a whole host of reasons why that would be wrong too. Lets face it the ME/CFS 'support' network has it in for Lightning Process! I feel ashamed to have ever been part of it in the past. I know its about ethics - I echo a previous post - is it ethical to condemn children to illness when they have a 85% chance of getting their lives back. NHS are definitely interested in Lightning Process because they have seen the amount of positive results.

  • Suzanne Spearing - 9 years ago

    This is awful to try this treatment on our very physically ill children.Our daughter has a neuro endocrine Immune Disease.We were under Dr Crawley until we educated ourselves about the treatment methods of the cfs/me clinics.All form of Graded Activity programme made her worse.Total rest 23 hours a day is helping alot better.We need this money to be put into a study into Immune System,Neurological or Endocrine System or the brain.

  • Daisy888 - 9 years ago

    We need serious biomedical research into the serious disease of ME/CFS. I have taken a course based on the Lightning Process...I improved for a while but always felt the undercurrent illness underneath despite trying not to...it came back....was that my fault? I have now tested positive for XMRV. All this though is not the point. The point is, is this ethical? Is doing an unproven, unregulated experiment (I loathe using this word but cannot think of another one) on children ethical before it has been fully tested and verified? My answer has to be no...and this is no disprespect to the Lightning Processl. I would much prefer the £164,000 to be spent on important biomedical research and treatment for this serious disabling illness.

  • Suzy Chapman - 9 years ago

    Children are considered a vulnerable research group. The Medical Research Council (MRC) and other institutions, for example, the Royal College of Paediatric Child Health (RCPCH), publish specific ethical guidelines for research using children.

    All extracts from document MRC Ethics Guide: MRC Medical Research Involving Children (Nov 2004, revised Aug 2007)

    http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430

    "(1.3) Research should only include children where the relevant knowledge cannot be obtained by research in adults."

    "(4.1) Does the research need to be carried out with children? Research involving children should only be carried out if it cannot feasibly be carried out on adults."

    "(4.3.2) Have previous laboratory studies, animal research, studies with adults, or other data provided a sufficient basis for proceeding with research involving children?"

    "(4.3.2) Is inclusion of children necessary to answer the scientific question posed by the research?"

    Since no RCTs have been carried out in adults, there is no reliable data on the safety of the application of the Lightning Process in patients with CFS and ME.

    There are concerns that with no access to robust data, the research team and the Research Ethics Committee(s) considering the application will have no basis on which to assess the safety, acceptability, short and long-term effects of the Lightning Process and are not in a position to determine that overall the likely benefits of the research outweigh any risks to child participants and that undergoing the training program would not be detrimental to a child’s current health status and psychological well-being, as a patient diagnosed with CFS or ME.

    Furthermore, parents, and children considered competent to give consent, are not in a position to give informed consent because there is no data from adult RCTs.

    It is a matter of public interest that the RNHRD NHS FT/University of Bristol research team should be seeking ethics research committee approval for a study using children where this is incongruent with the Medical Research Council (MRC) guidelines for research using children.

  • v99 - 9 years ago

    Only a sick mind would attempt to try this on children first. The number of horror stories about this dodgy therapy cannot be ignored.

  • Paula Gilfedder - 9 years ago

    Having had the LP done twice at great expense.....which did not work at all, but actually made me worse.....I find it beyond comprehension that it would be permitted to be tried on vulnerable, sick children. How low does humanity have to sink to even consider this? I sincerely hope the parents of these children do NOT allow them to be used in an experiment which could possibly make them worse.

  • Eric - 9 years ago

    PART 2

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

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

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

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

    NOTES TO EDITORS

    References:

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

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

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

    Advertising Standards Authority ruling:

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

  • Eric - 9 years ago

    http://www.meassociation.org.uk/index.php?option=com_content&view=article&id=1363:scientific-trial-involving-children-and-the-lightning-process-is-unethical-says-joint-statement-issued-by-two-national-me-charities&catid=30:news&Itemid=161

    Scientific trial involving children and the Lightning Process is unethical, says joint statement issued by two national ME charities
    Wednesday, 04 August 2010 17:15
    A plan to recruit children with ME/Chronic Fatigue Syndrome to a scientific trial comparing the efficacy of an unproven psychologically-based training programme with specialist medical care is “unethical”, say two of Britain’s leading ME/CFS charities – The ME Association and the Young ME Sufferers Trust.

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

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

    The pilot study, scheduled to start in September, will look at the feasibility of recruiting children aged eight to 18 with ME/CFS into a randomised controlled trial (RCT) comparing the Lightning Process with specialist medical care. It is planned that over 90 children aged between eight and eighteen and their families will be involved in the study.

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

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

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

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

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

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

    Furthermore, we

  • Fred - 9 years ago

    @Lyn - because it hasn't been tested on adults first. There is a reason why universal medical ethics require that research be carried out on adults first. It isn't just there for amusement. If there are any negative effects from applying the Lightning Process to children (and there are plenty of horror stories from adults with ME who have tried the process), then these must be identified in consenting adults before children are exposed to the risk.

  • Lyn - 9 years ago

    Why should children wait until they are adults to be given an opportunity to become fully well and get their lives back.
    This trial is overdue already, the numbers of successes using the Lightning Process cannot be ignored.

  • polly - 9 years ago

    In my experience the lightning process has had a damaging effect to the majority of people who have tried it . The only people the Lightning process benefits hugely are the practioners themselves by boosting their bank balance no end . It is on par with a pyramid selling scheme . It actually reminds me of a religious cult in the way it recruits people , the questions asked on the questionairre you have to fill out before you are even accepted should ring alarm bells in the mind of any sane person and they are wanting to trial this on kids ? Ludicrous .No doubt the LP practitioners who I will just remind everyone need no medical training whatsoever to undertake this will declare that LP cures XMRV infection too . I would laugh at that point but actually it isnt funny.LP IS A TRAINING PROGRAM AKA BRAINWASHING

  • fred - 9 years ago

    @ Jen and Jackie: you are missing the point. A core tenet of medical ethics is that research must be carried out on adults before children. This poll asks if a trial on children is ethical "when no rigorous RCTs into the application of LP in adults have been undertaken?". This is what people are (or should be) voting for or against. Those who have voted that they believe this trial to be ethical are voting against universal medical ethics and against the interests of the children which they are intended to protect.

  • Jackie - 9 years ago

    To anyone reading this I would say ask yourself this exactly what is out there for people with CFS, M.E and the like. You don't have to look very far, there is nothing!!! The lightning Process has been around for ten years now and has had huge success. In my experience people have completely changed their lives around both children and adults alike, so I say this great news anything that may help both children and adults that are stuck in illness is good in my book.I speak from experience having recovered.

  • Jen - 9 years ago

    Thousands and thousands of people have used the Lightning Process to get well....these numbers cannot be ignored any more I think. If something works on numbers like this, lets hear more about it! Also for the NHS to be even considering it, must be something in it for sure. I worked on the NHS health authority many years ago and I know how tight they are with their budgets! Mega tight! Esp with the current government too...

  • Nicola Reiss - 9 years ago

    Utterly appalling that this is even being considered. NLP is hardly a valid medical practice - purely some quack 'therapy' for misguided Californians. And we all know what a mess California is in. I think a boycott of Sainsbury's is in order (yes, that's where the money ultimately comes from).

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