TYMES TRUST ALERT 06 August 2010 ====== LIGHTNING PROCESS STUDY IN CHILDREN UNETHICAL Joint Statement with the ME Association ====== Here is your own copy of the Statement that was made public on 4th August. It is of course everyone's right to take up whatever treatment or training program they wish. This statement addresses a different issue: the ethics of experimentation on children when there are legal issues of informed consent and suitable education, and when research on adults has not been done. I discussed the Lightning Process in The Brief 2008-1 (page iv), at www.tymestrust.org/tymesmagazine.htm. Best wishes to all Jane Colby Executive Director The Young ME Sufferers Trust PO Box 4347, Stock, Essex, CM4 9TE www.tymestrust.org Tel: 0845 003 9002 ====== The ME Association and The Young ME Sufferers Trust are issuing this joint statement due to widespread public concern, together with our own serious reservations, about a forthcoming study of the psychologically-based Lightning Process on children. The pilot study, scheduled to start in September, will look at the feasibility of recruiting children aged eight to 18 with ME/CFS into a randomised controlled trial (RCT) comparing the Lightning Process with specialist medical care. It is planned that over 90 children aged between eight and eighteen and their families will be involved in the study. The Medical Research Council (MRC) produces specific guidelines for research involving vulnerable patient groups. The document 'MRC Medical Research Involving Children' is quite clear on this issue. It poses the question: 'Does the research need to be carried out with children?' In answer, the MRC states: 'Research involving children should only be carried out if it cannot feasibly be carried out on adults.' The ME Association and The Young ME Sufferers Trust do not believe that it is ethically right to use children in trialling an unproven and controversial process such as the Lightning Process. A survey of 4,217 people carried out by the ME Association on the management of ME/CFS found that over a fifth of those who had tried the Lightning Process were made worse (7.9% slightly worse,12.9% much worse). If any trial is to be held, it should first be on adults, who can give informed consent. No rigorous RCTs into the application of the Lightning Process have ever been undertaken. Despite many years of scientific research there is still no single diagnostic test for ME/CFS, nor is there a curative treatment. The theory upon which the Lightning Process is based, together with its claim that the prolonged nature of the illness is caused by 'the adrenaline, nor-adrenaline and cortisol loop' is not scientifically proven. Moreover, the Advertising Standards Authority recently ruled that an advertisement in an internet sponsored link containing claims of its effectiveness by a Lightning Process practitioner should be removed. We understand that the practitioner will be involved in this study and we find this concerning. The Trading Standards departments of two local authorities have also taken action over therapeutic claims by Lightning Process practitioners following referrals by Dr. Charles Shepherd of the ME Association. The Lightning Process calls itself a training programme, not a medical treatment, combining concepts from Neuro-Linguistic Programming, Life Coaching and Osteopathy. It claims to be effective for ME/CFS and psychological problems such as anxiety, stress, depression, guilt, low self esteem. Any evidence for this effectiveness on ME/CFS is purely anecdotal. ME has long been classified by the World Health Organisation as a neurological illness, not a psychological condition. We cannot approve of a study involving children as young as eight when no rigorous trials have first been undertaken into the safety, acceptability, long and short-term effects of the application of this controversial and unregulated 'process' with adults. Furthermore, we have serious concerns about the primary outcome measure, which is school attendance after six months. Children have a legal right to 'suitable education' for their particular needs, which may or may not include school attendance. The statutory guidance 'Access to Education for Children and Young People with Medical Needs' explains that whilst it is desirable for children to be educated in school, other forms of education must be provided for those who need it. The Chief Medical Officer's Working Group Report on CFS/ME (DOH 2002) stated that most children with ME will need education in their homes at some time, potentially for a considerable period. In 2009 the Education White Paper 'Back on Track : A strategy for modernising alternative provision for young people' included virtual education. Chapter 7, 'Learning from the best and supporting innovation', spoke of 'e-learning and virtual provision, particularly for pupils who cannot attend school due to health needs.' Accessible education is also provided for in disability discrimination law. If school attendance is the primary outcome measure of this study, families involved may then feel pressurised into avoiding alternative forms of education which would benefit their children and to which they are legally entitled. For all these reasons, it is our considered opinion that this study of the Lightning Process in children is unethical and should be abandoned. ====== READ PREVIOUS ALERTS AND REGISTER FOR FUTURE ONES AT www.tymestrust.org To unsubscribe, send an email via the website Contact Us form. ====== DO YOU KNOW ANYONE WHO WOULD LIKE TO RECEIVE OUR ALERTS? ====== You are welcome to redistribute or reprint this email without seeking our permission provided: 1) you do not abbreviate, add to, or change the text in any way; 2) the authorship information is retained; and 3) www.tymestrust.org is credited as the source. Jane Colby is Executive Director of The Young ME Sufferers Trust. She was a Headteacher for nine years, a member of the government Chief Medical Officer's Working Group on CFS/ME and co-authored ME/CFS In UK Schools, the largest epidemiological study of ME to date. She is a member of the National Association of Educational Inspectors, Advisers and Consultants (now ASPECT), a life member of the National Association of Head Teachers and a Fellow of the Royal Society of Arts. Copyright (c) 2010 The Young ME Sufferers Trust