Joint Press Release and statement issued today by the ME Association and The Young ME Sufferers Trust
Update @ 11 August
On 4 August, the ME Association released a list of recipients of the press release issued earlier that day jointly with the Young ME Sufferers Trust. The list is media recipients is appended beneath the press release.
ME agenda welcomes this very strong opposition statement from the ME Association and The Young ME Sufferers Trust. The iniative to liaise with Trading Standards is also welcomed.
The joint press release says:
“If any trial is to be held, it should first be on adults, who can give informed consent.”
My own position is that to undertake RCTs on any patient group would be giving credence to the Lightning Process as having potential as a treatment for ME and would also legitimise it, ethically, as a potential treatment. I would not want to see any RCTs into the application of the Lightning Process, whether undertaken with ME patients, MS patients or for any other medical disease, condition or syndrome.
For background to this issue see ME agenda 5 July report:
From the ME Association
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 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
‘£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:
Advertising Standards Authority ruling:
MEA and TYMES Trust 4 August 10 press release recipients
(NB: this may not be a comprehensive list)
The press release has gone out to
The Times news desk
David Rose, health reporter, The Times
The Independent news desk
Steve Connor, science editor, The Independent
Jeremy Laurence, health editor, The Independent
Sunday Times news desk
Daily Telegraph news desk
Sunday Telegraph news desk
The Lancet news desk
BMJ news desk
Daily Star, news desk
The Sun, news desk
Daily Mail, news desk
Daily Mail, health editor
Fergus Walsh, BBC health correspondent
Western Morning News, newsdesk
Bristol Evening Post, news desk
Western Daily Press, news desk
You and Yours, Radio 4
Today programme, Radio 4
Panorama, BBC 1
Evening Gazette Colchester
Channel 4 news
Breakfast, BBC 1
GMTV news desk
Randeep Ramesh, health reporter, The Guardian (Sarah Boseley is on holiday til August 9)
The Guardian, news desk
East Anglian Daily Times, news desk
Daily Express, news desk
Daily Express, health editor
Private Eye, news desk
Anna Winkles, health reporter, BBC Online
Press Association, health editor
All Together Now magazine
News of the World
Tom Moore, health editor, Sky News, and his news desk.
Stacey Poole, the ME-aware health editor at Meridian, ITV station for south of England.
Emailed Times Ed Supplement, highlighting educational aspects of the release and suggesting they speak with Jane Colby.