“Unethical” Lightning Process pilot study in children receives ethics approval
Update on the Dr Esther Crawley led Royal National Hospital for Rheumatic Diseases (RNHRD) NHS FT, Bath/University of Bristol Lightning Process pilot study for children aged 8 to 18 (now 12 to 18).
For background to this pilot study issue see ME agenda 5 July report:
Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)
For joint ME charity opposition statement and press release see:
Joint Press Release and statement: ME Association and The Young ME Sufferers Trust
Source: Protocol document
A pilot study on the controversial Lightning Process using children as young as eight has received the go ahead from a South West Region Research Ethics Committee (REC), despite widespread public concern and condemnation by two UK national patient organisations.
In August, ME patient charities, The ME Association and The Young ME Sufferers Trust, issued a joint press release describing the study as “unethical” and calling for it to be abandoned .
The organisations said:
“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…
“…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.”
Today, information received from University of Bristol Information Rights Officer, Matthew Morrison, confirms that the pilot study has now been granted ethics approval. Recruitment to the study, which is being funded by the Linbury Trust and the Ashden Trust, was scheduled to start in September.
What has been published?
A large number of documents are published today on the University of Bristol website.
Information on accessing the research protocol and other published material can be found in the next post.
SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME)
Advertising Standards Authority (ASA) ruling
In June, ME agenda reported that Alastair Gibson, who had previously identified himself as one of two Lightning Process coaches involved with the NHS study, was the subject of an Advertising Standards Authority (ASA) ruling .
The ASA upheld a complaint about unsubstantiated claims made for the efficacy of the Lightning Process in ME and CFS in an advertisement for Mr Gibson’s “Withinspiration” company.
At least one Lightning Process company has made changes to the wording on its website following the ME Association’s discussions with Trading Standards.
Currently, the ASA’s remit does not extend to website content but from May 2011, the ASA will broaden its remit and will be able to consider complaints about:
• Advertisers’ own marketing communications on their own websites and;
• Marketing communications in other non-paid-for space under their control, such as social networking sites like Facebook and Twitter.
On 1 September, the Advertising Standards Authority issued a news release setting out its extended remit:
Landmark agreement extends ASA’s digital remit (Lightning Process pilot study in children)
Department of Health responses
Concerns about the pilot study have been taken up with Earl Howe (Parliamentary Under-Secretary of State for Quality). Earl Howe is a Patron to The Young ME Sufferers Trust. An unsatisfactory response was received from Bill Davidson, Research Governance Manager, Department of Health, on 30 August, who responded on behalf of Earl Howe.
In July, Annette Brooke, MP, Mid Dorset & North Poole forwarded my concerns and documents to the Rt Hon Andrew Lansley MP, Secretary of State for Health, Department of Health. Paul Burstow MP, Minister of State for Care Services, responded briefly on behalf of the Secretary of State for Health, on 12 August.
Mrs Brooke is Vice-chair of the newly reformed APPG on ME (Acting chair, David Amiss, MP).
The ME Association had also written to the Department of Health requesting that their joint press release be forwarded to the ethics committee reviewing the application. The DoH refused to do so – a decision which the ME Association considered unacceptable.
The name of the South West Research Ethics Committee, which had met to review the application on 8 July, was identified on 27 August in a response to my request for information under the Freedom of Information Act. The contact details for this regional RE committee chair have been passed to the ME Association.
The South West Regional Manager for the National Research Ethics Service (NRES) confirmed to me, in May, that there is apparently no process through which REC decisions might be challenged by the public.
 Press Release, University of Bristol, 2 March 2010
 Joint Press Release and statement: ME Association and The Young ME Sufferers Trust
 MRC Guidelines Medical Research Involving Children (Nov 2004, revised Aug 2007)
 Request for information under FOI and FOI Office responses
 Action for M.E. article on Lightning Process, InterAction magazine, March 2007
 Patient Survey 2008, Action for M.E. and AYME
Patient Survey May 2010, ME Association
 LP Doesn’t Work for ME: Personal accounts from LP “trainees”
Letter: Lightning process for ME didn’t work for me
Personal account of Lightning Process technique as applied to patient with ME
Personal account of Lightning Process as applied to patients with ME and MS
 Sample Lightning Process application form
 ASA adjudication against “Withinspiration”
 RNHRD Bath Chronic Fatigue Syndrome/ME Service for Children & Young People