Lightning Process pilot for children with CFS and ME aged 8 to 18: Update and a response from Research Governance Manager, Department of Health
For background to this issue see ME agenda 5 July report:
Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)
For joint ME charity statement and press release see:
Joint Press Release and statement: ME Association and The Young ME Sufferers Trust
It’s now five and a half months since the RNHRD NHS FT Bath/University of Bristol announced its intention to undertake a pilot study looking into the application of the Lightning Process in children aged 8 to 18. The press release issued 2 March can be read here: Press Release, a media article here: Media article.
Joint charity press release
On 4 August, the ME Association and The Young ME Sufferers Trust issued a joint statement and press release strongly opposing the pilot study and calling for it to be abandoned. Their joint press release can be read here.
The press release was issued too late for inclusion in the ME Association’s Autumn issue of ME Essential. But the magazine does include a write up, on Page 4, of the Advertising Standards Authority (ASA) adjudication against Lightning Process company “Withinspiration”.
ASA adjudication against Lightning Process company
In June, the ASA upheld a complaint against an advertisement in which unsubstantiated claims had been made about the efficacy of the Lightning Process for CFS and ME.
Read the full ASA adjudication against “Withinspiration” here.
Alastair Gibson, the Lightning Process practitioner associated with the company, had let it be known in March that he was one of two Lightning Process practitioners involved with this controversial NHS study. This information no longer appears on the “Withinspiration” website and the current status of his involvement in this pilot study is unknown.
25% ME Group position
On 11 August, Simon Lawrence, Chair of the 25% ME Group Management Committee, confirmed that the 25% Group is intending to issue a position statement shortly and that my concerns and documents sent to them have now been passed on to their medical advisors, Dr Byron Hyde, Canada, and Dr Nigel Speight (former NHS paediatrician with a special interest in ME in children).
Requests for information under the Freedom of Information Act
On 22 July, I submitted a formal request to the University of Bristol’s Director of Legal Services for an internal review of their decision to withhold nearly all information around the study under FOIA Clause 22(1)(a). A response is due on or before 19 August. My request for an internal review can be read here.
On 3 August, I submitted a request for information to the National Research Ethics Service (NRES). This is due for fulfilment on or before 31 August. Questions submitted under FOIA around the application for ethics approval and the application timeline can be read here.
Responses from parliamentarians and government departments
In July, I approached my MP, Annette Brooke (Lib Dem, Mid Dorset and North Poole), for her involvement with this issue. (Mrs Brooke is the MP who gave the adjournment debate speech on ME before Parliament dissolved prior to the election and is now Vice-chair of the recently reformed APPG on ME.)
On 31 July, I received a copy of a paper letter from the Parliamentary Office of Annette Brooke to the Rt Hon Andrew Lansley MP, Secretary of State for Health, Department of Health, dated 29 July. Mrs Brooke has requested that the Secretary of State for Health look into this matter. A response is pending.
I also raised my concerns with the Countess of Mar, Lord Clement-Jones and Earl Freddie Howe, all three being Patrons to the Young ME Sufferers Trust. Earl Howe is the Parliamentary Under-Secretary of State for Quality.
My communication was forwarded by Earl Howe to Matthew Harpur, Department of Health. Mr Harpur forwarded it to Bill Davidson, Research Governance Manager, Department of Health, who has responded on behalf of Earl Howe.
Response from Bill Davidson, Research Governance Manager, Department of Health on behalf of the Parliamentary Under-Secretary of State for Quality:
30 July 2010
Thank you for your e-mail of 16th July to the Parliamentary Under-Secretary of State for Quality regarding a research project involving the “Lightning Process” in 8- to 18-year-olds with myalgic encephalomyelitis. Earl Howe has asked me to reply.
You are quite right that new treatments should be compared with current standards to see which is better. You are also right that this comparison should be made in appropriate participant groups.
New treatments are not generally tried out first in children before there is evidence of their safety and efficacy in adults, but sometimes it is appropriate to do so. It is a matter for a research ethics committee to be assured that the evidence supports the extension of the new treatment to children.
We require the decisions of research ethics committees to be independent and free from bias and particular stakeholder interests. It would therefore be inappropriate to have a mechanism through which particular stakeholders might seek to affect a research ethics committee’s decision. We require research ethics committees that become aware of a possible breach of good practice in research to inform the relevant authorities so that they can take appropriate action.
Our National Research Ethics Service publishes lay summaries of the research approved by research ethics committees. It is normal practice for researchers also to put details of interventional studies on an open-access register, before the first participant is recruited, unless there is very good reason for delaying disclosure.
I note that the outcome of the research ethics committee review of the proposal for this project has not yet been reached. I expect it will, in accordance with Department of Health policy, come to a decision that takes account of all the ethical issues, including the appropriateness of the proposed participant group.
Research Governance Manager
Department of Health
Leeds LS2 7UE
Tel: 0113 254 6184 / 07900 164755
Fax: 0113 254 6174