Letter from CMO 11th March 2011
I refer to your related emails of the 16th February at 16:26, 16:28
and 16:38 respectively.
Thank you for copying to me your correspondence with Joan Kirkbride,
head of operations for the National Research Ethics Service (NRES).
I cannot comment on the substance of the information you supplied to
Joan Kirkbride in respect of the research ethics committee review of
the “SMILE” study proposal. To command confidence, research ethics
committees and their decisions are, and must be seen to be,
independent of Government and free of political influence.
I can tell you that I understand the relevant research ethics
committee reviewed its opinion of the “SMILE” study proposal in light
of subsequent information, in accordance with NRES standard operating
procedures agreed by the UK health departments and the UK Ethics
Committee Authority, and that its opinion remains favourable.
Ethical research contributes to the scientific evidence about the
safety and efficacy of treatments and care. The study in question is
therefore expected to help show objectively whether the “Lightning
Process” is a safe and effective way of managing myalgic
encephalomyelitis — or whether it is not. I look forward to its
findings with interest.
sent by Caron Biart
Professor Dame Sally C Davies
Chief Medical Officer
Department of Health
Tel (R&D) 020 7210 5982
Reply to CMO 16th March 2011
Thank-you for your mail of 11th March.
I fully appreciate that it is not appropriate for you to comment on the letters I forwarded to you for your information. I was aware that the ethics committee had reviewed its decision, and sent Joan Kirkbride a detailed response to the minutes of the ethics committee meeting on 17th January, with a total of 90 co-signatures – it may be read here:
I agree with you that ethical research contributes to scientific evidence about the safety and efficacy of treatments and care, but this study fails on all counts as, a) it is not scientific in design or method, b) the Lightning Process is not a treatment, nor even a therapy – it is advertised as a training programme and the trainers are not medically qualified, c) telling children with myalgic encephalomyelitis to ignore their symptoms and to deny that they are ill cannot be described as care, d) the SMILE study is unethical – Dr. Crawley did not present adequate reason why this product should be tested on children before testing it on adults; her assertion that ME is different in adults and children is widely disputed and scientific evidence shows the contrary, and SW2REC was not given the full and correct information it needed to approve the study originally. This information was subsequently sent in by a number of individuals and organisations, but unfortunately, NRES did not properly or accurately assess the new evidence received – and so again came to a misguided conclusion.
I realise that your position is that it is not for politicians to intervene in such matters, and I believe that a formal complaint against NRES is now in progress. However, your final comment on the subject strongly suggests that you support this study, rather than taking an impartial stand at this stage, and I wonder whether you would wish to revise your comments, once you have read all the evidence and correspondence about The Lightning Process and the SMILE study.
For example, you say, “The study in question is therefore expected to help show objectively whether the “Lightning Process” is a safe and effective way of managing myalgic encephalomyelitis — or whether it is not.”
Are you aware that there are no objective outcome measures for this study and that this is one of the major concerns about it?
You may not be aware that the effectiveness of the Lightning Process relies on participants denying that they are ill. Are you sure that you believe this may be a safe way to manage neurological disease? Do you feel comfortable condoning the use of children to test the safety of this product before it has been tested on adults, given that it is not specifically designed for paediatric use and that it is advertised as being equally effective for adults and children? Would you not feel more at ease if the research were carried out on adults, before putting sick children at further risk?
Please bear in mind that the lead researcher, Dr. Crawley, did not disclose the risks to the children in her study proposal – this has been added to the patient information following the ethics committee’s review of its decision, prompted by the evidence provided by members of the public.
I realise that you will not wish to comment on the conduct of Dr. Crawley in this matter, as that is beyond your immediate control. However, it is clear that, as a doctor employed by the NHS, her involvement in this study is a matter of very serious concern. She did not provide NRES with the full information they needed to come to an informed decision in her original proposal, and unfortunately, NRES has relied on Dr. Crawley’s assurances in order to uphold their decision. NRES was also reassured by the involvement of AYME, but Dr. Crawley is AYME’s medical adviser. The unquestioning loyalty to their medical advisor, of AYME’s CEO, Mary-Jane Willows, is clear from her letter to the Ethics Committee dated 1st December in defence of Dr. Crawley. AYME’s role is intended to be as independent overseers of the study, so emotive support of the lead researcher, together with a clear bias in favour of The Lightning Process, is not appropriate.
I realise that the various publicly-funded individuals and organisations involved with this study have their relative responsibilities that you would not wish to interfere with at a political level, but as Chief Medical Officer, you are seen, by the voting public, to be ultimately responsible for what happens to these children while under the care of the NHS. You may not be in a position to take direct action to have this study stopped, as the weight of objective evidence shows that it should be, but as you have now been given full disclosure of the facts, risks and concerns relating to this study by members of the public – and by the other ME charities that have no vested interest in this research – I hope that you will revise your comments of approval of this study, which will be in the public domain.
You will see from the correspondence that the NRES’ attention was drawn to research that was published after they had originally granted ethics approval of SMILE.
Biochemical and Vascular Aspects of Paediatric Chronic Fatigue Syndrome:
http://bit.ly/1QBdBoG (Dundee University)
This is important as this is properly objective scientific research and shows evidence of persistent viral infection in children with ME/CFS and should be taken into account. These children are ill through no fault of their own and they rely on the adults in positions of responsibility for their health care. A mistake has been made with respect to approving the SMILE study – it is not too late to re-evaluate the evidence and correct that mistake.
I look forward to your reply.
With thanks and best wishes,
Reply from CMO 17th March 2011
Thank you for your further comments about the “SMILE” study.
I am sorry you misunderstood my explanation of the purpose and expected outcome of research as particular support for this piece of research. As I mentioned in my email of 11 March, research ethics committees’ decisions are independent of Government, so it would be inappropriate for me to enter into a discussion about a research ethics committee’s review or opinion of a particular research proposal, or about the ethics of a particular research proposal that a research ethics committee has reviewed or given an opinion of.
Reply to CMO 17th March 2011
Many thanks for your prompt response.
I assure you that I do understand your position and I do not expect you to engage in a discussion about ethics committee’s decisions. It was your final sentence that caused concern,
“I look forward to its findings with interest.”
This suggests that you take a favourable view of the study, and I hope you can understand how that sounds, under the circumstances; and given all the facts about the Lightning Process and this particular study of it in children with ME/CFS that have now been made available to you, I wondered whether that was what you intended to say.
Reply from Research Governance Manager on behalf of CMO 17th March
Dear Ms Best,
Thank you for your e-mail of 17th March regarding the “SMILE” study, which the Chief Medical Officer has passed to me as the responsible official.
The Department of Health naturally looks forward with interest to the findings of research, because research findings help us know which treatments etc are better than current standard practice, as well as which ones are not. That interest is not meant to suggest our particular favour for an individual research project.
I hope that clears up any ambiguity and deals with your concern.
Research Governance Manager
Department of Health
Leeds LS2 7UE
Tel: 0113 254 6184 / 07900 164755
Fax: 0113 254 6174
Reply to Research Governance Manager 17th March 2011
Dear Mr. Davidson,
Thank you for taking the trouble to clarify that ambiguity – I do feel
reassured that the CMO is not specifically looking forward to the
results of this particular study.
Just to clarify for you – the Lightning Process is not a treatment and
it is not a therapy – hence this study will not provide any
information about treatments.
I hope we are all clear now.
Thank you again.