1. Present: Jane Colby – TYMES Trust; Christine Harrison – BRAME; Bill and Janice Kent – ReMEmber; Peter Spencer – AfME; Charles Shepherd – MEA; Sue Waddle – MERUK; Mary-Jane Willows – AYME and Margaret Mar – Chairman
2. Apologies: Tanya Harrison – BRAME
3. Minutes of the last meeting – The minutes of the meeting of 24th November 2009 were agreed and signed by the Chairman.
4. Matters arising -The Chairman informed the group that she had learnt that Dr James Bolton had formerly worked in Atos. No further matters were raised.
5. DWP matters
a. Change from ICB to ESA -The Chairman advised the group that she had recently met with Professor Malcolm Harrington who had been asked by the Government to review the Work Capability Assessment component of ESA. Prof. Harrington had an interest in neurological conditions in his early career. His initial report is to be published very soon. His next step will be to look at long term fluctuating conditions. He was aware of the information that the DWP holds on specific health conditions, but that he was unhappy with the way the DWP had handled it. The Chairman had invited him to address the Group. [Meeting arranged for 14 December 2010].
The comment was made that people with M.E. are finding it extremely difficult to get Employment & Support Allowance (ESA) which ties in to the Work Capability Assessment Review. The recently announced cuts are causing even greater distress to people with M.E. as many of the people who are currently on Incapacity Benefit may not be found eligible for ESA.
A DWP speaker at the Action for M.E. conference had said that once the pilot migrations were completed, in the region of 10,000 people per week would be reassessed for transfer to ESA.
b. ATOS and Tribunal decisions – The Chairman asked the Group whether they would like her to invite Dr Jane Rayner from the tribunal service to address the Group. The Group agreed to this. [Meeting arranged for 26 January 2010].
6. Research – The Chairman distributed a paper from the Society for Endocrinology amongst the Group (see appendix). It was commented that the crux of the argument is whether static neuroendocrine tests done by private laboratories can give reliable results and that many endocrinologists are dismissive of these tests as a clinical tool.
a. MRC Expert Group proposals on research priorities The Group were given an overview of the recent work of the MRC Expert Group. Prof Stephen Holgate held a two day workshop for the Group in November 2009 at which 35 experts discussed where biomedical research on M.E. should be going. There was then a further meeting of the Group on 1 March 2010 to consider what had been provisionally decided. It was decided that a Prioritisation Group comprising of experts from the ME/CFS field and beyond who had attended the original workshop would decide which projects should be put before the MRC for funding. The Prioritisation Group met on 4 June 2010, chaired by Prof Hugh Perry, The minutes of the meeting are available on the MRC website including a list of the priorities set before the MRC. An initiative is now awaited from the MRC regarding funding of these priorities.
b. It was noted that the Group is putting an emphasis on the underlying pathologies of the illness, which is encouraging. The Group were told that Action for M.E. and the MEA were jointly funding a feasibility study into a bio-bank and they were looking at jointly funding a bio-bank using patients from the Disease Registry which was funded by the M.E. Observatory. Many patients have already indicated that they would be happy to take part in further study. Prof Stephen Holgate has agreed to be on standby with colleagues to peer-review the initial proposals so that a case may be made to the MRC or NIHR for matched funding.
c. Lightning Process trial involving children. The Group were informed that MEA and Tymes Trust had provided a joint statement on the SMILE Trial to Richard Ashby, Chair of the South West ethics Committee, saying that they felt the trial was unethical and that the ethics committee had probably not been made aware that the Advertising Standards Agency had ruled against a claim made by a Lightning Process Practitioner and that trading standards departments had been taking action in relation to misleading therapeutic claims. Concerns about the trial were being assessed by the National Research Ethics Service, headed by Joan Kirkbride. It was said that an increasing number of individuals were contacting ethics bodies to express concerns about the trial. The Group was told of a commentary in the Church Times by Prof Robin Gill, Chair of the BMA Ethics Committee, in which he criticised the research, and that Prof Gill planned to take this up with the BMA. The Chairman had tabled a question asking what the Government’s opinion is on this matter.
Christine Harrison asked whether a complaint had been made to the NSPCC regarding the SMILE Trial. Charles Shepherd replied that it had and the content of this could be viewed on the internet.
A discussion followed. Concern was expressed regarding the fact that the study involves research being conducted on children before it was tested on adults. It was recognised that the MRC guidelines stated circumstances under which it would be acceptable to perform a study on children in the first instance. The feasibility study would need to prove that these conditions were satisfied in order to achieve ethical clearance of the actual trial. The Principal Investigator would also have to prove that a robust risk management strategy had been developed to minimise any harm to participants.
Another concern was that the ethics committee seemed not to have been made aware of the ruling made by the Advertising Standards Agency in relation to claims made by a practitioner of the Lightning Process.
The point was made that 250 children a year undergo this treatment and a paediatrician had been approached and asked whether the treatment was safe. However there was a concern that parents who believed they must try everything that might be of benefit to their child could feel pressurised to try the treatment. Children could be very vulnerable to inappropriate pressure to say they felt better.
The Group was told that Dr Esther Crawley, the lead for the LP research, had received a large volume of malicious correspondence about her proposals. The Group agreed that this was not an appropriate or acceptable manner in which to demonstrate opposition and confirmed that none of them had been involved. It was suggested that it was activities such as this that drove young researchers from the field.
The Group was told that the research ethics papers submitted for the feasibility study were on the Bristol University website. Some of these papers made the case that M.E. in children was a different illness from M.E. in adults. It was drawn to the Group’s attention that Dundee University (in a biomedical study co-funded by Tymes Trust and MERUK), had discovered the same abnormalities in the blood of children that they had previously found in adults. Tymes Trust stated that this shows that ME in children was clearly not a different illness from ME in adults (see item 11).
The Chairman suggested that it was important to look at the recovery period covered by the study because M.E. was a relapsing condition.
d.Dundee research findings on children. The following paragraph was read from the research findings:
“We showed for the first time, to our knowledge, that oxidative stress, lower plasma anti-oxidant levels and increased plasma isophosphate levels and increased white blood cell apoptosis occur in children with CFS/M.E. We believe that the data presented herein are consistent with the findings that many patients with CFS/M.E. have an underlying detectable abnormality in the behaviour of their immune cells consistent with an active inflammatory process. The data are also consistent with a reactivating or persistent viral infection bringing about white cell apoptosis with an increased production of free radicals resulting from the consequent neutrophil respiratory burst.”
The Group were told that the study was very important because it replicated an earlier study that was performed on adults. The hope was that funding could be obtained to research a diagnostic marker for M.E. The Group discussed comments by Dr Rosemary Leonard on BBC TV who had remarked on the fact that the research was funded by an M.E. charity. This would not have been raised if the research had been performed for other illnesses. A number of people had complained to the BBC about this comment.
The Chairman gave suggested that the Group send their congratulations to the research team and the Group were in agreement.
e. XMRV and MLV’s – The Group were read a paragraph from the most recent review of XMRV in the Journal of the American Medical Association:
“In conclusion the fundamental question of whether XMRV is really an infectious agent circulating in the human population is still unresolved. The question will not be settled until reproducible assays for the virus have been established and validated. In turn this will require exchange of samples, and testing of well characterised standards followed by cross-comparison of results obtained in different laboratories.” The Group were told that, at present, the Whittemore Peterson Institute and their collaborators were the only research group to have published firm confirmation of a relationship between XMRV and ME/CFS. There are five or six other studies which have not been able to validate this finding and a separate study which had found a correlation with MLV’s (a similar type of retroviral infection). Until the reasons for different laboratories producing different results were resolved it is difficult to decide a route forward. The concern was raised that people were being tested privately for XMRV and that those who were XMRV positive were, in some cases, considering buying anti-retroviral medication on the internet.
It was observed that the NIHR seemed to have started using the term ME rather than CFS recently which seemed to imply that they are taking it more seriously.
7. NICE Guidelines revision – The Group were told that a recent NICE alert announces a consultation about the NICE review. The PACE trial, which might feed into a review, is likely to report at the turn of the year. The review will only look at new evidence.
It was commented that the PACE trial was the only evidence which would be likely to have any bearing. XMRV evidence would not be considered as it would not affect management at this stage. The Group were told of a study day at St Bart’s Hospital on the 29th of November where Prof Peter White was expected to announce the results of the PACE trial, so the results should be available quite soon.
Other comments were that there is much evidence which could have been considered but was not when the guidelines were first produced. M.E. needs to be recognised as a neurological condition and that it should be made extremely clear that the NICE guideline does not include relevant diagnostic criteria and that the Canadian Diagnostic Criteria should be used. Patient evidence should also be taken into consideration.
The Group then discussed the manner in which NICE prioritises research: It viewed evidence in a pyramid with randomised control trials at the top and patient evidence at the bottom. NICE would only look at new clinical trial evidence which would affect patient management and there was not much there.
Sir Michael Rawlin’s speech as the outgoing chair of NICE was quoted: “Randomised controlled trials (RCTs), long regarded as the ‘gold standard’ of evidence, have been put on an undeserved pedestal. Their appearance at the top of “hierarchies” of evidence is inappropriate; and hierarchies, themselves, are illusory tools for assessing evidence. They should be replaced by a diversity of approaches that involve analysing the totality of the evidence-base.”
The Chairman asked whether the Group would like her to invite the Chair of NICE to speak to them. The Group agreed.
8. Blood donors – The Chairman asked the Group whether they had seen the question that she had tabled on the ban on blood donation by people with M.E. for 8th November.
Doubt was expressed as to the suggestion that the reason for the ban was that it was in patient’s interests not to give blood.
It was suggested that Paul Burstow MP (Minister of State for Care Services at the Department of Health) be invited to speak to the Group. The Chair agreed to write to him.
9. Links to neurology groups -The Chairman told the Group that she thought that it was a good idea to collaborate with some of the All Party Groups that deal with other neurological conditions.The point was made that it might help to get into everybody’s psyche that M.E. is a neurological condition.
10. Any other business – The Group were told that the Tymes Trust has been given the Queens Award for Voluntary Service. The Group agreed to send their warmest congratulations to the 35 volunteers at Tymes Trust.
The Chairman raised the matter of the human right to education and the number of children with M.E. who are not getting an education, which she would like to raise at some point.
The Group were told of another anomaly affecting the education of young people with M.E. The Tymes Trust works closely with the Nisai Virtual Academy, whose virtual education courses for young people over the age of 16 with ME/CFS were being funded by the Learning and Skills Council before its demise. The Young People’s Learning Agency had taken over from the LSC but they are embedded within Local Education Authorities. The Young People’s Learning Agency refuses to recognise the Nisai Virtual Academy as a provider, although the Local Education Authorities in which they are embedded do recognise the Academy and are even funding courses for their under 16’s. As a result, students with ME are losing their funding.
The Chairman said that if she could be supplied with a written question on this she would be willing to raise the matter.
The Group was then told that it is rumoured that the Access to education document will cease to be a guideline. This is a document which despite its flaws can be used to fight for children to have appropriate access to education.
The meeting closed at 3.00pm

Addendum – Statement – Society for Edocrinology (SfE) – Proposal to Provide Information