Two responses around XMRV: Prof Simon Wessely; Dept of Health

Two responses around XMRV: Prof Simon Wessely; Dept of Health

Shortlink: http://wp.me/p5foE-2mS

Two users of the Whittemore Peterson Institute Facebook site have kindly given permission for the following responses to be reproduced here, on ME agenda.

Update: The response from Professor Simon Wessely following an enquiry by a member of the public has been removed since permission for publication and the terms under which Professor Wessely’s response might be republished had not been discussed.  A copy of the response was also published by me via Co-Cure together with the response from the Department of Health.  This is also being removed.

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Whittemore Peterson Institute on Facebook

Heath reported on 12 November that he wrote to the Department of Health.  The DoH response was:

Thank you for your email of 28 October to the Department of Health about xenotropic murine leukemia virus-related virus and chronic fatigue syndrome/myalgic encephalopathy (CFS/ME).

The Department of Health agrees with the World Health Organization’s classification of CFS/ME as a neurological condition of unknown cause. The Department also agrees that CFS/ME is a genuine and disabling illness and can have a profound effect on those living with the condition. That is why research breakthroughs such as the one outlined in your email, are so important to developing the knowledge base.

The National Institute for Health and Clinical Excellence (NICE) clinical guidelines are updated as needed so that recommendations take into account important new evidence. However, as I hope you will appreciate, as NICE is an independent body, the time-frame for revising guidance and the evidence it uses are matters entirely for NICE. You may therefore wish to raise this issue directly with NICE’s Chief Executive, Andrew Dillon, at the following address:

NICE
MidCity Place
71 High Holborn
London WC1V 6NA

I think it also helpful to emphasise that NICE clinical guidelines are just that – guidelines for healthcare professionals use in conjunction with their clinical judgement and based on an individual assessment of each patient’s needs. The guideline recognises that there is no one form of treatment to suit every patient and it does not force patients into treatments they do not want.

The guideline emphasises a collaborative relationship between clinician and patient, that treatment and care should take into account personal needs and preferences, and that healthcare professionals should recognise that the person with CFS/ME is in charge of the aims of the treatment programme.

Cognitive Behavioural Therapy is a rehabilitative approach designed to modify the way patients think and behave about their illness and so improve physical symptoms. In common with other illnesses and conditions where it has been successfully used such as chronic pain, cancer, heart disease and diabetes, its use does not imply that the cause of the illness is psychological.

The Department feels that it is not helpful to differentiate between biomedical and psychosocial treatments as, based on clinical evidence that is currently available, patients are best served by a holistic approach.

You also comment on the paucity of bio-medical research. I know that many of the Department’s stakeholders see biomedical research as the key to developing new treatments and the Department appreciates the concern about a lack of biomedical research in this area.

As you may know, the main agency through which the Government supports medical and clinical research is the Medical Research Council (MRC). The MRC is wholly independent in its choice of which research to support and it does not generally earmark funds for particular topics. It maintains a rigorous decision making process and only funds research that is likely to make a significant contribution to knowledge and is a good use of taxpayers’ money. Decisions to support proposals are taken on the grounds of scientific quality and whether the research proposed would be likely to inform the knowledge base. There is certainly no bias, and the Department knows that the MRC remains committed to funding scientific research in all aspects of CFS/ME.

The Department understands that the MRC continues to attract a small number of proposals for biomedical research. The problem is that there appears to be a shortage of good and innovative ideas within the scientific community itself. This is something the Department knows that the CFS/ME community and the MRC are aware of, and the MRC have endeavoured to address this by engaging with patient groups to encourage high quality research proposals. The MRC continues to acknowledge the importance of research into CFS/ME, and it is difficult to see what more the MRC could do without lowering the quality threshold.

I hope this reply is helpful.

Yours sincerely,

Priya Bassan
Department of Health

Related information:

Source: ME Research UK

http://www.meresearch.org.uk/information/publications/casetoanswer.html

The Medical Research Council: a case to answer?

[...]

CFS/ME projects currently funded by the MRC
(Sources: MRC website; Hansard, written answers)

•Two large clinical trials of new approaches to treating CFS/ME:
          PACE (Pacing, Activity and Cognitive Behaviour Therapy: a Randomised Evaluation, £2,076,363) [Prof. PD White, Psychological Medicine, Queen Mary and Westfield College]
          FINE (Fatigue Intervention by Nurses Evaluation, £824,129) [Dr AJ Wearden, Psychological Science, Uni. of Manchester]

•A preliminary epidemiological project to test the feasibility of identifying the risk factors for persistent symptoms of fatigue and abdominal and widespread pain (£118,263) [Prof. F Creed, Psychological Medicine, University of Manchester]

•An epidemiological study to assess ethnic variations of the prevalence of a CFS-like illness, associations with potential risk factors, and coping behaviours (£162,145) [Prof. K Bhui, Cultural Psychiatry and Epidemiolgy, Queen Mary and Westfield College]

•Indirect support through a trial exploring the management of patients with persistent unexplained symptoms [Specifics unknown]

•One project was mentioned in Hansard (12th June 2008) but is not on the MRC website: General and specific risk markers and preventive factors for chronic fatigue and irritable bowel syndromes (£367,000) [Dr C Clark, Centre for Psychiatry, Barts and The London School of Medicine]

 

Table. Unfunded applications to the MRC between 2002 and 2008

Time-frame   (number of applications)   CFS/ME subject area

2002 to 2005 (11 total) Neurophysiology of fatigue; Population-based/epidemiological studies (4 applications); Neurotransmitters and stress; Neuroimaging; Clinical and laboratory characterisation physiology/diagnosis); Dietary intervention — RCT; Facilitated self-help — RCT; Psychosocial and genetic factors in young people

2005 to 2006 (12 total) Pathophysiology, including studies regarding genetics/biomarkers, immunology and neuroimaging (7 applications); Population-based/epidemiological studies (3); Primary care study; Experimental medicine study

2006 to April 2007 (7 total) Cognitive outcomes in children — pathophysiology; Epidemiological studies — epidemiology; Biomarkers; Pathophysiology (2 applications); Molecular pathogenesis — pathophysiology; Molecular and genetic characterisation — pathophysiology; Neuroimaging — pathophysiology

May 2007 to June 2008 (3 total) Biomarkers — pathophysiology; Management and treatment — intervention; Management and treatment — observational study

ME Research UK response to XMRV study “XMRV and ME/CFS – A stunning find”

ME Research UK response to XMRV study “XMRV and ME/CFS – A stunning find”

WordPress Shortlink: http://wp.me/p5foE-2b7

UK research organisation, ME Research UK, has issued a response to the paper published in last week’s Science journal by researchers from the Whittemore Peterson Institute (WPI):

http://www.meresearch.org.uk/information/publications/xmrvfind.html

XMRV and ME/CFS – A stunning find

The XMRV retrovirus

The discovery of a potential retroviral link to ME/CFS, which is estimated to affect some 17 million people worldwide, has certainly caught the world’s attention – no bad thing for an under-researched and often-overlooked illness! The scientific report, entitled “Detection of infectious retrovirus, XMRV, in the blood cells of CFS patients”, appeared online in Science, one of the most prestigious scientific journals in the world, on 8th October 2009 and described the findings of a consortium of researchers from the Whittemore Peterson Institute (WPI, located at the University of Nevada, Reno), the National Cancer Institute (part of the National Institutes of Health) and the Cleveland Clinic, Ohio.

ME Research UK welcomes good-quality outline applications from Research Units anywhere in the world for funding to replicate and/or extend the work on the possible links between XMRV and ME/CFS. Applications will be processed rapidly, and the peer-review process expedited, for such applications.

The findings

The headline finding of the research paper was that DNA from a human gammaretrovirus, xenotropic murine leukemia virus-related virus (XMRV), could be detected in the peripheral blood mononuclear cells of 68 out of 101 ME/CFS patients (67%) compared with only 8 out of 218 healthy controls (3.7%). The extent of this difference in proportions is unusual, as it is the norm for scientific researchers to find relatively small yet significant differences between patients and closely matched control groups; in the modern world, novel associations of such magnitude are rarely found between long-standing chronic illnesses and infectious agents. In addition to the headline finding, the researchers determined that XMRV proteins were being expressed in blood cells from ME/CFS patients at very high levels compared with controls, and through cell culture experiments they showed that patient-derived XMRV was infectious and transmissible. So, as well as being the first to show infection with this novel virus in ME/CFS patients, the researchers appear to have been the first to be able to isolate XMRV particles from the blood, and to show direct transmission of this virus between blood cells – dramatic observations indeed.

What has caught the attention of the scientific world is that these observations seem to fit neatly, at least at a first glance, with what is already known about ME/CFS as a chronic illness. For example, viruses related to XMRV have been reported to be involved in damage to blood vessels and nerves, and natural killer cells (historically low in ME/CFS) are said to be susceptible to infection by XMRV. Also, the fact that retroviruses like XMRV are known to be able to activate some other (latent) viruses might explain why ME/CFS has been associated with a range of different viral triggers, such as herpesviruses like Epstein-Barr, over the years. Again, as Dr Judy Mikovits and colleagues point out in their paper, some of the most commonly reported features of ME/CFS include neurological symptoms and immune dysfunction with inflammatory cytokine and chemokine upregulation, and some of these observations could be accounted for by infectious XMRV in lymphocytes. The fact that such pieces seem to fit so well together is suggestive only at this stage, however, and a virologist at Tufts University was surely wise to say in New Scientist that while it’s not impossible that infection with this agent might cause a disease with neurological and immunological consequences, we don’t know for sure as yet.

The background

The scientific journey towards this discovery is an extremely interesting one, and includes several strands: prostate cancer, the RNAse L immune pathway, the discovery of the novel virus XMRV, and ME/CFS. XMRV is a human retrovirus similar to HIV, HTLV-1 and a group of endogenous murine leukaemia viruses found in the genomes of wild mice (see the informative presentation on retroviruses by Dr Jones of SAIC-Frederick/NCI-Frederick), and was first identified only in 2006 by Prof. Robert H. Silverman of the Cleveland Clinic, a co-author on the 2009 ME/CFS study. Prof. Silverman initially showed the presence of XMRV in prostate cancer tissue samples (PLoS Pathog, 2006), and subsequent work has confirmed XMRV protein expression in 23% of 334 prostate cancer biopsies (Proc Natl Acad Sci USA, 2009). Importantly, the men with prostate cancer initially studied by Prof. Silverman all had a specific genetic defect in their antiviral defences, the RNase L antiviral pathway which Prof. Silverman had been studying for 30 years, a lifetime’s work of scientific progression described in his fascinating essay, “Journey through the 2-5A/RNase L System”.

RNase L is the terminal enzyme in the 2,5A synthetase/RNase L antiviral pathway, and plays an essential role in the elimination of viral mRNAs. The enzyme has been the focus of research interest in ME/CFS patients for nearly 20 years, and deregulation of this pathway in subsets of ME/CFS patients has been reported extensively in the scientific literature (reviewed by Nijs and Fremont, 2008). In ME/CFS, a wide spectrum of “cleavage” of RNase L can be observed (a phenomenon also seen in multiple sclerosis patients), and such altered RNase L activity profoundly affects cellular physiology, including apoptosis. Overall, an upregulated RNase L pathway in ME/CFS is consistent with an activated immune state and a role for persistent viral infection in the pathogenesis of the disorder – and it is because of these and other findings that many researchers have come to view ME/CFS as primarily a disorder of the innate immune system (see Klimas and Kineru, 2008). It was thanks to the insight of Dr Judy Mikovits and her team at WPI that the potential connection between RNase L dysfunction in XMRV-infected prostrate cancer and in ME/CFS was recognised, and an exploration undertaken to test for the presence of the virus in the banked blood samples in the WPI tissue repository, the largest ME/CFS sample repository in the world.

What we don’t know

A plethora of unanswered questions arise from this discovery. Chief among these concerns cause and effect: the researchers’ work has shown a suggestive, significant association between the presence of XMRV and a diagnosis of ME/CFS, but this is far from proof that the virus has a direct or even indirect role in the development or maintenance of the illness. This and other points have been well-put in a fine “perspective” in Science by National Academy of Sciences member and expert retrovirologist, Prof. John Coffin, and colleague Jonathan Stoye, who say, “There is still much that we do not understand. Whether the virus plays a causative role in either chronic fatigue syndrome or prostate cancer is unknown.” They go on to point out that XMRV infection might be higher, by co-incidence, in the same locations as clusters of patients; that patients with ME/CFS or prostate cancer might be more readily infected due to immune activation; that XMRV might prefer to proliferate in cells that are dividing rapidly, and that the presence of these cells in these illnesses might simply make it easier to detect infection; and that the mechanism of viral transmission remains unknown, as does the prevalence or distribution XMRV in human or animal populations. In the aftermath of all initial scientific reports of a potentially major find, the unknown wildly exceeds the known – an exciting place for ME/CFS research to find itself.

The next steps

The researchers say that since publication they have continued to refine their test for XMRV, finding that 95% of 330 ME/CFS samples have tested positive for XMRV antibodies in the plasma (showing that these patients have at least been in contact with the virus at some time). They plan to continue their in-depth studies of XMRV to clarify its effects on the human immune system, and are clinically validating a blood test for the detection of XMRV in ME/CFS and other human diseases. And they will shortly begin the work of determining if any currently approved drugs, such as AZT, might be useful for suppressing XMRV. If these efforts are successful, human clinical trials to determine the most effective patient treatments in a clinical setting would surely be close behind.

At the same time, other independent laboratories across the world will be attempting to replicate the findings in their own local populations of ME/CFS patients. Since the WPI researchers used samples selected from several regions in the US where “outbreaks of CFS” had been documented (using patients diagnosed on CDC-1994 and 2003 Canadian Clinical criteria ), blood samples from patients in other countries (possibly diagnosed with less stringent criteria) might throw up very different results. Furthermore, it will be particularly important for independent laboratories to conduct double-blind studies to search for XMRV in ME/CFS patients and healthy matched controls, to strengthen the evidence base as a whole.

The long-term

This is a stunning find – like a comet from a cloudless sky to patients across the world. Yet it is too early to know whether the discovery will change the ME/CFS landscape or not. At worst, the discovery will be just one of a number of false dawns that have arrived over the years – albeit one that has brought, suddenly, the world’s attention to a neglected field largely ignored by mainstream biomedical medicine. In this scenario, XMRV might prove to be simply a passenger virus carried by an immune-depressed ME/CFS patient population, with little or no influence on the illness. At best, however, XMRV might be found to be the casual factor in the development and maintenance of ME/CFS, and a combination of anti-viral drugs will be found to eradicate the viral load from patients. One consequence of this “jackpot” scenario would be a demolition of the existing diagnostic criteria for the “syndrome” CFS (currently a ragbag of common non-specific symptoms, with many causes, shared with other illnesses), as well as the older criteria for myalgic encephalomyelitis. These would be replaced by objective diagnostic criteria based on state-of-the-art methodology – surely a welcome liberation for both CFS and ME patients currently parked in a Diagnostic Terminal. Indeed, the WPI group has already suggested that a new disease entity – X associated neuro-immune disease, or XAND – might arise from the rubble, implying (one assumes) that the one-third of ME/CFS patients found to be “negative” for XMRV in the WPI report would also acquire new, more appropriate diagnoses.

Like Dr Dan Peterson, medical director of the WPI, we are hopeful. As he says, “Patients with ME/CFS (XAND) deal with a myriad of health issues as their quality of life declines. I’m excited about the possibility of providing patients who are positive for XMRV a definitive diagnosis, and hopefully very soon, a range of effective treatment options.”

The Whittemore Peterson Institute has a very useful page of “Questions and Answers” on this topic, including items on clinical and treatment aspects.

Links to scientific coverage of the story

* Whittemore Peterson Institute Press Release
* Science News: Retrovirus might be culprit in chronic fatigue syndrome
* New Scientist: Chronic fatigue syndrome linked to `cancer virus’
* Scientific American: Retrovirus Linked to Chronic Fatigue Syndrome, Could Aid in Diagnosis
* Nature: Virus linked to chronic fatigue syndrome
* NIH News: Consortium of Researchers Discover Retroviral Link to Chronic Fatigue Syndrome

RSM “Medicine and me” event: Commentary by John Sayer

Royal Society of Medicine “Medicine and me” event on ME and CFS held Saturday, 18 July 2009

Commentary

John Sayer (Chair, M.E. Support-Norfolk)

25 July 2009

The half-day conference was organised jointly by the Royal Society of Medicine, the MEA, AfME, AYME, the 25% ME Group and TYMES Trust.

The promotional literature informed us that:

“‘Medicine and me’ conferences, initiated and developed by the Royal Society of Medicine, are specifically designed for patients. These meetings bring together patients, their families, carers, advocates, patient support groups, clinicians and researchers to discuss care and research issues in a particular condition…[and]…aim to provide a forum in which patients’ concerns about their illness are given top priority.”

Unfortunately, the pattern of the day – two presentations at a time followed by a five-minute slot for questions – did not really provide for much in the way of patient-led questions and/or discussion. It was, however, an opportunity to see what the various bodies involved had to say for themselves (and encouraging to hear Jane Colby of TYMES Trust underline in her welcome address that the title of the proceedings was “Medicine and me: ME *and* CFS”).

(This write-up is based on notes taken at the time by myself and Gus Ryan.)

Session 1 was chaired by Dr Charles Shepherd (MEA), who reminded us that there had been two parliamentary meetings [i.e. the All-Party Parliamentary Group on ME and the Countess of Mar's ForwardME Group] earlier in the week and that people still had a chance to submit written evidence to the APPGME’s NHS service provision inquiry.

Dr Abhijit Chaudhuri (of the Essex Centre for Neurosciences) spoke on “A rational, efficient and practical approach to diagnosis”. He said that ‘CFS’ represents a wide group of patients and the term does not help matters; that there should be earlier diagnosis, perhaps three months into illness onset (six weeks where children are concerned). He does not think the NICE Guideline has helped. In his view, post-exertional malaise, muscle cramps and *well preserved motivation and interest* (my emphasis) are key symptoms of M.E. and referral should be to a neurologist, since even psychiatrists admit that roughly 10% of ‘CFS’ sufferers have a neurological problem. He said that we need a national centre and funding for it (Romford being a treatment – not research – centre). His talk ended with a slide presentation of inflammation of the dorsal root ganglion, which he pointed out was “the gatekeeper of sensations”.

In the question slot Ciaran Farrell asked how we could change the NHS – to much applause from the audience. Dr Chaudhuri repeated that we need a national research centre.

“M.E. in children and adolescents” was presented by Shannen Dabson, a teenager whose story struck a particular chord with me as a teacher (prior to M.E.). She has had M.E. for six years, and now has very little trust in adults, having received virtually no respect for herself and her diagnosis. She found herself “written off” by her school, who didn’t send her work, didn’t mark the work she managed to do, didn’t send her the school newsletters or keep her informed of such things as the school photographs (which was the part that had me closest to tears, as I’d suffered the same treatment from my last employer: I will never forgive them for my absence from the school photograph of my form pupils; for both Shannen and me, it was like being airbrushed out of history). Shannen had had to make her own arrangements for taking exams, as her school refused to enter her on the grounds of a poor attendance record. To her admirable credit, she got six GCSEs anyway! I’m hoping to reproduce her talk for “MES-N” members, as it should be inspirational, especially for youngsters. She came up with what I personally consider to be a very practical, appropriate and *scientifically sound* slogan: “Work smarter, not harder!”

Hardip Begol (of the Department for Children, Schools and Families) spoke on “Addressing the educational impact of ME”, and said that Shannen’s situation is all too common from an educational point of view and that it was difficult to make teachers believe in ME/CFS. No personal disrespect to Mr Begol, but it struck me that what he had to say in his presentation did not have all that much immediate relevance, being, as one might expect, current government ‘fudge’. His comments were not actually specific to M.E., but here’s hoping that the conference gave him something to think about and take back to the DfCSF (though I’m not really holding my breath on that one).

In the question slot following these two talks Mary-Jane Willows (of AYME) said that the balance of power was with schools and Jane Colby pointed out that parents are too afraid to complain. (Personal note – no wonder, with the spectre of Social Services waiting in the wings, ready to pounce.)

Catriona Courtier (of the West London M.E. Self Help Group) spoke on “Treatment: the patient’s perspective”. She has had M.E. for twenty six years and her daughter is also ill. She reminded us that an AfME survey revealed that patients received very little proper treatment and that an MEA survey demonstrated that graded exercise therapy (GET) was the most dangerous form. She is ‘anti-NICE’. She said that staff at her local clinic *want* to help – but are misinformed.

Prof Anthony Pinching of the Peninsula Medical School, Plymouth, spoke on “Treatment – evidence-based and pragmatic approaches” and thinks that things are changing for the better. In his view, M.E. is a physical illness with psychological consequences and that people should work together and “not lob bricks at each other”. He said that the Cornwall service does make home visits. He advocates a ’symptom-control’ approach: which symptoms does a patient want most help with? I found him to be a bit vague and general, really, and he seemed to be saying that every individual needs different treatment (including psychological approaches), to be negotiated between patient and physician, and seemed to imply that success depended on the doctor-client relationship (which I personally find a bit too New-Agey: “permission to be ill and permission to have fun whilst you’re ill”). He did, however, say that there is a need for “building M.E. into the medical curriculum” (note – although it depends on exactly *what* is built in!). In response to a question about CBT from Dr Charles Shepherd, he indicated that such treatment should be ‘individualised’.

In the question slot Dr Chaudhuri expressed disagreement with Prof Pinching, saying that patients are *not* listened to and that the NICE Guideline is aimed at a *broad* group – these points being applauded by the audience. Prof Pinching responded that the NICE Guideline is not perfect, but should be used “to best effect”.

After a short (very short!) break, Sir Peter Spencer (Chief Executive Officer, AfME) chaired Session 2.

Dr Neil Abbott (ME Research UK) spoke on “Research: what do patients want and why isn’t it happening?” He suggested that the RSM host a biomedical conference on M.E. (Applause!) He said that the psychosocial model is predominant in the UK, although not quite so much in the US. He quoted Prof Simon Wessely with reference to psychosocial interventions: “certainly, those interventions are not the answer to CFS”. MERUK survey reveals that research on mitochondria, RBCs, immune cells, muscles, blood vessels, genes and brain are wanted; that this is not  “sexy” illness. ‘ME/CFS’ label is a problem: it is a process of elimination and that leads to a dustbin diagnosis. He is critical of the psychosocial approach, which is applicable to *all* illnesses (used to manage symptoms) and not specific to M.E. The real problem, in his view, is lack of funding.

Prof Stephen Holgate (University of Southampton) spoke on “ME: a research orphan for too long”. He said we need research because too little is known [sic] and said that the history of M.E. has dictated a mental health approach, it being perceived as having evolved from neurasthenia ['nervous debility']. He said, “It’s a system disorder” and that ‘omics’ should be used – i.e. genomics, proteomics and metabolomics. He referred to ‘ME/CFS’ as a “condition or conditions (25 or more)”; that the government won’t allow integrated research. He is putting together a workshop in November (the Medical Research Council Interdisciplinary Expert Group on M.E.), a systematic review deciding priorities, saying that a collaborative needs to be formed from charities [sic], the MRC and researchers, and that there is a need to ‘join up’ patients from clinics/centres. [Personal note: it all seemed to me a bit like reinventing the wheel and I have my misgivings about not only which 'charities' will be invited to participate but also the calibre of patients from the clinics/services.]

Dr David Misselbrook (Dean of the RSM) then invited questions to the panel of speakers. An elderly neuroscientist and his grandson tried to deliver a plug for the Lightning Process, the grandson claiming we had “wasted all this time talking when a cure has already been found” [sic], but Dan [from "M.E. Support-Norfolk"] pointed out that we hadn’t come all this way to hear a sales pitch for LP and Jane Colby expressed serious misgivings about success claims, citing an example of further harm caused to a patient; she also pointed out that no one can legally claim recompense if LP doesn’t cure a patient as it is not offered as a treatment, but a ‘training’.

Ciaran Farrell challenged Prof Holgate’s ‘history’ of M.E. but Prof Holgate said he had been misunderstood, that it wasn’t his own belief that M.E. was a form of neurasthenia and that he agreed with Ciaran, adding that he wanted to get rid of the terms “CFS” and “M.E.” [whatever that implies!].

In “Closing remarks”, Mary-Jane Willows said that there should be quick diagnosis, raising of awareness and no “one size-fits-all” approach. Doris Jones (of the 25% ME Group) read out a list of M.E. sufferers who have died and requested a minute’s silence in their memory, which was dutifully observed.

All in all, in my own opinion? A worthwhile day in order to find out what is going on in various quarters, but throughout the proceedings I did wonder who the ‘target audience’ was supposed to be, and for whose benefit this had all been arranged. Was it a ‘box-ticking’, ‘patient consultation’ exercise? The subtitle of the event, “Hearing the patient voice”, was a bit misleading, since we were mostly being talked at, not listened to; there certainly wasn’t enough time, as I said at the beginning, for much questioning or discussion. But maybe some of what was said will pay dividends. Fingers crossed.

John Sayer, Chair
M.E. Support-Norfolk

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Ed Notes:

1] Terms of Reference for the MRC’s Interdisciplinary Expert Group on M.E. have yet to be agreed (FOI Act).

2] ME agenda is unable to enter into correspondence around the Lightning Process.

Invest in ME: Statement regarding Forward-ME

The Minutes of the last meeting of the Forward-ME group (a caucus group to the APPG on ME, convened and chaired by the Countess of Mar) held on Wednesday 8 July, at the House of Lords, can be read here on ME agenda or here on the website of Forward-ME.

Invest in ME, who are members of this group, have issued a statement in connection with Forward-ME and the last meeting of the group:

Invest in ME

[Forward-ME] Meeting 8th July 2009

IiME were not able to attend the meeting of this group on 8th July 2009 in London. As for every other meeting we submitted our comments to the Countess of Mar and all other members of this group in advance.

1 Attendance at Meetings and Visibility of Comments

We would like to return to our previous email (submitted in an email on 12th December 2008) where we stated the following -

We understand that, as we were unable to attend the last meeting, any decisions made at the meeting would not include our vote.

However, we see no reference in the minutes of either of the meetings to show that our views, as submitted in documentary form prior to each of the meetings, have been discussed or included in the discussions.

We would like to see that our comments have been entered into the discussions. Will the minutes reflect this?

We never received any response from our email of 23rd March.

2 GOSH medical meeting on ME/CFS in September to be discussed and the subject of Lightning Process

In the next meeting the subject of the GOSH at a day long medical meeting on ME/CFS in September is to be discussed and the subject of Lightning Process.

Mary-Jane from AYME has written “I share your concerns about this (LP) being included in the meeting”

We find this strange and hypocritical.

AYME have advertised LP for its members and freely allow discussion without seemingly making any critical comment on the lack of a research base, the numerous cases where people have been made worse and the fact that the practitioners of LP are generally not registered healthcare practitioners and take no responsibility for the results.

To state that there are concerns seems to us to be hypocrisy.

One should also remember that AYME and AfME are not in a position to criticise GOSH for including behavioural therapies/businesses as most of their recent joint conference in Milton Keynes included known advocates of the behavioural causality for ME and also included an insurance company representative.

3 Questions for Esther Crawley CNRCC Children’s Services

We have the following questions for Esther Crawley.

In your CV it states that you published research showing “children with CFS/ME don’t go to school because they are unwell not anxious”. However, isn’t it true that you believe there is a condition termed Pervasive Refusal Syndrome (PRS)?

If the answer to i) is yes then what proof do you have of this, what research is there to prove this really exists?

If the answer to i) is yes then how many children who were diagnosed with ME have you believed to have PRS?

What medical tests do you perform on patients who are suspected of having ME/have ME?

Do you test for acute and/or reactivated infections?

From the minutes of the meeting it appears none of our points were discussed. IiME were informed by CoM [Countess of Mar] that the questions to Esther Crawley were not asked as they were not appropriate to the discussion. The minutes of that meeting are available here

Ends

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Please note that ME agenda is unable to enter into correspondence around the Lightning Process.  Please direct any enquiries regarding the content of the Minutes of Forward-ME meetings to the Chair of Forward-ME.  Please direct any enquiries regarding the content of Invest in ME’s statement to Invest in ME.

Examples of concerns raised by professional bodies about the NICE (draft) Guideline CG53 on “CFS/ME”

html version:  http://www.meactionuk.org.uk/Compilation_of_Professional_concerns.htm

Examples of concerns raised by professional bodies about the NICE (draft) Guideline CG53 on “CFS/ME”

by Margaret Williams  | 13 March 2009

In his Approved Judgment in the Judicial Review of the NICE Clinical Guideline 53 on “CFS/ME” released today, the Judge (Mr Justice Simon) stated:

“The circumstances are not such as to lead a fair minded and informed observer to conclude that there was a real risk of bias among the members of the GDG.”

Commenting on today’s Judgment, NICE’s Press Statement says: “Professor Peter Littlejohns, NICE Clinical and Public Health Director, responded to the High Court judgment saying…We are pleased that all members of the GDG and those involved in selecting the GDG were totally exonerated from the unfounded claims made against them”

(  http://www.nice.org.uk/media/001/6F/CFSMEJRJudgementStatement130309.pdf  ).

Read full document here on ME agenda: 14pp MS Word:  Compilation of Professional Concerns by Margaret Williams

Scottish Cross Party Group on ME: Julia Newton to speak at January meeting

Scottish Cross Party Group on ME: Professor Julia Newton to speak at January meeting

From the ME Association’s news page:

14 January 2009

Mingling ME politics and science at the Scottish Parliament

Members of the Scottish Parliament’s Cross Party Group on ME will hold their opening meeting of the year on Wednesday, January 21 – when they will have an update on the ME scientific research taking place at the University of Newcastle.

Julia Newton, professor of ageing and medicine at Newcastle, who is already well-known on the ME/CFS research conference circuit, will be the main speaker at the meeting will will be held in Committee Room 1 in the Parliament building. The meeting starts at 1pm and is expected to continue until 2.30pm.

Professor Julia Newton and her colleagues are developing studies into the autonomic nervous system and the role it plays in fatigue and cognitive impairment. She has already broken new ground with published work on primary biliary cirrhosis, a rare liver disease.

This year will see the publication of new guidelines for Scottish GPs on the diagnosis and management of ME/CFS – expected to be based partly on the ME Association’s own clinical management booklet ME/CFS/PVFS – an Exploration of the Key Clinical Issues, written by MEA medical adviser Dr Charles Shepherd and consultant neurologist Dr Abhijit Chaudhuri. The Cross Party Group has been consulted on the content of the new guidelines.

And the group is expected to keep up pressure on the Scottish Executive to carry out a nationwide needs assessment of ME/CFS to assist with the future provision of targeted health services for people with the illness.

People wanting to attend the meeting on January 21 are asked to notify the group secretariat in advance so that a list of the names of those attending can be made available to the parliament’s security staff. Please email Hazel Dawson hazel.dawson@afme.org.uk , or phone Hazel on 0141 353 9545.

Constitution of the APPG on ME: a clarification

Clarification regarding membership of the APPG on ME

May be reposted

I’d like to correct a misconception posted some months ago on the forum of the Benefits and Work site.

It has been posted that AfME (Action for ME), the MEA (The ME Association), AYME (Association of Young People with ME), TYMES Trust (The Young ME Sufferers Trust), The 25% ME Group, ME Research UK, BRAME (Blue Ribbon for Awareness of ME) and RiME (Campaigning for Research into ME) are all members of the All-Party Parliamentary Group on ME.

None of these are members of the APPG on ME.

In Associate Parliamentary groups, applications for membership may be accepted by the group officers from organisations, interest groups, commercial concerns and individuals other than MPs or Members of the House of Lords.

But the All-Party Parliamentary Group on ME is not constituted as an Associate Parliamentary Group and therefore only Members of the House of Commons or Lords are permitted membership of the APPG on ME, and only Members of the House of Commons or Lords have voting rights at its meetings.

So the only members of the APPG on ME are parliamentarians.

From the office of the Parliamentary Commissioner:

“Groups are only required to register with us the names of their officers and of 20 ‘qualifying members’. The full membership list, including names over and above that, resides with the group and it is for them to ensure that it is comprehensive and up to date. [...] Any MP (ie not just signed up members of the group) is entitled to turn up at any meeting of the group, and to speak and vote at the meeting – unless a subscription is charged in which case voting may be restricted to paid-up members of the group.”

The APPG on ME group’s current office holders and the twenty qualifying members (made up of cross party MPs and members of the House of Lords) can be viewed at the link, below.

http://www.publications.parliament.uk/pa/cm/cmallparty/register/memi389.htm

Under “BENEFITS RECEIVED BY GROUP FROM SOURCES OUTSIDE PARLIAMENT” AfME and The ME Association are listed as jointly providing the secretariat to the Group.

“Action for ME and The ME Association both provides secretarial support (addressing and stuffing envelopes, taking minutes, photocopying).”

AfME and the MEA alternate the task of minute taking and circulation of minutes and agendas for these meetings but they are not members of the APPG Group and their status as organisations and that of their representatives in relation to the Group is no different to that of any other organisation that sends a representative to attend these meetings.

Although APPG groups are not permitted to advertise their meetings as “Public Meetings”, meetings of the APPG on ME are held in House of Commons committee rooms and are open to members of the public, that is, national ME patient organisations, representatives of the committees of “local” and regional ME support groups and other interested parties; they are also open to individual members of the ME community and their carers, who can and do regularly attend and contribute to these meetings.

So none of the five national registered membership ME patient organisations listed above are members of the APPG on ME but they attend APPG meetings, send their representives to meetings, and in the case of AfME and the MEA, provide the secretariat function.

ME Research UK : a research organisation and a registered charity (Scotland), represented at APPG on ME meetings by Mrs Sue Waddle, a former trustee of Invest in ME.

BRAME : unregistered, non membership, run by Christine Harrison and her daughter, Tanya. Both Christine and Tanya attend APPG on ME meetings.

RiME : unregistered, non membership, run by Paul Davies. Paul Davies attends APPG on ME meetings, sometimes supported by other individuals.

A number of ME sufferers and carers of ME sufferers attend APPG on ME meetings and their names are sometimes listed as attendees in the minutes of meetings and their contributions to these meetings minuted.

I hope this clarifies any misconceptions about policy and proceedings at these meetings and the status of the organisations and individuals who attend them.

A Guide to the Rules on All Party Groups can be downloaded here:

http://www.parliament.uk/documents/upload/PCFSGroupsRules.pdf

The Countess of Mar’s meeting with ME patient organisations

[This post is an updated version of a posting first published on 2 November.]

The Countess of Mar’s meeting with ME patient organisations: how was it decided who would attend and what are its objectives?

On 8 October, in the hour prior to the last meeting of the APPG on ME, the Countess of Mar chaired a private meeting with selected ME patient organisations.

In his summary of the APPG meeting which followed, Dr Charles Shepherd (MEA) wrote:

“[...] The Countess of Mar has kindly agreed to chair a further meeting of the group which will allow a more detailed discussion of the issues to take place and look at how the various charities and organisations might work together on issues of common concern. She stressed that nothing was being done in secret and that the minutes of this meeting will be published in due course. The Countess of Mar is hoping to set up a website so that people can have easy access to the minutes and information about what the group is doing.”

The minutes of this private meeting have yet to be published and it’s still unconfirmed which organisations were invited to attend by the Countess of Mar, which organisations accepted her invitation and whether any organisations that had not been invited were successful in requesting that they should also be included.

Nor is it known what criteria were used by the Countess of Mar when deciding which organisations would be issued an invitation to participate in this meeting and any subsequent meetings that might be organised by her.  What was the rationale, for example, for the inclusion of the non membership organisation, reMEmber (The Chronic Fatigue Society)?

From the little information that has emerged, it is understood that representatives of the following organisations had been invited to attend the meeting - the membership organisations AfME, The ME Association, AYME, The Young ME Sufferers Trust and The 25% M.E. Group; the research organisation ME Research UK, the non membership organisation reMEmber (The Chronic Fatigue Society) and BRAME (Christine and Tanya Harrison).

In the October issue of Invest in ME’s newsletter, Invest in ME writes:

“IiME were recently invited to attend a meeting organised by the Countess of Mar in which she attempted to find common ground between different organisations involved with ME. On the first occasion we weren’t able to make the meeting but we provided the following input by email to the Countess which stated our position in relation to a number of points requested from all attendees at the meeting and why we feel progress has not been made with regard to ME.”

Invest in ME has since published its position response which can be read here and a copy is also appended – though it wasn’t generally known that Invest in ME had been amongst those organisations invited to participate in this meeting. 

It has been confirmed to me by Mary-Jane Willows (CEO AYME) that AYME had not been in a position to provide a representative to attend this initial meeting.

In October, Ian McLachlan published some concerns about this meeting and invited others to sign a statement which was forwarded to the Countess of Mar which can be read here

In a response to Mr McLachlan, in relation to a query about the inclusion of patient representatives, the Countess replied that she was open to receiving constructive written contributions from anyone within the ME community and the group will consider them.

If this is the case, why has the Countess of Mar not made this generally known and just what is the nature and remit of this “group”?

The Countess of Mar has mentioned plans for setting up a website for information about the business of this “group” – will this include a Statement of Objectives?

I have some questions and concerns about this meeting - or what now looks set to become a series of meetings to be chaired by the Countess of Mar:

1] On what basis and by whom was it decided how many and which organisations/patient representatives would be invited to attend the Countess of Mar’s meeting and any subsequent meetings which are planned? Did any other organisations/representatives apply to attend this meeting and were they turned down and if so, on what grounds?

2] We already have an established ME Alliance (albeit a rather nebulous body) who were understood to be reconvening earlier this year.

Who are the current members of the Alliance, who is the current convener and when is the next meeting of the Alliance anticipated? Does the current Alliance have a constitution and if so where can it be accessed? Does the Alliance intend to publish the agendas and minutes of any meetings it might hold in the future?  Did the proposed meeting, earlier this year, take place?

How does the current Alliance relate to this series of meetings now being held between the Countess of Mar and selected patient organisations?

3] Is it the intention that these meetings with the Countess of Mar might evolve into a replacement for the current, possibly moribund, Alliance and if so, is the aim to be more inclusive of a wider range of patient organisations/patient representatives than the Alliance has embraced in the past, for example, by extending participation to include The 25% M.E. Group, BRAME, Invest in ME, reMEmber (The Chronic Fatigue Society) and possibly other organisations and representatives?

Was RiME invited to attend this meeting with the Countess of Mar and if not, what was the basis for RiME’s exclusion? 
[I can now confirm that RiME was not invited to attend.]

If these meetings were to replace the current Alliance, then the appointment of the Countess of Mar to chair meetings of any new alliance/patient organisation group is another example of decisions made by the main charities behind closed doors, for the ME community has not been consulted over whether parliamentarians should be allowed membership of, or participation in an alliance of ME organisations/representatives or have influence over which organisations should be included in any reconstituted alliance.

3] Will the meetings of this “group” set a precedent for business being conducted away from public scrutiny at open APPG meetings to business being conducted at closed meetings?

Might these meetings lay the foundations for the current format of the APPG being replaced by an associate parliamentary group to which parliamentarians, the main charities and selected organisations are admitted membership but from which the ME patient community and members of the public would be excluded and representatives whose presence at APPG meetings may not be welcomed by the “establishment” group, marginalised?

Dr Ian Gibson has already expressed an interest in the concept of some kind of associate parliamentary group but one cannot assume that Dr Gibson’s vision of an associate group would necessarily accord with the needs and interests of the ME community. Many associate parliamentary groups also invite applications for membership from external agencies, commercial concerns, pharmaceutical companies and other interest groups. Would such a move be welcomed by the ME community?

4] What prompted the Countess of Mar to propose that she should hold this meeting with selected ME organisations? Does the Countess find it frustrating that the APPG on ME has to accommodate a range of diverse views amongst the various organisations as well as consideration of the views of members of the public who also attend these meetings or who have made written representations to the Chair of the APPG?

Is it envisaged that this “group” will be used as a filter of opinion and position on various issues which will then be fed back into the APPG as consensus, with a view to minimising discussion of certain issues at open APPG meetings – meetings which will then be used to rubber stamp decisions arrived at previously, behind closed doors?

We have already seen situations in the past where the “draft” wording for proposed EDMs and the “draft” Terms of Reference for the proposed NHS services inquiry have been put together in collaboration with one or more of the main charities and rushed through an APPG for agreement without adequate time for discussion and without prior consultation with the ME community over the content.

But whatever the rationale behind the calling of these meetings, Dr Shepherd has written: “The Countess of Mar is hoping to set up a website so that people can have easy access to the minutes and information about what the group is doing.”

Plans for a website and updates on “what the group is doing” suggests that the remit of this “group” is intended to be rather more proactive and enduring than merely the facilitating of a one-off discussion around “common ground”.

There seems to be some variance between the organisations invited to attend this meeting as regards to whether they prepared written responses in advance of the meeting to a series of questions on the Agenda.

I am advised that the 25% M.E. Group did prepare a written submission and copies were distributed to all those who attended the meeting.  A copy is published, below.  The 25% M.E. Group’s response sheet is signed “DJ” and I presume that Doris Jones attended the meeting as the representative for the 25% M.E. Group, though this has yet to be confirmed.

All organisations known to have participated have been asked whether they intend to publish any written responses submitted prior to the meeting or handed round at the meeting, itself.  I have received no replies to date, from the ME Association, reMEmber (The Chronic Fatigue Society) or BRAME.

Address for letters of concern:  The Countess of Mar, House of Lords, Westminster, London SW1A 0PW

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

25% M.E. Group: NOTES FOR CONSIDERATION TO BE BROUGHT UP AT THE 8.10.2008 MEETING WITH THE COUNTESS OF MAR

Main Aims and Objectives of the 25% ME Group?

a) Support severely affected members as well as possible with information and practical advice when needed.

b) Endeavour to secure appropriate treatment for severely affected members – CBT +/or GET are not meeting the needs of these patients.

c) Participate in talks, discussions and negotiations with governmental and other organisations in endeavours to secure a better deal for the severely affected, in relation to treatment, necessary social support and appropriate benefits.

d) Help to inform GPs and other healthcare professionals of the real nature of ME and the desperate need for proper help for patients.

What have been the obstacles to progress?

a) New Guidelines issued in 2007 by the DWP – Patients experience more problems getting necessary benefits.

b) The NICE Guideline – Patients report increasing problems in getting appropriate medical attention and care since the publication of this guideline.

c) The NHS Plus guideline on Occupational Aspects of the Management of CFS – A National Guideline – this has now been amended and hopefully will be more helpful for patients.

d) Disunity among UK ME/CFS Charities – some endorse the NICE Guideline, CBT and/or GET are accepted as being helpful to some patients with mild or moderate ME/CFS, but the severely affected find these approaches useless (CBT) and GET potentially harmful.

What are the solutions?

a) Put pressure on organisations like NICE to rewrite guideline or make necessary and appropriate amendments – support the applied for Judicial Review.

b) Put pressure on the DWP for necessary amendments to their new guidelines on CFS/ME.

It is important to bear in mind that ME/CFS is listed as a neurological disease not only in the WHO ICD-10 codes under G93.3, but it is also listed in the UK’s National Service Framework for longterm chronic conditions under neurological diseases, and it is listed as a neurological condition in the UK’s Read Code (under F286), which is used by GPs. Organisations like NICE, the DWP and others should be asked why they seemingly insist on maintaining an ambiguous stance on this issue.

How are the solutions to become actions?

a) It may be necessary to create or form a united UK ME/CFS (as opposed to CFS/ME) charity or Association which may be in a better position to put pressure on these organisations to stress the difference between the neurological disease ME/PVFS/CFS (as listed in ICD10-G93.3) as opposed to states of chronic fatigue, which come under various other headings and are deemed to be mental or behavioural disorders (such as Neurasthenia under F48) in the WHO ICD Codes.

b) Stress the different approach to diagnosis and treatment which is needed in these diseases and conditions. – CBT +/or GET may be beneficial to those patients who suffer from general chronic fatigue, but not those who suffer from the neurological disease ME/CFS (as most clearly defined in the 2003 Canadian guideline).

c) Achieve amendment of existing inappropriate / deficient guidelines (NICE + DWP).

d) Press the MRC and DoH/NHS for urgently needed funding to look into causes of ME/PVFS/CFS.

6.10.2008 DJ.

www.25megroup.org

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Invest in ME: Position responses tendered by Invest in ME for the meeting chaired by the Countess of Mar on 8 October 2008 which they were unable to attend:

http://www.investinme.org/Article-182%20CoM%20Cooperation%20Meeting%2001.htm

Cooperation Between ME Organisations

IiME’s input to the first meeting between representatives from ME charities and organisations – as organised by the Countess of Mar – October 2008.

In preparation for this meeting participants were asked to provide comments on several points. IiME were unable to attend the first meeting but sent in the document below.

What are the aims and objectives of your particular organisation?

Invest in ME is an independent UK charity campaigning for better education regarding ME/CFS and a national strategy of biomedical research into ME/CFS which will lead to correct diagnosis, valid treatment and cures for ME/CFS.

Our intention is to provide, where possible, free advice and information to people with ME/CFS, their families and also to healthcare organizations, physicians, researchers and the media.

We achieve this with our educational material and our annual biomedical research conferences.

Our main objectives are to facilitate development of a test which can properly diagnose ME/CFS and to facilitate or participate in finding treatments and cures for ME/CFS.

What have been the obstacles to progress (in getting ME patients better)?

To get ME patients better we feel we have to look at this logically.

The Name

Firstly, the name itself.

If we are using different names then it is difficult to agree on a consensus and difficult for patients, healthcare organizations and the media to be consistent when dealing with ME/CFS.

Without agreement on the name of the illness for we are campaigning then it would be difficult to agree on anything else. For example the NICE definition of the illness (they use CFS/ME or CFS) with fatigue plus one symptom is bound to include almost anyone from depression to burnout to misdiagnosed, rare illnesses. This isn’t acceptable.

ME/CFS is as described in the WHO classification ICD-10 G93.3 and stands for myalgic encephalomyelitis. This name should be used as standard when referring to ME or ME/CFS.

We should standardise on this name and force a similar standardisation amongst healthcare organisations.

ME and ME/CFS are considered to be the same for the purposes of this document.

Diagnosis

If the definition of the illness is vague (if the name is not agreed upon, the symptoms therefore not agreed, the diagnostic criteria not standardized) then, of course, the diagnosis and the treatment will be liable to be incorrect.

Misdiagnosis is a major problem.

To enable correct diagnosis then a set of diagnostic guidelines needs to be in place to enable proper and correct identification. The lack of a common set of guidelines has allowed too much flawed research to be funded thus wasting valuable time and money. This has been a major obstacle in obtaining progress for people with ME/CFS and has allowed far too many cases of missed or misdiagnosis to occur.

Biomedical Research

The lack of funding for biomedical research is a clear impediment to progress on treating and curing people with ME/CFS.

Without this then erroneous perceptions of ME can continue and valuable funding can be lost to flawed research priorities, enabling those not interested in curing people with ME to continue to monopolise scarce funding.

NICE

None of the above issues have been helped by the recent NICE guidelines. That document at best will do nothing and at worse will perpetuate false views of the pathology and therefore treatment of people with ME/CFS.

Therefore to summarise the first point the following obstacles are already in place -

a Lack of correct, standard terminology
b Lack of proper or correct diagnosis
c Lack of consistent clinical diagnostic criteria from being applied
d Lack of funding for biomedical research
e NICE

What are the solutions?

Clear usage of one name for this illness – ME/CFS (as defined by WHO ICD 10 G93.3) – myalgic encephalomyelitis. This clearly presents problems for other groups who may rely on the subscriptions from a broad range of members with varying conditions, not all of them having ME/CFS. However, this is one of the reasons for lack of progress on clearly identifying the illness and appropriate treatment(s).

Standardisation on one set of guidelines for diagnosis. Currently the Canadian guidelines are clearly the best for ME/CFS as they have been purposely written for ME/CFS and are already in use in many countries. Adoption by everyone of the CG will send a clear message to all of the correct way forward.

The promotion of these guidelines in healthcare organizations and government circles will provide benefits for patients and healthcare staff and help to avoid misdiagnosis.

We need to establish a strategy of funding for biomedical research into ME/CFS in the UK. Funding needs to be made available and a concerted campaign needs to continue to lobby for this.

There needs to be an emphasis on establishing biomedical clinics to treat people with ME/CFS and the removal of clinics offering purely psychological therapies.

How are the solutions to become actions?

All organisations need to recognise Myalgic encephalomyelitis as the name for ME/CFS and also use ME/CFS when referring to the illness.

The Canadian Guidelines need to be adopted by all ME organizations and the government, DoH, NHS, CMO and MRC). The CG need to be distributed to all healthcare professionals treating people with ME/CFS.

Some of the actions required to benefit people with ME/CFS and their families will be outside the control of support organizations. However, the above points would standardize the “ME landscape” and influence, we believe, policy making. Once these basics are in place then it will directly affect the outcomes in other areas (such as benefits issues and inappropriate treatments being forced on patients by insurance companies).

Any clinics treating people with ME/CFS need to adopt a biomedical approach to this illness.

The peer review system of the MRC needs to be challenged and made transparent so that biomedical research applications are seen to be given as much of a chance for funding as is currently provided to psychiatric research proposals.

The current NICE guidelines need to be rejected by the ME community.

www.investinme.org

NICE Judicial Review documents: Margaret Williams

Margaret Williams has issued a series of documents which have been created specifically for the NICE Judicial Review. These are being circulated by Stephen Ralph and are also available from the MEActionUK website.  I will be adding these to this page as they are released, so please check from time to time for new additions.

Stephen Ralph has created a page for all Judicial Review documents and this can be found on a button at the top of the main page of  www.meactionuk.org.uk

Alternatively you can find the page directly by clicking on this link:

http://www.meactionuk.org.uk/nicejr.htm

Please note that there is some duplication of documents already published.

 

Document 1: http://www.meactionuk.org.uk/Background_Information_re_CBT.htm

Background information and illustrations of evidence that CBT cannot improve ME/CFS which NICE disregarded

Margaret Williams 25 July 2008

 

Document 2: http://www.meactionuk.org.uk/Facts_re_GET.htm

Evidence that the Guideline Development Group that produced the NICE Guideline on CFS/ME (C53) failed to fulfil its remit

(particularly in relation to the potential dangers of graded exercise therapy)

Margaret Williams 7 July 2008

 

Document 3: http://www.meactionuk.org.uk/Cardiovascular.htm

Evidence of cardiovascular problems in ME/CFS that NICE disregarded

Margaret Williams 4 August 2008

 

Document 4: http://www.meactionuk.org.uk/Immunol_and_neuroendo.htm

Immunological, neuroendocrine and neurological evidence (including evidence of CNS inflammation) documented in ME/CFS that NICE chose to ignore in the production of its Clinical Guideline 53

Margaret Williams 31 August 2008

The Medical Research Council: a case to answer? Dr Neil Abbot

The Medical Research Council: a case to answer?

Dr Neil Abbot ME Research UK

[ A pdf version of this article can be downloaded from
http://www.meresearch.org.uk/information/publications/Breakthrough_Autumn2008pp8-9.pdf ]

In May 2003, the Medical Research Council (MRC) announced its “research strategy for CFS/ME”, widely welcomed as the first formal research strategy for the illness. It listed a number of strategic themes of particular importance (case definition, epidemiology, pathophysiology, interventions, health service research, research capacity and the value of lay participation). Subsequent initiatives by the MRC included the issue of a notice highlighting CFS/ME as a current strategic priority (2003), a CFS/ME workshop (2003), and a “Joint Action for ME” workshop (2006).

So, what research has since been funded? Well, at least five separate studies (see TABLE 1 below)costing at least £3,180,900 have been supported. From the bald titles, it is impossible to determine what each involves, but it seems that three fall far short of being definitive (one is for “indirect support”, one is for a “CFS-like illness”, and one is simply a feasibility study, albeit an expensive one), while the remaining two are randomised clinical trials (RCTs) of psychosocial strategies.

From details published in the National Research Register (before it ceased publication in October 2007), we know that the largest (PACE) trial is a four-arm RCT comparing cognitive-behavioural therapy (CBT), graded exercise therapy (GET), adaptive pacing and “usual medical care” alone. As its blurb explained, “CBT will be based on the illness model of fear avoidance… GET… on the illness model of deconditioning and exercise avoidance”.

The FINE trial, by contrast, offers severely affected patients supportive listening, GP “treatment as usual”, or a nurse-led self-help approach which includes elements of CBT and GET delivered in the patient’s home (four 90-minute sessions, with six 30-minute phone conversations over 18 weeks), with a qualitative interview to explore “patient views on illness causation, beliefs about chronic fatigue… and previous experience of treatment and doctor-patient relationships”.

In total, approximately 91% of the total grant-spend on ME/CFS in five years has gone on trials of non-specific management and coping strategies. It is important to point out, however, that neither of these trials is actually worthless; in an ideal world in which £100 million had been invested over five years in ME/CFS research, a 3% spend on assessing the usefulness of various coping strategies, such as CBT, relaxation or meditation, might have been acceptable. The point at issue is that most of the MRC’s inadequate grant-spend has gone on this aspect at the expense of truly biomedical research.

Thanks to the Freedom of Information Act, and the stalwart patients who have repeatedly requested information, we have a (fuzzy) picture of the research projects which the MRC has NOT funded to June 2008. They seem to total at least 33 (see TABLE 2 below), some biomedical and targeted at pathophysiology. It is unlikely that these 33 applications were so badly written that they could be rejected (since some were from established researchers with a track record in this and other fields, as our personal communications have established). So, was their scientific basis less sound than, say, the “pragmatic rehabilitation” of the FINE trial, supported by RCT data on ambulant patients but only a case report on the non-ambulatory patients of particular interest?

There are three main schools of thought about what has gone on. First, that within the MRC the biopsychosocial model of ME/CFS is the current paradigm, leading referees and committee members to be chosen, probably unwittingly, to deliver a particular outcome (since psychosocial aspects colour the perception of the illness across the board, this would be no surprise). Second, that the MRC is simply a large stolid bureaucracy for which ME/CFS biomedical research has very low priority indeed given the other demand on its resources (£1.3 billion in 2008 for all types of research on all illnesses). Third, that something even more fishy is going on.

In the summer of 2008, an answer to a parliamentary written question revealed that the MRC is to constitute a CFS/ME multi-disciplinary panel. If this is a genuine attempt to kick-start biomedical investigation rather than a public relations exercise, the mystery panel’s first act could be to discover whether or not the MRC has a case to answer over the non-funding of biomedical research since 2003.

TABLE 1: “CFS/ME” projects currently funded by the MRC (Sources: MRC website; Hansard, written answers)

1. Two large clinical trials of new approaches to treating CFS/ME:

a) PACE (Pacing, Activity and Cognitive Behaviour Therapy: a Randomised Evaluation, £2,076,363) [Prof. PD White, Psychological Medicine, Queen Mary and Westfield College]

b) FINE (Fatigue Intervention by Nurses Evaluation, £824,129) [Dr AJ Wearden, Psychological Science, Uni. of Manchester]

2. A preliminary epidemiological project to test the feasibility of identifying the risk factors for persistent symptoms of fatigue and abdominal and widespread pain (£118,263) [Prof. F Creed, Psychological Medicine, University of Manchester]

3. An epidemiological study to assess ethnic variations of the prevalence of a CFS-like illness, associations with potential risk factors, and coping behaviours (£162,145) [Prof. K Bhui, Cultural Psychiatry and Epidemiolgy, Queen Mary and Westfield College]

4. Indirect support through a trial exploring the management of patients with persistent unexplained symptoms [Specifics unknown]

5. One project was mentioned in Hansard (12th June 2008) but is not on the MRC website: General and specific risk markers and preventive factors for chronic fatigue and irritable bowel syndromes (£367,000) [Dr C Clark, Centre for Psychiatry, Barts and The London School of Medicine]

TABLE 2 Unfunded applications to the MRC between 2002 and 2008 by Time-frame (number of applications) and CFS/ME subject area

2002 to 2005 (11 total): Neurophysiology of fatigue; Population-based/epidemiological studies (4 applications); Neurotransmitters and stress; Neuroimaging; Clinical and laboratory characterisation physiology/diagnosis); Dietary intervention – RCT; Facilitated self-help – RCT; Psychosocial and genetic factors in young people

2005 to 2006 (12 total): Pathophysiology, including studies regarding genetics/biomarkers,  immunology and neuroimaging (7 applications); Population-based/epidemiological studies (3); Primary care study; Experimental medicine study

2006 to April 2007 (7 total): Cognitive outcomes in children – pathophysiology; Epidemiological studies – epidemiology; Biomarkers; Pathophysiology (2 applications); Molecular pathogenesis – pathophysiology; Molecular and genetic characterisation – pathophysiology; Neuroimaging – pathophysiology

May 2007 to June 2008 (3 total): Biomarkers – pathophysiology; Management and treatment – intervention; Management and treatment – observational study

ENDS

Dr Neil Abbot
ME Research UK
The Gateway
North Methven St
Perth PH1 5PP, UK
http://www.meresearch.org.uk