Category: Prof Hooper

Review of Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk by Chris Douglas

Shortlink to this posting:


At the 5th Invest in ME International ME/CFS Conference held in May, this year, a proposal was announced for the establishing of a “Centre of Excellence for ME” in Norfolk. To the best of my knowledge, Invest in ME had undertaken no national consultation with ME patients before drawing up its proposals.

Today I am publishing a review of Invest in ME’s proposal prepared by Chris Douglas.

A text version of this review is published in the next post.


Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

By Chris Douglas

27 August 2010


In August 2010, Invest in ME (IiME) published a document titled: ‘A New Era in ME/CFS Research: An Opportunity for Major Progress in Diagnosis, Treatment and Research into Myalgic Encephalomyelitis’¹.

It is assumed that this document is a precursor to a more formal and detailed proposal that will be used to secure consultative input and financial commitment to the project.

The following review highlights specific areas in which the proposal could be strengthened if, in particular, it is to maximise commitment from potential financial donors.

Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

Open Word document here: Norfolk Proposal Review 27.08.10

A text version of this Word document is published in the next post


Related information

Invest in ME

“Invest in ME is an independent UK charity campaigning for bio-medical research into Myalgic Encephalomyelitis (M.E.), as defined by WHO-ICD-10-G93.3.”

Invest in ME is constituted as a Trust, registered with the Charity Commission and run by a committee of three Trustees/Directors. Invest in ME is not a membership organisation. The organisation was founded in 2006 by carers and patients, Sue Waddle, Richard Simpson and Kathleen McCall (current chair). Ms Waddle has since stood down as a Trustee.

Invest in ME

A UK Centre for Biomedical Research into ME

Read the announcement here

The Research Proposal published by Invest in ME in July can be read here in PDF format:

       Biomedical Research Institute Proposal July 2010

“A New Era in ME/CFS Research 

“An Opportunity for Major Progress in Diagnosis, Treatment and Research into Myalgic Encephalomyelitis”


“Recent biomedical research and advances in knowledge and treatment regarding Myalgic Encephalomyelitis have brought more urgently needed awareness of this disease. In the East Anglian region of UK an opportunity now exists to bring real benefit to patients and establish a unique capability which will attract attention and recognition from across UK and Europe.”


Media coverage

Great Yarmouth Mercury

Hopes for ME centre in Norfolk raised

31 August 2010

“…The independent charity will carry out the official campaigning for funding for the centre once a formal agreement is made.

“Now the charity has offered to send some of the UEA researchers to a biomedical research symposium in Australia at the end of the year.

“Mr Simpson said: “This would involve them discussing work with the top ME researchers and clinicians in this field from around the world.

“Discussions are under way, and we are really hopeful this will move things forward. The centre could change the lives of patients with ME. Early diagnosis is so important, and this centre would help establish that.’

“The charity is also planning to organise a conference in Norwich with the UEA and the Norfolk and Norwich University Hospital and is lining up discussions with the US Whittemore Peterson Institute, an institute for neuro-immune disease in Nevada that helps thousands of people with ME through research, scientific developments and treatment…”


Norwich Evening News

Plans for world class Norfolk centre

Sarah Hall  |  27 August 2010


Environmental Illness Resource Blog

UK to get WPI Inspired Chronic Fatigue Syndrome Research and Treatment Centre

News – Chronic Fatigue Syndrome News

Matthew Hogg  |  13 August 2010



Norwich centre for ME sufferers planned

Sarah Hall  |  3 August 2010

Telegraph: Letters to the Editor: Breaking the ME enigma (jointly signed by ME spokespersons)

Telegraph: Letters to the Editor: Breaking the ME enigma (jointly signed by ME spokespersons)


Telegraph  |  06 February 2010

Breaking the ME enigma

SIR – The death of Lynn Gilderdale and the humane verdict in the trial of her mother brought home to many people for the first time what a devastating illness myalgic encephalomyelitis (ME) can be.

Many of the estimated quarter of a million people with ME in Britain experience not only extreme pain and disability, but also incomprehension, ignorance, lack of sympathy and at times outright hostility, not only from the public but also from professionals responsible for their care.

Such lack of understanding even extends to blaming parents for the severity of their child’s illness.

It is time the nation began to take ME seriously. Provision of adequate clinical and other services by properly informed and sympathetic professionals is currently subject to a postcode lottery. Such provision should avoid inappropriate treatments, and range from support for home tuition for school-age children to respite care for the severely affected.

Above all, we should fund biomedical research to resolve the enigma of the underlying pathology of this illness. We should build on recent scientific advances to develop effective treatments, so that no one in future need experience the pain, isolation and despair that were Lynn Gilderdale’s fate.

Countess of Mar
Secretary, All Party Parliamentary Group on ME
Dr Neil Abbot
Operations Director, ME Research UK
Jane Colby
Executive Director, The Young ME Sufferers Trust
Anne Faulkner
Hon Director, CFS Research Foundation
Tanya Harrison
Chairman, BRAME
Malcolm Hooper
Emeritus Professor of Medicinal Chemistry, University of Sunderland
Andy Kerr MSP
Dr Jonathan Kerr
Consultant Senior Lecturer, St George’s, University of London
Simon Lawrence
Chairman, 25 per cent ME Group
Kathleen McCall
Chairman, Invest in ME
Dr Luis Nacul
Consultant in Public Health, London School of Hygiene and Tropical Medicine Professor
Derek Pheby
National ME/CFS Observatory
Neil Riley
Chairman, ME Association
Dr Charles Shepherd
Dr Nigel Speight
Sir Peter Spencer
Chief Executive Officer, Action for ME
Des Turner MP
Chairman, All Party Parliamentary Group on ME
Dr William Weir
Mary-Jane Willows
Chief Executive Officer, Association of Young People with ME
Andrew Stunell MP
Vice Chairman, All Party Parliamentary Group for ME

Documented involvement of viruses in ME/CFS: M Williams 30 December 09

Documented involvement of viruses in ME/CFS by Margaret Williams

One of a series – see notice below


Full text here in MS Word format: Documented involvement of viruses in ME 30.12.09

and at:

Documented involvement of viruses in ME/CFS

by Margaret Williams

30 December 2009

For decades it has been known and shown that viruses play a role in ME/CFS. Now there is evidence of a direct association with a gamma retrovirus – XMRV – that disables the immune system in ME/CFS, thus allowing numerous latent viruses to re-activate, which could result in the protean symptomatology…


Magical Medicine: How to make a disease disappear – Hooper and Williams – Spring 2010

Prior to the publication of the MRC PACE Trial results in the Spring of 2010, Professor Malcolm Hooper and Margaret Williams will be releasing a series of linked documents addressing central flaws in the PACE Trial.

These documents form part of a more substantial document that has the provisional title

Magical Medicine: How to make a disease disappear

This document has a dedicated web page at:

This web page will contain an easily accessible Contents page so that people can surf and then select whatever section (or part of a section) they may wish to look at.

Although he and Margaret Williams have previously addressed some of the issues contained in the substantial document, Professor Hooper thinks it essential for there to be a single, comprehensive narrative of events and information leading up to and involving the PACE Trial.

Magical Medicine: How to make a disease disappear

Professor Malcolm Hooper and Margaret Williams

Spring 2010

Documents already published that form part of the larger PACE Response document:-

1. Interstitial cystitis and CFS (26th August 2009)

2. More evidence of inflammation in ME/CFS (14th November 2009)

3. The role of viruses in ME/CFS // XMRV (21st November 2009)

4. The MRC’s secret files on ME/CFS (10th December 2009)

5. Statements of concern about CBT/GET for the Judicial Review (12th December 2009)

6. Can the MRC PACE Trial be justified? (17th December 2009)

and now this latest one:

7. Documented involvement of viruses in ME/CFS (30th December 2009)

Statements of Concern about CBT and GET provided for JR: Margaret Williams 22 July 2009

Statements of Concern about Cognitive Behavioural Therapy and Graded Exercise Therapy provided for the High Court Judicial Review of February 2009

by Margaret Williams

22 July 2009

This document together with previous articles and commentaries by Margaret Williams can be found at ME Action UK

Over twenty renowned ME/CFS experts provided Statements in support of the Judicial Review of the NICE Guideline on “CFS/ME” heard in February 2009 in the High Court in London. They were specifically written in support of the challenge to the NICE Clinical Guideline on “CFS/ME” and they express concern about the recommendation by NICE that the only management of ME/CFS should be CBT and GET (the same interventions that are the subjects of the Medical Research Council’s PACE Trial).

None of the Statements was accorded the recognition that they merit.

Extracts from those Statements (some of which were of considerable length) are now being placed in the public domain in the interests of ME/CFS sufferers and those who support and care for them.

· “In my view, the Guideline is biased and over rigid in its recommendations and will put a large number of ME sufferers at risk of harm through its strong recommendations for the use of CBT and GET. CBT is based on the idea that somatoform disorders are maintained by abnormal or unhelpful illness beliefs which lead to abnormal or unhelpful behaviour. The first requirement for a somatoform diagnosis is that there be no physical cause for the symptoms. This is not the case in ME/CFS” (Malcolm Hooper, Professor Emeritus of Medicinal Chemistry, University of Sunderland, November 2007)

· “Two forms of treatment…are CBT and GET. CBT is a psychological treatment. Its application in what is certainly an organic disorder is basically irrational. Its putative mode of action is based on the proposition that patients with ME/CFS feel unwell because they have an ‘abnormal illness belief’, and that this can be changed with CBT. It has never been proven to be helpful in the majority of patients with ME/CFS. GET comprises a regime of graded exercise, increasing incrementally over time. It has been almost universally condemned by most patient groups. A number of patient surveys have shown it to be, at best, unhelpful, and at worst, very damaging. Its application is counter-intuitive, particularly when one of the most debilitating and well recognised symptoms of ME/CFS is post-exertional malaise which can put some patients in bed for days after relatively trivial exertion” (Dr William Weir, Consultant Physician, November 2007)

· “The GDG has placed undue reliance upon a small number of RCTs that were methodologically flawed because they did not adequately define the patient population” (Dr Terry Mitchell, formerly Consultant Clinical Lead (CNCC) of the Norfolk, Suffolk & Cambridgeshire NHS ME/CFS Service, 23rd June 2008)

· “The predominance of psychologists / psychiatrists on the GDG is entirely inappropriate and has led to a biased analysis in my opinion. The GDG has placed undue emphasis on a few UK clinical trials which support the use of psychological treatments, however, these studies did not properly or adequately define their patient population” (Dr Jonathan Kerr, Hon. Consultant in Microbiology; Consultant Senior Lecturer in Inflammation; Principal Investigator of the CFS Group, St George’s University of London, 11th August 2008)

· “You will see from my attached treatise that I consider that the recommendation of CBT and GET as blanket treatments of ‘clinically excellent’ first choice is extremely dangerous to patients. I am concerned that NICE claims that an adequate evidence base supports CBT/GET, when in fact the Guideline Development Group (GDG) relied almost exclusively on a handful of extremely controversial RCTs (random controlled trials). I have no doubt that patients in the research quoted by the GDG did not have ME/CFS” (Dr Irving Spurr, Newcastle ME Research Group; 12th August 2008)

· “My overall impression reading the Guidelines for the first time was one of alarm. I will limit my comments to the deficiency which has the greatest potential for harm to patients. The NICE Guidelines do not make any reference to the biomedical literature on ME/CFS. A physician who is new to the field and who has not had time to read the thousands of paper reporting measurable abnormalities in ME/CFS may get the impression that: (1) Biomedical issues are irrelevant in ME/CFS and that (2) CBT and GET actually make the core symptoms of people with ME/CFS better. A close read of the literature reveals that none of the core symptoms of ME/CFS improve with CBT or GET. The recommendation for GET stems from the often quoted but unproven assumption that deconditioning causes or exacerbates ME/CFS. In fact this assumption has been disproven (Bazelmans et al 2001; Harvey et al 2008) and cannot therefore be used as a basis for treatment. Informed consent is an ethical requisite in the practice of medicine. Informed consent requires that patients embarking on any therapy be told the potential benefits and risks of the therapy being recommended. Meeting this legal standard in ME/CFS requires that patients be told about the potential benefits and risks of CBT/GET. If patients are being coerced to believe what is not true, psychological trauma can result. If patients are pushed to increase activity beyond their capabilities, exacerbation of symptoms can be expected. The NICE Guidelines are biased towards a particular model of CBT/GET that is widely viewed as ineffective and potentially unethical” (Dr Eleanor Stein, Consultant Psychiatrist, Calgary, Alberta, Canada, 12th August 2008)

· “(Graded exercise therapy) is not therapy – it is simply the enforcement of an opinion rather than a treatment based upon any scientific examination of a patient’s pathology and treatment of that pathology. I believe that those who developed (the) graded exercise programme as a valid treatment of ME have already been soundly criticised to the Courts. I also believe scientific evidence that such a programme is against the best interests of ME patients has already been presented. The benefit of such a programme is to the interests of the insurance industry and not the patient. Graded exercise programmes may be significantly dangerous to many of these ME patients” (Dr Byron Hyde, Clinician specialising in ME, having examined over 3,000 patients between 1984 – 2008; Ottawa, Canada; 15th August 2008)

· “(The GDG) produced a Guideline that recommends CBT and GET as the prime treatment yet there is in fact published evidence of contraindication / potential harm with GET. This has been published by independent researchers (e.g. Peckerman et al). The NICE GDG claims that CBT/GET are supported by significant research. In fact the GDG relied almost exclusively on specious reports which are unproven” (Dr Derek Enlander, Virologist specialising in ME/CFS; formerly Assistant Professor at Columbia University and Associate Director of Nuclear Medicine at New York University; Physician-in-Waiting to the UK Royal Family and to members of HM Government when they visit New York; 18th August 2008)

· “I regard the continuing aura of disbelief surrounding the illness and mainly emanating from the psychiatrists as detrimental to both medical progress and the interests of sufferers” (Dr Nigel Speight, Consultant Paediatrician specialising in ME/CFS; 20th August 2008)

· “It is with regret that I note that the NICE Guidelines do not take into account recent developments in the management of ME. They lean towards a psychological and psychiatric basis, when it is now recognised that there are a large number of medical problems associated with ME. Recent studies on genetics, the central nervous system, muscle function and persistent infections have shown that there is a great deal of medical information available with regard to the management of ME” (Dr Terry Daymond, Consultant Rheumatologist and recently Clinical Champion for ME for the North-East; 22nd August 2008)

· “Research from the ‘organic school’ identified many pathophysiological abnormalities in patients with ME/CFS resulting from dysfunction in a number of vital control systems of the body such as the central nervous system, the autonomic nervous system, the endocrinological system and the immune system. The attitude of the ‘psycho-social’ school continues to be to largely ignore this research. It seems they can only maintain their hypothesis by discouraging the search for an organic basis and by denying the published evidence, which they are certainly doing. This unseemly battle of ideas has been settled politically by proclamation and manipulation, not by science, and not by fair and open means. CBT and GET appear to be based on the rationale that patients with CFS/ME have ‘faulty’ belief systems concerning the ‘dangers’ of activity, and that these aberrant beliefs are significant perpetuating factors. If CBT to ‘correct’ these ‘false’ beliefs can be combined with a graded exercise programme to re-condition these patients, it is virtually promised that a significant proportion of them will improve both their attitude and their physical functioning, and thus cure their illness. Using CBT, patients are therefore to be challenged regarding their ‘aberrant’ thoughts and expectations of relapse that the ‘psycho-social school’ psychiatrists believe affect symptom improvement and outcomes. Cognitions concerning fatigue-related conditions are to be addressed; these include any alleged ‘over-vigilance to symptoms’ and reassurance-seeking behaviours, and are to be dealt with using re-focusing and distraction techniques. It is when a therapy such as CBT begins to interfere with the natural warning systems, of which both pain and fatigue are a part, that the increased risks arise. In particular, musculo-skeletal pain and fatigue have essential function in modulating activity when the body is in a state of disease as in ME/CFS. NICE, however, recommends over-riding this essential safety-net, thus the risk of serious harm is increased in this situation of simultaneous activity and symptoms denial. This will become a more serious risk in patients with more severe ME/CFS. The Guideline does not indicate how the clinician can tell whether patients’ beliefs concerning their symptoms are aberrant and/or when the symptoms accurately point to the underlying state of the disease process” (Dr Bruce Carruthers, Consultant Physician, Vancouver, Canada, 29th August 2008)

· “There have been only five trials of CBT with a validity score greater than 10, one of which was negative for the intervention; and only three RCTs of GET with a validity score greater than 10. The total number of available trials is small; patient numbers are relatively low; no trial contains a ‘control’ intervention adequate to determine specific efficacy, and their results are relatively modest. In addition, some of the studies (particularly those on GET) have used the Oxford criteria for diagnosis, a rubric which allows selection of patients with chronic fatigue states and which do not necessarily exclude certain psychiatric disorders, raising the question of the applicability of the results of these studies to the many patients with specific biomedical symptoms and signs consistent with myalgic encephalomyelitis. Again, the heterogeneity of the trials, the potential effect of publication or funding bias for which there is some evidence, and professional doubts about the evidence base for some behavioural therapies themselves give grounds for caution as regards the usefulness of (CBT/GET). A commentary in the BMJ (Bolsover 2002) is particularly relevant: ‘Until the limitations of the evidence base for CBT are recognised, there is a risk that psychological treatments in the NHS will be guided by research that is not relevant to actual clinical practice and is less robust than is claimed’. Indeed, a large body of both professional and lay opinion considers that these essentially adjunctive techniques have little more to offer than good medical care alone” (Dr Neil Abbot, Director of Operations, ME Research UK; Hon Research Fellow, Department of Medicine, University of Dundee, 29th August 2008)

· “The overall flavour of the Guideline is to lump together all patients with ‘medically unexplained fatigue’, from relatively mild to profoundly disabling illness and to treat all patients with a standard approach of gradual reconditioning and cognitive behavioural modification. By lumping such a heterogeneous mix of patients…patients with CFS or ME are left with very limited options, and little hope. In addition, this document proscribes immunological and other biologic testing on patients with (ME)CFS in the UK, despite the evidence in the world’s medical literature that such testing produces most of the biomedical evidence of serious pathology in these patients. Equally unfortunate is the GDG’s recommendation for behavioural modification as the single management approach for all ‘medically unexplained fatigue’. This month we participated in the International Conference on Fatigue Science in Okinawa, Japan. Dr Peter White of the UK presented his work using behavioural modification and graded exercise. He reported a recovery rate of about 25%, a figure much higher than seen in US studies in (ME)CFS and, even if possible, simply not hopeful enough to the 75% who fail to recover” (Professors Nancy Klimas and Mary Ann Fletcher, University of Miami; 13th September 2008)

· Attached as an appendix to their Statement was a separate Summary of Current State of Understanding of (ME)CFS), from which the following quotations are taken: “Many of the symptoms of (ME)CFS are inflammatory in nature. There is a considerable literature describing immune activation in (ME)CFS. Overall the evidence has led workers in the field to appreciate that immunologic abnormalities are a characteristic of at least a subset of (ME)CFS and that the pathogenesis is likely to include an immunologic component. Fulcher and White (2000) suggest a role for deconditioning in the development of autonomic dysfunction and overall level of disability in (ME)CFS patients. On the other hand, Friedberg et al (2000) suggest the long duration (ME)CFS subjects are more likely to have symptoms suggestive of chronic immune activation and inflammation. We are currently working with investigators at the Centres for Disease Control and the University of Alberta looking at the mediators of relapse after exercise challenge using gene expression studies, neuroendocrine, immune and autonomic measures”

· “My main concern about the NICE document is that what must be great uncertainty in both costs and particularly in quality of life difference is not allowed for” (Martin Bland, Professor of Health Statistics, University of York, 17th September 2008)

· “The guideline is dominated by positive and largely uncritical recommendations for CBT and GET. However, the guideline plays down the fact that patient experience has consistently reported that significant numbers of people with ME/CFS find these approaches to be either unhelpful or, in the case of GET, makes their condition worse. Some of the hospital-based services are not being physician-led but ‘therapist-led’. In some cases people are now being given little more than a ‘therapist-led’ management assessment followed by an offer of CBT and/or GET. I received some very unhappy patient feedback on this type of service on Saturday 11th October (2008) in Colchester, Essex, where great dissatisfaction was expressed by many members of the audience who attended the ME Association’s ‘Question Time’ meeting” (Dr Charles Shepherd, Medical Adviser, ME Association, 24th October 2008)

· “I am a consultant immunopathologist and before retirement worked at St James’ University Hospital, Leeds. A key area of my professional interest was and remains myalgic encephalomyelitis and I have carried out research into the disorder. For a number of years I ran clinics specifically for patients with ME. In my opinion NICE guidelines overemphasise the usefulness of CBT and GET to the detriment of patients. I have no hesitation in stating that in my opinion, the situation for ME/CFS patients is worse, not better, since the publication of the NICE Guideline” (Dr Layinka Swinburne, Leeds, 22nd October 2008)

· “As my clinical freedoms were progressively eroded, it meant that I was becoming ineffective and indeed possibly dangerous as a practitioner. All that patients could be offered was CBT coupled with GET, which I consider not to be appropriate for many of my patients and in the case of GET potentially damaging for some” (Dr Sarah Myhill, General Practitioner specialising in ME/CFS, Powys; Secretary of the British Society for Ecological Medicine, 10th November 2008).

MEA: Judicial Review: Summary of High Court proceedings

Dr Charles Shepherd, Medical Adviser to the ME Association has published a summary of the Judicial Review High Court Proceedings

ME Association | 15 February 2009 | Dr Charles Shepherd

Judicial Review – summary of High Court proceedings

The Judicial Review of the NICE guideline on ME/CFS took place on Wednesday and Thursday, 11th and 12th February, at the Royal Courts of Justice in London. The hearing was held in Court 76 – a large modernised courtroom tucked away on the third floor of this historic maze of legal activity.

Unlike the preliminary hearing in June last year, there was plenty of room to move around along with comfortable non-squeaking seats and wheelchair access – although it was difficult at times for those at the back to hear precisely what was being said by barristers representing the two sides.

Around 50 members of the public, along with occasional brief visits from journalists, packed Court 76 to witness the proceedings. At times, a ‘Court Full’ sign had to be posted up. Not surprisingly, there did not appear to be a single person with ME/CFS who had come up to London to support the NICE guideline.

Outside the main entrance in The Strand, where all the TV news bulletin shots of the High Court are taken, a small peaceful demonstration against the NICE guideline took place over lunch. This managed to attract quite a lot of legal and public interest.

Almost all of Wednesday was taken up with a legal presentation from barrister Jeremy Hyam on behalf of the two claimants who suffer from ME – Kevin Short from Norfolk and Douglas Fraser from London.

In relation to the effects of the NICE guideline on practical patient care, two key issues were examined:

Firstly, the procedures by which the NICE guideline development group (GDG) had come to the conclusion that the only treatments worth recommending for people with ME/CFS were two behavioural interventions, namely cognitive behaviour therapy (CBT) and graded exercise therapy (GET), and this was to the exclusion of all others.

Secondly, the fact that a number of medical/drug and supplement interventions, which may be helpful in selected cases, were not therefore being recommended by NICE. As a result of not being recommended, doctors would not be willing to consider using them, and healthcare providers (ie PCTs) would not be willing to pay for them. Some people with ME/CFS would therefore be denied forms of treatment that could be of benefit.

In relation to the way in which a judicial review is there to examine procedures rather than actual decisions, it was argued that the decision making process had been based on a foundation of insufficient evidence of clear benefit being available to recommend the widespread use of CBT and GET. In particular, was the way in which a systematic review of results from randomised controlled trials involving CBT and GET (ie the York Review) had failed to demonstrate the sort of robust consistent evidence that could stand alone and satisfy the requirements for this type of recommendation to be made in a NICE guideline. Counsel for the claimants also argued that insufficient weight had then been given to certain other key sources of evidence further down the hierarchy of evidence that were made available to the guideline development group – in particular the results of patient questionnaires and stakeholder feedback which had reported that in a significant proportion of people with ME/CFS these treatments were either ineffective or even harmful.

When it came to the final analysis it was argued that with several members of the GDG being involved in clinical trails involving these two treatments, or expressing support for their use, there was an appearance of bias in the way that the GDG decided to recommend CBT and GET as the only forms of effective treatment. To support the appearance of bias reference was made to comments contained in a letter from a patient representative on the GDG (Tanya Harrison) who had resigned from the group as a result of what she believed was bias towards the psychosocial model. It was also argued that the appearance of bias towards CBT and GET was compounded by the absence of any health professionals on the GDG who were known to be in favour of the biomedical model of ME/CFS

The final part of the first day’s hearing, and almost all of Thursday morning, was taken up by counter arguments being presented by the barrister representing NICE, namely that the research evidence in favour of CBT and GET was sufficiently robust; that the process of collecting and analysing other types of evidence from clinical trials, stakeholders, experience of clinicians etc was thorough and transparent; and that no evidence of bias towards the psychosocial model had been shown by individual members of the GDG. Neither was there any bias in the way in which the members of the GDG were selected by nomination of the relevant Royal Colleges or professional bodies, and some of the accusations relating to bias, conflict of interest, or disclosure of interest were based on factual inaccuracies. In other words, the procedures that were followed by NICE were as robust and fair as could be achieved in the circumstances and that the decision to only recommend CBT and GET was not the result of any bias on the part of individual members of the GDG, or the group as a whole. Legal arguments on behalf of the defendants (ie NICE) went on till early afternoon on Thursday.

Thursday afternoon produced a further legal argument involving the cost effectiveness of both treatments. This was given by a barrister acting for an ‘interested party’ in the case against NICE. Evidence was put forward on behalf of this interested party to show that the cost effective analysis for CBT was seriously flawed and that no proper cost effectiveness analysis for GET had even been undertaken. In other words, it was claimed that NICE was recommending two forms of treatment that had not yet been properly shown to be cost effective. Again, this position was vigorously challenged by the barrister representing NICE.

A great deal of time was spent in discussing the points that are summarised above, along with legal technicalities. However, some of the other aspects of the case against the NICE guideline, which have surfaced in public discussion on the internet prior to the case being heard in Court, were not referred to or left very much out on the periphery (eg neurological classification of the illness).

Legal arguments and discussion went on till almost 5pm on Thursday and there is still some unfinished business for the Judge, Mr Justice Simon, to deal with. So it looks as though the Judge’s decision on the case will be delayed for at least a week, possibly even longer.

a  The ME Association has fully supported the case for Judicial Review that has been made by the two claimants – see here
b  A summary of press reports on the Judicial Review can be found here
c  For anyone involved with insurance companies referred to during the hearing – Exeter Friendly Society and Liverpool Victoria – some interesting and useful statements regarding their positions on recognition and classification of ME/CFS were made during the hearing.

Summary prepared by Dr Charles Shepherd

14 February 2009

Countdown: Judicial Review NICE CFS/ME Guideline

Royal Courts of Justice

Image | bortescristian | Creative Commons


High Court Hearing Countdown

Judicial Review NICE Guideline for CFS/ME

Where?  | Room 76, Royal Courts of Justice, The Strand, London WC2A 2LL

East Block location maps |

When? | 11th and 12th February 2009

Why? |

What else do I need to know? |

Whom do I contact? |


The NICE M.E. Guidelines Judicial Review new YouTube video

“Annette Barclay talks about the impending legal challenge to the NICE guidelines on M.E.”

8.17 mins | GBCOne

ME agenda site has no connection with any legal case involved in the NICE Judicial Review or with the unofficial supporters’ website. All enquiries about the Judicial Review, including media enquiries, should be directed to Leigh Day & Co or to the High Court, as appropriate.  Members of the ME community planning to attend the hearing or who are able to offer assistance should direct enquiries about arrangements for what is currently scheduled for a two day hearing to the web master of the NICE JR Supporters’ website

Reasons for Judicial Review of the NICE Guideline on “CFS/ME”: Williams

Margaret Williams announces a Hearing listing for the Judicial Review of the NICE Guideline on “CFS/ME”. ME agenda has no connection with the legal cases – please address all enquiries concerning the Judicial Review to the legal team representing the Fraser/Short case and the legal representives for the ONE CLICK case or to the High Court, where appropriate. Enquiries relating to the content of this article by Margaret Williams should be directed to Stephen Ralph of MEActionUK

For a document setting out what a Judicial Review is, what it is not and how it works see:

An unoffical site has been set up for supporters of the NICE CFS/ME Judicial Review, for information and updates for those planning to attend the hearing and for those able to offer assistance with arrangements and publicity.  The site can be found at:


“This [NICE Judicial Review] is undoubtedly a high profile case. At the preliminary Hearing in June, there was standing room only. The Hearing is listed for 11th-12th February 2009. High Court officials are now busy rearranging the Court venue in order to ensure not only disabled access and facilities, but also to accommodate the coach-loads of people from the UK ME/CFS community who are expected to turn up to witness what will undoubtedly be a landmark legal action that will have global ramifications.”  M Williams

Prejudice-based Medicine?

Reasons for Judicial Review of the NICE Guideline on “CFS/ME”

by Margaret Williams

27th October 2008

On 2nd November 1972 the London Medical Group held a closed meeting at which aversion “therapy” was promoted as a “cure” for homosexuality. The “therapy” was drug-induced nausea whilst the “patient” had to view homosexual acts (preferably live). The aim of this so-called “re-conditioning” was to “change the emotions where the person cannot change them of his own free will”. According to one of the speakers, psychologist Hans Eysenck, aversion “therapy” was “only undertaken where it is of the patients’ own choice”. Another speaker, Dr Isaac Marks, Senior Lecturer and Consultant Psychiatrist at the Maudsley Hospital, justified such abuse as being “in society’s interest”. The proponents of this “therapy” were praised by the chairman of the meeting for their “outstanding contributions to psychology” and were referred to as “these great men”.

People who underwent this “therapy” ended up as chronically depressed asexual vegetables (  ).

On 28th April 2008, another closed medical meeting was held in London, this time at the Royal Society of Medicine; once again the intention was to promote another currently faddish “therapy” as a “cure” for another so-called “aberrant” disorder. This time it was not about homosexuality but about myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS), which the psychiatrists to whom the RSM offered a platform prefer to call “CFS/ME” and claim that it is a behavioural disorder. These psychiatrists (known as the Wessely School) lump ME/CFS together with on-going tiredness or chronic “fatigue” such as is seen in depression and anxiety states, even though ME/CFS has been formally classified as a neurological disorder by the World Health Organisation since 1969 and the WHO has confirmed in writing that what these psychiatrists are doing is not permitted under the WHO taxonomic principles.

People with ME/CFS have been referred to by a leading UK Wessely School psychiatrist as “the undeserving sick of our society”, so this time, the “therapy” is a mind-altering technique to disabuse patients of their belief that they are physically sick, combined with incremental aerobic exercise (because the psychiatrists believe that these patients are merely de-conditioned through self-indulgent lazing about for secondary gain in the form of state benefits).

Of course, as in 1972, the “therapy” is only to be offered to those who choose it, but those who refuse it (because they are simply too sick to participate or are sufficiently well-informed to be aware of the potential dangers) are deemed not to want to get better, so their state benefits are summarily stopped. The “Pathways to Work” programme will require Incapacity Benefit (now known as ESA, or Employment & Support Allowance) claimants with ME/CFS to undergo CBT/GET before their benefits are reinstated. Not surprisingly, the suicide rate in ME/CFS has been documented at one per month, not because patients are mentally deranged, but because without help they have no means of surviving such a devastating disorder and can no longer cope with the extreme suffering.

It ought to be a matter of national concern that this current fad is now enshrined in a Guideline produced by the National Institute for Health and Clinical Excellence (NICE) and is to be implemented throughout the nation, even though the “therapy” in question may already have resulted in an untold number of non-suicide deaths (including a Member of Parliament who suffered from ME) and may have turned countless mildly affected sufferers into severely affected physical wrecks requiring 24 hour lifelong care. These very sick people are officially described on page 68 of the NICE Guideline as “a substantial burden on society”.

In supporting the psychiatric lobby’s attempt to make ME/CFS disappear within the maelstrom of undifferentiated fatigue states, NICE has contributed to the perpetuation of unacceptable practices by officially sanctioning – indeed promoting – this Government-funded current prejudice, the consequences of which will be catastrophic, not only for those afflicted by ME/CFS, but also for those committed researchers who are on the point of a breakthrough into the aetiology of what is by any standards a life-shattering multi-system disorder. Chronic “fatigue” has no more a relationship to ME/CFS than a pimple has to a malignant tumour.

In 2005, Professor Nancy Klimas, Professor of Medicine at Miami and President of the International ME/CFS Association was clear: “Our patients are terribly ill, misunderstood, and suffer at the hands of a poorly informed medical establishment”.

The following year (2006) she repeated the message: “There is evidence that the patients with this illness experience a level of disability that is equal to that of patients with late-stage AIDS, patients undergoing chemotherapy (and) patients with multiple sclerosis”.

In 2007, evidence was presented at an international conference held in Florida that the cardiac index of these patients is so severe that it falls between the value of patients with myocardial infarction (heart attack) and those in shock.

Although this evidence and more was brought to its attention, NICE remained unmoved and recommended only behavioural interventions designed for mental disorders, talking about “unhelpful beliefs”; “the relationship between thoughts, feelings, behaviours and symptoms”, “sleep hygiene” and “over-vigilance to symptoms”.

It seems that so determined was the Wessely School that NICE should recommend this latest fad that the Guideline Development Group (GDG) was specifically instructed to ignore over 4,000 peer-reviewed papers which clearly demonstrate that ME/CFS affects all major bodily systems, especially the immune system, the neurological systems (central, autonomic and peripheral), the neuroendocrine system, the cardiovascular system, the respiratory system, the musculo-skeletal system, the gastrointestinal system, the reproductive system and the ocular system.

The Wessely School psychiatric lobby dismisses all this evidence as being “not of clinical value” and insists that patients “are assumed to have ‘mental’ disease” because there is “no pathology”. They refer to ME/CFS as a “pseudo-disease”. It seems that NICE agrees.

To be fair to NICE, it is not required to address causation in its Guidelines; however, its remit in this case was to produce a Guideline to aid diagnosis. To do so, it was necessary for NICE to identify and define the disorder in question by considering the existing knowledge-base. Indeed, NICE is required to do so under the terms of the AGREE instrument, to which it is a signatory. In its Guideline on “CFS/ME”, NICE signally failed to do so.

Virtually all the UK ME/CFS charities condemned the Guideline as unfit for purpose: such was the outrage and disgust throughout the ME/CFS community at the way that NICE had deliberately ignored so much evidence about ME/CFS that a Public Law firm (Leigh Day & Co, rated number one in Chambers’ legal directory) agreed to seek permission to challenge the Guideline in the High Court by way of Judicial Review.

The initial Hearing was on 17th June 2008 before Mr Justice Cranston (Sir Ross Frederick Cranston), who in his Judgment said: “There is no doubt that ME is a debilitating condition and many of us will know of people who have the condition. Mr Hyam (for the Claimants) has pointed to the lack of balance in the composition of the group drawing up the Guidelines. Given the great public interest, it seems to me that this case ought to go forward for a full hearing”.

NICE is therefore once again being dragged kicking and screaming into the High Court in an attempt to justify what cannot logically be justified.

For example, NICE decided to reject the WHO formal classification of ME/CFS as a neurological disorder. The ME/CFS community has obtained an abundance of evidence that this might be because the psychiatrists’ gravy train would hit the buffers if NICE acknowledged that ME/CFS is a discrete neurological disorder. NICE’s position on this is unsustainable because not only does the WHO classify ME/CFS as a neurological disorder, but since 2003 the UK Read Codes used by all GPs also classify it as a neurological disorder. Furthermore, ME/CFS is included in the National Service Framework for long-term neurological disorders, and the Department of Health (by whom NICE is funded and to whom it is answerable) also accepts that ME/CFS is a neurological disorder, as does the Chief Medical Officer himself. It will be interesting for the public to see what “evidence” NICE produces to convince the Court that its position in this regard is justified.

It will also be interesting for the public to hear NICE’s explanation about the composition of the Guideline Development Group that prepared the Guideline, in particular, how NICE justifies its decision to exclude clinicians with a professional lifetime’s expertise in ME/CFS who were willing to serve on the GDG, and instead head-hunted non-experts with undeclared vested interests. For example, Dr William Hamilton was invited to be a member of the GDG specifically because of his published work which supports the notion that ME/CFS is a behavioural disorder that is best treated by CBT/GET (as recommended by the Guideline). Dr Hamilton just happens to be Chief Medical Officer of two medical insurance companies that rigorously resist claims made by ME/CFS patients, The Exeter Friendly Society and Liverpool Victoria (LV), which took over Permanent Health. The antics of LV in respect of ME/CFS claims have been brought to the attention of Members of Parliament at an All Party Parliamentary Group Meeting at the House of Commons.

NICE may be required to clarify why it preferred the expertise of a dietician, a reflexologist who also works as a hypnotherapist, an occupational therapist and a physiotherapist to experienced ME/CFS clinicians such as Dr William Weir, Dr Jonathan Kerr, Professor Julia Newton, Dr Terry Mitchell, Dr Nigel Speight and Dr Charles Shepherd. Again, it will be interesting to hear NICE’s explanation, especially as the physiotherapist just happened to have worked with psychiatrist Professor Peter White and it was she who wrote the handbook on graded exercise for the Medical Research Council’s “CFS” trial, of which Peter White is a Principal Investigator. This physiotherapist also works for the same medical insurance company as Peter White, which pays her to recommend (and carry out) GET for claimants (so could it be said that her vote in favour of GET was a forgone conclusion?). Furthermore, she works as a “healing” therapist using Human Givens “therapy” (which claims to “empower” patients but is described by one clinician as “dodgy psychobabble”). Many people have difficulty in understanding how this physiotherapist had more to offer the patients for whom the Guideline is supposed to be intended than the Medical Adviser to the ME Association.

None of the many competing interests of GDG members was declared in the Guideline: it was not until two months after the Guideline had been published that NICE released what purported to be the List of Competing Interests of the GDG; it barely scratched the surface of GDG members’ vested interests.

Then there is the interesting matter of how this Institute for Clinical Excellence produced its “evidence” out of thin air: since even NICE could not procure non-existent evidence to support its recommendations for behavioural therapy, it decided to create its own evidence by transferring data from one study and inserting that data into a totally different study to produce what might have been the desired results if the study in question had run for five years instead of only fourteen months. The fact that the transplanted data came from a study that had used different entry criteria and whose own data had been corrupted (admitted by the authors themselves) seems not to have troubled the Institute for Clinical Excellence. Most straight-thinking people might regard such doctoring of the evidence as fraudulent.

Another interesting area is the “Consensus” methodology that was used in the production of the Guideline on “CFS/ME”. It does seem to be the case that formal consensus methodology was conspicuous by its absence: indeed, on 10th May 2006 NICE made it known that the consensus technique was to be “modified” by NICE for the development of this particular Guideline. Scrutiny of this “modification” as it appears in the Guideline makes very interesting reading. It will not escape attention that the person described in the Guideline as the “Consensus Development Expert” was Professor Rosalind Raine, whose published track record happens to be that “CFS/ME” is a behavioural disorder that should be managed by CBT/GET. Raine specifically singled out “CFS” for study (funded by the MRC) and she is clear: CBT should aim to “modify thoughts and beliefs with the expectation that emotional and behavioural changes will follow”; behavioural therapies focus on “the modification of behaviour to positively reinforce healthy behaviours” and they “emphasise the role that social factors can play in the development and maintenance of functional somatic complaints. The goal is to identify and reinforce ‘well’ behaviours while reducing reinforcement for somatic behaviours” (Lancet 2004:364:429-437). The ME/CFS community may well be justified in maintaining that NICE’s “consensus” exercise was cosmetic.

There is in addition the matter of NICE informing the Court on 17th June 2008 at the initial Hearing before Mr Justice Cranston that it had no knowledge of certain documents before that Hearing, even though receipt of some of those documents had previously been acknowledged in writing on 23rd January 2006.

There is also the serious issue of Social Services continuing to seek to remove children with ME/CFS from their parents and placing them in “care”, citing the NICE Guideline as the reason.

NICE appears to be in breach of the AGREE instrument (to which it is obliged to conform in the production of its Guidelines) on no less than seven separate counts. It will be interesting to hear why this should be so in the production of the Guideline on “CFS/ME” and the Court may be keen to hear why NICE appears to have broken its own guidelines (that it is obliged to observe) in so many respects in the production of this particular Guideline.

This is undoubtedly a high profile case. At the preliminary Hearing in June, there was standing room only.

The Hearing is listed for 11th-12th February 2009. High Court officials are now busy rearranging the Court venue in order to ensure not only disabled access and facilities, but also to accommodate the coach-loads of people from the UK ME/CFS community who are expected to turn up to witness what will undoubtedly be a landmark legal action that will have global ramifications.

Literature References:  


Professor Malcolm Hooper, Journal of Clinical Pathology and Wikipedia

Update: As of 5 August 08, the reference to this paper by Prof Malcolm Hooper, published by the BMJ/JCP, has been reinstated to the Wikipedia article page and it has been recorded in the page History that the paper has not been retracted; the edit History tag also includes the URL to the clarification and apology to Prof Hooper published by the BMJ/JCP on its website. This reversion has been carried out by an editor other than “Jfdwolff” or “DGG” who had been requested to give this matter due attention.  Prof Hooper has been updated.


May be reposted

Professor Malcolm Hooper, Journal of Clinical Pathology and Wikipedia

By Suzy Chapman
2 August 2008

On 2 July 2008, it was published by Dr Marc-Alexander Fluks, via the Co-Cure mailing list, that Professor Malcolm Hooper’s paper: Myalgic encephalomyelitis: a review with emphasis on key findings in biomedical research. J Clin Pathol 2007;60:466-471 had been retracted. The source of this information was given as the Journal of Clinical Pathology website. The Co-Cure mailing can be accessed here:

Since this was news to Professor Hooper, himself, the Journal of Clinical Pathology was approached for a clarification.  In the interim, on 5 July, Professor Hooper issued the following statement via the Co-Cure mailing list and website, via Stephen Ralph of MEActionUK:


Please note. The title of Dr. Marc-Alexander Fluks’ Co-Cure posting of 2 July 2008 “Hooper retracts CFS paper” is misleading as Professor Hooper has NOT in fact retracted his paper entitled: Myalgic encephalomyelitis: a review with emphasis on key findings in biomedical research. J Clin Pathol 2007;60:466-471.. There is presently some confusion as to exactly what is going on at the JCP regarding this matter but Professor Hooper categorically states:

“I wish it to be known that I have NOT retracted my Journal of Clinical Pathology paper on biomedical ME research, I have no intention of doing so, I have had no official communication from the JCP on this matter and am currently seeking clarification.” [Professor Malcolm Hooper; 5 July 2008].


The BMJ Group subsequently issued a clarification and an apology to Professor Malcolm Hooper which can be read here on The Journal of Clinical Pathology’s website:

On 15 July 2008, the clarification of the status of this paper and the apology from the BMJ Group was published via the Co-Cure mailing list and on the Co-Cure website, by Stephen Ralph, on behalf of Professor Hooper, and can be read here:

I also append a copy.

The JCP reinstalled access to the paper and the abstract and full version of the original paper in PDF format can now be found back on the JCP website at:


PDF Full paper:


Statement of clarification from Prof Malcolm Hooper

[Published 15 July 2008 by Stephen Ralph]

A message from Professor Malcolm Hooper

“Attention is drawn to the recently-released apology from the Journal of Clinical Pathology regarding the alleged retraction of the Review ‘Myalgic Encephalomyelitis: a review with emphasis on key findings in biomedical research’ by Professor Malcolm Hooper. Professor Hooper notes that the immoderate and malicious comments which were posted on the internet regarding his paper have been shown to be false. He is saddened that such comments from those who profess to have the best interests of the ME community at heart have caused distress, dismay and confusion within the wider ME community”.

Statement of clarification and apology from Journal of Clinical Pathology

The BMJ Group wishes to inform readers that a series of technical errors resulted in the unjustified retraction of the article “Myalgic encephalomyelitis: a review with emphasis on key findings in biomedical research”. The article’s citation details remain as originally published (J Clin Pathol 2007; 60: 466 – 471; doi:10.1136/jcp.2006.042408).

The Journal of Clinical Pathology offers an unreserved apology to the author of the article, Professor Malcolm Hooper, and regrets any confusion or distress that may have been caused.

Note: The Original Paper can now be found back on the JCP website




In April 2008, a new Wikipedia article page was created titled:

ME/CFS controversies at:

The History Page for this article at: 

records that on 11 July 2008, Wikipedia Admin, “Jfdwolff”, removed a reference to Professor Hooper’s paper Myalgic encephalomyelitis: a review with emphasis on key findings in biomedical research. J Clin Pathol, Hooper M from the Diagnostic controversies section of the ME/CFS controversies article as it stood at that date.

The reason for this edit is given by Admin “Jfdwolff”, in the edit tag, as “Hooper review has been retracted and therefore ceases to be a reliable source.”

On 1 August, I contacted two Wiki Admins who have been working on this article and advised them that the Hooper paper had not been retracted. I provided them with copies of Prof Hooper’s own statement of clarification and the clarification and apology issued by the Journal of Clinical Pathology in July, the link for the JCP’s website where the clarification and apology can be read and the link on the JCP’s website where the full copy of the paper can be accessed.

The response so far, from one of the Wiki Admins approached, has been to tell me that as for the retraction, he considers it would be good to be able to quote some source outside BMJ/JCP for the status.

Since the BMJ’s Journal of Clinical Pathology has already published a clarification on its website that the reporting of Professor Hooper’s paper as having been retracted was the result of a series of technical errors on its part, since the paper is now reinstalled on the BMJ’s website and since the web pages which erroneously reported the paper as having been retracted have since been removed by the Journal, one has to question the rationale behind this Wikipedia Admin’s desire to be able to quote a source outside the BMJ/JCP for “the status”!

Professor Malcolm Hooper, University of Sunderland has been advised of the situation and that a request has been made for this issue to be addressed by Wikipedia Admins.

I will keep you updated on the progress of this issue. In the meantime, until this issue has been resolved and until the status of this paper has been updated at (and on any other Wikipedia pages where references to this paper might have been made), readers of Wikipedia and editors and Admins working on articles associated with CFS/ME, that is,

should rely on the clarification on The Journal of Clinical Pathology website for their information.