VIRAS Stakeholder comments on the Draft Scope for a new NICE Guideline for 'ME/CFS'
July 25th 2018
VIRAS COMMENTS ON THE DRAFT SCOPE
[The format is: comment number, page number, line number, comment]
1, general, general,
VIRAS group members are qualified in science and research and include healthcare professionals from varied disciplines as well as carers for and patients with M.E. and Lyme disease. We are stakeholders for the NICE guidelines for Lyme disease and we welcome the opportunity to provide our expertise to the development of new guidelines for M.E.
2, general, general,
The SCOPE omits to put M.E. and CFS in context.
The history of the diseases is relevant and vital to understanding how serious neuro-immune diseases have been trivialised in mainstream and medical media, and how it came about that the first NICE guideline for "CFS/ME" was influenced by vested interests which created and perpetuated discrimination against patients. The historical and political context is essential information for the guideline committee and this should be stated in the Scope.
The undue influences on the first guideline must be recognised. The pool of literature about M.E. and CFS has been tainted by decades of futile psychosocial theories of phobia, hysteria and hypochondria, and equally futile notions about deconditioning, fatigue and exercise. Notwithstanding consistent failure to prove any of these theories, they have been spun and disseminated so effectively that they have indoctrinated the thinking of some medical professionals, the media and the public.
The 2007 NICE guideline for 'CFS/ME' failed to identify and take into account the unproven nature and irrationality of these theories, or the vested interests of those who promoted them. As a result, an effect of the guideline was to confirm the opinions of those whose purpose was to psychologise patients, discredit their accounts of their symptoms and disqualify them as medical patients. This situation has facilitated the suppression of research, withholding and withdrawal of medical support, state benefits and in some cases, the support of the patient's own families, partners, friends and colleagues.
It would be a conceit to believe that NICE or its committee are above all this and that the past could, or should, simply be erased - that a blank-slate on which to write a world-class guideline for M.E. and CFS is possible in this contaminated environment. Therefore the prejudice and discrimination against M.E. and CFS patients must be recognised so that these can be dealt with if and when they impinge. This is the correct way to avoid repeating past mistakes.
There are around 1,500 documents on the NICE website which include the phrase: "Evidence Based". Yet it should be understood that NICE procedures permit 'evidence' to be drawn from virtually any source.
The recently published NICE guideline for Lyme Disease (NG95), provides 12 major items of information and recommendations: "Based on the experience and opinion of the Guideline Committee", three major items: "Based on very low quality evidence" and just one: "Based on moderate to very low quality evidence". That covers virtually the entire guideline. The result is an opinion-based guideline bereft of evidence and which represents nothing more than opinions. (https://www.bmj.com/content/361/bmj.k1261)
Therefore, when assumptions, opinions and theories substitute as 'evidence', their value, veracity and the vested interests of their origins must be critically interrogated from every angle. This can only be undertaken with a good understanding of the context and the history of M.E.
3, 1, 15,
"This guideline scope uses the term 'ME/CFS' but this is one of a number of names that have been used to describe this illness."
Why was this name chosen? The 2007 NICE guideline was for 'CFS/ME', a term which well informed patients and doctors immediately recognise as being the construct used to define patients with 'chronic fatigue', which subsumes patients with myalgic encephalomyelitis (M.E.) as well as those with critically defined chronic fatigue syndrome (CFS).
'CFS/ME' is a contrived heterogeneous diagnosis which produces wholesale misdiagnosis and obstructs the care of patients and research into their illness. One only has to read the 2007 guideline to confirm this.
Therefore for many years, patients and physicians who take M.E. seriously, and consider it to be a recognisable and diagnosable condition, have used the term 'ME/CFS'. This defines patients who are diagnosed by strict criteria for M.E., which is classified by the World Health Organisation, International Classification of Diseases under G93.3, 'neurological conditions'. It also includes patients who would meet the same criteria, but who have had a 'CFS' diagnosis foisted upon them.
That NICE have hijacked the term 'ME/CFS' for their own use appears to be a callous deception. It diverts attention away from the fact that numerous aspects of the draft scope show that NICE are actually preparing another guideline for 'CFS/ME', or in plain terms, for 'fatigue'.
If NICE are not clear about who and what they are preparing a guideline for, or alternatively, have named the topic of their guideline only for the sake of appearances, then they should not go any further without becomming familiar with the history of vested interests and the corruption which surrounds 'CFS/ME'.
4, 1, 16,
" It is recognised that there are people who need care but who may not meet existing clinical or research criteria."
Who are these patients that 'need care', by whom are they 'recognised' and what has this got to do with patients with M.E. and CFS? Does this refer to people who have 'fatigue' but who do not have post-exertional malaise (PEM) or Post-Exertional Neuroimmune Exhaustion (PENE) and therefore: DO NOT HAVE M.E. OR CFS?
Are NICE suggesting that these people who need care will not receive any unless they get an M.E. or CFS MISDIAGNOSIS and are covered by a NICE guideline? What is the evidence that there are people who 'need' but are not getting necessary medical or social care because they don't meet ME/CFS criteria? Is it NICE's intention that this phantom population should be incorporated into an unrelated guideline in development and subsumed into the ranks of M.E. and CFS patients, and that NICE are prepared to redefine 'ME/CFS' for this purpose?
Exactly what 'care' do NICE think that these subsumed patients will get if they are MISDIAGNOSED with M.E. or CFS? Why do NICE assume that this 'care' will be appropriate to their needs unless NICE have already decided what care will be recommended for ME/CFS? If so, then the treatment and management part of the guideline must be predetermined and the whole guideline development process, including the stakeholder consultation, is a bogus waste of everybody's time and effort.
Could this be a case of: 'why not include anyone who feels tired, after all, it's not as if this guideline is about a serious disease - it is not as though NICE would be including patients with a hangover-headache in a migraine guideline or clumsy people who sometimes drop things in a multiple sclerosis guideline. It's only a guideline for M.E. and CFS, so there is no need to be meticulous about it - is there?'
Please enlighten us if there is more to this than arbitrarily gathering patients with different illnesses without any scientific or medical justification.
We are not aware that it is a function of NICE to redefine the parameters of a disease. What authority and qualifications do NICE have to appoint themselves this role? If NICE intend to define their own set of diagnostic criteria then this should be undertaken and published before the guideline work commences, so that it can be properly peer-reviewed and validated. The 'peer-review' process of a NICE guideline (stakeholder feedback), is wholly inadequate for the purposes of constructing a new disease definition.
Somewhere in the morass of patients that NICE seem intent on helping to create,
those with M.E. or well-defined 'CFS', who suffer with the hallmark symptom
of PEM, will be swamped by people with fatigue, chronic fatigue, burn-out, a
long-lasting infection, sleep disorder, post viral malaise, the malnourished,
the anxious and depressed and predictably:
THESE AND MANY OTHERS WHO SHOULD BE DIAGNOSED WITH AND TREATED FOR A COMPLETELY DIFFERENT ILLNESS.
This is not the way to produce a credible or viable guideline. This bent for inclusiveness might appear to be considerate and kind - but in reality it shows ignorance and discrimination against the very patients that the new guideline is supposed to help.
In an approach opposite to NICE's apparent intention to broaden the scope to include all-and-sundry, VIRAS and others were concerned that patients with Lyme disease were being misdiagnosed with M.E. and CFS. We suggested that the NICE guideline for Lyme disease should recommend review and investigation of patients with these diagnoses because of the striking overlap of symptoms. This suggestion was ignored, which in our opinion demonstrates that NICE are quite prepared to accept having misdiagnosed ME/CFS patients who actually have different, diagnosable and even treatable diseases. This careless approach is a dereliction of NICE's incumbent responsibility.
This lax attitude towards the diagnosis of M.E. and CFS, will predictably result in continued or increased, missed and misdiagnosis of patients with different diseases.
5, 1, 19,
"ME/CFS is a disabling and distressing illness characterised by extreme and
debilitating fatigue, particularly after exertion."
Please redraft this sentence to say:
"ME/CFS is a disabling and distressing illness characterised and identifiable by Post-Exertional Malaise, which is the exacerbation of symptoms following activity and reported by some patients as extreme and debilitating fatigue"
Fatigue is non-specific and common. Post-Exertional Malaise (properly defined as Postexertional neuroimmune exhaustion (PENE) in the Myalgic encephalomyelitis: International Consensus Criteria) is specific and uncommon. If NICE proceed with the guideline on the misguided basis that fatigue, however extreme, characterises ME/CFS, then their investigation and advice will be erroneous.
Some of the draft scope content suggests that NICE might commandeer the commission to produce a guideline for 'ME/CFS' and use it to write a guideline for 'fatigue'. If this is so, then they should inform the Department of Health, VIRAS and other stakeholders of this fact immediately and explain why they have misled us and wasted our time and effort under false pretences.
Please note: 'Fatigue' is a reduced capacity for work following exertion and which therefore is restored by rest. Everyone experiences 'fatigue', even extreme fatigue, but this term does not describe nor provide insight into ME/CFS patient's symptoms and does not help to characterise their illness.
The Institute of Medicine Report states:
"Post-exertional malaise (PEM)
"PEM is worsening of a patient's symptoms and function after exposure to physical or cognitive stressors that were normally tolerated before disease onset. Subjective reports of PEM and prolonged recovery are supported by objective evidence in the scientific literature, including failure to normally reproduce exercise test results (2-day cardiopulmonary exercise test) and impaired cognitive function after exertion. There is sufficient evidence that PEM is a primary feature that helps distinguish ME/CFS (SEID) from other conditions." (https://www.nap.edu/resource/19012/MECFScliniciansguide.pdf)
6, 1, 20,
"Clinically, ME/CFS is heterogeneous and multifactorial"
NICE cannot claim this unless they also claim to know of at least two known causes of these illnesses. As the draft Scope later specifies that the cause is unknown, this sentence is inaccurate and self-contradictory.
The Scope could say: "Physician diagnosed patients with M.E. and CFS include misdiagnosed patients and therefore represent an heterogeneous group. This is due to the present lack of a definitive test, use of inadequate diagnostic criteria, overlooked alternative diagnoses (misdiagnosis), poor knowledge of the disease and a widespread misperception that these illnesses are characterised by fatigue."
PLEASE NOTE: In the PACE Trial, 3,158 patients were referred by a doctor for recruitment into the trial. 1,078 of these referrals were rejected because they did not meet the Oxford Criteria for 'CFS', despite this being the weakest and most inclusive criteria, which does not differentiate patients who only have fatigue. Therefore 34% of patients that doctors referred to participate in the research did not meet the laxest and most inclusive criteria for 'CFS'.
To illustrate how lax the Oxford criteria is, 38% of the patients who were enrolled in the PACE Trial, did not meet the 2003 Reeves et al International criteria for CFS and 44% did not meet the London criteria for M.E.
This means that 42% of patients referred by a physician to participate in 'CFS' RESEARCH did not meet International criteria. This demonstrates the shocking level of misdiagnosis which has been going on for years.
Using lax diagnostic criteria creates a 'heterogeneous' group of patients not by diagnosis, but by misdiagnosis. This predictably results in care recommendations applicable to some patients which are completely unsuitable for others. It is this impreciseness that resulted in the need for a completely new NICE guideline, because the 2007 guideline had treatment recommendations that are actually useless or harmful to properly diagnosed M.E. patients. In fact if a particular patient gets any benefit from the treatments recommended by NICE - it could be considered evidence that they are misdiagnosed, e.g., because patients cannot think or exercise themselves better from a neurological illness. The perpetuation of heterogeneity contributed to by NICE, produced a guideline which failed doctors and patients.
The scope must define what it is studying and what it is not, else it will not empower doctors to make a confident diagnosis and ensure that patients receive the correct information, treatment and management. It is disappointing that the draft scope has failed in this basic requirement.
7, 1, 21,
"and people experience the illness differently".
What is the purpose of this remark? Are NICE preparing a guideline about patient's subjective "experience" of being ill? This remark is only significant to those who attempt to portray ME/CFS as nothing more than a patient's subjective experience (i.e., their hysterical 'illness beliefs'). Do individuals with multiple sclerosis NOT 'experience the illness differently' from other patients? Do patients with Parkinson's NOT 'experience the illness differently' from other patients?
8, 1, 22,
The 'common symptoms' list is quite good, but it should include 'headache' and we suggest that 'cognitive difficulties' sounds trivial and does not describe a symptom. It could be replaced with 'cognitive impairment, which is sometimes described as 'brain fog' and features impaired memory and information processing.
9, 1, 26,
"The causes of ME/CFS are unknown but there are thought to be many contributing factors."
This could be clearer and it could mislead the committee. As it relates to fundamental information relating to the guideline topic please consider replacing it with:
"The cause or causes of ME/CFS are unknown. Some risk factors have been reported though none are shown cause the illness. These include: viral infection, stressful life events, vaccination, etc. A risk factor for poorer prognosis is reported to be the severity of the illness. Post-exertional malaise differentiates ME/CFS from chronic fatigue and is associated with a significantly worse prognosis than the latter." (Jason 2011. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3171164/)
10, 1, 27,
"commonly reported trigger". 'Trigger' implies cause-and-effect which in ME/CFS is unsubstantiated. Many illnesses seem to coincide with other factors in patient's lives but this does not establish them as a cause or a factor of their illness. Mention 'commonly reported coinciding factors' if you wish, but do not use a term which could mistakenly be interpreted as attributing a cause.
11, 2, 23,
"The previous NICE guideline (CG53) made recommendations on the use of cognitive behavioural therapy (CBT) and graded exercise therapy (GET). The evidence supporting these interventions has been challenged"
It is inaccurate to state: "The evidence supporting these interventions
has been challenged", because there are serious doubts that there is or
ever has been any 'evidence supporting' the use of these interventions. The
theories underlying the use of GET and CBT claim to know the cause(s) of patient's
illness but these theories have been proved wrong.
Please replace the section with:
"The previous NICE guideline (CG53) made recommendations on the use of cognitive behavioural therapy (CBT) and graded exercise therapy (GET). Claims that these interventions help M.E. or CFS patients have been robustly challenged in peer reviewed literature. Serious flaws in research which claimed to support their use have been established."
12, 3, 14,
"NICE has carried out an equality impact assessment during scoping. The assessment: lists equality issues identified, and how they have been addressed"
The assessment omits the single most significant cause of inequality encountered by patients and its omission is of concern.
Patients with M.E. and CFS have been subjected to 30 years of discrimination in every area of their lives. They encounter micro and macro discrimination in medical care, social care, the benefits system, in the media and in society. They have been denigrated, marginalised and bullied. NICE contributed to this discrimination by recommending treatments which do not help patients and which have harmed some. By recommending Graded Exercise Therapy (GET) and Cognitive Behaviour Therapy (CBT), NICE confirmed to medical professionals, the media and the public that patients are only suffering from 'deconditioning' (laziness) and irrational 'illness beliefs' (hysteria, hypochondria), in other words, they have a trivial, subjective illness which they would not have if they 'pulled themselves together'.
E.g.: Three and a half years after the 2007 NICE guideline was published and when it had long been in effect, the PACE Trial (2011) report was published in the Lancet. National newspapers reported it with these headlines:
The Daily Mail: "Got ME? Fatigued patients who go out and exercise have
best hope of recovery, finds study"
The Independent: "Got ME? Just get out and exercise, say scientists"
The Guardian: "Study finds therapy and exercise best for ME"
The Telegraph: "Exercise and therapy can help ME sufferers, study claims"
The Daily Express: "TRIAL OFFERS HOPE FOR ME SUFFERERS"
The Daily Record: "Exercise and therapy can reverse effects of ME"
These false claims have compounded and perpetuated discrimination against patients and it should be noted: the PACE Trial report was NOT in contradiction of the 2007 NICE guideline.
NICE may not want to address this elephant in the room - but it must, because their task is not simply to educate the medical professions and the public, it is their duty to reeducate them. Judging from the draft scope, this will not happen unless NICE themselves are reeducated and can ensure that the guideline development committee avoids repeating this historic prejudice and discrimination.
NICE have not yet "carried out an equality impact assessment", because if they had, then this horrible discrimination and inequality would have been identified.
13, 4, 6,
"Key areas that will be covered"
NICE have overlooked misdiagnosed patients and patients who develop additional diseases. These must be specifically addressed in the scope and guideline because they represent serious risks to patients.
30 years of biased 'research' and media reporting, was been compounded by the 2007 NICE guideline recommendations and false reporting of the PACE Trial. These have been effective in branding patients as phobic, neurotic, hypochondriac, lazy and unmotivated, and as a result, these illnesses are widely perceived to be trivial, psychological diagnoses with no medical basis. This perception means that patients do not have equal access to healthcare. Patients with these diagnoses who go to a doctor with a new or worsening symptom are sometimes investigated properly, but are sometimes dismissed.
This creates two significant risks for patients:
1/ Missed diagnoses. Patients could have a disease which has never been diagnosed but which is the actual cause of their illness. Delay, or failure to ever identify the cause of a patient's illness, especially if it is chronic and progressive, would obviously be a serious medical error. E.g., Lyme disease is a common missed diagnosis.
2/ Delay in diagnosing and treating additional diseases. The aforementioned perceptions mean that patients' accounts of their symptoms are viewed by some, as unreliable and exaggerated. Therefore there is a risk that new symptoms and diseases which occur in patients will not be promptly or properly investigated. This could have serious consequences for those who develop, e.g., cancer or heart disease - which are two major causes of death amongst M.E. and CFS patients.
14, 4, 22,
"Areas that will not be covered" "The specific management of symptoms"
"Lyme disease (2018). NICE guideline NG95"
We recommend that the short-version of NG95 should be required reading for the guideline development committee and suggest the British Medical Journal summary (https://www.bmj.com/content/361/bmj.k1261) and Rapid Responses by VIRAS and others (https://www.bmj.com/content/361/bmj.k1261/rapid-responses) should be taken into account.
It will be necessary to include a specific sections on Lyme disease in the NICE guideline when covering both the diagnosis and the review of patients. We recommend that the committee view this short presentation by a doctor experienced in diagnosing and treating both 'CFS' and Lyme disease:
15, 7, 15,
"3.6 Main outcomes
The main outcomes that may be considered when searching for and
assessing the evidence are:
1 Quality of life (for example, EQ-5D, SF-36)
4 Physical and cognitive functioning (a person's ability to do everyday
tasks and activities)
5 Psychological wellbeing
6 Care needs
The list omits the following objective signs of change:
" return to employment or study, (or increase in work/study hours per week)
" Change in sickness and disability benefits
" Change in social services provision
" Change to pre-illness activities (i.e., resumption of hobbies and sports)
" 2, 6, or 12 minute walk tests
" Step test
" Actometer recording
" Peak O2 exercise challenge (with day 2 repetition) (important because the IOM report states that published research into this test validates PEM)
" Blood lactic acid (mitochondrial function)
" ADP, ATP recycling (mitochondrial function)
" Tilt-table test (POTS)
" Nerve conduction studies
" Spect scan (changes to punctate lesions)
Number 1 and 4 need clearer specifications. In some M.E./CFS research (and other disabling diseases), it is the SF-36 Physical Function subscale (PF) which is used to measure impairment. The scope must be clear about which it is utilising and if it is the PF scale then it should be included in #4.
HOWEVER, NICE MUST TAKE INTO ACCOUNT EVIDENCE THAT THE SF-36 IS NOT AN ACCURATE MEASURE IN M.E./CFS.
Writing on the 'Prognosis of ME/CFS', Dr David Bell referred to his and
his colleague's studies of patients who became ill with CFS in their youth.
At the 25 year follow-up they observed: "All studies employed the Rand-36
(SF-36), a questionnaire is (sic) common use. The first question of this instrument
is 'how would you rate your health?' Many of the patients rated their health
as 'good', while the rest of the questionnaire demonstrated how poorly they
were actually functioning." Dr Bell concluded his essay: "Forty year
old adults who had an acute onset during their teenage years have the activity
of seventy year old adults."
(Bell D. Prognosis of ME/CFS. Open Medicine Foundation. https://www.omf.ngo/2016/08/01/prognosis-of-mecfs/. Accessed Jul 25th 2018)
FURTHERMORE, ME/CFS research and researchers disagree and contradict themselves and each other regarding what an SF-36 PF subscale rating means:
SF-36 Physical Function subscale.
Interpretations of ratings in CFS and normative data from the general population
Perhaps NICE plan to add their own interpretation to this list of confusion.
1. White PD, Goldsmith KA, Johnson AL, et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011 Mar 5;377(9768):823-36. doi:10.1016/S0140-6736(11)60096-2.
12. Bowling A, Bond M, Jenkinson C, Lamping DL. Health Survey England 1996. J Public Health. (1999) 21 (3):255-270.
13. Bleijenberg G, Knoop H. Where to PACE from here? Lancet. Volume 377,No.9768,p786-788. 5 March 2011. doi:10.1016/S0140-6736(11)60172-4.
14. White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med. 2013 Oct; 43(10):2227-2235. doi:10.1017/S0033291713000020.
15. Stulemeijer M, de Jong LWAM, Fiselier TJW, Hoogveld SWB, Bleijenberg G. Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial. BMJ. bmj.38301.587106.63v1. 10.1136/bmj.38301.587106.63.
16. See 14.
17. See 14.
18. Tummers M, Knoop H, van Dam A, Bleijenberg G. Implementing a minimal intervention for chronic fatigue syndrome in a mental health centre: a randomized controlled trial. Psychol Med. 2012 Oct;42(10):2205-15. doi:10.1017/S0033291712000232.
19. Reeves, W., Wagner, D., Nisenbaum, R. et al. Chronic Fatigue Syndrome - A clinically empirical approach to its definition and study. BMC Med. 2005;3:19. 10.1186/1741-7015-3-19.
20. Wearden AJ, Riste L, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S, Dunn G, Richardson G, Lovell K, Powell P. FINE Trial Protocol. BMC med. 2006,4:9. doi: 10.1186/1741-7015-4-9.
21. White PD. PACE Trial Registration. MRC. Online: http://web.archive.org/web/20030611144353/http://controlled-trials.com/isrctn/trial/%7C/0/54285094.html. Accessed 10 December 2016.
22. See 20.
23. See 8.
24. See 8.
25. Jenkinson C, Coulter A and Wright L. Short form 36 health survey questionnaire: normative data for adults of working age. BMJ. 1993 May 29;306(6890):1437-1440. PMCID: PMC1677870.
26. See 25.
FUTHERMORE, in the PACE Trial, 111 participants across all groups met the author's 'normal range' thresholds for both the fatigue scale and the SF-36 physical function subscale. Yet only 22 of these participants met 'normal range' for the 6 minute walk test, and 9 of those were still diagnosed with CFS. This shows a major discrepancy between SF-36 PF ratings and the more objective measure of ability to walk.
AND FURTHERMORE, in the PACE Trial, the 111 participants who met the author's
'normal range' thresholds for both the fatigue scale and the SF-36 physical
function subscale, had an average 6 minute walk test distance of 414 meters.
This is 100 meters LESS than the average for people aged 70-80 years in Casanova
(Casanova C, Celli BR, Barria P. et al. The 6-min walk distance in healthy subjects: reference standards from seven countries. Eur Respir J. 2011 37: 150-156; doi: 10.1183/09031936.00194909.)
NICE must consider if the SF-36 is a valid outcome measure for patients with M.E./CFS especially if it suggests improvement. If NICE decide to go ahead and use this measure, then trial data for the measure must be critically analysed and validated by a more objective measure. This applies especially if any of the interventions used could have resulted in bias, e.g., individual therapy claimed to treat the illness in the form of cognitive therapy or exercise.
16, general, general,
VIRAS would like to thank NICE and the stakeholders who contributed to designing and writing the draft scope. It has clearly required a lot of work and much of it looks very good.
The main problem we have is that NICE do not appear to have decided what disease the scope is for. The exact same mistake resulted in some failures of the 2007 guideline. This decision must be made before any more work is undertaken and we request to be informed. VIRAS never intended to be associated with a guideline for 'fatigue' and if NICE proceed on that basis we will oppose it.
Multiple sclerosis patients are not expected to tolerate guidance which incorporates patients who only have fatigue. Neither are lupus, myasthenia gravis, Sjogren's and Parkinson's patients. Patients with M.E. or CFS should not be expected to tolerate it either, and if NICE intend that they should - then that will be discrimination which VIRAS will challenge by every available means.
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