It is not about ME, it is not about Severe ME

Stonebird Response to NICE Guideline draft Scope Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. 

General Comment

This Scope is disturbingly very different from the previous draft scope. It has ignored, for example, most of what we recommended as a Stakeholder previously in conjunction with the 25% ME Group; it is hard to imagine that this Scope is a reflection of  the concerns that the ME Community has been expressing throughout the consultation period so far.

The Scope certainly does not reflect what we would expect it to, after so much input,  nor does it represent Severe ME at all, which is not recognised as a distinct group in the document; how then can  people with Severe ME be confident that their illness is understood, recognised  or that  any recommendation will be safe?

Fundamentally this Scope is about a heterogeneous group of people primarily with Fatigue still, not the WHO classified neurological disease, Myalgic Encephalomyelitis; it is certainly not about Severe ME.

Unless it addresses the following issues we fear that the new Guideline, like its predecessor CG53, will once again be a fatigue-focused document that, without defining the illness, will continue to ignore the full symptoms, physical experience and need, ultimately endangering or ignoring patients.

The listed  main outcomes, at the end of the doument, are of  particular concern as they are so limited in scope and do not appear to address the illness or challenge the fundamental  perception that it is primarily a fatigue illness.

1. In line with its obligations under the AGREE11 instrument,  NICE must specify
the population (patients, public, etc.) to whom the guideline is meant to apply.

It must be specifically described.

The Scope cannot possibly answer its own question : In whom should ME/CFS be suspected? without  identifying what “ME/CFS” means.

The Scope is fundamentally flawed precisely because it fails to define what it means by “ME/CFS”. It also continues to use the term encephalopathy, despite the fact that this is not a properly recognized,  acknowledged name for the disease.

The Scope should surely explicitly state that the World Health Organisation’s mandatory International Classification of Diseases categorises ME as neurological under ICD 10-G93.3. ME, an organic neurological disease can be fatal . "CFS", on the other hand, defined through the now discredited Oxford Criteria, which are no longer used in the USA, and the CDC/Fukuda Criteria, describes no distinct patient group.

The label “ME/CFS” is not formally acknowledged or classified by the WHO; it has no ICD Code. The WHO ICD-10 code as used in UK, Australia, Europe and other countries, has 'CFS' in the index only, indexed to G93.3; 'CFS' does not appear in the Tabular list, i.e. the main body of the classification listings, at that code. In ICD-10 'CFS' is not the same as 'Fatigue syndrome,' which is classified at F48.0 Neurasthenia under "Mental and behavioural disorders "

 This distinction is not made in the Scope, except to state that “ME/CFS is heterogeneous and multifactorial and people experience the illness differently.”In other words a disparate, vague group people ranging from those suffering from unexplained “chronic fatigue” to those with Severe/Very Severe ME  suffering profound, massive multi-system physical dysfunction lasting for decades.

In order to protect patients it  must also clearly state that the National Institute for Health and Care Excellence (NICE) does not list ME as a functional somatic disorder.

The Scope  must also clarify and state that ME is not "fatigue syndrome" (F48.0) and that the term Chronic Fatigue Syndrome specifically means  "chronic fatigue syndrome" (G93.3),  making it clear that ME/CFS refers to the neurological disorder WHO ICD-10 G93.3,  not "fatigue syndrome" F48.

This is particularly important  given how the ICD codes F44, F45 and F48 are currently being used as ‘catch-all’ codes in situations where clinicians feel there is an element of MUS affecting the patient and their management.

What is missing here is a statement that ME is currently incurable and there is no universal treatment.

2. The aetiology, pathology and biological research that provides explanation for ME symptoms and their underlying metabolic mechanisms should be included in the Scope.

The Scope acknowledges that “ the lack of understanding of the aetiology of the
condition has contributed to a number of different symptom-based definitions being used in research and in clinical care”  yet the aetiology and pathogenesis of ME, as in the 2007 Guideline, still lie outside the Scope’s remit.

How can the Scope ensure that the GDC use the safest definitions?

The Scope needs to clarify the cause, signs, symptoms of Myalgic Encephalomyelitis as part of  defining the disease for the GDG, to do this they must take into account the published biomedical evidence, over 7000 papers, that it ignored in the drafting of CG53.

Clarification of symptoms, inclusive of ME, is required so that they are nor mistakenly disregarded as “co-morbid” nor ignored if they are co-morbid.

What rational reason can there be for omitting aetiology and pathogenesis or the full symptom experience?

How can the GDG possibly know what disease and information to look at without this clarity?


3. The Scope should not rely on any opinion - based, blanket summary statements about aetiology and pathology. Aetiology and pathology  need to be included in the evidence review. At its core it should rely upon a specific definition of this multi-systemic neurological disease, which NICE so far has failed to present.

Will NICE remove the word “distressing” from the  Scope to describe ME, as this is associated with the definition/diagnostic criteria of MUS ? It would be better to replace this with acquired serious chronic, complex mutisystemic disease, as defined by the ICC criteria.

The Scope should list the full symptoms experience by people with ME, including the symptoms experienced by people with a Severe diagnosis, who will  have a wider range of symptoms, than those minimal symptoms so far recognised by NICE, including paralysis and the profound hypersensitivities: light, touch, sound, movement, motion, chemical and perfume sensitivity.

The only symptoms apart from fatigue that the Scope refers to are “chronic pain, disordered sleep, digestive problems and cognitive difficulties, this is a typical psychosocial minimization.

It is not clear how the Scope will provide an outcome for pain, as stated in its main outcomes, given it also says that neuropathic pain in adults has separate guidance and chronic pain assessment  and management is being developed and so will not be covered under these guidelines. This is a huge omission and also a large contradiction. We feel pain should be adressed as a whole within the ME Guidance to ensure it is understood in context.

4. The terms PEM/PENE, the cardinal symptom of ME, as described in the ICC Criteria,  should be referred to in the Scope, not just debilitating fatigue, particularly after exertion. “Fatigue” is not a full enough or correct term to cover the actual physical experience, following exertion, in Myalgic Encephalomyelitis. 

Furthermore, muscle fatigue also should be recognised as a specific symptom, so that it can be better investigated.

The Scope should provide a specific definition for PEM/PENE as provided in the ICC which includes delayed onset and inability to perform at the same level of exertion over consecutive days, corresponding with biological research on the impaired energy metabolism and aerobic systems in ME, the cardiac abnormalities that have serious implications for GET and are a contraindication of aerobic exercise. It is vital that the Scope acknowledges the severity of PENE in Severe ME particularly, especially in regard to “Activity Managment” as referred to CG53, to ensure it is not recommended, using elements of CBT and GET.

5. The Delphi Consensus methodology, where recommendations are based on opinion, not evidence should not be used in the drafting of the new Guidelines, because they will be totally reliant on the makeup of the GDG and the predominant attitudes that individuals hold towards ME, which can vary widely depending on what they represent - the psychosocial construct or a biomedical approach. 

CG53, for example, made the extremely dangerous  recommendation that people with Severe ME be offered Graded Activity Management, on the basis of consensus not evidence.

The Scope needs to clarify what exactly does it  mean by “evidence” when there is so little evidence available, especially in Severe ME. Will it be taking into account patient surveys and patient experiences, especially people with Severe ME?

6. Other NICE guidelines should not be automatically extrapolated to patients with ME, especially where there is no or little evidence of benefits or safety.

Safety is of high relevance here because the person with ME and particularly the person with a Severe diagnosis is at risk of serious harm and deterioration and unimaginable suffering, without comprehension and consideration of  the true nature of the disease. We would like to see a RISK assessment ensured before any recommendation and a specific acknowledgment that the slightest wrong action or interaction, for a person with Severe ME, is catastrophic and long term damage can ensue that cannot easily,  if ever, be put  right again. This is an extremely serious point. This includes recommendations on how to care for people.

The  unique nature of ME , particularly the post-exertional impact and deterioration, make other NICE Guidelines not necessarily transferable or appropriate. All aspects of ME should be included directly in the scope because of this.

It is dangerous to not recognise the acquired multi-system dysfunction, the serious drug sensitivity,  the metabolic disruption, the cardiac abnormalities, the reduced cerebral blood flow as well as the many possible biomarkers of ME.

The Scope should also clarify NICE’s position on its two sets of references regarding “CFS/ME” in  Improving Access to Psychological Therapies and the Guideline on “suspected neurological conditions” both of which include references to chronic fatigue syndrome as being a “functional” symptom or disorder, this is contradictory. This is another reason not to include CFS in the title of this Guideline.

7. Will Stakeholders and the GDG membership be expected to declare all Conflicts of Interest, including insurance, pharma and corporations taking over provision of health and social care services as integrated services /integrated care systems ACOs?

8. A quality standard, defining the absolute minimum to ensure safe and effective practice, needs to be developed for this Guideline, to prevent patients being diagnosed, mistreated or mislabeled as having non organic MUS in the IAPT LTC MUS pathway. 

It beggars belief that for the last 30 years the UK medical profession has taken seriously the claim, by psychiatry, without any basis, that the WHO classified neurological disease Myalgic Encephalomyelitis (ME) is a “Somatoform” disorder, inclusing MUS; this wrong must surely  be addressed by NICE in this Scope, in these Guidelines to ensure patient safety.

9. We are concerned that although treatments are not being considered by the Scope, therapies promoted as treatments may yet be wrongly included under management.

Most methods of management are not safe for they demand interaction and cognitive effort that especially in Severe ME, cannot safely be sustained.  Many people do not understand the enormous danger of deterioration in ME or for how far or for how long people can deteriorate. Cognitive activity, within the cognitive dysfunction of ME can lead to PENE.

This needs to be recognised.

10. People want real change and specific acknowledgment in the Guidance that the psychosocial paradigm will be no longer be allowed to  dominate and misinterpret ME. This is a concern that we feel has not been fully addressed by the Scope. 

We are extremely concerned that the minimal outcomes identified at the end of the Scope, with  their limited focus on sleep, fatigue and pain rather than full symptom recognition, full symptom alleviation, support and the appropriate meeting of  the needs of homebound people who cannot attend hospital settings, fail people with ME yet again.

The focus on fatigue as opposed to PENE and muscle fatigue is yet again inaccurate, unhelpful and  leaves the Scope vulnerable to the continued inappropriate inclusion of people with mental health conditions, alongside poorly diagnosed other illnesses, including undiagnosed or unrecognised rare diseases, under a heterogeneous umbrella term of ME/CFS that will yet again not help people with neurological ME or anyone get the right intervention, diagnosis and support.