Preprint Management of Nutritional Failure in People with Severe ME/CFS: Review of the Case for Supplementing NICE Guideline NG206, 2024, Edwards (Qeios)

As an editor (something I do have expertise in), I should probably make some comments, but I feel very nervous about doing so.

I can see the perspective of the authors of the open letter. There are problematic aspects of your letter @Jonathan Edwards from an editorial perspective, which mean that certain sections are ambiguous as to what is meant (implied or intended). In an area such as this, I think it's absolutely crucial to be explicit - very clear - about what you mean. There is no room for being misunderstood. But also, occupation of a "middle ground" may also be dangerous.

If the intended readers are those who are charged with providing care to those with severe ME, then special care needs to be taken to ensure that any anchoring beliefs in those readers are not pandered to.

One such anchoring belief is that there is no biomedical or physiological cause of ME. If you state there is "limited evidence" (multiple times), and then list no references, that anchor will be confirmed. It doesn't matter if you mean that physiological pathways are yet to be discovered. The implication is that there is no evidence, meaning such pathways don't exist and will never be found to exist.

This anchoring also means that when the reader comes across section 2 (History and Aetiology), and the only "evidence" cited is Acheson and McEvedy/Beard, their anchor is confirmed, and will colour the way they read the rest of the article. Saying "ME/CFS has no identified tissue pathology" and then citing no references is essentially making a statement of fact that is so obvious it needs no evidence to back it up. It is also untrue. The following sentence denying links to other conditions (MCAS, PoTS, EDS) is also untrue and unhelpful. These conditions are, at the very least, linked by co-occurrence and/or susceptibility in many people.

Another anchor is that NICE Guidance NG206 is not endorsed by some of the Royal Colleges for good reasons. We know the details of the history of that. But others won't. Again, it needs to be explicitly stated that you are endorsing NICE guidance NG206 (not withstanding your CoI wrt being on the guideline committee). It is not clear from your conclusions that you are doing this, or that you are also recommending the addition (appending) of another guideline (CG32).

Anchoring will also likely mean that your conclusions could be misinterpreted. For example:
"The simplest, and I think robust, analysis is that management of patients with stimulus challenge, often in the context of unsubstantiated diagnoses and outside established guidelines, has caused a huge amount of avoidable distress and needs to be abandoned."
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could be read as "management of [these] patients [who have sensory stimulus challenges] ... needs to be abandoned.", when what you mean is that the use of stimulus challenge in these patients should be abandoned.
 
That is a fairly lengthy series of editorial grouses @Lucibee but in return I can ask for your evidence - which you do not cite. It isn't there.

I deliberately published this on a site where positive and negative comments are welcome from everyone (at least I guess with an academic affiliation) and are in themselves publications and allow for me to respond. I could easily do that there if anyone made comments but there has been a stony silence from the professionals who will have been asked to comment, and from others.

I don't really see any ambiguity in what I have written - The things you charge me with seem out of court.

Lucibee said:
The implication is that there is no evidence, meaning such pathways don't exist and will never be found to exist.
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An editor might think that but not any scientist or properly trained medic I know of!!

Lucibee said:
The following sentence denying links to other conditions (MCAS, PoTS, EDS) is also untrue and unhelpful. These conditions are, at the very least, linked by co-occurrence and/or susceptibility in many people.
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Where is your evidence, @Lucibee? I have actually looked into this in considerable detail and can find nothing I would regard as meaningful evidence for an association. There are some quite good studies showing none. The situation for PoTS is complex because, as I note, there is definitely a link to OI, but the more one goes into it the more the PoTS concept falls apart anyway.

There is, as indicated to David, nothing 'middle road' about this. It is rigorously one-sided - on the side of needing evidence to be adequately relevant in order to base clinical care on it. I know from 35 years working on another disease that nothing in the ME/CFS field gets close to that.
 
Jonathan Edwards said:
What was intended to be implied was not really a middle ground, more a level playing field I think!! And a referee with a loud whistle.
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It is my experience that our understanding of any communication always starts from where we personally are in our own understanding of the matters being communicated, which only very rarely if at all, will be exactly where the communicator is coming from. We all read into things what we want/hope to see or sometimes don’t want to see. It makes communication all a bit messy and difficult sometimes.

So what follows is most definitely only about where I am regarding the usage and meaning I find in this quote from Jonathan's paper.

‘The simplest, and I think robust, analysis is that management of patients with stimulus challenge, often in the context of unsubstantiated diagnoses and outside established guidelines, has caused a huge amount of avoidable distress and needs to be abandoned.’

That looks to me like a description of a clear red card (sending off offence) being held up to ‘stimulus challenge’ in the context of diagnosing and treating ME/CFS.

When it comes to accepting or declining medical care, the law says the patient is the ‘Referee’ and the only one who can make the final call in all but the most unusual of circumstance. Having a diagnosis of ME/CFS is not that unusual circumstance and if that diagnosis is changed by another medical authority, they have to produce evidence as to why the original diagnosis should be replaced and provide positive evidence for their own usually ‘psychological/behavioural’ diagnosis.

We found psychological/behavioural diagnoses never could explain themselves and that is what, in my reading, NG206 finds as does Jonathan in this paper, and very many medical authorities and practitioners before them. Very many judgements at law found and continue to find the psychological/behavioural attribution to ME/CFS does not explain itself.

We did not have that wide a level of support to call on when we first went to law in the early 1990’s challenging the psychological attribution to ME/CFS and won. Granted it was not easy from a stress point of view, but it was very doable, and we found it opened up access to more appropriate health care and welfare support. Later referring to our earlier success at law was often enough on its own to mitigate some of the worst of the ‘stimulus challenge’ approach to ME/CFS, so favoured by many HCP’s.

We found having a ‘red card’ in your pocket only works if you are prepared to show it and use it. Bottom line is that you can reject the treatment you don’t want and ask for other proportionate treatment. Not easy to do I know, and itself a cause of considerable stress and suffering, but for us it beat this incessant going round and round in circles in a false scientific/medical argument.

ME/CFS Patients don’t have to prove they have a physical illness. They do have to choose between competing and poorly evidenced medical explanations/diagnosis and treatments which all come with varying degrees of risk for the patient, which HCP’s are compelled by law in the UK to fully explain to you and respect your decisions.

It is the fact that HCP’s don’t all fully explain or respect your rights to proportionate other medical care which is the problem and lay’s them open to legal (and professional) jeopardy, which I think, is also implied by Jonathan in his paper when he sets out the ethical and legal considerations.
 
I appreciate you have written this paper Jonathan, I don't have the cognitive ability or energy to process all the information into a coherent paper that colleagues might read and reflect on.

I have read the parents letter and I agree with most of what they say except this:

Despite the prevailing notion of ‘limited evidence’, ‘speculative diagnoses’, ‘unknown
mechanisms’, etc., decades of research (albeit poorly funded) have contributed to the
understanding of ME, with a significantly expanding literature since Covid-19. Pertinent
examples from this year alone include: Appelman et al. (2024); Armstrong et al. (2024); Chen
et al (2024); Eastman (2024); Keller et al (2024); Peluso et al (2024); Pretorius et al. (2024);

Ryabkova, et al (2024); Walitt et al. (2024). The common pathophysiology between post-
COVID syndrome and ME is now well-described, with Arron et al. (2024) providing a cohesive

model which calls for a holistic approach to diagnosing, researching, and treating ‘one of the
most misunderstood conditions in modern medicine’ (Arron et al. 2024).
/QUOTE]
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I have had ME for 30 years and practised in medical wards for many years before choosing to do psychiatry. I haven't forgotten my med school or medical training and I do not think the "common pathophysiology of ME" is well described (let alone the relationship to Long Covid). We are still talking about models (which is sadly mostly all we have in psychiatry) without the hard biological facts of what exactly is happening in the cell, how this impacts on a neighbouring but differing cell, etc etc to cause all the varied manifestations of our illness.

I read a lot in here and although I think there is a lot more understanding of ME in the last decade or so, and there have been improvements in treatments by ME clinicians, unfortunately, imho, if you put all the details and research together, it does not come, even close, to the most basic, irrefutable pathophysiology of a disease. (even though I think it is a biomedical disease). We have a long way to go with respect to research and finally having the answer.

It's fabulous to have all this new research happening in the ME sphere but I think ME clinicians who run big clinics (eg in the USA) should be running some proper treatment trials rather than putting out expert consensus and various protocols. I am sure if they explained this to their clients with ME, they could run some, even do cross-over trials so every one gets a go at the treatment. It may only be suitable to do on mild ME but something is better than nothing if proper informed consent is done.

Whenever I read the "expanding literature" the parents have referenced, which I have read and all the other ME scientific literature over the years, the language used nearly always rings bells in my head - such phrases as "maybe" "potential" and it seems, as Jonathan has said in various comments on various threads - somehow these models have become fact when it is still speculation (much like a lot of psychiatry). This, of course, allows the vast field of ME to get muddied by a huge variety of theories and often competing voices. It is not easy for me to keep up with the all the different theories and trials, my head just spins some days...I especially don't like the repeated reviews of the ME literature lately that seem to be skewed towards their "model" be it microclots, metabolomics, etc etc. but that is the nature of researchers trying to hype their research to get funding (I suppose) and give hope to us all....

But looking at the whole issue and I think everyone should be able to have their say, the question for me also, is - what should the treating doctors think and do? Medicolegally, they have to work within their scope of practice and if unsure consult others with more experience and training in ME. The physicians (and general practitioners) with a special interest in ME, they need to be rigorous in their analysis of the scientific research. Although, we then have to be diagnosed and treated in silos and consult various specialties and have our illness treated symptomatically, and that is definitely not an an ideal situation, that is the reality, whether we like it of not.

There are some very major systemic and financial problems within the health system both in the UK (and NZ). Having had some consultation-liaison experience in training but also as a community psychiatrist, it appears that general practitioners and outpatient physicians (eg gastroenterologists) are causing the initial failures in care and treatment. Also there is the issue of pain management, when should opiates or benzodiazepines be prescribed. What happens if tolerance develops and the dose has to be increased? what is the maximum dose for an outpatient etc etc? Often psychiatry is then consulted to rule out major mental health disorders that may contribute to the pain eg. a major depressive episode may make pain worse. Poor nutrition and fluid balance may cause psychiatric disorders, that are treatable by improving the standard of care, some medications and working through any misunderstandings within the concerned parties and the pwME and improving working relationships between primary carers and the treating doctor.

Physicians in hospitals appear to be out of their vocational depth with very severe people with ME, with nutritional problems, and with the added complexity of uncontrolled physical pain, that makes medical doctors they consult, who specialise in pain (eg anaesthetists, intensive care physicians etc) start feeling out of their depth too. They don't know the physical cause for the pain or why normal doses of pain medication are not working. Or they have tried everything they think is medicolegally defensible. Then, because they are stumped, they turn to CL Psychiatry (who have more experience using a variety of medication that may help symptomatically but are all non-proven in the ME population). They, of course, also bring all their psychological, psychosocial and psychosomatic models and then we all know things can get even worse...But their role is also to manage the anxiety and conflict between different specialties, staff caring for the pwME, family, support network and ME specialists (if available). Unfortunately, many psychiatrists, either by their lack of knowledge, prejudice and assumptions really put their foot into it, misdiagnose the pwME as having anorexia nervosa and start a variety of psychological "measures" (using the term used by a locum psychiatrist in the UK media for yet another such case of a severely underweight pwME currently in hospital in the UK). These are of course totally inappropriate for a pwME but I suspect they are trying to use behavioural treatments sometimes used in the treatment of anorexia nervosa in a psychiatric setting.

I don't know what it is going to take to get the College of Psychiatry in the UK to change their ways, specifically the subspecialty of Consultation Liaison Psychiatry. (this also goes for the RANZCP). Hopefully, public shaming by the media will get them to finally look at their contribution to these cases. But there is also the Medical Colleges that need to get on board too and put out some Position Statements for all their members on the treatment of nutritional and pain difficulties in pwME. (this also includes the NZ Colleges too, specifically the RNZCGP and RNZCP). That will require a lot of discussion and roundtables between all the different specialties and coming to some sort of consensus can be very difficult but it is not impossible, they just have to recognise there is a problem and come together and work on it.

Ultimately, sigh, I think it will only come down to having the indisputable pathophysiology for ME regardless of the causative trigger etc, until the last stalwarts within psychiatry, worldwide, are well and truly argued off the field by their Medical colleagues.
 
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hibiscuswahine said:
Ultimately, sigh, I think it will only come down to having the indisputable pathophysiology for ME
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In practice I think that is right.

But there is a crucial message hidden away behind that. In reality, the demonstration of indisputable pathophysiology (rather than structural changes that in many diseases are either hard to pin down or even not there) rests on reliable proof of the efficacy of a treatment that targets that pathophysiology.

Remember that nobody, not even the drug company that made it, wanted to use rituximab in RA until it was shown to be dramatically effective. We still do not have any undisptuable pathophysiology in RA (for the actual signalling) but we have enough evidence to treat people and that evidence came from trials.

However much it may be true that there are metabolic or circulatory or autonomic or immunological changes demonstrable in ME/CFS, none of that is good enough to base treatment on until the treatments have been shown to work. Moreover, it will be the showing the treatments to work that ultimately proves that those changes are not just epiphenomena.

The ultimate argument against the BPS theory is simply that the predicted treatment did not work.

What matters in medicine is not the science, but the clinical evidence. It just so happens that the clinical evidence provides the proof of the science.
 
Jonathan Edwards said:
What matters in medicine is not the science, but the clinical evidence. It just so happens that the clinical evidence provides the proof of the science.
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Plus I think to show the evidence, i.e. set up treatment trials properly, both a scientific mind and some clinical experience is needed -- whereas to see bad reasoning in trial setups/ reports and eventually in all research logical thinking and endurance (e.g. with thoroughly checking references) often seems to be sufficient.

Which is why I am sometimes surprised that very smart people can't agree on the often inaccurate argumentation and unwarranted conclusions analyzed in detail by forum people on hundreds of forum threads on all kind of research, be it biomedical or psychosomatic.
 
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Jonathan Edwards said:
I deliberately published this on a site where positive and negative comments are welcome from everyone (at least I guess with an academic affiliation) and are in themselves publications and allow for me to respond. I could easily do that there if anyone made comments but there has been a stony silence from the professionals who will have been asked to comment, and from others.
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Yes would be good to see people getting involved in the discussion there.

Apologies for being dumb, but I can't see a way to leave commentaries there. Do you have to register to even just see how to do that?

I only see the possibility to do a review or suggest reviewers. That would be helpful to get more people aware of the paper too, I guess?

Anyway, I so much hope people in charge will take notice and that this will lead to lives being saved.
 
dave30th said:
What legal judgements do you mean here?
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Apologies for this long post, but your question is a good one.

The situations outlined below all pertain either to HCP’s right to diagnose, investigate and treat ME/CFS as a primary biological illness and/or the patients and their main carers right to choose that clinical approach and gain access and entitlement to:

· Biological medicine both investigative and treatment: Examples of success at law here include the successful defending in legal process by HCP’s of their ‘Fitness to Practice’ licence against charges by the BPS that their biological view of ME/CFS was false and harmful to patients. Other examples are the very many recorded failures at law by BPS informed authorities to remove children from their parents care just because the parents chose the biological explanation and clinical approach to ME/CFS. The BPS false illness beliefs attribution could not be explained/justified at law in either of these scenarios.


In our own experience we also found that referencing these judgements and the law which supported those judgements was often enough to get access to previously denied medical care or social and welfare support for my wife and myself as her carer. We also had a child diagnosed with ME/CFS and our knowledge of those failed BPS informed child protection actions, the law on which the judgements were based, helped us navigate that particular BPS minefield successfully and not have to actually go to law to protect ourselves and our child’s rights. We faced a similar situation at the end of my Wife’s life with regard to Adult Safety concerns and again our demonstration of our understanding of the law and the failure of the BPS psychological diagnosis of ME/CFS to explain itself helped us navigate that particular difficulty.


· Social and Welfare support including State or other insurance backed financial support for being unable to work and for help with the extra costs of being disabled: Examples of legal success here are ourselves, the at least hundreds and more probably many thousands of other ME/CFS patients and even greater numbers of others who have successfully appealed refusal of State benefits on psychological BPS grounds for Invalidity/Sick Benefits/Disability Living Allowance/Mobility Allowance/Blue Badges etc. Entitlement to such benefits are based on law which set out the criteria, medical and otherwise upon which entitlement is based. Who gets these benefits is decided by non medical adjudication officers in accordance with requirements set out in the law. (In our case we had to take our case to the highest level a Social Security Commissioner but since then most now succeed at Tribunal Appeal.) The law requires that those giving a medical opinion must satisfy legal requirements for that medical opinion to be acceptable. I will discuss below the BPS failure to meet the acceptability requirement in more detail below as those legal requirements for medical opinion to explain itself at law is a common factor throughout all these situational scenarios. The important point here is that just like in ‘the consideration of risk’ with regard to ‘informed Consent’ it is not simply a matter of deciding which clinical judgement to accept but about the ‘reasonableness’ of that clinical judgement in respect to the individual patients' rights as set out in the legal statutes covering the situational scenario. The BPS spread their psychological (false disability belief attribution) to encompass many other long term illnesses and this also failed to stand up to legal scrutiny when challenged at law just as it fails in ME/CFS cases.


· HCP’s, Parents and carers rights to support those they care for with ME/CFS in the belief that the illness is physical and not a figment of the patients or their own imagination and also be provided with their own reasonable adjustments/social/welfare support: my primary example here is my own case, which concerns ‘the duty of care’ all HCP’s and those they advise like Employers, Insurers (State or Private) owe to the public and individuals. On advice from their Occupational Health Adviser my employer refused me ‘reasonable adjustments’ so as to help me cope with my caring duties for my wife who had severe, often very severe ME/CFS. Long story short, my health suffered substantially as a result. I got independent expert medical evidence that placed that failure of my health firmly at the door of my Employer’s refusal to make ‘reasonable adjustments to take account of my caring responsibilities with someone with severe ME/CFS’. At an Employment Tribunal my Employer accepted that Expert medical evidence that they had failed in their ‘duty of care’ towards me as a result of following their occupational health adviser’s personal unsubstantiated/unexplained BPS psychological view of ME/CFS, which conflicted with the advice given by my Wife’s own medical advisers on her ill health and care needs.



Some more words on the actual ‘facts’ in a legal sense which underpin all the above noted legal judgements against the BPS psychological diagnosis and treatment of ME/CFS.


Starting accepted Fact: Historically ME, CFS, PVFS etc) has been classified as a physical disease of the Nervous System in the WHO classification of disease since 1969. This classification was and is accepted by the UK Government and the Department of Health. The cardinal feature of the disease ‘effort intolerance’ leading to a prolonged worsening of all symptoms is well described in the medical and science literature by Ramsey amongst others. This feature and signs of biological irregularities in certain body systems, together with careful investigation for other identifiable causes including the exclusion of ‘psychological’ reasons for the clinical presentation in individual patients supported the diagnosis of it being a biological illness. Hence the WHO classification.


The law in various statutes including that pertaining to the award of sickness and other social security benefits require that patients must be given an explanation if that diagnosis of ME/CFS as a physical illness and its recognised cardinal feature of ‘effort intolerance’ is changed by another later medical authority.


The Kitchen Judgement confirmed this requirement setting two conditions to be met; the reasons and grounds on which the first ‘physical’ diagnosis fails and second the evidence relied upon to substantiate the new ‘psychological diagnosis of ME/CFS. We won our first case in the early 1990’s by referencing the Kitchen Judgement and the requirements it set out. The existing Social Security Act at that time also set out the same requirement that a changed diagnosis by a later medical authority should be explained to the patient/claimant.


The law also contains and sets out a test for deciding the level of impairment/disability necessary in order to legally qualify for the financial support offered.


The test for many different benefits is whether the patient can ‘safely sustainably and repeatedly’ undertake various physical activities necessary to be able either to be fit to work in the case of sickness benefits or look after their own personal needs in the case of Disability Living Allowance, PIP and Mobility Allowances.


All the legal successes referred to above found as a finding of ‘fact’ that the BPS psychological diagnosis of ME/CFS did not explain itself or why the previous physical attribution to the illness ME/CFS should be set aside. In addition, the Judgements implicitly found there was no reliable evidence to show that ‘effort intolerance’ was not a physical reality and that consequently ME/CFS patients met the qualifying criteria of being unable to ‘reliably, sustainably and safely’ undertake physical activities. They all implicitly reject the BPS assertion their recommended treatments of increasing activity are ‘safe’ for patients to undertake.




The later Montgomery Judgement further supports and expands on Kitchen and is in my view extremely important as it completely places the power as to which medical treatment a patient should undertake solely with the patient, because all treatments come with ‘risk’ and the acceptance of that risk can only be decided by the patient. The HCP has a legal duty to give full advice on all medical views, the associated risks and to respect the patients ‘informed consent’ choice. A failure to do so could constitute ‘Negligence’.


The BPS approach has been and is so far from obtaining individuals ‘informed consent’ as to be completely unsafe for patients in my view. The law in many situations as described above makes that conclusion also.


Information on legal successes against the BPS efforts to deny the biological reality of ME/CFS and the failure of their treatments have been reported over the years by many ME/CFS charitable and other organisations helping people with their claims for State benefits or in defence against child removal action.


Denial of State Benefits on BPS psychological grounds was also big news for a while in the UK about a decade ago. A senior Judge commented at the time that the DWP were losing so many cases at legal appeal that they should be fined for wasting the courts time. In his view they had no evidence to back up their refusals on the BPS medical grounds they applied. A substantial number of those successful appeals included ME/CFS cases. A little research online should draw it all out if you want to dig deeper.



I have over the years in various voluntary capacities, helped very many ME/CFS patients and their families get their entitlements originally refused on BPS medical advice by explaining the legal basis on which they could challenge that clinical view. You don’t have to prove ME/CFS is physical/biological that was done in the eyes of the law years ago. You have to show (at law if necessary) that the BPS medical view and treatments can’t/don’t explain themselves and are unsafe for you in the light of that pre existing physical/biological diagnosis of ME/CFS with its identification of ‘effort intolerance’ as the cardinal feature. This also applies to getting ‘reasonable adjustments’ in other settings because of other recognised ME/CFS intolerance features. This required getting medical advice to support that specific to each individual case. NG206 and Jonathan’s paper now medically and scientifically state and explain that unsafeness within and the inappropriateness of the BPS approach to ME/CFS explicitly and generically. Although only guidance to HCP’s they carry the weight of the law on ‘informed consent’ behind them and should prove useful tools for patients to use when choosing their medical care.


Where I and many others have been less successful, is in getting the GMC as the Medical Regulator to bring the BPS System of Medical Care into line with UK law governing their medical practice. They seem content to leave that job up to individuals as evidenced by the myriad of these little but very significant legal successes outlined in the scenarios described above.


Your own work does an excellent job in highlighting the inadequacies of the BPS system of science and medical care. Thank you for all your efforts, which help to empower patients in their choice of medical care for ME/CFS. The legal Judgements and processes outlined above also empower patients to make their own choices of acceptable to them medical care and in gaining access to other support services.
 
There's been an excellent comment posted on the excellent article.
The comment is by David Davies-Payne:

I thank Prof. Edwards for writing this supplementary guidance, clarifying the responsibilities of professionals tasked with caring for people with very severe ME/CFS and nutritional failure. It is a straightforward concept that nutritional support measures should be appropriately escalated, similar to the situation in other diseases such as cystic fibrosis, anorexia nervosa, short gut, or MMIHS.

This management guidance is based on the well-founded NICE 2021 Guidelines, formulated in an era that is seeing substantial progress into research of postviral chronic conditions. While the research clues implicate e.g., immunometabolic and neurovascular dysfunction, the evidence is currently not mature and robust. It is possible in this pandemic era that our understanding of mechanisms will accelerate and effective treatments of underlying pathology may then rapidly follow. In the meantime, adhering to this guidance will safeguard the highly vulnerable patients with the severe complications of this devastating condition — it will also protect practitioners from professional and ethical failure.
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"while research clues implicate [biological mechanisms].... evidence is currently not mature or robust" :thumbup:
"it will also protect practitioners from professional and ethical failure" :thumbup:
 
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Jonathan Edwards said:
That is a fairly lengthy series of editorial grouses @Lucibee but in return I can ask for your evidence - which you do not cite. It isn't there.
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There is a lot of evidence for anchoring biases and their effects: https://en.wikipedia.org/wiki/Anchoring_effect

The reason I was nervous is because I suspected that you would see me as a grouse rather than a dove. Please consider that *that* anchor has biased how you read my post.

I was commenting on how your paper might be read by those who are coming from a completely different perspective.

I don't think there is any point in me saying anything else.
 
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