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

"https://tinyurl.com/OpenResponseNFSevereME… An open response from parents and carers of people with Severe Myalgic Encephalomyelitis to ‘Management of Nutritional Failure in People with Severe ME/CFS: Review of the Case for Supplementing NICE Guideline NG206’"

 

While I can appreciate the sentiment in the response from parents and carers being one myself with a son with nutritional issues, I think they are expecting too much of Dr Edward’s paper.
My take on his paper is that it is directed at doctors & health care professionals who are unfamiliar with MECFS & are responsible for the care of a patient with MECFS who requires nutritional support. His instructions are clear;
1 Follow the NICE 2021 guidelines
2 If all other feeding attempts have failed and the patient requires tube feeding then provide it
3 It is unnecessary & inappropriate to consider psychological causes & treatments
4 If they require sensory accommodations then provide them
The paper is not designed to convince these doctors about the physiological basis of MECFS. They are not treating the MECFS per se. They are treating malnutrition & preventing starvation.

 

Just posting for those not on X:

https://twitter.com/user/status/1811668887957831993




Link to open letter:

 

Jo Cambridge used to bring bottles of Fairies dust essence back from Barbados yeas ago. Jack Iron I think it was called. Capable of combustion without the gunpowder. We often had happy thoughts with it on a Friday afternoon meeting but I don't recall anyone leaving the ground.

Re-edit; I had better look at this reply document!

 

I too have first hand experience of this situation as the carer of my late wife who died in a Hospice as a result of nutritional failure described as ‘Inanition’ on her Death Certificate with ME/CFS over the previous 30 plus years as a contributing factor. We had to fight very hard, reminding those involved with her care of our right to ‘informed consent’, our own knowledge about the science around ME/CFS and importantly also our knowledge of the law around ‘informed consent’. It got us admittance to the Hospice and its care facilities and reasonable adjustments re light and noise accomodations. The alternative on offer was referral to the local Mental Health Unit.

Our success in gaining access to Hospice care did nothing to improve or change the largely ‘challenge approach’ clinical judgements made by the medical team looking after her, which demonstrated all the biases and issues raised in the open paper response to Jonathan’s paper. It did however give us access to other spiritual and compassionate welfare services which not only validated our choices, but also helped us cope/face up to the very fast-approaching end of life for my wife, which they could not and did not know how to change.

I agree entirely with the analysis in the open paper but feel that if it were simply an issue of science/medical judgement then the problems would never have arisen in the first place, as ‘Informed Consent’ places the final choice of care with the patient unless it can be shown the patient cannot so consent.

There is no evidence that ME/CFS is ‘psychological or primarily behavioural’. There never has been any such evidence to support either the pseudo scientific research of such a notion or of treating ME/CFS as such by clinical practitioners. Jonathans paper makes it quite clear that patients should be told this fact and points to the legal judgements which require it.

His is not (imho) simply a pragmatic response to a (non valid) science/medical disagreement but one which sets out the woeful current state of science/medical practice with regard to ME/CFS and the current denial of the Patients right to choose and have offered to them, medical treatment proportionate to their symptoms and in accord with known/identified medical best practice protocols.

Several times during the very long course of my late wife’s journey with severe ME/CFS we had to take matters to law to gain access to healthcare and welfare services first denied on the grounds her ME/CFS was psychological. We won those cases because they could never explain or point to any evidence which supported the ‘psychological’ attribution. We received substantial financial restitution for damages caused by the unlawful denial of access.

The problem here is clearly a lack of respect for ME/CFS patients right to choose what happens to their own body after having been given all relevant medical advice.

We should not have had to go to law, but in terms of our quality of life in living with ME/CFS, it was doing that, which mitigated but did not eradicate the great harms and suffering we experienced from the entirely unevidenced ‘challenge school of thought’ regarding ME/CFS.

I am left with the question as to why those responsible for ‘Regulating’ practitioners' medical science and clinical practice which require those practitioners to obey the law, fail to act to protect patients but leave it up to them to fight their own individual battles to get their right to medical care choice through ‘informed consent’ respected by clinicians.

 

The open response document seems to focus on what is known about the pathophysiology of ME/CFS. Unfortunately, nothing clinically useful is known. Even if we were sure of the physiology data we still need studies showing that applying the inferences from such data to clinical care is beneficial. We have no reliable studies.

I forget whether I said I was taking a 'middle ground' approach. I was taking a deliberately even-handed approach maybe, in the sense that I considered all care based on theory without practical evidence was to be avoided, whatever the theory might be. But certainly not a middle ground between science and clinicians claims of efficacy. I was rigidly sticking to the need for a reliable evidence base.

I note that Janet Dafoe contributed to the writing and 'endorses' the response but it would be nice to know who considers themselves an 'author'. Maybe as carers and family there are reasons not to say, and I respect that. It is just easier to have a conversation when one knows who one is talking to.

 

Thanks for that. In a way the response not so much expects too much but misses the central point.

I guess I wrote it for everyone, including the very familiar, but yes it 'talks' to that audience.

The response paper includes this sentence:
The case histories of patients who have been harmed due to clinicians following
their judgment and not engaging with evidence-based expertise on managing ME do not
reassure patients and their carers

So why is it OK for physicians to follow their judgement if they have one sort of speculative theory rather than another? The argument raised seems to me to defeat the whole point of advocacy for better care. Some of those writing may genuinely believe we have an evidence base for care, I realise. But we don't, other than keeping people alive with feeding and not making things ten times worse by making them do things that cause distress.

 

I was also slightly surprised that Walitt et al was quoted as evidence for known physiology!!

 

Whilst I understand the sentiment of the response I fear the focus on “growing body of scientific and clinical evidence explaining the underlying pathology in patients with Severe ME.” makes the response a bit harder to read. After all the papers, such at the paper by Arron et which they cite to strengthen their position is merely a hypothesis paper which states “Since the exact pathophysiology of ME/CFS remains unclear, additional research is required to reveal further insight into this “neglected” disease.”.

I’m also not sure wether the focus on things such as lowered anaerobic threshold is really sensible, since emotional or cognitive activity have little impact on lactate, energy expenditure or something similar. I think the problems experienced by severe ME are far more profound than that and the biological phenomena underlying these problems haven’t been unraveled yet and as such can’t be treated.

I have no idea how this relates to the whole collection of: “orthostatic intolerance, dysautonomia, hypovolemia, autoimmunity, sleep disorders, fluid balance, gastroparesis, mast cell activation, and pain.”

In particular I don’t think we have more knowledge on the pathology of severe ME/CFS vs the pathology of ME/CFS, precisely because severe ME/CFS has essentially remained largely unstudied.

Nor do I know even if such knowledge existed, how any of it would relate to clinical care.

Perhaps the authors of this piece could be more specific when it comes to certain things as at least in the case of orthostatic intolerance there is a lot more that can be done than is currently done in clinical practice (I'm mainly referring to posture). However, from what I recall that is precisely also what @Jonathan Edwards had written in his piece.


The section “Implementation of NICE Guideline [NG206] and Focus on Clinicians’ Judgment” makes a much stronger argument I find and deals with the reality of patients and their caretakers.


Since this is a piece supposedly written by parents of patients that are very much suffering and this suffering is only ampflied by the current clinical care, rather than being a scientific paper, if scientific inaccuracies are part of the pathology of ME part of the response perhaps one can look past those and engage in a conservation with the authors of the piece that might be fruitful.

 

I understand the parents/carers wanting to write this letter, however what I saw as important in @Jonathan Edwards paper was that it was scrupulously accurate containing only points indisputable in a legal as well as an academic sense. He deliberately and I believe appropriately skirted the psychosocial versus physiological debate as irrelevant to the issue in hand.

I believe we can conclude on that there are physiological anomalies associated with ME, but we have no evidenced treatments for the condition in general or for the associated nutritional issues in very severe ME. This lack of any treatments is what dictates medical involvement is purely based on symptom management, not any models of the underlying condition. Obviously where oral feeding is failing to maintain adequate nutrition establishing tube feeding is the first step in managing the symptoms.

I feel the parents/carers letter could have also made more of the sensory issues so central to very severe ME which could be managed so simply if the clinicians involved just listened to the patient.

[cross posted with a number of comments above, so apologies for the overlap]

 

I agree, especially as where it is addressing medical professionals, they're more likely to be in Britain than the US. The health systems and medical cultures are very different.

 

I think you are correct @Trish, but I also took the implication that they felt anyone writing such a paper should automatically push the biological basis of ME. However is this appropriate when you are trying to engage a potentially hostile audience.

 

It is not explicit but my thought is that there is a fairly widespread view that some further procedures, and most specifically intravenous saline infusions, should have a NICE-type protocol. The problem is that we don't have the evidence. I don't refer to this specifically in my article but this is the sort of area where I think conflict between physicians is generated and as much as anything I am calling for everyone to stop arguing and just keep people alive.

 

The criticism that it "does not reference the biomedical evidence" is clearly misplaced. The only results that are currently reliable are negative ones (e.g. rituximab). While the CPET material is interesting it isn't as robust as it needs to be to be considered definitive (I don't think they've adequately accounted for every subjective variable).

They claim that NICE recognised that ME is "indisputably a biomedical condition" - if I recall correctly NICE did not advance a view as to aetiology, presumably deliberately. They say that "the onus should be on acknowledging what is now known and knowable"- yes, but you also need to understand how much is not genuinely known, rather than taking every claim in some two-bit journal as though it were undisputed fact.

The uncritical acceptance of Helmsley's statement seems to me to be also misplaced. Helmsley is trying to defend the actions of his hospital. There are no specially commissioned services for a lot of conditions; that doesn't mean you get to ignore the very real needs of the patient in front of you. Drawing attention to systemic issues may be welcome but should not detract from the very real institutional and individual failings that are occurring all too regularly.

They say that it is "unlikely that there will be a middle ground that patients and carers can safely accept" - pwME not dying absent unnecessary theorising isn't adequate enough middle ground?

 

Hemsley's statement is actually quite odd and I have yet to work out why he said it.

 

Handwaving about systemic issues and service provision seemed to me like a "patient-friendly" way to distract attention from his own hospital's very real failings. There's no specialist provision because there's no specialist treatment and in any event there are no specialist centres for a lot of conditions. The treatment that needs to be provided is supportive and can be given in any hospital. In fact he was wrong - there is specialist service provision that accepts out-of-area referrals: the Leeds centre, which takes a completely psychosomatic approach and is precisely what we don't need more of.

Drawing attention to systemic issues is commendable enough but this should not be allowed to displace individual and institutional responsibility. His hospital had a responsibility to their patient, and they abdicated that responsibility: in a more sane and rational world regulatory and legal consequences would flow directly from that.

 

Overstating the biological evidence does us more harm than good. If you brought n=17 studies like the Nath one to a UK consultant they would laugh. The unfortunate reality is that the is NO replicated evidence of biological mechanism. If there were, we wouldn't be dying of malnutrition in NHS hospitals while the attending psychiatrist says to "calm down".

 

I might be accused of being ignorant of the biological evidence but I did note that one of the papers quoted was of a study that was an extension of a project Jo Cambridge and I set up with IiME, with five members of my department as authors! (By that time I had decided not to be an author on data papers since I was no longer actively in the lab.) The findings were interesting but not suitable for basing clinical care on.