By David Tuller, DrPH
Jonathan Edwards, a professor emeritus of medicine at University College London, has released a document involving the provision of care for people with severe ME, an issue at the core of some recent high-profile cases in England. The document, which Professor Edwards posted on a pre-print server, is called “Management of Nutritional Failure in People with Severe ME/CFS: Review of the Case for Supplementing NICE Guideline NG206.” (NG206 is the ME/CFS guidance released three years ago by NICE, otherwise known as the National Institute for Health and Care Excellence.)
In the recent cases, adolescent girls or young women and their families have fought with hospitals over whether and how tube-feeding should be pursued, and related questions. These disputes often involve widely divergent interpretations of the symptoms and the illness itself, including whether it is a physiological ailment or a manifestation of psychiatric or psychological disorders.
In July, a coroner in Devon will hold a two-week inquest into the death of Maeve Boothby O’Neill, who died at 27 in October, 2021, after three hospitalizations failed to resolve her feeding and nutritional problems. The inquest is likely to focus more public attention on the issue.
Professor Edwards has been a longtime advocate for patients with ME/CFS, including when it comes to countering bogus claims made by proponents of cognitive behavior therapy, graded exercise therapy, and related interventions. When asked, he offered the following for why he took up the matter of severe ME cases:
“A number of people with ME/CFS and their carers had been pleading for more precise protocols for the care of very severe cases. Initially I was not convinced anything useful could be written, because we have so little evidence to go on. But it became clear that there were major failures in care and that something must be wrong. I asked people involved in regulatory organisations and charities and there was agreement that things were not working well but there appeared to be no easy route to producing an official document. After consulting lots of people, I came back to the conclusion that the only guidance that can be given is already out there.
“But I also sensed that I might be able to contribute to clarifying the situation by giving an outside viewpoint on why things are in such a mess and what the real problem is – that health professionals are not following the evidence-based guidelines available. There are polarised views – almost like in the current political arena – and the patients are suffering, stuck in the middle.”
Here’s the abstract of Professor Edwards’ review:
“In the United Kingdom, a small but steady stream of people diagnosed with ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome) have run into serious problems with nutrition because of difficulties with eating and drinking, and some have not survived. The clinical problem is extremely difficult, with little or no formal evidence on which to base diagnosis-specific recommendations for care, or information about prognosis. In several cases, however, the problem has apparently been compounded by a lack of provision of adequate services, misunderstandings, and conflict between health care professionals over diagnosis and approach to management. The following is a review of the clinical problem, including some suggestions for protocol content that might supplement NICE Guideline NG206. The main conclusion is that there is an urgent need for a consensus amongst professionals that focuses on practice based on reliable evidence rather than theory-laden diagnosis. The author is a physician with no direct involvement in ME/CFS care but with an interest in the clinical and scientific problems the condition poses.”
The obvious goal is to prevent patients from starving to death while families and clinicians and health care administrators argue over the nature and meaning of the illness. Whatever the cause, Professor Edwards argues, if patients are unable to eat at all or are unable to consume sufficient amounts to sustain themselves, they obviously need to be provided with nutritional support by some other means. That should be a self-evident point, but clearly in these cases it has not been.
The review is chock-full of common sense and thoughtful observations about ways to navigate the tension points that arise over patient care. Professor Edwards disentangles the complicated strands of the dilemma in a clear and straightforward manner. He acknowledges what is known about treatment of ME/CFS and what is not known. He also bluntly dismisses the biopsychosocial ideology and notes that presenting patients with physical or behavioral “challenges” has proven ineffective as a therapeutic approach. That principle should apply, Professor Edwards writes, whether the challenge is forcing patients to undergo graded exercise therapy or forcing them to eat when they have difficulty doing so.
Here is a key passage from the conclusion:
“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. It has become clear that the challenge approach was never validated before use, and subsequent studies have shown no evidence of efficacy. Theories about psychosocial factors have failed to stand up; methods used to corroborate them have been poor, but good enough to show that the theories are flawed. The least one can say is that if psychosocial factors are involved, nobody has shown a useful understanding of them, or of how to manage them.”
And what is Professor Edwards’ assessment of the guidelines currently available to help health care personnel manage these difficult cases? Here’s what he writes: “While there may appear to be a need for clearer guidelines, available guidelines on nutritional support appear to be adequate. They just need to be followed.”
Hopefully this document, the attention given to recent cases, and the upcoming inquest in the case of Maeve Boothby O’Neill help force the necessary changes and put a stop to these disastrous situations.
(Not the Professor Edwards who first popped into my head.)
It’s impressive when people see a problem and what’s needs to be done to fix it and just get on and do it rather than hoping that others will in time with or without some encouragement. This review appears to be desperately needed and I hope it fills the gaping hole and leads to changes in management so that severe ME patients can’t be deprived of nutrition while their doctors wrestle with how best to manage their cases. It shouldn’t be needed though and that Professor Edwards felt it was I think suggests that something has gone terribly wrong in medicine if doctors are failing to acknowledge physical decline that’s staring them in the face and/or refusing to believe that the patient’s situation is as bad as the patient or their family members are reporting. The biopsychosocial model should be all about monitoring the bio-, psycho- and social statuses of the patient equally and well and not neglecting any one aspect because the focus is on another. It seems to me to have become completely distorted because of an extreme focus on the ‘psycho’ component at the expense of everything else, leading to the situation where in some cases now it appears that there is ‘no health BECAUSE OF mental health’ (see -https://www.mentalhealth.org.uk/about-us/no-health-without-mental-health). I think medics need some serious re-educating about what the BPS model should mean in relation to the care that they give. I’d say that first and foremost they need to see with their eyes and listen with their ears rather then imagining all sorts with their brains.
Clearly the conclusion reached by Professor Edwards that:
“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. It has become clear that the challenge approach was never validated before use, and subsequent studies have shown no evidence of efficacy. Theories about psychosocial factors have failed to stand up; methods used to corroborate them have been poor, but good enough to show that the theories are flawed.’
reflects the situation described at paragraph 84 in the Montgomery Judgement referenced by Professor Edwards as setting out the legal situation around the need for Doctors to gain the patients ‘informed consent’ to medical treatment:
84. Furthermore, because the extent to which a doctor may be inclined to discuss
risks with a patient is not determined by medical learning or experience, the
application of the Bolam test to this question is liable to result in the
sanctioning of differences in practice which are attributable not to divergent
schools of thought in medical science, but merely to divergent attitudes
among doctors as to the degree of respect owed to their patients.
The Montgomery judgement sets aside the Bolam Test and reaffirms the long standing legal and ethical position that Doctors and other Health Care Professionals owe their patients/clients a ‘Duty of Care’ as described in paragraphs 82 and 83:
82. In the law of negligence, this approach entails a duty on the part of doctors
to take reasonable care to ensure that a patient is aware of material risks of
injury that are inherent in treatment. This can be understood, within the
traditional framework of negligence, as a duty of care to avoid exposing a
person to a risk of injury which she would otherwise have avoided, but it is
also the counterpart of the patient’s entitlement to decide whether or not to
incur that risk. The existence of that entitlement, and the fact that its exercise
does not depend exclusively on medical considerations, are important. They
point to a fundamental distinction between, on the one hand, the doctor’s role
when considering possible investigatory or treatment options and, on the
other, her role in discussing with the patient any recommended treatment and
possible alternatives, and the risks of injury which may be involved.
83. The former role is an exercise of professional skill and judgment: what risks
of injury are involved in an operation, for example, is a matter falling within
the expertise of members of the medical profession. But it is a non sequitur
to conclude that the question whether a risk of injury, or the availability of an
alternative form of treatment, ought to be discussed with the patient is also a
matter of purely professional judgment. The doctor’s advisory role cannot be
regarded as solely an exercise of medical skill without leaving out of account
the patient’s entitlement to decide on the risks to her health which she is
willing to run (a decision which may be influenced by non-medical
considerations). Responsibility for determining the nature and extent of a
person’s rights rests with the courts, not with the medical professions.
Professor Edwards intervention in this paper is a much-needed reminder of the primary importance of the Medical Ethics principle of:
‘First do no harm’ which rests on the need to respect the patients right to the giving or withholding of the patient’s ‘fully informed’ consent to any recommended medical treatment.
That patient ‘right’ has the force of law behind it and not to respect that ‘right’ is to be ‘negligent’ towards the patient as defined by that law.
Those patients to whom the ‘challenge approach’ has been widely recommended and applied as a valid diagnosis/treatment should have been informed by the prescribers it had not in fact been and has never been ‘validated’ at any stage. Patients have been and are routinely not so informed and in fact often told the opposite. If they had been advised as Professor Edwards now suggests, then the ‘huge amount of avoidable distress’ referred to by Professor Edwards would not have occurred in the first place.
It is a fact that countless numbers of ME/CFS patients have over the last 30 plus years been granted UK State financial support after challenging at law a refusal of such support on medical advice that ME/CFS was not a physical illness but a psychological/behavioural illness. Those diagnosing ME/CFS as not physical could not and cannot provide the Courts with any evidence to substantiate their diagnosis or their treatment approach of denying access to that financial support. They have not so far abandoned this behavioural/psychological approach to ME/CFS despite their prolonged failure both scientifically and legally to substantiate their diagnosis or treatments.
That such a paper needed to be written, and questions remain for this writer as to whether it will succeed in meeting its objective of the abandonment of the invalidated and failed theory of stimulus challenge with regard to ME/CFS, poses serious questions around the regulation of Medical Practice.
This Paper is not simply about a medical or scientific argument between health care professionals but a fundamental examination about whether Doctors are demonstrating, the required by law, respect for the rights of individual patients within the delivery of medicine/health care to them.
The Paper clearly demonstrates that in the medicine and science around ME/CFS Doctors have not and are not showing the required respect. Professor Edwards describes the reasons why they are failing and what needs to be done to correct this failure.
Professor Edwards is to be applauded not only for the clear common sense in this paper, but also for the respect he clearly demonstrates towards the ‘human and legal rights’ of patients.