Ethical classification of ME/CFS in the United Kingdom (2019) Diane O'Leary

[Barry]

Few conditions have sparked as much controversy as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Professional consensus has long suggested that the condition should be classified as psychiatric, while patients and advocacy groups have insisted it is a serious biological disease that requires medical care and research to develop it. This longstanding debate shifted in 2015, when U.S. governmental health authorities fully embraced medical classification and management. Given that some globally respected health authorities now insist that ME/CFS is a serious biological disease, this paper asks whether it can be ethical for the U.K. practice guideline now in development to characterize the condition as a mental health disorder. Following a brief history of ME/CFS controversy, I offer three arguments to show that it would be unethical for the U.K. to now characterize ME/CFS as a mental health condition, considering the relevance of that conclusion for ME/CFS guidelines elsewhere and for other contested conditions.

Paywalled at: https://onlinelibrary.wiley.com/doi/full/10.1111/bioe.12559

Full access at: http://sci-hub.tw/10.1111/bioe.12559

 

[rvallee]

Holy shit! She gets it so intensely well. Still reading but this is fantastic. Read it when you can.

If the United States is correct that ME/CFS patients are in need of medical care, and they are also correct that the recommendation to deny care has been based on compromised scientific standards, then PACE-gate presents us with an extraordinary phenomenon, where the research-to-guidelines system has actually obstructed access to medical care for millions of patients in need. No matter what conclusions we personally embrace about the PACE trial, it's clear this is an area where ethical discourse is sorely needed.

Just plug it straight into my veins.

Indeed, it is hard to imagine what everyday medical care would involve if physicians provided medical support, testing, and treatment only to patients whose need for them had been proven. It is unreasonable, and indeed unethical, to set the bar for general access to biological medical care uniquely high for patients with ME/CFS.

And make it a double.

Similarly, no matter what conclusions NICE professionals reach about medical harm with ME/CFS, the possibility of medical harm will remain, and that will establish that it is unethical to obstruct patients’ access to medical care.

Common sense:

Third, based on the principle that patients’ foundational right to access medical care from their doctors depends not on proof of need but on a substantial possibility of need, I have argued that it would be unethical for the guideline to characterize ME/CFS as a mental health condition. If NICE does choose to remain neutral on the debate, it must resist the very common temptation to obscure the boundaries between medical uncertainty and mental health diagnosis. A neutral NICE guideline must meticulously avoid language that encourages practitioners and patients to construe ME/CFS as a psychiatric disorder.

And basic duty of care:

The new U.S. position establishes that patients with ME/CFS do face that possibility of harm: so as long as we accept this foundational right, we must also accept that it is unethical to classify ME/CFS as a mental health condition.

One familiar name, another less so:

The Countess of Mar contributed to this article with a literature search, comments on the final version, and valuable discussion of core ideas. Gabriele Badano contributed with substantial discussion of NICE policies and the philosophical principles that underlie them. This article was greatly improved by the comments of three anonymous reviewers for the Journal of Medical Ethics, and by their unreserved enthusiasm for its contents.

And the reason she gets it:

Diane O'Leary PhD is a Visiting Fellow at the Rotman Institute of Philosophy in London, Ontario, and Adjunct Full Professor and Course Chair in Philosophy at University of Maryland University College. Her research focuses on confusions in medical reasoning about mind and body, and the ethical problems those confusions create in cases of diagnostic uncertainty.

 

[Daisybell]

I can’t access the sci-hub link...

 

[BruceInOz]

I can’t access the sci-hub link...

Worked for me.

 

[Snowdrop]

This article and the one by Hilda Bastian https://blogs.plos.org/absolutely-m...-the-me-cfs-exercise-dispute-matters-so-much/ feels like a breach in the wall.

 

[Hutan]

The challenge to NICE to make an evidence-based guideline in an eminence-based medical system:

PACE-gate, and the U.S. conclusion about it, are the most sub- stantial factors driving the need for NICE guideline revision, and this raises obvious ethical concerns. NICE has long maintained close ties to PACE researchers and advisors, who continue to hold authorita- tive positions with U.K. medical and mental health organizations. As an organization committed to evidence-based conclusions that meet bioethical standards, it is reasonable to hope that NICE can manage the challenge of an ‘acrimonious scientific row’ with a focus on pa- tient safety and well-being. It is also reasonable to note, though, how difficult it would be for any professional to acknowledge error at the magnitude of PACE-gate.

 

[Jonathan Edwards]

I see a big problem here. She is arguing for evidence-based guidelines but her argument is that treatment of PWME should not need to be evidence-based.

Her heart seems to be in the right pace but her logic looks to be hopeless, with the result that this is only likely to hinder the process of getting things sorted.

 

[Hutan]

I think I agree that the logic isn't quite right, although her view probably won't hinder anything.

I have suggested that, as a general rule, patients who face a substantial possibility of harm from disease have a foundational right to access biological medical care from their doctors.

She's saying where there is doubt, patients have a right to biological medical care. But, for PwME, there really is no evidence-based biological medical care available. There's only evidence that BPS treatments don't work. So, I guess there is no need to bother with ethics - economics will do. If the treatments don't work, there's no point wasting money applying them to patients.

I suppose where there is doubt, patients should be able to expect that biomedical aspects of their illness are researched. But I don't think she goes into that.

 

[Jonathan Edwards]

I think I agree, although her view probably won't hinder anything.

I think the view she holds is very likely to hinder things, but I would agree that her article will probably make little difference. The view is likely to hinder because it is the basis of the idea that 'every patient responds to something different so we should have a range of treatments' - which of course would include CBT and GET. That view has been expressed by one of the NICE staff working on evidence review and is quite likely to be held by some committee members.

In other words, contrary to what she is suggesting, it is her own view that is most likely to lead to a perpetuation of the unsatisfactory status quo.

 

[Peter T]

I see a big problem here. She is arguing for evidence-based guidelines but her argument is that treatment of PWME should not need to be evidence-based.

Her heart seems to be in the right pace but her logic looks to be hopeless, with the result that this is only likely to hinder the process of getting things sorted.

I have not read the full article yet, but isn't she arguing in relation to ME/CFS, that while evidenced based medicine is the goal, that even if you accept there is lack of evidence, it wrong to use such lack of evidence to [uniquely] deny people [with ME/CFS] access to medical care.

It would seem to me that her arguement is particularly relevant to the entire MUS as pseudo psychiatric diagnosis nightmare.

[added having read the full article- Some doctors provide medical symptom management for people with ME/CFS, but it is not clear whether this is evidenced based or not. We have evidence for example on the efficacy of pain killers, even though we may not have evidence for their use in ME/CFS. Isn't what O'Leary saying is that even if you conclude that we can not say that ME/CFS is either psychological or biological, this is not an ethical reason to deny people access to medical care that we have reason to think may help.

Personally I would argue that we do have evidence the CBT and GET are ineffective and potentially harmful, so not relevant to O'Leary's plea for people to access potentially helpful, but perhaps unproven treatments in relation to ME/CFS. However, I must accept she could clarify her arguements.]

 

[Peter T]

I can’t access the sci-hub link...

Try a different browser. I am on an iPad and could not access it from Safari, but after several tries in different browsers did manage to access from Puffin.

 

[Milo]

She's saying where there is doubt, patients have a right to biological medical care. But, for PwME, there really is no evidence-based biological medical care available. There's only evidence that BPS treatments don't work. So, I guess there is no need to bother with ethics - economics will do. If the treatments don't work, there's no point wasting money applying them to patients

I agree with you @Hutan however when you say ‘there is only evidence that BPS tx don’t work’- we are not quite there yet in my area. There is the promotion of group CBT, the good kind of CBT they say where they educate patients about Central Sensitization Syndrome, and introduce the concept of catastrophization. They encourage mindfullness and relaxation and deem CBT as being ‘evidence A’ (the best rating) for the treatment of ME. Then with a CSS diagnosis, who cares whether you got Me or FM or you are simply too anxious about your symtoms, they don’t care. You basically enter group therapy and that’s all. You are likely to be prescribed anti-depressants (another evidence A thing) Then if you get worse, it must be that you didn’t try hard enough in trying everything we taught you.

It’s unbelievably pernicious, making the patient believe they are receiving care, but getting nothing at all.

 

[Hutan]

It would seem to me that her arguement is particularly relevant to the entire MUS as pseudo psychiatric diagnosis nightmare.

Yes, I think her argument probably works with respect to diagnosis. If you take a quick look at a person presenting with chronic fatigue, see depression in their medical notes, find nothing in their routine blood test, slap a label of MUS on them, and send them off to do a Spice girl routine on a paper circle then that's not ethical.

If a person is no longer able to work and is struggling to get through their day, then that warrants a pretty decent and well-coordinated investigation, ethically and economically.

 

[Jonathan Edwards]

while evidenced based medicine is the goal, that even if you accept there is lack of evidence, it wrong to use such lack of evidence to [uniquely] deny people [with ME/CFS] access to medical care.

No, I just think this is wrong. Evidence-based medicine, in its true wide-angled form, requires that you have sufficiently reliable evidence of benefit outweighing risk before you use a treatment. It is not some asymptotic goal, it is basic policy. There are no treatments for ME in this category so people with ME are not being denied anything they should have in terms of medical care. (With the caveat that in the UK people with all sorts of problems are not getting the basic care they need because the system is bust.)

People with ME have access to medical care. They may be denied diagnostic review when they need it because they do not actually have ME after all - i.e. people who do not actually have ME may be denied access to diagnostic review. But that is a commonplace, that applies to women with cervical cancer, people with coeliac disease and so on. For those that really do have ME accurate diagnosis, honest explanation and long term support may be denied, but that is not to do with her claim that being categorised as mental means that treatments are denied.

Basically I think she has been primed by advocates who think that people with ME are missing out on some useful treatments and that threatens to get seriously in the way of rational and effective discussion at the NICE guidelines committee.

I have not had a chance to read the full article but I did not get the impression she was dealing with the harm caused by useless treatments.

 

[Mithriel]

Actually, I have been denied access to medical care with serious detrimental results. When I first became ill, I was not diagnosed properly because of the original claim that ME was just mass hysteria. At the time, 1968, doctors already said the cardinal symptom was getting worse with exercise. If I had been told that and encouraged to pace from the onset I might have had a healthy, productive life.

When I was finally diagnosed in 1984 I learnt that following my body and not pushing through was the most likely to stop me getting worse. At that point CFS reared it's head and although I had never had fatigue that is all anyone in authority believed it was. Alongside the idea that exercise was the way to go this meant that I did not get the help that friends with MS were given so I was left to struggle with worsening health coping with 3 children, 2 of them autistic.

In the 50 years I have been ill medicine has failed me because no research money was ever given to look at the disease I actually have. What other disease is like that? When I see a medical doctor they think "fatigue" at best, "hysteric" at worst. I have never had a health check, or any medication offered to me.

The makeup of the NICE committee does not give me hope for the future.

About 12 years ago, I developed severely painful eyes but I resisted seeing about them because of the fear I have of medical staff because of the horrendous experiences I have had over the years (from sarcasm to downright abuse; how many patients go to a doctor and say their eyes clench shut when they go into a bright light and get told they don't; hardly access to medical care. It is one thing to say nothing can be done but to be told it doesn't happen makes you very wary about going back)

It got so bad I was forced by my family to ask for a referral. The eye consultant was kind, believed me and offered me treatment. he explained I had recurrent corneal erosions damaging my cornea and that my eyesight was at risk because of lesions and the high risk of infections from them.

Other ME patients are not so lucky, the abuse they get from doctors cuts them off from medical care, then there are the ones who are bedridden but no one will come to see them, they do not get the same care other diseases get. With other disease there may not be the money, with ME there is often no will to help.

And don't get me started on children with ME. Going to a doctor could mean having them taken into care and locked away from the family.

And this is all ethical!!!

 

[ME/CFS Skeptic]

I'm sorry to say I'm rather critical of this paper.

1) Its main argument seems to be that there is an important distinction between a mental health disorder and a serious biological disease. I think mental health disorders are most often serious biological diseases as well. At one point the paper states: "The possibility of disease means it would not be ethical to characterize ME/CFS as a mental health condition." Patients suffering from a mental health condition might find such statements to be offensive.

2) The article claims that ME patients are denied access to biological medical care, without specifying what is meant by this. As pointed out by Jonathan Edwards and Hutan, such statements seem to suggest that there are treatments that work in ME/CFS and that these are denied to patients. I think the science is very clear that there are no evidence-based treatments for ME/CFS (Ampligen is the only thing that comes close). Clinicians or advocates who claim otherwise might cause confusion to ME/CFS patients who are too sick to read or follow the debate.

3) The article also suggests that there needs to be proof of a biological pathology before patients have the right to access decent medical care and that this forms the crux of the debate on ME/CFS. I do not share this premise. If a patient is sick he/she deserves access to care. And if a treatment has been proven to be cost-effective then that treatment should be offered to the patient. Whether science is able to detect and demonstrate the underlying pathology isn't relevant to having access to care. It only helps in finding treatments that work.

4) I think the main problem in the care of ME/CFS patients is that psychiatrists have promoted a false etiology of this disease and treatments that are more likely to harm patients than help them. I think this is more important than the recognition that ME/CFS is a biological disease (whatever that means) or that ME/CFS patients have access to biological medical care (there isn't any evidence-based treatment anyway).

I hope Diane O' Leary will join the debate on this forum, to discuss these issues further. Her efforts in writing about the ME/CFS classification and the dangers of MUS, are very much appreciated.

 

[Barry]

The article claims that ME patients are denied access to biological medical care, without specifying what is meant by this. As pointed out by Jonathan Edwards and Hutan, such statements seem to suggest that there are treatments that work in ME/CFS and that these are denied to patients. I think the science is very clear that there are no evidence-based treatments for ME/CFS

I don't agree with this. Medical care is not confined to pills and potions, but can and should include well informed advice and support. My wife was extremely lucky, we had a very tuned in and decent, caring doctor, and the specialist she was referred to said there was no treatment they could offer, because she was already doing all the right things anyway; my wife had already described to him how she did pacing, though we did not know it by that terminology at that time. (My wife is mild / moderate by the way). Although there was no treatment they could offer, the process my wife (and I in fact) went through still was, and felt like, medical care - because it was! Being taken seriously by our doctor, and a specialist then professionally validating what we were already doing, was in fact very caring and constructive medical attention. Looking back, I now realise that without this good medical care, and if it had been of the pushy CBT/GET variety, my wife might now be much much worse as a consequence, so we are in fact extremely grateful for the medical care she received at the time. Many people are denied even this level of medical care, which I find disgusting, and is I think what this paper is about.

Was it biological treatment? Not in the strictest sense I suppose, but that medical care very likely preserved my wife's biological functioning far better than any BPS cr*p ... at the time we would have known no different, and just put our faith in the medical professionals.

Being told honestly by the medical profession that there is little they can offer is actually a good starting point when it comes to building trust. Add in some real support with pacing properly (there is a skill to it that may not come naturally to everyone), and just being on the patient's side, is a massive help for people when there is little else that medical care can offer - but it is still invaluable medical care.

Teaching people to pace properly is itself a crucially important form of biological care, and should not be overlooked. If this is not made available to a pwME, but CBT/GET is pushed at them instead, then to my mind that ties in with what Diane O'Leary says.

It is not true to say there is no biological medical care that can be offered to pwME, because teaching and encouraging people to pace, assuredly is I think. It may fall far short of the most ideal medical care, but it is a hell of a lot better than nothing, and immeasurably better than pushing psycho 'treatments' that amount to administering poison to some people.

I think it would be very wrong to assume that biological medical care only includes pills and potions; to my mind it is all about helping preserve / improve a person's biological functioning. The BPS brigade believe that pwME's biological functioning will improve if they change how they think about their illness; good medical care helps pwME preserve their biological functioning as best as possible, by teaching sound, sane illness management.

Personally I think that when reading this paper, a less pedantic definition of 'medical care' should be considered.

 

[rvallee]

there is an important distinction between a mental health disorder and a serious biological disease

I interpreted the way you mean it, in that there are possibly mental health problems that are actually psychological and that it's important to make that distinction, whereas others likely have a pathophysiology and can't be reduced to psychological support, especially not as primary treatment.

Miscategorisation (or ideological obsession) has discouraged biomedical research on those diseases despite massive historical blunders that insisted on a psychosomatic model until research solved it, basically a self-fulfilling prophecy since not funding biomedical research guarantees results will be long delayed, which is highly unethical.

The article claims that ME patients are denied access to biological medical care, without specifying what is meant by this

Many diseases have no treatment or cure. Still, those affected are usually not told to get lost by medical professionals because "there's nothing we can do", something that is completely false. There isn't always a medical solution but medical professionals remain critical in the process, they are effectively the safety net, no help is available without medical consent (up to and including support from family, something we all know about). It additionally deprives clinicians of experience with those patients, further depressing knowledge and delaying treatment options.

The article also suggests that there needs to be proof of a biological pathology before patients have the right to access decent medical care and that this forms the crux of the debate on ME/CFS. I do not share this premise. If a patient is sick he/she deserves access to care.

That's the point I understood, that we are refused medical care for a reason that is definitely not a standard, but rather an arbitrary choice. Many diseases have no known pathology, that's usually not a problem because the need is respected. It's not supposed to be this way, yet it definitely is in our case, something that needs to be explained.

The main point I took from the article is not only that it would be unethical to continue with the status quo, it would be unethical to not examine how such a broken status quo could even occur. Were they allowed to, it's guaranteed that NICE would kabuki the process (even more than they are) and just slap a seal on approval on the status quo and call it a thing of beauty, yet this discussion isn't really being held thanks to the stranglehold that Wessely's gang has had for years. In essence: the whole treatment of this disease has been unethical for decades.

It's more of a point about MUS and psychosomatic medicine, but we are definitely some of the worst-off victims of this and it's very relevant to the NICE process.

 

[Barry]

but medical professionals remain critical in the process, they are effectively the safety net

Yes!

 

[Mij]

Being told honestly by the medical profession that there is little they can offer is actually a good starting point when it comes to building trust.

This.