Journal of Medical Ethics - Blog: It’s Time to Pay Attention to “Chronic Fatigue Syndrome” (2019) O'Leary

[ME/CFS Skeptic]

It would be entirely a matter of whether or not those treating had been diligent enough in establishing that the treatment worked. You could ask was the treatment of rheumatoid arthritis with gold on the basis that it was an aberrant form of tuberculosis ethical.

I think there are issues that go beyond the treatments a theory proposes. Suppose that doctors believed in the psychosocial theory of ME/CFS, namely that the disability of ME/CFS patients endures because they have false illness beliefs and unhelpful behaviors. And suppose that those doctors somehow agreed that GET and CBT do not work. In my opinion, there would still be a major problem. Spreading misinformation about perfectionist tendencies, catastrophizing, kinesiophobia and somatic attributions in ME/CFS patients is harmful because it changes how doctors look at ME/CFS patients and how they interpret their symptoms. Doctors might be more willing to challenge the patient's experience for example by suggesting the patient doesn't really need those sunglasses, that wheelchair or that many hours of sleep.

In fact, I would go one step further. Even if there was a psychosomatic theory on ME/CFS that somehow would not lead to such inappropriate management advice, but instead would result in doctors taking the patient seriously, I think there would still be a problem. Most ME/CFS patients experience their illness as a biomedical pathology that is mostly unrelated to their thoughts or behavior. If their doctor believes otherwise, that will be a source of frustration and stigma. So that's a major flaw that is inherent in psychosomatic theories and unrelated to their predictions regarding treatment and management. So even if ME/CFS patients had a doctor who took their symptoms seriously and offered correct treatment advice, the fact that he believes in an etiology that is contrary to the patients' experience, is still problematic. I think one could argue that it is unethical to promote an etiology that challenges the patient experience, without providing the necessary evidence to do so.

I agree that this isn't much of a problem in the NICE guideline which doesn't speculate much about etiology. But there was a Belgian government website on ME/CFS that provided pretty much this info. The website was restrained in offering GET/CBT but emphasized that CFS patients have a lot of psychosocial problems and that they have difficulties managing their activity pattern etc. A problem that does bother me in the NICE guidelines and that goes beyond GET/CBT, are their diagnostic criteria. Although the Canadian criteria were available at the time, they made up their own case definition, one that focuses mostly on the symptom of fatigue and only requirs 4 instead of 6 months of duration. If a guideline says that ME/CFS is unexplained fatigue accompanied by some other symptoms, that will probably result in doctors not taking this condition seriously because fatigue is everywhere and always poorly understood. The NICE criteria also probably resulted in overdiagnosis. This Chalder study, for example, looked at 200 patients who satisfied the NICE criteria. Of those, only 52,6% satisfied the Fukuda criteria. So if a guideline defines a condition differently which results in an increase of the prevalence, without offering any good reason (either data or expert opinion) to do so, that is a major problem and ethical issue.

So I think I might be taking a middle ground in this discussion. On the one hand, I don't think everything is going to be alright when GET and CBT are off the table. There are other major problems with the psychosocial theory and the way ME/CFS is defined. On the other hand, I doubt that these issues are best articulated using the biomedical/psychosomatic divide terminology. In my opinion the crux of the matter isn't really about having access to biomedical care.

 

[Binkie4]

Once a doctor has done no harm, then surely the next priority ethically should be to relieve suffering?
My level of OI is now so severe that I would try anything, in addition to chocolate, to relieve it. Also pem.

But there is simply no point in raising this again with my GP. He has nothing to offer to treat my ME symptoms and no real interest in discussing them.

My severe heart valve problems were not picked up because with a diagnosis of ME, you are not investigated. ( I have a recollection that at one time the NICE guidelines advised that ME patients should not be sent for further tests because it would reinforce their false beliefs). So you can go almost overnight from having nothing wrong with you ( ie psychosomatically ill) to being told you need open heart surgery. This happened to me.

And the person who saw I was ill and needed investigating was an exercise physiologist (employed by me to recondition me in line with Workwell’s advice after immobility due to a knee problem), not my GP. She had an open mind.

Once you have a diagnosis of ME, doctors treating you via the NHS, do not. You are not ill in their eyes and they see no further than CBT and GET. Ethically this is surely appalling medicine. It feels like a human rights issue.

 

[Inara]

I think in that wider context the ethical question Diane O'Leary poses is important.

I understood that's exactly the context she means. It's not about NICE or DEGAM or... - or UK or Germany or...It's about an unethical, nearly global behavior/discrimination against a certain group of people.

 

[Jonathan Edwards]

If someone spends 3+ months of hope, time, effort and money on some sort of involved therapy and it doesn't work, while this might not be considered a serious adverse effect, they have still been harmed.

I don't think that can be considered relevant. Treatment of rheumatoid arthritis or cancer frequently involves 3 months of time effort and money with no results. The difference is that adequate trials have shown that the chances of benefit are good enough to make that a reasonable risk.

 

[AR68]

Once a doctor has done no harm, then surely the next priority ethically should be to relieve suffering?
My level of OI is now so severe that I would try anything, in addition to chocolate, to relieve it. Also pem.

But there is simply no point in raising this again with my GP. He has nothing to offer to treat my ME symptoms and no real interest in discussing them.

My severe heart valve problems were not picked up because with a diagnosis of ME, you are not investigated. ( I have a recollection that at one time the NICE guidelines advised that ME patients should not be sent for further tests because it would reinforce their false beliefs). So you can go almost overnight from having nothing wrong with you ( ie psychosomatically ill) to being told you need open heart surgery. This happened to me.

And the person who saw I was ill and needed investigating was an exercise physiologist (employed by me to recondition me in line with Workwell’s advice after immobility due to a knee problem), not my GP. She had an open mind.

Once you have a diagnosis of ME, doctors treating you via the NHS, do not. You are not ill in their eyes and they see no further than CBT and GET. Ethically this is surely appalling medicine. It feels like a human rights issue.

Completely sympathise and, unfortunately, agree. This was the point I was making earlier re 'MUS'.

'CFS'/ME/'MUS' are potentially lethal 'diagnoses' whereby, to many doctors, everything subsequently is viewed through the prism of the mind playing tricks; the doctor not admitting to not knowing what is happening and, ultimately, blaming the patient.

 

[Esther12]

I'm not sure what I can say to the suggestion that I'm speculating about things I don't know for certain, that I don't tackle these issues carefully, or do not rely on direct quotes. Holy cow. Honestly it's hard for me to understand how anyone could think this is possible. I'm not writing social media posts. These are single-author, peer-reviewed articles in top journals. No one could publish these things without very substantial expertise in the history and methods of psychosomatic medicine. It's quite bizarre that I keep having to say that on this forum. This would never be necessary in academic settings.

I think that my comment came across as more wide ranging (and insulting!) than I intended. Sorry. I am pleased to see you posting here and appreciate you sharing your views.

I was talking specifically about the bit I quoted: "NICE diligently avoids language that sounds psychosomatic because there are zillions of studies that show this terminology makes patients mad". From my understanding it's quite difficult to know exactly what led to the exact phrasing seen from NICE. There was some (seemingly limited) involvement with patients, and my understanding is that not all members of the NICE committee endorsed a fully psychosomatic model of the illness, but instead imagined themselves to be taking a 'pragmatic' EBM approach towards care for those suffering from a poorly understood condition.

I think that you see that psychosomatic/biomedical divide as more important than I do and so you are more likely to present matters as if that is the central issue when I am left feeling a bit sceptical.

I'm not pulling rank, and I truly don't care about getting credit - but I think advocates get used to the idea that anyone who takes a stand for medical management of ME must not be professionally credible. That's not the case anymore! I do know how these guys are thinking, because I've studied psychosomatic research in a rigorous way for so many years.

Try the BDS paper, which presents an extensive defense of what I suggested above about the psychosomatic/biomedical divide. (So citation heavy that it's a great sleep aid!) I'll attach a link. For what it's worth I'm not seeing how the combative skepticism serves the cause, or the collective spirit of the group. I'm an ally.

https://docs.wixstatic.com/ugd/23f4ba_ae3ffbf6ff614c669f1e6ad9420a2dc9.pdf

I'm not saying I don't see you as an ally, but I just naturally post about any concerns I have with what I'm reading. This is how I am with everyone and I'm not trying to be combative.

I thought your paper was good - thanks. There were still a couple of places where you emphasised the psychiatric/biological divide more than I would, eg:

"Because the US conclusion establishes a strong possibility that patients with ME/CFS suffer from a biological disease that requires biological medical care, it also establishes an unacceptable level of risk with any diagnostic construct that would systematically channel care for ME/CFS down the mental health track. In this way, ME/CFS is an important cautionary tale. Regardless of which side we might favour in the ME/CFS debate, the very existence of the debate establishes that BDS carries significant medical risk."

I share many of your concerns about BDS, but I'm not sure that the US conclusions make BDS any more problematic than it would have been otherwise. Also, though, I can see how the US conclusions you referred to can be useful political tools that are valuable for those wanting to make certain forms of argument.

I thought you might be interested in Tuller's recent blog about seeming problems with some of the claims made about MUS: http://www.virology.ws/2019/02/25/trial-by-error-the-cost-of-mus/

I wondered if you had any thoughts about my concern of emphasising the importance of the labels used:

I really agree with you that the controversy in this area is an important issue for ethicists to look at and learn from, but I think that the 'psychosomatic' label very often distracts from the important ethical problems there are in this area. If the biopsychosocial crew suddenly start describing ME/CFS as a biological illness and they start talking a bit more about providing pharmaceutical interventions for some symptoms, but nothing else changes (and I fear that this is the way things are going) then that's very little progress.

I don't think that can be considered relevant. Treatment of rheumatoid arthritis or cancer frequently involves 3 months of time effort and money with no results. The difference is that adequate trials have shown that the chances of benefit are good enough to make that a reasonable risk.

Also, with most treatments patients are (should be) properly informed about the risks/evidence, so they've decided for themselves to engage with a treatment which make take time and effort and lead to no results. When patients are being managed into adopting 'positive' views about their illness, treatment and likelihood of recovery then I think those costs are better understood as an adverse effect of the treatment approach taken than just another part of life.

 

[Jonathan Edwards]

One of the more disturbing aspects of all this whole farce is how much is hand waved away and swept under carpets by those insisting that the physical-mental divide doesn't exist, is an old outdated view, unproductive, misleading, unimportant,... whatever.

But direction of causation not only matters, it is all that matters, for both explanations and therapeutic interventions.

The model used by the PACErs and allies explicitly invokes causal direction (mental –> physical) for explanation and therapy, so they are quite aware of the importance of directionality.

The confusing thing is, @Sean, that your account is probably closer to the BPS account than the account of biomedical scientists and physicians (of a non-BPS type).

There are 3 supposed views.

1. The BPS view that there are psychological or mental causes and these are different from biological causes and the two interact (this is what Descartes said so it is weird that the BPS people nock Descartes).

2. The straw man view that the BPS people attack - that there are psychological causes for psychological illness and biological causes for biological illnesses and they do not interact.

3. The view of biomedical scientists and non-BPS physicians, which is that all causes of illness are biological, including all the causes of illness dealt with in psychiatry or psychological medicine. Some biological causes may have 'mental' correlates in that they feel like something to the person but they are not a different type of causation. All sorts of biological causes, including the ones with mental correlates, interact in most illnesses. Thus most biomedical scientists are entirely in agreement with the original meaning of 'biopsychosocial' but might prefer not to use those syllables.

Nobody is questioning a divide between the psychosomatic or neo-biopsychosocial view and view 3. That seems to be another straw man in this discussion. The issue is whether or not the IOM report somehow changes what the NICE guidelines should be.

One thing that worries me is that the IOM report looks too much like view 2, or at least it may well be interpreted as implying view 2. View 2 is never going to get any support because it makes no sense if you are familiar with clinical medicine.

 

[Barry]

What treatment, if any, has been shown to work for improving or curing ME?
The answer to that has to be - there is none.

GET, CBT and other psychological and exercise based treatments that involve planned increases in activity do not work. There is no scientifically valid evidence that they work. Therefore they should have no place in the guideline.

Yes, in the context of the NICE guideline review (the most crucial key issue at the moment) we need to keep to the KISS principle (keep it simple stupid), so that this single most powerful argument for removing CBT and GET from the new guideline does not get muddled and lost on those who will make the decisions. I would only say that if there could be sufficient evidence level of possible harms, then that might counteract those who seek to convince that modest improvements are possible; even if some were convinced of possible minor improvement, such a cost/benefit equation should clearly err on the side of safety.

And as was clarified to me some while back now in this forum, any given NICE guideline never includes recommendations for co-morbid conditions, as there will be separate guidelines for those. So for example if anyone tried to suggest that CBT should remain in the new ME/CFS guideline because some pwME may suffer from co-morbid depression as a result of their illness, that would not wash - the separate guideline for depression is responsible for that.

 

[Jonathan Edwards]

Tilt table testing has been done at paediatric transition after securing a specialist referral (after a private consult)- the team carrying it out were smiles at the start and ashen faced when they had the results. POTS is a major part of the illness profile for this young person. With medication, the quality of life has been significantly improved (better education options are also being accessed).
To me this sums things up - even when there are clear symptoms present, the cognitive dissonance fostered by years of a particular mindset, denies treatment for some/ most.

So why have the people doing this test not published some useful research so that we can include it in an evidence-based guideline. What we are left with is an anecdote and that is no use to anyone. The onus is on the people doing these tests to show they tell us something useful. Otherwise they are in exactly the same boat as the PACE authors - not producing reliable evidence.

 

[Jonathan Edwards]

But I think it’s fair to say that a common thing among patients that have had bad long time prognosis, is that they didn’t do anything properly in the early phase. That’s a combination of factors like no advice, to strong will, pushing on, everything but preventive rest. But it is sadly true, that we don’t have an evidence base to back this up, other than patients surveys which is of scarce value in the era of EBM. Not saying surveys are knowledge as good as anything, but it is of value. Don’t know if possible to even set up such study, but it would be interesting to see a study of patients initial phase activity and long term development.

I sympathise with what you are saying. There probably are ways of doing research that will prove causal links, although they require a lot of work on developing methods.

But the solution is in front of our noses. If it just accepted that the evidence base for exercise therapy is no good - and we are getting pretty close to that with Cochrane wanting to withdraw its review - then exercise therapy comes to a stop.

And the only way to achieve that is to focus on reliable evidence. Distracting from the evidence weakens the case.

 

[Jonathan Edwards]

Also, with most treatments patients are (should be) properly informed about the risks/evidence, so they've decided for themselves to engage with a treatment which make take time and effort and lead to no results. When patients are being managed into adopting 'positive' views about their illness, treatment and likelihood of recovery then I think those costs are better understood as an adverse effect of the treatment approach taken than just another part of life.

Interesting points, but thinking about it I am pretty sure the paternalistic approach is pervasive in 'biomedical medicine' too. My rheumatological colleagues would not tell patients much about drugs maybe not working or not actually producing recovery. Being positive is pervasive in medicine. If you talked to people with rheumatoid arthritis attending prominent NHS clinics twenty years ago I think you would have encountered a pretty pissed-off group moaning about how little they were told and being led up the garden path. I would hope that is less so now because with biologic drugs people can be made completely well pretty quickly. I am not that confident though. Only a couple of weeks ago someone on a skylight was telling me about a friend who was pissed off with their rheumatologist ...

But there is still a huge difference, yes, and more and more I think there is a key ethical issue of active misrepresentation from the BPS crowd.

 

[duncan]

So why have the people doing this test not published some useful research so that we can include it in an evidence-based guideline.

$'s? Clinician/researcher territorialism? Risk to reputation? Non-monetary resources like staff and time?

 

[Jonathan Edwards]

So I think I might be taking a middle ground in this discussion.

Well you would be taking exactly the road I would take. I agree with all that post. I am not sure what more extreme road anyone is taking.

 

[Jonathan Edwards]

$'s? Clinician/researcher territorialism? Risk to reputation? Non-monetary resources like staff and time?

I don't buy those. I have been in this situation myself and I got on and did the research without the dollars, risking my reputation in the process. To base a service on unsubstantiated tests is laziness and is unethical. As simple as that.

 

[DokaGirl]

Doesn't stop me from trying. The way I see it is that if 1 ounce per day doesn't cure, that doesn't mean that 2 ounces won't. If not 2, maybe 1/4 lb will do. If you don't try, you'll never really know. You just have to commit.

Couldn't resist: GCT - Graded Chocolate Therapy!

 

[large donner]

But the solution is in front of our noses. If it just accepted that the evidence base for exercise therapy is no good - and we are getting pretty close to that with Cochrane wanting to withdraw its review....

Are we really getting close to that with Cochrane? It seems its gone silent over there, the review hasn't actually been withdrawn despite promising to do so and last we heard Larun was getting to seemingly readmit continuously despite failing to do so to the required standard.

It appears also now that Tovey has abandoned ship and the NICE guidelines review are next year. Feet dragging appears to be a tactic conveniently favouring the BPS side of this issue.

At the same time Crawely and chums are dumping as much crap into the "scientific literature" as possible.

 

[duncan]

I don't buy those. I have been in this situation myself and I got on and did the research without the dollars, risking my reputation in the process. To base a service on unsubstantiated tests is laziness and is unethical. As simple as that.

I would not agree. There are plenty of cautionary tales out there of clinicians who stuck their necks out to do research and had their heads handed to them on a plate. Dr. Ed Masters from Missouri leaps to mind. Burrascano, too.

 

[Cinders66]

So why have the people doing this test not published some useful research so that we can include it in an evidence-based guideline. What we are left with is an anecdote and that is no use to anyone. The onus is on the people doing these tests to show they tell us something useful. Otherwise they are in exactly the same boat as the PACE authors - not producing reliable evidence.

I thought that the two main researchers with this research interest Julia newton and peter Lowe? Had published on this. I’ve seen on MEA Facebook threads where papers saying “this percent” of pwCFS=ME also have POTS. I get confused regarding POTS and OI but IOM thought the evidence for OI was there and I have heard several people report that having POTS identified and treated brought improvement such as increased toleration if being vertical etc. We might not have much on this because in every area from imaging to muscles to whatever there’s only a few people doing the research. I would have thought that with being upright being an often reported challenge in pwCFS, testing for anything treatable would be worthwhile. I cannot remember what bacme said about this in their guidance.

 

[Jonathan Edwards]

Are we really getting close to that with Cochrane? It seems its gone silent over there, the review hasn't actually been withdrawn despite promising to do so and last we heard Larun was getting to seemingly readmit continuously despite failing to do so to the required standard.

It appears Also now that Tovey has abandoned ship and the NICE guidelines review are next year.

I think things are much closer than they once were. As I see it the Cochrane exercise review can no longer be presented to the NICE committee as meaningful opinion. Whatever the technical status the editor in chief made it clear that he did not think it was of a standard consistent with Cochrane's requirements.

 

[Jonathan Edwards]

I would have thought that with being upright being an often reported challenge in pwCFS, testing for anything treatable would be worthwhile.

Yes, at least as a research project. So why has nothing been published that sorts this out? OI is a symptom and to establish that someone has OI all you need to do is ask them. The cause might be postural hypotension but in postural orthostatic tachycardia it is still not clear what might be causing what.

Usually in this sort of situation if after 10 years nobody has written a paper that establishes some basic facts it means that when people have looked they have realised there is nothing consistent to find. Julia Newton was very gun ho about autonomic and cardiovascular changes about five years ago but remarkably little has come out of her group on these. The pity is that when people do not find much they tend not to publish anything.