NICE ME/CFS guideline - Stakeholder submissions to the draft and NICE responses - published 29th October 2021 - discussion thread

[Jonathan Edwards]

My money ' s on Stone.

Malcolm McLeod is another person to think of. He has waded in for SMC in the past.
There is a nice irony that his inaugural professorial lecture was on how not to do bad science.

 

[Jonathan Edwards]

As indicated on some other thread, I have, at least for the moment, been imbued by the (biological) motivation to write my book again. It will of course have a chapter on the NICE guidelines. It will also have a chapter including the ongoing inability of researchers and clinicians to understand common sense matters about the way human nature influences the gathering of evidence.

These people's comments provide a fertile source of evidence.

 

[adambeyoncelowe]

The Register of Lightning Process Practitioners have an answer to that : )

Yeah, they didn't note their own COIs, of course.

I admire the way they frequently use the phrase "conflict of interest" to indicate that someone had already investigated their treatment and found it to be rubbish. Presumably the committee should have consisted of people who had no prior opinion on any of these subjects at all

Exactly. NICE realised they couldn't have people who were experts and who didn't have opinions. So they tried to balance those opinions instead.

Importantly, we all basically had to agree to follow the evidence. This was a question used in our interviews to sift out those with intractable opinions from those who would be open-minded.

As I said, if they could show me evidence that GET was effective, I would support it and I wouldn't resign because you effectively lose your voice in further decisions.

As it happens, the evidence clearly showed GET wasn't quite cost-effective, which meant that with the impact of recorded harms, there weren't grounds to recommend it and there were grounds to not recommend it.

Cost-effectiveness is £20,000 or less per QALY. You can have treatments worth £30,000 or less if they are exceptional, but it was hard to argue that, given the complaints of harms.

The cost-effectiveness may also have been even weaker than expected (i.e., nonexistent), because the high risk of bias meant it was hard to interpret the results as benefit at all.

I particularly liked this classic by the RCGP, which could be nominated for entry to the category, 'Most out of touch stakeholder comment on the draft guideline', though there are many worthy contenders.

There were so many! I was assured that comments are usually brusque, but this one went beyond anything they'd received before.

If they can complain about prejudice when people point out flaws in their protocols and data, I definitely get to complain about racial discrimination because I'm ginger.

As someone who's half ginger and half African Caribbean, I feel your pain! The copper tints in my beard have been the source of much prejudice in my life.

They were remarkably patient. If my brothers kids whine for that long they get to sit on the stairs for a couple of minutes until they can behave.

Peter Barry, Ilora Finlay and Kate Kelley had to reply to each one individually. Luckily, many of them said the same thing, so they could use copy and paste.

Association of British Neurologists :


NICE:


ABN:


NICE [bolding mine]:


I'm not that far through the stakeholder comment tables, but it appears there may be a number of NICE comments that would be worth saving and using for advocacy purposes, as well as to ensure the guidelines are properly implemented.

Also, check out the references they use. There were a number of occasions that RCs misquoted studies to suit their own purposes. E.g., using a study about general malaise (not post-exertional) to 'prove' that PEM wasn't a defining symptom of ME, or using a study that said PEM should be mandatory to say it shouldn't.

I wasn't sure whether it was lying, incompetence or both. Take your pick!

 

[Hutan]

This from the British Society of Rehabilitation Medicine:

The second concern is that, if the person never considers or discusses increasing the activities they undertake, then the person can never get better. The concern here is with the word, exercise. Exercise should not be considered as some form of external ‘treatment’, analogous to taking a medication. Rather it is used as short-hand (unfortunately) for doing more activities that are or might be part of life – getting dressed, going up or down stairs, shopping etc.

It's as if they have never listened properly to their ME/CFS patients. This thing called PEM results from pushing, intentionally or otherwise, beyond the limit of what we can (edit. sustainably) do. Full-on PEM is awful, and yet virtually every person with ME/CFS picks themselves up from it, and sooner or later exerts themselves to a point where PEM results again. Because there are things we have to do, and things we want to do.

 

[Barry]

OMG the Association for British Neurologists are so steeped in the BPS culture, this doc is gripping and essential reading!

Long, long diatribes about the "evidence". Replete with long lists of references to work of BPS believers, including Hotopf and of course all the usual British BPS suspects. Who wrote this? It can't be an unbiased outsider, it must be someone deeply entrenched in the BPS culture.

Lots of reliance on "there's no evidence for XXX ". Which is always a defence for maintaining current consensus - for which no evidence exists.

I think this sums them up in a nutshell:

We do not believe that people with ME/CFS have a mechanism of fatigue which is radically different to other neurological conditions.

[my bold]

And they witter on about evidence!

 

[Barry]

In the new guideline it says:


Note that it clearly says "Do not offer", so is actively telling medics to not offer any of these treatments. This is not a passive suggestion by NICE that it "does not recommend" these treatments; it is an active statement by NICE to not offer them. A subtle but very important difference.

This means that medics will not have a loophole to argue "NICE does not prohibit these treatments, but merely does not recommend them". NICE clearly says that medics should not offer such treatments. So if medics subsequently do offer these treatments, they will very definitely be contravening the guideline.

This should have significant impact on health insurance ... and on who they decide should be their expert advisors!

 

[Barry]

Do we have any ideas of how the new guideline will influence:

• Future ME/CFS research?
• Currently ongoing ME/CFS research?

The guideline clearly says:

Note that the above also precludes PACE-stye CBT, which is deeply rooted in the deconditioning theory.

I would imagine that future research, based on any of this, should always fall flat at the ethics approval stage. But what of currently ongoing research, if that is already incorporating the above 'treatments'. The guideline itself does not speak of harms from these treatments, but it is mentioned in some of the NICE documents as part of the rationale for not offering them, including the round table presentation, which includes this about GET:

And this about exercise and energy management:


If treatments being applied in current trials are found to be unethical in a new guideline, what are the implications for those trials?

 

[Sbag]

The reason NICE gave for not recording it was to allow all the attendees to 'speak freely'. So the four RC attendees who signed the letter in the BMJ (not sure where else it was published) had absolutely no excuse for not raising their concerns at the roundtable meeting.

Edit: NICE did that for them and invited Dame Carol Black to chair the meeting, someone they cannot say would be unsympathetic to a biopsychosocial approach.

In response to their joint statement someone should ask them directly why they didn’t make their objections known at the round table that was convened for them for that purpose. It is professionally disgraceful to have gone to the meeting that was put together for them and then not used it for the reason it was set up.

 

[Jonathan Edwards]

if the person never considers or discusses increasing the activities they undertake, then the person can never get better.

This is very revealing. It assumes that getting better is mediated by doing more - exactly the false premise I put in my testimony. Why shouldn't someone get better while doing nothing? That is normally what happens during convalescence. Why should they be more likely to get better if they do things?

There is a complete lack of any sensible thinking about mechanisms. As there is here:

We do not believe that people with ME/CFS have a mechanism of fatigue which is radically different to other neurological conditions.

This is bonkers. Of course the mechanism is different. In other neurological conditions the fatigue is a consequence of trying to cope with a nervous system that does not work properly in specific ways.

 

[Woolie]

We do not believe that people with ME/CFS have a mechanism of fatigue which is radically different to other neurological conditions.

This is bonkers. Of course the mechanism is different. In other neurological conditions the fatigue is a consequence of trying to cope with a nervous system that does not work properly in specific ways.

Yes, but of course they believe that neurological fatigue is also due to psychoscial factors (depression, anxiety, negative attitudes, excessive symptom focussing and so on).

Basically, any symptom that cannot be consistently linked to a biomarker belongs to them.

(edited for typo!)

 

[Simbindi]

Long, long diatribes about the "evidence". Replete with long lists of references to work of BPS believers, including Hotopf and of course all the usual British BPS suspects. Who wrote this? It can't be an unbiased outsider, it must be someone deeply entrenched in the BPS culture.

It only starts to make sense when you see the expansion of 'Functional Neurological Disorder' clinics is happening across England and presumably Scotland (I am unsure about Wales and N.Ireland). 'FND' is openly described as another term for 'conversion disorder' and is considered a 'Medically Unexplained Symptom' disorder. Prior to this neurologists would have had no interest in conditions such as fibromyalgia or ME/CFS, but again, with the 'central sensitisation' theories, they are also growing MUS empires in their own field. This new ME/CFS guideline stands in stark contrast to how they want NICE to work for them. They've said it themselves, the new chronic pain guideline could not have been published in its current form if the committee for it had taken the patient-centred and scientifically rigorous approach to evidence that the current ME/.CFS guideline committee have done. They are feeling very threatened.

 

[Peter T]

This is a wily trick, @SNT Gatchaman. With the advent of fMRI, there are a whole new host of ways you can claim something has a "biological" effect when really it doesn't, not in the usual sense of the word.

For example, did you know that six weeks of mindfulness training can change your grey matter?
https://www.sciencedirect.com/science/article/pii/S092549271000288X

Of course, if we didn't change biologically with each experience, we'd have no memory of it afterwards! But now there are whole new ways people can bullshit about the "biological" benefits of their favourite form of woo.

The Scientologists were big on this in the 1970s and 80s, arguing their version of meditation resulted in predictable changes in the meditators neurophysiology. What the few I asked seeking to present this evidence to University audiences failed to answer was ‘depending on your starting point these supposed changes could leave you with the neurophysiology associated with variation psychiatric disorders, including that of psychopath.

This over simplistic pop psychology disappeared in the 1980s, so why supposed scientists bringing back now. We need much better understanding of both behaviour and scanning techniques before we even think about using psycho behavioural intervention to change brain function.

 

[Peter T]

if the person never considers or discusses increasing the activities they undertake, then the person can never get better.

This is very revealing. It assumes that getting better is mediated by doing more - exactly the false premise I put in my testimony. Why shouldn't someone get better while doing nothing? That is normally what happens during convalescence. Why should they be more likely to get better if they do things?

It is even sillier than you suggest @Jonathan Edwards, it implies no recovery is ever possible without conscious participation in the process, so presumably it is impossible to ever treat a neonate or someone in a coma and all of veterinary medicine must be throw out of the window.

 

[Suffolkres]

The reason NICE gave for not recording it was to allow all the attendees to 'speak freely'. So the four RC attendees who signed the letter in the BMJ (not sure where else it was published) had absolutely no excuse for not raising their concerns at the roundtable meeting.

Edit: NICE did that for them and invited Dame Carol Black to chair the meeting, someone they cannot say would be unsympathetic to a biopsychosocial approach.

 

[Mithriel]

I've read about 300 pages now and the one thing that leaps out is that they are not talking about a disease I would recognise as ME. They keep discussing normal reactions to exercise and rest when ME was originally described as an abnormal response to exercise.

Many of their arguments make little sense. They say their treatments help fatigue in other diseases so must be used to help ME but that is not true. For instance my grandson gradually became extremely fatigued till he could not stand without support. It was because he had developed diabetes and his blood sugar was reaching dangerous levels. Exercise would not have helped.

I don't experience much fatigue from my ME but at one point it became bad. I had developed type 2 diabetes. The fatigue lifted when that was treated and again, an exercise program would not have helped.

Similarly, other friends and family have had times of fatigue. Some of them after flu resolved in months, there was a thyroid storm, coeliac disease and cancer.

The myth of fatigue being due to deconditioning and the answer increasing fitness is just that even if it is pervasive.

Then the insistence that no one has ever said that ME is due to deconditioning. Technically true because they believe there are precipitating factors such as an infection that causes deconditioning which is then a perpetuating factor. A sneaky distinction.

Also noticed that some of the submissions talk about SMC in trials as specialised medical care rather than standard medical care so it sounds a lot better. Another error to join the rest which, strangely, are all in their favour.

It is disheartening because they feed into all the modern buzzwords, exercise good, inactivity dangerous and keep saying that they just want to help patients.

One submission seemed to be saying that a treatment should only be stopped if the number of patients harmed was higher than the number of patients recovered and there was no evidence for that. They conveniently ignored the fact that they have no way of knowing which patients would be harmed. Like the rest it sounds fine at first them you realise how outrageous it is.

 

[Sly Saint]

well why don't they set up a petition for 'put GET back' and see how many signatures it gets.

 

[Kitty]

well why don't they set up a petition for 'put GET back' and see how many signatures it gets.

 

[Trish]

This over simplistic pop psychology disappeared in the 1980s, so why supposed scientists bringing back now. We need much better understanding of both behaviour and scanning techniques before we even think about using psycho behavioural intervention to change brain function.

Maybe the clue is there. The generation who were young and impressionable in the 70's and 80's are now in charge and in a position to promote this stuff.

 

[ME/CFS Skeptic]

I think some of the assertiveness in the comments and the negative response from some royal colleges has to do with that this guideline 'goes against established rehabilitation practice'.

There are several hints that indicate this guideline is seen as a threat for 'established rehabilitation practice' and that some of this might spill over to other areas such as fibromyalgia, long covid etc. That would explain why so many did a personal attack on Jonathan Edward's testimony because it had implications for beyond ME/CFS.

The Royal college of physicians responded: "unblinded trials with subjective outcomes are specifically considered unreliable.” If NICE as an organisation were to generalise this opinion across all guidelines for example those for back pain, osteoarthritis and multiple sclerosis, what would the impact of this opinion be on these other guidelines?"
​

Similarly, the letter from the royal college of psychiatrists (obtained by a FOI) stated:

"publishing the guidance in its current form has the potential to undermine the treatment approach to managing fatigue in all neurological conditions and also long COVID"​

 

[Dx Revision Watch]

Do we have any ideas of how the new guideline will influence:

• Future ME/CFS research?
• Currently ongoing ME/CFS research?

Would also like to know how the new guideline will influence what IAPT currently offers to those with ME, CFS who have accepted referrals to the IAPT service.