NICE guideline for ME/CFS is unethical – Dr Diane O’Leary, Kennedy Institute of Ethics | 23 August 2

[Sean]

The basic science and ethics are on our side. But we failed to deal adequately with the inevitable political component, which is now the only major barrier to progress.

In the UK context, removing that barrier requires either a major shift within the medical establishment and a willingness to confront and dethrone the PACE/BPS faction, or a change of government to one prepared to acknowledge serious sustained policy failure on this issue, the appalling consequences of it, and force a more scientific and ethical policy upon the recalcitrant medical establishment.

(Hint: Take the first option, medicos. Regard it as a necessary therapeutic purgative to relieve serious scientific and ethical constipation. An unpleasant and humiliating experience to be sure, but you will feel much better afterwards. Your patients certainly will.)

Until then the PACE/BPS crowd will continue to hold the main political cards and nothing will fundamentally change in the UK, which makes it very difficult for rest of the world too.

 

[Jonathan Edwards]

In the UK context, removing that barrier requires either a major shift within the medical establishment and a willingness to confront and dethrone the PACE/BPS faction, ...

(Hint: Take the first option, medicos. Regard it as a necessary therapeutic purgative to relieve serious scientific and ethical constipation. An unpleasant and humiliating experience to be sure, but you will feel much better afterwards. Your patients certainly will.)

Trouble is they will not feel better after, so the medical profession will not move on this. I know from talking to them. It is convenient to have a policy that allows doctors to offload patients they do not know how to handle on to therapists who are glad of the salary. (At least for a while; a lot of psychotherapists I think bail out of treating CFS because they find giving useless therapy soul-destroying too.) Doctors really do not want to confront the possibility of taking responsibility for ME/CFS care themselves.

And to some extent I do not blame them, They are now so brow-beaten by starvation of resources that they can no longer be expected to provide a comprehensive service. I resigned because i could not do that in 2010.

So I think the change has to occur within non-clinical academia and public opinion more generally. It needs to be accepted that psychiatry is generating bogus data across a wide spectrum. The lack of quality control at the Lancet needs to be seen for what it is. Voices are being raised outside the UK but we need them within the UK too. And we need major media involvement.

 

[BurnA]

So why is it not self-evident to David Tuller? Or James Coyne?
The reality is that it is not self-evident.

Yup, it is rather scary. From what I gather there are thousands of duff trials out there in psychotherapy, probably nearly all of them. My view would, I think, be taken as self evident amongst physicians and clinical pharmacologists but it seems that in a psychiatry world where the book on trials is written by someone who has admitted they do not understand my argument things are different.

But havent some in the psychology world at least realised there is an issue - the replication crises demonstrates that it's possible most of psychology is built on an unstable foundation.

I don't see how your opinion and that of physicians and clinical pharmacologists could be any more damaging that what they already know.
I am sure several want to deny it but it seems inevitable that there will be a question mark over a significant no. of psycological studies ever performed.

 

[adreno]

So I think the change has to occur within non-clinical academia and public opinion more generally. It needs to be accepted that psychiatry is generating bogus data across a wide spectrum. The lack of quality control at the Lancet needs to be seen for what it is. Voices are being raised outside the UK but we need them within the UK too. And we need major media involvement.

A solid biomarker for ME could circumvent all this. But, it would still leave all the other victims of poor psychiatry where they are. The ethical thing to do here is too fundamentally question the poor methodology of psychiatry 'across a wide spectrum' of disorders, as you suggest. This is not an easy battle, however.

 

[Jonathan Edwards]

But havent some in the psychology world at least realised there is an issue - the replication crises demonstrates that it's possible most of psychology is built on an unstable foundation.

I don't see how your opinion and that of physicians and clinical pharmacologists could be any more damaging that what they already know.
I am sure several want to deny it but it seems inevitable that there will be a question mark over a significant no. of psycological studies ever performed.

It goes back to Popper and Freud and keeps re-emerging every generation but then gets re-buried. Freud got de-bunked and then standards slipped again. It is time for another session.

The replication crisis in psychology is being discussed much more in terms of core concepts like peer pressure on choices, instinctive behavioural patterns etc etc. - i.e. in the non-clinical literature.

 

[A.B.]

It goes back to Popper and Freud and keeps re-emerging every generation but then gets re-buried. Freud got de-bunked and then standards slipped again. It is time for another session.

It's the belief that the solution to unexplained physical symptoms is found in the psyche of the patient.

 

[Snow Leopard]

The suggestion that there is an additional signature on 2 day CPET for ME is controversial. Betsy Keller in fact found two different patterns and we have not heard much more since. And it is irrelevant to whether or not there is evidence for CBT and GET giving benefit. It is perfectly plausible that even if there was a 2 day signature it indicated something that responded with time to GET.

There are now about eight 2-Day CPET studies either published or soon to be published. Most if not all show the same finding, namely a substantial reduction in ventilatory/anaerobic threshold on the second day. This is very unusual even amongst patients with other medical conditions.

The reason for the "two patterns" is that some patients are not truly exercising to VO2Max (as indicated by lower than expected maximum heart rate) and so they are not seeing the reduction in VO2Max on the second day in all patients.

There is also talk that the HR measurements after a single test are unusual (as measured on the second day) and it may be possible to skip the second day of exercise testing.

 

[Valentijn]

But in your previous comment you rightly point out that they are closing their eyes and ears to the politics!

I don't think I said that - at least, I certainly didn't intend to. The science purporting to support CBT/GET is blatantly flawed, hence NICE is certainly not acknowledging the science. Their reasons for it seem to be political, such as demonstrated in the letter sent to Tuller where the identity of experts is withheld based on the assumption that patients will harm those experts. NICE itself is operating a purely political basis in the case of ME/CFS, and it's not just their experts doing that.

Surely the best thing to do would be to counter politics with science - which is I think what you are suggesting with CPET and would work wonders if F and M show a positive result from phase III rituximab.

Fighting politics with science will accomplish nothing if the political will results in science being ignored. The science is already there, and we need to force the political will to change to evaluate that science honestly and rigorously. The science fight was won years ago, if not decades. We just need a fair judge to acknowledge it.

And of course CPET is established as a measure of fitness. But what has that to do with ME? The suggestion that there is an additional signature on 2 day CPET for ME is controversial.

Not really. There has been some variation in what measurement gets worse on Day 2, but the maximal studies are consistent in showing worsening. I suspect any differences are down to minor variations in protocol, like encouraging the patient to keep exercising until they can't, or stopping when heart rate or respiratory exchange rate hit a certain threshold. Submaximal studies are more problematic.

But even a single CPET can indicate that incapacity is not due to deconditioning, if the results are poor enough. Deconditioned subjects will have below-average scores, but those scores will still be much higher than for a moderate or severe ME/CFS patient, or someone with cardiac or pulmonary dysfunction.

 

[A.B.]

I can feel that walking a certain distance on one day and then the same distance on the next, that on the next day it's harder. This is not due to exercise related muscle soreness or but a more general feeling of exhaustion, some resource deprived state.

I question whether CPET can really capture the full experience of PEM but it does seem to accurately capture the above aspect and researchers seem to find it very easy to replicate this. The general trend of worse performance on second day is replicable, while results diverge on the exact parameters affected but as said this could be due to differences in testing protocols.

I'm very supportive of CPET research because it seems to describe what is actually happening to us and also because objectively measurable abnormalities might just let us overcome skepticism and prejudice.

 

[Barry53]

I wish I knew. I think most of them are conflicted. They know there is a problem but find it too uncomfortable to confront.

Maybe because a lot of the advocacy surveys etc. that are cited inevitably have the same limitation, and perhaps these good folks do not want to draw too much attention to that. But I'm not sure hiding from such things is beneficial. If we face and address such issues, we can better unpick what counts and what does not, and why and why not.

 

[Snowdrop]

I wish I knew. I think most of them are conflicted. They know there is a problem but find it too uncomfortable to confront.

I expect in part the problem of not being able to confront problems in PACE is due to the fact that it would open up the real probability that there are many other research trials that suffer from same or similar problems. That would make it a more systemic issue and therefore harder to face.

 

[Esther12]

On the political front, it's also worth recognising how much reputational captial the UK medical Establishment has put into fighting against CFS 'campaigners'. They turned this into a battle of 'expertise' vs 'the rabble', like that of global warming or MMR/autism. If they now have to admit that they got it wrong, they're going to look pretty bad.