By David Tuller, DrPH
*For more about the significance of the new NICE guideline for ME/CFS, the blog ME/CFS Skeptic has this excellent summary. Also, psychologist Brian Hughes covers the deep concerns of leading medical groups that the guideline recommends against the Lightning Process.
It is not surprising that esteemed experts whose research has been publicly exposed as a bunch of crap would push back quickly, and that promoters of the debunked work would rally round in defense. Thatâ€™s what weâ€™ve seen in the wake of Friday’s publication of a new ME/CFS guideline from the UKâ€™s National Institute for Health and Care Excellence (NICE). The document, which reverses the recommendations of a 2007 guideline, specifically advises against the two long-standing first-line treatmentsâ€”graded exercise therapy (GET) and a specialized form of cognitive behavior therapy (CBT). Both interventions have long been promoted as cures for the underlying condition, based on the theory that patients’ symptoms were perpetuated by a combination of unhelpful illness beliefs and severe deconditioning rather than any organic dysfunction.
Two of the three lead authors of the now-discredited PACE trial, which was once billed as the â€œdefinitiveâ€ investigation of this approach, offered peevish responses that failed to address NICE’s concerns. In the statements, provided by the Science Media Centre as part of a round-up of comments about the new guideline, they mainly re-bleated past assertions about the benefits of their beloved treatments. (The Science Media Centreâ€™s decision to offer a wide range of comment, rather than just statements overwhelmingly in support of the GET/CBT approach, represents a big shift in how it handles this issue. Perhaps it realizes it needs to cut its losses rather than go down with the GET/CBT ship.)
Professor Trudie Chalder, for example, declared the following: â€œThe NICE guidelines for CFS/ME are at odds with the research evidence. Researchers from different Institutions [sic] in different countries have found graded exercise therapy and cognitive behaviour therapy to be effective for some patients with CFS. Evidence has shown they reduce fatigue and improve functioning without harm, if delivered by trained therapists in specialist clinics.â€
Poor Professor Chalder! She seems incapable of grappling with the humiliating fact that the NICE review found the evidence for the effectiveness of these interventions on fatigue and physical function, including from the PACE trial, to be of â€œvery lowâ€ or merely â€œlowâ€ quality. This was the case whether the research took place in the UK or other countries. As Professor Brian Hughes, a psychologist at the National University of Ireland, Galway, and I documented in this paper in the Journal of Health Psychology, Professor Chalder’s 2020 paper in the Journal of the Royal Society of Medicine on clinic outcomes for patients undergoing CBT relied on serious data misrepresentation in arguing for the effectiveness of the intervention. (Professor Sir Simon Wessely was one the co-authors.)
Given Professor Chalderâ€™s record, nothing she says in this domain can be considered credible. As part of the Science Media Centre round-up, her PACE colleague, Professor Peter White, made equally silly remarks in the same vein. They’re not worth discussing.
Statement from medical “leaders”
Not to be outdone, other NICE dissenters have issued an incoherent statement of defiance, posted on the website of the Royal College of Physicians under the following headline: â€œMedical leaders sign joint statement in response to NICE guidance on ME/CFS.â€ The groups listed, in addition to the Royal College of Physicians, were: the Royal College of Physicians of Edinburgh, the Royal College of General Practitioners, the Royal College of Psychiatrists, the Academy of Medical Royal Colleges, Faculty of Sport and Exercise Medicine, and Faculty of Occupational Medicine
The statement bemoans what it maintains is the guideline’s under-emphasis on “the importance of activity and exercise” in the management of ME/CFS. Among other foolish declarations in pushing this perspective, the “leaders” note the following:
â€œGraded Exercise Therapy) [sic] as defined in the guidance is not reflective of the personalised paced exercise programmes that are currently used in the NHS and termed GET. These have provided benefit to many patients and should not be discontinued. However, we recognise that the phrase GET is unhelpful and this terminology should be dropped to allow clinicians to work with their patients in a more productive way.â€
Letâ€™s parse this weirdness. First, they assert that the NHS is no longer doing GET in the way described in the NICE guideline. The guideline, of course, took its description of GET as well as CBT from PACE and related research, which are explicit about the theoretical bases underlying the interventions and the proper method of implementing them. The framing of GET in the guideline should therefore not be a surprise to anyone. (I wonder how Professors Chalder and White would respond to the news that the NHS has discarded the GET outlined in PACE.)
These medical â€œleadersâ€ provide no explanation for why NHS services no longer offer GET as proposed and researched by the leading experts in this field. The only logical conclusion would be that they realized it didnâ€™t work. Otherwise, they would presumably have kept doing it in its original form. But if they arenâ€™t offering GET as described in the literature, how do they know what to offer instead? In particular, what is the evidence in favor of the â€œpersonalised paced exercise programmesâ€ that the NHS now apparently refers to as GET?
And if the “leaders” acknowledge that the NHS is no longer using GET as described in PACE and related research, presumably because clinicians have realized it doesn’t work, why havenâ€™t they made this absolutely clear to the public before now? Moreover, why are they angry at NICE for highlighting in the new guideline that GET doesn’t work? Apparently they agree that GET shouldnâ€™t be offered; they also agree that the name is tainted and should be dropped. In short, theyâ€™re conceding that GET is an inappropriate intervention. So whatâ€™s their complaint about the NICE guidance? Why are they throwing a temper tantrum?
Then there is this comment about CBT: â€œCBT remains a valuable treatment for alleviating symptoms in ME/CFS and services should ensure patients have access to this and other psychological therapies.â€
The NICE guideline allows for CBT when it is offered as a supportive rather than a curative intervention, so the beef on the part of the “leaders” appears to be that this modality is not specifically promoted as beneficial. If the â€œleadersâ€ have evidence that CBT can actually result in recovery, as has been claimed by the PACE authors and others, or plays a â€œvaluable role for alleviating symptoms in ME/CFS,â€ they should provide it. Significantly, they have not.
A psychological intervention like CBT should probably have the same role in ME/CFS that it has in other chronic medical conditionsâ€”to help patients cope with their disease as well as to address co-morbid anxiety, depression and related mental health issues. These “leaders” might believe CBT tackles the underlying illness mechanisms in ME/CFS and deserves an especially prominent place in the treatment arsenal, but they do not seem to have mounted a viable case on that front.
Four of the “leaders” who signed the letter were present at a key roundtable hosted by NICE last Monday to air concerns raised by those objecting to publication. Yet the minutes of the roundtable, which NICE released along with the guideline, include no indication that these eminent professionals presented robust or indeed any evidence for their categorical claims of benefit from their “personalised paced exercise programmes.” If they possess such data, they have had ample opportunity to make it available. If they don’t, they should stop wasting everyone’s time with empty assertions of benefit. The groups they represent have had as much chance to be involved in the guideline development process as everyone else.
The â€œleadersâ€ report â€œdisquietâ€ over NICEâ€™s evaluations of the available evidence and data–even though that evidence and data is not about the “personalised paced exercise programs” they are now touting. As far as this revamped strategy, they seem to expect the right to do whatever they want without having to provide any rationale beyond that they themselves believe it offers benefits. That is not how â€œevidence-based medicineâ€ is supposed to work. The â€œevidence-basedâ€ approach was intended as an alternative to cliniciansâ€™ own positive but often unreliable assessments of the results of favored medical interventions.
These medical â€œleadersâ€ are jabbering in circles. They don’t like how NICE assessed the evidence, the evidence has nothing to do with what they’re offering anyway, and they have no evidence to support what they’re doing beyond their clinical impressions. That’s pretty much their argument. Either theyâ€™re stupid, or they think everyone else is stupid, or theyâ€™re trapped in some mental bubble that remains impervious to facts and logic. Their display of petulance is childish, unattractive and anti-scientific, but not surprising.
Tracey Burgess says
Jenny Wilson says
Medical leaders have signed a joint statement in response to Dr John Snowâ€™s misguided treatise on the alleged causes and origins of cholera.
We are taken aback at the effrontery of Dr Snowâ€™s unabashedly false statement to the effect that cholera is spread by drinking water. The idea is too repugnant to consider, and this opinion is echoed also in the Lancet, whose authority cannot be challenged.
Cholera is an acute, poorly understood condition which can be highly disabling and fatal unless the correct treatments of bloodletting and rectal infusions of mutton puree are administered in a timely fashion. The scientific basis of the way this condition is spread and appropriately treated is now well understood, but only by those whose medical education and intellect is sufficient, unlike that of Dr Snow. It is of obvious importance that all patients with this condition are given access to the best possible services and treatments available. This includes graded amounts of bloodletting and rectal infusions of mutton puree administered by appropriately qualified psychologists. This should be under the supervision of only those specialists of sufficient intelligence to have an understanding of the complexity of the condition.
Dr Snowâ€™s treatise contains some interesting ideas, but these do not go as far as we would have liked and understate the importance of activity and exercise in the management of cholera. Also the obvious connection between a typical cholera suffererâ€™s mental and physical health was completely ignored by Dr Snow; it is obvious to the medical cognoscenti of the Royal Colleges that the diarrhoea of cholera owes much more to noxious miasmata than to Dr Snowâ€™s extraordinary idea that drinking water is the source.
As with many such conditions, Cognitive Behavioural Therapy (CBT) and Graded Exercise Therapy (GET) are very useful adjuncts when rectal infusions of mutton puree and bloodletting are the mainstay approaches. The evidence base for such interventions is beyond challenge (because we say so).
There is considerable disquiet in the medical profession and some patient groups about the way the data and evidence have been assessed but the important thing now is that services are commissioned in a safe and effective way that does not disadvantage any cholera patients being treated now or in the future.
When commissioning services we would reiterate that:
Graded Exercise Therapy should be retained for the most severely affected, particularly those who think, misguidedly, that they have severe diarrhoea. The latter of course is simply imaginary, and can be effectively suppressed with Cognitive Behavioural Therapy. These have provided benefit to many patients and should not be discontinued.
CBT and GET thus remain valuable treatments for alleviating the delusional symptoms of cholera â€“ particularly the diarrhoea – and services for this terrible condition should ensure patients have access to this and other psychological therapies.
Royal College of Physicians
Royal College of Physicians of Edinburgh
Royal College of General Practitioners
Royal College of Psychiatrists
Academy of Medical Royal Colleges
Faculty of Sport and Exercise Medicine
Faculty of Occupational Medicine
“they seem to expect the right to do whatever they want”
Of course. Otherwise there is little point in clawing one’s way to the top of the heap. It is the same dismissive arrogance displayed by CDC and NIH. Institutions come first, and patients come last, since us useless eaters are at the bottom of the hierarchy.
I can imagine the angry discourse between Wessely’s pals and their insurance company handlers. It will be a financial disaster for the income protection insurers if they can no longer claim “CFS” is a mental illness, and then that spreads to the Long COVID sufferers as well.
The new guidance will make it difficult for them to coerce patients into exercise and therapy programs in order to qualify for benefits. They will have to find new excuses to delay and deny claims.
Insurers will also have to challenge the guidelines. The brain-dead Royal Colleges are obviously not up to the task. I speculate that a previously unknown astroturf group will emerge to be their public face. They will have a misleading name like “Patients for Exercise Therapy” or somesuch.
Richard Vallee says
This whole thing has a feel of hostage takers who haven’t realized yet that their demands were met even before they started but will simply pretend otherwise once they realize it because they’re committed (even though they don’t really understand why). With a hint of Wu’s on first for delivery. Especially after they signed off on the roundtable. Does that mean they are walking it back? Or just pretending to, without actually doing it? Whichever is more convenient. This whole zero accountability thing is really silly.
For years we’ve heard that CBT is used for support in other diseases so it should be offered. The guidelines specifically recommend it. But they want the guidelines to say it’s curative, while pretending they never meant it’s curative. And pretending there is evidence for it, which they can’t provide, but they know so it’s OK. It’s just layers of insanity. Like a lasagna of madness, or something.
Peter Trewhitt says
The Royal Collegesâ€™ statement, as you point out David, indicates a very complex relationship with GET or perhaps what we should now call â€˜not GETâ€™.
It should be pointed out that the survey commissioned by NICE as part of the guidelines review process relating to reports of harm from GET and CBT in the UK was aimed at people who had recently received either of these interventions in the UK.
There were very high levels of people reporting harm from GET, this primarily included people who had received what they understood to be GET in the NHS. So if UK services are not providing GET as previously understood but rather this new â€˜not GETâ€™ under the name of GET, then we can assume that these reported harms from â€˜GETâ€™ included substantial numbers of people receiving this new â€˜not GETâ€™.
The Science Media Centreâ€™s “wide range of comment” included reaction from Prof Kevin McConway (Emeritus Professor of Applied Statistics, The Open University), who noted that concern expressed by some over the GRADE grading of the evidence had led to the NICE committee looking at the evidence again. The concern seems to have centred on which diagnostic criteria were being used in the studies being evaluated – that studies that employed different diagnostic criteria to the criteria that NICE settled on were being downgraded for that very reason when a large proportion of patients in those studies would, in fact, have satisfied the NICE criteria (which included post-exertional malaise or ‘PEM’). But, according to Professor McConway, the NICE Committee’s re-analysis didn’t change their grading of the evidence at all in relation to most of the interventions and, while there were some changes in relation to GET, all the previously downgraded studies remained downgraded and NICE’s opinion on GET didn’t change. (Of course, ME patients have long been highlighting that the criteria being used by researchers were too broad, and if those researchers had listened to them and employed tighter criteria then their studies might have been more clearly representative of ‘ME/CFS’ patients and assessment of the evidence could have been more straightforward.)
So it appears that NICE bent over backwards for those who raised concerns/complained about their assessment of the evidence but the quality of the evidence still came out as poor…..and yet there are researchers who still maintain that evidence to support the use of GET and CBT to improve symptoms is there. It may well exist but, (unless there are some secret offerings that didn’t come out of hiding to find their way into NICE’s extensive search of the literature), it’s been found not to be of good quality, end of story. Going forward, researchers and doctors clearly need better instruction on how to carry out good quality research and on what good quality research should look like so that patients aren’t left suffering for decades again. That this area of medicine has, for such a long time, been saddled with such poor research evidence probably reflects a more general lack of scrutiny of medical research evidence and a lazy eminence-over-scrutiny approach. The NICE evaluation itself could now be used as a good example of the importance of scrutinizing research properly and of why eminence-over-scrutiny must not be allowed to prevail.
Lady Shambles says
Some excellent comments above in response to a very well written blog. Thank you.
I’m going to be more prosaic and alight on one phrase which reflects a concern many patients on social media have flagged up wrt their real life opportunities for ‘care’:
” But if they arenâ€™t offering GET as described in the literature, how do they know what to offer instead? ”
Indeed…how do they know? We have recently seen ‘Bedfordshire Chronic Fatigue Service’ offer something called ‘Graded Activity Management’ or ‘GAM’ (I’m wondering how long it will be before the acronym-addicted BPS devotees create a research paper entitled ‘GAMmyleg’? … but I digress) . The questions to ask of BCFS would , in my opinion, be
i) It is understood you changed your regimen from GET to this new therapy, ‘GAM’, sometime during the summer 2021. Why?
ii) On whose ‘say so’ was this change made? A name please?
iii) Provide evidence of what GAM actually *is* and how it differs from ‘GET’ .
iv) Provide peer reviewed RCT evidence of ‘GAM’ being effective for this population.
I don’t understand why the main patient charities aren’t following up on these possible (probable?) bastardisations of GET which seem to be designed to circumvent the new NICE Guideline. What we are likely to see in the coming months and years is a profusion of newly presented GET /’not GET’ regimes within the existing clinics under the guise of a different acronym. And I’m guessing the acronyms might not be the same across different centres.. a ‘quicksilver manoeuvre’ to create as much chaos as possible. But each and every one should be subject, in my opinion, to a FOIA request to drill down into what they constitute and on whose direction these new modalities are being fabricated. Also questions around CCGs not following this Guideline need to be interrogated too. This is what charities should be doing. It might mean a lot of extra work but this is about safeguarding patients.
Given all this it’s no surprise that one of the very few doctors in the UK who does understand what ME actually looks like, Dr Nigel Speight, has had to furnish the ME Community with his own very sensible advice which involves amongst other things avoiding neurologists and ‘Specialist ME Centres’.
Lady Shambles apologises for rambling and lack of cogency. LS is not firing on most cylinders.
The countries where GET was found to be effective were, erm, UK and ……Netherlands. (Where the used case definitions even broader than Oxford and where patients who didnâ€™t improve were removed from trials as they were clearly â€˜not motivatedâ€™. Dr S has witness statements.)
And where were the successful trials published? The BMJ and the Lancet. I am clearly in need of some CBT as my beliefs are obviously maladaptive. Like two countries doesnâ€™t say much to me. The trials in Australia and USA were not so good. (The often quoted rct by Wallman et al was on pacing. Itâ€™s in the first sentence.).
Do you know that I must be the only patient who has asked for cbt and was refused. By my GP. â€œWe canâ€™t always have what we wantâ€ was his response. I paid for private counselling. (Not terribly helpful. Talking to the MEA helpline was.)
Peter Trewhitt says
Apologies, but my post above contained an error of fact.
The most recent survey of harms from GBT and CBT was commissioned by Forward ME for the new guidelines process rather than directly by NICE themselves.
Guido den Broeder says
The criticism with regard to NICE’s interpretation of the evidence is entirely correct. You can’t base recommendations for one group of patients on research into another.
It shows once again that GRADE is unscientific and easy to manipulate.
To create a useful guideline you need to apply the scientific method, which requires a model-based approach.
Lady Shambles is absolutely right we need to pass on Nigel Speightâ€™s own very sensible advice in avoiding neurologists and â€˜Specialist ME Centresâ€™ if you have ME/CFS. The ME association and Action for ME refuse to do this – not sure why given the Specialist ME Centres are refusing to follow NiCE guidelines.
I really wish people would remember that the DWP helped funded the original PACE study. That’s a large part of the reason they are stubbornly clinging to this study. It’s not just institutional stubborness, it’s also governmental. The DWP was castigated by the UN for human rights abuses. And with the mass of claims coming from Long Covid, they have to do whatever they can to deny
â€œI really wish people would remember that the DWP helped funded the original PACE study. â€œ
The failing here is not just that some scientists wrote some rubbish papers (and that journal referees failed to spot the problems), but also that the government is paying for the bad science.
Possibly, the government deserves the lionâ€™s share of the blame (e.g. if it turns out that the government funding agency is pressurising the scientists it funds to falsify the results of clinical trials, that would be a big problem)
“pressurising the scientists”
Yes, certainly the Wessely School and fellow travelers are being pressurized with a steady stream of knighthoods and awards and important government appointments, as well as payments from the income protection insurers, royalties for useless computerized CBT, etc.
It all goes to show that the psychobabblers are delivering exactly what the establishment (see: Royal Colleges) has ordered, and the establishment has yet to change policy or agree to raise the social status of ME (and now Long COVID) people.
Corporations and state institutions are working hand-in-glove against our interests. And what do we call the unholy alliance of government and industry?
(pssss, the answer is “fascism”, also known as “corporatism”)
I’m just a little afraid the GET folks will be asking for more money so that they can do a better quality study on their pet projects, since the previous 5 million pounds wasn’t sufficient to do a high quality study.