By David Tuller, DrPH
Let’s give credit where it’s due. Apparently someone with decision-making authority at the National Institute for Health and Care Excellence (NICE) has a grasp on reality and is willing to challenge the claims of the biopsychosocial ideological brigades. That’s the only logical explanation for last Wednesday’s welcome but unexpected announcement that the agency would pursue a “full update” of the guidance for the illness it calls CFS/ME. From what I gather, that means NICE will essentially start the whole guidance development process from scratch.
In announcing the decision, NICE noted the many concerns stakeholders raised about the existing guidance, which was developed in 2007 and promotes treatment with cognitive behavior therapy (CBT) and graded exercise therapy (GET). At the same time, NICE rejected the recommendation of the internal team to which it had delegated the task of reviewing the literature and producing what was called a surveillance proposal consultation document. That consultation document concluded that no changes should be made to the guidance, After NICE released the consultation document in July, it invited input from stakeholders. The agency had previously indicated that it would announce its decision in October.
I have covered the NICE issue here, here and here. I also sent an e-mail to Sir Andrew Dillon, who heads the seven-member NICE guidance executive, with my questions about the consultation document and the review process. I critiqued the topic expert reports commissioned by NICE, which I received through a freedom-of-information request. One reason I wanted to keep on top of the issue was to make sure NICE was aware that its actions were being observed, and not just in the UK.
The NICE announcement was overshadowed by the same-day release of Professor Esther Crawley’s ludicrous study of a psychobabble technique called the Lightning Process as a treatment for kids. The Lightning Process is a mish-mash of positive affirmations, neurolinguistic programming and related doggie poo. That Professor Crawley received approval for this experiment on minors is unfortunate. Despite some credulous media coverage, the results cannot be taken seriously, for reasons others have documented.
I might be too optimistic, but I think the NICE decision is a game-changer. It suggests that the PACE authors and their colleagues, despite their enormous influence, have lost control of the narrative—even on their home turf. They can no longer count on those in powerful positions to provide monolithic support for their bogus claims that CBT and GET are effective treatments. That doesn’t remotely mean that the struggle is over. There are lots of remaining hurdles—especially the central task of ensuring that any new guidance is based on sound evidence. But this is still a significant moment in the ongoing demise of the PACE/CBT/GET paradigm.
The NICE statement about the decision highlighted stakeholder concerns about the Oxford criteria and the CBT/GET evidence base, among other issues. “Key trials (particularly PACE [Pacing, graded Activity, and Cognitive behaviour therapy; a randomised Evaluation], but also Cochrane reviews of CBT and GET) have been criticised for inflating the efficacy of interventions,” declared the statement. “Issues include that some studies only require fatigue in the case definition, which may incorporate other fatiguing conditions with the potential to complicate results.”
NICE reported that 39 stakeholder organizations submitted comments. Nine of them–including professional associations like the Association of British Neurologists and the Royal College of Psychiatrists–supported the recommendation to leave the guidance as is. No patient organizations took that position. The stakeholders collectively submitted about 300 pieces of new evidence. NICE selected thirteen that met its criteria for inclusion in its surveillance review.
This group includes a study criticizing the Oxford criteria as overestimating illness prevalence and two studies about the role of postural orthostatic tachycardia syndrome, or POTS—a key symptom ignored in the 2007 guidance. Also included is Keith Geraghty’s analysis of surveys about CBT, GET and pacing. The CBT/GET cheerleaders have generally dismissed the results of such surveys because the respondents are self-selected, so the inclusion of this study of patients’ real-world experiences is welcome.
The NICE decision is a slap in the face to the PACE authors and Sir Simon Wessely, who have routinely protrayed critics as vexatious, irrational and dangerous. It is also a possible set-back for Professor Crawley, who served on the 2007 guidance committee and believes PACE is a “great, great” trial. The consultation document highlighted Professor Crawley’s ongoing FITNET-NHS study of Internet-delivered CBT as an important future source of data. (Gee, I wonder who promoted the importance of FITNET-NHS to the surveillance team?) Since last week’s decision suggests that NICE is aware of and concerned about the methodological flaws afflicting the CBT/GET research field, FITNET-NHS could turn out to be irrelevant to the new guidance.
The NICE decision occurred not long after the Medical Research Council rejected an application from Professor Crawley’s much-ballyhooed Big Data project, the ME/CFS Epidemiology and Genomics Alliance. These successive events suggest that the public controversy over PACE and related CBT/GET studies might have reached a tipping point. Perhaps the anti-scientific arguments advanced by these researchers are finally losing credibility, even among academic and medical colleagues. Maybe there’s a growing awareness that open-label trials relying on subjective outcomes cannot provide reliable evidence. I mean, maybe not, but I hope so.
The topic expert reports revealed the profound shallowness of the NICE surveillance team’s efforts. The fact that three of the seven experts were psychiatrists and four were members of the 2007 guidance committee did not inspire confidence in the panel’s objectivity. None of the experts appeared to appreciate the extent to which research on physiological dysfunctions and the PACE debunking have transformed the debate in the last two years.
In fact, Expert #6 even argued that there was “increasing acceptance” among British patients and clinicians that the illness is an “emotionally driven disorder”—a claim so stupid and ill-informed that it should immediately have disqualified this person from being deemed an “expert.” It was troubling but unsurprising that the NICE surveillance team found this narrow range of purported expertise to be sufficient input for such a critical decision.
Developing a new guidance could take quite a while. And that’s a good thing, if it means getting it right. Considering the range of issues outlined in NICE’s statement, the new guidance committee will have to include experts who can argue forcefully on behalf of basic scientific principles. These experts will have a tough job. Those who have dominated the field for years touting research riddled with flaws will obviously demand a place at the table. But I have a sense that higher-ups in the NICE hierarchy are acutely aware that stacking the committee with CBT/GET hardliners would doom the effort to irrelevance and failure, not to mention damage the agency’s international reputation.
I have not written to the PACE authors themselves in a while. Given the significance of this development, however, I decided to make another effort to extract a comment. I haven’t heard back, of course, nor do I expect to. But that’s no reason not to pose the questions.
Here’s the message I sent to Professor Chalder, Professor Sharpe and Professor White:
I am writing a post for Virology Blog about NICE’s announcement this week that it is planning a “full update” of the guidance for the illness we have been debating. I am interested if any of you would like to make any comments about this decision.
Here are some of my questions: Are you surprised? Do you think this means NICE will remove CBT and GET from the updated guidance? Do you believe the CDC’s recent “dis-endorsement” of the treatments has influenced NICE’s decision-making? Do you believe the decision is an indication that the CBT/GET paradigm for treatment of the illness is collapsing, even in the UK? Do you believe the decision represents a rejection of the reported PACE trial results?
Thanks!—David
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Comments
42 responses to “NICE Rejects Current Guidance, Plans “Full Update””
Thanks David for a pretty thorough summary of the situation. My only major concern is the part where he says “We will now recruit a guideline committee which will include people with
the condition and their carers, the healthcare professionals who treat
them and the organisations which commission that treatment”. The healthcare professionals who treat them and the commissioners are already promoting CBT: will they be able to look at the evidence dispassionately, given that their use of CBT has only ever been supported by poor quality, subjective evidence?
I think we need to push for specialists in other fields, such as cellular biology, to offer a neutral and searching analysis of the evidence: if we could get that, I think this revision could prove to be very good.
Thanks David!
Unfortunately, I don’t share your optimism. I hope I’m proven wrong. Why would it take them until 2020 to do a review? Surely, there must be people who can look at the evidence and return a ‘review’ in less time? I’d imagine, sadly, that some of us won’t last until then.
I wonder who the reviewers will be? That’s an important question.
In my opinion, until the moniker of ‘chronic fatigue syndrome’ is removed from Myalgic Encephalomyelitis and the ICC is used for diagnosing, there won’t be correct guidelines and treatment for us.
I think they will need to consult international experts if that is allowed. There probably aren’t enough non GEt/CBT experts in the UK. Did you see the comment by Robin Callender Smith, a lawyer for QMUL who called the PACE trial cruel scientific fiction.
Only time will tell what happens to the NICE guidelines, expected in 2020. In that time a lot can happen.
In The Netherlands we also just heard that the Dutch Medical Board will come with their conclusions in the beginning of 2018. Also not a bad thing because the board has a high number of BPS-followers.
The CBT/GET ivory tower is starting to show cracks and dents, can’t wait till it falls.
A very important person from the Dutch insurance doctors also started to question the CBT…he just found out the put a stick in a wasp nest getting the all-to-familiar BPS-follower comment.
Patience please….patience…people are not moving along anymore because there is something to see…
Though obviously all will rest on who NICE commission to rewrite the guidelines this is potentially very good news. Though we in the UK probably need ongoing pressure from such as yourself David for effective banishing of the untested psychosocial model of ME and the damaging associated CBT/GET belief system. Also here the increasing inclusion of ME as a medically unexplained condition under psychiatric management will need some fighting. The new alternative diagnosis of functional neurological conditions that is increasingly being used instead of ME/CFS is part of this.
It may be that Prof Crawley’s ludicrous Lightening Process trial becomes the reductio ad absurdum of the flaw experimental design used to undermine the PACE school approach.
As ever, I thank you for continuing to add to your excellent repository of articles on Virology Blog, narrating the twists and turns of life in this almost subterranean world of ME, where patients are hidden by virtue of their disease and those who use their power to disenfranchise them work under cover of powerful organisations and parts of the Establishment. Pulling these inequities out into the open where they can be inspected in the cold light of day is an essential part of moving toward a time where people with this disease might get both the concern and the care they deserve.
I can’t help but read ‘Topic Expert’ as ‘Toxic Expert’. Well especially for number 6…
Personally I have little confidence in a desirable outcome. There’s a realistic chance they’ll use FITNET to make things worse. British officials in most offices are only too apply to explain that they’re listening or taking advice. But that’s nothing to stop them being ‘corrected by interested parties’ later on.
Now is the time for professionals with a stake in treating and researching ME/CFS properly to intervene in every way possible. The lack of transparency at NICE is frightning. How the government can ‘accept ME is neurological’ then NICE can utilise 3 psychiatric topic experts is astounding. The relationship between psychiatry and the Association of British Neurologists is exceptionally fishy.
I think there might be some journalistic intrigue to be found in the vicinity of Macleod and Blakemore.
Thanks for all your hard work, David. As someone who has been made markedly worse through exercise/CBT, removing these so-called treatments from NICE guidelines cannot come soon enough. My only fear is that they then decide to include LP, based on Crawley’s most recent pseudo-scientific efforts. I genuinely despair that the good progress we seem to be making is always, always overshadowed by bogus claims of this sort. The number of people harmed by CBT, GET, and/or LP is truly shocking – the more people with ME I connect with online, the more I realise my story is just one of countless others. NICE have a real chance here to make a positive change that will effect the chances of recovery for future ME patients. I really hope that they do the right thing, listen to patients and realise that this is a severe, serious illness that cannot simply be thought or exercised away.
The NICE statement about the decision highlighted stakeholder concerns about the Oxford criteria and the CBT/GET evidence base, among other issues. “Key trials (particularly PACE [Pacing, graded Activity, and Cognitive behaviour therapy; a randomised Evaluation], but also Cochrane reviews of CBT and GET) have been criticised for inflating the efficacy of interventions,” declared the statement.
——
And their safety.
Many thanks David.
“Let’s give credit where it’s due.” Abosolutely. Provided NICE follow through on this with the same good integrity, top marks for them.
“There are lots of remaining hurdles—especially the central task of ensuring that any new guidance is based on sound evidence.” Exactly. There is so much verbiage spouted by CBT/GET proponents for ME/CFS regarding “evidence based treatment”, many in authority seem oblivious to the fact it only counts for anything provided the evidence itself is high quality! Even when such treatments are based on very low quality evidence, people still seem to get away with claiming them to be evidence based treatments. Feel like insisting they call them “low quality evidence based treatments”. It’s so fundamental.
It does seem to be that this Lightning Process stuff is going to require just as thorough of a dismantling as the PACE stuff, in terms of a formal critique being released, for it to be dealt with effectively though.
Otherwise the press just seems to take all this stuff at face value in terms of how it covers it, unfortunately.
Thanks again. I agree I think this is a real change, a real crack in the BPS wall of power.
NICE now needs to urgently remove the 2007 guidelines or post a major caveat AND insure all doctors, all medical personnel are fully informed of this decision.
If there is to be a complete review it is admitting they strongly suspect the present guidelines are not fit for purpose. It is therefore beholden on them to fully inform the medical professions of this now, and indeed the public. It’s simply not enough to post a sentence or two on their website informing people that the guidelines are being reviewed, that won’t inform medics, that won’t protect patients.
In the UK, from 2015, the law on consent requires patents are fully informed of all material risks. NICE now know patients aren’t being fully informed via their present guidelines, neither are doctors who use them.
This won’t wait until 2020. They know there is a serious problem with the guidelines they need to act now to insure patients are protected and fully informed of the risks of CBT/GET prior to new guidelines in 2020.
Thank you, David, for all your work for people with #MECFS. Thanks to advocates like you, people are finally starting to hear us.
Do you have a link to where RCS said this? Thank you.
We think of the scientific process as being objective, rigorous, and even ruthless in separating out what is true from what we merely wish to be true, but in fact we have been shown it’s easy to manipulate results. At every step in the process, there is room to distort results, a way to make a stronger claim or to select what is going to be concluded. There is an intellectual conflict of interest that pressures researchers to find whatever it is that is most likely to get them funded but anyone who encouraged or enabled the Lightning Process while telling PWME it’s all in their heads is a new low even for NICE. I don’t know which of the hundreds of cries they heard but apparently it was loud enough.
Thanks as always for your work. Wish I shared your optimism. I think now is the time that we need ME experts, orgs and advocates in constant touch with NICE, working for transparency. Who they select to review the guidelines is key. As we saw in the preliminary decision, they tend to pick rabid psychobabblers. And hadn’t they announced that they were holding the decision until FITNET came out? A very clear bias towards the babblers. Furthermore they are still ignoring most of the biomedical research, that Oxford has been discarded by all researchers except babblers, and the multitude of severe problems with PACE that proves it meaningless.
And the old boys’ network is working assiduously – SW on the SMC’s Board of Trustees, orchestrating supportive coverage of LP on sick children while providing none on biomedical research, or once in a while trying to pan it.. And trying to get a psychiatrist for every hospital patient. Classifying CFS and ME as MUPS in another NHS branch aligned with the guidelines. Cochrane still putting ME and CFS under the ‘Common Mental Disorders Group’, promoting babblers and ignoring biomedical research. And didn’t Cochrane have some of the PACE authors participate in one of their supposed to be independent reviews?
At NICE people seem be more aware of the scientific developments and devastating CBT/GETresearch analyses that show CBT/GET do not work. The Health Council of the Netherlands still think they are going to improve the IOM/NAM report. President prof dr. Van Gool:’ We would like to say the IOM is like the Health Council of the Netherlands. But there are differences. There is less scrutiny. One can buy the membership. It is a different bussiness model.’ ‘Since the IOM report 1000 studies were published. We need to select a number of them We can include new studies. We have seen preliminary results of Dutch studies. We need to add quality to the IOM report’ The president of the Health Council says quality need to be added to the IOM report.
New developments to take into account: PACE-trial severely flawed & null effect, FITNET severely flawed & null effect LTFU. Several studies show biomedical problems in ME and CFS. Committee member prof dr Cohen Tervaert says ME is not a mental illness.
https://www.youtube.com/watch?v=p03zt9-P9W4 https://www.youtube.com/watch?v=CiiWhwaLt4Y
“The CBT/GET cheerleaders have generally dismissed the results of such surveys because the respondents are self-selected, so the inclusion of this study of patients’ real-world experiences is welcome.” I don’t think the burden of proof for asserting a treatment to be safe, should be the same as for acknowledging it possibly being harmful. In the latter case it should only be necessary to demonstrate “reasonable doubt” in order for safety to then need further investigations and the treatment be suspended, pending the outcome. Proof of safety should of course have have to be demonstrated by very solid evidence. We seem to have the absurd situation where CBT/GET are accepted as safe on much weaker ‘evidence’ than is available for it being harmful.
Yes on the need for advocacy. This is a point where things might, not will, change. All hands on deck!
Not just a lack of transparency, but a lack of accountability. These are two pillars of good governance, and both have been lacking.
I have written elsewhere that evidence base reviews contain provision for downgrading study quality for methodological and other failures. I have also stated that I regard the evidence for any success of CBT/GET in ME and even CFS to be just anecdotal, due to repeated systemic methodological failures.
Sadly cost and time saving measures mean most studies included in most EBM reviews are often purely on the technical details. Was it an RCT? Check. Was it something else? Cross. Now, the next study …
Yes, biomedical researchers should be included. If nothing else, they should be better placed to critique the evidence than other types of experts.
Let’s hope so. LP is explicitly designed to get the participant to deny their symptoms and claim they are well. So the research outcome is by definition one of claimed recovery. LP is absurd, whichever way you look at it. The study ought to undermine everything Crawley has ever said about ME/CFS research.
Requesting an urgent caveat is a great idea.
The diagnostic criteria are absolutely fundamental to the whole process.
It needs to be clear that they are talking about a specific condition and assessing research on that condition. The conflation with fatigue and fatigue studies is a flaw that is obvious to us, yet apparently very difficult to understand for many so-called experts.
Unfortunately the Cochrane review is hugely influential and did not differentiate between fatigue and ME. You would have thought that even with a tick the box approach, step one would be identifying the population to which the research applied. Then ensuring that the conclusion of the review described that population clearly. But no, they overlooked that.
(Mind you, the Cochrane organisation forgot to check for conflicts of interest, too. Rather basic.)
Yes, Cochrane reviews are not above their own methodological failures.This is not the only one. When the US AHRQ reconsidered the evidence base, allowing only for ME, they found there is no evidence that CBT or GET work in ME. However its important to counter the claim that the London criteria for ME were used in PACE. Two of the authors of that criteria are on record on being unhappy with how it was claimed to be used. My interpretation is that CBT and GET proponents have a history of operationalizing criteria in this area till they mean what they want, not what they are intended for.
This is why biomarkers are so critical for research, not just for diagnosis of individual patients. We do have candidate biomarkers now, one of which has been around for a decade, but its taking a long time to get the research to demonstrate specificity, which is about showing it is not positive in other diseases. We already have sensitivity, at 95%+, for some markers.
I do however wonder if the existing markers can be used not to diagnose, but to disprove a diagnosis. If someone fails a bunch of known markers they do not have ME. Its not enough to prove a diagnosis of ME but surely it can disprove one.
Thank you for your efforts and continued posts. I understand that ‘what you find depends on what you are looking for’. The observer does have an effect on what he is observing. As for active supression of evidence, the cigarette or asbestos industries didn’t do that, did they? Money talks, no wonder ME engenders so little. The ramifications of multi-chemical sensitivity that affect so many ME sufferers is as threatening to the manufacturers as it is to the patients; but, in a very different way. Let us hope PACE is in its death throes.
I was brought up in a small religious community and as a result am still in contact via various relatives with a large and varied group of people. I personally know about four people who have been ‘cured’ of ME by the lightening process, including one person who had been an invalid for about 30 years. The process itself is simply a very clear and well thought through collection of known self help remedies embedded in clear rituals that make it accessible and easy to carry out. That’s then combined with good practitioners and a backup organisation that provides support. It’s not magic but it certainly works.
The lightening process is only absurd for people who don’t want to believe that the mind and body are connected. The way to get the mind helping the body to overcome problems might seem absurd, but they are simply rituals that help activate the power of the mind. I am not a ‘believer’ but just a rational human being who reads and observes. I did the lightening process and it failed to help with my depression so I have no ax to grind. However I could sense it working to some extent but lost the back up of the local practitioner who ‘gave it all up’ and found it difficult to apply as the depression took hold. Rather than turn agaist the whole thing I realise that I wasn’t able to carry out the process in the way it should be. This is not just because I was let down by the practitioner, but also because I am ‘too’ rational and though I can intellectually understand why something can work, I need a lot of help and support to counter my less engaged rational self. I think we are all aware of the strong emotions discussion of ME brings to the table amongst both those who suffer from it and from the scientific community. So of course, most of the debate is simply irrational, driven by emotion – from both sides – and I should point out that ‘absurd’ is is an emotive word.
As a retired psychologist with training and experience in the use of NLP for a variety of applications, I stand by my claim that the use of LP for treating ME is absurd. I will add that it is, in the way it was used by Crawley in her study, unethical and carries a high risk of harm for people with ME. It should never have received ethics approval from a research institution.
They seem to be trying to reframe ME as a functional neurological disorder and there’s one neurologist in particular who seems to have carved a niche as a specialist in FND.
I notice that you repeatedly call it the lightening process – the name is Lightning Process – it was claimed to cure lightning fast in a three day training programme. The sales technique is so aggressive that many rational people have been duped by it, and there’s no money-back guarantee because, as you say, you weren’t “able to carry out the process the way it should be”. Others are told they’re not doing it right or that they simply need (to pay for) more sessions, it cannot be because the LP doesn’t actually work, as claimed, even if carried out according to instruction by firm believers in ‘the process’. I don’t think people would feel quite so repulsed by the SMILE trial had the trial participants been adults, following all the relevant research guidelines that research should be carried out with adults first.
Could you clarify why you say ‘as a retired psychologist’? You could mean that, as a member of a tribe that think in a certain way there is no point in discussing with you, or you could mean that you are in a better position to judge. But those are both a bit negative. Maybe there is another explanation.
On the basis that it might be worth discussing, I should point out that I grew up in a small religious community that gives me access to a very large number of people, many of whom I know personally. About eight years ago one of their member used the Lightning Process successfully. Word spread through the community and a number of people used it successfully. Three people having done it, I heard that a fourth, an invalid for about 30 years, was going to have a go. At this point I though ‘if it works on her, I should really take it seriously’. And it did work. Last I heard she was still fine after about 5 years. As a psychologist, you probably call this anecdotal. I call it sensible. And by the way, I left the religious community when I grew up.
I think the Invest in ME Research Scientific Advisory Board is a good place to look for such candidates. They are all specialists in their own fields and are currently involved in a programme of biomedical research into ME/CFS (Canadian Consensus Criteria) in UK.
Here is the link: http://www.investinme.org/IIMER-ab.shtml
Many call it the lightening process because of its primary effect, lightening their wallets or purses. This name is common in ME advocacy.
Mind-body discussions are dualist inventions. It distorts reasoning about the issue. I am a hard core monist on mind-body theory. Because of the vague notions about mind, its more sound to think about brain and brain function, rather than mind. It avoids reasoning from unsound conceptions about mind.
To understand the history of CFS, you have to know the “hit and run” strategy.
Opponents strike with some outrageous “pushback” concept and when it is no longer supportable, they “sunset” or retract it just prior to being used as evidence against them.
It’s not so much a concession as a strategic repositioning.
I wish I didn’t agree. The level of strategy from the Wessely group is extraordinary.
Just curious but why has your story suddenly changed?
You previously posted that, ‘Three people having done it, I heard that a fourth, an invalid for about 30 years, was going to have a go.’
Now in your second post, which apparently was posted on the same day, you’re saying that the 30 year invalid has actually been ‘cured’.
I imagine most people write posts straight off, rather than composing editing and then posting. So there are inevitably some inconsistencies. In the first post, I was talking about the situation as if I was back five years or so when the ‘fourth’ person was about to take the course. As I have just indicated, it all happened In the past.
I checked with my sister about a year ago and the ‘fourth woman’ was still ‘cured’. I use inverted commas because the underlying problem might still be there but managed with or without continued use of the techniques (I’m not aware of whether she still manages the condition or just leads a normal life now). As I said, I have known all these people and can easily get news of them, but I don’t bump into them in my own day-to-day life.
Incidentally, and of no particular relevance, the woman is quite strongly linked with me as her husband and his sister were looked after by my parents when their mother died (father unable to cope) and were a bit like younger brother and sister to me.