By David Tuller, DrPH
Update on January 29: I love how patients keep me on my toes. A savvy reader pointed out to me today that even members of the GET/CBT ideological brigades have dropped the notion that attributing symptoms to a physical cause itself leads to a poor prognosis. That was the prevailing outlook some years ago, but since then a number of studies from this group of investigators have acknowledged the fallacy of that position.
That hasn€™t made them wary of the idea that unhelpful beliefs lead to negative outcomes and that CBT is essential to altering such dysfunctional cognitions. They€™ve just focused on other apparently unhelpful beliefs, like patients’ purported fear of activity–that they maintain lead to negative outcomes and need to be changed.
Here are three such studies:
Knoop et al. 2010. The central role of cognitive processes in the perpetuation of chronic fatigue syndrome.
Wiborg et al. 2012. Towards an evidence-based treatment model for cognitive behavioral interventions focusing on chronic fatigue syndrome.
Heins et al. 2013. The process of cognitive behaviour therapy for chronic fatigue syndrome: Which changes in perpetuating cognitions and behaviour are related to a reduction in fatigue?
This raises another question for Professor Chew-Graham. Since she is presumably steeped in this literature, she should have known–even if I didn€™t–that her colleagues had already dissected and debunked this issue. Given that, why did she include such outdated information in the RCGP course in 2012, and why was it not removed during either the 2015 and 2018 reviews?
And here’s an over-arching question about this whole mess: Didn’t whoever advised Steve Brine MP to tout METRIC for addressing “misconceptions” about the illness realize that this public claim would lead to a closer look at the course? And that Brine would come off as foolish and clueless to be praising a program that unequivocally reinforces the very treatment paradigm that MPs were in the process of denouncing?
This situation is getting curiouser and curiouser.
During last Thursday’s historic debate on ME in the House of Commons, it was refreshing to watch one MP after another stand up and slam the PACE trial and the non-evidence-based treatment paradigm promoted for decades by the GET/CBT ideological brigades. It was also interesting to note that no one defended this egregious research or the eminent authorities who have produced it.
Of course, the government–in the person of Steve Brine MP, the Parliamentary Under Secretary of State for Public Health and Primary Care–presented its typical non-responsive response. Perhaps because he has been provided misinformation by proponents of the now-discredited GET/CBT treatment paradigm, Brine was able to offer little of value to his colleagues after their unanimous expression of revulsion at the long history of abuse and neglect perpetrated on patients and their families by the medical profession and its government enablers.
I want to focus on a point Brine made regarding the importance of including updated information about ME in medical education, one of the key planks in the motion passed by unanimous voice vote on Thursday. In suggesting that there are currently such resources available, Brine cited a training program developed by the Royal College of General Practitioners.
Here’s what he said: “The RCGP has also produced an online course on ME for GPs. It highlights many of the common misconceptions, and considers the challenges for primary care professionals that surround this complex condition.”
This statement is taken almost word-for-word from the course itself, so it is perhaps unfair to take it as an endorsement. But even a cursory perusal of this particular program, called METRIC (ME: Education, Training and Resources In primary Care) makes it immediately clear that it is an unequivocal piece of biopsychosocial garbage–much worse than nothing. Based directly on the FINE and PACE trials, it transmits their unscientific claims without any hesitation or caution–in effect perpetuating rather than clearing up the “misconceptions” about the illness.
Here is the description:
“This online course provides GPs and other primary care practitioners with an overview of the presentation, diagnosis, assessment and ongoing management of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME).
It highlights common misconceptions about CFS/ME and considers the challenges that surround this complex condition for patients, carers and primary care professionals.
This course was developed as part of the METRIC study, funded by the National Institute for Health Research (NIHR) Research for Patient Benefit programme, which aims to improve the care of adults with CFS/ME based on the biopsychosocial model and focuses on the deconditioning theory. It provides resources for patients and education for primary care professionals.”
METRIC was written in 2012–that is, before it was clear to most people, other than patients and advocates, that PACE was not only a sham but a likely example of research misconduct and that deconditioning had nothing to do with the illness. Most disturbingly, this program was reviewed in April of last year, long after the international community had expressed its dismay at the methodological and ethical violations committed by the PACE investigators. So Brine might want to think twice next time before citing this propaganda as an example of acceptable medical education.
Needless to say, those associated with this training program are card-carrying members of the GET/CBT ideological brigades. The lead author is Carolyn Chew-Graham, a professor of general practice research and the director of clinical academic training at Keele University. Not only does she endorse wholeheartedly this discredited treatment paradigm, she is also a leading proponent of the dangerous movement to psycho-pathologize patients who present with so-called medically unexplained symptoms, or MUS. In the UK, this phenomenon is why patients with ME are currently being railroaded into mental health treatment through the ongoing expansion of the program known as Improving Access to Psychological Therapies, or IAPT.
(More later on Professor Chew-Graham€™s erroneous claims about the cost of MUS to the NHS.)
In METRIC, Professor Chew-Graham misrepresents the findings from both FINE and PACE. She was in fact a co-author of the FINE trial, along with others on the METRIC team. Let’s remember that FINE produced null results for both of its primary outcomes–fatigue and physical function at follow-up one year after treatment. Nevertheless, METRIC has declared that “this project builds on our previous work–the MRC funded FINE Trail.” Why would the RCGP, or anyone, decide to anchor a training module in such a failed approach?
Well, in the case of FINE, METRIC cites post-hoc, non-peer-reviewed findings to justify the claim that pragmatic rehabilitation reduced fatigue levels in participants–without mentioning that the findings are post-hoc and not peer-reviewed. For PACE, she fails to point out that the reanalyses based on the original raw data and the protocol-promised assessment methods have shredded the findings of the published PACE papers. Since I have spent the years between 2015 and now explaining over and over and over again why this body of research stinks, I would have found the decision to ignore the massive ongoing changes in attitude toward the GET/CBT paradigm shocking if it weren€™t so predictable.
Let€™s review this purported medical education in more detail.
Here€™s how Professor Chew-Graham describes the FINE findings: Compared with treatment as usual by the GP, pragmatic rehabilitation improved fatigue, sleep and depression by the end of the treatment period, with the effect on fatigue persisting to one year of follow up.
Of course, this was NOT the reported finding from the FINE trial published in BMJ. On the contrary, the trial had null results for both of its primary outcomes–fatigue and physical function–at the one-year follow-up period. However, a post-hoc reanalysis of the fatigue data using a different scoring method did find modest benefits in fatigue at that assessment. It must be stressed that these findings were never peer-reviewed but published online as part of post-publication, rapid-response correspondence.
It is unacceptable for Professor Chew-Graham to cite post-hoc, non-peer-reviewed findings as if they represented the actual published, peer-reviewed, protocol-promised results of the study. To include such results at all would already be problematic, given that they contradict the peer-reviewed reported findings–which are not mentioned in METRIC. To highlight these results without making their questionable provenance very, very clear is highly deceptive, although it isn€™t, in the end, very surprising, considering the persistent pattern of fuzzy reasoning and irrational argumentation that mars the research and statements of this cohort of investigators.
In their desperate efforts to salvage something actionable from FINE, the GET/CBT ideological brigades have repeatedly cited these post-hoc findings without qualification, such as in the most recent Cochrane exercise review. Yet as a professor of “general practice research,” Professor Chew-Graham surely knows that such inaccurate citations are inappropriate–or if she doesn’t, then she should.
And here is what METRIC claims about PACE:
The PACE Trial (White P et al., 2011) provides convincing evidence that Graded Exercise Therapy (GET) and Cognitive Behavioural Therapy (CBT) are safe and effective therapies.
Adaptive Pacing Therapy (APT) has not been shown to be effective as delivered within the PACE Trial, but this may differ from activity strategies promoted by CFS/ME services nationally. This trial shows that approaches aimed at staying within limits imposed by the illness are less effective than those that test or extend such limits€¦This trial has also shown that people with CFS/ME who had support from specialist therapists to gradually increase their activity levels were more likely to report improvements in function and symptoms at the end of the year-long study.”
This would be laughable if it weren€™t so worrying. Remember, this content was supposedly reviewed last April, a month after publication of Wilshire et al, which authoritatively documented that the reported PACE findings were the result of data manipulation and outcome-switcing. (Disclosure: I was one of the seven co-authors of that paper.) It is dismaying that Professor Chew-Graham has not updated this section to address the changes that have occurred since€¦well, frankly, since I published my initial Trial By Error series and began orchestrating open letters that highlighted PACE€™s singular flaws and were signed by dozens of prominent scientists and other experts.
Under the heading “The Dysregulation Hypothesis,” METRIC includes these pearls of wisdom:
“Patients can find themselves in a vicious cycle. Excessive rest in healthy individuals can have the following effects:
Reduced exercise tolerance
Muscle pain (may be delayed) on activity
Weakness, dizziness, postural hypotension
Changes to body temperature regulation
Loss of concentration and motivation”
This is undoubtedly true. But the underlying implication is that the illness in question is due to “excessive rest” and the individuals are otherwise “healthy.” Of course, there is no legitimate evidence to back this claim about ME patients. So why is Professor Chew-Graham presenting information about the “vicious cycle” she claims afflicts healthy people? What does that have to do with ME, except in the minds of the GET/CBT ideological brigades?
Moreover, in discussing the “model for CFS/ME,” Professor Chew-Graham not surprisingly cites leading biopsychosocial myths, such as the suggestion that patients’ belief in a physical cause for their illness is itself leading to negative outcomes. (Research does show an association between belief in a physical cause and poorer prognosis, but the assertion that the first causes the second is unwarranted; the logical explanation is that those patients have worse outcomes because they have a realistic and correct understanding that their illness is physical. In short, Professor Chew-Graham, like her colleagues in this field, interprets the available data backwards–and incorrectly.)
It is disheartening to see such nonsense still being propagated, much less praised and endorsed by the government in parliamentary debate. Here are some other problematic statements in this section of METRIC:
“belief that symptoms are indicative of damage or impending relapse leads patients to stop doing things”
“fear driven avoidance of activity”
“significant others may inadvertently reinforce unhelpful beliefs and behaviors”
METRIC also includes a video from Professor Alison Wearden, lead investigator of FINE, about patients’ “erroneous health beliefs.” Let’s remember that, as I reported in a lengthy analysis of FINE more than three years ago, the trial website included a presentation comparing the illness to very severe jetlag. After explaining how and why pragmatic rehabilitation led to physical improvement, the presentation offered this hopeful message, in boldface: There is no disease€“you have a right to full health. This is a good news diagnosis. Carefully built up exercise can reverse the condition. Go for 100% recovery.
The PACE authors themselves chose to ignore FINE’s null results, failing to mention them in the text of the 2011 Lancet paper, despite claiming for years that Wearden’s study was PACE’s “sister trial.” Yet Brine has now presented treatments anchored in the FINE notion that “there is no disease” other than something comparable to “very severe jetlag” to be appropriate for these desperately ill patients in 2019.
Another document from 2012–the RCGP’s response to a government report on patient autonomy and the importance of shared decision-making in clinical care–provides some insight into the organization’s mind-set. It could help explain the irrational attachment to a program promoting debunked treatments, like METRIC.
Overall, this RCGP document endorses the shared decision-making concept. But there are exceptions–among them when the patient has illnesses referred to by the RCGP as “complex psychological problems, such as Chronic Fatigue Syndrome”:
“We would take issue with Paragraph 5.18–the statement that patients who had a choice of therapy were more content than those who wanted a choice but did not receive it is so obvious as to not need stating. Further, they were more content with their therapy–but what were the clinical outcomes? And what of patients with complex psychological problems, such as Chronic Fatigue Syndrome, where a choice of treatment might do more harm than good?”
In other words, the RCGP clearly views ME as a psychiatric or psychological disorder. And the organization singles out people with the illness at the core of METRIC–and last week’s parliamentary debate–as potentially too disturbed or irrational to make their own treatment choices. The apparent justification for suggesting that they might not warrant this fundamental right is that the RCGP has determined that their “choice of treatment” could be harmful to their health. Does Brine share this view of ME patients? [Paragraph edited after posting; see original paragraph at end of post.]
Since these misguided opinions appear to be the declared position of the professional group that developed METRIC, Brine should reconsider his decision to repeat the RCGP claims that the program addresses “misconceptions” about the illness. On the contrary, METRIC reinforces the misbegotten delusions that have caused such harm for this population.
If the RCGP does not believe that these patients should be able to decide for themselves what strategies to pursue, it is understandable that its members tend to accuse those who reject its treatments as being hysterical and anti-science–rather than acknowledging that the treatments themselves are not based on legitimate research but on biased studies that violate core principles of academic inquiry. This sort of attitude also likely explains why health professionals might decide to call in child protective services when parents seeking to protect their kids from harm refuse to let them undergo these possibly dangerous treatments.
In short, Professor Chew-Graham and METRIC are presenting fake news, in the words of my current president–as the real thing. Anyone involved in developing and promoting this terrible program has a lot of explaining to do. Rather than being hailed by Brine MP or anyone, METRIC should be withdrawn immediately.
Edited paragraph before editing: “In other words, the RCGP clearly views ME as a psychiatric or psychological disorder. And the organization singles out people with the illness at the core of METRIC–and last week’s parliamentary debate–as too disturbed or irrational to be allowed to make their own treatment choices. The apparent justification for depriving them of this fundamental right is that the RCGP has determined that to grant it would be harmful to their health. Does Brine share this view of ME patients?”