The claim that the cure for the crippling fatigue of ME/CFS was to change your mind always seemed bizarre. Now it really is on the way out…

By Jerome Burne

In September 2016 I posted a blog here about a research bombshell that had just exploded at the heart of one of the most bitter disputes in medicine – how best to treat a condition known as ME/CFS that involves relentless fatigue.

A team of senior academics had just reanalysed the trial, known as PACE, that supported the standard NICE-approved, psychology-based treatment and found that the claimed benefit didn’t reflect what results had shown – that the treatment was virtually worthless. 

I thought it was going to be a huge story and have all sorts of repercussions but instead it was largely ignored both by the press and by mainstream medics. I’ve come back to it now because there are signs that opinion professional and popular is turning against the treatment. These include:

**At the end of a debate on ME/CFS in the House of Commons last January, the House supported the proposal that use of this standard treatment should be suspended.

** Hilda Bastian, a veteran public health researcher and key opinion leader who has worked for organisations such as the Cochrane Collaboration in the UK, the German Institute for Quality and Efficiency in Health Care and the National Institutes of Health in America, has recently come out in favour of a change.

In a recent post, she comments that: ‘I think the balance should, and ultimately will, tip towards the ME/CFS consumer movement.’ In other words, it doesn’t work.

** A key feature of this dispute is the hostility between activist patients and their doctors. Once this was rare, now it is emerging in other areas of medicine along with calls for a better was of handling such disputes. This was the topic of my recent blog.

Angry and insulted patients

It should have been big story back them because ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome/) is a horrible condition that affects an estimated 250.000 people in the UK, 10% of them children. Patients can become bedridden for years and among the 60 symptoms linked to the disorder are a feeling of constant exhaustion – like a dead battery’ – muscle pain, swollen lymph nodes and being very sensitive to sound, light, heat and cold. It costs the NHS and other services billions.

The cause is unknown – although there is no shortage of theories – and there is a deep disagreement about whether it is a real neurological illness, as patient activists claim, or whether it is the result of the patients’ mistaken belief that they cannot exercise.

This puts them in the hands of psychologists who use CBT (cognitive behaviour therapy) to help them change this ‘unproductive belief’ and to exercise a little more each day with GET (graded exercise therapy).

A proportion of patients have long felt deeply angry and insulted by the psychological diagnosis with its implication that they were inflicting this relentless cascade of pain and distress on themselves. The psychologists claimed that the patients resisted the treatment because they didn’t want to be stigmatised as having a mental illness.

The reanalysis of the PACE trial has changed that. ‘For most patients now, the real issue has become that the treatment just doesn’t work,’ says Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine at University College London and an expert on ME/CFS. ‘That’s what a careful reading of the PACE trial indicates.’

Highly critical report ignored for years

Faced with this serious challenge, however, the authors of the original trial, called PACE, published in the Lancet in 2011, effective ignored the re-analysis and simply declared that both CBT and GET, did work for some people. And that was it.

Although the reanalysis was immediately available online and later published in the journal Health Psychology, it was clear that only a very few psychologists and medics were interested to know more. And so, the stalemate has continued until very recently.

What’s moving the story on now is that the researchers who did the re-analysis – including senior independent academics from Stamford, Chicago and University College London – have just published a response to the response by the authors of the PACE trial. The PACE authors repeated the claim that their treatment was effective and there was really no problem with the trial. However, the way the critics have responded makes it hard to see how claims that PACE is OK can continue to go unquestioned.

Patient activists fight to get hidden data from therapists

If you are familiar with the long-running debate over statins, you may be wondering how on earth the reanalysis of data from the big ME/CFS trial was done? For decades the data on the statin trials has remained hidden and requests it be made available ignored. The way the ME/CFS patient activist got hold of hidden data to analyse is the most dramatic moment of this civil war.

The re-analysis had only been possible because patient activists had obtained the raw data on the PACE trial held by Queen Mary’s University by sending in repeated Freedom of Information requests. The University then spent £200,000 challenging an FOIs that was accepted and only complied after a tribunal rejected their reasons for withholding it. The report on the tribunal can be found here.

So back in 2016, it was game-set-and-match to the patient activists and yet this apparently was not a news story. The strong determination by clinical researchers to keep raw data on trials secret is another parallel with the response to criticism by those holding the statin data. An FOI request is probably not relevant for statin data as that is commercial, while PACE received public funding.

How the definition of ‘recovery’ was changed

So, what did the critics discover was wrong with the trial? The published version had found that 22% of patients recovered with either GET or CBT vs 7% in the no-therapy group. But the re-analysis by the independent academics discovered that this had only been possible with some fancy statistical footwork. The true figures were dreadful, barely better than no-treatment; 4%, 7% and 3%.

The authors of the PACE had got their respectable results by changing the way they defined recovery. If you want to show people have benefited from treatment, you need to define what recovery looks like. Is it walking two hundred feet unaided or one hundred? Scoring 60% on a test or 40%.?

The trial had originally chosen a stricter measure for recovery and then changed it part way through to a more lenient one. It was the results from the lenient one that were published. The reanalysis figures came from applying the original standards. The lenient versions really were lenient; a patient could enter the trial, based on the original measures, get worse on two out of four criteria, and then still be rated as ‘recovered’ on the new version. 

What other data is being fudged in this way?

This was particularly shocking because the PACE trial had seemed copper-bottomed. It had been approved by the Research Ethics Committee and been peer reviewed by the Medical Research Council and was rapidly accepted by NICE as reliable enough to recommend the CBT and GET combo as the treatment for ME/CFS.

If the reanalysis is only half true, the fact that this was the best a trial can get, should set alarm bells ringing for the reliability of evidence-based medicine as it is currently practised.

The re-analysis also picked up on an inherent problem with trials of this sort of therapy – how to prevent patients knowing if they were getting the treatment or not – in other words in ‘blinding’ it. You are much more likely to say you benefitted if you know you got the treatment.

But the original trial made no attempt to deal with this issue. The psychologists were very enthusiastic about the treatment, telling the patients it was ‘powerful and safe and had been shown to be very effective in ME/CFS.’ Those on the comparison treatment of standard medical care were told nothing positive about their treatment at all.

Improvement in physical ability minimal

Even so, on clear tests of improvement in physical ability, the results for those getting the treatment were dismal. After a year of it, they were only able to walk 30 metres further than the control group. Another unambiguous test of improvement would be needing fewer government benefits; after a year of treatment, the percentage of patients getting benefits actually increased. What’s worse was that these negative results were only published years after the publication of PACE’s positive results.

As damning as the re-analysis was, it doesn’t give much of a sense of what it was like being involved with the trial. This was provided by one of the speakers in a debate on ME/CFS in the House of Commons in January 2019. Carol Monaghan MP, SNP spokesperson for the Armed Forces, reported what she had been told by patient groups about their experience of PACE-type treatment.

‘Many who were able to walk when they embarked on a course of graded exercise dropped out of the treatment in wheelchairs or bedbound. Furthermore, patients were pressurised to describe improvements that they did not feel. As the trial progressed and the results did not meet the authors’ expectations, they simply lowered the threshold to define improvement. In some cases, those whose condition had deteriorated were classed as “recovered”. That is simply not good science.’

Therapists comfortably hold two contradictory beliefs

The two recent papers by the PACE trial authors and the critics went into more and fascinating detail on the issue of changing of the definition of ‘recovery’. The PACE authors claimed that there was no good reason to prefer the original definition to the new ones; the critics responded that in any clinical trial, sticking to the way you measure changes is vital if results are going to mean anything.

Then the PACE authors came up with a remarkable justification for their view. They said they: ‘preferred their modified definition because it generates similar rates of recovery to previous studies and is also more consistent with our clinical experience.’ The critics pointed out that the aim of a trial is not to confirm what you expect to find but to do the opposite – you test to discover if your expectations are correct. They add sternly: ‘It is not appropriate to loosen the definition of recovery simply because things did not go as expected.’ Indeed.

Several of the disputed issues are too technical to go into here, certainly for me, but one that has always been at the heart of the battle is whether ME/CFS is an organic disorder or a psychological one. The PACE authors claimed that they didn’t have an opinion either way; all they cared about was whether the treatment worked. The critics showed why this couldn’t be true because PACE trial report assumed the exact opposite.

It stated, ‘that there was no underlying disease process,’ because what was keeping the patients ill was purely psychological: ‘their thoughts, feelings and behaviour.’ The CBT manual used in the trial took the same line, telling patients: ‘there is nothing to stop your body from gaining strength and fitness.’ A claim that would not be true if the root of the problem was, some sort of neurological malfunction.

The looming problem of compensation

As a result of such arguments, the tide of battle over the causes and treatment of CFS/ME is turning in favour of the patient activists. As well as support for suspending treatment with GET and CBT as means of treatment the Commons debate also called on the government to provide increased funding for biomedical research.

NICE – the body that approves medical treatments – currently recommends CBT/GET. But later this year, it is due to holding hearings about whether to continue recommending it. The committee hearing the is reported to be evenly balanced between supporters of each side.

If they do vote for a change, it will raise the thorny issue of compensation. If the theory that it is the patients’ beliefs that are keeping them ill is rejected, then will patients or the parents of children with the disorder, who have routinely been have been threatened with sanctions if they don’t undergo treatment to change their opinion, be eligible for compensation?

Jerome Burne

Jerome Burne

Jerome Burne is the editor of HealthInsightUK. He is an award-winning journalist who has been specialising in medicine and health for the last 10 years and now works mainly for the Daily Mail. His most recent book “10 Secrets of Healthy Ageing” was written with nutritionist Patrick Holford. He blogs at “Body of Evidence” – jeromeburne.com. 2015: Finalist for 'Blogger of the Year' award from Medical Journalists' Association.

14 Comments

  • Thank you, thank you and thank you once again Jerome, You are a star journalist…. like another one I know, academic, David Tuller!

  • Davis is soldiering on having to resort to Crowd Funding to fight our corner. Please flag this up to give him support pleease!

    Trial By Error: Crowdfunding Week 3 Matching Grant
    http://www.virology.ws/2019/04/22/trial-by-error-crowdfunding-week-3-matching-grant/

  • Good overview of the situation with PACE.

    Cochrane is also undergoing a review but the process has been very opaque so far and seems to be subject to constant pressure from PACE researchers and their allies. David Tovey kicked the can to his newly appointed successor, so it should be a while until this issue is resolved.

    The issue of compensation for promoting harmful treatment has been raised in the parliamentary discussion, I believe by Stephen Pound.

    In the process of the NICE committee, a patient survey was commissioned. The vast majority of responses were that the treatments are useless at best, and a majority stating it was harmful.

    This also aligns with a recent Australian patient survey that had similar responses, and in fact every patient survey. The harmful nature of the treatment has always been known, the cardinal symptom of ME is a worsening of illness from any exertion after all, but psychosocial ideologues simply dismissed those insistent, and consistent over several decades, warnings.

    In 2002, Australia adopted the concept of CFS (despite the fact that chronic fatigue is a secondary symptom of ME) with CBT and GET as recommendations. The committee in charge was duly warned of the harmful impacts that would follow and dismissed them out of hand. The NICE committee deciding the current guidelines did the same in 2007, rejecting all those warnings, backed by copious research, as irrelevant. A judicial review was rejected, siding with psychosocial researchers despite there being only weak, subjective evidence from biased research.

    The same debates are being held independently across many countries that have adopted similar guidelines. An overwhelming body of evidence is showing the psychosocial paradigm is intellectually and ethically bankrupt.

    Psychosocial researchers, like those who did the PACE trial were insistently warned that they were misguided and behaved petulantly, with arrogance and contempt rising to the level of hubris. The Mathees decision also revealed that allegations of harassment were “grossly exaggerated”. This did not deter Simon Wessely and Michael Sharpe from using their influence to renew those allegations (though well-toned down) in a recent media blitz of yellow journalism that Reuters published.

    The resistance to accepting those facts is understandable: there is enormous liability by hundreds of medical professionals who have utterly failed in their duty of care and enabled harm to be codified into official guidelines, leading to absurd situations of parents being threatened to have their sick child taken away from them, facing accusations of causing their child’s “unhelpful illness beliefs”.

    It will send shockwaves throughout the medical world, all that more powerful as pressure mounts while those responsible for this disaster try to protect their reputation.

  • Thank you. Hopefully this will help the public understand this story a little better.

    It is now well documented that patients with ME/CFS have abnormal physiological responses to exertion and that this cannot be explained by deconditioning. During the recent NIH conference on ME/CFS there were two experts in exercise physiology that once again presented data on this. The PACE authors are not experts in exercise physiology.

    Yet CBT/GET continues to be given to patients based on the assumption that patients erroneously believe they are ill. In fact, the real goal of CBT/GET is to eradicate these “unhelpful illness beliefs”. This is why CBT/GET is so harmful: it interferes with patients adjusting to the reality of their illness, and instead convinces them to adopt a view of their illness that is scientifically incorrect.

    Many health conditions are currently treated with CBT/GET or other treatments that are based on the same flawed methodology as the PACE trial: lack of blinding, subjective outcomes, and an inadequate control group. CBT for IBS was in the news recently and it’s based on the same junk science.

  • Fantastic piece. Thank you so much!! Encore!!

  • The tide may be turning but patient care remains abysmal. The simplest of accommodations are denied to ME patients, like a quiet place to lay down while waiting at the clinic or the Emergency Room.

  • Thanks for great article.

    The NICE committee may well be ‘reported’ to be evenly balanced, but unfortunately that is debatable in itself. Certainly the *voting* members are heavily weighted towards the psychological paradigm – with even a PACE trial author included i believe.

  • Thank you, Jerome. It is tragic that it took years of effort from so many very ill people to bring this to light, despite the fact that, right at the start, they tried to engage with the medical profession, and with medical journals, but were ignored.

    It is very saddening to keep coming across people in the medical or research worlds who either fall ill with ME themselves, or have someone close in the family with it, who are very reluctant for that to be known. It is easy to get researchers, medics, statisticians etc in the UK to agree how very poor the trial was, but very very difficult to get them to stick their heads above the parapet and say so. So thank you again: your comments are deeply appreciated.

  • Excellent reporting as usual. I’d love it if the Guardian picked up your article! Or maybe the Lancet or BMJ.

    It amazes me that the PACE authors would try to get away with claiming they didn’t have an opinion on whether ME/CFS is an organic disease or a psychological disorder. In Panel 1 of the PACE paper describing the treatments they claimed CFS is ‘reversible’ with CBT changing fear beliefs and avoidance behaviours; and with GET removing exercise intolerance theories; this despite post-exertional malaise/neuroimmune exhaustion (PEM/PENE) being the well-documented hallmark symptom of the disease. These descriptors of their preferred ‘treatments’ and the clear disregard for the science in the field illustrate their belief that the disease is a reversible psychological disorder with deconditioning present because of patients’ beliefs. .

    “CBT was done on the basis of the fear avoidance theory of chronic fatigue syndrome. This theory regards chronic fatigue syndrome as being reversible and that cognitive responses (fear of engaging in activity) and behavioural responses (avoidance of activity) are linked and interact with physiological processes to perpetuate fatigue. The aim of treatment was to change the behavioural and cognitive factors assumed to be responsible for perpetuation of the participant’s symptoms and disability. ”

    “GET was done on the basis of deconditioning and exercise intolerance theories of chronic fatigue syndrome. These theories assume that the syndrome is perpetuated by reversible physiological changes of deconditioning and avoidance of activity. These changes result in the deconditioning being maintained and an increased perception of effort, leading to further inactivity. The aim of treatment was to help the participant gradually return to appropriate physical activities, reverse the deconditioning, and thereby reduce fatigue and disability.”

    https://www.sciencedirect.com/science/article/pii/S0140673611600962#bib10

    • I somehow deleted the end of the last sentence n the first paragrah. It should have read “These descriptors of their preferred ‘treatments’ and the clear disregard for the science in the field illustrate their belief that the disease is a reversible psychological disorder with deconditioning present because of patients’ beliefs and avoidance behaviour.”

  • I just wanted to ask what the significance of crossed out links was in some of the articles on Healthinsight UK? I assumed for a while that the crossed out links no longer existed, but I’ve since discovered that isn’t true.

    • Editorial

      Yes it is a mystery to me too. I ocasionally get messages saying ‘broken links detected’ – from Word Press I think – but i became less interested in pursuing them after i had same experience.
      Sounds pathetic but i don’t know who detects them and indicates they don’t work or how to reverse them. Will consult my IT expert or blogmeister as I call him.

  • Read investigative journalist Martin Walker’s book “Skewed” (Slingshot Publications: http://www.slingshotpublications.com/Books) if you are ready to discover the culprits responsible for the ME/CFS scandal and their motives. It’s a disturbing and shocking (properly researched) read, but once I knew the facts I was at least able to realise that avoiding mainstream medicine and going it alone without any support was actually the best prospect for hope. Disgusting that this should be the case in one’s hour of deepest need, I know, but in retrospect I am in no doubt that having ones eyes forced wide open was the turning point for finding effective treatments and a path towards lifestyle recovery. Don’t give up!

  • Thanks for sharing this.

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