By Jerome Burne
A long-running battle between patients and therapists over the best way to treat debilitating chronic fatigue was won by the patients back at the beginning of November. In a dramatic U-turn, the NICE guidelines on the best way to treat ME (Myalgic Encephalitis)/ CFS (Chronic Fatigue Syndrome) were reversed.
Out went GET (Graded Exercise Therapy) – doing a bit more every day – and in came advice to only exercise as much as felt comfortable.
What hasn’t been made clear in reports of the change is that it was the culmination of a remarkable coup, pulled off four years ago by a group of ME/CFS patients, which had forced ME/CFS therapists to release the raw material collected during a trial that supposedly proved that GET was scientifically based.
The therapist said it proved the treatment worked, the patients claimed they found the treatment so ineffective and unpleasant that the results must be false.
The patients then had the full data reviewed by independent experts who reported that the results had indeed been “adjusted” to make them more favourable. The therapists dismissed the review as wrong and irrelevant.
At the time the story was almost completely ignored by newspapers and TV, with the exception of the Daily Mail which carried a story of mine.
The victory last month, which removed GET, came in a provisional review of the best treatment for CFS/ME. The patient activists, who had been campaigning for this change for years were on the committee that drew up the new guidelines.
I’m republishing an edited version of my September 2016 blog,which tells the story of the patients’ coup. Partly because their part in the guidelines U-turn has been effectively air-brushed out but also because it seems very relevant in the current climate when opposition to official medical views are routinely dismissed as fake and foolish or malicious. It’s a welcome reminder that the official view can be damagingly wrong and the patients and others who make informed criticisms deserve to be listened to.
A remarkable and unexpected legal victory (The post from 2016)
Would any doctor continue to prescribe a drug which they had been told would benefit 20 per cent of patients with a specific illness, once the truth was revealed to be around 7 per cent, only one per cent better than no treatment at all?
Something like this has just been discovered about the official treatment for a condition that affects an estimated 150,000 people in the UK. Many are bedridden or on disability allowance; refusing to follow this NICE-approved treatment, can lead to a withdrawal of benefits.
The condition is Myalgic Encephalitis (ME) or Chronic Fatigue Syndrome (CFS) and the discovery that exercise plus psychotherapy are effectively useless was the result of a remarkable and very unexpected legal victory last month.
It’s potentially a grave embarrassment for the senior psychiatrists involved and the Lancet, which published the report of the original trial supporting the treatment
The official view of ME/CFS is that the cause is unknown but that it has a strong psychological component so that the best treatment is a form of psychotherapy called CBT (cognitive behavioural therapy) along with GET – doing a bit more exercise every day.
Benefits of treatment wildly exaggerated
Patients respond to this remedy by pointing to the severe and debilitating symptoms such as profound fatigue, poor memory, irregular changes in blood pressure and unrefreshing sleep. These, they argue, are far more likely to be the result of a serious and fundamental biological disorder, perhaps in involving infection and the immune system.
In justifying their position doctors have relied on a big trial of CBT and GET, lasting five years and costing £5 million, which reported that 61 per cent of patients benefited.
But following the legal victory last month some of the data from this trial has been re-analysed and the result, published last week, suggests that the size of the benefit has been massively exaggerated.
It had been claimed that 60 per cent improved and 20 per cent recovered but the new analysis found that 20 per cent improved while the recovery rate was around 5 per cent. (Details here.)
The trial known as PACE (link to article) was published in The Lancet in 2011 and persuaded NICE that CBT and GET should be the standard treatment. Campaigning patients were far from persuaded, however, and ever since then, they have been trying to get access to unpublished trial data because they suspected something seriously dodgy had been done with the statistics to make the results so positive.
No grounds to refuse to release the data
Their letters and Freedom of Information requests for the data sent to the researchers at Queen Mary University in London (QMUL) have been rejected for the last five years on various grounds, such as the risk of revealing patient identities and being vexatious or a form of harassment.
But it turned out that these objections were either exaggerated or simply untrue. We know this because one of the FoI requests was supported by the Information Commissioner’s Office and earlier this year QMUL was ordered to cough up. The university refused and then spent over 200,000 pounds to have the order dismissed.
At a tribunal hearing (full report) in August, QMUL’s claims were put to the test. There might well be good reasons for keeping trial data confidential but if there aren’t, then continued secrecy is simply unscientific self-protection, damaging patients and undermining trust in doctors.
Doctors claim critics were ‘borderline psychopaths’
During the years after the PACE trial was published, those supporting it often raised doubts about the sanity and motives of those challenging the findings. It’s a line that the tribunal also rejected. An example of such claims can be seen in this extract from the transcript of an interview with Richard Horton, editor of the journal the Lancet, which published the trial, on an Australian radio station in 2011.
He described his critics as: “a fairly small, but highly organized, very vocal and very damaging group of individuals who have, I would say, actually hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients.”
At the tribunal one of the expert witnesses explained that they were ‘young men, borderline psychopaths’ a claim dismissed by the Information Commissioner as ‘wild speculation’.
How biased, unscientific and indeed evil
There is undoubtedly much anger among a substantial section of ME/CFS patients and they have been angry for a long time. I first wrote about this area over ten years ago after receiving a large bundle of documents in the post, supporting the idea of a biological cause, together with a note which read: ‘If you are able to expose just how biased, unscientific and indeed evil Wessely is, you would be regarded as a saviour of mankind.’ Excessive indeed but the material was plausible and scientifically literate.
The Wessely referred to is now Professor Sir Simon Wessely President of the Royal College of Psychiatrists who was then strongly identified with the psychological approach to ME/CFS. He wasn’t one of the authors of the PACE trial but was one of the doctors treating the patients and he has been a firm supporter. Last year he wrote a long blog post supporting the way the authors had handled their data.
When asked by an ME/CFS blogger last week about the finding that the effectiveness had been greatly exaggerated he was quoted as saying: ‘OK folks, nothing to see here, move along please.’
He added that that patients did improve and that the treatments were moderately effective. You can see how such a response could make patients who were getting no benefit from treatment furious, incandescent even. It’s a variant on: don’t you worry your pretty little head over it.
Senior clinicians call for the release of data on key trial
Such dismissive responses to informed criticism is common in other medical fields such as cutting heart attack risk with statins. Recently statin critics have been accused of killing people by discouraging them from taking these life-saving drugs. Complaints that doctors fail to listen to patients’ reports of side-effects from taking or trying to come off anti-depressants are common
The difference with the angry ME/CFS community is that they mounted an organised response. Over the past year, twelve thousand CFS/ME patients signed a petition to put pressure on QMUL to release data for independent analysis along with over two dozen charities in 14 countries. Among those who analysed the released data and signed an open letter to the Lancet published online last year calling for a reassessment of the PACE trial, were such senior clinicians and academics as:
Ronald W. Davis, PhD
Professor of Biochemistry and Genetics
Stanford University
Jonathan C.W. Edwards, MD
Emeritus Professor of Medicine
University College London
Leonard A. Jason, PhD
Professor of Psychology
DePaul University, Chicago
Bruce Levin, PhD
Professor of Biostatistics
Columbia University
Crucial to the critics’ success was the definition of recovery. What does it look like? Is it getting up for an hour longer or staying up all day? Being able to dress yourself or going back to work? If you make it easier to meet the definition, the number counted as ‘recovered’ will shoot up.
By getting some of the raw data from the trial, the independent researchers were able to assess what the recovery rates would have been if the original criteria had been stuck to. It emerged that all the criteria had been dramatically weakened long after the trial started, without seeking approval.
The result, claimed the patient blogger Julie Rehmeyer, was that participants could enter the trial, get worse on two out of four criteria, and then be called “recovered.” ‘It was possible,’ she pointed out, ‘to have poorer physical function than 92 per cent of the British working-age population and still have recovered’.
A victory for patients seeking proper therapies
It’s not clear what the effect of the re-analysis is going to be. The activists obviously feel spectacularly vindicated. ‘It’s a victory on multiple fronts,’ says Vincent Racaniello professor of microbiology and immunology at Colombia University in New York. ‘For patients seeking the proper therapies but also for transparency in science and the need to have data available for review by others.’
But like Professor Wessely, the authors are simply continuing to deny there is a problem. ‘It makes not a ha’p’orth of difference,’ says the lead investigator on the trial Dr Peter White responding to the reanalysis. ‘Cognitive behavioural therapy and graded exercise are still statistically significantly better than pacing or specialist medical care.’
This response of the therapists to an expert re-analysis of their work – an essential part of the scientific method – strongly suggests that there is a serious lack of any effective system for reassessing clinical results once they have been accepted. It took five years of informed campaigning plus a lucky legal action initiated by a bedridden man in Australia to trigger a review; this cannot be the best way to do it.
It would also be good if what’s happened with ME/CFS wasn’t regarded as just a little local difficulty. The need to take patient voices into account is much wider than that.
(Covid 19 is raising new questions about the benefits of graded exercise which is being recommended on NHS websites for the debilitating fatigue that can come with a serious Covid-19 infection known as ‘long Covid ‘. A number of those affected are doctors who have been amazed at how impossible graded exercise can be and are pushing for greater understanding of the biological basis of the condition. A feature of mine based around interviews with these doctors is due to be published soon after Christmas.)
Jerome Burne
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WINNER: 
Excellent reporting as usual Jerome. I did some pro-bono work on this years ago criticising the NICE report – which was absolutely dreadful. This was for a challenge in the high court to the guidelines.
The entire argument for the cost effectiveness of CBT/GET was based on one study of two hundred people in Belgium. The population were not matched properly (the treatment arm had a lower quality of life to start with), they got key figures upside down. It was a most terrible mess. The court decided that they could make no comment on the scientific data, or how it was reviewed, they could only make a judgement on whether or not NICE followed their agreed processes – which they did. They consulted with the key stakeholders, they reviewed all the data, they held ten meetings big enough to have an agreed quorum – whatever.
The decision essentially meant that only NICE could decided whether or not the NICE guidelines were correct. Of course, NICE did decided that their guidelines were correct – as they always do. Who guards the guardians, and all that. The High Court backed off making any judgement on the guidelines themselves.
I always knew this area was nonsense. Finally, it has come to pass. In part due to your own work. Good timing probably, because all of the people who are being left with long COVID were probably going to be forced into CBT/GET if they fail to recover.
Tying this to Dr Kendrick’s latest post on his blog (about Gary Taubes and his latest book The Case for Keto), I recall Taubes describing why he was so obsessive about his work on the science of diet and nutrition.
He talked about picking his kids up from school and often arriving when the class took an end-of-day run. Typically there would be a slender kid who ran like the wind leading the pack followed by most of the rest of class. Then there were two or three heavy kids bringing up the rear, huffing and puffing slowly to the finish line. “Those kids,” he said, “are being tortured. It’s not fun watching children being tortured.”
If “long COVID” patients are prescribed CBT/GET to make them “better”, it sounds like the same kind of useless and unnecessary (and likely harmful) torture those poor overweight children have to endure.