The publication of a study into what an MP called one of the “biggest medical scandals of the 21st century” has sparked a war of words between areas of the medical and science communities. Caught in the crossfire are between 17 and 24 million disabled people worldwide, on whom critics of this latest research are effectively declaring war if they dare to question current mainstream treatment.

PACE Trials: controversial from the start

The PACE Trial was a study into treatment for people living with myalgic encephalomyelitis/chronic fatigue syndrome, commonly referred to as ME/CFS. The research has also been applied to people living with fibromyalgia and Ehlers-Danlos syndromes (EDS), among other illnesses. The PACE Trial claims that people living with ME/CFS can improve their illnesses, and sometimes recover, by having cognitive behavioural therapy (CBT) and by using graded exercise therapy (GET).

The results of the £5m trial, part-funded by the UK Department for Work and Pensions (DWP), were originally published in The Lancet in 2011. But they have been dismissed by many medical professionals and disabled people alike as damaging and ineffective. In the US in 2016, the federal Agency for Healthcare Research and Quality (AHRQ) downgraded the reliability of GET for ME/CFS patients, saying there was “insufficient evidence of effectiveness of GET on any outcome”. It also said there was “low strength” or “insufficient” evidence about the effectiveness of CBT. In 2017, the US Center for Disease Control (CDC) also removed CBT and GET as recommended treatments.

In the UK, CBT and GET are still the NHS’s approved treatment under guidelines from the National Institute for Health and Care Excellence (NICE). But NICE is undertaking a review of this.

Now, a new study into the PACE Trial’s original research has been released. Its evidence completely contradicts the results of the original study, and to cast even more doubt over the PACE Trial’s findings, the study has used the trial’s original data to prove its point.

But some in the mainstream medical and scientific community have already hit back.

Patients: trying to “disrupt” research?

The Science and Media Centre (SMC) is a charity that promotes cooperative working between the media and the medical and scientific communities. On Wednesday 21 March, it appeared to strike out preemptively against the new research with an updated “factsheet” on ME/CFS called The illness and the controversy. Advocating for the PACE Trial’s results, it said it and CBT/GET were:

Highly controversial among a minority of patients and doctors.

Filmmaker Jennifer Brea, who lives with ME, noted it went on to ‘disrespectfully‘ dismiss patients and medical professionals who disagreed with the PACE Trial. The SMC said:

Some people do not accept that psychological factors play a role in the illness or its treatment… Some also claim that these treatment are harmful. A minority have engaged in activities designed to actively disrupt such research. Those who disagree with… [the PACE Trial’s] body of evidence cite review articles and reanalyses of trial data published in low impact factor journals…

But Brea, who made the groundbreaking film Unrest about living with ME, hit back at the SMC. She claimed it was “promoting pseudoscience” and that it was compromised by a trustee’s links to the psychological model of understanding ME.

So what caused the SMC to fire an opening salvo against this new research? And why is Brea so angry about its updated factsheet?

Fresh evidence: moving the goalposts?

The new research, led by Dr Carolyn E Wilshire and published in the BMC Psychology journal, disputes the PACE Trial’s original findings. In a BMC statement given to The Canary, the authors say that because the original PACE Trial researchers moved the goalposts on measuring the effectiveness of CBT and GET midway through the study, the results were exaggerated.

In the PACE Trial, 641 participants were randomised into four groups: a control group, a CBT group, a GET group, and a fourth group that received a novel treatment, Adaptive Pacing Therapy (APT). Wilshire and her colleagues said that in the original outline of the study in 2007, the authors said one of the measurements of the effectiveness of CBT and GET was the percentage of patients showing overall improvement 52 weeks after randomisation. Two measures contributed to the definition of improvement: self-rated fatigue and self-rated disability. But in May 2010, these were replaced with two continuous measures: fatigue and physical function ratings.

The first wave of results based on these measures was published in 2011. It showed that improvement levels were seen in:

59% of CBT patients.

61% of GET patients.

45% of control patients.

But when the Wilshire research team crunched the numbers based on the 2007 original measurement guidelines, the results showed improvement levels were only seen in:

20% of CBT patients.

21% of GET patients.

10% of control patients.

Abandoning the goalposts?

A second measure of the success of CBT and GET was also written into the PACE Trial. It was the proportion of patients who met the specified definition of recovery at the end of the trial. The definition of recovery was based on each participant’s scores on:

Two key self-rated measures: fatigue and physical function.

One further measure of overall self-rated improvement.

And also whether the participant still met various CFS case definitions.

But these results were never published. Wilshire says that, instead, a 2013 paper reported recovery rates based on a more “generous definition of recovery”. It showed that 22% of patients in each of the CBT and GET groups qualified as recovered, but only 7% in the control group. So once again, Wilshire’s researchers re-crunched the original numbers. And they found that:

Rates of recovery never exceeded 8% in any treatment group, and there were no statistically significant effects of treatment on recovery rates.

In the BMC statement of the findings, Wilshire said:

Until there is positive evidence to suggest otherwise, the conclusion we must draw is that PACE’s treatment effects are not sustained over the long term, not even on self-report measures. CBT and GET have no long-term benefits at all. Patients do just as well with good basic medical care.

But despite this new evidence, bodies like the SMC and the original authors of the PACE Trial still stand by their work.

Oh, what a tangled web we weave…

The impartiality of the SMC is questionable in this instance, and it’s these questions of impartiality which lie at the heart of disabled people’s concerns over the PACE Trial.

For example, sitting on the SMC governance committee is Sir Simon Wessely, whom Brea refers to as “one of the architects of the biopsychosocial school as applied to ME”. As The Canary previously reported, a group of 60 leading professionals and campaigners criticised the UK government’s appointment of Wessley as lead on the review into the Mental Health Act. They said that:

Wessely’s body of work on ME… demonstrates his lack of honesty, care and compassion for patients. His unsubstantiated claim that ME is driven by ‘false illness beliefs’ has led to patients being labelled as hypochondriacs, treated with contempt by some in the medical profession and stigmatised by society. His recommended treatment regime of Graded Exercise Therapy caused deterioration in function for nearly 50% of ME patients surveyed, yet he dismisses their evidence as unreliable and labels all critics of this work as irrational and extremist.

But he stood by his claims, telling The Canary he still supports GET as a treatment for ME/CFS, and that he still regards the PACE Trial as “well conducted”. But Wessley’s role in ME/CFS treatments, and the SMC’s “factsheet”, underscore the concerns about the PACE Trial.

Conflicts of interest?

Accusations of conflicts of interest have dogged the study from the outset. As The Canary reported in 2016:

The results of the trial also suited the aims of the… DWP, who part funded the trial, and the medical insurance industry which has connections to the PACE Trial via the researchers. Four of them declared working for the insurance industry in a conflicts of interest statement… The DWP is particularly keen on psychological explanations, a.k.a the bio-psychosocial (BPS) model for chronic ill health. Professor Tom Shakespeare says… BPS ‘played a key role’ in the narrowing of eligibility criteria for disability benefits such as Employment and Support Allowance (ESA). Shakespeare goes on to say BPS is used to “underpin increasingly harsh and at times punitive measures targeted at disabled people”, in an attempt by the government to cut the number of people receiving ESA. One of the medical insurance companies White had previously done work for is called Unum Provident Insurance (UPI). They are also proponents of the BPS model of ill health as it helps them to deny disability claims. In 2003 UPI were fined $31.7m in California for running ‘disability denial factories’…. UPI is one of the UK’s biggest providers of income protection insurance (IPI) . As a consequence of more holes appearing in the social security safety net, more people are likely to take out IPI, increasing UPI’s profits. Sir Mansel Aylward, Chief Medical officer for the DWP, sat on the PACE Trial steering committee which approved the mid trial changes to the methods. Aylward has also worked for UPI and is a keen proponent of the BPS model, being very influential in promoting it to the DWP.

It is these conflicts of interest which are so disturbing.

A torrid history, still being promoted

ME/CFS has a long and torrid history of being dismissed as ‘all in people’s heads’, “yuppie flu”, and being made worse by disabled people’s own “illness beliefs”. This deeply unpleasant “pseudoscience”, as Brea calls it, has left disabled people living with ME/CFS, and other similar illnesses like Fibromyalgia and EDS, traumatised. It’s important to note that this school of thinking still underpins the NHS’s treatment for ME/CFS in 2018.

When you are repeatedly beaten down, dismissed and mentally undermined by medical professionals, the results can be catastrophic, as this journalist has witnessed. This is exactly what the PACE Trial has done to millions of people; something the campaign “Millions Missing” has tried to address. Disabled people living with ME/CFS and other illnesses have understandably often lost all faith in the medical profession, seeing it as a third party abuser in their relationship with their illness.

But with research like Wilshire’s, could the tide of opinion be starting to turn? Possibly, but it will not come soon enough for millions of disabled people, some of whom have suffered years of abuse and dismissal at the hands of the profession supposed to be supporting them; abuse compounded by the PACE Trial.

Get Involved!

– Read more from The Canary’s Discovery section.

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Featured image via Millions Missing/YouTube