The PACE trial – “one of the biggest medical scandals of the 21st century”

This post was originally made by my retired partner, James Millar Craig and it is worth re-stating word for word. I have also left in comments left on the post at the time. The importance of the ongoing NICE review is reinforced every time we see clients whose insurers make fundamentally flawed and, dare I say it, intellectually dishonest decisions based on these discredited guidelines.

The PACE trial was a large-scale trial of different treatments for those suffering from Chronic Fatigue Syndrome and ME. The study compared standardised medical care alone to standardised medical care with Adaptive Pacing Therapy (APT), Cognitive Behavioural Therapy (CBT) and Graded Exercise Therapy (GET). The trial was funded by the UK Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, and the Department for Work and Pensions.

What were the PACE trial's findings?

The main outcomes were published in The Lancet in 2011 and the findings were that CBT and GET can be effective treatments for CFS/ME - 30% of patients went back to normal, while 60% improved following these treatments.

The outcome of this trial was seen as so important that it now dictates clinical policy in the United Kingdom in both the NHS and for privately funded treatment. The NICE guidelines for NHS-provided care recommend CBT and GET for the treatment of ME/CFS.

What is the issue with PACE trial?

Following the trial, the media reported that all ME sufferers had to do to recover was exercise. However, questions were soon raised among those suffering from the condition, who argued that exercise was a major contributor in making their symptoms worse.

Carol Monaghan MP (Glasgow North West, Scottish National Party) brought the issue to Westminster Hall and recounted the story of someone who had contacted her:

“I was determined to be a part of the...trial because I wanted to get better—so if this ‘treatment’ could make me better I wanted to give it the chance to do so. I was assigned Graded Exercise Therapy. It never occurred to me that it would actually make me more ill. Nor did it occur to me that decline would not be documented, and that despite patients not recovering (or in some cases worsening), they would publish that the treatment was successful...It was stressed that I would only get better if I tried harder, and even though the graded exercise was clearly making me worse, my struggle and pain was dismissed.”

The data from the trial was hidden until, after a long legal battle, it was finally published in August 2016. The data showed that the authors had changed the way in which they measured improvement and recovery, to increase the apparent benefit of the therapies. Analysing the results again showed that the improvement rate fell from 60% to 21% and the recovery rate fell from 22% to just 7%.

Carol Monaghan said:

"the failure of the PACE trial…could simply be put down to bad science, but unfortunately I believe that there is far more to it. One wonders why the DWP would fund such a trial, unless it was seen as a way of removing people from long-term benefits and reducing the welfare bill.’ Speaking after the debate she said ‘discovering that the PACE trial was funded by the DWP, no doubt with the intention to reduce the amount of people on benefits, should cause great concern."

Ms Moaghan, a former science teacher also told how "the impact of the PACE trial on those with ME has been devastating" and that it was her view that "when the full details of the trial become known, it will be considered one of the biggest medical scandals of the 21st century."

What does this mean for the future?

Since the publication of the data from the trial and the controversy surrounding its findings, NICE have said that they are reviewing their guidelines on ME and has removed the recommendations to embark on harmful exercise.

Caroline Dinneage, the Minister for Care said she:

"welcome(s) the NICE decision to undertake a full review of the guidance, which will examine the concerns around the PACE trial and any implications for its current recommendations."

However final guidance is not expected until October 2020.

Hopefully, the parliamentary debate will have shed some light on the flaws of the PACE trial and the controversy surrounding its findings. Much more is needed to be done in order to raise awareness and educate society and the medical profession about ME/CFS. This is a step in the right direction although it will be years until we will be able to tell what effect the debate has really had on medical policy and sufferers lives.

CLARIFICATION: Above we mention that NICE has 'removed the recommendations to embark on harmful exercise'. This is in reference to comments made by the MP. The NICE guidance on harmful exercise is as follows:

"1.4.6.2 The following strategies should not be offered to people with CFS/ME:

• Advice to undertake unsupervised, or unstructured, vigorous exercise (such as simply 'go to the gym' or 'exercise more') because this may worsen symptoms."

However, graded exercise is still recommended.