Search our news, events & opinions

6 March 2018 22 Comments
Posted in Opinion, Personal Injury

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

Posted by , Partner

On 20 February 2018 a Parliamentary debate on the PACE trial – a controversial study on ME/CFS treatment – highlighted the flaws of the original trial whilst also raising debate over whether more information is needed to educate the public and the medical professions about the devastating effects of ME/CFS.

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.

Leave a comment

Thank you for choosing to leave a comment. Please keep in mind that comments are moderated and please do not use a spammy keyword or a domain as your name or it will be deleted.

*required*

**required*

*optional*

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

  1. Posted by Jeff on March 8, 2018 at 4:33 am

    NICE may have “removed the recommendations to embark on harmful exercise”. But NICE still recommends Graded Exercise Therapy (GET).

    “1.6.2.4 Cognitive behavioural therapy (CBT) and/or graded exercise therapy (GET) should be offered to people with mild or moderate CFS/ME and provided to those who choose these approaches, because currently these are the interventions for which there is the clearest research evidence of benefit.”

    In the United States, the fact that NICE continues to recommend GET is cited in the by major healthcare companies such as Healthwise and Kaiser Permanente as support for their own continued recommendation of GET for ME/CFS.

    One would have thought that the CDC no longer recommending GET would be the end of it in the US. But apparently some US healthcare companies consider NICE and the CDC equally authoritative.

    • Posted by Billie Kotting on March 9, 2018 at 11:32 am

      Hi Jeff,

      Thanks for your insight into NICE’s authority in the USA. Hopefully the guidelines will be changed following NICE’s review, particularly after considering the controversy surrounding the PACE trial.

  2. Posted by Carol Binks on March 8, 2018 at 10:25 am

    Thank you for this James. I’d just like to point out that NICE has not removed its recommendations for CBT and GET, as called for by Paul Blomfield MP during the Parliamentary Debate, and despite calls to do so from informed Health Professionals, ME Charities and the Patient Community. In fact, they are refusing to do so. These ‘therapies’ are no longer recommended as a treatment for ME in the US and patients in the UK are asking: Who will take responsibility for harm caused by CBT and GET between now and 2020 when the new NICE Guidelines are released?

  3. Posted by B Robinson on March 8, 2018 at 10:39 am

    Thank you for highlighting this James.
    If PACE is a scandal, NHS Plus has produced guidance on the occupational aspects of the management of CFS/ME (search for ‘chronic fatigue syndrome’) is just as much a scandal.

    I am chasing NICE and others regarding what NICE stated in July 2017 about their Surveillance Review of ME Guidance. It will be of interest to you; relevant and material to your caseload and work defending rights of ME Patients.

    The Occupational Health Guidance came out in 2006 and predates both NICE and PACE- but Professor Peter White referenced it as medical director for Scottish Provident to justify rejection of PHI claims.

    In January, as a NICE Stakeholder, I attended the NICE Engagement event in London. I asked Professor Mark Baker of NICE to reassure me on a specific point.

    I wrote this, “How can Mark Baker claim he “did not know what I was talking about” re guidance NHS Plus( Health & Work) Occupational Guidelines for the Scoping exercise in January Engagement meeting?
    If PACE and Lightening plus EC are a problem and material to our fight with NICE, so is NHS Health and Work (NHS Plus)…….I was not reassured!!

    NICE state,
    https://www.nice.org.uk/guidance/cg53/documents/surveillance-review-proposal

    “We propose to liaise with Cochrane about the possibility of updating a Cochrane review from 2008 on cognitive behavioural therapy for chronic fatigue syndrome in adults to include data from the ‘Pacing, graded Activity, and Cognitive behaviour therapy; a randomised Evaluation’ (PACE) trial. A further review of the guideline may be considered following publication of the updated Cochrane review.

    During surveillance editorial or factual corrections were identified. Details are included in appendix A: summary of evidence from surveillance.

    * Just what we were all worried about…..the “justification for review being PACE and “EC”.

    Surveillance proposal for consultation

    We propose to not update the NICE guideline on chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) at this time.

    We propose to remove the guideline from the static list because:

     Evidence has been identified of important ongoing research in this area – for example a UK trial of internet-based cognitive behavioural therapy in children and young adults. This guideline therefore no longer meets the static list criteria. ”

    * Additionally; NHS Health at Work about Chronic fatigue syndrome/myalgic encephalomyelitis. page 45,

    “Editorial and factual corrections identified during surveillance

    During surveillance of the guideline we identified the following issues with the NICE version of the guideline that should be corrected.

     Recommendation 1.4.5.7 of NICE guideline CG53 has a footnote with a link to NHS Plus. However the NHS Plus project ended on 31 March 2013.

    It is noted that NHS Health at Work is progressing and developing this work.

    There is a section on NHS Health at Work about Chronic fatigue syndrome/myalgic encephalomyelitis. The following footnote needs to be updated with details on NHS Health at Work:

    [9] NHS Plus has produced guidance on the occupational aspects of the management of CFS/ME (search for ‘chronic fatigue syndrome’).

    NHS Health at Work about Chronic fatigue syndrome/myalgic encephalomyelitis.
    http://www.nhshealthatwork.co.uk/chronic-fatigue.asp

    http://www.meassociation.org.uk/2007/05/joint-statement-on-nhs-plus-occupational-health-guidance/

  4. Posted by Guido den Broeder on March 8, 2018 at 11:05 am

    Please distinguish between ME (G93.3), a specific neuro-immune disease, and CFS (R53.82) which stands for unexplained fatigue and malaise.

    PACE was a CFS study.

    A disease named ‘ME/CFS’ does not exist. The two are unrelated.

  5. Posted by Janice Johnson on March 8, 2018 at 11:19 am

    They have not yet removed CBT and GET from their recommendations. They are dilly-dallying. We are still campaigning to get CBT and GET removed by NICE

    Other countries have removed them since the PACE trials were discredited, but NICE still prevaricates

  6. Posted by Loretta gardner on March 8, 2018 at 11:41 am

    NICE were forced into reviewing its guideline on ME/CFS. Their new guideline is expected to be published in 2020. In the interim, NICE have refused to remove its recommended treatments of CBT and GET from the existing guideline.

    • Posted by Billie Kotting on March 9, 2018 at 11:39 am

      Hi Loretta, thank you for your comment. NICE have removed their advice to undertake ‘unsupervised, or unstructured, vigorous exercise (such as simply ‘go to the gym’ or ‘exercise more’) because this may worsen symptoms’ but as you correctly state they still recommend GET. Hopefully following the controversy surrounding the PACE trial their new guidelines will remove these recommendations.

  7. Posted by Carol Binks on March 8, 2018 at 12:13 pm

    “High Intensity” CBT and GET is still being used for people with CFS/ME in the NHS England IAPT Programme (Improving Access to Psychological Therapies) as well as in NHS CFS/ME Clinics around Britain, in spite of the fact that ME is NOT a Psychological Disorder. It has been categorised as Neurological by the WHO since 1969. Nor is it a ‘Medically Unexplained Symdrome’ (MUS). A review of over 9000 separate studies demonstrates this:
    http://www.meaction.net/wp-content/uploads/2015/05/ME2FCFS-RESEARCH-SUMMARY-Jamie-Seltzer.pdf

    Details on page 24 of the IAPT document from October 2017 ….

    http://www.yhscn.nhs.uk/media/PDFs/mhdn/Mental%20Health/IAPT-LTC/1.%20YH%20IAPT-LTC%20Slides%20-%20October%202017.pdf

    • Posted by Carol Binks on March 8, 2018 at 12:51 pm

      Apologies for the typo,
      which should read ‘Medically Unexplained Symptoms’.

  8. Posted by Karen Staples on March 8, 2018 at 12:46 pm

    Unfortunately this doesn’t end with ME I am now in a wheelchair with a leg that’s visibly swollen, I have blood test results that twice now I’ve been told to go away in wrong only to be later diagnosed with what I’d said in the first place. There are still things in my blood tests that are not being addressed. I live in intolerable amounts of pain, but keep getting told it’s a mental health problem.
    Mental health aren’t concerned over my mental health at all other than the effects the physical health is having.
    I have end stage liver disease and it seems to me it’s just an easy way not to make me more comfortable during the time I’ve got left.

  9. Posted by Craig M on March 8, 2018 at 2:59 pm

    Thank you for highlighting the plight of those still suffering from “one of the biggest medical scandals of the 21st century”. What will it take to get the government to fund more research into such a common and devastating illness?

    • Posted by Billie Kotting on March 9, 2018 at 11:49 am

      Hi Craig, thanks for your comment.

  10. Posted by Leela Play on March 8, 2018 at 5:44 pm

    Great coverage of the topic!

    There is a correction needed however. While the US has removed it’s recommendations for CBT and GET, and NICE is holding a review, NICE still has the old guidelines up and is refusing to remove the recommendations for CBT and GET.

    • Posted by Billie Kotting on March 9, 2018 at 11:51 am

      Hi Leela, thank you for your comment. NICE have removed their advice to undertake ‘unsupervised, or unstructured, vigorous exercise (such as simply ‘go to the gym’ or ‘exercise more’) because this may worsen symptoms’ but indeed they still recommend GET and CBT.

  11. Posted by Pauline Sykes on March 8, 2018 at 6:40 pm

    I am not aware that NICE “has removed the recommendations to embark on harmful exercise”. Please give authority for that statement.

    • Posted by Billie Kotting on March 9, 2018 at 4:36 pm

      Hi Pauline, thanks for your comment. NICE have removed their advice to undertake ‘unsupervised, or unstructured, vigorous exercise (such as simply ‘go to the gym’ or ‘exercise more’) because this may worsen symptoms’ but they still recommend GET. We have clarified this point at the bottom of the blog post.

  12. Posted by William Price on March 8, 2018 at 9:19 pm

    Thank you

  13. Posted by Adrienne Wooding on March 9, 2018 at 8:18 pm

    Can anything be done to stop more people being harmed?

  14. Posted by Customessaywriting on March 11, 2018 at 9:28 am

    Also needed: An independent investigation into the behavior of the DWP”s press officers and their campaign to suppress negative news, focusing particularly on how they managed to “spike”—or persuade journalists not to publish numerous stories which cast the DWP in a negative light.

  15. Posted by Ali on March 20, 2018 at 8:25 am

    Thank you.

Opinion

Learn more

Partner

T: 020 7842 1438 (DDI)
Email

Search our news, events & opinions