PACE Trial Results Misleading: Part I – Background

Karen Lee Richards Health Guide
  • In mid-February, the UK's Medical Research Council, with great fanfare, issued a press release announcing, “UK’s largest CFS/ME trial confirms safe and effective treatments for patients.”  The two treatments they claimed were so effective are Cognitive Behavioral Therapy and Graded Exercise Therapy. 

    Most of the national media, which prides itself on researching its stories and digging below the surface, did what they do with most announcements of medical research results – they dutifully repeated the information in the press release.  For the next couple of weeks, I saw dozens of headlines like these:

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    “Psychotherapy Eases Chronic Fatigue, Study Finds” – New York Times

    “Study: 'Talking And Exercise Could Cure ME'” – Sky News

    “Study Says 2 Therapies Help Fight Chronic Fatigue Syndrome” – Newsday

    “Psychotherapy And Exercise Look Best To Treat Chronic Fatigue Syndrome” – NPR

    “Pushing Limits Can Help Chronic Fatigue Patients” – Fox News

    I will give some credit to the New York Times; they at least acknowledged that ME/CFS patient organizations and some researchers disagreed with the findings, although they didn't mention the significant flaws of the study. 

    On the other end of the spectrum was Sky News.  They stated, “A landmark study has found that 60% of sufferers significantly improved if they were put on a tailored exercise programme or given talking therapy.  Half of these patients reported a return to normal energy levels.”  Neither statement was even close to the truth. 


    What concerns me about the media coverage is that rather than helping ME/CFS patients, one of these therapies – graded exercise therapy – could actually harm them.  They could have done a great service for ME/CFS patients if they had just taken the time to really look at the study and point out even a few of its flaws.


    Knowing what I know about ME/CFS and other research demonstrating the lack of effectiveness of the therapies in question, I found the news articles disturbing.  As I began to take a closer look at the PACE trial itself and the people behind it, what I found was even more disturbing.


    The History Behind the Study

    The study was labeled the PACE trial.  PACE is the acronym for “Pacing, Activity, and Cognitive behaviour therapy: a randomised Evaluation.”  The stated purpose of the study was to assess the effectiveness and safety of four treatments:

    • Adaptive pacing therapy (APT)
    • Cognitive behaviour therapy (CBT)
    • Graded exercise therapy (GET)
    • Specialist medical care (SMC)

    Problems with the PACE trial began long before the study was even conceived.  The UK government has a long history of and, in fact, leads the world in its efforts to have ME/CFS (myalgic encephomyelitis or chronic fatigue syndrome) reclassified from a neurological disorder to a mental and behavioral disorder.  

    Why is this so important to them?  Money, of course.  In the UK, most medical care is paid for by the government.  If they can reclassify ME/CFS as a behavioral disorder, they won't have to pay for long-term medical treatment, provide home care, or give disability allowances to the quarter of a million people there who suffer with ME/CFS.  It's interesting to note that since 1993, the US health insurance company UNUMProvident has been advising the UK's Department for Work and Pensions on the most effective ways of reducing benefit payments.

  • The UK government is supported in their efforts by a group of psychiatrists and their supporters, many of whom work for the health insurance industry, known as the “Wessley School.”  They are led by Professor Simon Wessely from King's College Hospital and the Institute of Psychiatry (IoP) London.  Wessely's goal is to “eradicate ME” – not by finding a cure, but by having it deleted from the World Health Organization's (WHO) list of neurological disorders.  Once he as accomplished that, he wants WHO to reclassify CFS as a behavioral disorder. 

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    Doesn't that make a nice, neat little package?  Get rid of an illness just be refusing to acknowledge its existence.  Then tell those patients who continue to be sick that they have a psychological problem and are causing their own symptoms.  If that works, maybe we could eradicate cancer by taking it off of the list, too.  Forgive me if I sound a bit snarky, but the absurdity of this idea is beyond belief. 

    Absurd or not, Wessely and his cohorts are determined to achieve their goal no matter what.  In 2000 he issued the IoP's “Guide to Mental Health in Primary Care” under the WHO logo, in which “CFS/ME” was classified as a mental disorder.  (Because the IoP is an acknowledged WHO Collaborating Centre on mental health, they are allowed to use the WHO logo.)  On two different occassions, the WHO issued statements repudiating this unofficial reclassification, saying it was at variance with WHO's position. 


    Note that Wessely also considers fibromyalgia, irritable bowel syndrome, multiple chemical sensitivity and premenstrual syndrome to be behavioral/somatization disorders.  Should he ever succeed in getting ME/CFS deleted and/or reclassified, I suspect those conditions would be his next targets.


    You may be wondering what all of this history has to do with the PACE trial.  Well, guess who was in charge of the PACE Clinical Trial Unit?  Yes, it was Professor Wessely.  And who funded the trial?  As you may have guessed, it was four agencies of the UK government:  the UK Medical Research Council, the Department of Health for England, the UK Department for Work and Pensions, and the Chief Scientist Office of the Scottish Government Health Directorates. 

    While these revelations certainly cast doubt on the motivation behind the PACE trial, we haven't even begun to scratch the surface of questionable aspects of the study.  To learn more about the study's specific flaws, read:  PACE Trial Results Misleading: Part II – Flaws in the Study

    White PD, et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011 Mar 5;377(9768):823-36.
    UK’s largest CFS/ME trial confirms safe and effective treatments for patients. Medical Research Council. Press release. February 18, 2011.
    Hooper, Malcom. Magical Medicine: How to make a disease disappear. University of Sunderland. February 12, 2010.

Published On: April 30, 2011