ME Action staement: Why ME patients are critical of the PACE trial

What is the PACE trial?
The PACE trial is a £5 million study that promotes the view that ME/CFS patients can recover if they gradually increase their physical activity. It is based on a psychogenic theory that the debility of the disease is due to patients’ “fear of activity” and subsequent deconditioning, despite extensive evidence to the contrary. This view negatively affects how ME/CFS patients are viewed by society and cared for in medical practice.

What are the flaws in the PACE trial?
A recent investigation by The New York Times journalist David Tuller reported major flaws in the study’s methodology. A letter authored by several prominent American researchers in fields as diverse as statistics, epidemiology, psychology, microbiology and genetics have written to The Lancet calling for an independent review.

Key criticisms include: changing the definition of “recovery” after the study was already
underway; the failure to report objective measures included in the original trial design in favor of reporting subjective outcome measures; a newsletter distributed to patients in the middle of the experiment touting the benefits of some of the treatment therapies and critiquing drug therapies; and failure to disclose conflicts of interest.

Yet when patients join these scientists in critiquing the PACE trial, they are criticised for
expressing their views. Here are a few common myths about ME patients and an  explanation of what we are really fighting for:

MYTH: The controversy is fueled by a vocal minority of “vociferous” ME militants on the
internet Patients connect with each other on the internet because many are housebound and bedbound.

Over 10,000 patients have signed a petition calling for an independent review of two studies: http://my.meaction.net/petitions/pace-trial-needs-review-now It has been translated into six languages.

MYTH: ​ME sufferers oppose GET because they are afraid of exercise
TRUTH: Many ME sufferers oppose GET because exercise makes them worse. The purpose of GET is to reverse the effects of deconditioning. A large body of scientific literature demonstrates that ME is an organic illness that causes neurological, immunological, and energy production impairment. Findings include alterations in cytokines, vascular signalling, and inflammation.

Two­day exercise tests which compared sedentary controls to ME sufferers found an increased debility, and degradation in max aerobic capacity (VO2Max), on the second day for ME but not the controls, proving the primary pathology is unrelated to deconditioning.

MYTH: ​ME sufferers oppose CBT because they are afraid of the stigma of mental illness
ME patients want effective treatments, no matter their origin, and would gladly accept
psychological treatment if ME were a psychological illness. ME patients are also open to
psychological support; CBT is used in a wide range of life­altering illnesses (e.g., cancer and
MS) to help patients cope. But proponents of PACE style CBT claim can lead to recovery by
convincing patients that they do not have an organic illness but are deconditioned.

Why these myths cause harm

1. ME/CFS is grossly under ­researched, making it imperative that misleading claims of recovery are not substitutes for real science and social intervention.
2. ME/CFS patients need treatment regardless of the branch of medicine providing the solutions. However, these treatments should be based on solid scientific processes that are repeatable and objectively measurable. The processes must utilize consistent patient selection criteria, which has been inconsistent across many studies due to the lack of global consensus.
3. It is rational and logical to petition for research which could treat the underlying cause and symptoms of ME/CFS and go beyond mere coping mechanisms provided within the psychogenic model of treatment. It is rational and logical to petition for a cure.

Top researchers who have reviewed the study conclude it is fraught with indefensible methodological problems

From David Tuller’s Virology article:
Dr. Bruce Levin, Columbia University:

“To let participants know that interventions have been selected by a government committee ‘based on the best available evidence’ strikes me as the height of clinical trial amateurism. I have never seen a trial design where eligibility requirements for a disease alone would qualify some patients for having had a successful treatment… I find it nearly inconceivable that a trial’s data monitoring committee would have approved such a protocol problem if they were aware of it.”

Dr. Ronald Davis, Stanford University:

“I’m shocked that the Lancet published it…The PACE study has so many flaws and there are so many questions you’d want to ask about it that I don’t understand how it got through any kind of peer review.”

Dr. Arthur Reingold, University of California, Berkeley:

“Under the circumstances, an independent review of the trial conducted by experts not involved in the design or conduct of the study would seem to be very much in order.”

Dr. Jonathan Edwards, University College London:

“It’s a mass of un­interpretability to me…All the issues with the trial are extremely worrying, making interpretation of the clinical significance of the findings more or less impossible. There is no ‘stigma of mental illness’. But there is an implication that there is no real illness beyond an irrational belief of being ill, for which there is no justification.”

References:
● Background and news coverage of the PACE trial:
http://www.meaction.net/background­to­the­petition/
● The most comprehensive examination of PACE, by David Tuller DrPH, was published
October 22, 2015: http://www.virology.ws/2015/10/23/trial-by-error-iii/
● Open letter to Richard Horton, editor of The Lancet:
http://www.virology.ws/2015/11/13/an-open-letter-to-dr-richard-horton-and-the-lancet/
NIH and top US Scientists take a different direction
● http://www.nih.gov/news-events/news-releases/nih-takes-action-bolster-research-myalgic-encephalomyelitis/chronic-fatigue-syndrome
● http://phoenixrising.me/archives/26602
● http://www.cortjohnson.org/?s=lipkin

Drafted collectively by several members of #MEAction. November 30, 2015. Last updated:
November 30, 2015