Quotes from critics of the PACE trial
The PACE trial received a substantial amount of criticism from various experts. The following includes a selection of quotes about the PACE trial from supporters and critics.
- 1 Action for ME - Sonya Chowdhury
- 2 Trevor Butterworth
- 3 Professor James Coyne
- 4 Professors James Coyne and Keith Laws
- 5 Professor Ronald Davis
- 6 Emeritus Professor Jonathan Edwards
- 7 Professor Rebecca Goldin
- 8 Dr Ellen Goudsmit
- 9 Professor Leonard Jason
- 10 Professor Bruce Levin
- 11 Professor Vincent Racaniello
- 12 Professor Arthur Reingold
- 13 Dr. Charles Shepherd
- 14 Dr David Tuller
- 15 Dr David Tuller and Julie Rehmeyer
- 16 Julie Rehmeyer
- 17 Dr Michael VanElzakker
- 18 Dr David Marks
- 19 See also
- 20 Learn more
- 21 References
Action for ME - Sonya Chowdhury[edit | edit source]
Seven years after the publication of the PACE trial, and shortly after the the re-analysis of the PACE trial patient data, Action for ME Chief Executive Sonya Chowdhury published a statement stating:
"By having a role on the [PACE trial] Steering Committee and Management Group, there was a de facto endorsement of the use of £5m of research funding to focus on behavioural treatments. Neither I nor the current Board of Trustees would agree to do this now, as reflected by our current research strategy, the focus of which is collaborative biomedical research.
"I am sorry that the charity did not advocate for this considerable level of funding to be invested in biomedical research instead. It was never our intention to contribute to any stigma or misunderstanding about the illness and I sincerely apologise to those who feel that, in not speaking out sooner and more strongly, we have caused harm... "
In the same statement, Sonya Chowdhury added:
"A summary of our position
"Action for M.E. does not support any treatment approach:
- based on the deconditioning hypothesis
in which patients' legitimate concerns about the consequences of exercise are dismissed or ignored.
"We fully support treatment approaches which:
- aim to reduce and stabilise symptoms before any appropriate increase in activity levels is attempted - put the person with M.E./CFS in charge of the aims and goals of the overall management plan."
Trevor Butterworth is the Editor of Sense About Statistics, an online collaboration between the American Statistical Association and Sense About Science USA.
"...the way PACE was designed and redesigned means it cannot provide reliable answers to the questions it asked. There is really not a lot that can be said to mitigate that; it’s a terminal prognosis."
Professor Coyne is Professor of Health Psychology, University Medical Center, Groningen and University of the Netherlands; Distinguished Visiting Professor at the Institute for Health Policy, Rutgers, the State University of New Jersey; and Professor Emeritus of Psychology in the Department of Psychiatry, University of Pennsylvania. He is one of the most cited psychologists in the academic literature.
"The data presented are uninterpretable. We can temporarily suspend critical thinking and some basic rules for conducting randomized trials (RCTs), follow-up studies, and analyzing the subsequent data. Even if we do, we should reject some of the interpretations offered by the PACE investigators as unfairly spun to fit what [is] already a distorted positive interpretation of the results."
"The self-report measures do not necessarily capture subjective experience, only forced choice responses to a limited set of statements."
"One of the two outcome measures, the physical health scale of the SF-36 requires forced choice responses to a limited set of statements selected for general utility across all mental and physical conditions."
"The validity [of the] other primary outcome measure, the Chalder Fatigue Scale depends heavily on research conducted by this investigator group and has inadequate validation of its sensitivity to change in objective measures of functioning."
Professor Coyne gave a public talk criticising the PACE trial in Edinburgh in November 2015. Video footage is available, as are a slide show full and an edited transcripts, and an audio recording.
Professor Coyne has questioned whether the PACE trial paper could ever have been properly peer-reviewed, given the large number of study authors and the small world of British science.
Professors James Coyne and Keith Laws[edit | edit source]
Professor Coyne and Professor Laws of the University of Hertfordshire have criticised, in a joint letter to Lancet Psychiatry, the long-term follow-up analysis of the PACE trial that was published in 2015. Referring to the results of the study as a whole, they said:
"There are no group differences, and the overall mean short-form 36 (SF-63) physical functioning score is less than 60. It is useful to put this number in context. 77% of the PACE trial participants were women, and the mean age of the trial population was 38 years, with no other disabling medical conditions. Patients with lupus have a mean physical functioning score of 63, patients with class II congestive heart failure have a mean score lower than 60, and normal controls with no long-term health problems have a mean score of 93."
Professor Ronald Davis is a world-famous geneticist at Stanford University, known for work that enabled the Human Genome Project.
"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."
Professor Edwards, of University College London, is internationally known for his pioneering work in establishing B-cell depletion therapy as an effective treatment for rheumatoid arthritis.
"It's a mass of un-interpretability to me…All the issues with the trial are extremely worrying, making interpretation of the clinical significance of the findings more or less impossible....Within the circle who are involved in this field, it seems there were a group who were prepared to all sing by the hymn sheet and agree that PACE was wonderful. But all the issues with the trial are extremely worrying, making interpretation of the clinical significance of the findings more or less impossible."
Professor Rebecca Goldin[edit | edit source]
Professor Goldin is Professor of Mathematical Sciences at George Mason University and Director of STATS.org (US).
"The PACE design changed so significantly as to leave many wondering whether there is value in the study itself."
"It seems that the best we can glean from PACE is that study design is essential to good science, and the flaws in this design were enough to doom its results from the start."
Dr Goudsmit is a retired health psychologist who has published a number of criticisms of the PACE trial.
"The PACE trial was scientifically extremely poor"
"A treatment like GET is simply not appropriate for a disease like ME which is linked to infection and metabolic abnormalities. Given the close relationship between exertion and symptoms, it follows that asking a patient to increase their activity levels is as logical as advising smokers with lung cancer to gradually increase the number of cigarettes they smoke"
Leonard Jason is a professor of psychology at DePaul University in Chicago, Illinois, and director of its Center for Community Research.
“The PACE authors should have reduced the kind of blatant methodological lapses that can impugn the credibility of the research, such as having overlapping recovery and entry/disability criteria.”
"My key points are that the PACE trial investigators were not successful in designing and implementing a valid pacing intervention and patient selection ambiguity further compromised the study’s outcomes."
Professor Levin is a professor of biostatistics at Columbia University and an expert in clinical trial design.
"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."
Professor Vincent Racaniello[edit | edit source]
"This is a flawed study, it has to be fixed and people are being harmed by it."
"... multiple flaws that are inexcusable."
"In short, the PACE study is a sham, with meaningless results. In this case, the emperor truly has no clothes. Dr. Horton and his editorial team at The Lancet are stark naked."
"I think they are going to ignore, obfuscate, and give their usual responses until we are all dead. I don't have hope that the PACE authors, or Lancet, will respond in any meaningful way until there is more of an outcry.
Professor Reingold is Head of Epidemiology at the 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 Shepherd, medical advisor to the ME Association, who also has ME/CFS, has criticised the trial's long-term follow-up analyses:
"Without robust objective evidence relating to improvement and recovery, the ME patient community will continue to regard the PACE trial as a tremendous waste of research funding money".
Dr David Tuller[edit | edit source]
Dr Tuller is is academic coordinator of the University of California, Berkeley's joint masters program in public health and journalism. He was a reporter and editor for 10 years at the San Francisco Chronicle, served as health editor at Salon.com and frequently writes about health for The New York Times. He has written extensively about the PACE trial.
"The study included a bizarre paradox: participants’ baseline scores for the two primary outcomes of physical function and fatigue could qualify them simultaneously as disabled enough to get into the trial but already 'recovered' on those indicators–even before any treatment. In fact, 13 percent of the study sample was already 'recovered' on one of these two measures at the start of the study."
"In the middle of the study, the PACE team published a newsletter for participants that included glowing testimonials from earlier trial subjects about how much the 'therapy' and 'treatment' helped them. The newsletter also included an article informing participants that the two interventions pioneered by the investigators and being tested for efficacy in the trial, graded exercise therapy and cognitive behavior therapy, had been recommended as treatments by a U.K. government committee 'based on the best available evidence.' The newsletter article did not mention that a key PACE investigator was also serving on the U.K. government committee that endorsed the PACE therapies."
"The PACE team changed all the methods outlined in its protocol for assessing the primary outcomes of physical function and fatigue, but did not take necessary steps to demonstrate that the revised methods and findings were robust, such as including sensitivity analyses. The researchers also relaxed all four of the criteria outlined in the protocol for defining 'recovery.' They have rejected requests from patients for the findings as originally promised in the protocol as 'vexatious.'"
"The PACE claims of successful treatment and 'recovery' were based solely on subjective outcomes. All the objective measures from the trial—a walking test, a step test, and data on employment and the receipt of financial information—failed to provide any evidence to support such claims. Afterwards, the PACE authors dismissed their own main objective measures as non-objective, irrelevant, or unreliable."
"In seeking informed consent, the PACE authors violated their own protocol, which included an explicit commitment to tell prospective participants about any possible conflicts of interest. The main investigators have had longstanding financial and consulting ties with disability insurance companies, having advised them for years that cognitive behavior therapy and graded exercise therapy could get claimants off benefits and back to work. Yet prospective participants were not told about any insurance industry links and the information was not included on consent forms. The authors did include the information in the 'conflicts of interest' sections of the published papers."
"The Lancet Psychiatry follow-up had null findings: Two years or more after randomization, there were no differences in reported levels of fatigue and physical function between those assigned to any of the groups... Yet the authors, once again, attempted to spin this mess as a success."
"This study is a piece of crap."
Dr David Tuller and Julie Rehmeyer[edit | edit source]
"The study’s primary case definition for identifying participants, called the Oxford criteria, was extremely broad; it required only six months of medically unexplained fatigue, with no other symptoms necessary. Indeed, 16% of the participants didn’t even have exercise intolerance—now recognized as the primary symptom of ME/CFS".
"After the trial began, the researchers tightened their definition of harms, just as they had relaxed their methods of assessing improvement."
"[T]he study was unblinded, so both participants and therapists knew the treatment being administered. Many participants were probably aware that the researchers themselves favored graded exercise therapy and another treatment, cognitive behavior therapy, which also involved increasing activity levels. Such information has been shown in other studies to lead to efforts to cooperate, which in this case could lead to lowered reporting of harms."
"... one of the most damaging cases of bad statistical practice that I have personally encountered in my years as a journalist"
"... an object lesson in how our systems can break down. In this case there were serious breakdowns statistically, scientifically, journalistically and in public health."
"Subjective measures of sick people before & after they are repeatedly told 'You're not sick' is a social psych study, not a clinical trial."
"In 5 years, the UK medical establishment's obdurateness on ME/CFS and PACE will be taught in medical schools as a cautionary tale."
"The PACE trial is a classic case of #badscience - researchers are determined to support their theory, even if the data do not."
Dr David Marks[edit | edit source]
Editor of the Journal of Health Psychology
"The many wrongs committed by psychiatry and medicine to the ME/CFS community can only be righted when the PACE trial is ultimately seen for what it is: a disgraceful confidence trick to reduce patient compensation payments and benefits."
"Gaslighting has been applied to the entire ME/CFS community by misapplication and misuse of the Biopsychosocial Model".
See also[edit | edit source]
Learn more[edit | edit source]
- 2016, The scandal of the £5m PACE trial for ME (video) - James Coyne
References[edit | edit source]
- Chowdhury, Sonya (August 29, 2018). "The PACE trial and behavioural treatments for M.E." Action for ME. Archived from the original on August 29, 2018.
- Butterworth, Trevor (March 21, 2016). "Editorial: On PACE". Sense About Statistics(American Statistical Association).
- Coyne, James (October 29, 2015). "Uninterpretable: Fatal flaws in PACE Chronic Fatigue Syndrome follow-up study". PLoS One Blog. Archived from the original on May 6, 2016.
- Coyne, James (November 16, 2015). "A skeptical look at the PACE chronic fatigue trial - video part 1". Edinburgh – via YouTube.
- Coyne, James (November 16, 2015). "A skeptical look at the PACE chronic fatigue trial - video part 2". Edinburgh.
- Coyne, James (November 16, 2015). "A skeptical look at the PACE chronic fatigue trial - video part 3". Edinburgh.
- Coyne, James (November 16, 2015). "A skeptical look at the PACE chronic fatigue trial - slide show". Edinburgh – via Slideshare.
- Coyne, James (November 16, 2015), "A skeptical look at the PACE chronic fatigue trial - complete transcript" (PDF), Mediafire, Edinburgh
- Coyne, James (November 16, 2015). "A skeptical look at the PACE chronic fatigue trial - summarised transcript" (PDF). Edinburgh.
- Coyne, James (November 16, 2015). "A skeptical look at the PACE chronic fatigue trial - transcript links". Phoenix Rising. Edinburgh.
- Coyne, James (November 16, 2015). "A skeptical look at the PACE chronic fatigue trial - audio recording". Edinburgh.
- Coyne, James (February 8, 2016). "The scandal of the £5m PACE trial for ME". YouTube.
- Coyne, James (February 8, 2016). "The scandal of the £5m PACE trial for ME - slide show".
- Coyne, James (November 25, 2015). "Was independent peer review of the PACE trial articles possible?". MindTheBrain Blog.
- Coyne, James; Laws, Keith (January 18, 2016). "(comment) Results of the PACE follow-up study are uninterpretable". The Lancet Psychiatry. 3 (2): e6–e7. doi:10.1016/S2215-0366(15)00551-9. ISSN 2215-0366.
- Tuller, David (October 21, 2015). "TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study - Part 1". Virology blog.
- Goldin, Rebecca (March 21, 2016), "PACE: The research that sparked a patient rebellion and challenged medicine", Sense About Statistics(American Statistical Association) (Review of Study Design)
- Goudsmit, Ellen (December 13, 2014), Response to article in the magazine published by the UK charity MCS-Aware
- Goudsmit, Ellen (February 19, 2016), The PACE trial. Are graded activity and cognitive-behavioural therapy really effective treatments for ME? (PDF)
- Jason, Leonard A (February 2017), "The PACE trial missteps on pacing and patient selection", Journal of Health Psychology, 22 (9): 1141–1145, doi:10.1177/1359105317695801
- Tuller, David; Racaniello, Vincent (July 10, 2016). "TWiV 397: Trial by Error". This Week In Virology (podcast) (video).
- Tuller, David (August 29, 2016). "Once Again, Lancet Stumbles on PACE". Virology blog.
- Anderssen, Alex (May 14, 2016). "Racianello: PACE Obfuscation will continue "until we are all dead"". The MEAction Network.
- Shepherd, Charles (January 18, 2016), "(correspondence) Patient reaction to the PACE trial", The Lancet Psychiatry
- "List of ME/CFS articles published at Virology Blog".
- Tuller, David (January 19, 2016). "Trial By Error, Continued: More Nonsense from The Lancet Psychiatry". Virology blog.
- Tuller, David (January 7, 2016). "Trial By Error, Continued: Did the PACE Trial Really Prove that Graded Exercise Is Safe?". Virology blog.
- #MEAction (August 8, 2016). "Rehmeyer makes statisticians' jaws drop over PACE". #MEAction.
- Michael VanElzakker [@MBVanElzakker] (August 17, 2016). "Subjective measures of sick people before & after they are repeatedly told 'You're not sick' is a social psych study, not a clinical trial" (Tweet) – via Twitter.
- Michael VanElzakker [@MBVanElzakker] (August 29, 2016). "In 5 years, the UK medical establishment's obdurateness on ME/CFS and PACE will be taught in medical schools as a cautionary tale" (Tweet) – via Twitter.
- Michael VanElzakker [@MBVanElzakker] (September 5, 2016). "The PACE trial is a classic case of bad science - researchers are determined to support their theory, even if the data do not" (Tweet) – via Twitter.
- David Marks [@david_f_marks] (July 31, 2017). "Gaslighting has been applied to the entire ME/CFS community by misapplication and misuse of the Biopsychosocial Model" (Tweet) – via Twitter.
Action for ME (AfME) - Action for ME is a British non-profit organization that was set up in 1987 as The M.E. Action Campaign. Its founders were Martin Lev, Sue Findlay and Clare Francis. In September 1993 it changed its name and logo to Action for ME and Chronic Fatigue. It then changed its name in 1993 to Action for ME.
Short Form 36-Item Health Survey (SF-36) - A 36-item patient-reported questionnaire, used to determine patient health status and quality of life.
genome an organism's complete set of DNA, including all of its genes
graded exercise therapy (GET) - A gradual increase in exercise or activity, according to a pre-defined plan. Focuses on overcoming the patient's alleged unhelpful illness beliefs that exertion can exacerbate symptoms, rather than on reversing physical deconditioning. Considered controversial, and possibly harmful, in the treatment or management of ME. One of the treatment arms of the controversial PACE trial.
subjective outcome An outcome of a clinical trial that depends on the judgement or opinion of the assessor or patient, e.g. asking if fatigue has increased or decreased "a little" or "a lot", patient questionnaires like the Chalder Fatigue Scale, and other patient-reported outcome measures (PROMs).