ME/CFS Skeptic
Senior Member (Voting Rights)
My brief comments on some of what is said in the article:
"The trial became the subject of controversy for several reasons. One is that it looked at ways of dealing with the symptoms of an illness rather than exploring a cure for a disease. Another is that it suggested there might be a psychological component to the manner in which sufferers experience the illness.”
When researchers publish clinical trials on other behavioral interventions for ME/CFS such as the envelope theory or pacing, there is little controversy. When papers describe the negative effects stigma and misunderstanding have on ME/CFS patients there are no claims that studying this psychological component is inappropriate. When the vice-president of the IACFS/ME Lily Chu, wrote an article about depression and suicide in ME/CFS and the lack of access to appropriate mental health care, she was lauded for raising the issue. Some of the most vocal critics of the PACE trial such as James Coyne, Leonard Jason, Ellen Goudsmit and Carolyn Wilshire have been academic psychologists. It seems rather unlikely that they criticize the trial for "suggested there might be a psychological component to the manner in which sufferers experience the illness.”"
"finally, question marks were raised over the trial’s methodology."
The article doesn’t mention that the authors deviated from their protocol in reporting the outcomes and results of the PACE trial. They failed to specify these changes in full and did not provide a sensitivity analysis to see how the changes affected the results. When this was pointed out, the PACE-authors refused to provide answers or information about the effect of these changes. PLOS One had to publish an expression of concern for one of the PACE-publications because the authors’ refused to share their data is as recommended by journal policy. Eventually part of PACE trial data became available, through a freedom of information request and first tier tribunal decision. A reanalysis according to the method specified in the published protocol, found that the PACE authors had inflated recovery and improvements rate threefold. There was no longer a significant difference between the intervention groups. An open letter signed by more than 100 prominent ME/CFS experts including researchers clinicians and MP's has called the Lancet to "commission an independent re-analysis of the individual-level trial data, with appropriate sensitivity analyses."
"David Tuller, a former HIV campaigner, who has become something of a hero to the ME/CFS community in the UK."
David Tuller is an experienced journalist and Senior Fellow in Public Health in Journalism at the Center of Global Public Health, School of Public Health, University of California, Berkeley, California. Tuller reported on the findings of the PACE-trial in 2011 in an article for the New York Times, titled “Psychotherapy Eases Chronic Fatigue Syndrome, Study Finds.” It’s only when confronted with critical comments that he began to delve deeper into the methodological issues and became a vocal critic of the PACE-trial.
"he was instrumental in persuading the respected science journal Cochrane Database of Systematic Reviews to withdraw a paper that looked at eight randomised controlled studies of exercise therapy for ME/CFS."
Cochrane received a formal complaint about its review on graded exercise therapy by Robert Courtney in 2018. An internal audit at Cochrane indicated Courtney’s criticism to be well-founded. Therefore Cochrane has insisted on a revised version of the review which is currently ongoing. A detailed analysis of the review was published by Vink & Vink-Niese in 2018 in Health Psychology Open, doi: 10.1177/2055102918805187.
"Sharpe says that the Cochrane editor “wilted badly… under direct pressure” from activists. The editor has since retired, and Sharpe understands that his decision is to be reversed."
This claim has proven to be unfounded. Regarding the decision to potentially withdraw the review, former Editor in Chief David Tovey publically stated, “this not about patient pressure.” An internal email exchange between Cochrane and the Norwegian Institute of Public Health (which houses two of the authors of the review) indicates that concerns about the Cochrane review were raised by multiple experts. “When a collection of experienced and dispassionate colleagues are all making, in effect, the same criticisms”, Tovey wrote in an email, “it is hard to ignore this.” https://wordpress.com/block-editor/post/mecfsskeptic.wordpress.com/16
"He maintains that there was nothing untoward or biased about the trial. “We got a fairly clear answer, but it wasn’t an answer that people wanted to hear.”
The main researchers of the PACE have designed, studied and promoted graded exercise therapy (GET) and cognitive behavioral therapy (CBT) in ME/CFS, before the start of the PACE trial. A document by the authors explaining the need for the PACE trial, wrote: “We ourselves completed three out of seven of the RCTs of CBT and GET. The therapies and measures to be used are essentially the same as used in these successful trials.” Michael Sharpe was the lead author of “the Oxford criteria” used to diagnose patients eligible for the trial. Another author, Trudie Chalder, was the lead author of one of the trial’s primary outcome measure tools – the Chalder Fatigue Scale. The hypothesis, as specified in the trial protocol, was that GET and CBT would outperform the medical care offered in the control groups. During the study, the PACE team published a newsletter for participants that included information about the new NICE guidelines recommending GET and CBT and glowing testimonials from earlier trial subjects about how much the “therapy” and “treatment” helped them.
"He believes ME/CFS activists are absolutely set against “any implication whatsoever that there could be any aspect to their illness which isn’t rooted in biological disease. Any little hint that it couldn’t be, becomes [the] equivalent of saying it’s not real, it’s imagined, you’ve made it up.”
I hope that ME/CFS advocates are entitled to a full reply to this accusation.
"The trial became the subject of controversy for several reasons. One is that it looked at ways of dealing with the symptoms of an illness rather than exploring a cure for a disease. Another is that it suggested there might be a psychological component to the manner in which sufferers experience the illness.”
When researchers publish clinical trials on other behavioral interventions for ME/CFS such as the envelope theory or pacing, there is little controversy. When papers describe the negative effects stigma and misunderstanding have on ME/CFS patients there are no claims that studying this psychological component is inappropriate. When the vice-president of the IACFS/ME Lily Chu, wrote an article about depression and suicide in ME/CFS and the lack of access to appropriate mental health care, she was lauded for raising the issue. Some of the most vocal critics of the PACE trial such as James Coyne, Leonard Jason, Ellen Goudsmit and Carolyn Wilshire have been academic psychologists. It seems rather unlikely that they criticize the trial for "suggested there might be a psychological component to the manner in which sufferers experience the illness.”"
"finally, question marks were raised over the trial’s methodology."
The article doesn’t mention that the authors deviated from their protocol in reporting the outcomes and results of the PACE trial. They failed to specify these changes in full and did not provide a sensitivity analysis to see how the changes affected the results. When this was pointed out, the PACE-authors refused to provide answers or information about the effect of these changes. PLOS One had to publish an expression of concern for one of the PACE-publications because the authors’ refused to share their data is as recommended by journal policy. Eventually part of PACE trial data became available, through a freedom of information request and first tier tribunal decision. A reanalysis according to the method specified in the published protocol, found that the PACE authors had inflated recovery and improvements rate threefold. There was no longer a significant difference between the intervention groups. An open letter signed by more than 100 prominent ME/CFS experts including researchers clinicians and MP's has called the Lancet to "commission an independent re-analysis of the individual-level trial data, with appropriate sensitivity analyses."
"David Tuller, a former HIV campaigner, who has become something of a hero to the ME/CFS community in the UK."
David Tuller is an experienced journalist and Senior Fellow in Public Health in Journalism at the Center of Global Public Health, School of Public Health, University of California, Berkeley, California. Tuller reported on the findings of the PACE-trial in 2011 in an article for the New York Times, titled “Psychotherapy Eases Chronic Fatigue Syndrome, Study Finds.” It’s only when confronted with critical comments that he began to delve deeper into the methodological issues and became a vocal critic of the PACE-trial.
"he was instrumental in persuading the respected science journal Cochrane Database of Systematic Reviews to withdraw a paper that looked at eight randomised controlled studies of exercise therapy for ME/CFS."
Cochrane received a formal complaint about its review on graded exercise therapy by Robert Courtney in 2018. An internal audit at Cochrane indicated Courtney’s criticism to be well-founded. Therefore Cochrane has insisted on a revised version of the review which is currently ongoing. A detailed analysis of the review was published by Vink & Vink-Niese in 2018 in Health Psychology Open, doi: 10.1177/2055102918805187.
"Sharpe says that the Cochrane editor “wilted badly… under direct pressure” from activists. The editor has since retired, and Sharpe understands that his decision is to be reversed."
This claim has proven to be unfounded. Regarding the decision to potentially withdraw the review, former Editor in Chief David Tovey publically stated, “this not about patient pressure.” An internal email exchange between Cochrane and the Norwegian Institute of Public Health (which houses two of the authors of the review) indicates that concerns about the Cochrane review were raised by multiple experts. “When a collection of experienced and dispassionate colleagues are all making, in effect, the same criticisms”, Tovey wrote in an email, “it is hard to ignore this.” https://wordpress.com/block-editor/post/mecfsskeptic.wordpress.com/16
"He maintains that there was nothing untoward or biased about the trial. “We got a fairly clear answer, but it wasn’t an answer that people wanted to hear.”
The main researchers of the PACE have designed, studied and promoted graded exercise therapy (GET) and cognitive behavioral therapy (CBT) in ME/CFS, before the start of the PACE trial. A document by the authors explaining the need for the PACE trial, wrote: “We ourselves completed three out of seven of the RCTs of CBT and GET. The therapies and measures to be used are essentially the same as used in these successful trials.” Michael Sharpe was the lead author of “the Oxford criteria” used to diagnose patients eligible for the trial. Another author, Trudie Chalder, was the lead author of one of the trial’s primary outcome measure tools – the Chalder Fatigue Scale. The hypothesis, as specified in the trial protocol, was that GET and CBT would outperform the medical care offered in the control groups. During the study, the PACE team published a newsletter for participants that included information about the new NICE guidelines recommending GET and CBT and glowing testimonials from earlier trial subjects about how much the “therapy” and “treatment” helped them.
"He believes ME/CFS activists are absolutely set against “any implication whatsoever that there could be any aspect to their illness which isn’t rooted in biological disease. Any little hint that it couldn’t be, becomes [the] equivalent of saying it’s not real, it’s imagined, you’ve made it up.”
I hope that ME/CFS advocates are entitled to a full reply to this accusation.
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