Editorial: On PACE
In 2011, amid many thoughtful avenues of research into a paralyzing syndrome that is as near to an off-switch on life as one can imagine, an $8 million dollar government-funded trial in the United Kingdom bulldozed a highway. The first results of PACE, the largest treatment trial ever conducted on ME/CFS— popularly, and unhelpfully, known as “Chronic Fatigue Syndrome”—announced a way out for, perhaps, a third of sufferers: As the British newspaper, The Independent, in a headline: “Got ME? Just get out and exercise, say scientists.”
This was not greeted as good news; indeed, to say sufferers were—to use a Britishism—gobsmacked was an understatement. The claim that ME/CFS could be ameliorated by graded exercise therapy (and cognitive behavior therapy) as the study suggested ran directly against many patients’ experience of the condition; moreover, the apparent success of these treatments in the trial suggested that the condition, or rather the prolonged experience of the condition, was mostly cognitive—‘in their heads,’ so to speak—rather than the result of any number of possible biological and organic infections or physical responses to the environment.
So what happens when the largest trial of its kind produces a result that overturns patient expectations and understandings? The institution of medicine trusts the trial; that’s the power of science, after all: the capacity of an appropriately designed study to disentangle perception from probability, cause from correlation, personal bias from objectivity. The PACE trial was “rigorously designed,” according to CNN, and it was published in one of the most prestigious medical journals, The Lancet, so its conclusions not only had the power to affect the way the condition was treated, they had the power to set the agenda for further research, potentially foreclosing other approaches.
As a result of PACE, the UK’s National Health Service, the Centers for Disease Control, the Mayo Clinic, and Kaiser all ended up recommending cognitive behavioral therapy and exercise for ME/CFS. There is now a PACE-like trial in children—MAGENTA. PACE has become the paradigm for understanding a condition affecting millions of people.
The PACE Trial and David Tuller’s investigation
raise other significant points:
- Study design is now one of the most pressing issues in scientific integrity. It is not just that the problems with PACE could have been—and should have been—seen beforehand; it is that poor study design appears to be a major factor behind the much larger reproducibility and replication crisis in science. This has implications for journalism too: Unless journalists start asking whether the studies they report on can actually answer the questions they claim to answer, science reporting will be little more than free PR. It’s also important to point out that PACE was government funded, and that it’s time to ditch the idea that independently funded research is intrinsically more reliable than industry funded research; all research needs to answer the design question.
- Patients need to be much more closely involved in the research process. You would think, following the transformational role played by patient groups in changing the way HIV/AIDS trials were designed, that patients would be seen as partners in research: they have, after all, an inside knowledge of their own suffering—histories that can be richly mined by researchers who are not lifetime experts in the disease. Patients come to research with a fundamentally different perspective to scientists; as Julie Rehmeyer puts it, their question is, “How does this new research fit or fail to fit with my experience?” Reaction to PACE from patients was that it did not—and that kind of reaction should not have been summarily dismissed.
- Scientific journals should be more interested in engaging in ideas and less reflexively defensive of the ones they publish. We can understand the Lancet editors’ loyalty to the researchers who publish with them, but openness to criticism in science cannot be construed as betrayal, even when the stakes are high.
- We can only imagine the challenges Tuller would have faced getting his mammoth investigation published in a conventional media outlet, so it’s important to point out that a long form, multi-part story on an academic blog (Virology) can change the world; and that is, in a word, awesome.
David Tuller, a journalist who had earned a doctorate in public health, and who ran the University of California Berkeley’s joint program in public health and journalism, believed the sufferers were onto something when they said there was something badly wrong with the way the trial was designed and conducted.
And the thing about patients who either suffer from a rare disease, or a more common and inexplicable one as with ME/CFS, is that they are usually a formidable resource—a network of distributed experts who have sifted and weighed the scientific research with the kind of avidity you would expect, given that their lives depended on it. In pharmacology, rare disease patient groups are highly respected and are seen as partners in research rather than just subjects and consumers of studies.
Tuller dug in the weeds and published his results in a four-part series on the blog Virology. The gravity of his investigation may be gauged by one of the experts he quotes, Ronald Davis, Ph.D., Professor of Biochemistry and Genetics at Stanford University: “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.”
Because we believe that study design is a critical issue in science, and because statistics is central to understanding study design, we felt it was important to look at PACE from this perspective.
But we were also spurred by science writer Julie Rehmeyer, who wrote a powerful essay for our series “Epistemically Challenged” (over at Sense About Science USA) about her own experience of ME/CFS, and how it changed her view of science. As Rehmeyer is the most recent recipient of the American Statistical Association’s Excellence in Statistical Reporting Award (an honor we think Joseph Pulitzer would have considered equal to his eponymous prizes given his love of statistics), we took her criticism of PACE as another important alarm.
The conclusion of Rebecca Goldin’s 7,000-word analysis on PACE’s design is this: “The best we can glean from PACE,” concludes Goldin, “is that study design is essential to good science, the flaws in this design were enough to doom its results from the start.”
The reaction to patient criticism and Tuller’s story by the PACE researchers and the Lancet has been to deflect rather than to dissect; and the story has become one of questionable demands for patient level data and social media provocations and threats.
While these are not trivial issues, they are something of a distraction from the fundamental one, which is that 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.
But there is one more important thing to say. Sometimes, justice is blind to those who serve its cause. Perhaps the service is not so easily rendered in the kind of heroic narrative that tempts Hollywood—the easy clarity of right triumphing over wrong. It takes digging in the weeds to understand who did what and why that was important—and we prize effortlessness, especially the effortless kind. David Tuller may not get a Pulitzer Prize for investigating PACE trial on a blog; but his service to—and we do not exaggerate—millions of sufferers around the world make it hard for us to think of another work of journalism so deserving of commendation.
— To read Rebecca Goldin’s 7,000-word analysis on PACE’s design, click on this link.
I’m an advocate for integrity in health marketing. I’m study the insult to injury of ME/CFS sufferers for a related matter of conflicts of interest in gov’t and “nonprofit medical associations/journals” causing false policy and poor treatment of the environmentally disabled.
The below paper came to my attention yesterday. It took me all of about 10 minutes to see that the powers that be are promoting that what they are doing is “evidence-based” founded upon “assumption”.
HOW CAN A MEDICAL ASSOCIATION PAPER THAT IS FOUNDED UPON “ASSUMPTION” “HELP CLINICIANS PRESCRIBE EVIDENCE-BASED” anything?
Direct quotes from “Prescribing exercise interventions for patients with chronic conditions” Canadian Medical Association Journal, March 2016 (early release subject to revision) are: “Based on the assumption that chronic fatigue syndrome is maintained by physiological changes of deconditioning and activity avoidance – which can be reversed” and “To help clinicians prescribe evidence-based exercise interventions”
One can read “Prescribing exercise…” here: http://www.cmaj.ca/content/early/2016/03/14/cmaj.150684
On page 2 it states, “To help clinicians prescribe evidence-based exercise interventions, we provide practical details for some conditions in Boxes 2–4 (low-back pain, COPD, diabetes) and Appendices 3–6 (osteoarthritis,falls prevention, chronic fatigue syndrome, heart disease; available at http://www.cmaj.ca/lookup/suppl/doi/10.1503/cmaj.150684/-/DC1).9–19
Reference 18 in support of the above is: “White PD, Goldsmith KA, Johnson AL, 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; 377:823-36.”
Appendix 5 in the link above is: “Appendix 5 (as supplied by the authors): Exercise for people with Chronic Fatigue Syndrome” It states, “Rationale for exercise: To reverse the physical deconditioning, exercise intolerance and avoidance that has been caused by inactivity and to gradually re-engage the person in physical activity. Based on the assumption that chronic fatigue syndrome is maintained by physiological changes of deconditioning and activity avoidance – which can be reversed.”
See link above. Reference for Appendix 5 is the same as the paper’s reference 18: “White PD, Goldsmith KA, Johnson AL, 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;377:823–36.”
A.) HOW CAN A MEDICAL ASSOCIATION PAPER BASED ON AN ASSUMPTION “HELP CLINICIANS PRESCRIBE EVIDENCE-BASED” anything?
B.). Why are the authors only able to cite one reference, PACE, in support of their assumptive-Evidence-Based physician education?
C.). Have you read about Evidence Based Medicine being hijacked? 3/16/2016 Retraction Watch: “Evidence-based medicine has been hijacked: A confession from John Ioannidis.” To quote:
“John Ioannidis is perhaps best known for a 2005 paper ‘Why Most Published Research Findings Are False.’ One of the most highly cited researchers in the world, Ioannidis, a professor at Stanford, has built a career in the field of meta-research. Earlier this month, he published a heartfelt and provocative essay in the the Journal of Clinical Epidemiology titled ‘Evidence-Based Medicine Has Been Hijacked: A Report to David Sackett.’ In it, he carries on a conversation begun in 2004 with Sackett, who died last May and was widely considered the father of evidence-based medicine. We asked Ioannidis to expand on his comments in the essay, including why he believes he is a ‘failure.’
Retraction Watch: You write that as evidence-based medicine ‘became more influential, it was also hijacked to serve agendas different from what it originally aimed for.’ Can you elaborate?
John Ioannidis: As I describe in the paper, ‘evidence-based medicine’ has become a very common term that is misused and abused by eminence-based experts and conflicted stakeholders who want to support their views and their products, without caring much about the integrity, transparency, and unbiasedness of science.”
Read the entire article at Retraction Watch: http://retractionwatch.com/2016/03/16/evidence-based-medicine-has-been-hijacked-a-confession-from-john-ioannidis/
D.). The “nonprofit” medical association CMA’s journal, CMAJ, which just published this assumptive-Evidenced-Based physician education, had a complete changing of the guard in late Feb 2016. From the tone of their announcement it does not appear to me to have been amicable transition. http://www.cmaj.ca/content/early/2016/03/02/cmaj.160283
E.). It’s dangerous, illogical, and I believe highly unethical to mass-market a self-acknowledged and unproven “assumption” as being a solid foundation for Evidence Based physician education.
F.) In some circles of research, medicine and policy-setting; Evidence-Based Medicine is jokingly referred to as “Iffy-Based Medicine”. For ME/CFS sufferers and others who are experiencing debilitating environmental illnesses and are being mistreated by miseducated doctors b/c of Evidence-Based-Medicine being hijacked — it’s not such a funny joke, eh?
I would like to draw attention to another important wrong assumption that has been made in the PACE study: that is, the assumption of a non-biological basis for ME/CFS (inherent within the supposition that recovery is simply a phenomenological one), is incorrect. The authors are aware of this but they knew they had to pay no attention to other science in order to pull off their deception.
IF the definition of recovery is stripped of and seperated from a large body of existing scientific data that demonstrates pathophysiological events do ‘coexist with’ (and may even be causative in this context) the unique symptom phenomenology of ME/CFS, how can the study truly be meaningful?
The question of what is knowledge is, is a very old one, that has many underpinnings in Greek Philosophy.
For example, the problem inherent between truth and the search for truth was put to us by Plato when he made Meno ask:
Why, on what lines, will you look, Socrates, for a thing of whose nature you know nothing at all? Pray, what sort of thing, amongst those that you know not, will you treat us to as the object of your search? Or even supposing, at the best, that you hit upon it, how will you know it is the thing you did not know?
This is the crux of the false claims made by the PACE Study. The PACE Study assumes its definition of recovery to be correct. It can only do so if and ONLY if it ignores other scientific information about the nature of ME/CFS. Had the PACE Study taken a more ‘truthful” approach, then, phenomenological recovery alone, as defined by this study, would clearly and evidently have been recognised as inadequate from the outset and £5 million could have been put to better use elsewhere.
I’m an advocate for integrity in health marketing. I’m study the insult to injury of ME/CFS sufferers for a related matter of conflicts of interest in gov’t and “nonprofit medical associations/journals” causing false policy and poor treatment of the environmentally disabled.
The below paper came to my attention yesterday. It took me all of about 10 minutes to see that the powers that be are promoting that what they are doing is “evidence-based” founded upon “assumption”.
HOW CAN A MEDICAL ASSOCIATION PAPER THAT IS FOUNDED UPON “ASSUMPTION” “HELP CLINICIANS PRESCRIBE EVIDENCE-BASED” anything?
Direct quotes from “Prescribing exercise interventions for patients with chronic conditions” Canadian Medical Association Journal, March 2016 (early release subject to revision) are: “Based on the assumption that chronic fatigue syndrome is maintained by physiological changes of deconditioning and activity avoidance – which can be reversed” and “To help clinicians prescribe evidence-based exercise interventions”
One can read “Prescribing exercise…” here: http://www.cmaj.ca/content/early/2016/03/14/cmaj.150684
On page 2 it states, “To help clinicians prescribe evidence-based exercise interventions, we provide practical details for some conditions in Boxes 2–4 (low-back pain, COPD, diabetes) and Appendices 3–6 (osteoarthritis,falls prevention, chronic fatigue syndrome, heart disease; available at http://www.cmaj.ca/lookup/suppl/doi/10.1503/cmaj.150684/-/DC1).9–19
Reference 18 in support of the above is: “White PD, Goldsmith KA, Johnson AL, 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; 377:823-36.”
Appendix 5 in the link above is: “Appendix 5 (as supplied by the authors): Exercise for people with Chronic Fatigue Syndrome” It states, “Rationale for exercise: To reverse the physical deconditioning, exercise intolerance and avoidance that has been caused by inactivity and to gradually re-engage the person in physical activity. Based on the assumption that chronic fatigue syndrome is maintained by physiological changes of deconditioning and activity avoidance – which can be reversed.”
See link above. Reference for Appendix 5 is the same as the paper’s reference 18: “White PD, Goldsmith KA, Johnson AL, 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;377:823–36.”
A.) HOW CAN A MEDICAL ASSOCIATION PAPER BASED ON AN ASSUMPTION “HELP CLINICIANS PRESCRIBE EVIDENCE-BASED” anything?
B.). Why are the authors only able to cite one reference, PACE, in support of their assumptive-Evidence-Based physician education?
C.). Have you read about Evidence Based Medicine being hijacked? 3/16/2016 Retraction Watch: “Evidence-based medicine has been hijacked: A confession from John Ioannidis.” To quote:
“John Ioannidis is perhaps best known for a 2005 paper ‘Why Most Published Research Findings Are False.’ One of the most highly cited researchers in the world, Ioannidis, a professor at Stanford, has built a career in the field of meta-research. Earlier this month, he published a heartfelt and provocative essay in the the Journal of Clinical Epidemiology titled ‘Evidence-Based Medicine Has Been Hijacked: A Report to David Sackett.’ In it, he carries on a conversation begun in 2004 with Sackett, who died last May and was widely considered the father of evidence-based medicine. We asked Ioannidis to expand on his comments in the essay, including why he believes he is a ‘failure.’
Retraction Watch: You write that as evidence-based medicine ‘became more influential, it was also hijacked to serve agendas different from what it originally aimed for.’ Can you elaborate?
John Ioannidis: As I describe in the paper, ‘evidence-based medicine’ has become a very common term that is misused and abused by eminence-based experts and conflicted stakeholders who want to support their views and their products, without caring much about the integrity, transparency, and unbiasedness of science.”
Read the entire article at Retraction Watch: http://retractionwatch.com/2016/03/16/evidence-based-medicine-has-been-hijacked-a-confession-from-john-ioannidis/
D.). The “nonprofit” medical association CMA’s journal, CMAJ, which just published this assumptive-Evidenced-Based physician education, had a complete changing of the guard in late Feb 2016. From the tone of their announcement it does not appear to me to have been amicable transition. http://www.cmaj.ca/content/early/2016/03/02/cmaj.160283
E.). It’s dangerous, illogical, and I believe highly unethical to mass-market a self-acknowledged and unproven “assumption” as being a solid foundation for Evidence Based physician education.
F.) In some circles of research, medicine and policy-setting; Evidence-Based Medicine is jokingly referred to as “Iffy-Based Medicine”. For ME/CFS sufferers and others who are experiencing debilitating environmental illnesses and are being mistreated by miseducated doctors b/c of Evidence-Based-Medicine being hijacked — it’s not such a funny joke, eh?
I would like to draw attention to another important wrong assumption that has been made in the PACE study: that is, the assumption of a non-biological basis for ME/CFS (inherent within the supposition that recovery is simply a phenomenological one), is incorrect. The authors are aware of this but they knew they had to pay no attention to other science in order to pull off their deception.
IF the definition of recovery is stripped of and seperated from a large body of existing scientific data that demonstrates pathophysiological events do ‘coexist with’ (and may even be causative in this context) the unique symptom phenomenology of ME/CFS, how can the study truly be meaningful?
The question of what is knowledge is, is a very old one, that has many underpinnings in Greek Philosophy.
For example, the problem inherent between truth and the search for truth was put to us by Plato when he made Meno ask:
Why, on what lines, will you look, Socrates, for a thing of whose nature you know nothing at all? Pray, what sort of thing, amongst those that you know not, will you treat us to as the object of your search? Or even supposing, at the best, that you hit upon it, how will you know it is the thing you did not know?
This is the crux of the false claims made by the PACE Study. The PACE Study assumes its definition of recovery to be correct. It can only do so if and ONLY if it ignores other scientific information about the nature of ME/CFS. Had the PACE Study taken a more ‘truthful” approach, then, phenomenological recovery alone, as defined by this study, would clearly and evidently have been recognised as inadequate from the outset and £5 million could have been put to better use elsewhere.
Many thanks from one of those millions of ME/CFS sufferers from around the world whose life has been put on hold for decades. Well said.
Many thanks from one of those millions of ME/CFS sufferers from around the world whose life has been put on hold for decades. Well said.
Excellent article Trevor.
Excellent article Trevor.
Thank you for your thorough and careful comments on this issue. To me, before a scientific idea can even reach the stage of being funded for research, surely, as Julie Rehmeyer suggests, the big question is whether this idea matches reality. The two ideas proposed by PACE were that those of us with ME/CFS are “held in limbo” as it were by a combination of fear and deconditioning. Now many people who fall ill will experience some form of fear or apprehension while returning to normal, whether it is wondering if a broken hip is strong enough to resume full weight, or, after a severe case of food poisoning, wondering whether it is safe to eat a similar meal again. Again, everyone who has been ill for a while, will become a little deconditioned. But here the suggestion is that the fear and the deconditioning are so extreme that patients become virtually housebound, or even bedbound for years. How on earth does that apply to the thousands that struggle on at work, full or part-time for months, often years, until they have to give up? Have these two ideas ever actually been tested? Surely if fear were such a big issue, it would be demonstrable in patients with ME when they subsequently break a hip or develop some other medical condition? If we were simply deconditioned, then studies of people who were very deconditioned should show similar biomedical abnormalities that have been noted in other trials of people with ME. (Sadly most biomedical studies have had to be funded through the ME charities, and so are small.)
Thank you, Trevor.
You write, “The reaction to patient criticism and Tuller’s story by the PACE researchers and the Lancet has been to deflect rather than to dissect”.
It’s horrifying to patients to see how both The Lancet and the PACE authors have got away with ignoring well-founded criticism. Something is badly wrong in the structures of medicine and science, to allow such a poor study to be funded in the first place and to have its results so successfully misrepresented by its authors in the second. They’ve even claimed that the null long-term follow-up data favour their therapies, and managed to get that claim published in Lancet Psychiatry.
Thank you for bringing this to people’s attention. The question is, how to prevent another PACE? Once a £5 million study has been done, there are surely some pretty big vested interests in having it be presented as a success. Science needs structures that are capable of withstanding those pressures, and it clearly doesn’t have them now.
What we are aiming to do with STATS and the AllTrials campaign (both are run by Sense About Science USA) is to raise awareness of the importance of study design, data analysis and clinical trial transparency in science and medicine. There needs to be a change in the culture of academic research in the sciences on these issues, and also, critically, a recognition of patients as partners in research. This is not something that can happen overnight. There are many vested interests in doing the same thing over and over again. But we do see change. This week the American Medical Association endorsed the AllTrials campaign; we did our first stats workshop at a news organization and the reaction was great; and we’ve been overwhelmed by the response to publishing what is a super wonky investigation. All this will add up over time. But from the perspective of the ME/CFS community, PACE strikes me as something of an “Act Up” moment.
Best
Trevor
Thanks for your reply, Trevor. PACE seems to me a very appropriate poster-child for all that’s currently wrong in the oversight of trials as all stages – funding, reporting, and post-publication critique.
There’s only so much that patients can do within the current framework. PACE is a demonstration of how weak patients are compared to scientists, even when patients’ science is demonstrably better than the professional scientists whom they’ve been critiquing. It’s only since David Tuller (a professional scientist) got on board that other scientists have joined in and it’s there involvement that has got the attention.
This is incredibly frustrating. I think we’ll know we’ve turned the corner when UK organisations start reporting this, as well as UK ones (and I speak as a Brit).
Thank you, Trevor.
You write, “The reaction to patient criticism and Tuller’s story by the PACE researchers and the Lancet has been to deflect rather than to dissect”.
It’s horrifying to patients to see how both The Lancet and the PACE authors have got away with ignoring well-founded criticism. Something is badly wrong in the structures of medicine and science, to allow such a poor study to be funded in the first place and to have its results so successfully misrepresented by its authors in the second. They’ve even claimed that the null long-term follow-up data favour their therapies, and managed to get that claim published in Lancet Psychiatry.
Thank you for bringing this to people’s attention. The question is, how to prevent another PACE? Once a £5 million study has been done, there are surely some pretty big vested interests in having it be presented as a success. Science needs structures that are capable of withstanding those pressures, and it clearly doesn’t have them now.
What we are aiming to do with STATS and the AllTrials campaign (both are run by Sense About Science USA) is to raise awareness of the importance of study design, data analysis and clinical trial transparency in science and medicine. There needs to be a change in the culture of academic research in the sciences on these issues, and also, critically, a recognition of patients as partners in research. This is not something that can happen overnight. There are many vested interests in doing the same thing over and over again. But we do see change. This week the American Medical Association endorsed the AllTrials campaign; we did our first stats workshop at a news organization and the reaction was great; and we’ve been overwhelmed by the response to publishing what is a super wonky investigation. All this will add up over time. But from the perspective of the ME/CFS community, PACE strikes me as something of an “Act Up” moment.
Best
Trevor
Thanks for your reply, Trevor. PACE seems to me a very appropriate poster-child for all that’s currently wrong in the oversight of trials as all stages – funding, reporting, and post-publication critique.
There’s only so much that patients can do within the current framework. PACE is a demonstration of how weak patients are compared to scientists, even when patients’ science is demonstrably better than the professional scientists whom they’ve been critiquing. It’s only since David Tuller (a professional scientist) got on board that other scientists have joined in and it’s there involvement that has got the attention.
This is incredibly frustrating. I think we’ll know we’ve turned the corner when UK organisations start reporting this, as well as UK ones (and I speak as a Brit).
Excellent. Thank you so much.
Excellent. Thank you so much.
Thank you- the PACE authors claims are not substantiated by their reported data, let alone by the “hidden dat”. Queen Msry of London Umiversity’s refusal to allow the non-identified raw data, of this publicly funded trial to be released, flies in the face of science. As does their lack of response to the serious scientific errors in the trial.
The UK certainly is out of step with the world!
Thank you- the PACE authors claims are not substantiated by their reported data, let alone by the “hidden dat”. Queen Msry of London Umiversity’s refusal to allow the non-identified raw data, of this publicly funded trial to be released, flies in the face of science. As does their lack of response to the serious scientific errors in the trial.
The UK certainly is out of step with the world!
It is a chilling fact, recently communicated to myself by current Canadian Minister of Health Hon. J. Philpott in response to a ministerial inquiry, that the Canadian Institutes of Health Research (ie, the Canadian Ministry of Health) co-funded Cochrane Reviews of this junk science, by the junk scientists themselves, as recently as 2015. This was, of course, during the tenure of the previous (Harper) government, which acted broadly on a very evident antipathy towards science in general, and in particular scientific work that supported anything other than their antediluvian belief systems.
The Minister did not offer an explanation or an apology for this action by the CIHR. This should be understood to be a serious concern for the ME community.
It is unsurprising, therefore, to discover that the Canadian Medical Association is prepared to further propagate the PACE campaign to dismiss, demean, and endanger patients with ME. Clearly the rot has seeped both wide and deep, and it will require stern action to overcome this corruption of both science and practice, worldwide.
The ME community has “played nice” for far too long, whilst being actively colluded against, and harmed physically, socially , and psychologically, by practitioners and “researchers” whose motives reach well beyond the simply unethical.
It is a chilling fact, recently communicated to myself by current Canadian Minister of Health Hon. J. Philpott in response to a ministerial inquiry, that the Canadian Institutes of Health Research (ie, the Canadian Ministry of Health) co-funded Cochrane Reviews of this junk science, by the junk scientists themselves, as recently as 2015. This was, of course, during the tenure of the previous (Harper) government, which acted broadly on a very evident antipathy towards science in general, and in particular scientific work that supported anything other than their antediluvian belief systems.
The Minister did not offer an explanation or an apology for this action by the CIHR. This should be understood to be a serious concern for the ME community.
It is unsurprising, therefore, to discover that the Canadian Medical Association is prepared to further propagate the PACE campaign to dismiss, demean, and endanger patients with ME. Clearly the rot has seeped both wide and deep, and it will require stern action to overcome this corruption of both science and practice, worldwide.
The ME community has “played nice” for far too long, whilst being actively colluded against, and harmed physically, socially , and psychologically, by practitioners and “researchers” whose motives reach well beyond the simply unethical.
I once attended a top level meeting at our local hospital, which refuses to treat ME,at which I was told the “Oxford Criteria”, upon which the PACE Trial is based, are the “Gold Standard”.
My wife has Very Severe ME, I have been fighting for way over two decades, for medical support and treatment for her but have been hampered at every turn, by the influence of the PACE Trial.
Even before the trial was published, the medical profession was extraordinarily willing to be duped by psychiatric propaganda, based on nothing more than personal opinion, that people with ME were victims of “malpractice thinking” and “deconditioning”, to be “cured” by CBT and GET and, cruelly, offered no more than basic medical screening.
Last year I was a finalist for the BJN Nurse of the Year Award. Most of my career has been spent caring full time for my wife, whose agony and experience defies description; it is so extreme, outside most people’s comprehension.
I have documented our journey here :
www.http://stonebird.co.uk
You could not imagine, in your worse nightmare, that such depths of illness would go univestigated, untreated, unresearched; there is no medical speciality, whatsoever in Severe ME.
Meantime my wife, left, all these years, to “get on with it”, has had to witness an all powerful psychiatric lobby go from strength to strength, exerting more and more influence.
Talk about David and Goliath, it has felt that everyone,the media, the medical profession, the Government, the NHS, has been against us – on the basis, not of science, but psychiatric spin and deceipt.
Incredibly, thanks to the many who, against all the odds, have never given up, the psychiatrist’s long reign, that house of cards, built without substance, as the PACE Trial shows, looks like it is about to collapse.
We have been deeply moved by all the comments from those living with and caring for those with ME/CFS; we hope that our very small effort to shed some light on this issue will be part of a much brighter path for all of you.
Thank you Trevor Butterworth and Rebecca Goldin and everyone at Stats for listening and responding to the comments.
All estimated 250,000 UK sufferers, 1 million US sufferers and 17 million worldwide thank you and Sense about Science USA and Stats for investigating this huge scandal of the PACE trial which has caused harm and prevented proper research and treatments being developed.
The ME community will be forever indebted for your bravery in standing up for science, statistics and some of the most severely disabled and vulnerable patient groups in exposing this matter.
P.S. I hope that you and your organisations will not also be smeared by the PACE investigators as “vexatious”, “militants”, “extremists” or against psychiatry as patients who have challenged bad science have been for the last two decades!!
Thank you!
I once attended a top level meeting at our local hospital, which refuses to treat ME,at which I was told the “Oxford Criteria”, upon which the PACE Trial is based, are the “Gold Standard”.
My wife has Very Severe ME, I have been fighting for way over two decades, for medical support and treatment for her but have been hampered at every turn, by the influence of the PACE Trial.
Even before the trial was published, the medical profession was extraordinarily willing to be duped by psychiatric propaganda, based on nothing more than personal opinion, that people with ME were victims of “malpractice thinking” and “deconditioning”, to be “cured” by CBT and GET and, cruelly, offered no more than basic medical screening.
Last year I was a finalist for the BJN Nurse of the Year Award. Most of my career has been spent caring full time for my wife, whose agony and experience defies description; it is so extreme, outside most people’s comprehension.
I have documented our journey here :
www.http://stonebird.co.uk
You could not imagine, in your worse nightmare, that such depths of illness would go univestigated, untreated, unresearched; there is no medical speciality, whatsoever in Severe ME.
Meantime my wife, left, all these years, to “get on with it”, has had to witness an all powerful psychiatric lobby go from strength to strength, exerting more and more influence.
Talk about David and Goliath, it has felt that everyone,the media, the medical profession, the Government, the NHS, has been against us – on the basis, not of science, but psychiatric spin and deceipt.
Incredibly, thanks to the many who, against all the odds, have never given up, the psychiatrist’s long reign, that house of cards, built without substance, as the PACE Trial shows, looks like it is about to collapse.
We have been deeply moved by all the comments from those living with and caring for those with ME/CFS; we hope that our very small effort to shed some light on this issue will be part of a much brighter path for all of you.
Thank you for your essay and your interest in this controversial topic.
If one believes that all of the many PACE investigators are grossly incompetent, then yes, one can assert that the study suffers from exceptionally poor design, execution, conclusions not supported by data, and inaccurate reporting of results, and that the researchers need remedial training in how to do research, or they should be encouraged to “retire”.
But if one believes that the researchers must have *some* competence, because, you know, they had enough competence to squeeze five million pounds from the funding agencies, then it is very difficult to avoid the conclusion that the study does *not* suffer from poor design, but is actually a deliberate fraud.
I sure hope Dr Tuller and associates are digging into just exactly how competent the PACE People really are.
Thank you for your essay and your interest in this controversial topic.
If one believes that all of the many PACE investigators are grossly incompetent, then yes, one can assert that the study suffers from exceptionally poor design, execution, conclusions not supported by data, and inaccurate reporting of results, and that the researchers need remedial training in how to do research, or they should be encouraged to “retire”.
But if one believes that the researchers must have *some* competence, because, you know, they had enough competence to squeeze five million pounds from the funding agencies, then it is very difficult to avoid the conclusion that the study does *not* suffer from poor design, but is actually a deliberate fraud.
I sure hope Dr Tuller and associates are digging into just exactly how competent the PACE People really are.
You cannot imagine the relief at finding these important scientific voices standing up for a much maligned, ignored and misrepresented patient population. This bad science has caused huge damage to the many, many patients struggling to cope, with erroneous conclusions leading to the trivialisation and stigma of an incredibly serious disease.
This illness has taken my teaching job, my health, my friends, my dreams. It has put immeasurable strain on my marriage, on my children, on my parents and my friendships. My life is now mostly bounded by the four walls of my bedroom – I count myself lucky I can still watch TV and read. I cannot always wash myself, dress myself or feed myself.
The pervasive myth that ME is a psychological illness led a neurologist to tell me he didn’t “believe” in my illness, and a psychiatrist to tell me that he was sure I was getting a “secondary gain” from being ill, that I simply liked the attention. I count myself exceedingly lucky that I have a good GP and a good pain specialist who both seem to understand the effect and the limitations this illness puts on me, but even with their support my condition is slowly worsening. Who would choose this life if there was a choice to be made?
It’s amazing isn’t it? What f*cking attention when you can’t even get a doctor to treat you and the rest of the world ignores, misunderstands or ridicules you?!!
Thank you so much for taking up the gauntlet on behalf of millions of patients worldwide who have been mistreated, abused and neglected by a medical system that was built on the false illness beliefs of a powerful psychiatric lobby with their own self interests. I’m watching my once vibrant, funny, sociable, bright young lad of 16 years slowly disintegrating over the last four years before my very eyes. Unable to leave his dark room, he is completely isolated, in excruciating pain, constantly nauseous and, in his words ‘every bit of him is broke and beyond repair’. The only ‘treatment’ he was ever offered was Prozac, from a psychiatrist, which he refused. Even at 13 years of age he was able to figure out that Prozac wasn’t going to do much about the fact that his bowels had completely shut down for over a year at that stage…. Anyway, I just wanted to stop by and thank you for your attention to this travesty. Each of us in our own way is trying to combat the deliberate misleading information that the psych lobby regularly put out through their controlled, biased media channels but it is an exhausting battle. When someone like yourself comes along and counteracts their propoganda so thoroughly, it is like a breath of fresh air that gives us the will to keep on keeping on…. Thank you again
Thank you so much for taking up the gauntlet on behalf of millions of patients worldwide who have been mistreated, abused and neglected by a medical system that was built on the false illness beliefs of a powerful psychiatric lobby with their own self interests. I’m watching my once vibrant, funny, sociable, bright young lad of 16 years slowly disintegrating over the last four years before my very eyes. Unable to leave his dark room, he is completely isolated, in excruciating pain, constantly nauseous and, in his words ‘every bit of him is broke and beyond repair’. The only ‘treatment’ he was ever offered was Prozac, from a psychiatrist, which he refused. Even at 13 years of age he was able to figure out that Prozac wasn’t going to do much about the fact that his bowels had completely shut down for over a year at that stage…. Anyway, I just wanted to stop by and thank you for your attention to this travesty. Each of us in our own way is trying to combat the deliberate misleading information that the psych lobby regularly put out through their controlled, biased media channels but it is an exhausting battle. When someone like yourself comes along and counteracts their propoganda so thoroughly, it is like a breath of fresh air that gives us the will to keep on keeping on…. Thank you again
It’s amazing isn’t it? What f*cking attention when you can’t even get a doctor to treat you and the rest of the world ignores, misunderstands or ridicules you?!!
The editorial is flawed from the start. It exudes attitudes foreign to scientific inquiry. Early on we get “… ME/CFS— popularly, and unhelpfully, known as “Chronic Fatigue Syndrome”. This heralds what is coming. Let us recollect that ME stands for Myalgic Encephalitis or some such. Encephalitis is a tangible pathology yet to be demonstrated in this context. Chronic Fatigue is in contrast a regular dominant disabling symptom reported and is a reasonable surrogate title. The author’s flip remark demonstrates an unhelpful mindset.
PACE may well be an unreliable source of knowledge and unworthy of further attention. I have not the time to investigate and in any case, like most of the commentators, I have not the expertise to judge. What we should however note seriously is that however flawed it may have been it was an honest attempt to find help for suffering individuals by the most reliable method available, the method of scientific inquiry. The alternative, seemingly valued by the author, is worse. To determine an agenda, to establish constraints to inquiry by attending largely to the views, as opposed to the experiences, of sufferers is the method of folk medicine, used faux de mieux for millennia with little to show for it. We owe the sufferers our best endeavour which is based on humane concern for their suffering without necessarily adopting their quite natural perceptions as to what may be the mechanism. Mistaken endeavour will hurt the sufferers most.
Spare a thought as well in this takedown for any of the PACE subjects who actually did derive benefit from the study.
“however flawed it may have been it was an honest attempt to find help for suffering individuals by the most reliable method available, the method of scientific inquiry.”
That’s the problem. It was NOT an honest attempt. Most people not immersed in the ME/CFS field will not understand the twists and turns behind the whole story but suffice it to say the PACE trial clearly violated good practice in medical research. For example,
1) The researchers changed the outcomes mid-trial without a good explanation; we know they did because they published the scientific protocol beforehand. If patients had not brought up the changes, no one would have noticed.
2) Subjects in the study were told by therapists that two particular treatments (exercise/ therapy) were good/ safe for them ahead of the end of the trial. If we are to test an intervention in a “blinded” manner, subjects should not be unduly influenced before then.
3) Conflicts of interest were not clearly disclosed. Some of the authors had consulted for disability insurance companies that had an financial incentive to cut off claims of patients who were disabled by the disease. If it could be shown that patients could improve with exercise or cognitive therapy, then patients’ cases could be weaken with the claim that patients were “choosing” to malinger and not get well.
The issue isn’t whether SOME patients benefit from the treatment. For those who do, it’s not as though anyone is preventing them from seeking such care and receiving it. Rather it’s about protecting those who did not improve or even would deteriorate under such treatment. About 50% of patients who have undergone exercise programs cite such programs as worsening their health. When some patients have deferred treatments, their doctor have labelled them as “noncompliant” or refuse to help them with other issues. At the extreme end, parents have been prosecuted in court for child abuse/ neglect and had their children taken away from them when they refused exercise/ cognitive therapies on their child’s behalf.
I write all of this not only as a patient but as a physician and medical researcher. So I understand that research can come out wrong even with the best intentions. But some of the things the PACE authors did, in my own field, if I did those things, I would not be publishable and in addition lose the respect and esteem of my peers.
“however flawed it may have been it was an honest attempt to find help for suffering individuals by the most reliable method available, the method of scientific inquiry.”
That’s the problem. It was NOT an honest attempt. Most people not immersed in the ME/CFS field will not understand the twists and turns behind the whole story but suffice it to say the PACE trial clearly violated good practice in medical research. For example,
1) The researchers changed the outcomes mid-trial without a good explanation; we know they did because they published the scientific protocol beforehand. If patients had not brought up the changes, no one would have noticed.
2) Subjects in the study were told by therapists that two particular treatments (exercise/ therapy) were good/ safe for them ahead of the end of the trial. If we are to test an intervention in a “blinded” manner, subjects should not be unduly influenced before then.
3) Conflicts of interest were not clearly disclosed. Some of the authors had consulted for disability insurance companies that had an financial incentive to cut off claims of patients who were disabled by the disease. If it could be shown that patients could improve with exercise or cognitive therapy, then patients’ cases could be weaken with the claim that patients were “choosing” to malinger and not get well.
The issue isn’t whether SOME patients benefit from the treatment. For those who do, it’s not as though anyone is preventing them from seeking such care and receiving it. Rather it’s about protecting those who did not improve or even would deteriorate under such treatment. About 50% of patients who have undergone exercise programs cite such programs as worsening their health. When some patients have deferred treatments, their doctor have labelled them as “noncompliant” or refuse to help them with other issues. At the extreme end, parents have been prosecuted in court for child abuse/ neglect and had their children taken away from them when they refused exercise/ cognitive therapies on their child’s behalf.
I write all of this not only as a patient but as a physician and medical researcher. So I understand that research can come out wrong even with the best intentions. But some of the things the PACE authors did, in my own field, if I did those things, I would not be publishable and in addition lose the respect and esteem of my peers.
The editorial is flawed from the start. It exudes attitudes foreign to scientific inquiry. Early on we get “… ME/CFS— popularly, and unhelpfully, known as “Chronic Fatigue Syndrome”. This heralds what is coming. Let us recollect that ME stands for Myalgic Encephalitis or some such. Encephalitis is a tangible pathology yet to be demonstrated in this context. Chronic Fatigue is in contrast a regular dominant disabling symptom reported and is a reasonable surrogate title. The author’s flip remark demonstrates an unhelpful mindset.
PACE may well be an unreliable source of knowledge and unworthy of further attention. I have not the time to investigate and in any case, like most commentators, I have not the expertise to judge. What we should however note seriously is that however flawed it may have been it was an honest attempt to find help for suffering individuals by the most reliable method available, the method of scientific inquiry. The alternative is worse. To determine an agenda, to establish constraints to inquiry by attending largely to the views, as opposed to the experiences, of sufferers is the method of folk medicine, used faux de mieux for millennia with little to show for it. We owe the sufferers our best endeavour which is based on humane concern for their suffering without necessarily adopting their quite natural perceptions as to what may be the mechanism. Mistaken endeavour will hurt the sufferers most.
Spare a thought as well in this tirade of invective for any of the PACE subjects who did derive benefit from the study.
Your comment reflects unfamiliarity with both the extensive medical research into ME/CFS, and the statistical flaws in the PACE Trial.
The US Institute of Medicine report on ME/CFS, ‘ Beyond Myalgic Encephalitis/Chronic Fatigue Syndrome, Redefining an Illness’.
https://www.ncbi.nlm.nih.gov/pubmed/25695122
after examining the thousands of research papers and other information concerning ME/CFS came to the following conclusions:
It is incorrect to regard this illness as a psychiatric disorder.
The term ‘Chronic Fatigue Sydrome’ trivialises this disease, does a disservice to patients, and should be retired.
This is a ‘disease’ which is defined by the fact that ‘exertion of any type, physical, cognitive or emotional, may adversely affect many organ systems.
This precisely contradicts the fundamental premiss of the PACE Researchers (the lead author of which did not declare his position as a paid consultant for the medical insurer, Swiss Re as a conflict of interest) ..that this disease is a psychiatric disorder and that graded exercse is beneficial.
He is also apparently uaware that in mid-trial, the criteria for recovery were modified to the extent that 13% of those regarded as ill enough to qualify for the trial were also above the new criteria for recovery.
And he is apparently unaware that the research institution responsible for the research spent nearly a quarter of a million pounds trying to resist a Freedom of Information request that the data be released. If a piece of scientific research is sound, it would be strengthened by producing its data and methods to public view.
He has said he doesn’t have the time to look into the research properly. If he doesn’t, then he really shouldn’t be making comments based only on his opinions.
A year later this is still awesome. I link to your articles all the time. Thank you so much for writing and publishing about how this trial stuffed up the protocol.
If I can offer one small revision. PACE was not the beginning of CBT/GET. There were studies before; just they were pretty small, and again with poor design and implementation. AHRQ has amended its report to downgrade the evidence of the pre-PACE studies (though, inexplicably, they still rate PACE as a good quality study; I think they were just dazzled by the size and that it was randomized and by some accounts, controlled).
As someone else mentioned, the Cochrane study still continues to be influential. In order for the practice guidelines to be changed, UpToDate and such resources have to be changed, and for that I think someone needs to point out where Cochrane has gone wrong. Or else publish something really good about medical science in a high-impact journal. Or explain to everyone why checking the publishing journal’s impact factor is not a substitute for checking the quality of the information (nor a proxy indicator of how reliable it will be). Or most of this.