By David Tuller, DrPH
In an eagerly awaited draft report, an Australian advisory committee on ME/CFS has called for the development of up-to-date domestic clinical guidelines and an increase in biomedical research into the pathophysiology of the illness. The draft report, which could have a major impact on health policy going forward, also highlights the potentially dangerous impacts of graded exercise therapy, the international controversy over the PACE trial and the challenges that Australian patients confront accessing federal disability benefits.
In October of last year, the Office of the National Health and Medical Research Council established the ME/CFS Expert Advisory Committee to provide recommendations about â€œthe research and clinical guidance needs for ME/CFS in Australia,â€ per the draft report. When I visited Australia last March and April, it seemed that many community members did not have high hopes for the outcome. Although two smart patient representatives were among those appointed, the list also included Professor Andrew Lloyd, an infectious disease doctor at the University of New South Wales. Professor Lloyd has been Australiaâ€™s main champion for GET and to a lesser extent CBT, which he has offered for years at his rehabilitative clinics.
The advisory committee could presumably have endorsed the longstanding recommendations for GET and CBT, which were included in 2002 guidelines from the Royal Australasian College of Physicians. That the committee chose not to endorse these recommendations suggests that the debate in Australia has shifted, as it has elsewhere, away from blind faith in the pronouncements of the GET/CBT ideological brigades. Instead, the draft report recommends â€œupdating or developing new ME/CFS clinical practice guidelines to provide clinicians with an updated evidence-base for diagnostic and management/treatment strategies.â€
The draft report does read in some places like a compromise document. But overall, in pivoting away from the dominant GET/CBT dogma, it comes across as something of a rejection of the views of the biopsychosocial schoolâ€”and that includes Professor Lloyd, Australiaâ€™s self-described â€œleading lightâ€ for the illness. I doubt he is too pleased with this draft report.
The NHMRC is soliciting public comments on the draft report. These comments are due by February 18th.
Presumably the agency wants to hear from patients and advocates about both positive and negative responses to the draft report, including about its expressions of concern related to GET and the call for developing up-to-date clinical guidelines rather than continuing to rely on the 2002 document. As part of its focus on improving the quality of research in the field, the draft report also highlights post-exertional malaise as a distinguishing feature of the illness and recommends the consistent use of the 2003 Canadian Consensus Criteria to improve research in the field.
In my own interview with Professor Lloyd last spring (well, it was last autumn in Australia), he made clear that he rejected the long-prevailing â€œdeconditioningâ€ model of ME/CFS. Instead, he favored a model relying on â€œcentral sensitizationâ€ of fatigue pathwaysâ€”although he acknowledged the paucity of current evidence supporting this proposed mechanism of action. Of course, the â€œdeconditioningâ€ hypothesis was the initial theoretical basis behind GET, but never mind that. It seemed that Professor Lloydâ€™s version of GET now rested on a different unproven notion–that incremental increases in activity can effectively â€œdesensitizeâ€ the body from over-responding to minimal exertion.
Professor Lloyd has long enjoyed close relationships with the lead PACE authors and other GET/CBT cult leaders. He would undoubtedly have preferred the draft report to provide support for the biopsychosocial treatment paradigm that has prevailed in Australia, as it has in the UK. Such an endorsement could have augmented his status as the countryâ€™s pre-eminent expert on the illness and undermined calls for more biomedical research.
An endorsement of this approach could also have provided Professor Lloyd with greater opportunity to roll-out his proposed online training program for allied health professionals interested in learning how to manage ME/CFS patients with his rehabilitative therapies. But as has become clear to impartial observers, treatments like GET and CBT for ME/CFS are best described as examples of â€œeminence-basedâ€ medicine, not evidence-based medicine, to quote Brian Hughes, a psychology professor at National University of Ireland, Galway. Given that the science mostly stinks, these treatments have become the standards of care based on the prestige and reputations of the proponents, not on the quality of the data.
Luckily, the draft report does not adopt or endorse Professor Lloydâ€™s approach. Instead, it punts the issue of appropriate treatments into the future by calling for the development of guidelines based on the latest evidenceâ€”one of its key recommendations. What will obviously be critical is who will get to serve on any new guidelines development group. The process of selecting such a panel could be as fraught in Australia as it has been in the UK.
The draft report contains a pointed but accurate critique of GET and PACEâ€”I have included this key section below. This critique implicitly calls into question Professor Lloydâ€™s claims about the success of his treatment strategies. Indeed, the overall impression left by the report is that Professor Lloydâ€™s influence on the national debate has waned. As has happened with the PACE authors, events seem to be moving beyond him. His continued advocacy of a widely rejected treatment like GET, even with a refurbished hypothetical underpinning, makes him seem adrift in the past.
The advisory committee also weighed in on an issue that is apparently beyond the NHMRCâ€™s scopeâ€”the difficulties faced by ME/CFS patients seeking benefits through Australiaâ€™s National Disability Insurance Scheme. This issue was the subject of an excellent TV segment during my trip to Austraila; I was interviewed for it. (I got teary-eyed for a few seconds during the interview, which turned out to be a great method of increasing donations to the crowdfunding campaign I was running at the time!) Because of the importance of this issue, I have included that section below as well.
Excerpt from committee report about GET and PACE:
Graded Exercise Therapy, the PACE Trial and other options for physical activity
Options for physical activity and exercise for patients with ME/CFS range from mild and gentle physical activity through to more structured and rigorous exercise programs that are sequentially graded. Physical activity and exercise therapy treatments have received significant attention in the media, amongst ME/CFS research sectors and the wider community. Patients and advocates have a real concern about the harms caused by some exercise modalities. These options for physical activity are of interest and a controversial topic of debate within all sectors (research, patients and clinicians), given the variety of responses to this form of management, and its effectiveness. These are briefly discussed below.
Graded Exercise Therapy
Graded Exercise Therapy is considered a controversial treatment. The primary reported concern with recommending graded exercise therapy for ME/CFS patients is the onset of post-exertional malaise (PEM) and the risk of worsening symptoms.
Specialist clinicians and researchers maintain that graded exercise therapy is effective when administered correctly and substantiate this with a number of clinical trials. However, these trials have been questioned by some patients, advocacy groups, academics, clinicians and Australian and international researchers. For example, the US Agency for Healthcare Research and Quality stated in their 2016 Addendum on the diagnosis and treatment evidence for ME/CFS:
â€œâ€¦By excluding the three trials using the Oxford (Sharpe, 1991) case definition for inclusion, there would be insufficient evidence of the effectiveness of graded exercise therapy on any outcomeâ€¦missing from this body of literature are trials evaluating effectiveness of interventions in the treatment of individuals meeting case definitions forâ€¦ME/CFS.â€ – Smith et al (2016) pp. 11-13
One trial that has received significant attention is the UK PACE trial.
In 2011, The Lancet published a randomised controlled trial by White et al (2011): Comparing adaptive pacing therapy, cognitive behaviour therapy , graded exercise therapy and specialist medical care for treatment of ME/CFS, referred to as the PACE trial. The PACE trial supported the use of cognitive behavioural therapy and graded exercise therapy in treating ME/CFS as the results implied a moderate improvement of outcome measures. Participants were recruited using the Oxford (1991) diagnostic criteria. PEM is not a mandatory feature in the Oxford (1991) criteria and this has contributed to dispute over whether patients recruited using this criterion actually have ME/CFS.
The PACE trial has been the subject of sustained criticism. In March 2014, a freedom of information request was lodged with Queen Mary University of London (QMUL) asking for the release of patient level data. QMUL refused to release the data, citing confidentiality concerns. In October 2015, the UK information commissioner conducted a decision notice advising QMUL to release the withheld data. QMUL appealed; the appeal was dismissed in August 2016 and the data released.
Re-analysis of the data by Geraghty (2017) suggested that the PACE trial team overstated claims of benefit for cognitive behavioural therapy and graded exercise therapy through methodological alterations made throughout the study that skewed outcomes. The PACE trial was also criticised for its exclusion of severe ME/CFS cases and the potential inclusion of those with fatiguing conditions other than ME/CFS.
The UK Medical Research Council (MRC) Executive Chair released a statement in August 2018 following a letter calling for The Lancet to reanalyse the PACE trial data. MRC, as funder of the trial, rejected the view that the scientific evidence was unsound, stating:
â€œThe PACE trial was funded following expert peer review, was overseen by an independent steering committee, and its published findings were also independently peer reviewed. The process through which PACE was funded, supervised and published therefore meets international standards for clinical trials.â€ â€“ MRC 28 August 2018.
Excerpt from draft report about NDIS:
Whilst not within the remit of NHMRCâ€™s statutory responsibilities, as part of the work to develop this report, ONHMRC and the Department of Health (DoH) have been informed of the reported exclusion of some patients severely affected by ME/CFS from accessing the National Disability Insurance Scheme (NDIS) and other supportive services. Access to support services like NDIS is an issue of significant concern to the Australian ME/CFS community and has been a major focus of advocacy efforts.
To date, there have been three submissions to the Joint Parliamentary Committee on the NDIS (by Emerge Australia, ME/CFS Legal Resources Australia and ME/CFS & the NDIS Facebook group), as well as a national #MillionsMissing advocacy campaign. Advocates have raised concern about the lack of understanding of the condition by National Disability Insurance Agency (NDIA) assessors, and the rejection of claims of people who are significantly impaired. Patients have indicated that a requirement of NDIS is that ME/CFS patients undergo graded exercise therapy and/or cognitive behavioural therapy before they can access NDIS or supportive services. To access care through the NDIS patients need to show they have a significant disability. For these ME/CFS patients, graded exercise therapy may not be appropriate. The following is a summary of the submissionsâ€™ proposed recommendations to NDIS:
1. Recognition of ME/CFS as a serious debilitating condition.
2. The condition should be listed on the NDIS under list B: neurological disorders.
3. That assessment guidelines for NDIA assessors be developed in collaboration with clinicians with expertise in management of ME/CFS and the ME/CFS community.
Claudia Heath says
Thank you very much, David, for discussing the context of the NHMRC committee draft report, which is such a critical first step towards changing the paradigm in Australia. Your excellent, important meetings and reporting during your visit this year give you and others clear insight into the issues we face in Australia and have helped us to come together to act.
Now we must encourage as many people as possible who understand the issues to take this golden opportunity to respond to the draft report. ( I admit I have yet to read it myself).
Every recommendation was very hard fought, as you would understand, knowing Professor Lloyd and a tribute to our patient representatives’ excellent knowledge and perseverence. We can be much more hopeful now of getting medical guidelines that are helpful to patients, rather than the huge obstacle they still represent.
Lady Shambles says
In an ideal world Australia would play this ‘straight’ and only follow the science ( as opposed to trying to rig the process and co-opt those who prefer the status quo as is the case with NICE in the UK). In an ideal world they might decide to adopt the ICC as being a more recent, and therefore more up to date version, in preference over CCC. From that baseline Australia might credibly lead the world in sensible acceptance of what ME actually is.
Its Christmas morning and I have just read this. What a Christmas present.
Thank you David.
Erik Johnson says
I predict things are going to get much more entertaining as various competing factions battle for supremacy in taking over (by redefining) ME and CFS.
To the complete exclusion of the 1955 Royal Free Hospital outbreak & the 1985 Lake Tahoe Mystery disease.
That’s not how science is done, and they know it.
In essence, total fraud
Helen Donovan says
As I mother of a severely ill son who has ME/CFS it was a great Christmas present to read this David.
I have not read the draft as yet but will certainly do so and put my comments forward.
Hopefully ME will be given the acknowledgment it deserves!!
John Whiting says
Great work and thank you, especially this being Christmas, when you could easily have been doing other things. I think you have identified many key points, and in identifying the monopolising adverse effects that Professor Lloyd has had on the NDIS and other bodies, you have pointed out the importance of having more than just one expert advising this body, given that nearly 110,000 individuals with this illness in Australia, how misrepresented so many such sufferers have been by allowing this single doctor to have far more say than he deserves, and who has failed in his responsibility to correct a misunderstanding of prognosis of ME/CFS held by the NDIS by a misinterpretation of Dr Lloydâ€™s submissions to this body. It is time for Australia and its scientific community to embrace the new truths about this condition, especially given the large amount of good current research in Australia will eventually overturn many of the misconceptions of the past, even though such research has not yet accumulated enough to be an evidence based submission for now.
Sally James says
Thanks for this succinct analysis. Like others, I am yet to read the report and comment – it is high on my after-Christmas to do list. Very best wishes. Sally James.
Oh the irony!
Professor Lloyd wants to say that we are “allergic” to exercise in a psychological sense, that is, that we are afraid to try.
Well I am definitely “allergic” to activity, that is, just getting off the couch activates mast cells and I start itching anywhere. Anti-histamines mostly controls the itching and lots of other symptoms like IBS, hot flashes, insomnia, etc. But I still have severe limitations, and PEM, so I speculate that mast cell activation is only one part of the illness.
Even his ideas about “central sensitization” could maybe have a kernel of truth. My sudden episodes of near-hypothermia can potentially be explained by the activation of mast cells located near or in the hypothalamus. [1,2] Since the brain is considered part of the central nervous system, sensitized mast cells in the brain could perhaps be called “central sensitization” in a vague, hand-waving sort of way – the way the Wessely School always talks. But the idea that exercise can “desensitize” mast cells is rubbish. If exercise were the cure, I would’ve never gotten sick!
Unfortunately most doctors, probably including Professor Lloyd, know even less about mast cells than they think they know about ME. Funny that. They know nothing about POTS, neurally mediated hypotension, IBS, fatigue, or any of the multitude of symptoms I deal with constantly. How can that be? Yes trauma surgeons often do truly amazing work. But what about the rest of them? Is there *anything* doctors are good at besides selling vaccines, mammograms, statins, and the all-purpose “Its All in Your Head” diagnosis?
New guidelines are all well and good, but will doctors bother to read them?
 Matsumoto et al; Brain Mast Cells Act as an Immune Gate to the Hypothalamic-Pituitary-Adrenal Axis in Dogs; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2193441/
 Shaw; Hypothermia produced in mice by histamine acting on the central nervous system; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1667148/
Eimear Forde says
Thank you David, this is great news… the winds of change. Thank you for everything. I hope you will stick with us for another year! Merry Christmas. I would love to hug you!
Thank you David, you hit the nail on the head without Lloyd on the panel the report would undoubtedly been more science based. The skeleton in the closet is the idea of updating the flawed 2002 Guidelines. We have the ICC and the CCC both of which guide clinical practitioners. We need the urgent adoption of these Australia wide. South Australia – has for many years had guidelines based on the CCC. It took from 1997 to 2002 to produce the flawed 2002 guidelines that were even then rejected by the patient community and many clinicians as harmful. NOT adopting existing guidelines just lets Loyd weasel around and push for GET and his unproven centralisation theory. It also leaves us open to being sucked into following whatever NICE in the UK does. Things are not looking good in the UK with the review panel dominated by pyschosocial and proponents of medically unexplained syndrome – MUS. We had hoped for better ie something building on the science from the USA and building on our own expert researchers published and non published findings.
Kathy Collett says
Prof Lloyd fell in with the wrong crowd eg Wessely and co and the CDC and visited the latter. He was granted research funding repeatedly even though the results were poor. In the thirty years he has been looking at the illness, he should have achieved results but tragically it is only now that the NHMRC can see changes need to be made.
Nancy Blake says
Evidence overlooked….in the LA hospital epidemic, and I would guess also in the Royal Free epidemic, most patients recovered. It was only a minority who went on to become chronically ill. These people were by definition, being treated in hospital, where the conventional treatment was staying in bed.
Since bed rest has become anathema, and patients are chivvied into activity within days and out of hospital asap, and since excercise has become the modern panacea, ME/CFS is commonly described as a progressive disorder from which almost no one recovers.
What a coincidence!
It should not be an impossible exercise for a medical historian to find recovery rates from old hospital records, and for a public health researcher to find recovery rates today.
If, as Ramsay and Acheson insisted, the best prognosis was for those patients given protracted bed rest, and the apparent high recovery rate at that time was confirmed to be significantly better than that for ME/CFS patients today…..
I think that the obvious conclusion is so unacceptable in todayâ€™s cultural climate that it would make no difference whatever…..
Nancy Blake says