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 “the research and clinical guidance needs for ME/CFS in Australia,” 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 Australia’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 “updating or developing new ME/CFS clinical practice guidelines to provide clinicians with an updated evidence-base for diagnostic and management/treatment strategies.”
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 school—and that includes Professor Lloyd, Australia’s self-described “leading light” 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 “deconditioning” model of ME/CFS. Instead, he favored a model relying on “central sensitization” of fatigue pathways—although he acknowledged the paucity of current evidence supporting this proposed mechanism of action. Of course, the “deconditioning” hypothesis was the initial theoretical basis behind GET, but never mind that. It seemed that Professor Lloyd’s version of GET now rested on a different unproven notion–that incremental increases in activity can effectively “desensitize” 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 country’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 “eminence-based” 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 Lloyd’s approach. Instead, it punts the issue of appropriate treatments into the future by calling for the development of guidelines based on the latest evidence—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 PACE—I have included this key section below. This critique implicitly calls into question Professor Lloyd’s claims about the success of his treatment strategies. Indeed, the overall impression left by the report is that Professor Lloyd’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 NHMRC’s scope—the difficulties faced by ME/CFS patients seeking benefits through Australia’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:
“…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 outcome…missing from this body of literature are trials evaluating effectiveness of interventions in the treatment of individuals meeting case definitions for…ME/CFS.” – 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:
“The 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.” – MRC 28 August 2018.
Excerpt from draft report about NDIS:
Whilst not within the remit of NHMRC’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 submissions’ 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.