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Consultation on draft report to the NHMRC CEO for ‘Myalgic Encephalomyelitis / Chronic Fatigue Syndrome’ submission

ID: 
17
Personal Details
First Name: 
Susanna
Last Name: 
Agardy
Specific Questions
1a. How well does the report present the difficulties faced by ME/CFS patients in receiving clinical care?: 
Ok
Comments: 
The report understates the extraordinary combination of factors affecting ME/CFS patients. The impact of being unable to carry out activity in sustained and repeated ways, even being upright for too long due to PEM, or being bedbound for long periods (39) due to extreme severity, is not understood by doctors and the community. This condition is not provided for by services. For 54% being ill is itself a barrier to accessing medical services (39). Medical attitudes ( 4.5.2) can create iatrogenic harm, ‘A climate of illness disbelief may lead to risk of suicide’ (14). The paucity of medical publications on the pathophysiology of ME/CFS and PEM adds to its exclusion from medical awareness and acceptance, in spite of the IOM conclusion (17). Due to ignorance and dismissal of ME/CFS patients can be excluded from services or even rejected outright. No medical specialty owns ME/CFS, which leaves patients abandoned and exhausted in searching for help, creating also costs and inefficiencies. Emergency departments may miss diagnoses and invalidate patients (Timbol, DOI https://doi.org/10.2147/OAEM.S176843). Of the specialist consulted by patients, neurologists were the worst rated (39) and a Queensland neurological service expressly refuses routine service for CFS although WHO has classified ME as a neurological disease (33). CBT/GET treatment may be imposed, without informed consent and at the risk of harm. This can occur regardless of the qualifications of the professional guiding its implementation (4.5.1) (Kirke, https://journals.sagepub.com/toc/hpqa/22/9). In disregard of PEM, exercise tolerance is expected to increase (2) (48) putting pressure on patients. When these treatments are ineffective or make patients worse, patients may be blamed for boom and bust behavior (2) or incorrect application of the treatment. Accessing welfare assistance often depends on uncertain medical support and enforcement of the risky CBT/GET treatments, putting patients in an impossible position.
1b. How well does the report present the challenges facing clinicians in providing care, when there is lack of clarity on diagnostic and management tools, and minimal professional education about the condition?: 
Ok
Comments: 
The report acknowledges doctors’ difficulties but needs to state that doctors’ ‘misperceptions’ of ME/CFS serve both patients and medicine poorly, presenting risk of harm, conflict with patients and loss of credibility of medicine’s avowed principles of relying on objective evidence (4.5.2) Officially, medicine has not accepted the objective evidence for the biophysical hypotheses of ME/CFS which exist (Morris, https://doi.org/10.1007/s11011-019-0388-6). However, it has uncritically accepted the biopsychosocial model (4.1) and CBT/GET treatments for which there is no biomedical basis. The model and treatments are based on the unsupported assumption of deconditioning, assumed to be perpetuated by patient beliefs and behaviours (48). Studies supporting CBT/GET rely mostly on patient self-reports without objective outcome measures or little evidence of objective improvement (52). They barely acknowledge PEM, which is poorly understood by doctors. Claimed reversibility or even objective improvement is (48) is unsupported by PACE trial (52) and similar studies. Doctors do not generally use the IOM report, the CCC, ICC or IACFS/ME 2014 Primer which would help them with diagnosis and precautionary management, and miss objective signs. [NHMRC has removed third party information]
2a. The research and clinical guidance recommendations accurately address the specific needs of the ME/CFS community.: 
Agree
Comments: How could the recommendations be improved?: 
The Strategies (5.3) broadly address patient needs albeit in some generic ways. Implementation is crucial. Success depends on the projects funded and their conceptualisation. Use of the CCC with focus on PEM in its multi-domain detail and consumer collaboration should ensure a proper pathophysiological focus. Exercise should be a subject of research only as provocation while seeking evidence of its physiological effects. The harm associated with the dominant treatment paradigm of CBT/GET. (4.5.1) needs further explanation in the report. Harms are not acknowledged by doctors nor reported in the CBT/GET studies. In the PACE study, PEM is not considered a harm and virtually defined out of existence (Kindlon, Vink, https://journals.sagepub.com/toc/hpqa/22/9). Patient reports of getting worse or even bedridden following GET (not fully explored in surveys) are ignored or psychologised. There is an absence of official documentation in a register or published studies, of adverse effects, leaving doctors uninformed. This results in a lack of validation of individual patients’ reports of harm, creating a vicious circle. It also interferes with work performance expectations and gaining disability supports. Important aspects of the underlying pathophysiological features of ME/CFS are then also easily overlooked. The informed consent of patients should be required with the risk of harms from CBT/GET spelled out. It also needs to be recognized that patients can reach a plateau and not improve further. Medical education needs to be grounded in the CCC-based biomedical model and abandon the dominating psychosocial speculations. The HANDI RACGP page on GET should be withdrawn. The harmful Australian ME/CFS Clinical Guidelines which understate the condition and rely on the misleading pragmatic rehabilitation approach should be discarded and replaced by guidelines based on the pathophysiology. Meanwhile, the CCC, IACFSME 2014 Primer or the ICC should be adopted with pacing -based treatments in collaboration with patients.
2b. The research and clinical guidance recommendations provide an accurate representation of the current gaps in research.: 
Neutral
Comments: How could the recommendations be improved?: 
Please acknowledge: Research into ‘management’ of ‘fatigue’ via CBT/GET has used up most of the research funds, rather than understanding of the pathophysiology of ME/CFS. This should be avoided. Even if GET benefits other conditions, this does not automatically justify it for ME/CFS. We need rigorous research and the meaning of PEM must not be diluted into general ‘fatigue’. Claiming that PEM is not unique to ME/CFS (5.2.2) conflates PEM with fatigue; ignores the multiple symptoms of PEM and delayed onset; fails to acknowledge the significance of flu-like symptoms (73); ‘Sore throat, tender lymph nodes, and flu‐like symptoms obviously are not specific to ME but their activation in reaction to exertion is abnormal’ (20); ignores the objective manifestations of PEM in the 2-day CPET tests (Snell, doi: 10.2522/ptj.20110368) so far not seen in other conditions, eg, MS, where CPET differentiates between it and ME/CFS (Hodges doi: 10.1111/cpf.12460); the conflation confuses definitions and research results as shown by AHRQ (46). The diagnosis of ME/CFS may be obstructed by lack of accessibility to tissue types. This requires research on post-mortem tissue, eg, spinal cord and brain: ‘Neuroinflammation of the dorsal root ganglia, gatekeepers of peripheral sensory information travelling to the brain, has been observed in spinal autopsies (Chaudhuri A. Royal Society of Medicine Meeting 2009)‘ ICC (20). Specific studies on such tissue may be more useful than a standing biobank. The ABDS must restore a separate category for ME/CFS using the CCC for diagnosis. Median measures of duration, eg, 7 years for ME/CFS (4.4.1) are misleading, suggest limited duration, ignoring indefinite duration, which may be 32 years (68) and counting. Severity level and course of disease need to be included: there is no inevitable improvement as is often suggested. There may be continuation ( Rowe, doi: 10.3389/fped.2019.00021), deterioration or a recurring course.
2c. The research recommendations inform the CEO of the most effective and strategic research options currently available.: 
Agree
Comments: How could the recommendations be improved?: 
The report provides good but limited options. Further comments for the report : Considering the deprived condition of ME/CFS, exploratory hypothesis-generating research is still needed. In addition, replication studies are needed for validation of potential markers on larger samples of CCC-defined patients to advance to possible diagnostic test status. (eg Attachment B). In view of the multisystem nature of ME/CFS we need, a.) multivariate, multi-specialty collaboration studies which embrace the molecular and multi-organ manifestations of the disease to discover the holistic picture. b.) to establish a medical specialty which would embrace the multi-level complexities of the condition in a coherent way. This would assist patients and doctors, create efficiency and assist in translation. Qualified doctors are also needed to diagnose patients for inclusion in research. Unlike many of the CBT/GET management studies, research must utilise objective physical measures while making use of patient input. Precision research is required, using appropriate techniques in all areas of ME/CFS research. Eg, as described by VanElzakker, (https://doi.org/10.3389/fneur.2018.01033) brain scans and cytokine studies need to take into account type of body tissue, details of technique, comparability of techniques, and confounding biological, methodological, and behavioral factors which have yet to be identified and controlled for. Lack of funding has constrained such precision research. The inconsistencies in ME/CFS research findings may in part be due to differences in such factors. Funding must go to the condition defined by CCC with PEM as major feature and not various ‘fatigue’ states. Attention has been diverted from the pathophysiology of ME/CFS to non-evidence-based psychosocial interpretations, which have consumed funding and undermined the credibility of this condition. ME/CFS now needs to be legitimized in the eyes of the medical profession. It requires urgent attention and funding , taking into account its many complex issues.

Page reviewed: 23 September, 2019