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

ID: 
67
Personal Details
This submission reflects the views of
Organisation Name: 
ME/CFS and Lyme Association of WA Inc
Specific Questions
1a. How well does the report present the difficulties faced by ME/CFS patients in receiving clinical care?: 
Ok
Comments: 
Thank you for this report, and NHMRC’s recognition of the biomedical landscape change in ME/CFS and recognition of the difficulties faced by patients. The report broadly examines those difficulties, but there’s little detail quantifying the difficulty to obtain medical care. We have increasing patient reports where patients are refused acute clinical care in hospital EDs or consistent care from GP’s in the home setting. Bed/homebound patients have no choice but to rely on locums to address complex medical care issues and cannot access specialist care. The report recognises the difficulty in describing the ME/CFS symptom experience and severity, and how the word ‘fatigue’ does not represent disability or severity. Patients describe coexisting disorders which ‘flare’ during symptom exacerbation of PEM - often complicating ME/CFS diagnosis. Studies show high levels of undiagnosed patients and misdiagnosis. Patients would benefit from doctors using updated differential diagnosis lists and objective and/or validated tests such as the DePaul Questionnaire, CPET and the tilt table test. The report does not emphasise the physical and psychological damage, and isolation, from failed CBT and GET treatments. Patients have advised that there are components of CBT and GET which are helpful, such as pacing (living in the energy envelope and using a heart rate monitor) and stress reduction. As an organisation who supports patients, the lack of ‘disease prestige’ of ME/CFS affects our ability to obtain funding. (4.5.3) A common patient complaint is that access to DSP is often rejected because PEM cannot be adequately assessed under Table 1 due to the delayed nature of symptom onset. We thank the NHMRC for recommending that the NDIS add ME/CFS to list B. However, the proposed recommendations should also address difficulties accessing Centrelink support.
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 reports touches on some of the challenges and has some positive recommendations to better support clinicians. We acknowledge the difficulty in diagnosis and management of ME/CFS for clinicians who have limited exposure to ME/CFS. We note that 4.5.2 (p17) the report states that “Clinicians are trained to diagnose conditions with observable objective data (signs) and ME/CFS challenges this approach.” We also note that on page 20, Box1, the BMJ “Best practice on Chronic Fatigue Syndrome” is recommended for describing ME/CFS under 5.2.2. Consistency. We would like to draw your attention that the BMJ document lists objective signs of ME/CFS such as the tilt table test, the DePaul questionnaire for PEM, and CPET. For consistency, the recommendation for use of the BMJ document be extended to include objective signs. We cannot emphasise enough that PEM in ME/CFS is unique and its characterisation will lessen the difficulties for clinical diagnosis. (4.5.1) Positive to read acknowledgement of the benefits of pacing. (4.5.2) “...only half of GP’s believe that ME/CFS is a real condition.” This statement is alarming but supports patient reports of their experience. This requires addressing in the medical community. IACFSME, CCC, and ICC documents are available for reference until new Australian clinical guidelines are developed. Of very real concern is that the RACP Guidelines of 2002 and RACGP-HANDI remain available, and both need retraction. The over-reliance of this document on the psychosocial model impedes diagnosis and treatment for patients. Reports of patient harm should warrant cautions on using these outdated guidelines, however, by remaining the go-to document for GP’s in Australia, the NHMRC is indirectly endorsing the document, despite the assertion (page 10) that the 2002 RACGP Guidelines were not endorsed by the NHMRC.
2a. The research and clinical guidance recommendations accurately address the specific needs of the ME/CFS community.: 
Neutral
Comments: How could the recommendations be improved?: 
We commend the recommendation that the 2002 clinical guidelines be updated and or new guidelines developed. We strongly urge that new guidelines be developed. The 2002 guidelines fell short by ignoring biological aspects of the illness, and promoting the illness as ‘psychological’ which has resulted in a negative stigma. Much biomedical evidence has since accumulated, and it is time for new guidelines, and collaboration with the patient community. It is unclear if the recommendations indicate consistent and ongoing funding for ME/CFS research. One-off funding, such as a TCR, is very welcome, however ongoing investment in research should be recommended to be commensurate with the economic burden of the illness. (3.1. key point 3) – Many diseases do not have a biomarker and are yet to be fully understood. ME/CFS research and funding is disadvantaged and undermined by emphasis on a biomarker. Preliminary research findings have found abnormalities and while the science progresses, research and recognition should not be put on hold in wait for a confirmed and replicable biomarker. (5.3.1 point 1) - The report acknowledges that ME/CFS research is at early stages, and is in need of research funding for initial hypothesis generation. Flexibility of funding criteria could help support early stage biomedical research. A lack of a reliable biomarker should not impede this progress. (5.3.2. Key Points) – “Report on child and adolescent impact, including impact on parents and carers”. Please also include impact on parents caring for adult children, children caring for parents, and impact on partners caring for their partners. (5.3.3.1. - guidelines) – Ideally, NHMRC to firmly recommend the 2002 guidelines be removed pending outcome of the guideline review. Please consider recommending the IACFSME, CCC, ICC, and/or IOM guidelines as reference for medical practitioners.
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?: 
(3.1.1) Please emphasise the lack of historical funding in comparison to other illnesses. ME/CFS funding has been funnelled or diverted into psychosocial research, fatigue, chronic fatigue, and fatiguing illnesses, which are not the same as ME/CFS. Those funds should not be classified as ME/CFS allocated funding. (5.3.1.2.) We welcome the recommendation of a consortium to identify gaps in research. We believe a well-rounded panel of experts, working in collaboration with the ME/CFS community, would be in the best position to act on the NHMRC recommendations to further identify gaps in Australian research. Strategic focus 1, Objectives: Omits to mention that funding should be in proportion with the burden of the disease. (5.3.2.1. Economic) - clinicians omit to record a diagnosis of ME/CFS in PHRN and NCRIS. This is not included within the objectives - for accurate data this is essential. - Not clearly stating that there is a conflating of the words fatigue, chronic fatigue, and fatiguing illnesses with CFS – these are not the same and are confusing to research funding, including NHMRC’s own previous grants for ME/CFS. Please note, there are multiple international studies and drug trials which have not been included in the report. - Evidence of widespread metabolite abnormalities in Myalgic encephalomyelitis/chronic fatigue syndrome: assessment with whole-brain magnetic resonance spectroscopy.PMID 30617782 - Metabolic features of chronic fatigue syndrome. PMID 27573827 - Metabolic profiling indicates impaired pyruvate dehydrogenase function in myalgic encephalopathy/chronic fatigue syndrome. PMID 28018972 - Rituximab Serum Concentrations and Anti-Rituximab Antibodies During B-Cell Depletion Therapy for Myalgic Encephalopathy/Chronic Fatigue Syndrome. PMID 30502905
2c. The research recommendations inform the CEO of the most effective and strategic research options currently available.: 
Neutral
Comments: How could the recommendations be improved?: 
We have sighted ME/CFS South Australia Inc’s submission and endorse the points they have made, and add the below. In broad terms, the recommendations inform the CEO of the strategic research options. We strongly agree that the use of the CCC and CDE’s is a start to aligning research. 5.3.1.1 TCR - could include Microbiomics in this list too - “those severely affected by the condition” – reasonable mandatory inclusion of the severely ill should be built into research to prevent statistical skew of results. 5.3.1.2 - The consortium model has not included national and state consumer representative organisation engagement as a priority. 5.3.2.1 - Burden of disease and prevalence studies MUST include PEM characterisation using CCC. Previous BOD studies have relied on the broader definition of fatigue of Fukuda criteria, resulting in the inclusion of other fatiguing conditions. The ME/CFS component of these studies are unknown and the recommendation for updated data is welcome. 5.3.3.1 - We are seeking new patient guidelines rather than review and amendment of current Australian Guidelines. “Patient mistrust” does not adequately define how the patient community views GET. 5.3.4.1 - We welcome the development of capacity through International Collaboration. 5.3.4.2 - Biobank appears to be a large and unwarranted expense at present. We support the view that collaboration with the UK biobank is sufficient at this time.

Page reviewed: 23 September, 2019