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

Personal Details
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Specific Questions
1a. How well does the report present the difficulties faced by ME/CFS patients in receiving clinical care?: 
1) There is a consensus that GET is not effective in ME/CFS This draft report claims that specialist clinicians and researchers maintain that graded exercise therapy (GET) is effective in ME/CFS. In doing so, it makes reference to the 2017 Cochrane review by Larun et al. This meta-analysis is no longer reliable. Cochrane warns readers the review is “substantially out of date and in need of updating.”[1] According to a more recent analysis of the literature “objective outcomes reveal GET to be ineffective.”[2] The Agency for Healthcare and Research Quality (AHRQ) [3] In the US and the Health Council [4] in the Netherlands concluded that there is no evidence for GET in ME/CFS. A recent assessment report of the ME/CFS convention in Belgium said GET should no longer be prescribed to ME/CFS patients. [5] Previously, the CDC has removed its recommendation for GET, while in the UK NICE is in the process of reviewing its guidelines due to concerns regarding GET. These examples show that there is an international consensus on GET being ineffective for patients with ME/CFS. [NHMRC has removed third party information]. [6] In the UK this would constitute a non-financial professional conflict of interest. In such instances, NICE recommends a partial exclusion: “the person can engage in committee discussion or provide advice to the meeting (for example, because of their expert knowledge), but is excluded from developing recommendations and decision-making on the matter relating to the interest. Involvement may be limited to answering direct questions from the committee.” [7] References: [1] https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003200.pub7/information#whatsNew [2] Vink M, Vink-Niese A. Graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome is not effective and unsafe. Re-analysis of a Cochrane review. Health Psychol Open. 2018 Oct 8;5(2):2055102918805187. [3] July 2016 Addendum. Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Evidence Reports/Technology Assessments, No. 219. Beth Smith ME, Nelson HD, Haney E, et al. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Dec. https://www.ncbi.nlm.nih.gov/books/NBK379582/ [4] Gezondheidsraad. ME/CVS. Den Haag: Gezondheidsraad, 2018; publicatienr. 2018/07. https://www.gezondheidsraad.nl/documenten/adviezen/2018/03/19/me-cvs [5] Persoons P, Vanhoof L, Aerts L, Van Den Houtte M, Peters G, Claes S. 2018. Eindverslag van de revalidatieovereenkomst tussen het Rijksinstituut voor Ziekte- en Invaliditeitsverzekering (RIZIV) met het Multidisciplinaire Diagnostisch Centrum voor het Chronische Vermoeidheidssyndroom (MDC-CVS) van het Universitair Ziekenhuis Leuven (UZ Leuven)/Universitair Psychiatrisch Centrum KU Leuven (UPC KU Leuven) – Artikel 2 §3 van de Revalidatieovereenkomst met multidisciplinaire diagnostische centra voor CVS. https://www.riziv.fgov.be/SiteColle...MnNRacaNqviRf9eP1D67XeTIbiV2yavQYOhx-HEiwSwr4 [6] A randomised controlled trial of online continuing education for health professionals to improve the management of CFS. Registration number: ACTRN12616000296437. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370222 [7] National Institute for Health and Care Excellence. Policy on declaring and managing interests for NICE advisory committees. https://www.nice.org.uk/Media/Defau...rocedures/declaration-of-interests-policy.pdf
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?: 
2) PEM is characteristic of ME/CFS, if assessed correctly According to some committee members post-exertional malaise (PEM) is not unique to ME/CFS, as it is evident in some other fatiguing illnesses, including post-cancer fatigue, post-polio syndrome and multiple sclerosis. This is a misleading statement. Some of the studies referenced simply asked if patients experienced ‘post-exertional malaise’. This is equally unreliable as asking patients if they have ME/CFS. A more thorough investigation into the effects of exertion on a patients’ health is necessary to determine the presence of PEM. A brief questionnaire with only several items to assess PEM was remarkable effective in differentiating ME/CFS patients from patients with multiple sclerosis or post-polio syndrome. This indicates PEM to be a characteristic symptom of this illness. [1] According to the 2015 report by the Academy of Medicine PEM refers to an abnormal response to minimal amounts of physical or cognitive exertion that is characterized by a delayed onset, a prolonged recovery period and immune-related symptoms that are not usually described after exertion. [2] Such a phenomenon has not been reported in other conditions while it has been present in the ME/CFS literature for more than 30 years. According to a study from Stanford university : “there exists no medical condition the authors are familiar with where exertion or emotional distress causes immune/ inflammatory-related symptoms like sore throat, tender lymph nodes, or flu-like feelings, yet 60% and 36% of our subjects, respectively, reported these symptoms with either stimuli and about a quarter experienced all 3 with exertion. [3] Finally, ME/CFS patients demonstrate a failure to recover on a two-day cardiopulmonary exercise test (CPET) protocol. [4] According to one research group, “ME/CFS patients currently represent a unique class of ill patients who do not reproduce maximal CPET measures, unlike individuals with cardiovascular disease, lung disease, end-stage renal disease pulmonary arterial hypertension and cystic fibrosis.”[5] A preliminary study suggests the repeated CPET protocol is able to distinguish ME/CFS patients from other fatigue-related conditions such as multiple sclerosis. [6] References: [1] Cotler J, Holtzman C, Dudun C, Jason LA. A Brief Questionnaire to Assess Post-Exertional Malaise. Diagnostics (Basel) 2018;8(3):E66. [2] Institute of Medicine. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness. Washington, D.C.: The National Academies Press, 2015. [3] Chu L, Valencia IJ, Garvert DW, Montoya JG. Deconstructing post-exertional malaise in myalgic encephalomyelitis/ chronic fatigue syndrome: A patient-centered, cross- sectional survey. PLoS One. 2018 Jun 1;13(6):e0197811. [4] Stevens S, Snell C, Stevens J, Keller B, VanNess JM. Cardiopulmonary Exercise Test Methodology for Assessing Exertion Intolerance in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Front Pediatr. 2018 Sep 4;6:242. [5] Keller BA, Pryor JL, Giloteaux L. Inability of myalgic encephalomyelitis/chronic fatigue syndrome patients to reproduce VO₂peak indicates functional impairment. J Transl Med. 2014 Apr 23;12:104. [6] Hodges LD, Nielsen T, Baken D. Physiological measures in participants with chronic fatigue syndrome, multiple sclerosis and healthy controls following repeated exercise: a pilot study. Clin Physiol Funct Imaging. 2018 Jul;38(4):639-644.
2a. The research and clinical guidance recommendations accurately address the specific needs of the ME/CFS community.: 
Comments: How could the recommendations be improved?: 
3) The report overestimates recovery in ME/CFS This draft report overestimates recovery in ME/CFS. The data and references used are not peer reviewed and are only found in grey literature. For example: the claim that 60% of young people with ME/CFS recovered after 5 years and 88% after 12 years is based on an conference abstract, [NHMRC has removed personal information]. Her figures were reported during an oral presentation at the IACFS/ME Biennial International Conference Ottawa, Ontario, Canada in 2011. [1] They have not been published in a peer review article where the trials methodology can be checked and criticized by other scientists. A meta-analysis of the 14 studies reported a median recovery rate of 5% in patients with ME/CFS. Recovery was low, regardless of diagnostic criteria and research methodology. [2] References [1] IACFS/ME Biennial International Conference Ottawa, Ontario, Canada Abstracts from General Session September 23, 2011. https://iacfsme.org/portals/0/pdf/Fall2011-AbstractsOttawa-112-200.pdf [2] Cairns R, Hotopf M. A systematic review describing the prognosis of chronic fatigue syndrome. Occup Med (Lond). 2005 Jan;55(1):20-31.
2b. The research and clinical guidance recommendations provide an accurate representation of the current gaps in research.: 
Comments: How could the recommendations be improved?: 
4) Research needs a proper diagnosis of ME/CFS There is an urgent need for specialist multidisciplinary centers where the diagnosis of ME/CFS can be made. Several Australian studies such as Wallman et al. 2004 [1] and Broadbent et al. 2016 [2] are flawed because the authors were not able to diagnose ME/CFS patients according to international protocols. Patients did not receive a thorough investigation by specialists in internal medicine, as is the case in other countries [3,4]. Instead these studies had to rely on the judgement of the patient’s doctor, often a general practitioner. This is an unreliable method that can invalidate the study’s outcomes. Research from the universities of Ghent [3], Newcastle [4], London [5,6] and Griffith [7] has shown that around 40% of the patients suspected to have ME/CFS, have in fact a different illness, mostly sleep- and psychiatric disorders. In order for sound research to occur in Australia, ME/CFS patients have to be diagnosed correctly. References [1] Wallman KE, Morton AR, Goodman C, Grove R, Guilfoyle AM. Randomised controlled trial of graded exercise in chronic fatigue syndrome. Med J Aust. 2004 May 3;180(9):444-8. [2] Broadbent S, Coutts R. Graded versus Intermittent Exercise Effects on Lymphocytes in Chronic Fatigue Syndrome. Med Sci Sports Exerc. 2016 Sep;48(9):1655-63. [3] Mariman A, Delesie L, Tobback E, Hanoulle I, Sermijn E, Vermeir P, Pevernagie D, Vogelaers D. Undiagnosed and comorbid disorders in patients with presumed chronic fatigue syndrome. J Psychosom Res. 2013Nov;75(5):491-6. [4] Newton JL, Mabillard H, Scott A, Hoad A, Spickett G. The Newcastle NHS Chronic Fatigue Syndrome Service: not all fatigue is the same. J R Coll Physicians Edinb. 2010 Dec;40(4):304-7. [5] Devasahayam A, Lawn T, Murphy M, White PD. Alternative diagnoses to chronic fatigue syndrome in referrals to a specialist service: service evaluation survey. JRSM Short Rep. 2012 Jan;3(1):4. [6] Darbishire L, Ridsdale L, Seed PT. Distinguishing patients with chronic fatigue from those with chronic fatigue syndrome: a diagnostic study in UK primary care. Br J Gen Pract. 2003 Jun; 53(491): 441–445. [7] Johnston SC, Staines DR, Marshall-Gradisnik SM. Epidemiological characteristics of chronic fatigue syndrome/myalgic encephalomyelitis in Australian patients. Clin Epidemiol. 2016 May 17;8:97-107.
2c. The research recommendations inform the CEO of the most effective and strategic research options currently available.: 
Comments: How could the recommendations be improved?: 
5) Earmarking funds for ME/CFS The draft report should be applauded for recommending a targeted call for research. This is necessary to attract new scientists to the field of ME/CFS. Because of the stigma and prejudices attached to this illness, good research proposals are sometimes rejected on irrational grounds. In the US even international respected scientists such as Ronald Davis [1] and Ian Lipkin [2] have been rejected or ignored when they applied for research into ME/CFS. As a consequence, new research proposals in the field of ME/CFS are scarce due to the fear of being rejected on irrational grounds. This creates a vicious cycle of inertia that can only be broken by earmarking funds for ME/CFS. References [1] https://www.meaction.net/2015/08/20/ron-davis-nih-proposal/ [2] Interview with Dr. W. Ian Lipkin, ME/CFS Alert Episode 95. (December 2, 2017).

Page reviewed: 23 September, 2019