Australia’s NHMRC ME/CFS Advisory Committee draft report released for public consultation

Here’s what the NHMRC says the terms of reference are (noting that they distinguish ME and CFS):

Terms of reference

The NHMRC Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Advisory Committee will advise the Chief Executive Officer of NHMRC on the research and clinical guidance requirements for Australia of Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS).

To provide this function, the Committee will advise on:

  1. the status of national and international research into ME and CFS
  2. gaps in research on ME and CFS. This will include but not be limited to research on the immunology, psychology, microbiology and virology of the conditions, as well as any health services research
  3. the status of clinical guidance on ME and CFS available to doctors and health professionals
  4. requirements and opportunities for improved clinical guidance
  5. any other issue on ME and CFS that the NHMRC Chief Executive Officer may request
  6. submissions received through the public consultation process
The Committee will be effective for the period 31 October 2018 to 30 April 2019 and will report to the Council and Chief Executive Officer of NHMRC.
 
http://www.sacfs.asn.au/about/guidelines/letter_mar_7.htm (ME/CFS Australia (SA) Inc: Letter to eMJA (March 7, 2002))
Dear DR Van Der Weyden,

I am writing to you on behalf of the ME/Chronic Fatigue Syndrome Association of Australia Ltd. The Association is an affiliation of all State Associations of ME/CFS.

The Association recognises fully the need for the dissemination of reliable information about the diagnosis and management of chronic fatigue syndrome (CFS) and has looked forward to the publication of a document that would herald major advances both in the recognition of CFS as a serious illness and in the standard of medical care available.

However, the Association considers that the RACP Chronic Fatigue Syndrome Clinical Practice Guidelines fall seriously short of being such a document and that their publication will be a backward step.

After an in-depth analysis of the Guidelines, an evaluation of the available evidence and extensive discussion with people with CFS, the Association is firmly and unanimously of the opinion that publication will result in:

• further cases of misdiagnosis;

• inappropriate and inadequate medical care; and

• the promotion of widespread misconceptions about the illness,

with potentially far-reaching and long-lasting, adverse effects for the 40-140,000 Australians with CFS.

More specifically it is considered that the Guidelines:

• do not describe accurately and fully the symptoms and characteristics of the illness;

• misrepresent the illness and people with CFS;

• do not provide an accurate, balanced and objective consideration of the research evidence;

• demonstrate a consistent bias towards a psychiatric-psychological approach to the illness;

• dismiss, downplay or ignore biological evidence;

• make illness management suggestions that are potentially harmful for many with CFS; and

• do not mention other ways of effectively managing the illness.
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This is why we are facing so much irrational obstruction and sabotage. Every legitimate warning has come to pass. Objections have been consistent and evidence-based for decades. Guidelines were implemented without evidence despite strong and legitimate objections from patients, advocates and competent researchers and clinicians.

Changing course will require acknowledging that this has been a massive failure, not just avoidable but largely manufactured. A disease model built purely on ideology and implemented through the desperate pleas of thousands begging for help. Not a good look when it is soberly analyzed outside of ideological suspension of disbelief.
 
This will help people providing feedback to the NHMRC:

It is definitely worth being familiar with the 2002 Australian chronic fatigue syndrome guidelines and their flaws, which dictate Australian government decisions on applications for the disability support pension, workers’ compensation, superannuation and insurance claims and the National Disability Insurance Scheme.

Have a look at the contrast between Aus 2002 CFS definition and ICC ME definition:

https://meaustralia.net/2018/11/30/...n-chronic-fatigue-syndrome-guidelines-and-me/
 
Ok, here's what I will be submitting:


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.

It should be noted that some committee members such has Andrew Lloyd and Suzanne Broadbent have studied GET and have promoted its use in the past. Professor Lloyd is currently conducting a study on educating healthcare professionals about the importance of using GET in patients with ME/CFS. [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


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.


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, on which committee member Katharine Rowe appears as single author. 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.


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.

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).
 
Impressive work @Michiel Tack! :thumbup:

Still working on my own submission. Being limited to 15min/day, max, combined with poor memory of what I read/thought the previous session makes it a challenge. But I will get there! Probably close to deadline. And without (m)any references.

Just want to make this point about references: if you are able to make a well-referenced submission like @Michiel Tack – brilliant! But if you can't, don't let that put you off from making a submission. Your support for an against certain points will still count.

Points I'm considering making so far (some are similar to @Michiel Tack's):
  • Australian guidelines must be replaced as recommended in the report. But not via update. That would take forever and the result may be less than optimal. Certain parties would likely fight tooth and nail to keep GET & CBT in any updated guidelines. And in the meantime doctors keep using the old ones. Better, for now at least, to simply ditch the current Australian guidelines and refer to Primer and ICC instead and use money saved on update to educate clinicians on using Primer and ICC.
  • Suggest establishing a Clinicians Council along US & EU lines (biomedical evidently). This CC could eventually create some new Australian guidelines, but that'd be down the track.
  • Establish a system to record harm from treatments.
  • Clear clinical pathway including access for very severe patients.
  • Concern about current research efforts by some committee members into ways to increase ME/CFS patients' exercise levels.
  • Recognise ME-PEM as a distinct and core ME phenomenon.
  • Concern about page 18 “That assessment guidelines for NDIA assessors be developed in collaboration with clinicians with expertise in management of ME/CFS”. Must ensure selected clinicians do not adhere to BPS/GET/CBT beliefs.
  • Support the report recommendation for strong consumer (patient) engagement. Concern: engagement must not become a token afterthought without any real influence.
  • Concern that any update of “the estimates of Australian prevalence and burden of ME/CFS” risks being meaningless if done before more stringent diagnostic criteria are commonplace.
  • Page 22 “Encourage hypothesis-generating research.” Agree that this is important but also encourage thorough testing of hypotheses, including existing ones, plus replication research. That's to avoid the business of a constant stream of small new findings that are rarely properly followed up with larger strictly defined cohorts and suitable (illness) control groups.
  • Support biobank in collaboration with overseas ones. Idem patient registry, possibly in collaboration with SMCI You+ME.
I'm wavering whether to include these 2 points:
  • Should I throw in a moonshot suggestion? Namely that the report recommend an international collaboration to establish a sort of Center of Excellence for Replication & Expansion studies into ME/CFS (mixed physical and virtual campus). This would help overcome the current publication bias towards original, positive, but often small, findings at the expense of solid replication studies and negative findings. Such a center could give young researchers solid methodological training, a broad overview of the field, and a career pathway: start at the Center then move on to other labs to undertake original research of high quality.
  • Report recommends CCC. I prefer ICC because it has more emphasis on PEM and less on fatigue but internationally CCC seems to be more widespread so CCC may make international collaboration and comparisons easier?
 
MyalgicE said:
ME Australia will be publishing our feedback soon so I’ll provide a link when it’s up.
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Will this feedback include a walk down memory lane? When the 2002 guidelines were adopted, strong warnings were given by patient organisations about the predictable outcome it would lead to. Some of it warned of misrepresentation of the disease, systemic discrimination, denial of medical care, aggravated harm, misdiagnosis. All correct. I'm sure there were further communications over the years while the disaster was unfolding.

If only to put it on record that "we told you so". Even if it has no immediate effect it will matter in the long term against pathetic excuses like "we didn't know". Ideally all in legalese, to make them understand that this will prominently feature in future legal proceedings. This is the only threat authorities will understand. Denial of basic medical care is serious stuff and "I just didn't believe it" is not even close to be a good justification.
 
Inara said:
that's a great summary! I saved it also for later, maybe I can use it for my processes. So two times thank you
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Thanks, Inara. It's not really a summary though. I've just picked out some subjects I wanted to criticize. Ravn's post above shows that there are many other issues that I didn't highlight.

Hope that many others will be submitting feedback as well, even if it's only a short comment (mine was a bit longer than indicated but they've accepted it). This seems to be an important moment for our friends down under.
 
rvallee said:
Will this feedback include a walk down memory lane? When the 2002 guidelines were adopted, strong warnings were given by patient organisations about the predictable outcome it would lead to. Some of it warned of misrepresentation of the disease, systemic discrimination, denial of medical care, aggravated harm, misdiagnosis. All correct. I'm sure there were further communications over the years while the disaster was unfolding.

If only to put it on record that "we told you so". Even if it has no immediate effect it will matter in the long term against pathetic excuses like "we didn't know". Ideally all in legalese, to make them understand that this will prominently feature in future legal proceedings. This is the only threat authorities will understand. Denial of basic medical care is serious stuff and "I just didn't believe it" is not even close to be a good justification.
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This 2002 letter from ME/CFS Australia to the MJA (which published the guidelines) was one of the strong warnings. It is included in the report (the quote in italics is taken from the letter):

“Although the guidelines were well received by some clinicians in 2002, they were not well received by all clinicians or by ME/CFS Australia (a national organisation representing patients). ME/CFS Australia was concerned that the guidelines would result in “further cases of misdiagnosis, inappropriate and
inadequate medical care, and the promotion of widespread misconceptions about the illness.”

 
#MEAction Network Australia has been hosting a 4 week read-along of the report, in several Facebook groups and on our Facebook page. Key points which have been raised in the read along discussion will be published next week, and can be used by anyone to help guide their own submission.
 
The NHMRC ME/CFS Advisory Committee draft report read along is now over! There's been some great discussions about the report on the ME Action Network Australia Facebook page & group.

The key points which arose during the group’s discussion have been now been collated. They are currently arranged according to the questions on the NHMRC’s feedback form. Feel free to use these to help clarify your thinking & to help you submit feedback on the report. These aren’t the only points you could make, they’re just the ones that came through most strongly in the group’s discussion.

The key points document can be found here.
 
There's still 9 hours to make a submission :)
An hour may be long enough to register, skim the summaries in the draft report, give feedback to the committee on their work in the five drop down menus and add a few comments. (Edit - and then have a good lie down.)

e.g. agreeing with the committee's call for a Targeted Call for Research, or giving your view on the biobank proposal, or calling for a new clinical guideline that doesn't recommend GET and CBT.

You don't need to write long comments; there are five questions and the maximum length of the reply is 300 words per question. Even just a sentence will do.

Ravn's post has some useful links for getting started.
Ravn said:
If you possibly can, please make the effort to make a submission, even if only a partial one. Our advocates have worked hard on getting this draft report to be as positive as it is. Let's help them push it further by making lots of submissions. I'm working on mine.

Register here to make a submission: https://consultations.nhmrc.gov.au/user/register
Submission guidelines here: https://consultations.nhmrc.gov.au/submission-guidelines
Download the draft report here: https://consultations.nhmrc.gov.au/public_consultations/mecfs-2019a (39 pages plus 31 pages of attachments)
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There are good ideas for comments in the posts above.
The link from ME Action Network has lots of ideas set out for each of the five questions.

simondelfavero said:
The key points document can be found here.
Click to expand...
 
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