DOCUMENT 1
FOI 22/23-1186
From:
Jacalyn on behalf of
Chris
s22(1)
s22(1)(a
To:
Geoffrey s47F -
Subject:
RE: INVITATION TO MEET WITH NDIA [SEC=UNOFFICIAL]
Date:
Tuesday, 21 April 2020 5:10:00 PM
Attachments:
image001.png
Hi Geoffrey
On behalf of Chris, I would like to acknowledge receipt of your email below.
Kind regards,
Jacalyn s22(1)(a)(i
Executive Assistant to Chris Faulkner
Operations and Support Division
National Disability Insurance Agency
Phones22(1)(a)(ii) - irr
Mobile s22(1)(a)(ii) - ir
Email jacalyns22(1)(a)(@ndis.gov.au
From: Geoffreys47F - pe <geoffrey
@mecfs.org.au>
s47F - pe
Sent: Tuesday, 21 April 2020 1:37 PM
To: FAULKNER, Chris <xxxxx.xxxxxxxx@xxxx.xxx.xx>
Cc: ME/CFS Australia Ltd Info <xxxx@xxxxx.xxx.xx>; Joh s47F - personal xxxx@xxxxx.xxx>
Subject: INVITATION TO MEET WITH NDIA
cc: Dr. John
(ME/CFS Australia Specialist Medical Advisor)
s47F - pe
Dear Chris
Please find attached the following:
1. Correspondence of today's date;
2. ME/CFS Australia submission with respect to the current NDIS ME/CFS assessment policy;
Kind regards
Geoffrey s47F - personal privacy
Chair - ME/CFS Australia
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Page 1 of 83
FOI 22/23-1186
I have enclosed a copy of correspondence from the NHMRC’s CEO, Professor Anne s47F - person, dated 18
October 2019 for your reference. This correspondence confirms that the CEO has accepted the
Committee’s recommendations in April 2019. These recommendations, which are summarised on
page vi of the Report, incorporate reference to clinical guidance and an undertaking in regard to access
to the NDIS.
I appreciate that our submission is detailed and may take some time to review. The Executive
Summary of the attached document outlines our key concerns and the matters we wish to discuss.
I look forward to discussing a mutually agreeable date to meet with you. As per your request, we
anticipate the attendees would be: Ms. Penelope s47F - personal privacy (Board Director, Chair of ME/CFS South
Australia, and member of the NHMRC ME/CFS Advisory Committee); Dr. John s47F - personal
priva (Specialist
Physician and Medical Advisor to ME/CFS Australia); and myself. In light of the COVID-19 situation,
we would be happy to achieve this via Skype, Zoom or a conference call.
Yours sincerely,
Geoffrey s47F - personal privacy
Chair, ME/CFS Australia Ltd
Page 3 of 83
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Table of Contents
1. PRELIMINARY MATTERS .................................................................................................... - 1 -
1.1.
Definitions ........................................................................................................................... - 1 -
1.2.
Nomenclature ..................................................................................................................... - 1 -
1.3.
Brief Background ................................................................................................................. - 1 -
2. OPERATIONAL POSITION ................................................................................................... - 1 -
3. THE TOPIC OF DISCUSSION ................................................................................................ - 1 -
3.1.
NDIA Policy .......................................................................................................................... - 1 -
4. KEY POINTS OF CONTENTION ............................................................................................ - 2 -
4.1.
Policy ................................................................................................................................... - 2 -
4.2.
Literature – General Comments ......................................................................................... - 2 -
4.3.
Guidelines ........................................................................................................................... - 3 -
4.3.1.
NHMRC ME/CFS Advisory Committee ........................................................................ - 3 -
4.3.2.
2002 RACP GUIDELINES .............................................................................................. - 4 -
4.3.3.
NICE Guides ................................................................................................................. - 5 -
5. PROFESSOR LLOYD ............................................................................................................ - 9 -
5.1.
No Consumer Support......................................................................................................... - 9 -
5.2.
Views of Professor Lloyd ................................................................................................... - 10 -
5.2.1.
Conflicting Evidence .................................................................................................. - 10 -
5.2.2.
The Dubbo Study ....................................................................................................... - 12 -
5.2.3.
The Guidelines........................................................................................................... - 15 -
6. EVIDENCE BASED TREATMENTS ....................................................................................... - 16 -
6.1.
Absence of Notification ..................................................................................................... - 16 -
6.2.
CBT, CET and GET .............................................................................................................. - 16 -
6.2.1.
NHMRC ME/CFS Advisory Committee’s Position ...................................................... - 16 -
6.2.2.
ME/CFS Australia’s Position ...................................................................................... - 21 -
6.3.
Risk of Harms .................................................................................................................... - 47 -
6.3.1.
Public Health Context................................................................................................ - 47 -
6.3.2.
Precautionary Principle ............................................................................................. - 47 -
6.3.3.
Harms and Treatment ............................................................................................... - 48 -
6.3.4.
Submission ................................................................................................................ - 51 -
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7. ADDRESSING THE LEGISLATION ....................................................................................... - 51 -
7.1.
Operative Legislation ........................................................................................................ - 51 -
7.2.
Addressing the Legislative Requirements ......................................................................... - 52 -
7.2.1.
Meaning of Disability ................................................................................................ - 52 -
7.2.2.
Element 1 - Impairments .......................................................................................... - 54 -
7.2.3.
Element 2 - Permanency ........................................................................................... - 56 -
7.2.4.
Element 3 - Activities ................................................................................................ - 60 -
7.2.5.
Element 4 - Participation .......................................................................................... - 64 -
7.2.6.
Element 5 – Lifetime Support ................................................................................... - 69 -
7.2.7.
Element 6 - Variation ................................................................................................ - 69 -
8. SUMMARY SUBMISSION ................................................................................................. - 70 -
9. LIST B-INCLUSION ........................................................................................................... - 71 -
10. ME/CFS ADVISORY GROUP.............................................................................................. - 72 -
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Executive Summary
What is ME/CFS Australia?
ME/CFS Australia Ltd. is a registered charity which has been the peak body for ME/CFS within
Australia since 1999. ME/CFS Australia is made up of member States and other organisations
representing the majority of people with ME/CFS throughout Australia. ME/CFS Australia is the
national advocate for those member organisations and together, form a collaborative network and
voice.
Definitions
ME refers to Myalgic Encephalomyelitis. CFS refers to Chronic Fatigue Syndrome. The organisation
utilises the combined acronym of ME/CFS to include patients diagnosed under the various criteria
for ME, CFS and ME/CFS.
NHMRC Recommendations
On 18 July 2019, the NHMRC ME/CFS Advisory Committee (‘the Committee’) provided a detailed
report to the NHMRC CEO, Professor Anne Kelso. The report included a number of specific
recommendations to the CEO, including recommendations to support research and treatment
options for ME/CFS. The Committee was composed of ME/CFS stakeholders, clinicians and patient
advocates – a diverse group representing the medical complexities of ME/CFS.
The national organisation received confirmation on 18 October 2019 that the Committee’s
recommendations of April 2019 had been accepted by the NHMRC CEO, Professor Anne Kelso
(encl.).
ME/CFS Australia is of the view that the Committee’s report represents a broad understanding of the
needs of patients, including identifying the fact that the current Australian treatment guidelines are
not fit for purpose and the inappropriateness of current NDIA assessment policy. The
recommendations acknowledged the change in the global ME/CFS research conversation and
captured the disconnect between Australian biopsychosocial treatments and the lived experience of
patients with ME/CFS.
On the specific issue of NDIS access, the Committee expressed their views under point 4.5.3 entitled
National Disability Insurance Scheme and access to supportive services. The report is succinct in its
description of the difficulties ME/CFS patients experience to gain access to the scheme. To quote the
document:-
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, DSP or supportive services. To access care
through the NDIS and DSP patients need to show they have a significant
disability. For these ME/CFS patients, graded exercise therapy may not be
appropriate. The following summarises the submissions’ proposed
recommendations to NDIS:
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•
recognition of ME/CFS as a serious debilitating condition
•
the condition should be listed on the NDIS under list B: neurological
disorders
•
that assessment guidelines for NDIA assessors be developed in
collaboration with clinicians with expertise in management of ME/CFS
and the ME/CFS community.
We would also like to draw your attention to point 5.3.3.1 of the NHRMC report entitled “Australian
ME/CFS Clinical Practice Guidelines”. The report states that the 2002 RACP CFS Guidelines are to be
updated and/or replaced by NHMRC developed clinical guidelines, which better represent clinical
pathways for ME/CFS. Please note that the report supports the use of a consistent diagnostic criteria
for clinical use and research.
ME/CFS Australia supports this recommendation and sees it as one of the key underlying issues in
the ongoing disconnect between the symptoms of chronic fatigue and the disabling condition,
ME/CFS. Older research outcomes, such as the The Dubbo Study and the Cochrane – In reviewing
psychotherapies for functional syndrome (including CFS), the authors identified multiple
methodological concerns in psychotherapy trials, including the high drop out rates and the selection
bias in sampling.. This criticism from Cochrane raises the credibility of ME/CFS Australia’s assertions
that studies with respect to ME/CFS are inherently flawed, particularly PACE; are in question due to
the limited applicability of the studies to more recent diagnostic criteria which include Post
Exertional Malaise as a defining symptom. The NHMRC ME/CFS Advisory Committee report
recommended the use of an adaption of the Canadian Consensus Criteria or International Consensus
Criteria.
Current Policy Concerns
In the correspondence dated 15 August 2018, the writer stated that the NDIA had consulted with
Professor Andrew Lloyd from the University of New South Wales. ME/CFS Australia is well versed
with Professor Lloyd’s background and research portfolio.
It was indicated that Professor Lloyd NDIA Policy across various key points, including the aetiology of
ME/CFS, medical and allied health specialities involved in diagnosis and treatment, clinically
indicated treatment options for the condition, likelihood of permanency, and the prevalence of
ME/CFS being diagnosed as a stand-alone condition as opposed to being part of a comorbidity. He
additionally provided information “regarding the evidence and research regarding Graded Exercise
Therapy (GET) and Cognitive Behavioural Therapy (CBT)”.
ME/CFS Australia has devoted significant time and efforts to reviewing the literature upon which
Professor Lloyd bases his opinion. It was noted that a significant portion of this comes from his own
research (approximately 30%), and much of which was outdated, and most of which was grounded
in the biopsychosocial model. A number of articles were in the process of review because the
approach to treatment and the evidence base surrounding it was called into question. We also found
significant contradictions and discrepancies within the evidence base provided, which we believe the
NDIA needs to be aware of.
With respect to Professor Lloyd’s opinion as to treatment requirements for ME/CFS and the efficacy
of those approaches, ME/CFS Australia, along with all patient organisations throughout Australia,
stand at odds with the view. Moreover, it is contrary to the current, established biomedical
research findings. It stands contrary to the position of the US Centres for Disease Control which has
expressly dropped the program put forward by Professor Lloyd and unequivocally stated “Exercise is
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not a cure for ME/CFS”. Most significantly, ME/CFS Australia asserts that the research relied upon
does not claim cure, nor indicate any significant indicators that the proposed treatment provide any
significant benefits, and certainly does not demonstrate any long term resolution to the condition.
Respectfully, Professor Lloyd’s opinion is fatigue centric. It is based on a broader definition of CFS in
which fatigue is the primary focus without due regard for the other symptoms of the condition -
particularly the cardinal symptom of Post-Exertional Malaise. This approach does not accord with
the generally accepted definitions applied by ME/CFS biomedical researchers - especially here in
Australia and as endorsed by the NHMRC report. The detailed explanation of our concerns can be
found in our attached PRELIMINARY MATTERS.
ME/CFS Australia does take particular umbrage with Professor Lloyd’s specific requirements
expressed as follows:
[ME/CFS must have] been present in a stable, non-improving pattern,
despite evidence-based management (such as … CBT … GET … and
cognitive remediation) for 5 years the Australian expert guidelines
indicate that the condition should be regarded as permanent for
medico-legal purposes.
To the knowledge of this organisation, cognitive remediation is not offered by any other clinic in
Australia or the world. It is only offered within Professor Lloyd’s Fatigue Clinic in NSW. There have
been no replication studies for his work, and the only large study on it is his own, and it includes
patients with cancer related fatigue - hence is a fatigue focused study - not an ME/CFS study. The
treatment does not appear in the RACP 2002 guidelines nor any other guideline anywhere in the
world. It is certainly not an NHMRC ME/CFS Advisory Committee recommendation - a body upon
which Professor Lloyd was a member. Pragmatically with a small clinic of limited resources located
only in Sydney, It is simply impossible for the vast majority of patients to
No Centres – The Fatigue
Clinic is based in Sydney. There is a facility in Melbourne that purports to deliver CBT, not uniform in
approach with Sydney. Outside of these locations, there is nothing, hence it is impossible for
people to access. Again, Rule 5.4. of the
Rules requires that the treatment be available. For the
majority of Australians, there is no availability;, let alone comply with in order to access the NDIS.
Based on its review and consideration of external research, ME/CFS Australia are very concerned
that the NDIA has only sought the view of one practitioner with experience in ME/CFS - a
practitioner with a very narrow, polarised view of the condition. There is simply no patient
organisation that supports his views, let alone his research. He and his researchers have never
involved a consumer organisation in that research. That, in our view, is a telling sign here, as to the
inappropriateness of the approach.
ME/CFS Australia is of the view that any policy approach should be drawn from consultation
with clinical and other experts across the biomedical field who address ME/CFS. .Most importantly,
a diverse clinical understanding of the condition can provide an expert opinion of the viability of any
potential treatments, identify potential limitations, as well as potential harms that might limit their
viability or general application.
Guidelines Concerns
ME/CFS Australia also holds concerns that the NDIA have relied upon the RACP 2002 and 2007 NICE
CFS Guides. The criteria deferred to in the NICE Guides do not reflect that used in Australia, and are
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13 years old. The medical and health framework in which they are set simply Lack of Available
Resources, hence they have no practical application even if they were valid. Due to their age, and
questions as to their fitness for purpose, these guidelines have been undergoing review for over two
years now.
The RACP Guidelines are 18 years old and defer to literature in the realm of 20 to 30 years old. Both
documents defer to criteria which apply to broader chronically fatiguing conditions - not ME/CFS.
The NICE Guides are simply not compatible with Australian medical framework - the care provided in
the guidelines is not available in Australia.
The NHMRC report discussed the review of CBT/GET efficacy outcomes, such as the Cochrane
Review - a commonly cited publication in ME/CFS literature which has been translationally applied to
ME/CFS clinical guidelines. This review is now complete and amendments made, but the editor-in-
chief of Cochrane conditioned those changes, stating “This amended review is still based on a
research question and a set of methods from 2002, and reflects evidence from studies that applied
definitions of ME/CFS from the 1990s.” Again, the Cochrane review is grossly outdated, and based
on unsafe criteria and research methodology, hence it is not appropriate to apply here in Australia
today.
Patient Concerns
Within the ME/CFS community, many have expressed concerns with respect to the NDIS application
and administration across a variety of issues. Reports include rejected applications, communication
channel difficulties and unknown expectations. Those few who have access have identified that the
planners are not listening to their needs, nor addressing them with appropriate solutions. The net
result of these engagements is the further deterioration in the condition itself, resulting in lower
capacity and an exacerbation of impairments. Adding to patient concern, is the lack of
understanding of ME/CFS by the NDIA leading to inconsistent decision making across Australia.
Three common reasons cited by our community for exclusion from the scheme include;
− that ME/CFS is a medical condition and not a disability;
− that the condition is not a disability because it is not permanent; and
− that the condition does not result in a substantial reduction of the various activities,
hence it is does not raise an impairment;
The NDIA correspondence makes it clear that applications are being assessed against the criteria
provided by Professor Lloyd. It is inherently apparent that the requirements set out by Professor
Lloyd are creating hurdles that are leading to the denial of applications on the above grounds.
ME/CFS Australia is firmly of the view that these requirements are flawed and causing unnecessary
delay in otherwise valid applications.
Discussion Points
ME/CFS Australia therefore see the key discussion points for our meeting as:
1. Discussion of the inclusion of ME/CFS into List B as recommended by the NHMRC ME/CFS
Advisory Committee – linking the NHMRC’s recommendations to current patient
requirements under the NDIS;
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2. Formation of an ME/CFS advisory group with the aim to establish NDIS policy which supports
our ME/CFS cohort based on contemporary research and clinical experience;
3. Discussion of how ME/CFS Australia can best support our community to successfully apply
for the NDIS, particularly the moderate to severely ill;
4. Discussion of the provision of services by ME/CFS Australia to those not covered by the NDIS
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1. PRELIMINARY MATTERS
1.1. Definitions
For clarity, a reference to ME is a reference to Myalgic Encephalomyelitis and a reference to CFS refers
to Chronic Fatigue Syndrome.
1.2. Nomenclature
For the purpose of clarity, the ME/CFS in our organisation’s name represents an ‘all-inclusive’ term,
encompassing CFS (as set out in the 1994 criteria), ME/CFS (as set out in the 2003 Carruthers, et al
consensus criteria) and ME (as set out in the criteria of 1988 Ramsay and the distinct ICC criteria of
the 2011 Carruthers, et al documents).
1.3. Brief Background
In approximately May 2017, ME/CFS Australia Ltd initiated contact with the NDIS and attempted to
engage the NDIA/NDIS on the specific issue of ME/CFS given significant feedback from individuals
indicating that their applications had been rejected on the basis that ME/CFS was a medical condition
not a disability. Most significantly, the members were reporting that the NDIA was stating that
ME/CFS was not permanent.
Multiple contacts were made with the NDIS with a view to discussing the potential for a List B
categorisation and clarification of the NDIA policy with respect to ME/CFS. Ultimately via contact
with the CEO in 2018, the NDIA began engagement with ME/CFS Australia. Discussions were held with
Ms. Faulkner around the ME/CFS issue, and access to the NDIA policy.
ME/CFS Australia was provided an insight into NDIA policy considerations with respect to ME/CFS via
Ms. Kate
s47F - persona D
irector A/G, Advisory Team, Technical Advisory and Complaints Branch, who was kind
enough to outline the foundation of the policy in her correspondence of 15 August 2018.
2. OPERATIONAL POSITION
Feedback to ME/CFS Australia from applicants to the NDIS have indicated that there is a consistent
position being expressed that ME/CFS, CFS and ME are not permanent conditions and most
significantly, the NDIA has expressed a position that most people recover. This appears to be the
default position.
3. THE TOPIC OF DISCUSSION
3.1. NDIA Policy
Ms. Agus had confirmed the following:
1. The NDIS does not have any policy/guidelines regarding determination of ME/CFS NDIS
applications and each case is assessed on a case by case basis in accordance with the
legislation;
2. The NDIS consulted with Professor Andrew Lloyd of the University of New South Wales;
3. Professor Lloyd was utilised because of his “credentials and experience”;
4. Professor Lloyd provided “information on the aetiology of ME/CFS, medical and allied health
specialities involved in diagnosis and treatment, treatment options clinically indicated for the
condition, likelihood of permanency, and prevalence of being diagnosis as a stand-alone
condition as opposed to being part of a co-morbidity.” He additionally provided information
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“regarding the evidence and research regarding Graded Exercise Therapy (GET) and Cognitive
Behavioural Therapy (CBT)”.
5. Professor Lloyd has purportedly advised the NDIA that:
(a) The evidence on permanency for ME/CFS is “conflicting”;
(b) “Information indicates that many individuals recover without intervention over weeks to
months”;
(c) “… approximately 10% will meet diagnostic criteria for ME/chronic fatigue syndrome at
six months”;
(d) Of that 10%, “a small subset may go on to suffer from both severe disabling and very
prolonged (greater than 5 years) ME/chronic fatigue syndrome” and “these patients may
be housebound or even bed-bound as a result of the illness and despite best available
evidence-based treatment”;
(e) When ME/CFS has “been present in a stable, non-improving pattern, despite evidence-
based management (such as … CBT … GET … and cognitive remediation) for 5 years, the
Australian expert guidelines indicate that the condition should be regarded as permanent
for medico-legal purposes”;
6. The NDIA considers the individual’s participation in the above alleged “evidence-based
treatments” so that permanency can be assessed. Without it, eligibility cannot be assessed;
7. The Australian Guidelines are the accepted guidelines for diagnosis and management and the
United Kingdom’s NICE Guides are also being used as a source of reference;
8. A list of references from Professor Lloyd was provided – with no context as to their use.
I do note, that Ms. Agus did not actually provide a copy of the document from Professor Lloyd, in
which he sets out his position.
4. KEY POINTS OF CONTENTION
4.1. Policy
It is noted that the NDIA deny the existence of a policy or a guideline with respect to ME/CFS.
However, the NDIA’s Ms. Agus has clearly stated that the NDIA are referencing advice of Professor
Lloyd when the NDIA “assess the potential permanency of the impairment”.
Respectfully, the dictionary definition of the word policy is “a course or principle of action adopted or
proposed by an organization or individual”. This definition appears to cover the characteristics of the
method by which the NDIA has applied the Lloyd advice. Claimants are clearly being rejected on the
basis of not being able to meet his requirement – hence a course of action is being taken, being a
denial of access to the NDIS.
Hereinafter, for ease of communication and consistency of understanding, we shall refer to the Lloyd
advice as the ‘policy’.
4.2. Literature – General Comments
By way of observation, we do note, with some concern, the age of the literature being cited by
Professor Lloyd, and the weight accorded to his own work, the work of his colleagues, or the work of
groups that he has affiliations with.
For what is a significant policy, we would have expected a much broader representation of the
literature that is available.
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4.3. Guidelines
Ms. Agus advises that the NDIA are referencing two sets of guidelines, being the 2002 RACP
Guidelines1 and the 2007 NICE Guides.2 We make three significant submissions:
4.3.1. NHMRC ME/CFS Advisory Committee
The Committee released its Draft report for consultation in December 2018, with submissions closing
on 18 February 2019.3 The final report was released on 18 July 2019.4 In this final report, the
committee (which included Professor Lloyd) made the following statements with respect to the
Guidelines issue:
1. The 2002 RACP Guidelines “…were developed at a time when not much was known about
ME/CFS”5;
2. “There has been considerable debate and concern about the 2002 RACP guidelines, including
that they recommend diagnostic criteria that could be seen to be too inclusive, not
considering post exertional malaise (PEM) as a mandatory symptom, as well as
recommending treatments such as graded exercise therapy and cognitive behavioural
therapy.”6;
3. “… they were not well received by all clinicians.”7;
4. “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.”8
5. “These guidelines, however, have been criticised by some patients, advocacy groups,
academics, some clinicians and some Australian and international researchers.”9
6. “The Committee advises updating or developing new Australian ME/CFS clinical practice
guidelines as well as developing General Practitioner educational material and patient
engagement strategies. The currency of these resources should be maintained to reflect the
latest high quality evidence; this may help to re-establish patient trust and confidence in
health care practitioners.”10;
7. “In the interim, the Committee recommends a range of resources for clinical use, currently
available on the NHMRC webpage for this project.”11;
We submit that the net effect of the NHMRC report is the retirement of the 2002 Guidelines in terms
of their clinical recommendations.
1 RACP Working Group, ‘Chronic Fatigue Syndrome - Clinical Practice Gudelines’
Med J Aust. 2002; 176: S17-55;
2 NICE, ‘Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management
(22 August 2007) < https://www.nice.org.uk/guidance/cg53>.
3 NHMRC ME/CFS Committee, ‘Consultation on the Myalgic encephalomyelitis and Chronic fatigue syndrome
Advisory Committee Report to the NHMRC Chief Executive Officer: Draft for Public Consultation’, (December
2018) <https://consultations.nhmrc.gov.au/public_consultations/mecfs-2019a>.
4 NHMRC ME/CFS Committee, ‘Consultation on the Myalgic encephalomyelitis and Chronic fatigue syndrome
Advisory Committee Report to the NHMRC Chief Executive Officer’, (30 April 2019)
<https://www.nhmrc.gov.au/file/14332/download?token=8q3RRIz6>.
5 Ibid, p. 5.
6 Ibid.
7 Ibid.
8 Ibid.
9 Ibid, p. 19.
10 Ibid, p. 20
11 Ibid.
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4.3.2. 2002 RACP GUIDELINES
With respect to the submissions of ME/CFS Australia, we put forward the following position with
respect to the 2002 Guidelines.
The RACP Guidelines were first drafted in 1997. 2002 was the final version that was ultimately
published. We make the following points:
1. the RACP Guidelines are 18 years old;
2. the RACP Guidelines have never updated;
3. no formal process of review has ever been conducted - at one point, only Professor Lloyd
was deferred to on the matter of updating the RACP Guidelines and his opinion was that
they were still fit for purpose. This is far from a formal or appropriate review process;
4. the science and knowledge base has moved forward significantly since the publishing of the
2002 RACP Guidelines, which were themselves based upon the bulk of journal articles up to
1997 (for the original draft), with very few from the period of 1998 to 2001 which preceded
the 2002 publication. In short – the weight of evidence is in the vicinity of 20 to 30 years
old – which is entirely unreasonable;
5. the NHMRC’s site on updated Guidelines is currently under development.12 In 1998
however, the relevant policy on
Guide to the Development, Implementation and Evaluation
of Clinical Practice Guidelines Development13 was very clear:
“A
date should be set for revision of the guidelines. The National Health and
Medical Research Council recommends that this
occur every three to five
years and more often where the subject matter or circumstances are
prone to
rapid change…
The potential for guidelines to be used as evidence in court depends on the
process used to develop them, the extent to which they are evidence-based,
the degree of consensus about them, and
whether they are up to date…
In general, guidelines should be summaries of the evidence, should have an
expiry date, should not be unduly prescriptive, and should acknowledge areas
where there is disagreement. An
independent review of the guideline
development process is recommended.”14 (Emphasis added)
It is also noted that the current NRMRC site does state:
“Guidelines issued by NHMRC
have a limited life. They are
regularly reviewed
and will be updated or withdrawn in light of important new evidence that
may emerge.”15
Whilst the RACP Guidelines were not endorsed by the NHMRC, there are a number of very
appropriate points to be made:
12 NHMRC, ‘Guideline for Guidelines’ (2019) <https://www.nhmrc.gov.au/guidelinesforguidelines/update>.
13 NHMRC, ‘A Guide to the Development, Implementations and Evaluation of Clinical Practice Guidelines’ (16
November 1998), <https://www.nhmrc.gov.au/sites/default/files/images/a-guide-to-the-development-and-
evaluation-of-clinical-practice-guidelines.pdf>.
14 Ibid, pp. 5-6.
15 NRMRC, Guideline, (2019), <https://www.nhmrc.gov.au/health-advice/guidelines>.
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• The limited life of these guidelines has been exceeded for quite some time – a
fact acknowledged by the NHMRC ME/CFS Advisory Committee (see above at
4.3.2.);
• 18 years is not 3 to 5 years;
• No date was ever set down for a revision of the guidelines;
• They are not up to date, hence not fit for use in court or other settings;
• No independent review of the guidelines ever took place.
The NHMRC process demonstrates the prudent practice that existed in 1998 when the 1997
draft guidelines were released. In the case of the RACP Guidelines this course of action has
not taken place. No revision policy or independent review was put into place. There has
been a clear breakdown in what ethical medicine would consider the prudent practice of
guideline revision to be.
ME/CFS Australia submit that the 2002 RACP Guidelines are not fit for the purpose to which
the NDIA has put them. Respectfully, there is no rational foundation to assert that such
guidelines could possibly represent best-practice, let alone reflect current knowledge;
4.3.3. NICE Guides
The use of the NICE Guides by the NDIA is particularly perplexing for ME/CFS Australia and we were
somewhat surprised that the NDIA would defer to such a document. We would make the following
points:
4.3.3.1. NHMRC ME/CFS Advisory Committee Views
The NHRMC ME/CFS Advisory Committee’s report reviewed the NICE Guidelines and noted the
following:
1. “Some patient groups have expressed concerns over the broad diagnostic criteria and
some treatment options suggested in the 2007 guidelines, including graded exercise
therapy.”16
2. “Patient mistrust and lack of confidence have also been observed in the UK and have
stimulated the revision of the NICE 2007 ME/CFS clinical guidelines, with patient/
consumer engagement a priority.”17;
ME/CFS Australia submits that the NHMRC’s observations of the 13 year old NICE Guide echo similar
concerns to that which exists with respect to the 2002 RACP Guidelines. The fact that the NHMRC
expressed such concerns, combined with the revision that is currently being undertaken, makes them
inappropriate for the NDIA to follow.
4.3.3.2.
UK Document ME/CFS Australia makes a number of observations and submissions with respect to the NICE Guides.
Firstly, the NICE Guidelines were not created by an international panel of experts with experience in
ME/CFS, ME or CFS. They are a domestic guideline for the United Kingdom that was created by way
of consensus committee whereby the majority of members were proponents of the biopsychosocial
view of ME/CFS. Significantly, one of the two patient representatives resigned from the Guideline
16 NHMRC, above n. 4, p. 6.
17 NHMRC, above n. 4, pp. 19-20.
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Development Group because she could not, as a patient representative who purported witnessed bias
and flaws in the process, support the NICE Guidelines as fit for purpose.18
Secondly, the literature review utilised the flawed York review methodology and excluded the vast
majority of biomedical evidence, including evidence of harms from exercise and focused upon the
psychosocial hypothesis, particularly that of one UK research group with a strong psychological bias.
Respectfully, the document is not fit for current usage in the health sector and has no relevance to
contemporary disability services.
4.3.3.3. Out of Date
Like the 2002 Australian Guidelines, the 2007 NICE Guide being 13 years old, and clearly out of date.
The NICE Guide acknowledges a review of evidence was to occur every 2 to 4 years – yet that did not
happen.19 A review occurred in September 2017, and concluded “there was no clear signal that
identified new evidence would result in changes to the recommendations”.20 Following stakeholder
consultation and evidence provided, NICE concluded “broader issues with the guideline were
highlighted that called into question the guideline scope and its current relevance.”21
A decision has been taken to “fully update the guidelines”22 and that is expected to be concluded by
14 October 2020.23
4.3.3.4. Apples and Oranges
Whilst the NICE Guide may well utilise the term CFS/ME. this is not the same condition that is
diagnosed here in Australia. We point out the following:
1. The definition utilised is not an internationally recognised criteria and is not utilised in
clinical practice here in Australia, hence it is incompatible;
2. The patient cohort that this specific criteria defines are not the same type of patient as
experienced here in Australia because of the over-inclusivity of the criteria - ergo their
requirements are different and more chronic fatigue patients are identified, as opposed to
CFS or ME/CFS;
3. The literature review considered and utilised numerous pieces of research that were
conducted using the Oxford Criteria, a criteria used only in the UK. Biomedical research
was largely not considered;
4. The Oxford Criteria is considered by contemporary health practitioners and researchers to
be overly inclusive because it only focused on fatigue and does not require the presence of
other symptoms. It is not used within the international research community and never
18 Tanya s47F - personal
privac ‘Personal Response to the NICE Guidelines on ME/CFS’ (22 August 2007)
<http://www.brame.org/contact2.html>.
19 NICE, above n. 2, p. 41.
20 NICE, ‘Surveillance report 2017 – Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy):
diagnosis and management (2007) NICE guideline CG53’, (20 September 2017)
<https://www.nice.org.uk/guidance/cg53/resources/surveillance-report-2017-chronic-fatigue-
syndromemyalgic-encephalomyelitis-or-encephalopathy-diagnosis-and-management-2007-nice-guideline-
cg53-4602203537/chapter/Surveillance-decision>.
21 Ibid.
22 Ibid.
23 NICE, ‘Myalgic Encephalomyelitis (or Encephalopathy)/Chronic Fatigue Syndrome: Diagnosis and
Management: In Development [GID-NG10091]’ (2019)
<https://www.nice.org.uk/guidance/indevelopment/gid-ng10091/documents>.
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utilised in Australia. Indeed, Lloyd and his colleagues were critical of the Oxford and
London criteria as far back as 199424;
5. The US National Institute of Health commissioned Pathways to Prevention review of
ME/CFS concluded:25
“Furthermore, the multiple case definitions for ME/CFS have hindered
progress. In particular, continuing to use the Oxford definition
may impair
progress and cause harm. Therefore, for progress to occur,
we recommend
that this definition be retired …”26 (Emphasis added)
The mere fact that the acronyms CFS and ME are utilised in the NICE Guidelines title, does not
accord them standing as equivalent or relevant to that which exists in Australia.
4.3.3.5. Lack of Available Resources
The NICE Guidelines are premised on the basis that the UK has various resources available within the
NIH framework. They have no application in Australia because:
1. The assumed knowledge of the GP community in the UK is significantly greater27;
2. There is an expectation of support for the guidelines from UK healthcare practitioners;28
3. There are National Health Services Specialist Services for people with CFS/ME in the UK that
can deliver services tailored to the condition and the individual;29
With respect, none of this framework exists in Australia. Even if the NICE Guidelines were fit for the
Australian experience, the fact is that their framework simply does not exist here. The NDIA is
holding applicants to an unachievable standard for the vast majority, simply because it has not
grasped that the infrastructure of the UK does not exist here.
4.3.3.6. CBT/GET
If the NDIA are taking on board the NICE Guidelines, there does appear to be some disparity in the
expectations by the NDIA, that the severely ill must have attempted CBT/GET, when the Guidelines
state
1.6.2.4. - Cognitive behavioural therapy (CBT) and/or graded exercise therapy
(GET) should be
offered to people with mild or moderate CFS/ME and provided
to those who choose these approaches, because currently these are the
interventions for which there is the clearest research evidence of benefit.30
(Emphasis added)
24 A. Wilson, I. Hickie, A. Lloyd, and D. Wakefield. ‘The Treatment of Chronic Fatigue Syndrome: Science and
Speculation’
The American Journal of Medicine 1994: 96(6); 544–550 at 544-545).
25 C.R. Green, P. Cowan, R. Elk., et al, ‘National Institutes of Health Pathways to Prevention Workshop:
Advancing the Research on Myalgic Encephalomyelitis/Chronic
Fatigue Syndrome’
Annals of Internal Medicine. 2015; 162: 860-865, p. 864.
26 NICE, above n. 2, p. 25.
27 Ibid, p. 2.
28 Ibid, p. 2.
29 MEAction, ‘National Health Service’, (13 February 2019) <https://me-
pedia.org/wiki/National_Health_Service>; NICE, ‘Specialist CFS/ME Care’ (August 2007)
<https://www.nice.org.uk/guidance/cg53/ifp/chapter/Specialist-CFSME-care>.
30 NICE, above n. 2, p. 25.
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We will come back to the relevance of this at a later point.
4.3.4.
Position with Respect to Guidelines
In light of the above review, ME/CFS Australia are of the view that the NDIA’s reliance on the 2002
Australian and UK NICE Guidelines is, for the majority of applicants, inappropriate and unsupported
by the current scientific and medical community. This cannot be emphasised more clearly than the
comments of the NHMRC.
ME/CFS Australia again defers to the NHMRC ME/CFS Advisory Committee’s final position on the issue:
“These guidelines, however,
have been criticised by some patients, advocacy
groups, academics, some clinicians and some Australian and international
researchers. The treatment recommendations made in the RACP guidelines,
including graded exercise therapy and cognitive behavioural therapy, as well
as the ambiguity around the management of the condition
have led to some
patient mistrust, and a lowering of patient confidence in the guidelines and
health care services more generally. Patient
mistrust and lack of confidence
have also been observed in the UK and have
stimulated the re-development of the NICE 2007 ME/CFS clinical guidelines, with patient/consumer
engagement a priority.”31 (Emphasis Added)
Given this position, but for a few potentially useful sections on medicolegal in the Australian
Guidelines, both should be abandoned by the NDIA altogether as unsafe.
The NHMRC ME/CFS Advisory Committee concluded that there was a strong need to re-establish
patient trust and confidence in clinical practice guidelines, and recommended that guidelines be
constructed internally by the NHMRC. In the interim, the NHRMC has adopted the 2003 Consensus
Criteria32 or the 2011 International Consensus Criteria33 (the ICC having been constructed here in
Australia with an international committee) and the 2017 Paediatric Primer34. The 2003 Consensus
Document contains an extensive clinical guideline which provides objective evidence to establish the
condition, and the criteria focuses upon the key symptoms that the 1994 Fukuda criteria omit.
It is noted that Professor Lloyd has provided the 2011 ICC Criteria paper to the NDIA, yet omitted the
three most significant documents, being the 2003 ME/CFS Consensus Guidelines35, the 2015 Institute
of Medicine’s redefinition of ME/CFS36 and the 2017 Paediatric Primer. The IOM paper draws heavily
of the 2003 and 2011 documents, as does the Paediatric Primer.
The 2003 criteria and guidelines are commonly utilised throughout Australia. In 2004, for example,
the South Australian government distributed a set of clinical guidelines based on the 2003 Consensus
31 NHRMC, above at n. 4, p. 19.
32 B.M. Carruthers, A.K. Jain, K.L. De Meirleir, et al, ‘Myalgic Encephalomyelitis/Chronic Fatigue Syndrome:
Clinical working Case Definition’.
Journal of Chronic Fatigue Syndrome, 2003; 11(1): 7-117.
33 B.M. Carruthers, M.I. van de Sande, K.L. De Meirleir, et al, ‘Myalgic Encephalomyelitis: International
Consensus Criteria’.
Journal of Internal Medicine, 2011; 279(4): 327-328.
34 Rowe PC, Underhill RA, Friedman KJ, Gurwitt A, Medow MS, Schwartz MS et al. Myalgic Encephalomyelitis/
Chronic Fatigue Syndrome Diagnosis and Management in Young People: A Primer.
Front Pediatr 2017; 5(121).
35 Carruthers et al, above n. 32.
36 IOM (Institute of Medicine). 2015.
Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining
an Illness. Washington, DC: The
National Academies Press.
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Guidelines, to all GPs in the state.37 Since then, a summary document has enabled practitioners to
implement the Guidelines in clinical practice.38
Respectfully, ME/CFS Australia submits that the NDIA’s reliance on the two nominated guidelines, that
are acknowledges as outdated, to the exclusion of the 2003 Guidelines and/or the 2011 ICC criteria
and 2017 Primer, has now been clearly signalled as inappropriate.
5. PROFESSOR LLOYD
5.1. No Consumer Support
We understand that the NDIA perceives that Professor Lloyd would be considered an ‘expert’ in the
area of ME/CFS. ME/CFS Australia would, however, make the following points:
1. Professor Lloyd’s research background is in CFS – not ME/CFS, nor ICC ME. His C.V. contains
his research portfolio and he does not research in either area. Respectfully, there is a
distinction;
2. Professor Lloyd and his work does not enjoy the support of any State or National
organisation or support group within the ME/CFS community and his research with respect
to GET and CBT is not held in high esteem by the majority of patients within Australia for
over a decade now;
3. There are multiple ME/CFS research programs throughout Australia, with equally
credentialled, if not better credentialled, research programs which study ICC ME and/or
2003 ME/CFS, as well as 1994 Fukuda CFS, and their views differ significantly on key issues
addressed by Professor Lloyd;
4. Professor Lloyd is out of step with the current prevailing views with respect to ME/CFS here
in Australia;
5. Professor Lloyd holds a significant perceived, if not actual, conflict of interest (pecuniary and
non-pecuniary) given he holds a key position within the Fatigue Clinic at the University of
New South Wales, where he is actively involved in the prescription of the highly contentious
treatments of CBT and GET. His conflict arises out the benefits derived from continuation of
these treatment recommendations, particularly when he holds a substantial part of the
market;
6. Professor Lloyd is a member of the NHMRC ME/CFS Advisory Committee and was fully aware
of the Committee’s preference for the 2003 Guidelines or 2011 ICC criteria and 2017
Paediatric Primer, yet had apparently not provided the 2003 Guideline, 2005 Summary
documents nor 2017 Paediatric Primer to the NDIA;
7. Professor Lloyd is regarded as a proponent of the psychosocial school of thought and his
literature provided to the NDIA reflects that approach in the weight of documents provided.
37 Government of South Australian, Human Services. Metropolitan Division.,
Myalgic Encephelopathy/Chronic
Fatigue Syndrome (CFS): Management Guidelines for General Practitioners (2004)
<https://sacfs.asn.au/download/guidelines.pdf>.
38 B.M. Carruthers and M.I. van de Sande,
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Clinical Case
Definition and Guidelines for Medical Practitioners: An Overview of the Canadian Consensus Document, (2005)
<http://sacfs.asn.au/download/consensus_overview_me_cfs.pdf>.
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ME/CFS Australia does not endorse, nor would it recommend, the views of Professor Lloyd.
Respectfully, it would be inappropriate of the NDIA to dismiss the view of the consumers, the
national representative body and its member states organisations, particularly when those views are
shared by the NHMRC ME/CFS Advisory Committee in its report to the CEO of the NHMRC.
ME/CFS Australia’s view are by no means intended to disparage or disrespect Professor Lloyd or his
work. ME/CFS Australia is a patient organisation which is well versed in the views of its members.
We are therefore reflecting the views of the patient community when stating that Professor Lloyd
does not represent the contemporary views of the wider Australian ME/CFS consumer and research
community. We would submit that the NDIA should not be deferring to a minority view, particularly
when the weight of evidence supports alternative views.
5.2. Views of Professor Lloyd
We note that the NDIA have outlined a series of views put forward by Professor Lloyd that have
fuelled the NDIA’s policy with respect to ME/CFS. ME/CFS Australia will address each in succession.
5.2.1. Conflicting Evidence
The NDIA have stated that Professor Lloyd reports that the evidence as to whether ME/CFS is
permanent is ‘conflicting’. The NDIA do not elaborate upon the details of those comments, the
literature upon which Professor Lloyd bases his opinion, nor how he arrives at his conclusion that the
evidence is conflicting.
5.2.1.1. NHMRC ME/CFS Advisory Committee’s View
The NHMRC ME/CFS Advisory Committee provided a cursory examination of the literature with
respect to the issue of recovery, reliant primarily upon the 1993 and 2003 Australian Burden of
Disease (‘ABD’) data.39 With no disrespect to the NHMRC ME/CFS Advisory Committee, the
Committee failed to check the references behind the position of the 2003 ABD figures.40
Respectfully the ADB authors commit the same error that the NDIA has with respect to the ‘Dubbo
Study’ (see: below at 5.2.2) and fail to distinguish between the research team’s identification of
provisional cases of Post Viral Fatigue Syndrome (89% of cases) and actual PVFS (11% of cases). To
this end, the NHMRC’s comments with respect to the ADB are unreliable.
The NHMRC Advisory Committee’s report indicates that there are broad range of:
“In comparison, international estimates for recovery indicate 17-64% of
patients improve with treatment, but less than 10% of patients have full
recovery to pre-morbid levels of functioning, and approximately 20% of
patients may worsen overtime.
This is in contrast to recent paediatric data, which indicate that the majority of
young people (who seemed to be more likely to have infection as a trigger)
39 NHMRC, above n. 4, p. 9.
40 S. Begg, T. Vos, B. Barker, C. Stephenson, L. Stanley, and A.D. Lopez, ‘The Burden of Disease and Injury in
Australia 2002’, (May 2007) https://www.aihw.gov.au/getmedia/f81b92b3-18a2-4669-aad3-
653aa3a9f0f2/bodaiia03.pdf.aspx, pp 178-179.
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had a mean duration of illness of five years with a range of 1-15 years. By five
years, 38% reported recovery and by 10 years 68% reported full recovery.
In the 2011 ABDS study, however, ME/CFS was excluded as a separate disease
given the then outdated prevalence estimates used in the 2003 ABDS. Instead
ME/CFS was included under ‘other neurological diseases’.38 These ‘other
neurological conditions’ (including ME/CFS) were responsible for 9.8% of the
total DALYs for neurological conditions in 2011.”41 (Footnotes Omitted)
ME/CFS Australia observes that whilst the NHMRC indicates that there has been a wide range of
estimates for recovery, the committee did not distinguish between the measures used to assess
recovery, nor how many measurers were utilised. It is our view that the issue of recover warrants a
more thorough examination.
5.2.1.2. ME/CFS Australia’s View
ME/CFS Australia submits that:
1. The assertion that evidence is conflicting is correct to the extent that issues with respect to
defining recovery, and/or measuring recovery with subjective measures has caused
conflicting outcomes;
2. The NIH Pathways to Prevention committee “recommend … the ME/CFS community …
patients, clinicians, and researchers agree on a definition for meaningful recovery.”42
3. The IOM review of ME/CFS literature showed an equivocality of evidence with respect to
prognosis and recovery.43 Specifically, the IOM noted:
(a) that “[s]everal studies found that 20 to 48 percent of pediatric patients diagnosed using
the Fukuda definition showed no improvement or actually had worse fatigue and
physical impairment at follow-up times ranging from 2 to 13 years”44;
(b) identified that the research on recovery is impacted by the fact that the 1994 Fukuda
CFS definition does not require post-exertional malaise (‘PEM”), which is a hallmark of
the condition, hence the 2003 and 2011 Carruther’s criteria diagnose a more defined
patient population45;
(c) “… studies of recovery from ME/CFS vary widely as a result of the use of different case
definitions in the study samples; differing definitions of “recovery”; the lack of temporal
metrics of function obtained before, during, and after treatment; and the use of
patients’ subjective assessment of their own progression of illness and recovery”46;
(d) that a 2014 systematic review of 22 studies on recovery, revealed that studies where a
single domain was measured tended to show high recovery rates, whereas those with
multiple domains measured significantly lower rates of recovery. The study also
identified that “the term ‘recovery’ often included less than full restoration of health as
reported by the patients, and typically was based on limited assessment.”47 The study
41 NHRMC, above at n. 4, p. 9.
42 Green et al, above n. 25, p. 864.
43 IOM, above n. 35, p. 183.
44 Ibid.
45 Ibid, pp. 259-260.
46 Ibid.
47 Ibid, pp. 263-264.
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also noted that the majority of studies into recovery failed to utilise objective measures
of recovery, making it impossible to determine if recovery actually occurred;
(e) various other systematic reviews that utilised objective measures of recovery
demonstrate that whilst some patients improved, the majority did not fully recover and
remained symptomatic.48
With respect, what Professor Lloyd has not presented to the NDIA is the fact that objective measures
of recovery tended to show that patients did not fully recover and stayed symptomatic. Studies
using subjective data, or using single domains to define recovery, created the perception of
recovery.
ME/CFS Australia submits that the key issue that the NDIA is focused upon is whether the individual
returns to health or maintains symptoms of the condition. The fact is, the IOM demonstrated that
studies which focused on objective measures did not reveal recovery. This is significant and is
congruent with our experience of our membership and the patient community.
5.2.2. The Dubbo Study
The NDIA have asserted, based on Professor Lloyd’s opinion, that
1. “Information indicates that many individuals recover without intervention over weeks to
months”;
2. “… approximately 10% will meet diagnostic criteria for ME/chronic fatigue syndrome at
six months”;
3. Of that 10%, “a small subset may go on to suffer from both severe disabling and very
prolonged (greater than 5 years) ME/chronic fatigue syndrome” and “these patients may
be housebound or even-bed bound as a result of the illness and despite best available
evidence-based treatment”;
With respect, the outcomes of the Dubbo study have been misconstrued. ME/CFS Australia submits
as follows:
5.2.2.1. Recovery Without Intervention
The 2006 study by Lloyd and his colleagues (‘the Dubbo study’) followed the patients of 94
practitioners who had acute Epstein-Barr virus, Q-fever or Ross River Fever.49 Before progressing,
ME/CFS Australia will make four very clear points with respect to the limitations of the study:
1.
Infections - The study clearly outlines that CFS can result from “acute infectious illness” and
outlines that “post-infective fatigue states have been linked to a diverse spectrum of
infections”50. The study outlines the numerous infections that can occur, but then focus in
on just three.51 This therefore makes the study an exceptionally limited one in the scheme
of CFS. It is not a study that can be generalised as reflective of all CFS. The 2007 Burden of
48 Ibid, p. 264.
49 I. Hickie, T. Davenport, D. Wakefield, U. Vollmer-Conna, B. Cameron, S.D. Vernon, W.C. Reeves, and A. Lloyd,
‘Post-infective and Chronic Fatigue Syndromes Precipitated by Viral and Non-Viral Pathogens: Prospective
Cohort Study’
BMJ 2006; 333(75688): 575-581, 575.
50 Ibid.
51 Ibid.
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Disease report claims that “post-infective fatigue syndrome … constitutes between 30%-40%
of cases”52. The study only refers to three infectious agents – hence in the scheme of CFS, it
represents less than 10% of the cases;
2.
Recovery - The study does not, at any time, define recovery, nor deal or purport to deal with
the issues of recovery. The NDIA is extrapolating something which is not present. There is
nothing in the study that allows the NDIA to claim that recovery without intervention has
occurred53;
3.
No Follow-up – The study followed patients with CFS for one year. All participants enrolled
were assessed at 12 months, but there has never been a follow-up study beyond 12 months.
The onset of CFS can be gradual. That means that the onset of CFS in those who did not
initially quality at 6 months or those who ‘recovered’ from CFS within two years, were never
checked to see if the condition subsequently occurred, or if it returned to those previously
diagnosed. This is an exceptionally significant weakness in the study in a condition where
onset can be delayed or recurrent.
On the basis of these issues alone, the NDIA’s elevation of the study to a position in which all
sufferers of ME, ME/CFS or CFS are to be assessed, is simply scientifically unconscionable, medically
incorrect and morally wrong.
5.2.2.2. Misconstrued Case Definitions
The NDIA has clearly misconstrued 89% of the participants as having CFS, when the study did not
claim that this was the position. This is a major oversight by the NDIA.
The study set down the case definitions very clearly:
“
Case definitions
We classified participants as
provisional cases of post-infective fatigue
syndrome if their SOMA scores at all time points
up to and including three
months exceeded the established threshold score. We invited these cases,
and control participants matched by age and sex
who had recovered
promptly from the same infection, at six months for a medical interview, examination by a physician (AL), and laboratory investigation to exclude
alternative medical explanations for ongoing symptoms, such as
hypothyroidism or primary sleep disorder. A psychiatrist (IH) also assessed
them, to ensure that no exclusionary psychiatric diagnosis was evident and
to allocate comorbid diagnoses according to the Diagnostic and Statistical
Manual of Mental Disorders, fourth edition (DSM-IV).
Where appropriate, AL
and IH diagnosed the chronic fatigue syndrome (termed here confirmed
post-infective fatigue syndrome) by consensus at six months after the onset
52 Begg et al, above n. 40, p. 178.
53 Hickie et al, above n, 49, p. 575.
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of symptoms, according to the international diagnostic criteria.”54
(Footnotes omitted, Emphasis Added)
For absolute clarity – only those patients who had persisting fatigue symptoms at the end of 6
months were able to be accorded a diagnosis of Chronic Fatigue Syndrome (or Post Viral Fatigue
Syndrome – ‘PVFS’) as the authors called it.
The study clearly showed that of the 250 cases of
provisional PVFS, only 28 went on to receive a
diagnosis of Chronic Fatigue Syndrome (i.e. the other 89% that did not make it to the 6 month mark
did not, at any stage, achieve PVFS, hence were never CFS).55 Again – the word provisional is used
deliberately. These remaining 28 patients had more than simple fatigue, and met the Fukuda 1994
criteria.
Whomever reached the conclusion that the majority of participants recovered from CFS without
intervention is grossly in error.
Whilst PVFS comes under the category of a CFS diagnosis, the patients prior to end of 6 months only
had a provisional diagnosis of PVFS. Until their fatigue (and other) symptoms reached 6 months and
1 day, they did not have PVFS – they were merely potential candidates for the diagnosis. Only 28 of
250 reached that point.
Given this is the case, the NDIA statement that the majority recover without intervention is patently
false. They never had the diagnosis of CFS to recover from in the first place.
It must be reiterated again that the Dubbo study was a very limited study, in that it only followed the
patients who experienced one of three viruses. There are numerous causal associations as well as
unknown causes for CFS.56
5.2.2.3. Meeting Diagnostic Criteria
The statement by the NDIA that “… approximately 10% will meet diagnostic criteria for ME/chronic
fatigue syndrome at six months” – is completely incorrect.
Yes, in the study of PVFS there was a result of 12% of participants meeting the criteria for PVFS at 6
months – this is fact (n=29/250).57 At 12 months, 9% (n=22/250) of the original cohort had a
diagnosis of PVFS. This a study of PVFS specifically. That means at 12 months, 75% of patients who
acquired a diagnosis of PVFS at the 6 month point, still held the diagnosis.
As stated above at 5.2.2.1. this is a study of a limited number of infectious agents causing PVFS.
PVFS accounts for 30-40% of cases. These infectious agents account for less than 10% of CFS cases.
54 Ibid, p. 576.
55 Ibid, p. 577.
56 IOM, above n. 35, p. 192.
57 Hickie et al, above n. 49, p. 577.
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There was nothing in the study that suggested that there was no intervention in the cases that did
not meet the criteria at 12 months.58
5.2.2.4. Severe Cases
ME/CFS Australia asserts that there is nothing in the Dubbo study that equates to 10% of CFS patients
going on to be severe. This is factually apparent in the text.
A cursory literature review of Professor Lloyd’s work reveals that there is no study by Lloyd that
indicates that 10% go onto be severe. Most significantly, this figure stands contrary to the
comprehensive IOM literature review and findings encompassed under the heading of “Disability and
Impairment”:
“Several ME/CFS symptoms—including fatigue, cognitive dysfunction, pain,
sleep disturbance, post-exertional malaise, and secondary depression or
anxiety—may contribute to impairment or disability (Andersen et al., 2004;
Tiersky et al., 2001).
Patients with ME/CFS have been found to be more
functionally impaired than those with other disabling illnesses, including
type 2 diabetes mellitus, congestive heart failure, hypertension, depression,
multiple sclerosis, and end-stage renal disease (Jason and Richman, 2008;
Twisk, 2014).
Symptoms can be severe enough to preclude patients from
completing everyday tasks, and 25-29 percent of patients report being
house- or bedbound by their symptoms. Many patients feel unable to meet
their family responsibilities and report having to reduce their social activities
(NIH, 2011). However, these data include only patients who were counted in
clinics or research studies, and may underrepresent the extent of the
problem by excluding those who are undiagnosed or unable to access health
care (Wiborg et al., 2010). More information on disability in ME/CFS can be
found in Appendix C.”59 (Emphasis Added)
Respectfully, the unsubstantiated and unreferenced opinion of Professor Lloyd should not be
preferred over that of the detailed IOM literature review.
For the purposes of clarity, the figure of 25% is often cited. More often than not these most serious
cases are omitted from studies because the condition prevents the severe and very severe from
participation in the majority of studies.60 Those who do undertake research into ME/CFS rarely take
the studies to participants at the severe end of the spectrum, in their residences. Most significantly,
the IOM suggests that limitations on the cited studies mean that the figure of house-bound patients
is likely to be higher.
5.2.3. The Guidelines
The NDIA have asserted, based on Professor Lloyd’s opinion, that when ME/CFS has “been present in
a stable, non-improving pattern, despite evidence-based management (such as … CBT … GET … and
cognitive remediation) for 5 years, the Australian expert guidelines indicate that the condition
58 Ibid.
59 IOM, above n. 35, pp. 31-32.
60 Ibid, p. 72.
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should be regarded as permanent for medico-legal purposes”.
6. EVIDENCE BASED TREATMENTS
The NDIA states that it considers the individual’s participation in “evidence-based treatments”
(being CBT and GET) is required before permanency can be assessed. ME/CFS Australia wishes to
express its concern on this specific issue from a number of perspectives.
6.1. Absence of Notification
The NDIS provides information about accessing the NDIS on its website. Under the “Providing
Evidence”61 tab, there is no information provided which indicates that the NDIA will be assessing the
application by way of reference to a policy. It does notify that additional evidence might be
required. There is nothing at any point in the Guidelines that indicates that the NDIA will reference
an undisclosed policy.
ME/CFS Australia wishes to register its concern that the NDIA holds and is applying a policy to
applicants without revealing:
(a) that the policy exists;
(b) that a discrete decision process is occurring in which that policy is being applied; and
(c) without having provided applicants a copy of the policy so that procedural fairness is
accorded and more information provided to address the policy requirements.
We are particularly concerned that those who have applied for information under a Freedom of
Information request were not provided with, nor made aware of, the existence of the policy, nor
provided a copy.
In our view, the NDIS application process should be transparent. As it currently stands, that is not
the case.
6.2. CBT, CET and GET
The NDIA has apparently been provided evidence and recommendations from Professor Lloyd that
held CBT, Cognitive Remediation (‘CET’) and GET to be essential requirements in the treatment of
ME/CFS. In relying upon those representations, the NDIA has subsequently elevated such
treatments to a status whereby an application is denied if the applicant has not engaged in these
treatments and demonstrated no benefit.
ME/CFS Australia holds grave concerns for this position and the evidence base upon which it is
founded. The organisation therefore makes the following submissions.
6.2.1. NHMRC ME/CFS Advisory Committee’s Position
The NHMRC ME/CFS Advisory Committee expressed the following:
61 NDIS, ‘Providing Evidence’ (16 January 2019) <https://www.ndis.gov.au/applying-access-ndis/how-
apply/information-support-your-request/providing-evidence-your-disability>.
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1. When addressing the 2002 RACP Guidelines and their recommendations of GET/CBT as
the treatment option of preference, the NHRMC ME/CFS Advisory Committee stated:
“There has been considerable debate and concern about the 2002
RACP guidelines, including that they recommend diagnostic criteria
that could be seen to be too inclusive,
not considering post exertional
malaise (PEM) as a mandatory symptom, as well as
recommending
treatments such as graded exercise therapy and cognitive
behavioural therapy. However, the historical context of these
guidelines must be noted, as they were
developed at a time when not
much was known about ME/CFS. They provided some guidance for
clinicians on a poorly recognised condition that did not have much
evidence on causation, including
guidance on ways to manage
ME/CFS. 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.”62
(Footnotes omitted; Emphasis Added)
The submissions of this organisation were ignored. Without placing too fine a point on
it, the concerns raised were accurate and well founded.
2. With respect to the NICE guidelines, the NHMRC Report states:
“Some
patient groups have expressed concerns over the broad
diagnostic criteria and some treatment options suggested in the 2007
guidelines,
including graded exercise therapy.”63 (Emphasis added)
Once again it is the end users, being the patient groups, that are expressing concerns
over GET, and once again, the guideline is under review.
3. The NHMRC Advisory Committee has recognised that GET is particularly controversial:
“
Controversial treatments such as graded exercise therapy have
contributed to a disparity in approaches and some disengagement
between patients and clinicians.”64 (Emphasis added)
4. The Committee then stated:
62 NHMRC, above n. 4, p. 5.
63 Ibid, p. 6.
64 Ibid, p. 8.
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“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 harm 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...
Graded Exercise Therapy is considered a controversial treatment and
there is some ambiguity in its application in the clinical care setting. The primary reported concern with recommending graded exercise
therapy for ME/CFS patients is it
causing post-exertional malaise
(PEM), exacerbation of symptoms and unintended harm. Many public
consultation submissions
expressed concern about the potential for
harm from graded exercise therapy.
Some specialist clinicians and researchers maintain that graded
exercise therapy is effective
when correctly administered as a patient-
centred management strategy, 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 United States 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. 11-1348
A Cochrane review of exercise therapy for ME/CFS is currently the
subject of ongoing review, with an update posted on Cochrane’s
website in March 2019:
“
Cochrane’s editors and the review author team have jointly agreed
that there will be a further period up to the end of May 2019, in which
time the [review] author team will amend the review to address
changes aimed at improving the quality of reporting of the review and
ensuring that the conclusions are fully defensible and valid to inform
health care decision making. The changes will also address concerns
raised in feedback since the …complaint. The amendment will not
include a full update, but a decision about this will [be] made
subsequently.”
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Concern about the potential for harm from graded exercise therapy
was a common theme expressed in public consultation submissions, and the Committee acknowledged this as a reality for many patients.
The Committee noted that
GET should not be offered as a cure for
ME/CFS but that it might have a role in a patient’s overall management
strategy, helping with any secondary anxiety, de-conditioning and
stress.”65 (Footnotes omitted; Emphasis added)
The key reason for the NHMRC Advisory Committee’s attention to these issues was the
feedback of the end users of these treatments and the users’ reporting of harms.
A recent English study into the reporting of harms and adverse outcomes during or after
rehabilitative therapies by NIH specialist centres demonstrated that “there was an
almost universal absence of criteria for detecting harm, and that no clinic reported any
harm as having occurred in their patients.” 66 Most strikingly the paper reported that
“clinics mainly reported providing little information to patients about the possibility of
harm, although several advised patients that setbacks or relapses could happen”67:
Within Australia there are a few of clinics scattered throughout the country and it is
clear from our experience that:
(a) They have no formal, ongoing patient follow up;
(b) They do not follow up those who drop out to identify reasons for their
drop-out, such as harms;
(c) No longitudinal studies have been undertaken to see the impact of GET
over the long term.
There are of course, various providers that purport to provide GET, yet they do so with
no real understanding of the condition, no appreciation of the potential harms, nor any
structure to report harms. In their 2018 survey, Emerge Australia noted:
“The findings clearly show that
increased activity/exercise makes
most people feel worse. A total of 89% reported feeling worse
after increasing their level of exercise/activity, comprised of 54%
reporting they feel worse straight away and 35% reporting that
they initially feel better, but then feel worse later.
Only 5% report
that exercise/activity makes them feel better. For those with
severe symptoms, the incidence of
gaining any benefit from
increased activity/exercise is much lower (26% better at first
then worse, 3% better), the majority just feel worse (68%).
65 Ibid, pp. 11-12.
66 G. McPhee, A. Baldwin, T. Kindlon and B.M. Hughes ‘Monitoring Treatment Harm in Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome: A Freedom-of-Information Study of National Health Service
Specialist Centres in England.’
J Health Psychol. 2019 Jun 24: 135910531985453, p. 8.
67 Ibid.
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Of those who said they feel worse after increased
activity/exercise, for a quarter of people it is immediate (28%),
with around a third (37%) saying it takes a few days.
Recovery
from feeling worse after increased activity/exercise mostly takes
some time, with 69% reporting the recovery period as days, and
27% saying it can take weeks. … The treatments most often reported as making people feel
worse were:
•
Graded exercise therapy (47%);
•
Graded activity therapy (38%); and
•
Hydrotherapy (28%).”68 (Emphasis added)
Emerge Australia particularly noted that there was a higher reporting of deterioration
caused by the various exercise regimens among the severely affected, compared to
those with mild/moderate symptoms.
5. The NHMRC Advisory Committee then reviewed the key study unpinning the majority of
the evidence base that Professor Lloyd presented with respect to Graded Exercise.69
The PACE Trial utilised the now retired Oxford Criteria. The NHMRC specifically noted
that if the PACE trial was taken on face value, the best that the study demonstrated was
that “the use of cognitive behavioural therapy and graded exercise therapy in treating
ME/CFS as the results implied a moderate improvement of outcome measures.”70
There was no evidence that the effect was permanent or sustained.
The committee noted the sustained criticism of the study, the sustained attempt by the
researchers to prevent access to data, and ultimately the fact that reanalysis of the
eventually released data showed the authors “overstated claims of benefit for cognitive
behavioural therapy and graded exercise therapy through methodological alterations
made throughout the study that skewed outcomes”.71 The NHMRC also criticised the
trial because it specifically omitted those who had severe CFS, and likely included those
with fatiguing conditions that were not ME/CFS.72
6. The NHMRC Advisory Committee specifically address the issue of the NDIS requiring
patients to undergo GET73, stating:
“Advocates have raised concern about the
lack of understanding of
the condition by National Disability Insurance Agency (NDIA)
68 Emerge, ‘Emerge Australia Health and Wellbeing Survey of Australians with ME/CFS: Report of key findings’
(September 2018), <https://emerge.org.au/wp-content/uploads/2018/09/Emerge-Australia-Health-and-
Wellbeing-Survey-of-Australians-with-MECFS-2018.pdf>, p. 2.
69 NHMRC, above n. 4, p. 11.
70 Ibid.
71 Ibid.
72 Ibid, p. 12.
73 ibid.
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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, DSP or supportive
services. To access care through the NDIS and DSP patients need to
show they have a significant disability.
For these ME/CFS patients,
graded exercise therapy may not be appropriate.”74 (Emphasis
added)
The NHMRC identify that severity is a factor that is not being recognised by the NDIA
when assessors are rejecting claims because they require GET. GET is not appropriate
for such people. The risk of harm is far too high.
6.2.2. ME/CFS Australia’s Position
6.2.2.1. The NDIA Rules
Rule 5.4. of the
National Disability Insurance Scheme (Becoming a Participant) Rules 2016 (‘the
Rules’) states:
“An impairment is, or is
likely to be, permanent (see paragraphs 6.2(a)(i) and
(ii)) only if there are no known,
available and
appropriate evidence-based
clinical, medical or other treatments that would be LIKELY TO REMEDY the
impairment.” (Emphasis Added)
Respectfully – the NDIA is required to apply the rules as it is written and intended, and not merely
apply a policy without due regard for how it acquits the requirement of that rules.
There is an apparent disconnect between the outline provided by the NDIA, and the requirement
under the Rules.
6.2.2.2. Submissions of Specific Treatments
Whilst ME/CFS Australia is in substantial agreement with the views of the NHMC Advisory
Committee identified above, ME/CFS Australia would submit the following on the specific
treatments put forward:
• CBT and GET have been expressly removed by the Centres for Disease Control from its
recommended treatments since 2018, and Cognitive Remediation is not and has never been
recommended;75
• CBT, Cognitive Remediation or GET has not been utilised in those with severe ME/CFS at any
time, hence there is no evidence base for this group;
• Neither CBT, Cognitive Remediation nor GET is curative (i.e. not likely to remedy);
• Neither CBT, Cognitive Remediation nor GET has been shown in any study to demonstrate a
sustained improvement in symptoms;
74 NHMRC, above n. 4, p. 11.
75 Centres for Disease Control and Prevention, ‘Myalgic Encephalomyelitis/Chronic Fatigue Syndrome:
Treatment’ (12 July 2018) < https://www.cdc.gov/me-cfs/treatment/index.html>.
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• Neither CBT, Cognitive Remediation nor GET that is provided in Australia, is the same as
what was studied in the PACE trial and is therefore not compatible with that research;
• There is no evidence-base to recommend either treatment.76
On specific matters, ME/CFS Australia submits as follows:
6.2.2.2.1.
ME/CFS Has No Cure
First and foremost, we make it clear to the NDIA that it is the position of ME/CFS Australia, and
indeed every patient organisation and/or advocate in Australia, the NHMRC, the US NIH and CDC,
the UK NICE, advocates, researchers and the like, that there is no treatment or management
available anywhere in the world that ‘cures’ ME/CFS.77,78,79
ME/CFS Australia is confident that Professor Lloyd would not and did not claim that CBT would cure
ME/CFS. We make this statement because it not apparent what the NDIA itself had interpreted his
advice to mean.
6.2.2.2.2.
Likely to Remedy
Secondly, it is ME/CFS Australia’s position that the three treatment options that the NDIA are reliant
upon are not, in fact, likely to remedy the impairments outlined in Section 24(a) of the
NDIS Act –
being intellectual, cognitive, neurological, sensory, physical or psychiatric. The NDIS
Operational
Guidelines at 9.2. explains the meaning of “likely to remedy” as “cure or substantially relieve”80 We
have reviewed the relevant case law within the AAT and Federal Court jurisdictions, and the phrase
is given its ordinary meaning, consistent with the guideline.
6.2.2.2.2.1. No Appropriate Evidence Base
Rule 5.4 expressly requires there to be an appropriate evidence base with respect to a remedy for an
impairment.
ME/CFS Australia submit on a global basis encompassing all three treatments, that even at its
strongest, there simply is no satisfaction of Rule 5.4. of the
Rules, being no appropriate evidence
base within the literature provided by Professor Lloyd, or indeed any literature that achieves the bar
set by the legislation: that being a remedy for an impairment or impairments arising from ME/CFS.
This position is not simply a self-serving statement of ME/CFS Australia. Self-evidently it is in the
interests of the patient community that there be remedies for the condition and that if this were so,
it would be embraced accordingly. This position is based upon experience and constant literature
review by our Medical Consultant, as well as the decades of experience and monitoring of literature
76 IOM, above n. 36, pp. 264-265.
77 Carruthers et al, above n. 32, p. 50.
78 IOM Committee, above n. 36, p. 10.
79 NICE, above n. 2, p. 19.
80 NDIS, ‘Access to the NDIS - Early intervention requirements’, (16 July 2019)
<https://www.ndis.gov.au/about-us/operational-guidelines/access-ndis-operational-guideline/access-ndis-
early-intervention-requirements>.
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by our directors (several of whom have the skills and experience in research required to conduct
such reviews).
Professor Lloyd does, however, provide the 2015 IOM report. Within Chapter 4 of the report, the
IOM Committee expressly reviewed the evidence base with respect to treatments for ME/CFS and
CFS and drew the following conclusion:
“Similar to the literature on treatment in ME/CFS patients,
there is little
evidence on the efficacy of interventions in ME/CFS patients with respect to
function and disability.
The efficacy of cognitive-behavioral therapy (CBT) in improving cognitive
function in ME/CFS patients is unclear. Knoop and colleagues (2007) found
a decrease in self-reported cognitive impairment following CBT, yet ME/CFS
patients did not differ from a support control group on results of the subscale
of alertness behavior of the Sickness Impact Profile (SIP-ab).
These results do not preclude the use of CBT to mitigate cognitive
impairment in ME/CFS, but do suggest that any effects of CBT may not be
measurable by a single scale such as the SIP-ab.
A systematic review showed that while a few studies found improvement in
symptoms over time,
no variables, including gender or length of illness,
predicted improvement or positive work or functional outcomes (Ross et al.,
2002). Furthermore, analysis of existing studies revealed
no evidence of
treatments effective at restoring the ability to work. Another systematic
review found that the placebo response is lower in behavioural intervention
studies than in medical intervention studies of patients with ME/CFS (Cho et
al., 2005).
Consistent with the findings of the systematic review of Ross and colleagues
(2002, 2004), studies reviewed by Taylor and Kielhofner (2005) provided no
evidence regarding the efficacy of employment rehabilitation, such as CBT
and/or graded exercise therapy. Variation in methodologies, outcome
measures, subject selection criteria, and other factors precluded drawing
conclusions about the efficacy of interventions designed to enable ME/CFS
patients to return to work.”81 (Emphasis Added)
It bears noting that following the IOM report and its position with respect to the retirement of the
Oxford criteria, and following the criticism of the methodological flaws in the UK’s PACE trial, the US
Centres for Disease Control expressly dropped its recommendations for CBT and GET and specifically
states that exercise cannot cure ME/CFS.
81 IOM, above n. 36, pp. 264-265.
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ME/CFS Australia therefore defers to the independence of the IOM report and its independent
review of the available literature. The IOM committee affirms the position of ME/CFS Australia and
was unable to identify any appropriate evidence base for treatments of ME/CFS that could be
considered to remedy or be likely to remedy ME/CFS, let alone restore function or impairments.
6.2.2.2.2.2. The Severely Ill
6.2.2.2.2.2.1. Evidence Base
With respect to the severely ill, ME/CFS Australia submits that the NDIA have no basis for rejecting
applications from this applicant cohort. Rule 5.4 of the
Rules expressly requires there to an
appropriate evidence base with respect to a likely remedy for an impairment.
That evidence base simply does not exist. Indeed we would argue that Professor Lloyd’s own cache
of papers upon which the NDIA relies, represents an empirical foundation for that position.
ME/CFS Australia reiterates the NHMRC’s Committee’s specific point with respect to the severely ill
– there is no appropriate evidence base with respect to treatments (particularly those that the NDIA
have required). They simply have not been the subject of research papers with respect to
treatments.
Professor Lloyd provides the 2015 IOM report – an independent and arguably thorough review of
the available literature up until 2015. Within Chapter 4 of the IOM report, the committee expressly
reviewed the evidence base with respect to ME/CFS and CFS and its symptoms and manifestations.
The committee reported:
“Studies on ME/CFS used different inclusion criteria and different sources of
ME/CFS patients and control participants. The end result is heterogeneity in
both patient and control cohorts,
creating an unclear picture of the
symptoms and signs of the disorder and its outcomes. Findings are based
on samples with a large majority of middle-aged women (late 40s to early
50s) who are Caucasian and of higher educational status, perhaps limiting
the generalizability of the studies. Very few stuadies focused on other
population subsets, such as pediatric or geriatric patients, or included ethnic
and racial minority patients. Some studies recruited patients from specialized
ME/CFS treatment centers, while others used community-based samples.
These different sampling methods may result in patient groups that differ in
demographic characteristics and symptom type and severity.
Furthermore,
those most severely affected by ME/CFS may be bedridden or homebound
and may not have been included in any of these studies (Wiborg et al.,
2010). Thus, there are selection biases in the studies’ sample composition.”82
(Emphasis Added)
Similarly the Full NICE Guide acknowledge the deficiency in research, stating:
82 IOM, above n. 36, pp. 71-72.
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“
Randomised controlled trials, with adequate power, are needed to
compare different methods of delivering standard methods of care, and
whether outcomes differ depending on whether they are delivered in
primary or secondary care. Subgroup analysis may clarify which approach is
most efficient (that is, cost effective without decreasing efficacy) in different
groups of people with CFS/ME (
for example, people who are severely
affected).”83 (Emphasis Added)
6.2.2.2.2.2.2. Acceptance of the Severely Ill
ME/CFS submits that in the complete absence of any evidence base, let alone an appropriate
evidence base with respect to treatment, the NDIA needs to put in place a policy that automatically
accepts the severely ill (refer to 7.2 below for the full submissions).
In summary, ME/CFS Australia asserts this position on the basis that:
(a) ME/CFS is classified as a neurological condition by the World Health Organisation hence the
condition meets the requirement under Section 24(1)(a) of the
NDIS Act which requires that
an applicant’s disability be due to one of six categories of impairment – namely neurological;
(b) ME/CFS holds symptoms that create intellectual, cognitive, sensory or physical impairments,
as well as comorbid psychiatric conditions that can impair. Such impairments are identified
within Section 24(1)(a). Those who fall within the severe category and are bed bound have a
physical impairment. Those who are housebound also have a physical impairment. The
broad variety of symptoms outlined in the 2003 Consensus Guideline, the 2011 ICC
Guidelines, the 2017 Paediatric Guidelines and the IOM Committee’s report, indicate that
intellectual, cognitive, sensory and psychiatric impairments (e.g. depression), are inherent to
the condition;
(c) The absence of an appropriate evidence base with respect to the severely ill demonstrates
that no treatment has been identified that is likely to remedy the impairments associated
with ME/CFS. Given this is the case, the condition fulfils the requirements of Section 24(1)(b)
of the
NDIS Act in establishing the condition to be permanent or likely to be permanent;
(d) The severely ill have substantially reduced functional capacity and psychosocial capacity to
undertake activities such as communication, social interaction, learning, mobility, self-care
and/or self-management, and cannot work or engage in social participation. This therefore
satisfies the requirements of Section 24(1)(c) and (d) of the
NDIS Act;
(e) The evidence base simply does not demonstrate that the majority of those affected by
ME/CFS are likely to recover. As demonstrated above, the Dubbo study upon which the NDIA
has relied, has been grossly misconstrued. Whilst the study merely covered a small
percentage of those with PVFS mediated CFS, it did demonstrate that 75% of those diagnosed
with PVFS still had the condition at 12 months. This study did not represent the severely ill
patient cohort. The severely ill are likely to require support from the NDIS throughout their
lifetime, hence they satisfy the requirements of Section 24(1)(e) of the
NDIS Act.
83 NICE, above n. 2, p. 39.
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6.2.2.2.3.
The Treatments
ME/CFS Australia has reviewed the literature provided to use by Ms. Agus, which was purportedly
provided by Professor Lloyd. ME/CFS Australia has reviewed this literature and submits as follows:
6.2.2.2.3.1. Cognitive Remediation Therapy
The NDIA has asserted that cognitive remediation therapy (called Cognitive Exercise Therapy or CET)
is a treatment that must be attempted by applicants. ME/CFS Australia is particularly perplexed at
why the NDIA is relying upon such a treatment. Professor Lloyd has put forward a treatment from
his own research group, and the evidence base for that treatment made up of two papers he
provides in the literature list, of which he is an author (albeit, his name is omitted on the documents
provided to us by Ms. Agus).84,85
Putting aside the apparent self-serving nature of the treatment advice provided by Professor Lloyd,
ME/CFS Australia submits the following very serious issues:
1.
Single Study – This is a single study. It has not been replicated;
2.
Level III-3 Evidence – When deferring to the “Quality of Evidence Ratings” applied by
Professor Lloyd in the 2002 RACP Guidelines, this ranks as Level III-3 evidence.86 This
level of evidence was rarely relied upon as an evidence base in those guidelines;
3.
Small Sample Size – The study involved only 36 patients with CFS87;
4.
Not Randomised – The study acknowledges it was not a randomised control study
(‘RCT’)88;
5.
No Severe Cases – The study did not include any participants that represent a severe
case of ME/CFS. Note that the study examined only those who were able to attend the
UNSW Fatigue Clinic, hence no person who was house-bound or bed-bound could
participate;
6.
Selection Bias – The participants were obtained from “an academic, a tertiary referral
clinic specializing in the management of chronic fatigue states”. The clinic was
acknowledged as “UNSW Fatigue Clinic” and it provided “assistance in recruiting
participants for the study.”89 Professor Lloyd is a director and his wife is a practice
84 R.L. McBride, S. Horsfield, C.X. Sandler, J. Cassar, S. Casson, E., Cvejic, U. Vollmer-Conna and A.R. Lloyd,
‘Cognitive remediation training improves performance in patients with chronic fatigue syndrome’
Psychiatry
Research. 2017 Nov; 257: 400-405.
85 C.X. Sandler, B.A. Hamilton, S. Horsfield, B.K. Bennett, U. Vollmer-Conna, C. Tzarminas and A.R. Lloyd,
‘Outcomes and predictors of response from an optimised, multidisciplinary intervention for chronic fatigue
states’
Intern Med J. 2016 Dec; 46(12): 1421-1429.
86 RACP, above n. 1, p. S21.
87 McBride et al, above n. 83, p. 401.
88 Ibid, p. 404.
89 Ibid, p. 404.
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manager.90 There was no community based participant selection;
7.
No Conflict of Interest Declared – The UNSW Fatigue Clinic is run by Professor Lloyd91
and his wife, Andrea Lloyd, is the practice manager. The clinic is the only facility in the
world offering the treatment and stands to benefit financially from validation of the
treatment. Despite these factors, no conflict of interest declaration was made in the
publication;
8.
Short Time Period – The participants received 11 weeks of treatment, and were followed
up at 24-weeks post-baseline. Beyond that, they study does not examine the
longitudinal effect to see if those obtaining benefit sustained it, or if those who suffered
harms from participation recovered their pre-treatment levels92;
9.
Harms – The study acknowledges that it did not measure “the impact on fatigue and
other symptoms immediately after the training sessions and in the program at all”93;
10.
No Likely Remedy – The study purports to show “improvements on a number of
objective cognitive performance domains when tested formally”94 but there is no
evidence of a curative effect on cognitive function, hence this does not reach the bar
within Rule 5.4 of the
Rules – “likely to remedy”;
11.
No Post-Exertional Testing – The study at no point tested participants in a post-
exertional state, i.e. 24-48 hours post exercise;
12.
Preliminary – The study is preliminary in nature, and acknowledges this, stating
“subjective and objective performance improvements suggest that a computerized,
home-based cognitive training program may be an effective intervention for patients
with CFS, warranting RCT’s.”95
13.
Not Generalizable – The study is small scale, does not represent the cross section of
ME/CFS subgroups, ethnic backgrounds, or other demographic characteristics, is not
randomized, is subject to multiple limitations and very basic. It cannot be generalised as
applicable to all persons with ME/CFS.
ME/CFS Australia is exceptionally disappointed that the NDIA would take a preliminary small scale
one-off study with no validation, no replication and a number of self-acknowledged limitations, and
elevate it to the status of an “evidence-based” treatment.
90 UNSW Fatigue Clinic, ‘About the Clinic’ (2019), < https://www.fatigueclinic.unsw.edu.au/about-us/about-
the-clinic>.
91 Ibid.
92 McBride et al, above n. 84, p. 402.
93 Ibid, p. 404.
94 Ibid, p. 403.
95 Ibid, p. 400.
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Aside from the fact that the treatment completely ignored potential harms, it has not been shown to
be safe, let alone sustainably effective, and the study is limited to the Fatigue Clinic in Sydney as a
research treatment only. It does not show any cure of cognitive or other impairments at any point
in the study.
This treatment cannot possibly be held out as a requirement for applicants. It simply does not come
close to meeting the requirements of Rule 5.4 of the Rules. It is acknowledged that CET was used in
a larger scale study in 2017 and this is examined below in 6.2.2.3.3.3.
6.2.2.2.3.2. Cognitive Behavioural Therapy
The NDIA appears to be asserting that CBT is an appropriate “evidence-based management” in
accordance with the
Rules – ergo it is “likely to remedy” the impairments associated with the
claimed condition.
We therefore conclude that the NDIA therefore requires an applicant to engage in CBT prior to
obtaining access to the NDIA.
ME/CFS Australia have noted that the policy outlined to this organisation does not actually state that
Professor Lloyd has represented that CBT is “likely to remedy” the impairments that arise in ME/CFS.
We can only infer that the NDIA is representing that the use of CBT remedies ME/CFS.
ME/CFS Australia therefore submits as follows:
6.2.2.2.3.2.1. Evidence Base
As outlined in Section 6.2.2.2.2.1. the IOM found no literature to support the view that CBT improves
function.
6.2.2.2.3.2.2. CBT Not Uniform
The NDIA has been provided a variety of papers in which CBT has been studied or recommended.
ME/CFS Australia makes the following points:
1.
CBT Not Compatible - The mere fact that a treatment is referred to as CBT, does not equate
to uniformity of treatment protocol – they are superficially similar only. In short – the
various studies and meta-analyses do not actually examine the same type of protocol
applied within CBT;
2.
Criteria Not Compatible – The literature that Professor Lloyd provides contains various
reviews, including a mish-mash of criteria including the 1994 Fukuda criteria, the 1991
Oxford Criteria and 1994 London Criteria. The latter two focus on fatigue and have been
rejected from use in research by the IOM and NHMRC. Respectfully, any research from the
UK utilises the latter two criteria – hence any papers from White, Chalder, Wessely, Cleare,
Sharpe et al, or utilising such papers (e.g. the two Cochrane Reviews, the NICE Guides, the
2002 RACP Guidelines and the work of Prins, et al.) also incorporate those criteria. In short,
almost half of Professor Lloyd’s literature is tainted with these criteria;
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3.
Not Transferrable – The CBT utilised in the UK within their CFS centres within the National
Health Service (NHS, cannot be transferred to an Australian context – there simply is not
that trained infrastructure. It is noted that Rule 5.4. of the
Rules requires that the
“appropriate evidence-based” treatment be “available” – clearly that is not the case;
4.
No Training – There is no training of any psychologists throughout Australia in the
application of CBT for ME/CFS, hence the expectation that CBT could be delivered by any
psychologist without experience, or with the pretence of some knowledge, or an approach
that is not informed by an actual evidence-based program, is arguably dangerous and/or
ineffective. The NHMRC ME/CFS Advisory Committee highlights in its report that the
knowledge of allied health staff is quite poor to non-existent. The NICE Guides actually
make the point quite firmly:
“A course of CBT should be delivered only by a healthcare
professional
with appropriate training in CBT and experience in CFS/ME, under
clinical supervision.
The therapist should adhere closely to empirically
grounded therapy protocols.”96
The NHMRC ME/CFS Advisory Committee made the point repeatedly that training of medical
and allied health staff is a priority given there are very few knowledgeable or experienced
practitioners in Australia;
5.
No Centres – The Fatigue Clinic is based in Sydney. There is a facility in Melbourne that
purports to deliver CBT, not uniform in approach with Sydney. Outside of these locations,
there is nothing, hence it is impossible for people to access. Again, Rule 5.4. of the
Rules requires that the treatment be available. For the majority of Australians, there is no
availability;
ME/CFS Australia submits that the NDIA is operating under a false belief that the literature provided
by Professor Lloyd provides an appropriate evidence base that complies with Rule 5.4. of the
Rules.
The NDIA erroneously makes the following assumptions about the literature provided by Professor
Lloyd:
(a) the criteria and condition examined within each paper or guidelines is uniformly compatible;
(b) treatment protocols are the same and are delivered in uniform approach;
(c) there exists an available and knowledgeable infrastructure to deliver treatment throughout
Australia.
Respectfully, what might be represented in those articles and guidelines is not what is being
delivered in reality. The reality is there is no uniform protocol and no infrastructure throughout the
majority of the country. Additionally, the reality is that poor delivery of CBT could do more harm
than good.
96 NICE, above n. 2, p. 26.
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6.2.2.2.3.2.3. Access
The NDIA is under the false assumption that CBT is accessible to one an all, uniformly throughout
Australia. ME/CFS Australia submits:
1.
Two Centres – As outlined above there are two centres that formally deliver what they
assert is “evidence based” CBT for ME/CFS. There is no evidence that the protocol of CBT
delivered is consistent with any evidence-based protocol, or that there is a consistency in
such protocol between the two centres. There is no evidence that these centres are
effective in their delivery of CBT when applied to patients with 1994 Fukuda CFS or 2003
Consensus Criteria ME/CFS – because there has never been a properly conducted RCT of
these patients, using effective, objective measures and inclusive of the reporting of harms
and drop outs;
2.
Accessibility – Even if an applicant were located in a city where there was a facility, there are
numerous limitations that can prevent access:
(a) Affordability – Most people with ME/CFS struggle financially, hence cannot necessarily
afford access to delivery of the treatment;
(b) Transport – Assuming an applicant has access to a vehicle, they may not be able to drive
themselves because of the symptoms of the condition, may not have someone to drive
them, or may not be able to afford to drive to the centre. Those who have access to
public transport may not be able to use it because the trip exposes them to exacerbators
of their symptoms, e.g. smells, chemicals, sensory overload, PEM, orthostatic
intolerance, photophobia, etc.;
(c) Post-Exertional Malaise – Assuming a person is able to travel and attend, the process of
travel and engaging in the CBT can cause the applicant to enter a crash state, or suffer
PEM;
3.
Severe Patients – Attendance at a centre and/or participation in CBT simply is not feasible
for the majority, if not all, that fall within the severe group of applicants;
6.2.2.2.3.2.4. Efficacy
The NDIA is under the false assumption that CBT provides a remedy for one or more of the
impairments outlined within Section 24 the
Act. ME/CFS Australia submits:
1.
PACE Trial – The PACE trial (which utilises the retired Oxford Criteria and focuses on a fatigue
cohort), if one accepts the validity of its results from subjective measures, at their best
reveals that CBT will only deliver “moderately improve[d] outcomes”.97 The PACE trial was
conducted on the basis of the behavioural/deconditioning model of CFS in which it is
97 P.D. White, K.A. Goldsmith, A.L. Johnson, et al, ‘Comparison of adaptive pacing therapy, cognitive behaviour
therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a
randomised trial’
Lancet 2011; 377: 823–36, 823.
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believed that patients are deconditioned and this is being perpetuated by a fear of
worsening the symptoms through doing activity. CBT purportedly did little to improve
walking, the only objective measure of activity used, but purportedly improved depression.98
The authors declared CBT to be a “moderately effective outpatient treatment”.99 The
authors claim that 30% of CBT participants fell with the “normal range” after treatment.100
In arriving at these conclusions, the authors acknowledge that “recovery” does not mean
recovery of all symptoms of the condition. The authors also make it very clear that results
do not apply to patients satisfying the 1994 Fukuda criteria or the 2003 Canadian Criteria or
other international criteria except where the primary symptom is fatigue. Note that this is a
small subset of these latter patients. Follow up reviews of the participants at two years
showed little evidence of improvements in physical function.101,102
2.
PACE Trial Review – Following critical review of the PACE trial103,104,105,106,107 and a legal case
initiated by Australian, Alan Matthees, in the UK High Court, the PACE data was released,
with the authors proffering multiple reasons and allegations that the Court rejected as
baseless.108 The PACE Trial authors originally released the protocol for the study in 2007 and
this differed substantially from the final study.109 Tuller110, Coyne111, and indeed numerous
eminent authors112 have revealed that the PACE authors engaged in post-hoc outcome
98 Ibid, p. 834.
99 Ibid, p. 831.
100 NB – The major criticism of the PACE trial is the fact that the normal range was altered downwards
significant from the pilot study, to a level that is below was an c. 80 year old person’s physical function is – a
range that simply is not consistent with the ordinary meaning of recovery
101 T. Chalder, K.A. Goldsmith, P.D. White, et al., ‘Rehabilitative Therapies for Chronic Fatigue Syndrome: A
Secondary Mediation Analysis of the PACE Trial’
The Lancet Psychiatry 2015; 2(2): 144-152.
102 M.C. Sharpe, K.A. Goldsmith, A.L. Johnson, et al., ‘Rehabilitative Therapies for Chronic Fatigue Syndrome: A
Secondary Mediation Analysis of the PACE Trial’
The Lancet Psychiatry 2015; 2(12): 1067-1074.
103 D. Tuller, ‘Trial by Error: The Troubling Case of the PACE Chronic Fatigue Syndrome, (21 October 2015),
<http://www.virology.ws/2015/10/21/trial-by-error-i/>.
104 D. Tuller, ‘Trial by Error: The Troubling Case of the PACE Chronic Fatigue Syndrome (Second Instalment), (22
October 2015), <http://www.virology.ws/2015/10/22/trial-by-error-ii/>.
105 D. Tuller, ‘Trial by Error: The Troubling Case of the PACE Chronic Fatigue Syndrome (Final Instalment), (23
October 2015), <http://www.virology.ws/2015/10/23/trial-by-error-iii/>.
106 J. Coyne, ‘Uninterpretable: Fatal flaws in PACE Chronic Fatigue Syndrome follow-up study’, (29 October
2015) PLOS Blogs Network <https://blogs.plos.org/blog/2015/10/29/uninterpretable-fatal-flaws-in-pace-
chronic-fatigue-syndrome-follow-up-study/>.
107 J.C. Coyne and J.R. Laws, ‘Results of the PACE follow-up study are uninterpretable’
Lancet Psychiatry 2016
Feb 1; 3(2): e6-e7.
108
Queen Mary University of London v The Information Commissioner and Alem Matthees [2016] UKFTT
2015_0269 (GRC).
109 P.D. White, M.C. Sharpe, T. Chalder, et al., ‘Protocol for the PACE trial: a randomised controlled trial of
adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist
medical care versus standardised specialist medical care alone for patients with the chronic fatigue
syndrome/myalgic encephalomyelitis or encephalopathy.’
BMC Neurol 2007 Mar 8; 7: 6.
110 Tuller, above n. 103-105.
111 Coyne, above n. 106-107.
112 ‘Special Issue: The PACE Trial’,
Journal of Health Psychology, 2017; 22(9), 1103-1216 – this issues contained
19 articles from a variety of authors, addressing various issues with respect to the PACE trial, including
investigator bias, null effect, patient selection errors, harms, disregards for principles of science, bias methods,
unreliable outcomes, misleading information, and lack of objective measures.
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switching, alteration of entry and recovery criteria, failure to declare conflicts of interest and
various other misdeeds that overinflated the results to make the effect of CBT and GET seem
to be much better than it was. The recovery criteria came under significant criticism
because:
• The definition of recovery was “loosely defined” and did not reflect the “commonly
understood” definition 113 and fails to “capture the core meaning of recover – that is, a
return to good health”114;
• The recovery criteria was “substantially modified after the publication of the trial
process”115;
• The claims that the symptoms of CFS were fully reversible were not justified116;
• On the objective criteria “none of the ‘recovered’ patients achieved a normal walking
distance in the six-minute walking test”117;
Following the release of the data, the PACE trial authors released a revised analysis of the
data which employed the original protocol.118 The effect of the revision was a reduction in
the significance of various measures. The authors concluded that little had changed. In
contrast, Wilshire et al summarise the issues and then apply the original protocol to the
data.119 The authors reveal that their figures were similar in outcome to the revision of the
PACE trial authors. However, when the original protocol for recovery was restored, the
recovery rate from CBT dropped from 30% to 7%, hence there was no longer a statistically
significant effect of treatment on recovery rates.120
The long-term outcomes of CBT, GET, Adaptive Pacing and specialist medical care showed
none were effective, hence the null effect invalidates the use of CBT and GET in
ME/CFS.121,122
What is significant, in our submission, is that the study does not provide some form of
reference point by which the NDIA can deduce that the impairments under the Act are able
to be remedied.
113 S. Wilshire, T. Kindlon and S. McGrath, ‘PACE Trial Claims of Recovery are Not Justified by the Data: A
Rejoinder to Sharpe, Chalder, Johnson, Goldsmith and White (2017)’,
Fatigue: Biomedicine, Health & Behavior 2017; 5(1): 62-67, 62.
114 Ibid, p. 63.
115 Ibid, p. 62.
116 Ibid, p. 63.
117 Ibid, p. 65.
118 K.A. Goldsmith, P.D. White, T. Chalder, et al. ‘The PACE Trial: Analysis of Primary Outcomes Using
Composite Measures of Improvement: Unpublished Report’, (8 September 2016) Queen Mary University of
London <https://www.qmul.ac.uk/wolfson/media/wolfson/current-
projects/PACE_published_protocol_based_analysis_final_8th_Sept_2016(1).pdf>.
119 C.E. Wilshire, T. Kindlon, R. Courtney, et al., ‘Rethinking the Treatment of Chronic Fatigue Syndrome—A
Reanalysis and Evaluation of Findings From a Recent Major Trial of Graded Exercise and CBT’
BMC Psychology 2018; 6(6).
120 Ibid, p. 6.
121 M. Vink, ‘The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic
Encephalomyelitis/ Chronic Fatigue Syndrome: A Review’
Journal of Neurology and Neurbiology 2016; 2(3), 10.
122 K.J. Geraghty and C. Blease, ‘Cognitive behavioural therapy in the treatment of chronic fatigue syndrome: A
narrative review on efficacy and informed consent’
Journal of Health Psychology 2016 Sep 15; 23(1): 127-138.
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3.
Cochrane – In reviewing psychotherapies for functional syndrome (including CFS), the
authors identified multiple methodological concerns in psychotherapy trials, including the
high drop out rates and the selection bias in sampling.123. This criticism from Cochrane
raises the credibility of ME/CFS Australia’s assertions that studies with respect to ME/CFS
are inherently flawed, particularly PACE;
4.
Fatigue Clinic Study – Professor Lloyd’s UNSW Fatigue Clinic team conducted a study which
examined and mixed in participants with Post-Cancer Fatigue and CFS, which the authors
categorise as medically unexplained fatigue states, hence this is not a CFS study.124 The
study, which is not a RCT, incorporates two arms: one which integrates CBT treatment; and
the other being CBT and GET.125 This study clearly defers to the construction and outcomes
of the PACE trial and is identified as such.126
As per point 1 above, the PACE study focused on participants who fulfilled to Oxford criteria
where the primary symptom was chronic fatigue, and the study was only comparable to
1994 Fukuda where fatigue was the primary symptom. Participants were selected on the
basis of prolonged fatigue. This UNSW study’s primary measure was an improvement in
fatigue, with secondary measures focused on functional outcomes, mood and sleep.127 The
study purported to report harms and identified only three adverse events. There was no
follow-up of participants beyond 12 months, hence there is no validity for this study to
purport to remedy impairments. There is nothing in the study that indicates that it purports
to remedy the condition or remedy impairments.
Despite purporting to report on CBT alone, the study actually contains no outcomes with
respect to CBT alone. The authors do not report any conflicts of interest, despite Professor
Lloyd being a director of the Fatigue Clinic, his wife being the practice manager128 or the fact
that he receives a pecuniary and/or non-pecuniary benefit from the validation of protocols
utilised in the clinic. The study does not reveal the severity of participants’ sympyoms,
however it is self-evident that participants who fall into the severe end of the spectrum of
the condition are not studied. There is nothing in the study that purports to help
participants achieve recovery, and nothing to indicate that the effects last long term.
5.
UK Survey for NICE – In responding to a request for evidence from the NICE Guidelines
Review Committee129, the patient organisations collected data and a report was produced by
123 N. Van Dessel, M. den Boeft, J.C. van der Wouden, ‘Non-pharmacological interventions for somatoform
disorders and medically unexplained physical symptoms (MUPS) in adults’
Cochrane Database of Systematic
Reviews 2014; 11: CD011142.
124 Sandler et al, above n. 103, pp. 1421-1422.
125 Ibid, p. 1421.
126 Ibid, p. 1422.
127 Ibid, p. 1425.
128 UNSW Fatigue Clinic, above n. 89.
129 Forward ME Group, ‘CBT and GET Survey Results Published by Forward-ME Group’, (3 April 2019)
<https://www.meaction.net/2019/04/03/cbt-and-get-survey-results-published-by-forward-me-
group/?fbclid=IwAR3sEJmAbYjfnOW0acxDTQ0gVYxOjLBbDAuyFIIDLxnLp1bsXB2fYfXUFOQ>.
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Oxford Brookes University.130 The large survey of patients (n = 670) reveal with respect to
CBT that 16.2% experienced improvement in physical health, 53% reported no change and
24.6% experienced deterioration in their physical health. With respect to mental health,
41.5% reported improvement in mental health, 28.1% experienced no change and 26.9%
experienced deterioration.131
6.
Other Surveys – Prior to the above study, Action for ME in UK conducted a patient health
and well-being survey. The survey had over 2000 respondents, hence was a significant
study. When indicating the impact of CBT, 54% reported that CBT was a little or very
helpful, while 34% indicated no change and 12% reported that the treatment made them a
little bit or a lot worse.132
6.2.2.2.3.2.5. Submission
ME/CFS Australia submits the following with respect to CBT:
•
Not Recommended by CDC - The US Centres for Disease Control and Prevention removed
CBT from its recommended treatments in mid-2018 and it is no longer included on their
website. This removal coincided with their retirement of the 1994 Fukuda Criteria in favour
of the IOM’s emphasis on systemic exertion. The inference has to be drawn that this
removal clearly signals that CBT is not regarded as an effective treatment133;
130 H. Dawes, ‘Evaluation of a survey exploring the experiences of adults and children with ME/CFS who have
participated in CBT and GET interventional programmes’ (27 February 2019) < http://www.meaction.net/wp-
content/uploads/2019/04/NICE-Patient-Survey-Outcomes-CBT-and-GET-Oxford-Brookes-Full-Report-
03.04.19.pdf>.
131 Ibid, pp. 6-7.
132 Action for ME, ‘M.E. Time to Deliver’ (12 May 2014) < https://www.actionforme.org.uk/uploads/pdfs/me-
time-to-deliver-survey-report.pdf>, p. 19.
133 CDC, above, n. 75.
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•
Severe Not Included - Nothing in the alleged “evidence-base” purports to research the use of
CBT on patients who fall within the severe category of ME/CFS, hence there simply is no
justification to argue that this literature forms an evidence base for this patient cohort. It
therefore fails the requirement under Rule 5.4. The evidence base provided is not
appropriate;
•
Retired Oxford Criteria - The evidence-base provided by Professor Lloyd is primarily based
upon the now retired Oxford criteria, which focuses on fatigue;
•
Oxford Criteria Focused on Fatigue - Research utilising the Oxford criteria simply does not
represent the majority of patients diagnosed under the 1994 Fukuda criteria or the 2003
Consensus Criteria. This criteria is focused on patients who have fatigue as their primary
symptom and requires no other symptoms, unlike Fukuda and the Consensus Criteria. This
evidence base therefore does not satisfy the requirement that evidence be “appropriate”
within Rule 5.4 of the
Rules;
•
Treatments Do Not Remedy - Even if the evidence base provided by Professor Lloyd was
accepted, the studies do not show that a person receiving the treatment is likely (i.e. high
probability of occurring or being true134) to have their impairments remedied, because the
effect is moderate at best;
•
Significant Harms Reported -The most recent evidence from the UK provided to the current
NICE review committee at the committee’s request, sourced from over 2000 patients, clearly
shows that the majority of survey respondents derived no benefit from CBT, whilst most
concerningly, there were significant rates of minor to major harms to patients that arose
from the CBT they received;
•
Evidence Base Not Appropriate -The evidence base provided by Professor Lloyd is
exceptionally limited and highly contentious – hence does not fulfil the criteria of
“appropriate” within the meaning of Rule 5.4. of the
Rules;
•
Evidence Base Focused on Fatigue - The evidence base provided by Professor Lloyd, even if
accepted, is focused upon those patients for whom fatigue is the primary symptom. The
PACE trial authors make it clear that the treatments are suitable for those patients who
meet the Fukuda and Consensus criteria “ONLY if fatigue is their main symptom”.135 For
the vast majority of patients who do not experience fatigue as their primary symptom, the
evidence base provided by Professor Lloyd does not address their symptoms. The evidence
base is therefore does not meet the definition of appropriate within the meaning of Rule
5.4. of the
Rules.
6.2.2.2.3.3. Graded Exercise Therapy
The NDIA appears to be asserting that GET is an “evidence-based management” in accordance with
the rules, ergo it is “likely to remedy” the impairments associated with the claimed condition. The
NDIA therefore requires an applicant to engage in GET prior to obtaining access to the NDIA.
134 Merrium-Webster, ‘Likely”, (2019) <https://www.merriam-webster.com/dictionary/likely>.
135 White et al, above n. 97, p. 834.
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ME/CFS Australia have noted that the policy outlined to this organisation does not actually state that
Professor Lloyd has represented that GET is “likely to remedy” the impairments that arise in ME/CFS.
We can only infer that the NDIA is representing that the use of GET remedies ME/CFS.
ME/CFS Australia therefore submits as follows:
6.2.2.2.3.3.1. Evidence Base
As outlined in Section 6.2.2.2.2.1. the IOM found no literature to support the view that GET
improves function.
6.2.2.2.3.3.2. GET Not Uniform
The NDIA has been provided a variety of papers in which GET has been studied or recommended.
ME/CFS Australia makes the following points:
1.
GET Not Compatible – As submitted above with respect to CBT, the mere fact that a
treatment is referred to as GET, does not equate to uniformity of treatment protocol. They
are superficially similar only. In short, the various studies and meta-analyses do not actually
examine the same type of protocol applied as GET. The Cochrane review of GET in CFS
acknowledges this issue within studies, stating:
“Exercise therapy lasted from 12 to 26 weeks. Seven studies used
variations of aerobic exercise therapy such as walking, swimming,
cycling or dancing provided at mixed levels of intensity of the aerobic
exercise from very low to quite vigorous, whist one study used
anaerobic exercise.”136
2.
Criteria Not Compatible – As submitted above with respect to CBT, the literature that
Professor Lloyd provides is tainted with a mismatch of various incompatible criteria for
participant selection;
3.
Not Transferrable – The form of GET utilised in the UK within their CFS centres within the
National Health Service (NHS), cannot be transferred to an Australian context. There simply
is not that trained infrastructure. It is noted that Rule 5.4. of the
Rules requires that the
“appropriate evidence-based” treatment be “available”. Clearly that is not the case;
4.
No Training – There is no training of any exercise physiologist or physiotherapist throughout
the country with respect to GET in the context of ME/CFS, hence the expectation that it can
be delivered by any practitioner, without experience, or with the pretence of some
knowledge, or an approach that is not informed by an actual evidence-based program, is
arguably dangerous and/or ineffective. The NHMRC ME/CFS Advisory Committee highlights
in its report that the knowledge of allied health staff is quite poor to non-existent. As with
CBT, the NICE Guides made the same point with respect to GET:
136 L. Larun, K.G. Bruberg, J. Odgaard-Jensen, and J.R. Price, ‘Exercise Therapy for Chronic Fatigue Syndrome’,
Cochrane Database Sys Rev 2017; 4; CD 003200, 6.
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“GET should be
delivered only by a suitably trained GET therapist with
experience in CFS/ME, under appropriate
clinical supervision.”137
(Emphasis Added)
The NHMRC ME/CFS Advisory Committee made the point repeatedly that training of medical
and allied health staff is a priority given there are very few knowledgeable or experienced
practitioners in Australia;
5.
No Centres – The Fatigue Clinic is based in Sydney. There is a facility in Melbourne that
purports to deliver GET, although not uniform with Sydney. Outside of these locations,
there is nothing, hence it is impossible for people to access a structured, purportedly
“evidence-based” program. Again, Rule 5.4. of the
Rules requires that the treatment be
available. For the majority of Australians, there is no availability;
ME/CFS Australia submits that the NDIA is operating under a false belief that the literature provided
by Professor Lloyd provides an appropriate evidence base that complies with Rule 5.4. of the
Rules.
The NDIA erroneously makes assumptions about the literature provided by Professor Lloyd, that:
(a) the criteria and condition examined within each paper or guidelines is uniformly compatible;
(b) treatment protocols are the same and are delivered in uniform approach;
(c) there exists an available and knowledgeable infrastructure to deliver treatment throughout
Australia.
ME/CFS Australia repeats the point raised with respect to CBT: what might be represented in those
articles and guidelines is not what is being delivered in reality. The reality is there is no uniform
protocol and no infrastructure throughout most of the country. Additionally, the reality is that poor
delivery of GET can do more harm than good.
6.2.2.2.3.3.3. Access
The NDIA is under the false assumption that GET is accessible to one an all, uniformly throughout
Australia. ME/CFS Australia submits:
1.
Two Centres – As outlined above there are two centres that formally deliver what they
assert is “evidence based” GET. There is no evidence that the protocol of GET delivered is
consistent with any evidence-based protocol, or that there is a consistency in such protocol
between the two centres. There is no evidence that these centres are effective in their
delivery of GET when applied to patients with 1994 Fukuda CFS or 2003 Consensus Criteria
ME/CFS, because there has never been a properly conducted RCT of these patients, using
meaningful, objective measures and inclusive of the reporting of harms and drop outs;
2.
Accessibility – Even if an applicant was located in a city where there was a facility, there are
numerous limitations that can prevent access:
(a) Affordability – Most people with ME/CFS struggle financially, hence cannot necessarily
afford access to delivery of the treatment;
137 NICE, above n. 2, p. 28.
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(b) Transport – Assuming an applicant has access to a vehicle, they may not be able to drive
themselves because of the symptoms of the condition, may not have someone to drive
them, or be able to afford to drive to the centre. Those who have access to public
transport may not be able to use it because the trip exposes them to exacerbators of
their symptoms, e.g. smells, chemicals, sensory overload, PEM, orthostatic intolerance,
photophobia, etc.;
(c) Post-Exertional Malaise – Assuming a person is able to travel and attend, the process of
travel and engaging in the GET can caused the applicant to enter a crash state, or suffer
PEM;
3.
Severe Patients – Attendance at a centre and/or participation in GET simply is not feasible
for the majority, if not all, that fall within the severe group of applicants;
6.2.2.2.3.3.4. Efficacy
The NDIA is under the false assumption that GET provides a remedy for one or more of the
impairments outlined within Section 24 the
Act. ME/CFS Australia submits:
1.
PACE Trial – ME/CFS Australia defers to its position with respect to the criteria, fatigue focus
and subjective measures identified above with respect to CBT (at 6.2.2.2.3.2.4). The PACE
trial, if one accepts the validity of its results with respect to GET and subjective measures,
only delivered “moderately improve[d] outcomes”.138 GET purportedly improved walking,
the only objective measure of activity used, slightly more than CBT, but did not improve
depression.139 The authors claimed GET to be “moderately effective outpatients
treatments”.140 The authors claim that 28% of GET participants fell with normal ranges after
treatment.141 In arriving at these conclusions, the authors acknowledge that “recovery”
does not mean recovery of all symptoms of the condition. The authors also make it very
clear that results do not apply to patients satisfying the 1994 Fukuda criteria or the 2003
Canadian Criteria or other international criteria, except where the main symptom is fatigue.
Note that this is a small subset of these latter patients. Follow up reviews of the participants
at two years showed little evidence of improvements in physical function.142,143
2.
PACE Trial Review – Following critical review of the PACE trial144,145, and the Freedom of
Information legal case mentioned above146, the PACE trial’s original 2007 protocol147 was
138 White, et al, above n. 97, 823.
139 Ibid, p. 834.
140 Ibid, p. 831.
141 NB – The major criticism of the PACE trial is the fact that the normal range was altered downwards
significant from the pilot study, to a level that is below was an c. 80 year old person’s physical function is – a
range that simply is not consistent with the ordinary meaning of recovery
142 Chalder et al, above n. 100.
143 Sharpe, et al, above n. 101.
144 Tuller, above n. 103-105.
145 Coyne, above, n. 106-107.
146
Queen Mary University of London v The Information Commissioner and Alem Matthees [2016] UKFTT
2015_0269 (GRC).
147 White et al, above n. 109.
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applied to the data by Wilshire et al and revealed a lower rate of ‘recovery’.148 The GET arm
of the PACE trial was, like the CBT arm, the subject of numerous serious anomalies that
overinflated the effectiveness of the treatment.149,150,151
The PACE authors revised their data analysis in 2013 using their original protocol, concluding
that little changed, with recovery from GET falling from the claimed 30% recovery rate, to a
statistically significant 22%.152 Wilshire et al analysed the data with the original protocol153
revealing a similar outcome. However, when the original parameters for ascertaining
recovery were restored, the recovery rate from GET dropped from the originally reported
rate of 30% recovery to a statistically insignificant 4%, hence there was no longer a
statistically significant effect of treatment on recovery rates.154
The long-term outcomes of CBT, GET, Adaptive Pacing and specialist medical care showed a
null effect, hence the original protocols invalidated the use of GET and CBT in ME/CFS.155,156
Consistent with our submission with respect to CBT, ME/CFS Australia reiterates that the
study does not provide some form of reference point by which the NDIA can deduce that the
impairments under the Act are able to be remedied.
3.
Cochrane – There are a number of Cochrane reviews with respect to CFS referred to in the
literature list from Professor Lloyd, however the reference is duplication.157 The NDIA have
not stated when Professor Lloyd provided his evidence base, but it does not appear to be
post May 2017. The NDIA were therefore been made aware that an editor’s note was
published on 25 October 2018 advising that a formal complaint had been received about the
Cochrane publication.158 On 8 March 2019, the editor in chief published the following note:
“Cochrane’s editors and the review author team have jointly agreed that
there will be a further period up to the end of May 2019, in which time
the author team will amend the review to address changes aimed at
improving the quality of reporting of the review and ensuring that the
conclusions are fully defensible and valid to inform health care decision
148 Wilshire et al, above n. 118.
149 Tuller, above n. 103-105.
150 Coyne, above n. 106-107.
151 ‘Special Issue: The PACE Trial’,
Journal of Health Psychology, 2017; 22(9), 1103-1216 – this issues contained
19 articles from a variety of authors, addressing various issues with respect to the PACE trial, including
investigator bias, null effect, patient selection errors, harms, disregards for principles of science, bias methods,
unreliable outcomes, misleading information, and lack of objective measures.
152 Goldsmith et al, above n. 119.
153 Wilshire, above n. 118, p. 6.
154 Ibid, p. 6.
155 M. Vink, ‘The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic
Encephalomyelitis/ Chronic Fatigue Syndrome: A Review’
Journal of Neurology and Neurbiology 2016; 2(3), 10.
156 K.J. Geraghty and C. Blease, ‘Cognitive behavioural therapy in the treatment of chronic fatigue syndrome: A
narrative review on efficacy and informed consent’
Journal of Health Psychology 2016 Sep 15; 23(1): 127-138.
157 Larun et al, above n. 136.
158 Ibid – see ‘Notes’
<https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003200.pub7/information>.
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making. The changes will also address concerns raised in feedback since
the Robert Courtney complaint. The amendment will not include a full
update, but a decision about this will made subsequently” 159
The complaint of Robert Courtney160 focused upon the fact that the Cochrane review failed
to publish a “rigorous, unbiased, transparent and independent analysis”, having included the
technically and methodologically flawed PACE trial within the studies accepted for review,
without having adequately considered these flaws. Courtney also noted that three of the
Cochrane authors were working with members of the PACE trial authors on other projects,
hence a significant conflict of interest existed.
Putting aside these issues and examining the study on face value, the Cochrane authors:
• relied on five studies that selected patients based on the retired Oxford criteria.161
These studies are focused on fatigue only. Only eight studies were included in total;
• identify that there was no uniformity to the delivery mode or duration of the GET
utilised162;
• claimed the “seven studies consistently showed a reduction in fatigue following
exercise therapy at end of treatment”163;
• assert “serious adverse reactions were rare” in the two studies that made an
attempt to measure such events164;
• concluded that “[p]atients with CFS
may generally benefit and feel less fatigued
following exercise therapy, and
no evidence suggests that exercise therapy may
worsen outcomes. A positive effect with respect to
sleep, physical function and self-
perceived general health has been observed, but
no conclusions for the outcomes
of pain, quality of life, anxiety, depression, drop-out rate and health service
resources were possible …
Randomised trials with low risk of bias are needed to
investigate the type, duration and intensity of the most beneficial exercise
intervention.”165
ME/CFS Australia submits that were the Cochrane review taken at face value as reliable and
unfettered by the criticisms currently levelled against it, the study still falls well short of
purporting to remedy impairments or the condition as a whole.
No studies examined included the severely ill patients that make up approximately 25% of
the ME/CFS population, hence there is no evidence base for this group..
159 Ibid.
160 R. Courtnery, ‘Formal Complaint – Cochrane review CD003200’ (18 February 2018)
<https://www.dropbox.com/s/uhy95caezsmcue7/Robert%20Courtney%20Cochrane%20complaint(1).zip?dl=0
&file_subpath=%2FRobert+Courtney+Cochrane+complaint.pdf>.
161 Larun et al, above n. 136.
162 Ibid, p. 2.
163 Ibid.
164 Ibid.
165 Ibid.
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The key point made was a purported “reduction in fatigue”, hence not “likely to remedy”,
ergo falls well short of the bar required under the Rules. This submission is strengthened by
the fact that the authors qualified their position heavily when stating patients “may
generally benefit and feel less fatigued”. This degree of uncertainty does not fulfil the
requirement of rule 5.4. of the
Rules which requires that it be “likely to remedy”. The
Cochrane review asserts possible benefits, not probable benefits, with respect to fatigue.
With respect to other symptoms, the review finds “no conclusions for the outcomes of pain,
quality of life, anxiety, depression”.
4.
Cochrane Review – The Cochrane paper was reviewed following multiple criticisms of its
approach to conflicts of interest and particularly its handling of the PACE trial.166 A recent
article by Vink and Vink-Niese identified seven key areas of concern with respect to the
paper:
•
Conflicts of Interest – The Cochrane authors held an allegiance to the CBT and
GET model, and were proponents of the biopsychosocial approach to CFS. ME
and CFS are classified as a neurological condition by the World Health
Organisation. Seven of the eight papers reviewed came from the
biopsychosocial approach to the condition, whilst the eighth did not and
concluded that no treatment strategy was superior to another in all areas167;
•
Exclusion of Study – The authors excluded a study that found no intervention
improved health-related quality of life scores, and led to worse physical function
and bodily pain scores. CBT and GET were found to be ineffective and potentially
harmful168;
•
Broad Criteria – The authors included five studies that utilised the Oxford criteria,
which only requires six months of unexplained fatigue and no other symptoms.
This criteria allows the selection of participants with mild fatigue and chronic
idiopathic fatigue, and mislabels them as CFS. The inclusion of such participants
confounds the ability to interpret the results for people with ME/CFS. It was
noted that the US IOM and the Agency for Healthcare Research recommended
retirement of the criteria because of this potential for inaccuracy. Additionally,
40% of participants within the studies selected had comorbid psychiatric
disorders, which can explain a chronic fatigue state and excludes classification as
CFS. The erroneous inclusion of people who do not have CFS may mean they are
susceptible to the interventions, hence confounding the results169;
•
Entry Score Requirements Not Sufficiently Strict – Five studies had entry
requirements that potentially allowed high-functioning participants to enter the
studies. Three of these studies had no entry score requirements. These
166 M. Vink and A. Vink-Niese, ‘Graded Exercise Therapy for Myalgic Encephalomyelitis/Chronic Fatigue
Syndrome is Not Effective and Unsafe. Re-analysis of a Cochrane Review‘
Health Psychology Open 2018 Jul-Dec: 1–12.
167 Ibid, pp. 1-2.
168 Ibid.
169 Ibid.
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weaknesses potentially allowed participants into the study who did not have
CFS170;
•
Primary Outcome was Subjective Fatigue Measured by Self Report – Whilst the
eight studies claimed to be blind, they used two subjective primary outcomes
being fatigue and adverse outcomes. Participant self-report is unreliable as a
measure and leads to pronounced bias as participants are open to outside
influence. Efficacy can thus be misreported and the outcome assessed is
unreliable. The Cochrane authors recognised this potential for bias. All but one
study used objective outcomes, but the Cochrane review did not use these
objective measures. The measures used were unreliable171;
•
Chalder Fatigue Scale Flawed – The scale employed in most of the studies has
four specific flaws: not a comprehensive reflection of fatigue severity,
symptomology or functional disability in CFS; ceiling effect, because maximum
score at baseline cannot increase; inability to distinguish healthy controls and
fatigue; the focus is on fatigue, not intensity. Its use to measure subjective
fatigue, being the primary outcome measure on each study, casts doubts on
reported outcomes from those studies utilising it172;
•
Dropout Concerns – Dropout percentages varied between studies. Those
participants adversely affected are likely to drop out or be lost to follow-up. This
potentially causes inflation of improvements because the dropouts were
excluded, hence raising doubts about the reliability of each study.173
Vink and Vink-Niese reviewed each paper and identified various flaws within the papers,
particularly the PACE trial. The authors noted the reporting of harms was omitted from six
of the eight studies, and those reports were questionable in their measures. The Cochrane
review acknowledged the limitations, yet confidently declared there was no evidence that
exercise therapy would cause symptoms to worsen.174 Vink and Vink-Niese concluded that
the bias within the trials examined was high. Across two decades of studies, the authors
conclude that the objective evidence generated did not show any improvement from the
GET interventions. The authors pointed out that PEM is a cardinal symptom of ME, and
would be triggered by GET, hence an adverse impact should have resulted in such patients.
This suggests that no participants had ME and the participants were unlikely to have issues
with exercising.175 Additionally the severely ill were excluded from these studies.
The criticisms of the Cochrane review called into question the reliability of the review and
the conclusions with respect to the effectiveness of GET.
170 Ibid, pp. 2-3.
171 Ibid, p.3.
172 Ibid.
173 Ibid.
174 Ibid, p. 7.
175 Ibid, pp. 8-9.
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5.
Cochrane Revision– Following its completion of the review of the Cochrane Review’s
approach to ME/CFS with respect to exercise therapy, the authors released the amended
document on 2 October 2019.176 The key amendments were:
•
Bias – The Cochrane authors identified a high risk of performance and detection
bias in every study included;
•
Adverse Effects – The Cochrane authors acknowledged that the evidence in
regards to serious adverse reactions caused by GET was uncertain due to the fact
that the certainty of evidence was very low;
•
CBT – The authors admitted that the evidence with respect to CBT did make the
drawing of conclusions as the comparative effectiveness of CBT, with respect to
GET, impossible;
•
Criteria – The authors acknowledged that the primary studies were drawn from
the 1991 Oxford Criteria and 1994 Fukuda criteria. The authors admitted that if
a patient was diagnosed by way of another criteria (such as the 1988 Ramsay ME
Criteria, 2011 ME criteria or 2003 Consensus criteria) the impact of GET may well
be different;
•
Certainty of Evidence – The authors acknowledged that the grades for each study
with respect to certainty of evidence, was low to very low across the papers;
The Editor in Chief provided a statement177 outlining Cochrane plans to undertake a new
review of the ME/CFS evidence in 2020, with a view to a protocol being developed in
consultation with an Independent Advisory Group inclusive of patient-advocacy groups.
ME/CFS Australia are seeking to have a nominee participating in this process.
6.
Fatigue Clinic Study – As examined in the CBT section above, Professor Lloyd’s UNSW Fatigue
Clinic study on fatigue states, not on CFS alone, examined the combined use of CBT/GET
within one arm of the study and CBT in the other.178 CET was used at intervals but was not a
major component of the study.179 This study clearly defers to the construction and
outcomes of the PACE trial and this is identified.180 We reiterate our position with respect to
the PACE study and the criteria used, as made above.
Participants within the Fatigue Clinic study were selected on the basis of prolonged fatigue
and fatigue was the primary measure, whilst secondary measures focused on functional
outcomes, mood and sleep.181 The study purported to report harms and identified only
three adverse events. There was no follow-up of participants beyond 12 months, hence
there is no validity for this study to purport to remedy impairments.
176 L. Larun, K.G. Bruberg, J. Odgaard-Jensen, and J.R. Price, ‘Exercise Therapy for Chronic Fatigue Syndrome’,
Cochrane Database Sys Rev 2019; 4; CD 003200.
177 Cochrane, ‘Publication of Cochrane Review: ‘Exercise therapy for chronic fatigue syndrome’ (2 October
2019) < https://www.cochrane.org/news/publication-cochrane-review-exercise-therapy-chronic-fatigue-
syndrome?fbclid=IwAR3C5yukjNA8b4MOw1bBZGHz-_GrASAtAxJ2_dUbZO1lc9HaqPhc9k0ppH0>.
178 Sandler et al, above n. 103, p. 1421.
179 Ibid, p. 1423.
180 Ibid, p. 1422.
181 Ibid, p. 1423.
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The study did not have participants that fell within the severe category of patients.
The authors do not report any conflicts of interest as identified above, despite apparent
pecuniary and non-pecuniary benefits and other identified issues.
The key outcome measures, being fatigue severity and cognitive complaints, were measured
by way of self-report, i.e. subjective measures. Multiple instruments were employed.182
With respect to the use of GET with CBT, the primary measure was fatigue. The study
reported that “the severity of self-reported fatigue improved significantly between baseline
and end-of-treatment” and at the 24 week follow up, purporting that the improvement was
“generally sustained” with some deterioration.183 The authors claimed physical function
showed “consistent improvements” at the conclusion of the study and at the 24 week
follow-up.184 Mood and social functioning improved from base-line to the end of treatment,
and social functioning increased from end of treatment to follow-up. These improvements
applied to 34.5% of patients at the end of treatment and dropped to 20.5% at follow-up.185
This study does not show any outcomes beyond 24 weeks, hence is not longitudinal and
cannot be generalised as sustaining a long term or permanent effect.
Putting aside the inherent flaws in the study, the fact that it is not a CFS study, and the fact,
as its title states, this is a study on “fatigue states”, ME/CFS Australia submits that the key
issues relevant to the
Rules and the
Act are not met.
First and foremost this study omits the severely ill. Secondly, the study ends at follow-up,
some 24 weeks after commencement. It does not and cannot claim to demonstrate that the
purported benefits are permanent. Thirdly, the study does not address the majority of
specific impairments outlined in the
Act and no amount of extrapolation between its effect
on symptoms can give it application. Fourthly, the study is, yet again, focused on fatigue as
the primary measure, and this is not reflective of the condition for the majority. Finally, the
study does not, at any point, demonstrate that the treatments are “likely to remedy” the
impairments. There is no claim of a cure, to be utilised to deny permanency.
7.
UK Survey for NICE – As with CBT, the recent survey in the UK by patient organisations
conducted by Oxford Brookes University186 at the request of NICE Guidelines Review
Committee187 demonstrates that GET is associated with significant harms:
Of the respondents, some 67% reported deterioration in physical health following GET, while
13.3% reported an improvement, and 11.7% reported no improvement. GET also caused the
182 Ibid.
183 Ibid, p. 1435.
184 Ibid.
185 Ibid, p. 1426.
186 Forward ME Group, above n. 129, p. 11.
187 Dawes, above n. 130.
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mental health of 53% of respondents to deteriorate, whilst 25.5% reported no improvement
and 12.8% reported improvement.188
When CBT and GET were combined, 48.4% reported that CBT did not improve physical
health, whilst 11.8% reported an improvement in physical health. 35.5% of respondents
reported that their physical health deteriorated with CBT. Mental health improved in 29.4%
of respondents, whilst 32.7% reported no improvement and 34.3% reported deterioration.
The report also found that some 58.4% reported a worsening of symptoms.189
8.
Other Surveys – The 2014 Action for ME in UK’s 2014 patient health and well-
being survey reported that 35% of respondents identified GET was a little or very
188 Forward ME Group, above n. 129, p. 11.
189 Ibid, p. 13.
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helpful, while 18% indicated no change and 47% reported that the treatment
made them a little bit or a lot worse.190 The 2019 Emerge Australia survey
reported 47% of respondents deteriorated after GET.”191
6.2.2.2.3.3.5. Submission
ME/CFS Australia submits the following with respect to GET:
•
Not Recommended by CDC - The US Centres for Disease Control and Prevention removed
GET from its recommended treatments in mid-2018 and it is no longer included on their
website. This removal coincided with their retirement of the 1994 Fukuda Criteria in favour
of the IOM’s emphasis on systemic exertion. The inference has to be drawn that this
removal clearly signals that GET is not regarded as an effective treatment192;
•
Severe Not Included - Nothing in the alleged “evidence-base” purports to research the use of
GET on patients who fall within the severe category of ME/CFS, hence there simply is no
justification to argue that this literature forms an evidence base for this patient cohort. It
therefore fails the requirement under Rule 5.4. The evidence base provided is therefore not
appropriate;
•
Retired Oxford Criteria - The evidence-base provided by Professor Lloyd is primarily based
upon the now retired Oxford criteria, i.e. it is focused on fatigue;
•
Oxford Criteria Focused on Fatigue - Research utilising the Oxford criteria simply does not
represent the majority of patients diagnosed under the 1994 Fukuda criteria or the 2003
Consensus Criteria. The Oxford criteria is focused on patients who have fatigue as their
primary symptom and requires no other symptoms, unlike Fukuda and the Consensus
Criteria. This evidence base therefore does not satisfy the requirement that evidence be
“appropriate” within Rule 5.4 of the
Rules;
•
Treatments Do Not Remedy - Even if the evidence base provided by Professor Lloyd was
accepted, the studies do not show that a person receiving the treatment is likely (i.e. high
probability of occurring or being true) to have their impairments remedied because the
effect is moderate at best;
•
Significant Harms Reported - The most recent evidence from the UK provided to the current
NICE review committee, at the committee’s request, sourced from on over 2000 patients
clearly shows that the majority of survey respondents derived no benefit from GET, whilst
most concerningly, there were significant rates of minor to major harms to patients that
arose from the GET they received;
•
Evidence Base Not Appropriate - The evidence base provided by Professor Lloyd is
exceptionally limited and highly contentious – hence does not fulfil the criteria of
“appropriate” within the meaning of Rule 5.4. of the
Rules;
•
Evidence Base Focused on Fatigue - The evidence base provided by Professor Lloyd, even if
accepted, is focused upon those patients for whom fatigue is the primary symptom. The
PACE trial authors make it clear that the treatments are suitable for those patients who
meet the Fukuda and Consensus Criteria only if fatigue is the primary symptom. For the
vast majority of patients who do not experience fatigue as their primary symptom, the
190 Action for ME, above n. 132, p. 19.
191 Emerge, above n. 68, p. 2.
192 CDC, above, n. 75.
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evidence base provided by Professor Lloyd does not address their symptoms. The evidence
base therefore does not meet the definition of appropriate within the meaning of Rule 5.4.
of the
Rules.
6.3. Risk of Harms
ME/CFS Australia holds serious concerns that the current policy of the NDIA. As it stands, the
scheme requires applicants to place themselves at risk of harm from potentially harmful treatments
in order to meet the entry criteria of the NDIS under the policy that the NDIA is enforcing. It is our
position, based upon the above, that CBT, CET and GET will not and cannot remedy the impairments
in circumstances where it is a well-established fact that such treatments can, and do, cause harm for
a significant percentage of the patient population.
6.3.1. Public Health Context
Public health is the science of ensuring the safety and improving the health of people within the
community, through education, policy making, research and injury prevention. ME/CFS impacts up
to 1% of the population. By its very definition ME/CFS is classified as a public health issue.
At the Commonwealth level193 and within each state jurisdiction there is an enactment with respect
to public health.194
6.3.2. Precautionary Principle
6.3.2.1. Role Within Public Health
Whilst more commonly enshrined in legislation within the sphere of environmental law, the
precautionary principle also has application within the context of public health. Shirlow and Faunce
explain that “[t]he precautionary principle is a risk management tool which justifies action taken to
prevent potential risks, even where the existence of such risks has not been conclusively
ascertained.”195
Within the United States, the precautionary principle was instituted within public health in 1990s.
Goldstein explains:
“The precautionary principle has been advocated for public health because
of the
importance of anticipating unintended health consequences of well-
intentioned public health interventions. Seeking to
avoid creating new
problems while solving existing ones is an important aspect of the
precautionary principle, but it is not the
only way in which precaution can
benefit public health.”196 (Emphasis Added)
193
National Health Act 1953 (Cth).
194
Public Health Act 2010 (NSW),
Public Health Act 2005 (Qld),
South Australian Public Health Act 2011 (SA),
Public Health and Wellbeing Act 2008 (Vic),
Public Health Act 1997 (Tas),
Public Health Act 1997 (ACT),
Public
Health Act 2016 (WA),
Public and Environmental Health Act 2011 (NT).
195 E. Shirlow and T. Faunce, ‘Recent Legal Developments and the Authority of the Australian Therapeutic
Goods Administration’.
Journal of Law and Medicine 2009 June; 16: 764, 767.
196 B.D. Goldstein, ‘The precautionary principle also applies to public health actions.’
American Journal of Public
Health. 2001; 91(9): 1358-1361, 1359.
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The principle is, for example, encompassed within Section 6 of the South Australian and Victorian
legislation, albeit different definitions. Within the Northern Territory legislation it appears at Section
5 and is similarly worded to the South Australian Act.
Within these jurisdictions, stakeholder involvement in policy development is required in order to
balance the interests of stakeholders, and arrive at a solution to issues addressed.197 The
application of the precautionary principle plays a significant role in that process, allowing a
calculation of risk to be made with respect to imperfect literature. Within other jurisdictions, there
is a role for the precautionary principle in creating policy.
6.3.2.2. Definition
There are variations to the definition of the precautionary principle. The
Wingspread Statement on
the precautionary principle developed at the Wingspread Conference in 1998 defined the principle
as:
“… it is
necessary to implement the Precautionary Principle: When an
activity raises threats of harm to human health or the environment,
precautionary measures should be taken
even if some cause and effect
relationships are not fully established scientifically. In this context the
proponent of an activity, rather than the public, should
bear the burden of
proof. The process of applying the Precautionary Principle must be open,
informed and democratic and must include potentially affected parties. It
must also involve an
examination of the full range of alternatives, including
no action.”198
Judicially, Sackville J in the
Matter of the Friends of the Hinchinbrook Society Inc v Minister of
Environment (1997) 93 LGERA 249, provides an element of relevant direction to the principle, when
stating:
“The commonsense (sic) principle that caution should be exercised
where
scientific opinion or scientific information is incomplete.”
It is in this context that we believe ME/CFS and the precautionary principle meet.
6.3.3. Harms and Treatment
6.3.3.1. Applying the Precautionary Principle
ME/CFS Australia has critiqued the literature provided by Professor Lloyd to the NDIA, and offered
literature which indicates that there are significant flaws within these studies. It is our submission
that the NDIA literature itself demonstrates clearly that the scientific information is incomplete.
Within those documents there are a variety of qualifications, and encouragement for further
research. We would argue such statements are indication of an evidence base that is incomplete.
197 L.A.J. Kruck, ‘A Values Analysis of Attitudes Towards the Use of Law to Prevent Obesity. How Might These
Values Inform Public Health Law Theory and Practice?’, (PhD Thesis, Queensland University of Technology,
2015), 144.
198 N. Ashford, K. Barrett, A. Bernstein, et al, ‘The Precautionary principle’.
Rachel’s Environment and Health
Weekly, 1998 Feb 19; 586: <http://www.psrast.org/precaut.htm>, 586
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Additionally, we have presented evidence that demonstrates that the application of the various
treatments lead to harms being visited upon patients, when such treatments are taken out of the
controlled environment of a study, into the real world. The “threats of harm to human health”
trigger precautionary measures, even when the “cause and effect relationships are unknown.”
6.3.3.2. Harms and ME/CFS
At various points throughout this submission, ME/CFS Australia has consistently raised the issue of
harms arising from the recommended treatments. At 6.2.2.2.3.2.4. and 6.2.2.2.3.3.4. above, we
specifically reference various surveys of patients in the UK and Australia and the common theme
was the large percentage of the respondent cohorts who reported deterioration. What stood out in
contrast, was the fact that the studies provided by Professor Lloyd either didn’t have reporting of
harms, or handled the reporting of harms poorly.
The Cochrane review identified that only two of the eight studies examined serious harms, and
noted one of the studies provided “moderate-quality evidence”. They stated the “sparse data made
it impossible for review authors to draw conclusions”.199
In his 2011 paper Kindlon drew upon survey evidence and studies published around that time.200
Kindlon reviewed the literature, noting that various studies identified physiological abnormalities
when study participants engaged in exercise.201 Such studies included gene expression testing,
Cardiopulmonary Exercise Tests, immune dysfunction and impaired ion channels. Kindlon reviewed
survey data from multiple surveys and identified that “[h]igh rates of adverse reactions following
[graded activity/exercise] programs have been reported in large patient surveys in various countries
over the last two decades”. Indeed, Kindlon reported 51.24% of exercise programs resulted in an
adverse impact, while CBT resulted in deterioration in 19.91%.202 Kindlon identified that the
reporting of harms from CBT and GET was lacking in quality, while those who did not adhere to
treatment and those lost to follow-up may well have been adverse events, yet the studies had failed
to obtain the information.203
In is 2017 paper, Kindlon examined the reporting of harms in the PACE trial. Kindlon noted that
historically the reporting of adverse events in clinical trials is poor.204 The author complimented the
PACE trial on some elements of reporting harms and noted that the majority of clinical trial evidence
on harms comes from the PACE trial.205 Kindlon identified that the CONSORT statement requires
reporting of non-adherent participants who are followed up or lost to follow-up, because this may
well be indicative of an inability to tolerate the intervention. Kindlon was critical of the PACE trial
which had a primary measure of attendance of an appointment as a compliance measure. He was
also critical of definition of harms within the trial as unrealistic. He suggested the minimal changes
199 Larun et al, above n. 136, p. 2.
200 T. Kindlon, ‘Reporting of Harms Associated With Graded Exercise Therapy and Cognitive Behavioural
Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.’
Bull IACFS ME. 2011; 19(2): 59–111.
201 Ibid, p. 62.
202 Ibid, p. 64.
203 Ibid, p. 68.
204 T. Kindlon, ‘Do Graded Activity Therapies Cause Harm in Chronic Fatigue Syndrome’.
Journal of Health
Psychology 2017; 22(9): 1146-1154, 1146.
205 Ibid, p. 1147.
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in fitness across the 12 months indicate non-compliance by participants.206 Kindlon recommended
future studies utilise objective measures such as heart rate monitors and actometers to help
establish what the authors are testing when using CBT and GET. In the absence of such data, and
the survey reports indicating high rates of harms, he urged caution with respect to the safety of
using CBT or GET.207
In their 2018 paper on the reanalysis of the PACE data, Wilshire et al considered the safety issues
that arose in the study.208 The authors noted the significant difference between the small number
of adverse reports measured in the PACE trial and the significant percentages of adverse effects
reported in multiple very large informal surveys.209 The authors questioned participant selection and
the fact that despite the PACE authors collecting objective evidence by way of actigraphy. this data
was excluded from their papers.210
Most recently, McPhee et al conducted an examination of the quality of reporting with respect to
harms arising from treatments for ME/CFS within the NHS specialist centres in England.211 The
authors obtained data from the centres by way of a freedom of information request. The authors
identified that a significant number of clinics (47%) had not provided guidance to its staff with
respect to identifying whether a patient had, or might have been, harmed212. Half of the centres did
not even address the question as asked. No clinic reported any harm to any patient. The authors
concluded that “such clinics place little focus on dealing with such [treatment related] harms”, but
noted that 18% of the clinics did, however, report drop outs without identifying the reasons why213.
The authors concluded that the assessment of zero-harm was overly optimistic. They expressed
significant reservations with respect to the manner in which NHS ME/CFS clinics handled adverse
outcomes during or after therapies. The universal absence of a criteria for detecting harm and the
absence of any report of harm accorded the authors particular concern. The authors viewed such
information as especially important for the acquiring of informed consent from patients prior to
treatment.
6.3.3.3. Unreasonable Risk
ME/CFS Australia submit that a fair review of the literature reveals that there are serious
deficiencies within the research provided by Professor Lloyd with respect to the reporting of harms.
Indeed, the Cochrane review provided by Professor Lloyd confirms this view. A review of the
significant papers published with respect to harms reveals significant points of weakness within the
existing reporting within the studies provided to the NDIA.
206 Ibid, p. 1149.
207 Ibid, p. 1151.
208 Wilshire et al, above n. 119, p. 10.
209 Ibid.
210 Ibid.
211 G. McPhee, A. Baldwin, T. Kindlon and B.M. Hughes, ‘Monitoring treatment harm in myalgic
encephalomyelitis/chronic fatigue syndrome: A freedom-of-information study of National Health Service
specialist centres in England’.
Journal of Health Psychology 2019 Jun 24; 135910531985453.
212 Ibid, p. 5
213 Ibid, pp. 5-6
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ME/CFS Australia also considers that there is a disconcerting disconnect between the harms
reported within large scale, multisite patient surveys and those reported within the limited papers
utilising an instrument, including that of Professor Lloyd’s fatigue states paper.
ME/CFS Australia submits that the absence of reliable research with respect to harms, combined
with the strong indicators of harms from the large scale surveys, strongly suggests that there is an
unreasonable risk involved in engaging in GET and CBT. In our view the NDIS legislation, Rules and
Guidelines, combined with the current state of the case law, do not require that an applicant engage
in an intervention with an inherently unreasonable risk attached to it, in order to achieve a possible
improvement. This, we submit, is not appropriate.
6.3.4. Submission
ME/CFS strongly submits that a public health issue of the nature of ME/CFS warrants the application
of the precautionary principle by the NDIA. The NDIA’s policy currently requires that patients
demonstrate engagement in the three interventions in order to attempt to remedy the impairments
arising out of the condition.
ME/CFS Australia submits that:
• there is conflicting literature with respect to interventions;
• the literature forming the basis of the policy employed by the NDIA does not, even at its
best, indicate that the interventions are “likely to remedy” the impairments outlined within
the act, regardless of severity or duration;
• there is an inherent unreasonable risk of harm attached to engaging in the interventions,
which at worst can render someone bed bound permanently.
Given this is the case, and taking account of central tenets of the precautionary principle:
• the interventions raise “threats of harm to human health”;
• the “cause and effect relationships are not fully established scientifically”;
• “precautionary measures should be taken”;
• the onus of proof falls on the NDIA to prove otherwise, and the literature of Professor Lloyd
falls well short;
• no action should be taken, i.e. no intervention should be required, because no alternatives
exist.214
7. ADDRESSING THE LEGISLATION
7.1. Operative Legislation
ME/CFS Australia acknowledge that access to the NDIS is by way of demonstrating a person meets
the disability requirements contained within Section 24 of the
NDIS Act. Section 24 states:
214 N. Ashford, K. Barrett, A. Bernstein, et al, ‘The Precautionary principle’.
Rachel’s Environment and Health
Weekly, 1998 Feb 19; 586: <http://www.psrast.org/precaut.htm>, 586
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“Section 24 - Disability requirements
(1) A person meets the disability requirements if:
(a) the person has a disability that is attributable to one or more
intellectual, cognitive, neurological, sensory or physical
impairments or to one or more impairments attributable to a
psychiatric condition; and
(b) the impairment or impairments are, or are likely to be, permanent;
and
(c) the impairment or impairments result in substantially reduced
functional capacity to undertake, or psychosocial functioning in
undertaking, one or more of the following activities:
(i) communication;
(ii) social interaction;
(iii) learning;
(iv) mobility;
(v) self-care;
(vi) self-management; and
(d) the impairment or impairments affect the person's capacity for
social or economic participation; and
(e) the person is likely to require support under the National Disability
Insurance Scheme for the person's lifetime.
(2) For the purposes of subsection (1), an impairment or impairments that
vary in intensity may be permanent, and the person is likely to require
support under the National Disability Insurance Scheme for the person's
lifetime, despite the variation.”
7.2. Addressing the Legislative Requirements
ME/CFS Australia respects that the NDIA, as an inherent component of its claims process, is required
to address Section 24 of the
NDIS Act so that it might satisfy itself as to the eligibility of each
individual applicant to the scheme. We do not in anyway assert that this process requires
abrogation. We do raise concerns about the evidence provided by Professor Lloyd with respect to
specific elements of the legislation.
We therefore address each specific element of the Section 24 requirements.
7.2.1. Meaning of Disability
Before proceeding to each element in turn, we do wish to confirm our understanding of the term,
disability, as it pertains to the
NDIS Act. In doing so, we take account of the case law, the
NDIS Act,
NDIS Rules and the NDIS
Access to the NDIS Operational Guidelines.215
215 NDIS, ‘Access to the NDIS Operational Guidelines’ (16 July 2019) <https://www.ndis.gov.au/about-
us/operational-guidelines/access-ndis-operational-guideline>.
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7.2.1.1. The Decision in Mulligan
ME/CFS Australia is familiar with the seminal case of
Mulligan216 in 2014 where the Senior Member
Toohey and Member McCallum made clear that;
“… the NDIS was not intended to provide funded supports (as opposed to
general supports) for every person with a disability” hence it is
“intended
to cover a subset of those affected by disability”– a much smaller cohort
of those impact with a disability.”217 (Emphasis Added)
We are also aware the tribunal affirmed that the NDIS Act and Rules had not defined the words
‘disability’ or ‘impairment’.218 In the 2014 case, Senior Member Toohey and Member McCallum
state at [24]:
“A person may have a disability
without necessarily meeting all, or even any,
of the disability requirements in s 24(1)(b), (c), (d) and (e). For example, a
person might have a temporary disability, or a permanent disability that has
only minimal effect on functioning, or no effect on his or her social or
economic participation.
The fact that s 13(1) states that the NDIA may
provide support to people with disability who are not participants tends to
support this view.” (Emphasis Added)
The Tribunal in
Mulligan found that given the intent that a subgroup of people with disabilities will
be included with the NDIS, the definition of disability “cannot be read down”.219 When the matter
proceeded to the Federal Court in 2015, Mortimer J affirmed this position, stating “s 13 of the Act
indicates the Act intends a wide concept of ‘disability’ and “is not to be construed as limited to
people who meet the access criteria in Ch 3 of the Act”.220
7.2.1.2. The Decision in Fear
In
Fear v NDIA221, the AAT affirmed the scope of the term ‘disability’ stating “there may be little
obvious distinction between disability and chronic illness or medical conditions.”222 A ‘chronic
health condition’ can be classified as a disability because it can be disabling.223 In
Fear224, the AAT
defined a health condition as:
“The
term “health conditions” may also be broad. In the World Health
Organisation International Classification of Functioning, Disability and Health
it comprehends “diseases, disorders and injuries”. In some cases, the
neurological or physical impairment that gives rise to a disability for the
216
Mulligan and NDIA [2014] AATA 374 per Toohey and McCallum, [52].
217 Ibid, [39].
218 Ibid, [19].
219 Ibid, [52].
220
Mulligan v National Disability Insurance Agency [2015] FCA 544, [17]-[18] per Mortimer J.
221
Fear by his mother Vanda Fear and NDIA [2015] AATA 706.
222 Ibid, [51].
223
Mulligan and NDIA [2014] AATA 374 per Toohey and McCallum, [43].
224
Fear by his mother Vanda Fear and NDIA [2015] AATA 706.
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purposes of the disability requirements in s 24(1) of the Act might also be
regarded as a chronic health condition.”225 (Emphasis Added)
It is conceded that a person can have a disability, yet possibly not meet all, or indeed any, of the
requirements under Section 24(1)(b)-(e) (National Disability Insurance Scheme, 2014c, p. 3).
ME/CFS, therefore, need arguably not satisfy the criteria within Section 24 in any event because it is
a chronic health condition, in that ME/CFS and CFS arguably fulfil the criteria for both.
7.2.1.3. Locating ME/CFS
In speaking to its views with respect to chronic health conditions, the Productivity Commission
stated:
“The Commission does not favour a blanket ‘yes’ or ‘no’ response to the
question of whether individuals with chronic health conditions would be
covered by the scheme. Rather,
the answer should be informed by whether
the NDIS is the most appropriate system to meet the person’s needs.”226
(Emphasis Added)
McCallum stands as precedent for the NDIA’s position that a ‘chronic health condition’ can be
classified as a disability because they can be disabling.227
Fear has reinforced that understanding.
ME/CFS is, by definition, a chronic health condition. ME/CFS is, by definition, disabling because the
diagnostic criteria requires a substantial reduction in activities in order to obtain a diagnosis. It is
the position of ME/CFS Australia, that ME/CFS is a disability within the scope of the legislation.
7.2.2. Element 1 - Impairments
Section 24(1)(a) of the
NDIS Act enables the establishment of a disability, in part, by demonstrating
that the applicant has “one or more intellectual, cognitive, neurological, sensory or physical
impairments or to one or more impairments attributable to a psychiatric condition”.
When considering Ms Agus’ correspondence of 15 August 2018, there is no assertion that the NDIA
considers ME/CFS fails to meet this element. ME/CFS Australia will address this point for clarity.
7.2.2.1. Impairment Defined
As explained in the 2014
Mulligan case – ““Impairment” commonly refers to a loss of, or damage to,
a physical, sensory or mental function. “228 This concurs with the
NDIS Operational Guidelines.229
7.2.2.2. ME/CFS and Impairment
ME/CFS Australia submits that ME/CFS is an impairment on the basis of several heads under Section
24(1)(a):
225Ibid, [55].
226 Ibid.
227
Mulligan and NDIA [2014] AATA 374 per Toohey and McCallum, [43].
228 Ibid, [19].
229 NDIS, ‘Access to the NDIS – The Disability Requirements’ (16 July 2019) < https://www.ndis.gov.au/about-
us/operational-guidelines/access-ndis-operational-guideline/access-ndis-disability-requirements#8.1>.
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(a)
Neurological – First and foremost, ME was initially classified as a neurological
condition in 1969 when it was first included in the International Classification of
Diseases (ICD)230. It remains classified under G.93.3 in the current ICD-10.231 The
NHMRC ME/CFS Advisory Committee recently adopted the International Consensus
Criteria.232 Carruthers et al reviewed the literature and stated that “Myalgic
encephalomyelitis is an acquired neurological disease with complex global
dysfunctions. Pathological dysregulation of the nervous, immune and endocrine
systems, with impaired cellular energy metabolism and ion transport are prominent
features.”233. The authors set out the various neurological impairments, including:
• Neurocognitive impairments – difficulty processing information, short-term
memory loss;
• Pain – Headaches, Significant pain;
• Sleep Disturbance – Disturbed sleep patterns, unrefreshed sleep;
• Neurosensory, Perceptual and Motor Disturbances;234
On this basis alone, ME/CFS meets the requirements of an impairment;
(b)
Physical – ME/CFS is a physical condition. Carruthers et al specifically identify the
physical issues within the 2003 Consensus Criteria, including:
(i)
Fatigue – “The patient must have a significant degree of new onset,
unexplained, persistent, or recurrent
physical and mental fatigue that
substantially reduces activity level.”235
(ii)
PEM and/or Fatigue – “There is an inappropriate loss of
physical and mental
stamina, rapid muscular and cognitive fatigability, post exertional malaise
and/or fatigue and/or pain and a tendency for other associated symptoms
within the patient's cluster of symptoms to worsen. There is a pathologically
slow recovery period – usually 24 hours or longer.”236
(iii)
Other Physical Impairments – The criteria also sets out other physical
attributes that feature in the condition, including sleep dysfunction, pain,
neurological/cognitive manifestations, autonomic manifestations,
neuroendocrine manifestations, and immune manifestations237;
The physical symptoms of the condition are the cardinal features of the condition.
(c)
Cognitive – Neurocognitive symptoms are inherent symptoms of the condition.238
Carruthers et al outlines the issues in the 2011 International Consensus Criteria,
stating it impacts as follows:
230 World Health Organization, ‘WHO: International Classification of Diseases. (ICD 8), Eighth’ (1969).
231 World Health Organization, ‘WHO: International Classification of Diseases. (ICD 8), Tenth’ (1990).
232 NHMRC, above n. 4, p. 15.
233 Carruthers, above n. 33, pp. 327, 329.
234 Ibid, 130.
235 Carruthers, et al, above n. 32, p. 11.
236 Ibid.
237 Ibid, pp. 11-12.
238 Ibid, p. 34
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“a. Difficulty processing information: slowed thought, impaired
concentration e.g. confusion, disorientation, cognitive overload,
difficulty with making decisions, slowed speech, acquired or
exertional dyslexia;
b. Short-term memory loss: e.g. difficulty remembering what
one wanted to say, what one was saying, retrieving words,
recalling information, poor working memory.“239
(d)
Intellectual – Intellectual impairment relates to intellectual functioning such as
reasoning, learning and problem solving, and adaptive behaviour. The 2002 Clinical
CFS Guidelines specifically note “reduced … intellectual capacity” and “loss of …
intellectual performance”.240 For the most severely ill, a diagnosis of an acquired
brain injury can occur. Their function is so severely impacted that it affects
communication, speech and thought241,242,243,244;
(e)
Psychiatric – Depression is a secondary consequence of ME/CFS because of the
situation that patients find themselves in.245 Other conditions such as Post
Traumatic Stress Disorder can also arise from post illness onset issues that impact
the individual.
ME/CFS Australia submit that the condition inherently satisfies Section 24(1)(a) if only by virtue of
the fact that it is classified as a neurological condition by WHO and the ICD-10 which is adopted
within Australia. The remaining heads merely reinforce the satisfaction of Section 24(1)(a).
7.2.3. Element 2 - Permanency
The key wording within Section 24(1)(b) centres not only on actual permanency but also “likely”
permanency. ME/CFS Australia is of the view that ME/CFS is more likely than not to be permanent.
The NDIA has, respectfully, been provided a very limited view of the issue of permanency.
Moreover, there has been a misconstruing of the Dubbo study, and indeed the meaning of recovery
per se. We feel that it is exceptionally important for the NDA to comprehend the inherent nature of
the condition and the limitations of various studies that have narrow meanings for the term
‘recovery’, issued within studies that are not significantly longitudinal in nature, nor appropriately
followed up. We therefore submit as follows:
239 Carruthers, above n. 33, p. 329.
240 RACP Working Group, above n, 1, p. S29.
241 F. Friedberg, L. Bateman, L.A . Jason et al, ‘ME/CFS: A Primer for Clinical Practitioners’ (2014)
<http://iacfsme.org/portals/0/pdf/Primer_Post_2014_conference.pdf>, p. 27.
242 G. Crowhurst, ‘Supporting People With Severe Myalgic Encephalomyelitis’
Nursing Standard 2005 Feb 2;
19(21): 38-43, 40.
243 V. Strassheim, R. Lambson, K.L. Hackett & J.L. Newton ‘What is known about severe and very severe chronic
fatigue syndrome? A scoping review’
Fatigue: Biomedicine, Health & Behavior, 2017 Jun 19: DOI:
10.1080/21641846.2017.1333185, 11.
244 T. Pendergrast, A. Brown, M. Sunnquist, et al, ‘Housebound Versus Nonhousebound Patients with Myalgic
Encephalomyelitis and Chronic Fatigue Syndrome’ Chronic Illness, 2016; 12(4); 1-16, 11.
245 Carruthers, et al, above n. 32, p. 27.
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7.2.3.1. The NDIA Position
The NDIA position with respect to permanency has been based upon the evidence base provided by
Professor Lloyd. ME/CFS Australia have clearly and accurately addressed the foundation of the
NDIA’s position with respect to its misconception that the majority of patients with ME/CFS recover
without intervention. Clearly the NDIA was in serious error (see: 5.2.2. above).
The 2002 RACP Guidelines clearly highlight the inaccuracy of the NDIA position, when the committee
clearly state “
most people with CFS improve gradually, and
some eventually recover.”246 With only
some recovering, the majority do not, ergo they are most likely to have it for life. It is for this
reason that ME/CFS Australia asserts that the evidence base supports permanency.
7.2.3.2. Concessions of the NDIA
The correspondence from Ms. Agus does, however, concede that 2002 RACP Guidelines, of which
Professor Lloyd was the primary author, considered that permanency can be assumed where
ME/CFS has “been present in a stable, non-improving pattern, despite evidence-based management
(such as … CBT … GET … and cognitive remediation) for 5 years.”
ME/CFS Australia has clearly demonstrated that there is no “appropriate evidence base” that
demonstrates that CBT/GET/Cognitive Remediation is “likely to remedy” ME/CFS, thereby triggering
Rule 5.4 of the
Rules (see: 6. above).
7.2.3.3. Prognosis
ME/CFS Australia has already addressed the issue of recovery (see: above at 5.2). We draw your
attention to the IACFSME Primer and its position with respect to prognosis. The Committee states:
“Patients may be very ill at the onset of the illness, but the majority of
patients report improvement,
reaching a plateau, within five years of
becoming ill. The
severity of illness varies between the extremes of some
patients who are completely bedbound and others who are able to go out to
work.
Remissions and relapses are common. Over time, many patients
improve enough so that they no longer keep their ME/CFS diagnosis, but
they
also DO NOT RETURN TO THEIR PREMORBID LEVEL of functioning.
Restoration of full premorbid health is rare in adults, but more common in
children. Patients who do recover often need more rest than their
contemporaries. Some patients may slowly get worse.
Patients with ME/CFS
who also have FM are less likely to improve than patients with ME/CFS
alone.
A review of 14 studies found on average that
5% of patients recovered (range 0–31%);
40% of patients improved during follow-up (range 8–63%);
8-30% returned to work;
5-20% of patients reported worsening.
246 RACP, above n. 1, p. S46.
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Risk factors for severity of the illness are:
* The
severity of the illness at onset;
* The
standard of early management of the illness, e.g., late diagnosis or
overexertion in the early stages of the illness are
likely to lead to
deterioration;
* Having a
mother with the illness”247 (Footnotes Omitted; Emphasis Added)
The 2002 RACP Guidelines reveal similar findings. The committee state that some 22% of patients
meet the criteria for Fibromyalgia248, which is significant in terms of prognosis as the IACFSME
Committee indicated. The committee also noted patients “reported improved functioning rather
than return to completely normal health was a relatively common outcome.”249 The RACP
Guidelines also points to severity as a key indicator, stating:
“At the more
severe end of the clinical spectrum, although improvement
over time can occur,
the prognosis for recovery is poor. Patients who have
had CFS for more than 10 years are more disabled than those with shorter-
duration illness, and
have significantly more severe symptoms (particularly
cognitive impairment) and
more frequent symptoms of fibromyalgia.”250
(Footnotes Omitted; Emphasis Added)
The 2003 Consensus Criteria identify that the criteria used to clinically diagnose the condition play a
significant role in the prognosis cited for recovery. Specifically, it states:
“A systematic review of prognosis studies show that
the less stringent the
clinical criteria, the better the prognosis. In two of the studies reviewed, 22%
and 26% of
patients with chronic fatigue reported recovery, respectively,
whereas
none and 6% of the ME/CFS patients recovered from fatigue.
Therefore, care must be taken
not to classify patients experiencing chronic
fatigue as ME/CFS patients unless they meet all the criteria for ME/CFS, as
the outcomes for these two patient groups are substantially different.”251
(Footnotes Omitted; Emphasis Added)
Like the RACP, the Consensus committee found severity, the criteria and the presence of
Fibromyalgia was an indicator of prognosis, stating:
“There is a general tendency for the clinical course to plateau from between
six months and six years. In a nine-year study of 177 patients, 12% of patients
reported recovery. The patients with the
least severe symptomology at the
beginning of the study were the most likely to recover but there were no
demographic characteristics associated with recovery. Patients with
comorbid fibromyalgia syndrome demonstrated greater symptom severity
247 Friedberg et al, above n. 239, p. 26.
248 RACP, above n. 1, p. S43.
249 Ibid, S. 44.
250 Ibid, p. S32.
251 Carruthers, above n. 32, p. 48.
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and functional impairment than individuals with CFS alone. Other studies
suggest that less than 10% of patients return to premorbid levels of
functioning.
As the criteria become more stringent the prognosis appears to
worsen.”252 (Footnotes Omitted; Emphasis Added)
7.2.3.4. Key Indicators as to Permanency
ME/CFS Australia submits that the appropriate evidence base demonstrates a number of key points:
1.
Severity – The appropriate evidence base demonstrates that where the severity at onset is
higher, the more likely the prognosis will be poor;
2.
Fibromyalgia – The appropriate evidence base demonstrates that where there is comorbid
Fibromyalgia, the greater the symptom severity and functional impairment;
3.
Criteria – The appropriate evidence base demonstrates that where the diagnostic criteria is
more stringent, the more the prognosis is likely to be poor. The Oxford criteria is the least
stringent and is not used in Australia. The 1994 Fukuda criteria is less stringent that the
2003 Consensus Criteria. The 1988 Ramsay ME criteria is more strict again and the 2011
International Consensus Criteria is the strictest. It is noted that the 2003 Consensus Criteria
and 2011 Consensus Criteria have been adopted for research in Australia by the NHMRC.
4.
Recurring – One of the key limitations raised with respect to the various studies cited above
was the fact that follow-up of so-called ‘recovered’ patients simply did not occur. ME/CFS is
a fluctuating condition. The RACP Guidelines state “The course of the illness also varies.
About two-thirds of individuals report continuous symptoms with fluctuating levels of
severity, and 15% have a relapsing-and-remitting course.”253 The appropriate evidence base
therefore fails to seek evidence of relapse and cannot be claimed to indicate recovery.
5.
5 Years Requirement – The NDIA accepts the RACP Guidelines position that an applicant who
has had the condition for 5 years or more, is likely to permanently have the condition.
On the basis of these points, and the appropriate evidence base, ME/CFS Australia submits the
following:
(a) Likely to be Permanent – a return to pre-morbid function is “rare”. The condition is life-long
for the majority of patients, whether they be severe and continuous, or remitting with
relapse;
(b) Criteria – in the alternative, those who meet one of the following criteria can be considered
to be permanent:
• those who have a severe onset can be assumed to be likely to be permanent;
and/or
252 Carruthers, above n. 32, p. 48.
253 RACP, above n. 1, p. S43-S44.
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• those who have fibromyalgia can be assumed to be likely to be permanent; and/or
• those who fulfil the stringent diagnostic criteria, i.e. the ME or ME/CFS criteria, can
be assumed to be likely to be permanent; and/or
• those who have had the condition for 5 or more years are likely to be permanent.
ME/CFS Australia believes that the evidence base that Professor Lloyd has provided, being the 2002
RACP Guidelines and 2011 International Consensus Criteria, and the NHMRC Report’s accepted
criteria, being the 2003 Consensus Criteria, support the contention that ME/CFS is likely to be
permanent.
7.2.3.5. Addressing the Principles
Section 8.2 of the
Operational Guidelines outline the principles for guidance with respect to
impairment.254 We will address these principles briefly:
1.
Likely to Remedy - ME/CFS Australia has addressed the requirements of Rule 5.4. above at
6.2.2.2.. It is our position that the treatment recommendations of Professor Lloyd are not
likely to remedy the condition;
2.
Variability – ME/CFS can be a variable condition, and result in impairment that varies in
intensity. The fluctuating nature of the condition has been covered above at 7.2.3.3. and
7.2.3.4.;
3.
Potential Improvement – In accordance with Rule 5.5 of the
Rules, ME/CFS can be
considered a variable condition in which the severity of its impact on function can fluctuate
and potentially improve in some cases. The fluctuating nature of the condition has been
covered above at 7.2.3.3. and 7.2.3.4.. In the cases of severe ME/CFS, there can be ongoing
deterioration;
4.
Medical Treatment/Review – Rule 5.6 of the
Rules consider a condition to be permanent
where a condition does not require further medical treatment or review. ME/CFS can reach
a point, as described in 7.2.3.4., where further review is not required to regard the condition
as permanent. The evidence within this submission demonstrates that permanency is
medically demonstrated. With respect, the evidence with respect to CBT/CET/GET does not
provide some prospect of success.
The appropriate evidence base deferred to above demonstrates that CBT/CET/GET are not
treatments that provide some prospect of success because the research is significantly
deficient as described and is not longitudinal, hence cannot claim to remedy or be likely to
remedy.255
7.2.4. Element 3 - Activities
254 NDIS, above n. 227.
255 cf.
Mulligan and NDIA [2014] AATA 974 at [71].
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The third element is Section 24(1)(c) which requires that the impairments cause a reduction in
function with respect to one or more of the six specific activities outlined from Section 24(1)(c)(i)-
(vi): communication, social interaction, learning, mobility, self-care and self-management.
It is apparent, however, that the NDIA has potentially received advice from Professor Lloyd that the
treatments that he recommended rectify the impairments to activities. The NDIA have not specified
or outlined how such representations were made. ME/CFS Australia makes the following
submissions.
7.2.4.1. The Diagnostic Requirements
In order to have a diagnosis of ME/CFS or CFS, a patient must meet the criteria under the 2003
Consensus Criteria or the 1994 Fukuda Criteria or the 2011 International Consensus Criteria. On
rare occasions the 1988 Ramsay ME criteria may be utilised.
The relevant operative condition of the 1994 criteria is the requirement that condition fatigue
“results in
substantial reduction in previous levels of occupational, educational, social or personal
activities.”256 It must be noted that this is a research criteria and strict compliance is required in
research. In clinical practice the criteria is relaxed in the 2002 RACP Guidelines.257 The 2003
Consensus Criteria states that: “The patient must have a significant degree of new onset,
unexplained, persistent, or recurrent physical and mental fatigue that
substantially reduces activity
level.”258 The Guidelines further state:
“A symptom has
significant severity if it substantially impacts
(approximately a 50% reduction) on the patient’s life experience and
activities. In
assessing severity and impact, compare the patient’s activity
level to their
premorbid activity level. Establishing the severity score of
symptoms is
important in the diagnostic procedure, and should be repeated
periodically.”259 (Footnotes Omitted; Emphasis Added)
The Fukuda criteria forms the basis of much of Professor Lloyd’s evidence base. The Oxford Criteria
also requires substantial reductions in activities due to fatigue. He completely omitted the 2003
Consensus Criteria from the evidence base when clearly it is a significant document as the NHMRC
Report, to which he was a signatory, has identified.
ME/CFS Australia makes a number of relevant submissions:
7.2.4.1.1.
Relevant Activities
ME/CFS Australia accepts that there is a loose correlation between the criteria for 1994 Fukuda CFS
and the activities in Section 24(1)(c) being (ii) social interaction (iii) learning and potential personal
256 K. Fukuda, S.E. Straus, I. Hickie, et al, ‘The Chronic Fatigue Syndrome: A Comprehensive Approach to Its
Definition and Study’.
Annals of Internal Medicine 1994; 121(12): 953-959, 956.
257 RACP, above n.1, p. S27.
258 Carruthers et al, above n. 32, p. 11.
259 Ibid, p. 14.
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activities and would encompass (i) communication, (iv) mobility, (v) self-care; and (vi) self-
management, although this is unclear. We will err on the side of inclusion.
With respect to the 2003 Consensus Criteria, it is arguable that the criteria encompasses activities in
general and as such all activities within Section 24(1)(c) are inclusive.
7.2.4.1.2.
Focus on Fatigue
ME/CFS Australia made the point that studies selected by Professor Lloyd focus on studies that
involved the Oxford Criteria, e.g. PACE and Cochrane, and as such were focused on fatigue. At
6.2.2.2.3.2.4. above it was made clear that Professor Lloyd’s research group also focused on fatigue.
Whilst the criteria under the 1994 Fukuda and 2003 Consensus Criteria have fatigue as a primary
symptom, and such symptom related to activities, there are issues of exceptional importance to be
considered if one accepts those studies:
1.
No Removal of CFS Condition – A fair review of the studies within the Lloyd evidence base do
not claim that treatment results in patients no longer satisfying the CFS criteria. They do,
however, claim to improve the primary symptom, which is fatigue. The participants still
fulfilled the criteria for CFS, being Oxford or Fukuda. Even the PACE trial’s Oxford Criteria
cohort has best claims for moderate improvement for about 30%, which again does not
reverse the diagnosis. Under reanalysis using the original published protocol it was much
less and not statistically significant at all;
2.
Substantial Reduction – The criteria for 1994 Fukuda CFS requires a substantial reduction in
activities as a result of fatigue in order for the diagnosis to persist. As pointed out above,
the treatments did not remedy the impairments. Even if a person had a positive response
to the treatment, they still had a diagnosis of CFS;
3.
Meets Legislation – No matter what the generalised view of Professor Lloyd or the NDIA
might be with respect to the effect of the treatments, it is the words and effect of the
legislation that is the paramount consideration.
Within each study contained in the evidence base, the research participants still met the
requirements of this subsection, regardless of purported treatment used or outcome
concluded. The legislation requires a substantial impairment of activities.
The word ‘substantial’ can be taken to have its ordinary meaning, in the absence of any
evidence to the contrary. The word ‘substantial’ is also used when assessing the impact of
fatigue upon activities in the Fukuda and Oxford definitions of CFS. The meanings are
therefore one and the same.
Even if one were to accept that the claimed evidence base was untainted and accepted that
it showed treatments had an effect as significantly as claimed, there is nothing within the
literature that states or demonstrates that patients no longer met the fatigue criteria for
CFS. Given the participants still met the criteria, it can be concluded that they must
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therefore still have substantial reduction in one or more activities. Without a substantial
reduction in activities, a patient cannot sustain the key component of the research criteria.
Even if they did not, the evidence above demonstrates that the result would not be a full
recovery, but a remission. At some point in time, symptoms were likely to recur;
ME/CFS Australia submits that even if the NDIA accepted the papers on face value and accepted that
participants with CFS improved, patients still had the diagnosis of CFS (Fukuda or Oxford) and still
had a substantial reduction in functional capacity to engage in activities.
7.2.4.1.3.
No Focus on Other Symptoms
ME/CFS Australia makes the point that whilst some of the alleged evidence based treatments
claimed to improve some physical symptoms, such as pain for example, they did not address the
specific symptom matrix that make up 1994 Fukuda CFS or 2003 Carruthers ME/CFS.
The other physical symptoms of ME/CFS impact upon the ability of a patient to carry out activities
and cause substantial reduction in pre-illness activities, including those within Section 24(1)(c). The
2003 Carruthers criteria, as identified in 7.2.4.1. above, also considers severity of the other
symptoms, hence it can be presumed that a diagnosis of ME/CFS meets the criteria of substantial.
7.2.4.1.4.
No Requirement for Diagnosis
ME/CFS Australia also submits that even if a person failed to continue to meet the criteria for
ME/CFS or CFS, they can still meet the requirements for a disability under Section 24, by virtue of
their remaining symptoms (a) being permanent (b) causing a substantial reduction in activities.
7.2.4.1.5.
Summary Submission
It is submitted by ME/CFS Australia that the evidence base provided by Professor Lloyd does not
provide any evidence in the literature to suggest that applicants who have undertaken treatment
have reversed the substantial reduction in activities set out in the legislation.
7.2.4.2. Addressing the Activities
Section 8.3 of the
Operational Guidelines outline the functional capacity of an applicant to undertake
activities.260 The guidelines reiterate the position of the Federal Court in
Mulligan261, that it is
unnecessary for the NDIA to be satisfied that an applicant’s impairment is as serious, or more serious
than, another. The NDIS assessment is based upon a functional, practical assessment of what the
person can and cannot do.
7.2.4.2.1.
Assessing Functional Capacity
Section 8.3.1. of the Operational Guidelines outline the considerations when assessing functional
capacity to perform one of more activities,262 deferring to Rule 5.8(a)-(c) of the
Being a Participant
Rules. ME/CFS Australia recognises that the use of assistance (technology, equipment, home
modifications, aids, etc.) in order to participate is a consideration when establishing whether an
applicant can participate effectively or completely in an activity. Additional considerations including
260 NDIS, above n. 227.
261
Mulligan and NDIA [2015] FCA 44 at [56].
262 NDIS, above n. 227.
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regard to the normal expectations of persons of similar age, safe completion of tasks and speed of
tasks are considered. With respect to ME/CFS specifically such considerations are an individual
assessment. ME/CFS Australia is of the view that the evidence base from Professor Lloyd does not
inform this assessment.
7.2.5. Element 4 - Participation
The fourth element under Section 24(1)(d) is consideration of whether the impact of impairment(s)
affect the person's capacity for social or economic participation.
7.2.5.1. Relevant Case Law
ME/CFS Australia draws your attention to
Mulligan263 in 2014 where the Senior Member Toohey and
Member McCallum made clear that:
“We accept that Mr Mulligan
retains substantial capacity for social and
economic participation but the test in this requirement is only that a
person’s capacity for social and economic
participation be affected. There
is
no requirement that it be affected to any particular degree. We accept
that Mr Mulligan’s participation in social life is reduced, mainly on account
of his fear of exerting himself and bringing on a panic attack, and we accept
that he has been on leave of absence from his work with the Samaritans for
the past three months on account of his sciatic pain.”264 (Emphasis Added)
7.2.5.2. Operational Guidelines
The Operational Guidelines further clarify this position. Stating:
“The NDIA is required to only consider whether
any permanent
impairment, or permanent impairments when considered together, affect
a person's social or economic participation.
For example, the NDIA must be satisfied that a prospective participant's
permanent impairment/s
affect their capacity to find or maintain work,
play sport, go to the movies, perform voluntary work or travel.
This disability requirement does not require a person's impairment to
reduce, substantially reduce or affect to any particular degree their social
or economic participation. Rather,
the impairment merely needs to affect
the person's social or economic participation.”265 (Emphasis Added)
7.2.5.3. The Evidence Base
ME/CFS Australia acknowledges that some aspects of the evidence base provided by Professor Lloyd
include general references to social activities and employment.
263
Mulligan and NDIA [2014] AATA 374 per Toohey and McCallum, [52].
264 Ibid, [50].
265 NDIS, above n. 227.
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7.2.5.3.1.
RACP Guidelines
The 2002 RACP Guidelines included a number of references of relevance including:
• “Social isolation”266;
• “Loss of social contacts and access to social learning”267;
• “Activities should be undertaken in a ‘paced’ fashion’”268;
• Severely affected are “confined to bed or wheelchair”269;
• “At the severe end of the spectrum of CFS, people may be housebound and experience
profound fatigue simply from the necessities of self-care, such as showering or
dressing”270;
• “Many people with CFS struggle to continue working”271;
• “Many patients choose to stop working, or unable to continue, either temporarily or
permanently”272;
• “Unpredictability resulting from the fluctuating nature of fatigue symptoms is a
significant problem in conforming to a work routine”273;
• “People with CFS are commonly in crisis with their school or workplace because of the
accumulated time lost as a result of the illness”274;
• “Limited energy, cognitive impairment and memory lapses can impair work
effectiveness, placing jobs in jeopardy”275;
• “In people who have been severely disabled and unable to work for more than five
years, the probability of substantial improvement within 10 years is less than 10%-20%.
This may be regarded as ‘permanent disability’ for medicolegal purposes”276;
The 2002 Guidelines encourage return to social and employment activities277 and recommend CBT to
overcome what it asserts was a “belief that complete withdrawal from work, school and social
activities is necessary”278, noting that ME/CFS Australia disagree that beliefs drive withdrawal, as
opposed to the obvious ill health and associated impairments.
The 2002 Guidelines provide a number of references that assist in comprehending that social and
work issues are significant problems. The inference can be drawn that the ability for social and
economic participation is impacted. For the severely ill, their inherent inability to leave the house at
all, or to any degree, creates an obvious impact.
7.2.5.3.2.
International Consensus Criteria Paper
266 RACP, above n. 1, p. S36.
267 Ibid, p. S44.
268 Ibid.
269 Ibid, p. S45.
270 Ibid, p. S36.
271 Ibid, p. S45.
272 Ibid.
273 Ibid.
274 Ibid, p. S36.
275 Ibid, p. S45.
276 Ibid, p. S46
277 Ibid, p. S39.
278 Ibid, p, S40.
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The 2011 ICC included a number of references of relevance to social and economic participation,
including:
• The operative parts of the criteria are similar to other criteria. The ICC states:
“A. Postexertional neuroimmune exhaustion (PENE pen’-e):
Compulsory
This cardinal feature is a pathological inability to produce sufficient
energy on demand with prominent symptoms primarily in the
neuroimmune regions. Characteristics are as follows:
1. Marked, rapid physical and ⁄ or cognitive fatigability in response to
exertion, which may be minimal, such as
activities of daily living or
simple mental tasks, can be debilitating and cause a relapse.
2. Postexertional symptom exacerbation: e.g. acute flu-like
symptoms, pain and worsening of other symptoms.
3. Postexertional
exhaustion may occur immediately after activity
or be delayed by hours or days.
4. Recovery period is prolonged, usually taking 24 h or longer. A
relapse can last days, weeks or longer.
5.
Low threshold of physical and mental fatigability (lack of
stamina) results in a substantial reduction in pre-illness activity
level…
Operational Notes … ”
Consider activity, context and interactive
effects. Recovery time: e.g. Regardless of a patient’s recovery time
from reading for ½ hour, it will take
much longer to recover from
grocery shopping for ½ hour and even longer if repeated the next
day – if able.
Those who rest before an activity or have adjusted
their activity level to their limited energy may have shorter recovery
periods than those who
do not pace their activities adequately.
Impact: e.g. An outstanding athlete could have a 50% reduction in
his⁄her pre-illness activity level and is still more active than a
sedentary person.”
Activities of daily living include employment and social activities.279
• “Determine total illness burden by assessing symptom severity interaction and overall
impact. Consider all aspects of the patient’s life – physical,
occupational, educational,
social and personal activities of daily living. Patients who prioritize their activities
may
be able to do one important activity by eliminating or severely reducing activities in
other aspects of their life.”280;
• “Children cannot be expected to judge pre-illness function with current function. Assess
impact by comparing hobbies, educational,
social and sport activities the child
participated in before illness with present activity level.”281;
279 Carruthers et al, above n. 33, p. 129.
280 Ibid, p. 333.
281 Ibid.
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Whilst the ICC paper is not as comprehensive as the IOM Report (to follow), it does offer up an
insight into the impact of ME/CFS on the ability to participate in social and economic activities. With
PENE the cardinal symptom of the condition, the ability to repeat an activity declines, hence the
activity is impacted.
7.2.5.3.3.
IOM Report
The 2015 IOM Report included a significant number of references of relevance to social and
economic participation, including:
• The proposed criteria includes the requirement that “A substantial reduction or
impairment in the ability to engage in preillness levels of
occupational, educational,
social, or personal activities,”282;
• “… patients have reported several other ways in which the stigmatization of ME/CFS
affects them, including
financial instability (such as job loss or demotion), social
disengagement …”283;
• “Many patients feel unable to meet their family responsibilities and report
having to
reduce their social activities.”284;
• “Jason and colleagues … found that
impairments in physical functioning, social
functioning, and role-physical had the
greatest sensitivity and specificity in identifying
patients who met the Fukuda definition of ME/CFS.”285;
• “This
fatigue results in a substantial reduction or impairment in the ability to engage in
pre-illness levels of
occupational, educational, social, or personal activities and persists
for more than 6 months.”286;
• “There is sufficient evidence that slowed information processing is common in patients
with ME/CFS, and a growing body of evidence shows that it may play a central role in
overall neurocognitive impairment associated with the disease. Such a deficit may be
responsible for the disability that results in loss of employment and loss of functional
capacity in social environments.”287;
• “There is clear evidence of the impact of ME/CFS on the
education and social
development of these young people ... The stigma and
social effects of pediatric
ME/CFS include the
loss of normal childhood activities and in some extreme instances,
inappropriate forcible separation of children from their parents.”288;
• “Impact on Daily Activities, Responsibilities, and Social Interaction … Daily activities,
responsibilities, and
social interactions—perhaps the most important of which are
adults’ ability to work and children’s attendance and performance in school—can be an
important indicator of disability and impairment (Schweitzer et al., 1995). Patients
coping with the burden of disease will often
reduce certain activities such as
282 IOM, above n. 32, p. 6.
283 Ibid, p. 30.
284 Ibid, p. 32.
285 Ibid, p. 76.
286 Ibid, p. 78.
287 Ibid, p. 107.
288 Ibid, p. 183.
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extracurricular school activities or social gatherings in order to fulfil these essential
responsibilities.”289;
• “Upon follow-up, 66 percent believed that their
illness had an overall social effect on
their life that varied from mild to severe.”290;
• “Children with ME/CFS scored substantially lower than controls on the global health
item of the Child Health Questionnaire (CHQ), as well as most other items,
including
physical functioning, social limitations due to emotional and health limitations, pain
and discomfort, mental health, self-esteem, general health perceptions, and family
activities. Most notably, a comparison of scores on nine items of the CHQ revealed that
the
ME/CFS children scored lower than children with type 1 diabetes and asthma, as
well as healthy controls.”291;
• “
Reductions in employment and productivity per hour resulted in a 37 percent
reduction in household productivity and a
54 percent reduction in labor force
productivity.”292;
• “ME/CFS often lasts for many years, and beyond lost income, inflicts substantial
economic costs at both the individual and societal levels.”293;
• “Regarding work-related impairment, unemployment rates in 13 of 15 studies
varied
from 35 to 69 percent.
Job loss ranged from 26 to 89 percent, which was consistent
with job loss among those with other chronic illnesses.
Decreased work performance
also was consistently reported in the literature and was attributed to impairments of
short-term memory and learning, decision making, attendance, and communication
skills and increased dependence on coworkers to perform work duties, among other
reasons. Studies in this review were based primarily on unstandardized self-report, and
some data
indicated that symptom severity was associated with inability to work.”294;
The IOM Report also considered employment as an indicator of recovery, including from
interventions, stating:
• “A systematic review by Taylor and Kielhofner (2005) examined employment status as an
indicator of recovery. The
review included three longitudinal studies that found little
change in employment status over time ... A 5-year follow-up study by Andersen and
colleagues (2004) found that work disability of ME/CFS patients, identified in accordance
with the Fukuda definition,
increased from 77 to 91 percent, indicating no evidence of
recovery.”295;
• “A systematic review showed that while a few studies found improvement in symptoms
over time, no variables, including gender or length of illness, predicted improvement or
positive work or functional outcomes ... Furthermore,
analysis of existing studies
revealed no evidence of treatments effective at restoring the ability to work. Another
289 Ibid, p. 260.
290 Ibid, p. 261.
291 Ibid, p. 262.
292 Ibid, p. 32.
293 Ibid.
294 Ibid, p. 260.
295 Ibid, p. 264.
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systematic review found that the placebo response is lower in behavioural intervention
studies than in medical intervention studies of patients with ME/CFS...”296;
• “Consistent with the findings of the systematic review of Ross and colleagues…, studies
reviewed by Taylor and Kielhofner …
provided no evidence regarding the efficacy of
employment rehabilitation, such as CBT and/or graded exercise therapy. Variation in
methodologies, outcome measures, subject selection criteria, and other factors
precluded drawing conclusions about the efficacy of interventions designed to enable
ME/CFS patients to return to work.”297;
The IOM report lends significant weight to the view of ME/CFS Australia that the condition invariably
has an impact upon the social and/or economic activities of applicants at some point throughout
their lifetime. The fact that there is no weighting as to the degree of impact within the legislation
means that the NDIA can be satisfied that for the majority, if not all, the assumption of impact under
this element is appropriate. Most significantly, the IOM report identifies no interventions that
demonstrate that the impact is removed completely at any point in the lifetime of a patient.
7.2.5.3.4.
Summary Submission
The evidence base provided by Professor Lloyd sets out the significant impacts of ME/CFS upon
applicants. There is a consistency in regards to the criteria where there is a requirement that there
is an impact upon activities which include social and economic. There are also clear indications that
there is no effective treatment that will restore social or economic participation completely, i.e. a
cure for all symptoms throughout an applicant’s lifetime.
The condition is, as demonstrated above, one that can be consistent throughout a patient’s lifetime,
whereas some will have a period of remission and relapse. Regardless the variations, there is
satisfaction of Section 24(1)(e).
It is acknowledged that Professor Lloyd provides an evidence base that suggests that treatments
lead to improvements in various domains, including social and economic participation. Again, if we
take those studies at face value, they are not significantly longitudinal to be extrapolated to a life
time (noting the chronic recurrent nature of the condition is either ongoing, or fluctuation of
remission/relapse) and they do not demonstrate a complete recovery to pre-illness health, hence
the impact upon social and economic activities, even minor impacts, are sufficient to meet the
criteria within Section 24(1)(e).
7.2.6. Element 5 – Lifetime Support
ME/CFS Australia have demonstrated that the condition is permanent or is likely to be permanent.
Given this is the case, an applicant is inherently “likely to require support under the National
Disability Insurance Scheme for the person's lifetime”.
7.2.7. Element 6 - Variation
The final element is that of variation contained within Section 24(2) of that pertaining to variation.
ME/CFS Australia defer to its submissions above at 7.2.3.3. to 7.2.3.5. Given the inherent nature of
296 Ibid, p. 265.
297 Ibid.
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the condition is one of fluctuation for many, and for some others it is a progressive deterioration,
the condition meets the requirements of this section.
8. SUMMARY SUBMISSION
The purpose of this submission is to present to the NDIA an alternative and balanced perspective
regarding the policy with respect to applicants to the NDIS. Whilst ME/CFS Australia appreciates
that the NDIA is not an expert with respect to its comprehension and appreciation of the finer
nuances of the literature and the condition, it made attempts to inform itself of the current state of
the literature when seeking out an opinion from Professor Lloyd.
ME/CFS Australia has informed itself of the applicable legislation and rules and, via a balanced
consideration of the literature provided by Professor Lloyd, considered what the evidence base
demonstrates and how that information relates to the requirements of the
Act and
Rules.
ME/CFS Australia submits that when the legislature contemplated the construction of Section 24,
and Rule 5.4, it had in mind that the evidence base gathered by the NDIA would speak directly to the
requirements it set down. To this end, the operative word “likely” stands out as a critical
requirement for assessing the permanency of impairments and the probability of success of
remedies. Specifically, it requires that the NDIA undertake a weighting of the information with
respect the evidence based interventions in order to satisfy itself that the intervention will likely
remedy the impairment, or not remedy the impairment.
ME/CFS Australia submits that the NDIA has not appreciated that:
• It has grossly misconstrued the recovery rates with respect to CFS due to a
misunderstanding of the Dubbo study;
• the evidence base does not, at any point, consider those who fall within the severe category
of ME/CFS, hence there is no grounds upon which to conclude that any intervention would
remedy the condition;
• the evidence base contains outdated information (e.g. studies utilising the retired Oxford
criteria; the deference to outdated guidelines);
• the evidence base contains mismatched information (e.g. significantly different criteria;
incompatible delivery of the same treatment label);
• the evidence base focuses on interventions for fatigue, which is not the primary symptom in
ME/CFS;
• the evidence base does not speak to the majority of impairments and cannot be
extrapolated to do so on the basis of the evidence base provided;
• the evidence base, if taken at face value, does not demonstrate at any point that the
symptoms of ME/CFS are remedied;
• the evidence base, if taken at face value, does not achieve the threshold of “likely to
remedy” at any point;
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• in accepting the evidence base uncritically, it has been made aware that the evidence base is
far from settled, the interventions are highly contentious, and there existed a significant
base of evidence identifying numerous critical flaws in key documents within the evidence
base;
• critical aspects of the evidence base, particularly with respect to guidelines and criteria, have
moved forward to the exclusion of past such documents;
ME/CFS Australia has, in providing a balanced critique, attempted to provide sufficient evidence
base to the NDIA to allow it to arrive at an informed decision with respect to policy. In assisting the
NDIA to that policy, ME/CFS Australia, as the peak body encapsulating the consumer voice, has
offered to discuss the matter with and assist the NDIA in considering relevant issues.
ME/CFS Australia has urged the NDIA to adopt the precautionary principle that applies with respect
to matters of public health, which ME/CFS is, in order to avoid potential and actual harms to
applicants who will likely subject themselves to the dangers of the interventions in an attempt to
access the NDIA.
ME/CFS Australia therefore urges the NDIA to amend its current policy for the protection of the
applicants from harms and to allow full and fair consideration of the impairments of the applicants
against the requirements of the scheme.
9. LIST B-INCLUSION
The final issue that ME/CFS Australia wishes to address within this submission is the matter of List B
inclusion. ME/CFS Australia submits that the NDIA holds the discretion to relieve claimants of the
controversy and hurdles that have arisen on almost every ME/CFS claim to date (noting some have
moved through to acceptance where another condition was accepted as the primary issue).
The NHMRC Report recently supported this position, stating:
“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, DSP or supportive
services. To access care through the NDIS and DSP patients need to show
they have a significant disability.
For these ME/CFS patients, graded exercise
therapy may not be appropriate. The following summarises the submissions’
proposed recommendations to NDIS:
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• recognition of ME/CFS as a
serious debilitating condition • the condition should be
listed on the NDIS under list B: neurological
disorders • that
assessment guidelines for NDIA assessors be developed in
collaboration with clinicians with expertise in management of ME/CFS and
the ME/CFS community.”298
ME/CFS Australia submits that the evidence before you, whilst not an exhaustive account of the
literature, is a persuasive and sufficient justification for the inclusion of ME/CFS under List B with
other Neurological Conditions.
10. ME/CFS ADVISORY GROUP
ME/CFS Australia is aware that the NDIA has a number of reference groups with whom it consults
and works to improve the process and supports under the scheme.299 ME/CFS Australia seeks to
partner with the NDIA to improve the current situation. We would be happy to assist with the
sourcing of experts and consumers, and use our best endeavours to source appropriate service
providers.
We have reviewed the Autism Advisory Group and believe that this is an excellent template to work
from should such a Group commence.300
298 NHMRC, above n. 4, p. 12.
299 NDIA, ‘Reference Groups’, (31 July 2019) <https://www.ndis.gov.au/about-us/reference-group-updates>.
300 NDIA, ‘Autism Advisory Group’ (5 December 2018) <https://www.ndis.gov.au/about-us/reference-group-
updates/autism-advisory-group>.
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