FOI 25 0162 LD Documents for release.PDF.pdf

FOI 25-0162 LD - Document 1
s22
From:
Sonya Marshall-Gradisnik <x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx>
Sent:
Wednesday, 17 July 2024 6:21 AM
To:
s22
; Natalie Eaton-Fitch
Cc:
s47F
; s22
; s22
; CARLILE, Chris
Subject:
RE: FOR CLEARANCE RE: NCNED Developments [SEC=OFFICIAL]-reply #3
Dear s22
and colleagues,
Further to our previous email I am delighted to inform an independent research team from Germany evaluated our
TRPM3 research for the underlying pathology of ME/CFS and Long COVID with potential application for LDN as a
treatment and concluded a) TRPM3 as the underlying of the pathology of ME/CFS and LC and 2) LDN may be an
effective treatment intervention for ME/CFS and LC.
This is wonderful news for us as this is all our work in ME/CFS and Long COVID where it proves our research findings
are correct for the identification of the pathology of ME/CFS and Long COVID as well as potential treatments. We
count not be more thrilled with this publication and firmly cements our international position the world leaders in
pathomechanism/treatment ME/CFS and long COVID. In addition, notable international clinical/research institutes
have been contacting us to undertake work with them.
under
Link: Potential pathophysiological role of the ion channel TRPM3 in myalgic encephalomyelitis/chronic fatigue
syndrome (ME/CFS) and the therapeutic effect of low-dose naltrexone - PMC (nih.gov)
Finally, our research in illness presentation in ME/CFS and Long COVID patients has also been published and also
presented at the International Public Health Conference. We continue to be the first in the world and nationally to
report these findings too.
Link: Illness presentation and quality of life in myalgic encephalomyelitis/chronic fatigue syndrome and post COVID-
19 condition: a pilot Australian cross-sectional study - PubMed (nih.gov)
Best wishes and take care.
Sonya
This document has been released
the Freedom of Information Act 1982
Dr Sonya Marshal -Gradisnik
by the Department of Health and Aged Care
Inaugural Stafford Fox Medical Research Foundation Professorial Research Fellowship
Professor Immunology
Director: National Centre for Neuroimmunology and Emerging Diseases
Griffith University | Gold Coast Campus | QLD 4111 | s47F
T +61 7 5678 0725 | E x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx
From: Sonya Marshall-Gradisnik
Sent: Tuesday, April 30, 2024 8:27 AM
To: s22
; Natalie Eaton-Fitch
Cc: s47F
; s22
; CARLILE, Chris
Subject: RE: FOR CLEARANCE RE: NCNED Developments [SEC=OFFICIAL]-reply
Dear s22
and colleagues,
Thank you for your email and e-introduction to s22
1
Page 1 of 18

FOI 25-0162 LD - Document 1
We look forward to receiving the communique and thank you for including our Best Practice Guidelines for Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome.
Re The National Academies of Science Engineering and Medicine (U.S.A.) link or source: We are yet to receive the
link or the document. It is our understanding this link will be provided in the coming two months. As soon as Natalie
and I receive this information we will send it to you. If we are able to assist with new Clinical Guidelines for ME/CFS
or provide further direction for PASC we would welcome these opportunities to collaborate with you and your team.
The embargo for our latest research findings will be removed this Thursday. ABC National interviewed us yesterday
where we anticipated our world first research will be promulgated Thursday/Friday.
Natalie and I will continue to appraise you of our achievements and research/external invitations seeking our
expertise.
Best wishes and I hope you have a great week.
Sonya
Dr Sonya Marshal -Gradisnik
Inaugural Stafford Fox Medical Research Foundation Professorial Research Fellowship
Professor Immunology
Director:
under
National Centre for Neuroimmunology and Emerging Diseases
Griffith University | Gold Coast Campus | QLD 4111 | s47F
T +61 7 5678 0725 | E x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx
From: s22
@health.gov.au>
Sent: Friday, April 26, 2024 6:19 PM
To: Sonya Marshall-Gradisnik <x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx>; Natalie Eaton-Fitch <n.eaton-
xxxxx@xxxxxxxx.xxx.xx>
Cc: s47F
@griffith.edu.au>; s22
@Health.gov.au>; s22
@health.gov.au>; CARLILE, Chris
<s22
@health.gov.au>
Subject: RE: FOR CLEARANCE RE: NCNED Developments [SEC=OFFICIAL]
Dear Sonya and colleagues. This document has been released
Thank you for keeping us updated on your interesting research work. Please do keep us updated with any
the Freedom of Information Act 1982
publication details.
by the Department of Health and Aged Care
My team is preparing a communique to go out through the various departmental Primary Care newsletters about
available resources/publications (Australian and International) for the clinical management of symptoms for post-
infection on set conditions such as PASC and ME/CFS, amongst others. We are hoping to have a communique ready
in mid-late May, and will be including the Best Practice Guidelines for Myalgic Encephalomyelitis/Chronic Fatigue
Syndrome that you and Natalie were involved with. I was wondering if there is a URL/website for the National
Academies of Science Engineering and Medicine (U.S.A.) paper that Natalie mentioned in her previous email?
Lastly, I’d like to e-introduce you to s22
, who has joined my team last week. s22
team has
responsibility for a range of post infection onset conditions, including ME/CFS & PASC, as well as a number of other
chronic conditions. s22 is a registered nurse with a strong background in Chronic Condition management, and
most recently worked in the Chronic Conditions technical advisory team in the National Disability Insurance Agency
(NDIA). s22
is still in my team, but working on other chronic conditions now.
With best regards,
s22
2
Page 2 of 18

FOI 25-0162 LD - Document 1
From: Sonya Marshall-Gradisnik <x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx>
Sent: Monday, April 22, 2024 12:01 PM
To: Natalie Eaton-Fitch <x.xxxxxxxxxxx@xxxxxxxx.xxx.xx>; s22
@health.gov.au>;
CARLILE, Chris s22
@health.gov.au>
Cc: s47F
@griffith.edu.au>; s22
@health.gov.au>;
s22
@health.gov.au>
Subject: RE: FOR CLEARANCE RE: NCNED Developments
Dear Chris, s22
and team,
Further to Natlie’s email we are delighted to provide you with further achievements:
1. Early next week there will be a press release re NCNED latest long COVID research findings.
The research is embargoed at the moment, however, we provide this confidential information so you are
abreast of our work:
Confidential:
Investigation into the restoration of TRPM3 ion channel activity in post-COVID-19 condition: a potential
pharmacotherapeutic target.
Etianne Martini Sasso, Katsuhiko Muraki, Natalie Eaton-Fitch, Peter Smith, Andrew Jeremijenko, Paul
Griffin and Sonya Marshall-Gradisnik.
Frontiers in Immunology. Accepted.
under
2. Dr Eaton-Fitch and I were invited by Australian Doctor- largest Australian GP Communication Journal- to
write an article on the management and potential treatment of ME/CFS and long COVID. This paper is
nearing the final stages of publication where we will send this to you upon publication.
3. NCNED has just published a research paper that is the first in the world to report neurochemical
changes in ME and Long COVID patients are the same. This novel study revealed level of neurochemicals in
the brain were associated with symptoms like cognitive impairment, unrefreshing sleep, and physical
limitation in long COVID and ME/CFS patients. This finding suggests these neurochemicals may play a key
role in the development and progression of these conditions. Finally, this research was undertaken using 7
Tesla MRI and aligns to the laboratory gold standard findings we are reporting on ion channels (ie TRPM3).
The paper was published in the American Journal of Medicine.
Link: https://www.amjmed com/art.../S0002-9343(24)00216-X/fulltext
This document has been released
4. NCNED published two
the Freedom of Information Act 1982
weeks ago a research paper that is again the first in the world to report
𝙨𝙞𝙜𝙣𝙞𝙛𝙞𝙘𝙖𝙣𝙩
by the Department of Health and Aged Care
𝙧𝙚𝙙𝙪𝙘𝙩𝙞𝙤𝙣𝙨 𝙞𝙣 𝙩𝙝𝙚 𝙛𝙪𝙣𝙘𝙩𝙞𝙤𝙣𝙖𝙡 𝙘𝙤𝙣𝙣𝙚𝙘𝙩𝙞𝙫𝙞𝙩𝙮 𝙗𝙚𝙩𝙬𝙚𝙚𝙣 𝙩𝙝𝙚 𝙗𝙧𝙖𝙞𝙣𝙨𝙩𝙚𝙢 𝙖𝙣𝙙 𝙘𝙚𝙧𝙚𝙗𝙚𝙡𝙡𝙪𝙢
𝙧𝙚𝙜𝙞𝙤𝙣𝙨 𝙤𝙛 𝙈𝙀/𝘾𝙁𝙎 𝙥𝙖𝙩𝙞𝙚𝙣𝙩𝙨 compared with healthy controls. The brainstem and cerebellum are involved
in the motor, cognitive and autonomic functions, providing rationale for the clinical symptoms, such as
cognitive and physical impairment reported by ME/CFS patients. Functional connectivity analysis using
ultra-high-field MRI is a promising technique for reliably deciphering the underlying pathomechanisms
involved in the origin and progression of ME/CFS.
The paper was published in Frontiers in Neuroscience.
Link:
https://www.frontiersin.org/articles/10.3389/fnins.2023.1318094/full?&utm_source=Email_to_authors_&
utm_medium=Email&utm_content=T1_11.5e1_author&utm_campaign=Email_publication&field=&journal
Name=Frontiers_in_Neuroscience&id=1318094
5.. NCNED has been successful for funding from the United Kingdom. NCNED researchers have been
successfully been awarded an ME Research UK grant for $438,000 to track the progression of Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Long COVID. The study will use an ultra-high
3
Page 3 of 18

FOI 25-0162 LD - Document 1
field 7 Tesla (7T) MRI to capture a clearer depiction of brain regions and detect subtle brain changes in
ME/CFS and Long COVID patients.
6. NCNED will commence the first national Long COVID clinical trial on May 20, 2024. This clinical trail is
the first CT in Australia for long COVID patients and is underpinned by our world first results for Long
COVID we have published since 2021. This funding has been provided by Mineral Resources, WA.
Best wishes
Sonya
Dr Sonya Marshal -Gradisnik
Inaugural Stafford Fox Medical Research Foundation Professorial Research Fellowship
Professor Immunology
Director: National Centre for Neuroimmunology and Emerging Diseases
Griffith University | Gold Coast Campus | QLD 4111 | s47F
T +61 7 5678 0725 | E x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx
From: Natalie Eaton-Fitch <x.xxxxxxxxxxx@xxxxxxxx.xxx.xx>
Sent: Tuesday, March 5, 2024 4:11 PM
To: s22
@health.gov.au>; CARLILE, Chris <s22
@health.gov.au>
under
Cc: s47F
@griffith.edu.au>; s22
@health.gov.au>;
s22
@health.gov.au>; Sonya Marshall-Gradisnik <x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx>
Subject: RE: FOR CLEARANCE RE: Feedback on ME/CFS guideline proposal from NCNED following meeting Thursday
2nd November [SEC=OFFICIAL]
Dear Dr s22
Mr Carlile and team,
I hope this email finds you all well.
We are writing to notify you of the release of Best Practice Guidelines for Myalgic Encephalomyelitis/Chronic Fatigue
Syndrome published in BMJ (U.K.). These guidelines were a collaborative effort by Sonya and myself with Professor
James Baraniuk who is internationally known for his efforts in ME/CFS. To best align with new research and the
evolving understanding of ME/CFS, we endorsed the removal of treatments and management protocols that are at
risk of causing harm, such as graded exercise therapy (GET) which is currently incorporated within the Australian
guidelines for ME/CFS. The contribution of NCNED researchers in the mentioned BMJ Guidelines was well-received
This document has been released
by Australians living with ME/CFS.
the Freedom of Information Act 1982
by the Department of Health and Aged Care
When we met in early November, we also discussed that Sonya and myself were involved in the writing of guidelines
and recommendations of Long COVID for National Academies of Science Engineering and Medicine, U.S.A. Our
contribution has been accepted for publication following review and will be published in the coming weeks. We will
ensure this documented is forwarded once available.
We anticipate the results of the 2024/2025 budget, particularly in relation to potential funding allocated for the
development of new Australian guidelines for ME/CFS.
If you have any questions regarding the guidelines above, please let us know.
We look forward to hearing from you and appreciate your time.
Kind Regards,
Natalie Eaton-Fitch, PhD
4
Page 4 of 18

FOI 25-0162 LD - Document 1
Research Fellow | pronouns: she/her
Naonal Centre for Neuroimmunology and Emerging Diseases (NCNED)
Consorum Health Internaonal for ME (CHIME)
MENZIES Health Instute Queensland
Griﬃth University | Gold Coast |s47F
P +617 567 89282 | M +s47F
| E n.eaton-ﬁtch@griﬃth.edu.au
I choose to work & send emails outside normal oﬃce hours. There is no expectaon to respond to my email outside of your work
hours.
under
Griﬃth University acknowledges the people who are the tradional custodians of the land and pays respect to the Elders, past
and present, and extends that respect to all Aboriginal and Torres Strait Islander peoples
Gold Coast campus is situated on the land of the Yugambeh/Kombumerri peoples.
From: Sonya Marshall-Gradisnik <x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx>
Sent: Friday, December 1, 2023 6:03 AM
To: s22
@health.gov.au>
Cc: Natalie Eaton-Fitch <x.xxxxxxxxxxx@xxxxxxxx.xxx.xx>; s47F
@griffith.edu.au>; CARLILE, Chris
<s22
@health.gov.au>; s22
@health.gov.au>; s22
@health.gov.au>; Natalie Eaton-Fitch <x.xxxxxxxxxxx@xxxxxxxx.xxx.xx>
Subject: RE: FOR CLEARANCE RE: Feedback on ME/CFS guideline proposal from NCNED following meeting Thursday
2nd November [SEC=OFFICIAL]
This document has been released
Dear s22
the Freedom of Information Act 1982
by the Department of Health and Aged Care
I hope this email finds you well.
Your timing could not be more perfect. Thank you.
We are currently refining this document and anticipate submitting it on December 19.
We will advise you when we have lodged the submission.
Best wishes and take care.
Sonya
Dr Sonya Marshall-Gradisnik
Professor of Immunology
Griffith University
Menzies Health Institute Queensland
Director National Centre for Neuroimmunology and Emerging Diseases
5
Page 5 of 18

FOI 25-0162 LD - Document 1
s47F
Parklands QLD, 4222
Telephone: 07 5678 0725
s47F
Email: x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx
To help p  o ect you  p  ivacy  M c  osoft Off ce p  evented au omat c download of th s pictu  e f  om the Inte  net
From: s22
@health.gov.au>
Sent: Friday, December 1, 2023 5:50 AM
To: Sonya Marshall-Gradisnik <x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx>
Cc: Natalie Eaton-Fitch <x.xxxxxxxxxxx@xxxxxxxx.xxx.xx>; s47F
@griffith.edu.au>; CARLILE, Chris
<s22
@health.gov.au>; s22
@health.gov.au>; s22
@health.gov.au>
Subject: FW: FOR CLEARANCE RE: Feedback on ME/CFS guideline proposal from NCNED following meeting Thursday
2nd November [SEC=OFFICIAL]
Dear Sonya and team
Thanks again for meeting with us to discuss your proposal for the development of clinical practice guidelines for
ME/CFS a few weeks ago. I hope the conference went well on 9-10 November.
under
As mentioned during our meeting, consideration around funding for activities such as the development of ME/CFS
guidelines is generally determined through the budget process. It is anticipated that the Treasury will open a page
on its website in December and make a call for proposals to be considered as part of the 2024-25 Budget. Even with
this process, there is no certainty of funding for activities within your proposal.
Below we have provided some feedback on the proposal you shared with us that may assist you in refining your pre-
budget submission to Treasury:
o  Consider/outline how your proposal aligns with relevant frameworks and strategies such as the National
Strategic Framework for Chronic Conditions to show the proposal aligns with government policy.
o  Provide a few costing options e.g. – low cost proposal (eg. develop guidelines only), medium and high cost
options (eg. additional time for maintenance and implementation ) and include justifications of each
approach. This could also include differing timeframes - what could you do with 1, 2, or 3 years of funding
(report
This document has been released
financial years not calendar years). The detailed budget breakdown you have provided in your
proposal is a good example of the detail required for the funding breakd
the Freedom of Information Act 1982  own for each option but should be
presented in financial years  Also, explain why one option is recommended over the others.
by the Department of Health and Aged Care
o  Its pleasing to see that you have considered activities that translate information for consumers and the
development of education for health professionals to support implementation of guidelines, but it would
also be helpful for you to outline plans for future management of guidelines beyond funding being
requested to develop and implement them. For example, are there plans to review the guidelines in future?
Who would maintain the guidelines?
I hope this information is of assistance as you refine your proposal.
With best regards,
s22
Dr. s22
(Her/She)
Director – Chronic Conditions – Projects
Cancer, Hearing and Chronic Conditions Division | Hearing Services and Chronic Conditions Branch
Primary and Community Care Group | Australian Government Department of Health and Aged Care
6
Page 6 of 18

FOI 25-0162 LD - Document 1
T: 02 s22
| M: s22
| E: s22
@health.gov.au
GPO Box 9848, Canberra ACT 2601, Australia
This email comes to you from Ngambri and Ngunnawal country.
Location: Sirius 9.S
PO Box 9848, Canberra ACT 2601, Australia
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country
throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and
their cultures, and to all Elders both past and present.
From: s47F
@griffith.edu.au>
Sent: Thursday, 2 November 2023 7:54 AM
To: CARLILE, Chris s22
@health.gov.au>
Cc: s22
@Health.gov.au>; Sonya Marshall-Gradisnik <s.marshall-
xxxxxxxxx@xxxxxxxx.xxx.xx>; Natalie Eaton-Fitch <x.xxxxxxxxxxx@xxxxxxxx.xxx.xx>
Subject: Brief for meeting with Griffith University, NCNED - 2.45 p.m. Thursday 2nd November
under
Good morning Mr Carlile
Thank you for the invitation extended to the National Centre for Neuroimmunology and Emerging Diseases
(NCNED).
We have pleasure in providing you with our brief in preparation for the meeting.
We are looking forward to meeting with you and appreciate the opportunity to brief you on the expertise of the
Centre.
Kind regards
s47F
s47F
This document has been released
Executive Officer - Disability and Rehabilitation/
the Freedom of Information Act 1982
Centre Coordinator, National Centre for Neuroimmunology and Emerging Diseases
by the Department of Health and Aged Care
Menzies Health Institute Queensland
s47F
Gold Coast campus
Griffith University Qld 4222
Hours: 7.00 a.m. - 3.00 p.m.
Telephone: +s47F
Email: s47F
@griffith.edu.au
7
Page 7 of 18

FOI 25-0162 LD - Document 1
under
https://app.secure.griffith.edu.au/griffithpay/me-cfs-international-conference-2023-rid-research-innovation-and-
discovery.html
This document has been released
the Freedom of Information Act 1982
by the Department of Health and Aged Care
8
Page 8 of 18

FOI 25-0162 LD - Document 1
From: Sonya Marshall-Gradisnik <x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx>
Sent: Wednesday, 4 October 2023 9:31 AM
To:s22
@health.gov.au>
Cc: Natalie Eaton-Fitch <x.xxxxxxxxxxx@xxxxxxxx.xxx.xx>;s22
@health.gov.au>; CARLILE, Chris <s22
@health.gov.au>;s22
@Health.gov.au>;s22
@health.gov.au>
Subject: RE: Reply #5 : NCNED ME/CFS Friends of Parliament: Attention Mr Chris Carlile
[SEC=OFFICIAL]
REMINDER: Think before you click! This email originated from outside our organisation. Only click links or open
attachments if you recognise the sender and know the content is safe.
under
Dear s22
Apologies for the delay, we are writing a grant for s22
as well ass22 We
have been collecting data to include in these grants, hence last week was a little hectic.
Dr Eaton-Fitch and myself are able to travel to Canberra any time after 21 October. We would be
delighted to meet with yourself and Mr Carlile to outline our pro
This document has been released posal utilising and adapting the
documents we have produced for overseas agencies as well as the m
the Freedom of Information Act 1982 odels we have been working
with overseas (ie Stakeholder Committees) to deliver the new Australian Clinical Gu
by the Department of Health and Aged Care idelines for the
patient groups you listed in your email.
We are looking forward to meeting with you and await s22
notification for a meeting.
Best wishes
Sonya
9
Page 9 of 18

FOI 25-0162 LD - Document 1
From: s22
@health.gov.au>
Sent: Wednesday, 27 September 2023 2:58 PM
To: Sonya Marshall-Gradisnik <x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx>
Cc: Natalie Eaton-Fitch <x.xxxxxxxxxxx@xxxxxxxx.xxx.xx>;s22
@health.gov.au>; CARLILE, Chris <s22
@health.gov.au>;s22
@Health.gov.au>;s22
@health.gov.au>
Subject: FW: Reply #4 : NCNED ME/CFS Friends of Parliament: Attention Mr Chris Carlile
[SEC=OFFICIAL]
Hi Sonya,
under
Thank you for your email to Chris Carlile. I am currently acting in Chris’ position and responding on
his behalf.
I appreciate you sharing this information about your important work. Our team would be interested to
hear your thoughts about how your work could be adapted or adopted to replace the existing
guidelines in Australia, or used to inform the development of new clinical guidance on ME/CFS for the
Australian context. We would also be interested to discuss the links/overlap of your ME/CFS clinical,
research and management guideline document has with long COVID, Fibromyalgia and Ehlers-
Danlos Syndromes.
This document has been released
the Freedom of Information Act 1982
I have copied s22
who will be in touch to organise a meeting. Please advise if you will be in
by the Department of Health and Aged Care
Canberra at some stage in the near future, otherwise a virtual meeting can be organised.
Kind regards, s22
s22
A/g Assistant Secretary, Hearing Services and Chronic Conditions Branch
Cancer, Hearing and Chronic Conditions Division | Primary and Community Care Group
10
Page 10 of 18

FOI 25-0162 LD - Document 1
Australian Government Department of Health and Aged Care
T: 02s22
| M:s22
| E:s22
@health.gov.au
This email comes to you from Ngunawal country
Location: Sirius Building Level 9 South
GPO Box 9848, Canberra ACT 2601, Australia
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional
Owners of Country throughout Australia, and their continuing connection to land, sea and
community. We pay our respects to them and their cultures, and to all Elders both past and present.
under
From: Sonya Marshall-Gradisnik <x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx>
Sent: Tuesday, 19 September 2023 2:52 PM
To: CARLILE, Chris <s22
@health.gov.au>
Cc: Natalie Eaton-Fitch <x.xxxxxxxxxxx@xxxxxxxx.xxx.xx>
Subject: RE: Reply #4 : NCNED ME/CFS Friends of Parliament: Attention Mr Chris Carlile
[SEC=OFFICIAL]
This document has been released
the Freedom of Information Act 1982
Dear Chris,
by the Department of Health and Aged Care
Further to my previous email, I would like to advise you Dr Eaton-Fitch, Professor Baraniuk (USA) and
myself have completed and submitted the British Medical Journal (BMJ) Best Practice Clinical
Guidelines for ME/CFS. The Editor has engaged relevant stakeholders/reviewers for final
amendments where this important document will be finalised by 25 November, 2023.
In addition, our second clinical document Dr Eaton-Fitch and I were requested by the National
Academies for Medicine and Science, USA, has been submitted. It now resides with the Stakeholder
Committee (clinicians, researchers and patient advocates) for minor amendments (if any) that will be
finalised Feb, 2024. This ME/CFS clinical, research and management guideline document also
addresses the overlap with long COVID, Fibromyalgia and Ehlers-Danlos Syndromes. The feedback
11
Page 11 of 18

FOI 25-0162 LD - Document 1
from the National Academies has been “we have gone above and beyond the statement of work” for
these guidelines.
Given we are recognised as world authorities in this field, and we have successfully completed these
important ME/CFS guidelines by international agencies, we seek your guidance how Dr Eaton-Fitch
and myself may provide leadership for the new Australian Clinical Guidelines for ME/CFS.
We would welcome a face-to-face meeting to further discuss this initiative and the framework we
have used/implemented with stakeholders to ensure the successful outcome of these clinical
guideline documents by these overseas agencies.
All my very best and we look forward to your reply to developing these new Australian Clinical
Guidelines.
under
Sonya
From: Sonya Marshall-Gradisnik
Sent: Tuesday, 20 June 2023 9:25 AM
To: CARLILE, Chris s22
@health.gov.au>
Cc: Natalie Eaton-Fitch <x.xxxxxxxxxxx@xxxxxxxx.xxx.xx>
Subject: RE: Reply #3 : NCNED ME/CFS Friends of Parliament: Attention Mr Chris Carlile
[SEC=OFFICIAL]
This document has been released
the Freedom of Information Act 1982
Dear Chris,
by the Department of Health and Aged Care
Thank you for not only your prompt response, but also acknowledging the work currently underway at
the NCNED.
As discussed it is critical that new Australian ME/CFS clinical guidelines are completed. Given
NCNED’s expertise and international recognition we seek your direction to submit a proposal to
deliver these new and timely ME/CFS Guidelines to improve the lives of 250,000 Australians (plus
emerging cases).
The current guidelines are 20 years out of date and more importantly can adversely impact on the
health of patients ( eg graded exercise therapy) As you know our NCNED researchers are leading the
way in the establishment of the Clinical Guidelines and the UK and USA( see description of activities
below) but there is no activity on Australian guidelines. We understand the framework for successful
12
Page 12 of 18

FOI 25-0162 LD - Document 1
implementation, we have the expertise to achieve these guidelines but to be successful the
Government needs to support this work.
With reference to your previous email, the first clinical guidelines document underway is implement
through the British Medical Journal as the UK guidelines for ME/CFS mirroring recent adaptation of
the ME/CFS National Institute for Health and Care Excellence (NICE) guidelines undertaken
according to "Developing NICE guidelines: the manual". The development of these guidelines has so
far been achieved through a consultation process with medical professionals, including psychiatrists
given ME/CFS was originally labelled as a psychiatric illness before now being characterised as a
neurological disease under the International Classification of Diseases version 11. I assisted with
facilitating this re-classification through my position as the only Australian on the Board of Directors
of the International Association for ME/CFS.
Furthermore, the consultation process has been with medical professionals (via BMJ), Professor
Baraniuk and Professor Don Staines. This has ensured the potential challenges that have been
evident with previous iterations over the years were mitigated. For example, the removal of
detrimental treatment recommendations such as Graded Exercise The
under rapy and Cognitive
Behavioural Therapy (GET/CBT), which were raised on Tuesday. Under these new BMJ guidelines
being constructed by myself, Dr Natalie Eaton-Fitch and Dr James Baraniuk, GET/CBT has been
removed from the treatment algorithm and instead labelled as treatment of uncertain efficacy lacking
evidence of benefit. In addition, further mitigation has also entailed peer-reviewed clinical and
research evidence obtained international and collated through a series of systemic reviews
undertaken. The BMJ follows internationally consistent guideline development protocols whereby
guidelines are developed by unbiased experts with consultation of expert multidisciplinary
organisations (organised through BMJ) before publication and subsequently undergoes annual and
bi-annual review. Additionally, these guidelines implemented through BMJ had limited consumer
stakeholders. Importantly, stakeholder and end-user engagement is undertaken using a series of
overlapping protocols internationally (as published by the NHMRC, NICE, and NIH etc). In recent
years, the NHMRC has advocated for stakeholder engagement and consumer consultation when
developing guidelines given only 14% of guidelines published between 2005-2013 reported consumer
This document has been released
involvement.
the Freedom of Information Act 1982
by the Department of Health and Aged Care
Our second document being constructed with the National Academies in the US has addressed the
stakeholder involvement through the establishment of a committee comprising of national patient
advocacy groups, clinicians, and specialist ME/CFS clinicians, as well as biomedical researchers.
This approach is outlined by the Institute of Medicine (IOM) "Clinical Practice Guidelines We Can
Trust". The initiation of their process began with consultation with focus groups to identify gaps in
diagnosis, treatment and care to organise the collation of evidence to support the development of
these new ME/CFS clinical guidelines NCNED is now writing and to be delivered at the latter part of
2023 for the committee to endorse, followed by implementation through these networks and
agencies. Thus, all stakeholders are fully engaged and endorse the adaptation of these new
guidelines for implementation through US health services and agencies, such as the CDC and NIH for
timely action to benefit health consumers.
13
Page 13 of 18

FOI 25-0162 LD - Document 1
Hence, the two guidelines we are constructing provides for international standardisation and
uniformity, for example the classification of GET/CBT as treatments with uncertain efficacy and
lacking evidence of benefit. While we refer to the abovementioned independent processes, the
challenges identified during the BMJ Guideline development have been addressed in the National
Academies Guidelines, ensuring successful uptake and implementation. Moreover, the approach we
have taken with the National Academies enables the “least path of resistance” that we could adopt
her in Australia. The proposed new Clinical Guidelines for Australia would also provide for additional
up-take through the ME/CFS Primary Health Network Model that is currently underway in QLD,
however this could be implemented in other states and territories of Australia.
We believe it is pertinent to highlight that there has been no substantial funding provided to
undertake these guidelines and there is no potential for these international agencies to support the
Australian guidelines. Our expertise and the protocols identified through undertaking these
international guidelines provide the ability for us to refine and implement a seamless process from
design, development and implementation in Australia.
Given our international expertise and given the clinical guidelines mod
under els we have been requested to
deliver, and knowing the landscape of the Australian ME/CFS environment (both patient and clinical)
we have the capability to deliver a new ME/CFS Clinical Guidelines ensuring a successful outcome to
the Australian Federal Government that promotes international uniformity and standardisation.
NCNED seeks direction to submit a proposal to deliver these new and timely ME/CFS Guidelines to
improve the lives of 250,000 Australians (plus emerging cases).
All our very best.
This document has been released
the Freedom of Information Act 1982
Sonya
by the Department of Health and Aged Care
From: CARLILE, Chris <s22
@health.gov.au>
Sent: Friday, 16 June 2023 8:07 AM
To: Sonya Marshall-Gradisnik <x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx>
Cc: Natalie Eaton-Fitch <x.xxxxxxxxxxx@xxxxxxxx.xxx.xx>
Subject: RE: NCNED ME/CFS Friends of Parliament: Attention Mr Chris Carlile [SEC=OFFICIAL]
14
Page 14 of 18

FOI 25-0162 LD - Document 1
Sonya
Many thanks for the email and the attached documentation.
It was a pleasure to be able to attend a very informative launch of the Parliamentary friends of
ME/CFS. I want to acknowledge the work that you are doing towards developing ME/CFS guidelines.
Thank you for the information you have provided both in hard copy and electronically.
I would also be interested to learn of the final outcomes of your work.
Kind regards
under
chris
From: Sonya Marshall-Gradisnik <x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx>
Sent: Thursday, 15 June This document has been released
2023 2:45 PM
To: CARLILE,
the Freedom of Information Act 1982
Chris <s22
@health.gov.au>
Cc: Natalie
by the Department of Health and Aged Care
Eaton-Fitch <x.xxxxxxxxxxx@xxxxxxxx.xxx.xx>
Subject: NCNED ME/CFS Friends of Parliament: Attention Mr Chris Carlile
REMINDER: Think before you click! This email originated from outside our organisation. Only click links or open
attachments if you recognise the sender and know the content is safe.
Dear Chris,
15
Page 15 of 18

FOI 25-0162 LD - Document 1
Thank you for taking the time to attend the Friends of Parliament for ME/CFS, June 13,2023.
I, along with Professor Staines and s47F
were very thankful you were so generous with
your time and spoke with us in detail regarding our biomedical, clinical and economic work in the
field of ME/CFS.
The National Centre for Neuroimmunology and Emerging Diseases (NCNED) employs a ME/CFS
patient- researcher- clinician model, a unique model that has positioned us as the world leader in the
field of ME/CFS and more recently Long COVID.
The NCNED brief that is attached to this email (also provided to you in hardcopy at the Friends of
Parliament for ME/CFS meeting) details key achievements and our world leading
standing/recognition. As indicated to you, Dr Eaton-Fitch and I, along with our collaborator Dr James
under
Baraniuk, Georgetown University (USA), were invited to write the New ME/CFS Clinical Guidelines for
the British Medical Journal (UK). Moreover, my expertise, Dr Eaton-Fitch and Professor Staines’
expertise in this field has been recognised by the US Health Services through the National Academy
of Medicine and Science to write the report for the clinical guidelines and research direction for
ME/CFS, FM and Long COVID. Our expertise, in conjunction with our strong collaborative relationship
with ME/CFS stakeholders nationally and internationally has enabled us to identify and mitigate
potential challenges to ensure successful delivery of these guidelines to benefit ME/CFS patients and
medical professionals with the aim to reduce the cost to the Health Care System. Presently in
Australia the annual health care costs are $14.1 billion (NCNED research that was quoted by the
second speaker at this event on Tuesday). New ME/CFS Australian Guidelines would provide for
global standardisation and unification; a first for this disease.
This document has been released
I, along with Professor Staines,
the Freedom of Information Act 1982
are co-authors of the International Case Definition for ME/CFS,
hence,
by the Department of Health and Aged Care
we are well position for additional alignment in the international context.
The impact of our research and clinical findings have underpinned the successful QLD Health
Pathway for ME/CFS program piloted in the West Moreton District (QLD). This has now gone “live” for
QLD and is implement through the Primary Health Network (ME/CFS- PHN).
Our QLD ME/CFS-PHN model is an exemplar to deliver a national health service for ME/CFS.
We would be delighted to continue our discussions with you and your staff.
16
Page 16 of 18

FOI 25-0162 LD - Document 1
Thank you for taking the time to read this email.
Best wishes
Sonya
Dr Sonya Marshall-Gradisnik
Inaugural Stafford Fox Medical Research Foundation ME/CFS
Professorial Research Fellowship
Professor Immunology
under
Director: National Centre for Neuroimmunology and Emerging Diseases
Program Director: Disability and Rehabilitation
Menzies Health Institute Queensland
Griffith University | Gold Coast Campus | QLD 4111 |s47F
T +61 7 5678 0725
Ms47F
This document has been released
the Freedom of Information Act 1982
E x.xxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx.xx
by the Department of Health and Aged Care
17
Page 17 of 18

FOI 25-0162 LD - Document 1
"Important: This transmission is intended only for the use of the addressee and may contain
confidential or legally privileged information. If you are not the intended recipient, you are notified
that any use or dissemination of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all copies of this transmission."
"Important: This transmission is intended only for the use of the addressee and may contain
confidential or legally privileged information. If you are not the intended recipient, you are notified
that any use or dissemination of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all copies of this transmission."
under
This document has been released
the Freedom of Information Act 1982
by the Department of Health and Aged Care
18
Page 18 of 18

FOI 25-0162 LD - Document 2
s22
s22
From: s22
s22
s22

Sent: Saturday, July 20, 2024 5:43 PM
To: Butler, Mark (MP) <xxxx.xxxxxx.xx@xxx.xxx.xx>
Subject: Form Submission - Contact Form - Health
s22
under
Sen t via form su bmiss ion fro m Mark Butler MP
Name: s47F
Email: s47F
@o utlook.com
Phone: s47F
Sta te/Territ ory: s47F
Suburb: s47F
Post code: s47F
This document has been released
Mess age: Dear Min ister Butle r,
the Freedom of Information Act 1982
Thanks for you r great wo rk.
by the Department of Health and Aged Care
I sit as s47F
o n a n ot-for -pro fit Foundatio n reg istered with the AC NC, with DGR status granted
by the ATO.
The Fo undation is a Sponso r in the only TGA a pproved Clinic al trial in Aus t ralia, headed by Dr Andrew
Luc as , to determine if EBOO ozone can treat M E/CFS .
I also note that you are in the proc ess of revamping the clinical guidel i nes that a re over 20 yea rs old at
the moment. I t's grea t n ew s that thes e outda ted c linic al guidel ines are bein g looked at.
I am c onc erned tha t m ore than 2 50,00 0 Aus tralians are affec ted by t his c ondit ion, yet we c annot
obtain funds to st art t hi s critic al clinic al trial.
I was hoping you r de par tment m ay ass is t us.
I can provide fu rther de tails i f nec ess ary.
I look forward to hea rin g fro m y ou sho rtly,
s47F
Manage Submiss ions
1
Page 1 of 2

FOI 25-0162 LD - Document 2
Does this submissi on look like spam? Rep ort i t here.
under
This document has been released
the Freedom of Information Act 1982
by the Department of Health and Aged Care
2
Page 2 of 2

FOI 25-0162 LD - Document 3
Ref No: MC24-011562
s47F
s47F
@outlook.com
Dear s47F
Thank you for your correspondence of 20 July 2024 to the Minister for Health and Aged
Care, the Hon Mark Butler MP, regarding funding for a clinical trial to explore the potential
of EBOO ozone as a treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
(ME/CFS). The Minister has asked me to reply.
As you referenced, the Government is responding to the need for better support for people
under
with ME/CFS, Long COVID, and related conditions by allocating $1.1 million to the National
Health and Medical Research Council (NHMRC) to develop new Australian clinical guidelines.
These guidelines will be developed in collaboration with patient groups, health
professionals, and medical scientists.
Regarding your question about clinical trials, the Government directly supports health and
medical research through the complementary Medical Research Future Fund (MRFF) and
the NHMRC. The NHMRC is the Australian Government’s primary funding body for health
and medical research.
It’s important to note that the majority of NHMRC funding is not al ocated to any specific
disease, discipline, or health issue The subject matter of each investigator-initiated
application is determined by the applicants based on the expertise and research interests of
those applying for funding. Research teams decide their res
This document has been released earch area and strategy prior to
submitting an application to receive NHMRC funding. The NHMRC
the Freedom of Information Act 1982 welcomes all grant
applications relevant to human health through our established research-fundi
by the Department of Health and Aged Care ng
mechanisms. More information is available through the NHMRC website at:
www.nhmrc.gov.au/.
Additionally, the MRFF’s Preventive and Public Health Research initiative offers funding for
research that tests innovative approaches to preventive and public health issues in
Australia. It will provide $596.5 million over 10 years from 2022-23 for research projects
that address risk factors that contribute to chronic and complex diseases in Australia.
Through the MRFF’s Clinical Trials Activity Initiative and Emerging Priorities and Consumer
Driven Research Initiative, up to $18 million in funding was available for the 2022 Multiple
Sclerosis Research grant opportunity. Applications for ME/CFS grants were able to be made
under Stream 3 and 4 of this Grant Opportunity. More information on funding opportunities
can be found through the Department of Health and Aged Care website, at
www.health.gov.au/our-work/mrff.
Page 1 of 2

FOI 25-0162 LD - Document 3
Thank you for writing on this matter. I wish you the very best of success with your research
funding applications.
Yours sincerely,
s47F
s22
Director - Chronic Conditions Projects
Hearing Services and Chronic Conditions Branch
Cancer, Hearing and Chronic Conditions Division
20 August 2024
under
This document has been released
the Freedom of Information Act 1982
by the Department of Health and Aged Care
Page 2 of 2