By Sasha Nimmo and ME Australia

Australia’s National Health and Medical Research Council (NHMRC) called for feedback on their advisory committee’s draft report at the end of 2018. The report contained misleading errors, stating 99% of people recover (except in cases lasting more than seven years, the report claims the recovery rate is 50-80%). This is markedly different to a systematic review of the scientific literature which found that the average recovery/remission rate is 5% (which includes very broad definitions of chronic fatigue syndrome and no definitions of ME).

If the government listens to this advice, it is unlikely the government will see urgency in a change to treatment guidelines or for medical research.

ME Australia’s response to the NHMRC focussed on the recommendations. Here is the introduction of ME Australia’s submission to the NHRMC.

The establishment of an advisory committee to investigate Myalgic Encephalomyelitis (ME) and chronic fatigue syndrome (CFS) by the NHMRC and the recommendations in this draft report are positive developments for people with ME. ME Australia supports the report being finalised quickly to support agencies urgent consideration of the recommendations. We agree with the committee that once a final report is available, it will provide a starting point for consideration by relevant agencies.

Report recommendations

We strongly support the recommendation to issue a targeted call for research, providing funding is directed to biomedical research. The prevalence (100,000 to 250,000 Australians), burden of disease (1 in 4 people house or bed bound) and years of failing to fund needed biomedical research into ME and CFS, make a clear case for biomedical research funding[i]. It is recommended the NHMRC consider allocating $15 million to fund biomedical research into ME and CFS.

This amount of funding will bring forward diagnostic tests, and over time, treatment. It would be useful for the NHMRC to consider how collaboration can best be supported and how data from these funded studies can be made available.

The recommendation to establish new clinical guidelines is strongly supported. There is a clear need to improve the accuracy of diagnosis in Australia. Two in five people diagnosed as having ME or CFS by a primary health physician in Australia do not meet the CFS Fukuda criteria, only 32 per cent meet the International Consensus Criteria for ME[ii]. There are also numerous examples of people going undiagnosed for decades. New guidelines will assist diagnosis, provide guidance on treatment/management of common symptoms and stop preventable worsening of the disease, due to misguided medical advice.

The RACP guidelines commissioned by the Government are contributing to misdiagnosis and misleading research findings (due to incorrect cohort selection). It is more than 16 years since the Australian Senate passed a resolution requesting the Guidelines be reviewed, noting[iii]:

‘The RACP guidelines are not representative of the consultation process, incorrectly concluded the illness was fundamentally psychological, produced treatment plans that were inadequate and calls for their immediate review.’

While less critical than biomedical research funding and new clinical guidelines, the recommendation to include ME and CFS in existing health policy tools and health service research is supported. Our view is that consideration of their inclusion, should occur once new clinical guidelines are established. While not disagreeing with conducting research into the economic impact of ME and CFS on the more than $1.8 trillion Australian annual GDP, this is considered a lower priority than other recommendations.

Overview of draft report

The willingness of committee members volunteering to look into ME and CFS is appreciated. Their efforts in providing a starting point for relevant agencies will benefit a large number of people over the medium to long term.

When building on this starting point, it is essential that agencies obtain the relevant scientific expertise. This includes scientific researchers with biomedical experience in ME and CFS. The lack of relevant scientific expertise in the committee has been raised directly with the NHMRC by scientists, stakeholders and members of the Australian Senate[iv]. Agencies should consider how they will include this expertise, patients, carers and stakeholders in next steps.

We ask the NHMRC to note that while the report treats ME and CFS as indivisible and calls it ME/CFS, this is at odds with how the World Health Organization classifies these diseases[v]. It is also at odds with the Institute of Medicine report that describes ME/CFS as an umbrella term that includes both ME and CFS[vi]. It is important for people with ME or CFS that both are taken seriously and not treated as identical diseases. It is also worth noting the term ME/CFS appears inconsistent with the revised terms of reference at Attachment G, which refers to ME and CFS.

Recommendations

Report

1. NHMRC should encourage the committee to finalise the report quickly, with minimal nuance and change
2. To inform their responses to the report, agencies should consult biomedical researchers with experience in ME and CFS, and stakeholders.

Research funding – the NHMRC should:

3. Consider issuing a targeted call for research above its standard $3m to $5m, providing $15m would bring promising research to scale
4. Restrict the targeted call for research to biomedical research into ME and CFS
5. Maximise the return on investment, by funding applicants with existing biomedical research experience in ME or CFS, or partner with those who have existing experience
6. Require commissioned research to use the ME: International Consensus Criteria (ICC) and
   1. Allow researchers to use other diagnostic criteria, providing these results are published independently alongside the ME: ICC results
   2. Allowed researchers to include people with comorbidities, providing these results are independently published alongside the ME: ICC results.

Guidelines

7. The NHMRC establish an expert panel of scientists with biomedical expertise in ME and/or CFS to guide the development of new clinical guidelines
8. Adopt an open and transparent process in developing the guidelines
9. Develop guidelines that recognise differences between ME and CFS
10. Avoids mistakes of the RACP Guidelines commissioned by the Government.

Advisory Committee process

The NHMRC should continue to consider how it can improve its advisory processes.

Read the full submission to the Australian government’s National Health and Medical Research Council: ME Australia’s response to the NHMRC on the committee’s draft report on ME and CFS.

[i] Pendergrast, T. Brown, A. Sunnquist, M. Jantke, R. Newton, J., Bolle Strand, E. and Jason, L. 2017. Housebound versus nonhousebound patients with myalgic encephalomyelitis and chronic fatigue syndrome. Chronic Illness, Volume 12(4), pp. 292-307.

Carruthers, B. van de Sande, M. De Meirleir, K. Kilmas, N. Broderick, G. Mitchell, T. Staines, D. Powles, A., Speight, N. Vallings, R. Bateman, L. and Bell, D. 2012. Myalgic Encephaloymelitis – Adult & Paediatric: International Consensus Primer for Medical Practitioners. Available at: https://nhmrc.gov.au/sites/default/files/documents/attachments/ME-International-Consensus-Primer.pdf

Australian Bureau of Statistics. 2018. Australian Demographic Statistics, Jun 2018. Available at: http://www.abs.gov.au/ausstats/abs@.nsf/mf/3101.0  [Accessed 31 December 2018]

[ii] Johnston, S. Staines, D. and Marshall-Gradisnik, S. 2016. Epidemiological characteristics of chronic fatigue syndrome/myalgic encephalomyelitis in Australian patients. Clinical Epidemiology, Volume 8, pp. 97-107.

[iii] Australian Parliament House, 2002. Journals of the Senate No.13, Thursday 16 May 2002. Available at: http://www.aph.gov.au/binaries/senate/work/journals/2002/jnlp_013.pdf [ Accessed 31 December 2018].

[iv] Australian Senate. 2018‑2019 Budget Estimates. Available at: https://www.aph.gov.au/Parliamentary_Business/Senate_Estimates [Accessed 31 December 2018]

Australian Senate. Questions on Notice‑ SQ18‑00301. Available at: https://www.aph.gov.au/Parliamentary_Business/Senate_Estimates  [Accessed 31 December 2018]

[v] World Health Organization, 2018. International Classification of Diseases 11^th Revision. 2018. Available at: https://icd.who.int/browse11/l-m/en#/http%3a%2f%2fid.who.int%2ficd%2fentity%2f569175314 [ Accessed 31 December 2018].

[vi] Committee on the Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome; Board on Health Select Populations; Institute of Medicine. 2015. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness (Chapter One: Introduction and Chapter Two: Background). Washington: National Academies of Press.