Senator Scott Ludlam asked about the progress of proposals to research ME and CFS at a budget estimates hearing in Parliament House, Canberra. Prof Anne Kelso, CEO of Australia’s National Health and Medical Research Council (NHMRC), said she was delighted to hear of the important advance made by Griffith University but explained they may not be consulted as ‘experts’ as they may be the ones applying for funding.
The NHMRC received proposals but hasn’t decided whether it will fund any of them, or when it will happen. Prof Kelso said “it’s work for this year to decide how to progress”.
Prof Kelso acknowledged the dire need for research to find treatments.
“There aren’t clear diagnostic tests, there aren’t established treatments and methods for looking after patients which is exactly why there is a need for research,” she said.
Prof Kelso is correct that there aren’t clear diagnostic tests readily available (although there have been a number of tests announced and patented) but this hasn’t stopped Norway’s researchers from trialling rituximab with promising results, using the Canadian Consensus Criteria for ME. The researchers are currently conducting a phase III RCT. Invest in ME, in the UK, are also planning a rituximab trial.
Senator Ludlam raised concerns about GP (general practitioner) education, saying that the Australian Health Department must equip GPs with the skills to treat patients.
“At the moment there is obviously a range of views in the GP community about whether this is psychosocial or rather than biomedical. What is the process for funding education programs for GPs and distributing this research that’s been done so that we can winnow out some of the frankly quite harmful treatments that have been proposed?” asked Ludlam.
The question will be answered later by Health Department officials.
Australian clinical guidelines
Concerningly, Prof Kelso believes Lyme-like illnesses and ME/CFS “are quite similar, to the extent that these are syndromes and there isn’t a clear clinical definition”, ignoring the International and Canadian Consensus Criteria for ME (ICC/CCC) endorsed and distributed to some GPs by all of Australia’s patient organisations. Griffith University researchers are some of the experts who worked on the consensus criteria.
From the ICC Primer for Medical Practitioners:
“The label ‘chronic fatigue syndrome’ (CFS), coined in the 1980s, has persisted due to lack of knowledge of its etiologic agents and pathophysiology. Misperceptions have arisen because the name ‘CFS’ and its hybrids ME/CFS, CFS/ME and CFS/CF have been used for widely diverse conditions. Patient sets can include those who are seriously ill with ME, many bedridden and unable to care for themselves, to those who have general fatigue or, under the Reeves criteria, patients are not required to have any physical symptoms. There is a poignant need to untangle the web of confusion caused by mixing diverse and often overly inclusive patient populations in one heterogeneous, multi-rubric pot called ‘chronic fatigue syndrome’. We believe this is the foremost cause of diluted and inconsistent research findings, which hinders progress, fosters scepticism, and wastes limited research monies.
Our panel strongly recommends that only the name ‘myalgic encephalomyelitis’ be used to identify patients meeting the ICC because a distinctive disease entity should have one name. Patients diagnosed using broader or other criteria for CFS or its hybrids (Oxford, Reeves, London, Fukuda, CCC, etc.) should be reassessed with the ICC. Those who fulfill the criteria have ME; those who do not would remain in the more encompassing CFS classification.”
The NHMRC were due to endorse a set of clinical guidelines in 2012. Nearly five years later there are none, despite the NHMRC being asked to accept the International Consensus Primer for Medical Practitioners as Australia’s clinical guidelines.
The 2002 Australian chronic fatigue syndrome guidelines, which are still up on the RACGP website, were never accepted by experts or patients. When they were originally released, the chairman of MECFS Australia said they would result in misdiagnosis, inappropriate and inadequate medical care and the promotion of widespread misconceptions about the illness.
Even before they were released, on 10 April 2002 Democrats Senator Lyn Allison asked the Health Minister in Parliament, “given the stated opposition by the ME/Chronic Fatigue Syndrome Association of Australia to the recently-released draft of the RACGP’s Chronic Fatigue Syndrome Clinical Practice Guidelines, will the Government call for the publication, currently planned for May 2002, to be delayed pending a review?”
The Health Minister’s answer: “No. I am satisfied that an appropriate process has been followed in developing the guidelines. This has included development by an expert Working Group with a consultative process including input from consumers”.
Senator Allison followed up, asking why the grants the NHMRC awarded were heavily weighted towards psychiatric/psychological aspects rather than treatment and management. In the 15 years since then, the same question could be asked every year.
Last year a committee investigated Lyme-like illness in Australia. Here is their final report. It is unsurprising to find chronic fatigue syndrome mentioned in the report due to huge percentage of misdiagnosis in ME and chronic fatigue syndrome. (A Griffith University study shows a problem with the diagnosis of chronic fatigue syndrome by GPs in Australia; 38% don’t meet Fukuda CFS criteria, 68% don’t meet ICC ME criteria.) Lyme disease is clearly listed as an exclusionary illness in the ICC/CCC ME medical primers.
Last year Senator Ludlam asked the Health Department what a clinical advisory group do. The department said “they are a time-limited group of mostly clinical experts in a field formed to provide advice to the Chief Medical Officer. While the advice provided by a clinical advisory committee may contribute to decisions and policy development within the department, these committees do not make decisions, nor do they develop government policy. The two most recent advisory committees were on Lyme disease and PIP breast implants.”
Keep asking questions
Senator Ludlam has championed research and treatment for Australians with ME and chronic fatigue syndrome. He asked questions at the Senate budget estimates hearing in 2015 where he said “I am struggling to think of a cohort of people in our community that large for whom there is so little”.
In February 2016 Ludlam said “ME needs much more targeted research to give people guidance on what they have. It is scary to have wide sets of symptoms and it feels like sustained research could help” and had more questions for the NHMRC because their answers raised more questions. Those further questions revealed that Australia’s health department inflated figures on research spending and they had, in fact, only spent $1.6 million since 2000. Ludlam then asked the key question, how much is going towards “investigating cognitive behavioural therapy or graded exercise therapy“?
The majority of the NHMRC funding is awarded to Prof Andrew Lloyd, including $1,065,000 in fellowships, to support his work which includes developing a training module for health professionals to use GET/CBT on people diagnosed with chronic fatigue syndrome. Recently more than 700 people petitioned the government to withdraw funding because of the evidence of harm to patients. Griffith University’s Prof Staines recently described exercise as ‘unbelievably bad’ for patients.
Video and transcript
You can watch the hearing online (starts at 2:23:40) or below is a transcript of Senator Scott Ludlam and Professor Kelso, CEO of the National Health and Medical Research Council at the hearing.
Ludlam: Welcome back Professor. We going to have to race through these. Anything that seems moderately complex I’d be happy for you to take on notice. On 2 February this year the NHMRC advised via your website there are two proposals under consideration for targeted calls for research. Tick-borne and Lyme-like illness, you’re aware of the committee which had a fair bit to do with this last year, and Myalgic Encephalomyelitis/chronic fatigue syndrome. Tell us what happens from here with those two proposals. Do you look at both or is there some triaging underway?
Kelso: It’s true we have provided a pathway for community and professional groups to nominate topics that can be considered for a targeted call for research. So we have several different pathways for such topics to be brought to us for an expert committee to then go through those proposals and prioritise them and give advice to our research committee on whether they should be put forward for consideration as a targeted call for research. So, as you say, we received suggestions of targeted calls of research around ME/CFS and also Lyme-like illness in Australia.
So both of those proposals have been looked at carefully. At this stage we need to refine them further and we are going to need to have expert advice to be able to decide whether and how they should be supported for research. The difficulty at the moment is, the two cases are quite similar, to the extent that these are syndromes for which there isn’t a clear clinical definition. There aren’t clear diagnostic tests there aren’t established treatments and methods for looking after patients which is exactly why there is a need for research.
But the scope of the research that is needed to address all of those issues for both those complex illnesses is very, very broad so we’re going to have to find a way to target the research so it can be effective with the funds available.
There is more work to be done and a decision has not yet been taken on whether and when those will be funded.
Ludlam: Can you tell us what your timeline is for decision-making?
Kelso: So, we don’t have a specific timeline. We are working through a number of such proposals so I can’t give you a date today but it’s work for this year to decide how to progress.
Ludlam: Some of the advocates from the ME and CFS groups, the ones I’m aware of anyway, are very concerned that any delay after the next round of funding submissions in April/May mean that these folk drop off, so can you assure us that this is not the case, that they are still under consideration?
Kelso: Yes, they are still in consideration.
Ludlam: In terms of the experts you would consult, could I draw your attention to the work of this committee from last year that Senator Siewert chaired where some of these experts were brought to the table and also whether or not the work of NCNED, the unit at Griffith University who are doing superb work on diagnostic criteria for MECFS. Would they be among the experts you would consult as part of this funding round? The reason that I raise that is that they are very, very close to diagnostic criteria. They’ve had some breakthroughs that have been heralded around the world.
Kelso: The full range of expertise is including those people who would be considered for forming a panel to advise us but in that case they may well be applicants so that creates an interesting situation for us because we would want the very best people to be able to apply for funding and support so we have to we have to work very carefully with conflicts of interest to ensure that those who are advising us on what should be funded aren’t exactly the people you want to have doing the research. But we are aware of the work that’s been done by at Griffith and really delighted to hear there is an important advance been made.
Ludlam: I’m getting the windup by the chair, so this is probably going to stray into the realm of ‘on notice’ but the other thing I’m interested in is as we move from diagnostics to treatment and we’re going to need to skill up the nation’s GPs. At the moment there is obviously a range of views in the GP community about whether this is psychosocial or rather than biomedical. What is the process for funding education programs for GPs and distributing this research that’s been done so that we can winnow out some of the frankly quite harmful treatments that have been proposed?
Kelso: Senator, that’s beyond the scope of the national health and medical research council so I’m not really qualified to comment at all.
Ludlam: That’s okay. Minister or Mr Secretary could I please throw that one to you and on notice as were out of time. In the specific case of when you’ve got diagnostic criteria been identified for conditions such as this that’s been out there in the cloud for sort of a while, that’s been very misunderstood, how do we get that information into the hands of GPs so that people are properly diagnosed?
Senator Nash: We’ll take it on notice.
This first appeared in MEAustralia news.
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In August, we shared with you that we and six other ME/CFS organizations had submitted a proposal to the National Center of Health Statistics (NCHS) to fix the coding of ME/CFS in the US International Classification of Diseases (ICD-10-CM). Today, we are writing with an update on that proposal and asking that you sign the