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Australian House of Representatives Hansard for 2nd June 1998
APPROPRIATION BILL (No. 1) 1998-99

Mr JENKINS (Scullin) (9.05 p.m.)
This is a bit off the mark in the portfolio, but I will briefly mention the chronic fatigue syndrome society's concerns about the guidelines that have been put out by the NHMRC, which really emphasise what it believes to be the psychological aspects of the disease rather than that it has other bases. I hope that the government will look at that. (Time expired)

Australian House of Representatives Hansard for 2nd June 1998
APPROPRIATION BILL (No. 1) 1998-99

Mr WARWICK SMITH (Bass--Minister for Family Services) (9.10 p.m.)--
On the issue of chronic fatigue syndrome, my colleague Dr Nelson was nodding his head in agreement. I feel sure that he is correct and that others have made note of your comments tonight. I am sure that some action will be happening in that direction as well.

Mr TAYLOR (Groom) (10.52 p.m.)
Once again, this evening I want to raise an issue not only as the member for Groom but also as the patron of a local community support group for those affected by myalgic encephalomyelitis, ME, or chronic fatigue syndrome, CFS/ME--a potentially disabling and chronic condition affecting the immune and central nervous systems. I regret that I was not able to acknowledge this in the last sitting week when International CFS/ME Day occurred--in fact, on budget day, May 12. It is a complex illness and the list of symptoms can be extensive and profound in the more severe cases, highlighted in the recent drugs in sport case involving the Australian Rules footballer, Alastair Lynch, which, thankfully, was settled to everybody's satisfaction earlier today.

Current research suggests a dysfunction of the immune system and the central nervous system. The complexity of the illness means that the prognosis can be very difficult to predict. Some patients will make slow and gradual progress over several years to a full recovery. The majority will make variable progress with relapses which may be severe and prolonged. They may reach 70 to 80 per cent of their former functions.

Others remain severely disabled with little progress, needing a lot of help with their personal needs. A smaller percentage may deteriorate and be bed bound for much of the time. Peak incidence appears to be in the 20 to 40 years age group, with a slight predominance to females. Unfortunately, cases involving young children are increasing. Clearly, it is a very real and, for many, a very debilitating illness. The consequences of living with ME-CFS/ME for the sufferer, the carer and the whole family unit need to be understood.

I take the opportunity to pay particular tribute to two Toowoomba women, Joan Sheath and Lyn Wilson, both of whom are sufferers and support group leaders, without whose persistent efforts the community group would not be what it is today.

In this place in March of last year I expressed support for a working group established under the auspices of the Royal Australasian College of Physicians with the aim of developing clinical practice guidelines for the assessment and for the treatment of CFS/ME. The major task of the working group was to evaluate the rapidly growing body of scientific literature on CFS/ME and to make recommendations to medical practitioners and to the community.

I regret to inform the House that patient support organisations and CFS/ME clinical experts are critical of the results. To illustrate, I quote in part from a recent letter to me from the Toowoomba support group:

It is with deep concern that we implore you to use your Parliamentary influence to reject the Draft Clinical Practice Guidelines . . .

If those guidelines are accepted and imposed they are going to cause untold hardships on sufferers and their families.

The questions we all want answered are, "How can these people make guidelines about the management of an illness that so little is known about?:

And, "Wouldn't the money being spent on these guidelines be better spent on research into CFS/ME/FM?"

They go on to indicate some of the things in the working group's management plan, but they finish by saying:

We're sure it would be of great concern to the Australian Government if the Royal Australasian College of Physicians were to lose their credibility with researchers and physicians around the world.

Undoubtedly, CFS/ME is a debilitating illness which we cannot and must not ignore. Seemingly, the guidelines reactivate perceptions that this is a condition of the mind rather than of the body. Clinical experts and sufferers reject that simplistic view.

Australian House of Representatives Hansard for 25th May 1998
APPROPRIATION BILL (No. 1) 1998-99

Mr WILLIS (Gellibrand) (8.26 p.m.)--
Despite the attempts by the member for Corangamite (Mr McArthur) to shore up support for this budget by quoting such well-known independent observers as Terry McCrann and Piers Ackerman, I think it is true to say that this year's budget was generally assessed by the media as a do-little budget. What else could you expect from a budget that was brought down on International Chronic Fatigue Syndrome Day?

Australian Senate Hansard for 26th March 1998
QUESTIONS ON NOTICE
Medicare
The following answers to questions were circulated:
(Question No. 1052)

Senator Lees asked the Minister representing the Minister for Health and Family Services, upon notice, on 23 December 1997:

The answers provided by Senator Herron--The Minister for Health and Family Services are represented in blue.

(2) With reference to the Budget Paper's promotion of `Evidence-based Medicine' as a way to ensure `the most cost effective and medically appropriate outcomes', in particular, one of the Government's `cost effective clinical practice guidelines' projects:

(a) is the statement made by the Minister in Parliament on 11 February 1997, that `one thing the Government has done is to contribute money to the RACP to develop guidelines into the most cost effective treatments', a statement in relation to Chronic Fatigue Syndrome (CFS/ME); and

Yes.

(b) how does the Minister intend to develop further guidelines.

With the CFS/ME Clinical Practice Guidelines now in the final stages of preparation (an Exposure Draft was widely circulated for comment in December 1997), there are no plans to develop further guidelines on CFS/ME in the immediate future.

(3) Given the terms of the Government contract with the Royal Australian College of Physicians (RACP) specified that these guidelines were to be completed by 31 December 1996:

(a) are these guidelines for CFS/ME now available: if not, when will they be made available; and

Having sought and received approval for the extension of the contract until 30 June 1998, the RACP working group distributed an Exposure Draft of the CFS/ME Guidelines titled Draft Clinical Practice Guidelines on the evaluation of prolonged fatigue and the diagnosis and management of chronic fatigue syndrome for comment in December 1997. A copy of that Exposure Draft has been sent to the honourable senator. The Exposure Draft is also available on the world wide web site http://www.mja.com.au/public/guides/cfs/cfsl.html The closing date for comments is 16 February 1998 and publication of the final guidelines, as a free standing supplement to the Medical Journal of Australia is scheduled for May 1998.

(b) is the Minister aware that the co-chairman of the RACP working party, Dr Loblay, has written publicly that `we do not regard the conditions of grant as binding us', `conditions of grant are not relevant to our deliberations', `As far as I'm concerned they are simply an administrative necessity which enables the bureaucracy to justify the expenditure to their political masters'; and `we did not believe that questions of cost would enter into our deliberations, and indeed they have not'.

The Minister is not aware of Dr Loblay's comments.

(4) (a) Does a member of the Department sit on the working group; if so, was he or she aware of the decision in September 1996 not to do cost studies; and

No Departmental officer is a member of the RACP working group. However, an officer has been an observer at some meetings. The departmental officer is not aware of the decision referred to. This project involves the development of guidelines on the most clinically relevant and cost effective methods of diagnosing and treating CFS/ME. New cost studies are not required in the project outline, only a survey of existing literature.

(b) when was the Minister made aware of that decision.

Since the Department was not aware of any such decision, the Minister was not advised of the matter.

(5) Given the Budget Paper's promotion of `Evidence-based Medicine' as a way to ensure `the most cost effective and medically appropriate outcomes', and given that the RACP working party does not intend to look at cost effectiveness, are they looking at medical outcomes.

As mentioned above, the purpose of the grant was to enable the RACP in consultation with other relevant bodies and consumers, to develop guidelines on the most clinically relevant and cost effective methods of diagnosing and treating CFS/ME. The guidelines were to cover definition, diagnosis, management of the condition and research. The process adopted by the RACP working group in developing the guidelines is described in Part 6 of the Exposure Draft and summarised under the heading Guideline Development in that document's Preface.

(6) Did the Minister advise Parliament on 11 February 1997 that CFS/ME research, including health outcomes research, has not been funded.

While stating that the NHMRC has not specifically funded research for CFS/ME, the Minister advised that a new subcommittee of the NHMRC, the Strategic Research Development Committee, whose role was to advise on the need for targeted research into different health issues, could properly address this issue. The Minister also mentioned the funding provided to the RACP to develop the guidelines. He expressed the hope that if agreement on this matter could be attained, people suffering from CFS/ME would more easily be accepted by the broader medical profession. There was no explicit mention of health outcomes research in the Minister's response.

(7) Is it a fact that, despite a special ministerial committee, the CFS/ME Review Committee, making recommendations on funding general practice research, CFS/ME health outcome surveys in general practice have still not been carried out.

In its 1994 Report, the CFS/ME Review Committee recommended that a suitably structured survey of the attitudes, knowledge and practices of general practitioners regarding CFS/ME be undertaken to establish a baseline. The Royal Australian College of General Practitioners was contracted to conduct such a survey in March 1995 and produced its report the following year. A copy of the Report has been sent to the honourable senator.

(8) Is the Minister aware that the previous minister instructed the department to implement CFS Review Committee recommendations but that these have not been carried out.

No instructions were ever issued to the Department by the former Minister for Human Services and Health with regard to the recommendations of the Chronic Fatigue Syndrome Review Committee's report. However, the Government has taken the report seriously and has given effect to the spirit of its recommendations. The production of evidence based guidelines through a process involving consultation with CFS/ME support groups, relevant medical experts and individuals was judged to be a more appropriate way of providing guidance to doctors in the diagnosis and treatment of CFS/ME than the Consensus Conference recommended by the Committee.

(9) Is it a fact that CFS/ME consumer groups' requests for funding to carry out health outcome surveys have also recently been denied, the reason given being that the Minister has every confidence in the integrity and process being followed by the working group.

The Department is not aware of any requests for funding of health outcome surveys from CFS/ME consumer groups. A number of letters have been sent to the Minister from consumer groups and other individuals expressing concern about the composition of the RACP working group. The Minister's response to the letters included information on the membership of the working group and the statement that he has every confidence in the integrity of that group and the process being followed to produce the CFS/ME guidelines. He also noted that every effort had been made to ensure that consumers and professionals had been able to express their views throughout the process. While one CFS/ME Action Group has sought funding to conduct a "Consumers' Conference", the Department is not aware of any applications which seek specific funding for health outcomes surveys.

(10) Is it a fact that the RACP working group, despite the emphasis on outcomes in the National Health and Medical Research Council (NBIRC) guidelines and despite the provisions for such outcome surveys under the NHMRC process, does not intend to carry out health outcome surveys.

Yes. Under the conditions of the grant, the RACP working group was not required to carry out health outcome surveys. However, the RACP working group did generally follow the process recommended and endorsed by the NHMRC which is based on the general approach to improving health outcomes as agreed by Australian Health Ministers. The main purpose of the guidelines is to achieve better health outcomes by improving the practice of health professionals and by better informing consumers about treatment options.

The NHMRC recognises that clinical guidelines should be based on the identification and synthesis of the best scientific evidence, a goal which the RACP working group is pursuing. The RACP working group used the NHMRC process to conduct an exhaustive review and evaluation of the relevant published scientific studies on prolonged fatigue and CFS/ME. Evidence was systematically evaluated and the findings published and cited in the draft guidelines.

(11) Has there been any breach of the terms of the contract relating to the CFS/ME Review Committee.

The Minister is not aware of any breach of the terms of the contract with the RACP.

(12) Is the `adoption of Best Practice by the profession' under the Better Practice Payments scheme, a requirement to adhere to clinical practice guidelines of the nature of those currently being produced in CFS/ME, which lack research on appropriate outcomes and lack cost-effectiveness studies.

No. Nor is it the case that the draft clinical guidelines produced by the RACP Working Group lack research on appropriate health outcomes, since it contains an exhaustive review of current world literature on this aspect.

(13) Can it be confirmed that it is not the Government's intention to reduce Medicare availability of treatments without first carrying out appropriate health outcomes research, as well as cost-effectiveness studies.

To attract a Medicare benefit, the Health Insurance Act 1973 (the Act) requires a professional service to be "clinically relevant". A clinically relevant service is defined in the Act as being a service rendered by a medical practitioner that is generally accepted in the medical profession as being necessary for the appropriate treatment of the patient to whom it is rendered. Provided a treatment meets this definition, Medicare benefits can be paid.

(14) Can it be confirmed that the RACP-CFS/ME clinical practice guidelines will not be used to reduce Medicare availability of diagnosis or treatments in CFS/ME until appropriate cost-effectiveness studies are carried out.

The intention has always been that the work will be available as guidelines for treating practitioners. The basis of a valid Medicare claim remains clinical relevance, not rigid adherence to guidelines.

(15) Will the department be instructed to ensure that the RACP process complies fully with the NHMRC guidelines for production of clinical practice guidelines current at the time of formation of the working group.

No. The Department will not be so instructed. The process the RACP has followed would in any event obviate the need for such an instruction.

While the contract with the RACP makes no mention of NHMRC endorsement of the CFS/ME guidelines, the Working Group at its first meeting on 21 September 1996 agreed that such endorsement was desirable. The guidelines were, therefore, developed with this objective in mind

(16) Will the Government provide research funding for CFS/ME health outcome surveys.

The National Health and Medical Research Council (NHMRC) provides funding for health and medical research on the basis of scientific merit and subject to a rigorous peer review process. The NHMRC does not, as a rule, direct researchers to undertake research in any particular field, although it recognises that particular areas of research may need special attention, including strategies to facilitate the development of further research.

The Strategic Research Development Committee (SDRC) of the NHMRC will examine data on CFS/ME, according to the following criteria, in order to determine research priorities:

• the significance of CFS/ME as a health issue in the Australian context, including impact on sufferers;
• the research currently under way in Australia and internationally; gaps in Australia's research effort in this area; and
• the capacity for additional research to be undertaken in Australia.

It will take several months to undertake this analysis and the results will need to be carefully assessed against other competing priorities. It is expected that this assessment will be completed by April 1998. The issue of health outcome surveys will be considered in this context.

(17) Is the Minister aware that the RACP working group has not contacted all Australian researchers with scientific emerging treatments and therefore valuable contributions on diagnosis and treatment will not be included in the guidelines.

I am assured that the RACP Working Group has consulted widely and made good use of Internet access as well. In January 1997, a letter was sent to 46 organisations (including 21 doctors) seeking written submissions. The RACP working group received 80 submissions in total. Of these, 17 were from individuals and bodies representing alternative organisations and 15 responses were from doctors who were either writing as individuals or as representatives of academia or other such organisations. The circulation of the RACP working group draft guidelines asking for comment provides a further opportunity for all Australian researchers with scientific emerging treatments to provide input.

(18) Is it lawful for practitioners to itemise to Medicare services delivering emerging treatments in new areas of medicine such as CFS/ME.

The basis of a lawful Medicare claim is set out in the Health Insurance Act 1973. A professional service must be clinically relevant, i.e. a service rendered by a medical practitioner that is generally accepted in the medical profession as being necessary for the appropriate treatment of the patient to whom it is rendered. New procedures must be evaluated for safety, efficacy and cost-effectiveness before being listed on the Medicare Benefits Schedule. For professional attendances, where no listed procedure is performed, the clinical relevance test still applies. The treatment must still be accepted in the medical profession as being necessary for the patient. Some "emerging" treatments may not meet this test.

(19) Will the Minister: (a) guarantee Medicare funding of any identified CFS/ME emerging treatments until they can be documented and evaluated for cost effectiveness;

No. All new procedures must be properly evaluated before Medicare Benefits can be paid. However, the new MSAC may recommend that some treatments which are promising, but as yet unproven, be the subject of further research and interim benefits could be paid in these circumstances.

(b) implement the CFS/ME Review Committee recommendations to provide funds to general practitioners to document emerging treatments;

No. The RACP working group process took the place of the CFS/ME Review Committee recommendations.

(c) instruct the department to investigate the use and/or the threat of prosecutions to general practitioners itemising services delivering emerging treatments in CFS/ME; and

No such `threats' have been or are being issued by the Department or the Health Insurance Commission. The test for whether a service attracts a Medicare benefit is whether it is a clinically relevant service as defined in the Health Insurance Act 1973 as being a service rendered by a medical practitioner that is generally accepted in the medical profession as being necessary for the appropriate treatment of the patient to whom it was rendered.

(d) acknowledge the `Catch-22' situation that the department has placed on doctors prepared to scientifically document emerging treatments in CFS/ME

Doctors treating CFS/ME patients have faced a difficult task, trying to sort out which of the vast range of new treatments emerging for CFS/ME over the past decade are worthwhile. This is the reason the Department has funded the RACP to develop and publish guidelines based on a scientific assessment of evidence. The draft guidelines developed by the RACP Working Group fully assess health outcomes and new emerging treatments.

(20) Given that the RACP contract without outcome surveys, without identification of emerging treatments, without cost effectiveness studies only serves to continue this situation: what steps will be taken to correct this matter.

The distribution of draft clinical guidelines by the RACP working group in December 1997 provides the clearest perspective to date of which treatments and diagnostics are generally agreed to be clinically relevant in respect of CFS/ME. The distribution of the final version will enhance this situation. Anyone who believes that the draft contains inaccuracies, makes incorrect conclusions or omits relevant material should take this opportunity to inform the Working Group accordingly.