ME/CFS AUSTRALIA (SA) INC
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South Australia 5007
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ME/CFS Australia (SA) Inc supports the needs of sufferers of Myalgic Encephalomyelitis, Chronic Fatigue Syndrome and related illnesses. We do this by providing services and information to members.
ME/CFS Australia (SA) Inc aims to keep members informed of the various research projects, diets, medications, therapies etc. All communication, both verbal and written, is merely to disseminate information and not to make recommendations or directives.
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Letter to The Medical Journal of Australia
ME/Chronic Fatigue Syndrome Association of Australia
April 24, 2002
Dr Martin Van Der Weyden, FRACP, FRCPA
Dr Van Der Weyden,
RACP Chronic Fatigue Syndrome Clinical Practice Guidelines
I am writing to thank you for responding to my letter of the 7th March 2002. I am glad to see that you specifically acknowledged receipt of the evidential supplement dated March 8th 2002 which accompanied the original letter and which has been subsequently replaced with an improved version of the supplement document.
I note that the nub of your response is encapsulated in the last sentence of the second paragraph of your letter:
I would like to make an important observation in response to the suggestion that we, in effect, simply seek to “censor” the publication, a step that you say is unprecedented in publishing in Australia.
My observation is this: if it were simply a matter of freedom of speech or freedom of research, we would have greater appreciation and acceptance of your Journal’s stand. We would join with you in condemning censorship. However, with the publication of the proposed Guidelines it is demonstrably clear that the primary purpose of publishing is not the dissemination of information simply for academic interest or intellectual advancement, rather the primary purpose is clearly to proactively encourage medical practitioners to accept the conclusions of the Guidelines and to thereafter apply them to patients in the course of their medical practice. The difficulty as I see it, and I am afraid that I am unable to see it through eyes other than that of a Queen’s Counsel with a particular experience in predicting trends in litigation at the cutting edge of the law and public policy (having been, inter alia, the national president of two professional institutes in the course of my career), is that the publishers and authors of clinical guidelines personally take on a far greater social, moral and legal responsibility than would be the case with the publication of, say, an academic treatise.
It is for this reason that I must stress that the “Critical Analysis” document forwarded to you is more than just simple criticism of an academic paper, rather it is an in-depth work that unambiguously explains the basis for our Association’s proposition that the proposed Clinical Guidelines are seriously flawed. Whether you accept our proposition that the Guidelines are flawed is not a relevant concern, what matters is whether there is a potential that the Guidelines are so flawed that their publication is likely or inevitably going to lead to patients (and it only needs one patient to be of concern legally) being misdiagnosed or subjected to inappropriate treatment. That is the primary concern of our Association.
Within the area of medical research into ME/CFS, papers are published in learned journals and in the proceedings of conferences throughout the world throughout each year. As one might expect, in these papers opinions vary: researchers are often at loggerheads - such debate must be and is acknowledged by our Association. However, the purposeful publication of clinical guidelines intended to encourage medical practitioners to adopt a particular approach to treatment gives rise to an entirely different scenario. The onus or responsibility is a heavy one - and it is one that gives rise to legal liability should the underpinning assumptions or conclusions be flawed.
Those advising the Association, who have the responsibility of monitoring the world body of ME/CFS research literature, report that the tide of research is clearly running one way with increasing momentum. An insight, indeed a mere glimpse, into that tide is clearly indicated in the “Critical Analysis” document now in your possession (and in the possession of the Royal Australasian College of Physicians). This tide of research confirms that the Guidelines that you propose to publish in your Journal are flawed and, worse, their application may imperil both patients (medically) and medical practitioners (legally). With the provision of the “Critical Analysis” document, all recipients are on notice that the Guidelines are potentially flawed and that reliance upon them may potentially give rise to unfortunate legal ramifications.
Following an extensive review of the literature, it is considered that the evidence is not good enough for the Guidelines to be called ‘evidence-based,’ the assessment and presentation of the evidence has not been objective, the Working Group was not truly representative and so the end product is unreliable. The document provides potentially harmful management suggestions with insufficient supporting evidence. The Guidelines primarily represent one school of thought to the illness.
Because of the selectivity of the evidence used in the writing of the Guidelines and the composition of the Working Group, the ‘censorship’ of other evidence and alternative opinion has already occurred but the reader does not know this. It could be said therefore, that rather than ‘censoring,’ the Association is opposing what is effectively ‘censorship’ that has already been carried out by the Working Group prior to publication.
It seems that consumer opposition to the Guidelines is being treated like an academic debate, with opportunity being given by the MJA “to argue not anecdotally but with peer reviewed evidence” in subsequent editions of the Journal. Reply in a separate edition is not the same as having opposing information and alternative views clearly expressed in the actual guidelines where they can be read whenever the Guidelines are consulted. This would be considered a standard practice in guideline-writing and is recommended by the NHMRC. It is also a recommended practice that the dissent of groups to particular recommendations be acknowledged.
It is instructive to consider the following passage, appearing under the heading “Legal liability of preparers of guidelines and bodies auspicing guideline development,” from page 28 in the NHMRC’s Guidelines for the Development and Implementation of Clinical Practice Guidelines dated October 1995:
The Association is speaking out on behalf of people with CFS, to try and protect them from potential harm. It is unfortunate that the MJA is more focused on the issue of potential censorship of their Journal than consideration of the underlying issues and the possible outcomes of publication for people with CFS. It seems that the MJA is unconcerned that their publication might be flawed and could be harmful to people with CFS and put practitioners at risk. I accept that the President of the RACP does not accept that the Guidelines may lead to misdiagnosis and inappropriate medical care, however the critical question for the MJA Board is whether the Guidelines truly present a responsible appraisal of the differing opinions regarding the illness and the differing approaches to treatment. In this regard, DR Van der Weyden, given your own publicly expressed views on the subject of guideline writing, I would have thought that your own attitude would have been consistent with the very approach my Association is calling on the MJA to adopt. Allow me to quote you.
It is my intention to publish your letter of the 9th April and a copy of this, my letter in reply, in all newsletters, journals and websites of all the ME/CFS Societies and Support Groups in Australia and New Zealand, which I understand have an estimated active readership in excess of 100,000 patients and carers. These two letters will be published with a website cross reference to the “Critical Analysis” document so that all readers will understand what material has been placed before your Journal’s Editorial Board and the Royal Australasian College of Physicians prior to publication.
Simon R. Molesworth AM, QC,