ME/CFS/FM SUPPORT ASSOCIATION QLD INC. - Queensland, Australia
The final version of the Guidelines "Chronic Fatigue Syndrome Clinical Practice Guidelines - 2002" was published as a Supplement to the Medical Journal of Australia (Vol.176), on May 6th 2002, despite the best efforts of so many to prevent publication of the existing form; being aware of the adverse impact this document could have on those with ME/CFS.
Prior to publication, both the ME/Chronic Fatigue Syndrome Association of Australia and the Alison Hunter Memorial Foundation had written to the Editor of the MJA, and the President of the RACP, rejecting the Guidelines and requesting they not be published.
The almost 6 years of Guidelines saga has been dealt with over that time by this Toowoomba Support Group, by active contribution of submissions, and reports in the 'Communicator' ... as have all the other Support Societies in Australia.
Leading up to and since publication, there has been an extensive media coverage throughout Australia, beginning with an article in the Sydney Morning Herald "Sick and tired patients in uproar" 29.04.02, and in The Age "Report on Chronic Fatigue fuels row" also on 29.04.02, by Medical writer Julie Rowbotham.
Further articles by Julie Rowbotham also appeared in the Sydney Morning Herald on May 4th "Riddle of the Quiet Killer" telling the story of Alison Hunter who died aged 19, and other severely affected patients ... and "Brain Link to Fatigue Syndrome" dealing with South Australian research on cerebral blood flow in CFS.
Simon Molesworth, President of the ME/Chronic Fatigue Syndrome Association of Australia Ltd gave interviews to many of the major newspapers including Time Magazine; also interviews to major radio stations in Sydney, Melbourne, Adelaide, and Darwin. He has also contacted every politician in Australia alerting them to the Guidelines.
For those with internet access a comprehensive account of all of the background to the Guidelines, and the media articles may be read at the following Websites:
Alison Hunter Memorial Foundation and ACT ME/CFS Society Inc.
Contents of the 'Guidelines document' are available at the Website of the Medical journal of Australia:
http://www.mja.com.au/public/guides/cfs/cfs2.html
The following correspondence is published in accordance with a request from the National President, Simon Molesworth, that these be published in all CFS Society Newsletters, Journals, and Websites in Australia .....
Since then there has been on-going dialogue to attempt to move forward, with the hope to improve and update the Guidelines document, so that it reflects current knowledge.
The response of the Editor of the MJA to Simon Molesworth's letter of 7th March 2002:
Dear Mr Molesworth
Re: RACP Chronic Fatigue Syndrome Practice Guidelines
Many thanks for your letter dated March 7, 2002 and its evidential supplement dated March 8, 2002. The letter outlines the reservations of your Association about the guidelines and the request not to publish the same.
Allow me to comment on divergent opinions in guidelines developments. Committees convened to develop guidelines or position statements do not always achieve complete consensus as poignantly illustrated in an article in the Journal recently published (MJA 2002; 176: 332-334). Committees have to make judgements on the strength of published evidence and this process is but human but it is the only vehicle we have at this time. Of course your Association may register its concern with the guidelines to the Committee but to take on the role of a censor and ask a Journal to desist from publication is unprecedented in scientific and clinical publishing in Australia.
I have forwarded your concerns to the President of the Royal Australasian College of Physicians and Chairman of the Committee.
It is the intention of the MJA to publish the Clinical Guidelines both in the MJA and the eMJA www.mja.com.au. The Journal will also publish after the guidelines publication evidence-based Letters to the Editor on the Web or in the print version, but these will undergo the usual Editorial processes. This I believe is the most appropriate way forward.
You and your association/s will have the opportunity to argue not anecdotally but with peer reviewed evidence your Association's divergence from the content of the guidelines.
(signed:) Martin Van Der Weyden MD FRACP FRCPA, Editor, The Medical Journal of Australia
The response of Simon Molesworth to MJA letter above:
Wednesday, 24th April 2002
Dear 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:
"Of course your Association may register its concern with the guidelines to the Committee but to take on the role of censor and ask a Journal to desist from publication is unprecedented in scientific and clinical publishing in Australia".
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 indepth 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:
"Guideline developers need to demonstrate that they have taken reasonable steps to ensure that the guidelines were properly prepared and that they provide the best available information at the time of publication".
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.
"As the practice guideline movement has matured, the interest and debate surrounding guideline developments has shifted from the what to the how."
"The story suggests that the debate in guideline development should now shift even further from the how to the who."
"Its central message is that practice guideline development is not a black and white affair, and that the time has come for open disclosure of conflicts of interest and the degrees of consensus or dissent. As guidelines have a powerful influence on clinical practice, doctors and their patients deserve nothing less than complete openness and transparency."
"... conflicts of interest comprise those which may not be fully apparent and which may influence judgment of authors, reviewers or editors. They have been described as those which, revealed later, would make a reasonable reader feel misled or deceived."
(From "Clinical Practice Guidelines: time to move the debate from the how to the who" Editorial, MJA, Van der Weyden, April 1, 2002)
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.
Yours sincerely,
Simon R. Molesworth
AM, QC, FEIA, FAICD, FAIM, FVPELA, Hon.FRAPI
National Chairman,
ME/Chronic Fatigue Syndrome Association of Australia
The final version of the Guidelines "Chronic Fatigue Syndrome Clinical Practice Guidelines - 2002" was published as a Supplement to the Medical Journal of Australia (Vol. 176), on May 6th 2002. Since then, there has been on-going dialogue to attempt to move forward, with the hope to improve and update the Guidelines document, so that it reflects current knowledge.
The following letter, prepared jointly by the then President of the RACP, Professor Richard Larkins; and the President of the National ME/CFS organisation, Simon Molesworth AM QC; and sent to the MJA 3rd June 02, is published in this Web Site in accordance with a request from Simon Molesworth.
The Letter was published by the MJA 1st July 2002 ...... as follows:
Mr Simon Molesworth AM, QC
Immediate Past-President
ME/Chronic Fatigue Syndrome Association of Australia
19 Linacre Rd, Hampton, Victoria 3188
Professor Richard Larkins
Chairman
Royal Australasian College of Physicians
145 Macquarie St. Sydney, NSW2000
Dear Sir,
The ME/Chronic Fatigue Syndrome Society of Australia Ltd. has expressed its concern over the content of the Royal Australasian College of Physicians' Chronic Fatigue Syndrome Clinical Practice Guidelines published in the Medical Journal of Australia. Recognising a shared objective to overcome the challenges of CFS, neither the ME/Chronic Fatigue Syndrome Society of Australia Ltd nor the Royal Australasian College of Physicians believe that conflict will provide a useful path to future answers. Accordingly, as the Chairman of the ME/Chronic Fatigue Syndrome Association of Australia and the President (at the time of the publication of the Guidelines) of the Royal Australasian College of Physicians we would like to document the common ground that has been identified.
All clinical guidelines should be viewed as documents that will, in time, require refinement, rewriting and replacement. Medical practitioners must be cognisant of the limitations of all such guidelines and be aware that the investigation and management of a patient's condition must be determined with the assistance of the best and latest information as it emerges and in all instances be tailored to the needs of the individual patient.
Yours sincerely,
Professor Richard Larkins FRACP
Chairman
RACP (demitted May 6th,2002)
Simon Molesworth AM, QC
President
ME/CFS Association of Australia
Following the joint letter to the Editor of Medical Journal of Australia, by Larkins and Molesworth (Published in the August/September 'Communicator'), the current issue of the MJA (published 4th November '02) has published 3 letters responding to Larkins and Molesworth by Psychiatrists lan Hickie, James Hundertmark, and Emeritus Surgeon Donald Beard.
The psychiatrists' responses predictably maintain the psychiatric view .... but Beard puts a different view .... as per this extract ....
"Larkins and Molesworth state that treatment plans should be 'within the capabilities of the patient': is there evidence to indicate that stimulating each patient to do just that little more each day will do harm?
One of the problems is that, as soon as a medical advisor informs a patient that investigations have shown no serious abnormality, the patient often goes away and says to himself or herself or family that the 'doctor said there is nothing the matter with me and that it is all in my head'. Nothing could be further from the truth."
The 4th letter is a positive reply from Larkins and Molesworth.
The Letters may be read at the following Web Sites:
Chronic fatigue syndrome clinical practice guidelines: psychological factors. James D Hundertmark. MedJ
Aust 2002; 177(9): 525-527.
http://www.mja.com.au/public/issues/177_09_041102/hundertmark_041102.html
Chronic fatigue syndrome clinical practice guidelines: psychological factors. lan B Hickie. MedJAust 2002: 177(9):526.
http://www.mja.com.au/public/issues/177_09_041102/hickie_041102.html
Chronic fatigue syndrome clinical practice guidelines: psychological factors. Donald D Beard. Med J Aust
2002; 177(9): 526.
http://www.mja.com.au/public/issues/177_09_041102/beard_041102.html
In reply: Chronic fatigue syndrome clinical practice guidelines: psychological factors. Richard G Larkins and Simon R Molesworth. MedJAust 2002; 177 (9): 526-527.
http://www.mja.com.au/public/issues/177_09_041102/larkins_041102.html