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Patients to DHHS: Fix the Broken ME/CFS Case Definitions NOW!

change-request-form-hiOn May 12 – International Awareness Day for ME/CFS/FM/MCS/etc – Phoenix Rising joined with 8 other US ME/CFS patient organizations and 26 independent patient advocates to call on the Department of Health and Human Services (DHHS) to finally fix the problem of the many and diverse case definitions associated with our disease. In a letter to Secretary Sebelius, Dr Howard Koh, Dr Thomas Frieden and Dr Francis Collins, we explained our concerns about the current definition activities of the DHHS in relation to “Chronic Fatigue Syndrome”, and listed the steps we believe must be taken to rectify the situation.

You can read our letter to the DHHS here.

The signatories on the letter are:

Chronic Fatigue Syndrome, Fibromyalgia and Chemical Sensitivity Coalition of Chicago, CFS/Fibromyalgia Organization of Georgia, Inc., MAME (Mothers Against Myalgic Encephalomyelitis), PANDORA (a.k.a. CFS Solutions of West Michigan), Phoenix Rising, The Fibromyalgia-ME/CFS Support Center, Inc., Rocky Mountain CFS/ME and FM AssociationSpeak Up About MEWisconsin ME/CFS Association, Inc., Bobbi Ausubel, Rich Carson, Lori Chapo-Kroger, R.N., Kati Debelic, R.N., Mary Dimmock, Pat Fero, MEPD, Joan Grobstein, M.D., Jean Harrison, Eileen Holderman, Suzan Jackson, Jill Justiss, Mindy Kitei, Michele Krisko, Denise Lopez-Majano, Mike Munoz, Matina Nicolson, Donna Pearson, Leela Play, Justin Reilly, J.D., Mary Schweitzer, Ph.D., Meghan Shannon MS MFT, Marly Silverman, Rivka Solomon, Tamara Staples, Charlotte von Salis, J.D., Michael Walzer.

For those of you who wish to sign this letter and become a part of this important initiative, we will provide a mechanism to do that within a few weeks and will send out additional information at that time.

Why have we written this letter?

Of all the issues that we face today, the one issue that has created the most problems is the diverse case definitions associated with our disease. This single issue has severely impacted research, drug development and clinical care and misled the medical community on the very nature of this devastating disease, causing many doctors to not believe that their patients are really sick. Until this issue is addressed, patients will continue to pay the price. This must stop now.

Today, the CDC states that there are at least 5 different definitions for “CFS”. Three of these definitions – the Canadian Consensus Criteria, the ME International Consensus Criteria and the Pediatric Criteria – require hallmark criteria like PEM/PENE and neurological, immunological and energy production impairments. Unfortunately, two of the most commonly used definitions, Fukuda and Oxford, do not require these hallmark criteria. In fact, Oxford only requires 6 months of disabling fatigue – no other symptom – and allows primary psychiatric disorder.

The result? Myalgic encephalomyelitis, the disease seen in outbreaks throughout the twentieth century and recognized by the World Health Organization in 1969, has disappeared, and in its place we are left with “CFS”, an amorphous umbrella of unrelated fatiguing conditions including, according to the literature, depression, deconditioning, medically unexplained chronic fatigue, and for some researchers and clinicians, fatigue due to “excessive rest” or “false illness beliefs”. In clinical practice, the diagnosis of CFS is given to a heterogeneous mix of patients – those with ME, those with the varied fatiguing conditions listed above, and those who were misdiagnosed or whose doctors use the diagnosis of CFS as a catch-all for unexplained fatigue. And in 2012, an American Family Physician article proclaimed that Oxford and Fukuda are the appropriate definitions for “CFS” and further stated: “[CFS] patients with poor social adjustment, a strong belief in an organic cause for fatigue, or some sort of sickness benefit (i.e., financial incentive) tend to have worse responses to [cognitive behavioral] therapy.”

Exactly what disease are we talking about here?

Patients have paid dearly for the proliferation of these overly broad and non-specific definitions – bedbound or homebound, unable to work or take care of their families, suffering for 10, 20, 30 or more years from the myriad symptoms that plague their bodies, unable to get adequate medical care and ultimately more likely to die prematurely from cancer, cardiovascular disease and suicide. 

As Dr. Carruthers stated in the ME International Consensus Criteria, “Research on other fatiguing illnesses, such as cancer and multiple sclerosis, is done on patients who have those diseases. There is a current, urgent need for ME research using patients who actually have ME.”  We must have a disease appropriate definition for ME that is separate and distinct from all the other unrelated conditions encompassed by the overly broad, fatigue-focused “CFS” definitions.

What are we asking for?

Our letter to the DHHS asks them to:

  1. Adopt a disease-appropriate case definition for ME now, utilizing the Canadian Consensus Criteria as recommended by DHHS’ own advisory committee CFSAC, and train doctors with appropriate medical guidance.
  2. Stop using the terms “CFS” and “Chronic Fatigue Syndrome” along with the non-specific definitions like Fukuda and Oxford and the medical education material based on these definitions.
  3. Manage the adoption of the Canadian Consensus Criteria to ensure that insurance and disability do not lapse and that no patients fall through the cracks.
  4. Fully engage ME stakeholders in the planning and execution of the adoption of the Canadian Consensus Criteria.

Is this the right thing to do?

You may ask whether we really know enough about the disease or whether we need more study before we change definitions. Certainly, with more study, we can better operationalize the definition and validate biomarkers to make patient diagnostics easier. But in the meantime, we know that PEM/PENE is a hallmark symptom that reflects a distinctive biological pathology and we must utilize a disease definition that requires that symptom.

Some of you may prefer the ME International Consensus Criteria over the Canadian Consensus Criteria. The ME-ICC certainly has some excellent features. But practically, the Canadian Consensus Criteria has been used clinically and in research for a decade. Studies have been done with it. The U.S. government has posted the IACFS/ME Primer, based on the Canadian Consensus Criteria, on DHHS’ Guidelines.Gov. This is more likely to be acceptable to DHHS and is a reasonable first step, especially when considered against the alternative of continuing to use Fukuda while more study is done.

What about dropping the name “CFS”? You may be concerned that this means we will lose the literature base that has provided insights into the pathology of ME. Admittedly, some of the best articles used the term “CFS”. And so do some of the worst. The point is that the literature base is a mess because multiple diverse and unrelated definitions have inexplicably been allowed to use the very same name for years. We all should stop using the term “CFS” because it no longer has any real meaning.

Finally, what about the name ME? Does it really describe the disease? Is there a better name? That is a question that science will need to decide over time, something that has happened in many other diseases. But what is clear is that “chronic fatigue syndrome” will never be an appropriate name and should never have been established as the alternative or synonym for ME.

Patients have borne the brunt of the failure to address the definitional issues for the last thirty years. We cannot wait for more study to finally stop the harm being done to patients, especially given that more study with non-specific definitions will only perpetuate the problem. The time to address this problem is now.

Questions and Answers

We realize that patients, carers and advocates may have a number of questions about this initiative, and we hope that the following questions and answers will address any concerns you may have.

1. We can not abandon the patients that have been incorrectly given a “CFS” diagnosis.

This is very true. It is critical that implementation of this change is carefully managed so that these patients are re-evaluated and given a correct diagnosis. If unexplained conditions remain, it will be necessary to perform the studies needed to understand these conditions and establish more appropriate names and definitions.

2. We can not afford to have our disability or insurance impacted.

Yes, this is very important. It will be important to have a carefully thought out implementation plan that manages this to ensure that patients do not lose disability or insurance benefits.

3. The vast majority of the 6000 articles in the literature use the name “CFS”, not “ME. If we stop using the name “CFS”, we will lose all that literature.

Currently, when the search term myalgic encephalomyelitis is used, the CFS literature is returned. This will not change. But that literature base contains both articles relevant to ME and also a significant number of articles about “CFS” and child abuse, false illness beliefs, deconditioning, etc. This creates significant confusion for anyone trying to use that literature. For that reason, the non-specific term “CFS” should be abandoned by the U.S. and more specific terms like ME used going forward.

4. We have more important issues to deal with such as funding, and attracting new doctors and researchers.

It is critical that we have more funding but if we don’t fix the definition issue first, we will continue to study the wrong disease and have progress impeded by poor definitions. The resultant confusion will make it difficult to attract young researchers and doctors who will not see career opportunity in “CFS”.

5. Research centers have recently been established and if we stop using the name “CFS” we will confuse our donors.

It is true that a number of research institutes have recently been opened and some of them use the term “”CFS” or even “CF”. But the donors to these institutes today have a personal connection to the disease. They will continue to fund. Attracting additional funders, however, will be negatively impacted by the confusion around the disease. The sooner we can resolve this issue, the better in the long run.

6. CFS biobanks have been established using Fukuda and we don’t want to lose those samples.

The biobanks that have only been characterized by the Fukuda definition could contain a mix of patients with the hallmark criteria of ME and those who do not have these hallmark criteria. Using these mixed samples will continue to confound research. It is important that we have a well-characterized set of samples in the biobank and know which samples are from ME patients.

7. ME may not be the right name. Shouldn’t we wait for the science to figure out what the right name is?

It is possible that with further study, we will determine a better name than ME and it will naturally evolve. But ME, adopted by the World Health Organization in 1969, is the best placeholder until that time and avoids the serious issues caused by the use of the term “CFS”.

8. The best course is to tighten up the “CFS” definition, not get rid of it. Then we can keep the literature base, the biobanks, etc.

There are two problems with this approach. First is the long history of the term “CFS”, which is non-specific and now widely associated with diverse conditions, especially including psychiatric issues. This has severely tainted the term and made it clinically meaningless. Second, the term “CFS” is used for those studying patients that meet Oxford criteria (essentially chronic fatigue) and we have little control over that continued usage.

9. Lenny Jason recently published a paper that reports that the ME-ICC and the Canadian Consensus Criteria include more psychiatric co-morbidities than the Fukuda and recommends that more study be done. Does that mean we should wait to recommend any criteria until then?

  • Dr. Jason’s paper did find that the ME-ICC found more psychiatric co-morbidity than Fukuda. But Dr. Jason acknowledged the need for more study because this one used a questionnaire designed for Fukuda CFS, and that they were unable to assess one of the key ME-ICC criteria because data on this criteria was not available. Further, the study did not look at homebound or bedbound patients.
  • But what is also significant in Dr. Jason’s study is that ME-ICC identified a much tighter group of patients (39 compared to 113 for Fukuda) with more of the functional impairments and physical, mental and cognitive problems seen in ME-ICC patients than in those meeting the Fukuda criteria.
  • Clearly additional study is needed to operationalize the definition and to improve how it characterizes the disease, especially around subtypes. But continuing to use the 19-year-old consensus-driven Fukuda definition – which is also not operationalized and does not describe subtypes – in the meantime is not going to advance that knowledge and will only continue to hurt patients.
  • The Canadian Consensus Criteria has been used clinically and in research for over 10 years and better represents the disease. Using the CCC now will allow us to begin to make forward progress in research and identifying treatments, and begin to address the disbelief in the medical community. 

10. Is this the same thing as the Name Change initiative?

No. This is first and foremost about the definition being used – adopting a definition that effectively describes the disease and stopping the use of the definition – and name – that have created so much confusion and so many problems.

11. Why CCC and not ME-ICC?

The CCC has been used clinically and in a number of studies, providing the experiential foundation for its use. It is expected that as additional data is obtained, this definition will evolve. This must be done in partnership with the experts who developed the ME-ICC and the CCC.

 

We hope and believe that this initiative will be welcomed by the majority of the patient community, and we hope that the questions above have addressed any concerns. Of course there is always room for debate over details, but very few if any of us are happy with the existing definitional mess, and this letter represents a consensus amongst 9 patient organizations and 26 independent advocates on the best path towards change. As such, we encourage the community to get behind this initiative and seize this opportunity to resolve the problem of the broken case definitions used for our disease.

 

[appeal]?

 

{ 239 comments… add one }

  • Bob May 21, 2013, 10:32 pm
    Ember

    As an aside, I considered the likelihood that I was immuno-compromised in deciding whether or not to undergo radiation. I walked out when my GP told me not to think like that because ME/CFS is a syndrome, in any case, and not a disease.

    Sorry to hear that you had to go through that sort of nonsense, Ember.
    I know that my GP would think similarly.

  • Ember May 21, 2013, 10:47 pm
    Bob

    I know that my GP would think similarly.

    GPs adhere to case definitions, and these do have consequences. I'm grateful that Dr. Carruthers accompanied me through that nightmare. I wonder how many such stories it takes to inspire change.

  • Ember May 22, 2013, 1:19 am
    alex3619

    The primary difference between CCC and ICC in this context is not based on the definitions, but on the politics.

    My questions about process remain unanswered, so unfortunately I'm left to speculate. The authors of the ICC have asked that a CCC diagnosis be left in the more encompassing CFS classification. Is the broadening of the ME designation in this initiative, so as to denote CCC-defined ME/CFS, supported by the IACFS/ME? I ask because of a rumour to similar effect from a year ago:

    PENE

    What it is:
    The term PENE didn’t exit prior to it’s début in the ICC ME publication. It is an attempt to create a very unique type of fatigue category and is being put forward as the defining symptom for ME. There are rumors that the IACFSME group is negotiation with the CDC for the creation of the ME category and a move of a set of patients to this designation under the coding of G93.3. According to the rumors the CDC wants to keep the CFS designation, the Reeves Empirical definition and the data sets from Wichita and Georgia. However, they have agreed that those persons who have a viral onset can be moved to the new category. In an effort to keep the ME category as broad as possible the IACFSME group wrote the definition of PENE to be somewhat open and a little vague in hopes of being able to catch more patients into the ME definition than the more narrow definition currently being demanded by the CDC. However all of the above is rumor and supposition and has no supporting evidence (italics added).

    I notice that the IACFS/ME hasn't yet included the ME-ICC in its list of case definitions.

  • Mark May 22, 2013, 3:06 am
    Ember

    My questions about process remain unanswered, so unfortunately I'm left to speculate.

    I answered your questions as best I can in #20 above. Medfeb's been busy the last few days but I expect she'll say more when she's able.

    As I described in #20, the process of drafting the letter involved many representatives of ME/CFS patient organizations and individual patient advocates. Now it's been sent to the DHHS and we're having a more public discussion about it. We'll see what emerges during that discussion; I expect this campaign to continue and evolve as the issues are opened up and discussed more widely.

    The merits of CCC and ICC for the purposes of this letter were discussed while the letter was being drafted, and it's no surprise to me that this question is a focus for the discussion now. I hope that some of those who were involved in those discussions will explain here in more detail why the letter focused on the CCC, but the rationale has already been clearly summarised in the article:

    Some of you may prefer the ME International Consensus Criteria over the Canadian Consensus Criteria. The ME-ICC certainly has some excellent features. But practically, the Canadian Consensus Criteria has been used clinically and in research for a decade. Studies have been done with it. The U.S. government has posted the IACFS/ME Primer, based on the Canadian Consensus Criteria, on DHHS’ Guidelines.Gov. This is more likely to be acceptable to DHHS and is a reasonable first step, especially when considered against the alternative of continuing to use Fukuda while more study is done.

    11. Why CCC and not ME-ICC?

    The CCC has been used clinically and in a number of studies, providing the experiential foundation for its use. It is expected that as additional data is obtained, this definition will evolve. This must be done in partnership with the experts who developed the ME-ICC and the CCC.

    That seems to me a strong argument that the CCC is a far more realistic objective and I think it's pretty clear from the above that those who debated these issues simply preferred to campaign for what they consider to be realistic objectives. Since the ICC has not yet been proven by practical use, it's harder to argue for its adoption at this point in time.

    And since the ICC is itself a (young) evolution of the CCC, if the CCC were adopted in the way that the letter argues, in time there would eventually be further evolution of the definition, likely from CCC to ICC or from CCC to some other new and similar case definition. It seems to me more practical, if one does actually want to achieve change, to get behind a broad campaign for 99% of one's objectives, and with a very good prospect of achieving the remaining 1% in the fullness of time, rather than opposing that campaign and arguing about the 1%.

    So from my point of view, it's fairly clear that the difference between the current situation of a mixed population defined by definitions like Fukuda and Oxford, and the position argued for in the letter, is a much, much bigger difference than the technical difference between ICC and CCC. This would be a big step forward, and to oppose the letter on the basis that it should have argued for ICC rather than CCC seems like a case of "the best is the enemy of the good". As wikipedia puts it: "insisting on perfection often results in no improvement at all". Or as Winston Churchill put it: The maxim "Nothing but perfection" may be spelled "Paralysis”.

  • alex3619 May 22, 2013, 4:19 am

    Mark As a perfectionist, I have the opinion that demanding perfection often leads to a logical trap and inaction, just as you quoted from Winston Churchill. Perfectionism often goes with a rational choice, and the best choice is not often the most useful. When criteria about how useful a choice may be are used, often the best choice becomes impractical, while a lesser choice becomes highly desirable. I think thats the the issue here: long term the CCC is a better initial choice unless things change. Things will indeed change in time, and at that point the ICC might be much more easily adopted. How hard will it be to convince someone to accept ICC if CCC is already adopted as the standard? Not hard at all is my guess.

  • taniaaust1 May 22, 2013, 8:25 am
    Bob

    Maybe I've missed your meaning, tania, but there is an edit function on the forum, and a delete function.

    It either wasnt coming up at the time or my brain had dived into some hole.

  • taniaaust1 May 22, 2013, 8:29 am
    Sasha

    I don't ever expect to see the perfect advocacy letter that accurately expresses all my opinions and that I agree 100% with – I'm happy to sign up to something that is 70% or 80% there.

    We're too large a community and the issues too complex to ever get such a thing. I think our best strategy is to get behind something that has already been thought through by a lot of us and has got broad consensus and, if implemented, would improve our situation. Our situation now is appalling. We can't wait for perfection.

    Too right.

    We've all seen how things stagnant when it comes to ME/CFS so hence we need to keep progress moving forward. As long as its doing so, we are getting somewhere.

  • taniaaust1 May 22, 2013, 8:46 am
    Nielk

    What is the characteristic difference between the CCC – CFS definition and the ICC-ME definition?

    The ICC-ME definition for one.. a person needs 2-3 more symptoms then the CCC-CFS definition to fit it fully. There was also some other difference too but sorry I forgot now what.

  • Ember May 22, 2013, 2:26 pm
    Mark

    I answered your questions as best I can in #20 above. Medfeb's been busy the last few days but I expect she'll say more when she's able.

    My specific question above was about the broadening of the ME designation by this initiative through its use of the term ME to denote CCC-defined ME/CFS. That move runs counter to the direction set by the ICC authors. You mention a future partnership with the experts who developed the ME-ICC and the CCC, and the joint letter states that “key stakeholders – ME patients and ME experts — must be engaged in a full and open partnership to plan for and ensure the implementation of this change.”

    I accept that Phoenix Rising entered the process partway through, and I've assumed that you can't answer any question about the early decisions. I've asked whether any medical or policy experts were consulted. The ICC authors and Dr. Jason are frequently cited. Was Dr. Jason afforded the courtesy of reviewing the joint letter before it was sent? The lead authors of the CCC and the ICC apparently were not.

  • Bob May 22, 2013, 11:48 pm

    I assume that it was this letter that got mentioned and praised during the CFSAC meeting.
    I'll provide a link to the short discussion when the video gets posted.

  • Ember May 23, 2013, 12:06 am
    taniaaust1

    The ICC-ME definition for one.. a person needs 2-3 more symptoms then the CCC-CFS definition to fit it fully.

    Our perceptions differ here. By my count, the ICC requires one fewer symptom for an ME diagnosis and three fewer symptoms for an atypical ME diagnosis.

  • Ember May 23, 2013, 12:13 am
    Bob

    I assume that it was this letter that got mentioned and praised during the CFSAC meeting.

    We also heard something of Dr. Unger's response: the CCC selects a heterogeneous population; PEM may not be unique to CFS; PEM has been difficult to define; it isn't clear whether or not a patient without PEM would be managed as a CFS patient. These are all issues that have been raised and tackled by the ME-ICC.

  • Bob May 23, 2013, 12:57 am
    Ember

    We also heard something of Dr. Unger's response: the CCC selects a heterogeneous population; PEM may not be unique to CFS; PEM has been difficult to define; it isn't clear whether or not a patient without PEM would be managed as a CFS patient. These are all issues that have been raised and tackled by the ME-ICC.

    It's a shame that the CDC didn't tackle these things decades ago, so that they are not now unknowns for the CDC.

  • Mark May 23, 2013, 2:56 am
    Bob

    I assume that it was this letter that got mentioned and praised during the CFSAC meeting.

    Yes, it was. Eileen Holderman mentioned it, right at the end of the day, describing it as an 'outstanding position paper', and Gailen Marshall said he too was impressed with it. There were also several patients who called on CFSAC to recommend adoption of the CCC. Holderman argued that we have quite enough evidence now to 'embrace the CCC and move forward with that'.

    According to my notes, Unger's main argument against the CCC (in reference to the CDC's website) was that some physicians are 'frightened and intimidated' by the complexity of the CCC and the severity of the symptoms it describes, and this might put them off from caring for ME/CFS patients at all. I liked the response from a committee member who basically said that would be a good thing if it meant they referred the patients to somebody who knew what they were talking about.

    Unger would, I feel sure, apply her later comment that 'even the CCC defines a heterogeneous population' equally to the ICC: the context for that comment was her justification of the CDC's approach in its multi-site study, and she was arguing that identifying markers that show which patients respond to which treatments would ultimately make the case definition question redundant. She was arguing there against any role for any kind of 'a priori case-definition' approach (whether ICC or CCC), and arguing instead for the CDC's fresh and 'agnostic' approach to beginning anew on studying the whole, wider patient population (minus the seriously ill, of course) and trying to subgroup that population in an evidence-based way, before deciding anything about definitions.

    The committee members pointed out a number of serious flaws in the CDC's approach, especially the failure to study any housebound patients and the failure to include appropriate testing such as 2-day exercise challenge (they almost seem to be consciously omitting anything that might yield useful results). I really don't see any evidence from today's discussion that the CDC would listen to somebody talking about the ICC any more than the CCC. In fact I didn't see any real evidence of them hearing anything that anybody (everybody) was telling them today…

    I was really pleased to hear Gailen ending the meeting by saying that the working sub-groups of the CFSAC can involve whoever they want, because from the discussion earlier I was already thinking that if CFSAC now needs to provide evidence in support of the whys and the anticipated benefits of its recommendations, then the wider community (in particular the group of orgs and advocates who drafted this letter) can provide invaluable help with that task. I think the committee will be very open to receiving helpful submissions of evidence in support of its recommendations. There were many positives today, but the key problem, perhaps, is how to find some kind of hole in the apparent brick wall (or should I say stone wall?) of the CDC; there were one or two hints of slight progress there, but it does seem like a very slow and frustrating process to try to get anything through to them…and I seriously doubt that the committee would have any more luck if everyone was united behind the ICC rather than the CCC.

  • Ember May 23, 2013, 4:23 am
    Mark

    According to my notes, Unger's main argument against the CCC (in reference to the CDC's website) was that some physicians are 'frightened and intimidated' by the complexity of the CCC and the severity of the symptoms it describes, and this might put them off from caring for ME/CFS patients at all.

    On the four points that I've mentioned, I found myself having to agree this time with Dr. Unger. But I tuned in late and missed her comments about the frightening complexity of the CCC. If I'm not mistaken (based on the audio), she was backed up in these concerns by Drs. Friedberg and Friedman.

    I'd like Dr. Unger to be confronted with the full laboratory/investigative protocol from the ME Primer, including the consecutive-day cardiopulminary exercise stress test:

    PENE:
    A 2 consecutive day comprehensive 8-12 minute cardiopulmonary exercise stress test (measuring heart, lung, and metabolic function) – only ME patients have significantly worse scores the second day & abnormal recovery from exertion.* Exercise tolerance test with expired gas exchange – (2 consecutive days) – measure cardiovascular, pulmonary & metabolic responses at rest & during exercise: peak oxygen consumption VO2 or VO2 at anaerobic threshold (AT) – decline of 8% or greater on test 2 indicates metabolic dysfunction, post-exercise blood analysis – increase in sensory, adrenergic and immune genes – increase in metabolite receptors unique to ME

    She'd prefer the cardiopulminary exercise testing from the ME/CFS Guidelines:

    Cardiopulmonary Exercise Testing: AMA Guide for Evaluation of Permanent Impairment. Lower cardiovascular and ventilatory values at peak exercise help determine functional capacity, and peak oxygen consumption levels determine disability categories.

    Correct me if I'm wrong, but I don't see any exercise testing suggested in the ME/CFS Primer.

  • taniaaust1 May 23, 2013, 7:50 am
    Ember

    Our perceptions differ here. By my count, the ICC requires one fewer symptom for an ME diagnosis and three fewer symptoms for an atypical ME diagnosis.

    Not sure how you are coming up with that unless Im reading something completely wrong.

    The Canadian consensus definition has http://sacfs.asn.au/download/consensus_overview_me_cfs.pdf
    – a couple of different kinds of fatigue mentioned which is equivalent to the ICCs Postexertional PENE
    – 2 neuro/cognitive symptoms
    – 2 symptoms (the 2 have to be one each from different catagories autonomic, neuroendocrine or the immune)
    – the other two symptoms being optional eg the pain and sleep dysfunction IF one had an infectious onset to the illness they are optional otherwise those two things are needed as well. the pain and sleep dysfunction are starred due to being optional)

    So that's 5 symptoms needed (combining the types of fatigue as they are all combined in the ME International criteria and not separated into 2 like the canadian) but the symptoms will go to 7 if you include the 2 optionals.
    …………….

    The International ME Consensus Criteria (for a diagnoses which is not non typical) http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full

    – postexertional PENE
    – 3 symptoms out of 4 catagories of 1/ Neurocognitive
    2/ Pain
    3/ Sleep Disturbance
    4/ Neurosensory, perceptual or motor disturbance

    -1 symptom from energy production/transportation
    – 3 more symptoms are needed on top of what Ive written above if I understand the following the following wording right
    "1 symptom out of 3 of 5 catagories" The catagories are 1/Flu like which worsens on exertion
    2/ Susceptibility to virual infection
    3/ Gastro-Intestinal tract
    4/ Genitourinary
    5/ Food sensitivities, MCS

    So that is 8 symptoms needed for the international ME consesnus defination for a standard ME diagnoses
    compared to the 5 needed symptoms and 2 optionals for a diagnoses with the canadian one.

    Actually these in comparison are closer then i'd previously thought.

    edited due to a mistake Id made in this.. thanks to ember for pointing it out.

  • taniaaust1 May 23, 2013, 8:11 am
    Mark

    According to my notes, Unger's main argument against the CCC (in reference to the CDC's website) was that some physicians are 'frightened and intimidated' by the complexity of the CCC and the severity of the symptoms it describes, and this might put them off from caring for ME/CFS patients at all. I liked the response from a committee member who basically said that would be a good thing if it meant they referred the patients to somebody who knew what they were talking about.

    Im so glad the committe member made a comment like that. What the those in power are ignoring is that just cause the complexity of ME is being ignored (not putting that info out to doctors is an ignoral of it) that doesnt mean that doctors out there are not getting this complex patient group coming to them. (I went throu over 35 doctors.. not specialists.. just to find one who could handle just having a severe ME patient, ..and that wasnt even expecting the doctor to treat it.. that doctor would only take me on under the care of a CFS specialist to advise).

    Where does it lead to now with NOT having the info known.. It leads to "frightened and intimidated doctors" who end up refusing to see ME patients like myself cause they say "Your illness is too complex" ,they are scared something is going to go wrong and that they then would be liable for missing something. Ive been abandoned by so many doctors due to this!! (its either that or they think you are nuts with having so many symptoms and be far worst then what they are currently being taught this illness is like. A doctor asks you about your ME and one says.. well where do I start, I have 93 different symptoms.. just watch how fast that doctor will be trying to kick you out the door!!).

    I told my specialist the other day that Im only eatting once a day due to not being well enough to cook.. his reply "try harder", he has very little understanding of the whole illness cause the heads of the medical stuff let our doctors down by not giving them good info on the more severe ME patients (that is 25% of us). I cant cut back any further on anything I do so I cant cook more without my condition worsening…but have a specialist (sadly one who sees ME/CFS patients but he dont understand the severe subgroup), getting annoyed at me cause I cant stick to his diet.. one he thinks will improve my health…. so Im going to end up being blamed for not wanting to get better.

    Its a problem when our very own CFS specialists dont have the info THEY NEED too cause the medical profession hides it from them the severity of this illness. All we apparently shoulld do is GET and CBT and get better!! The whole situation puts ME patients who are very sick at severe risk of even getting worst then they are now.. possibly of death! (If I crash more to the point where I arent able to cook one meal a day without making myself worst.. I could starve to death.. my severe insulin issues dont allow me to eat many quick food things). Who's at fault.. places like the CDC who hold back the info on the severe patient group cause they've had their heads buried in the sand for all these years… they are way behind the boat and its time for them to accept they have FAILED, and something others have done like the Canadian Consensus doc. ME/CFS patients have waited long enough to stop being ignored.

    Physicans are being "frightened and intimidated" now by the severe patient group.. who just then ends up being poorly treated and abandoned due to how things are now.

  • Ember May 23, 2013, 10:56 am
    taniaaust1

    Not sure how you are coming up with that…

    On the worksheet (page 2) of the ME/CFS Guidelines, #1, #2, and #7 are separate. For #3 and #4 to be missing would be exceptional. And at least one additional symptom from each of two categories is required in #6.

  • taniaaust1 May 23, 2013, 6:22 pm
    Ember

    On the worksheet (page 2) of the ME/CFS Guidelines, #1, #2, and #7 are separate. For #3 and #4 to be missing would be exceptional. And at least one additional symptom from each of two categories is required in #6.

    Thanks for explaining where you are coming from with this as I was truely wondering.

    #7 which is "The illness may persist for 6mths, isnt a symptom. It's a time duration which got made up for this illness. People of cause have ME from the start and dont just suddenly get it after 6mths. The International ME consensus criteria fortunately gets rid of the situation in which someone cant be diagnosed for 6mths even when its clear what they have.

    From the International ME Consensus Doc on thatl

    The Canadian Consensus Criteria were used as a starting point, but significant changes were made. The 6-month waiting period before diagnosis is no longer required. No other disease criteria require that diagnoses be withheld until after the patient has suffered with the affliction for 6 months. Notwithstanding periods of clinical investigation will vary and may be prolonged, diagnosis should be made when the clinician is satisfied that the patient has ME rather than having the diagnosis restricted by a specified time factor.

    The Canadian Diagnostic criteria #1 Fatigue and 2# Post exertional Malaise and/or Fatigue..
    one can count these as two separate things as you are doing as that is the way they are listed in that document but here's tthe ME International one and how its lists its Fatigue/PENE area for diagnoses which I only counted as one before but you can see its actuallly has 5 different points in that area put as just one thing (compared with the canadians only 2 areas for fatigue which they separate which can make it appear they have more but if you compare actual description they dont, under a "fatigue" label they both end up probably being fairly equal).

    A. Postexertional neuroimmune exhaustion (PENE pen’-e): Compulsory
    This cardinal feature is a pathological inability to produce sufficient energy on demand with prominent symptoms primarily in the neuroimmune regions. Characteristics are as follows:
    1. Marked, rapid physical and/or cognitive fatigability in response to exertion, which may be minimal such as activities of daily living or simple mental tasks, can be debilitating and cause a relapse.
    2. Postexertional symptom exacerbation:e.g.acute flu-like symptoms, pain and worsening of other symptoms.
    3. Postexertional exhaustion may occur immediately after activity or be delayed by hours or days.
    4. Recovery period is prolonged, usually taking 24 h or longer. A relapse can last days, weeks or longer.
    5. Low threshold of physical and mental fatigability (lack of stamina) results in a substantial reduction in pre-illness activity level.

    #3 and #4 to be missing, I do completely agree that it would be exceptional but was being black and white about what is actually stated and needed in the Canadian consensus criteria for a diagnoses seeing that is what we were discussing (even they thou state its unusual).

    Oh boy.. thanks.. I did miss #6 so that would be two more symptoms added to my tally for the Canadian consenus definition..so brings them very close in comparison then. I'll change my original post on it to fix the error. thanks again for pointing out i'd missed that.

  • Mark May 23, 2013, 6:36 pm
    Ember

    On the four points that I've mentioned, I found myself having to agree this time with Dr. Unger.

    My sympathies, I imagine that doesn't come easily. 😉

    But I tuned in late and missed her comments about the frightening complexity of the CCC. If I'm not mistaken (based on the audio), she was backed up in these concerns by Drs. Friedberg and Friedman.

    They may have accepted the point that the CCC is quite complex but I think it would be misrepresenting them to suggest that they don't like the CCC and don't think it should be used. I didn't get that impression at all and I was listening to the whole thing quite carefully to see whether anybody explicitly argued for the ICC rather than the CCC. I suspect the consensus amongst pretty much all advocates is that the ICC is a better case definition, but that's not really the point, the issue is what it is feasible to get operationalized now in order to move things forward.

  • Ember May 23, 2013, 8:52 pm
    Mark

    They may have accepted the point that the CCC is quite complex but I think it would be misrepresenting them to suggest that they don't like the CCC and don't think it should be used. I didn't get that impression at all and I was listening to the whole thing quite carefully to see whether anybody explicitly argued for the ICC rather than the CCC. I suspect the consensus amongst pretty much all advocates is that the ICC is a better case definition, but that's not really the point, the issue is what it is feasible to get operationalized now in order to move things forward.

    I wasn't suggesting that the Friedberg and/or Friedman comments were designed to support the ICC. IACFS/ME supports its own ME/CFS Primer. Dr. Jason also promotes his four-symptom ME model. He's been criticizing the ICC since September 2011 for having too many symptoms and potentially selecting psychiatric co-morbidity. (The ICC excludes primary psychiatric conditions.)

    I'm disappointed that Dr. Friedberg would use the CFSAC meeting to claim that the ICC, with more symptoms, selects psychiatric disorders. CFSAC should focus on patient interests, not on competing research interests. I'm disappointed too to hear the CCC criticized for having too many symptoms.

    What do you mean by getting the ICC operationalized?

  • Mark May 23, 2013, 10:17 pm
    Ember

    I wasn't suggesting that the Friedberg and/or Friedman comments were designed to support the ICC. IACFS/ME supports its own ME/CFS Primer. Dr. Jason also promotes his four-symptom ME model. He's been criticizing the ICC since September 2011 for having too many symptoms and potentially selecting psychiatric co-morbidity. (The ICC excludes primary psychiatric conditions.)

    I'm disappointed that Dr. Friedberg would use the CFSAC meeting to claim that the ICC, with more symptoms, selects psychiatric disorders. CFSAC should focus on patient interests, not on competing research interests. I'm disappointed too to hear the CCC criticized for having too many symptoms.

    What do you mean by getting the ICC operationalized?

    Thanks for your clarifications Ember.

    My word 'operationalized' was a bit rushed, I wanted really to mean 'getting it into use' in the sense that the committee today was talking about CCC use: in that particular context, perhaps main idea would be something like making it mandatory for govt-funded research, and on the clinical side, making it the focus of information and education. The details of all that, I guess, start to come as and when we get a response from the DHHS, but I would expect that some parts of that (eg info on websites) might well include mention of ICC as well.

    I thought of a question for you during today's CFSAC meeting, Ember, which I think might help me clarify where you're coming from. Asking you for a guess or estimate really, don't want to pin you down on precise numbers, but the question is this: considering the population of people who you would consider to be properly defined as "ME", what proportion of patients defined as "CCC" do you think really have "ME" (and what proportion don't), and the same question for "ICC": what proportion of them really have "ME"? And I suppose also, in both cases, what proportion of people with what you define as "ME" might be missed by those two case definitions. Just so I can get some sense from you of where you feel the land lies here. And finally, I guess also important to ask is what definition you think we should be campaigning for and what should be used to define ME?

  • alex3619 May 24, 2013, 4:35 am

    Most studies seem to have a split in the ME population in how they test or respond. I don't know if this is just natural variation, or an actual diagnostic split that has been missed. For example, why do 70% respond to Rituximab and 30% don't? Why are there two different exercise response profiles from the Light's research? Are these due to different co-morbidities? Different triggering/causal pathogens (including different strains of the same pathogen)? Different disease/genetic responses? Or two or more diagnostic entities that are muddled together? Nobody knows. The CCC or the ICC are not perfect. Its now clear that the CDC study will not use the best testing we have, so their results could well miss the mark, What is really clear though is that as long as the world thinks of this as "fatigue", and uses CFS definitions, then things will not improve. Something has to change, as fast as possible, then we select a new strategic target and work to change that. Repeat until we have a cure. We cannot be the hare. We are sick of being the tortoise. This strategy is the bulldog strategy. Take a big bite, don't let go, and when the time is right take an even bigger bite.

  • Ember May 24, 2013, 10:32 pm
    Mark

    I thought of a question for you during today's CFSAC meeting, Ember, which I think might help me clarify where you're coming from. Asking you for a guess or estimate really, don't want to pin you down on precise numbers, but the question is this: considering the population of people who you would consider to be properly defined as "ME", what proportion of patients defined as "CCC" do you think really have "ME" (and what proportion don't), and the same question for "ICC": what proportion of them really have "ME"? And I suppose also, in both cases, what proportion of people with what you define as "ME" might be missed by those two case definitions. Just so I can get some sense from you of where you feel the land lies here. And finally, I guess also important to ask is what definition you think we should be campaigning for and what should be used to define ME?

    Where am I coming from? Being no wiser than an international panel of experts, I define ME patients as patients who meet the ME-ICC. So far, the only complaint that I've heard from any patient who feels that he would meet other ME criteria but doesn't meet the ICC involves its exclusion of primary psychiatric disorders.

    We can be sure that the ME population is smaller than the ME/CFS population, but we can't know without research how much smaller it is. Perhaps the Johnston et al. article that Bob posted is encouraging:

    Advances in clinical case definitions during the past 10 years such as the Canadian Consensus Criteria have received little attention in prevalence research. Future assessments of prevalence should consider adopting more recent developments, such as the newly available International Consensus Criteria. This move could improve the surveillance of more specific cases found within CFS.

    I believe that we need to campaign for the ME-ICC because it best serves the needs of patients. The joint letter risks harming ME and CFS patients alike.

    ME patients shouldn't have to wait any longer for an appropriate case definition. Our history doesn't suggest that moving incrementally from the CCC to the ICC would ever be easy. If we succeed in confounding ME with a fatiguing ME/CFS syndrome now, we will have missed a precious opportunity to separate ME from CFS.

    The authors of the ICC recommend removing ME patients from CFS, not dismantling the CFS classification. Patients who sign an initiative during a campaign may feel that they have something to gain. But they're not bound as are medical or policy experts to consider the good of the entire patient population.

    We shouldn't wait idly by, hoping that the ICC will have its turn. The ICC is an orphan definition for an orphan disease. It's met serious opposition from entrenched interests, and it has no medical or political body paving its way. If patients don't get behind it, another independent panel of experts won't likely dedicate their efforts to our cause.

    The CCC has served its day; today it's a trap. It offers the forlorn hope of compromised change. When the CCC was published, it was called “ME/CFS: Clinical Working Case Definition, Diagnostic and Treatment Protocols.” Eight years later, I asked (half joking) if we couldn't please dub the ICC the American Consensus Criteria. After a decade of inaction, we need to stop begging the American government to adopt these obsolete Canadian criteria. We have the ICC, and we need to move on.

  • Mark May 25, 2013, 2:17 am
    Ember

    ME patients shouldn't have to wait any longer for an appropriate case definition. Our history doesn't suggest that moving incrementally from the CCC to the ICC would ever be easy. If we succeed in confounding ME with a fatiguing ME/CFS syndrome now, we will have missed a precious opportunity to separate ME from CFS.

    I'm arguing in support of the letter, Ember, but I do want to stress that your position in preferring the ICC to the CCC for this letter is a perfectly respectable one and has a lot of merits. If the ICC were an equally achievable goal (and it may perhaps be so) then I think I would prefer that. It's a more recent definition, and I do think it's better. My personal position, though, is that given a letter and a broad campaign with many signatories calling for the CCC, I want to support that: the difference between ICC and CCC populations is not as significant to me as the difference between either one and the current situation.

    You speak of 'succeeding in confounding ME with a fatiguing ME/CFS syndrome', but that is the situation now: ME is currently confounded with an ME/CFS syndrome already, and moving to the CCC would reduce that confounding dramatically. ICC might reduce it slightly more still, but CCC would still be a huge improvement.

    The authors of the ICC recommend removing ME patients from CFS, not dismantling the CFS classification. Patients who sign an initiative during a campaign may feel that they have something to gain. But they're not bound as are medical or policy experts to consider the good of the entire patient population.

    The board members of all the ME/CFS non-profits are very much bound to consider the good of the entire patient population. As a board member of one of those non-profits that signed, it's my responsibility to act not in my own interests, but in pursuit of the non-profit's mission, which is basically to support and advocate for the whole ME/CFS population. I take that responsibility very seriously, and the interests of ME and CFS and ME/CFS patients – everyone – are always what I keep in mind. The same is true of the other PR board members and I am quite sure it is true of the other non-profit board members as well. That is what serving on the board of a non-profit means, there is no other motivation. I don't think we are any less bound than medical or policy experts in that respect.

    In my analysis, and I presume in the analysis of those who drafted and signed the letter, moving to a tighter definition of ME (ICC or CCC) and not also dismantling CFS would be wrong. If one is of the opinion that the "CFS minus ME" population is a heterogeneous one – and surely all of us are? – then I don't see how that heterogeneous diagnosis of CFS can be in the interests of the "CFS" population any more than it is in the interests of the ME population to be dumped into that wastebasket. The only possible respect I can see in which there is any benefit to that diagnosis is legal – maintenance of medical insurance, benefits, etc – and I'm very clear that any dismantling of CFS would have to carefully take those concerns into account and ensure that those benefits are maintained. I don't see any medical or scientific benefit to keeping the 'wastebasket' concept for anyone. If there is any benefit of having such an 'I dunno' category, it's certainly not well served by the demeaning and tainted name of "Chronic Fatigue Syndrome". I do see, however, that there may be a political benefit to ME patients – a trade-off or compromise with those who want to maintain Fukuda or Oxford – to say to those people: OK, you can keep your CFS wastebasket, but we want ME taken out of it. But I believe that the dismantling of CFS – and the transition of those patients to getting their missed diagnoses recognised and diagnosed, and any other homogeneous disease sub-populations remaining recognised – would be in the interests of 'CFS' patients.

    We shouldn't wait idly by, hoping that the ICC will have its turn. The ICC is an orphan definition for an orphan disease. It's met serious opposition from entrenched interests, and it has no medical or political body paving its way. If patients don't get behind it, another independent panel of experts won't likely dedicate their efforts to our cause.

    I think these factors that you cite are a big part of the reason why the letter was drafted to back the CCC rather than the ICC. Regrettably, the ICC has little or no research or traction behind it yet – excellent though the process to construct it was, it is still young. In my understanding, the CCC has more history, momentum and support, making it a more realistic short-term objective. And at the end of the day, when research is consistently done on a population that is close enough to ME for that research to be meaningful, that hastens the day (which I think is already fast approaching) when none of the definitions are relevant any more because the disease(s) are all defined by biomarkers. All of these definitions are interim anyway. They are symptom-based; in that sense they are no more than tools to define populations to study. When the study is done on those populations, and the research leads to understanding of the pathophysiology, the diagnosis will then be based on biomarkers. I believe the CCC is good enough to help the existing scientific understanding to be developed into clear and demonstrable biomarkers, and that's why I support this letter.

  • Ember May 25, 2013, 3:23 am
    Mark

    The difference between ICC and CCC populations is not as significant to me as the difference between either one and the current situation.

    Why are you referring to populations? This initiative is about clinical and research definitions. Why leave behind a decade of progress on the case definition?

    You speak of 'succeeding in confounding ME with a fatiguing ME/CFS syndrome', but that is the situation now…

    The ICC defines ME, and the CCC defines ME/CFS. That's the situation now because that's the way that the definitions were written. The authors of the ICC have asked that the CCC be considered a CFS definition.

    The joint letter, by contrast, proposes that the CCC be adopted and calls it ME. That decision has the CCC defining ME, which it does not. The initiative confounds ME with a fatiguing ME/CFS definition, i.e., the CCC.

    In my analysis, and I presume in the analysis of those who drafted and signed the letter, moving to a tighter definition of ME (ICC or CCC) and not also dismantling CFS would be wrong.

    Your decision is inconsistent with that of the International Panel of Experts. Have you consulted any medical or policy experts?

    The only possible respect I can see in which there is any benefit to that diagnosis is legal – maintenance of medical insurance, benefits, etc…

    Not a trivial consideration in the context of advocacy.

    All of these definitions are interim anyway. They are symptom-based; in that sense they are no more than tools to define populations to study.

    Are the definitions important or are they not? This initiative is undertaken in the belief that they are. Case definitions are used both clinically and in research.

    I believe the CCC is good enough to help the existing scientific understanding to be developed into clear and demonstrable biomarkers, and that's why I support this letter.

    Your opinion is inconsistent with that of the International Panel of Experts.

  • Mark May 25, 2013, 6:11 am
    Mark

    The difference between ICC and CCC populations is not as significant to me as the difference between either one and the current situation.

    Ember

    Why are you referring to populations? This initiative is about clinical and research definitions. Why leave behind a decade of progress on the definition?

    Because what matters is the nature of the population (the group of people) who fit the definition. That's what the definition defines. If they are substantially the same people then the difference is a technicality, and a smaller difference in practice compared to keeping the current definition (Fukuda). I've explained the reasons for choosing an established definition rather than a new one, for the purposes of this letter, a few times now.

    Mark

    You speak of 'succeeding in confounding ME with a fatiguing ME/CFS syndrome', but that is the situation now…

    Ember

    The ICC defines ME, and the CCC defines ME/CFS. That's the situation now because that's the way that the definitions were written. The authors of the ICC have asked that the CCC be considered a CFS definition.

    The joint letter, by contrast, proposes that the CCC be adopted and calls it ME. That decision has the CCC defining ME, which it does not. It confounds ME with a fatiguing ME/CFS definition, i.e., the CCC.

    If it's OK for the ICC authors to ask that the CCC now be considered a CFS definition, then apparently the concept that the ICC defines 'ME' and the CCC defines 'ME/CFS' is not fixed in stone.

    I do understand from your point above why you would be concerned that the CCC be called ME, if you think that the ICC is now the true definition of ME. But saying that the CCC is a 'fatiguing' definition (??) (because the ICC authors now want to call that 'CFS'?) seems a bit much.

    It would make more sense to me if you were arguing that the CCC includes more people who don't have ME than the ICC does, but I'm not sure whether that is what you're saying. I've tried to discuss this in terms of the populations or sets of people defined by the various definitions, but you don't seem to want to think about it that way. Instead, it is as if you are arguing from an assumption that the labels ME and CFS refer to something real and well-defined – as if ICC is ME now, and CCC is CFS – on the basis that the authors of the ICC argue for that definition. But that seems circular to me; everything you say boils down to a very simple proposition: that we should classify ME and CFS in the way that the ICC says we should. It's a point of view but your only argument for it seems to be appeal to authority. Don't get me wrong, it's a strong argument: we should classify ME and CFS in the way that the ICC authors say we should, because they are the leading authorities. It's just that there doesn't seem to be any other argument than that.

    In reality, these definitions are all attempts to classify disease populations in the absence of the full knowledge of what the disease(s) are. They are all sketches of something we don't yet understand fully; tools to be used to help us gain a better understanding. As any engineer knows, you don't necessarily use the latest new tool for every job: sometimes it's appropriate to use an older tool for a particular purpose. I can't always code in the latest version of Java; sometimes the libraries to support it aren't yet in place on the platform I'm coding for and it would break other code if if I upgraded those libraries. Most institutions don't switch to the latest version of Windows until it's had a couple of service packs and people have had a chance to test it. I don't know if the analogy works for you but that's how I'm seeing this.

    Mark

    In my analysis, and I presume in the analysis of those who drafted and signed the letter, moving to a tighter definition of ME (ICC or CCC) and not also dismantling CFS would be wrong.

    Ember

    Your decision is inconsistent with that of the International Panel of Experts. Have you consulted any medical or policy experts?

    Appeal to authority again. The boards of the organizations and the individuals who drafted and signed the letter contain plenty of people with relevant medical and industry experience, and plenty of advocacy experience. Anyone can go through the list and examine their credentials. Hopefully medfeb will answer your question on which medical and policy experts were consulted. Have you asked any members of the ICC panel of experts whether they disagree with the letter?

    Regardless of what the ICC says, I stick with my view that CFS should be dismantled. You know as well as I do that it's an artificial fatiguing construct that lumps patients with different conditions into one un-researchable bucket, and that the name has negative implications for perception of those so labelled. That's why you want out of it. What justifies leaving people who fit CCC but not ICC in that bucket? (Other than appeal to authority).

    Mark

    The only possible respect I can see in which there is any benefit to that diagnosis is legal – maintenance of medical insurance, benefits, etc…

    Ember

    Not a trivial consideration.

    Certainly so. I think the letter makes it clear that those considerations must be addressed during the dismantling of CFS.

    Mark

    All of these definitions are interim anyway. They are symptom-based; in that sense they are no more than tools to define populations to study.

    Ember

    Are the definitions important or are they not? This initiative is undertaken in the belief that they are. Case definitions are used both clinically and in research.

    Yes they are important, because they are tools for use in both research and clinical practice. It's also true that they are interim symptom-based tools that will be superseded when the pathophysiology of the disease(s) and treatments are understood well enough to replace them with reliable biomarkers.

    Mark

    I believe the CCC is good enough to help the existing scientific understanding to be developed into clear and demonstrable biomarkers, and that's why I support this letter.

    Ember

    Your opinion is inconsistent with that of the International Panel of Experts.

    That's an appeal to authority, without any supporting evidence being offered that the panel of experts (individually or collectively) really do disagree with my belief.

    Returning to the software analogy, your comment here is analogous to saying that Microsoft would argue that Windows 7 is not good enough to help run software because they wouldn't have written Windows 8 if it was. It doesn't follow: even if one accepts that the ICC is better than the CCC, it doesn't mean that the CCC is not 'good enough to help', and it doesn't mean that the ICC authors (individually or collectively) would not ever argue in favour of using the CCC for anything. It wouldn't surprise me if I could find examples of some of the ICC panel members authoring research using the CCC since the ICC was written, but I'm too tired to look for such examples now…

  • Ember May 25, 2013, 6:35 am

    Have I done due diligence to the best of my ability, Mark? Yes, I have. But I'm not the one with responsibilities for advocating for this population. Since you opened this thread, I've been asking about the due diligence behind this advocacy initiative, and I haven't yet received that reply.

    Why would you accuse me of an appeal to authority when the joint letter contains pages of footnotes making that same appeal? I'm not sure which of my statements you most want me to back up, but I'm prepared to do my best to oblige.

  • Mark May 25, 2013, 6:39 am
    Ember

    The authors of the ICC have asked that the CCC be considered a CFS definition.

    I can't find that request within the ICC paper, do you have a reference for it?

    I also can't find anything in the ICC paper that is inconsistent with our request to dismantle the CFS construct. Again, do you have a reference to back up your claims that any of this is inconsistent with the opinion of the International Panel of Experts (individually or collectively)?

  • Ember May 25, 2013, 6:50 am

    I'll provide references for you, Mark. But it's late here, so I'll leave off for now.

    As an aside, you write, “You know as well as I do that it's an artificial fatiguing construct that lumps patients with different conditions into one un-researchable bucket, and that the name has negative implications for perception of those so labelled. That's why you want out of it.” Please in the future do me the courtesy of asking rather than assuming that you know my motivation.

  • Mark May 25, 2013, 6:51 am
    Ember

    Have I done due diligence to the best of my ability, Mark? Yes, I have.
    [

    I'm sure we both have.

    But I'm not the one with responsibilities for advocating for this population. Since you opened this thread, I've been asking about the due diligence behind this advocacy initiative, and I haven't yet received that reply.

    As I've said, I pass that over to medfeb. She's been at CFSAC (and on the way there and back) so that's why you don't have your answer yet. As I've mentioned, there have been physicians and other medical professionals involved in the drafting, as representatives of their organizations, and experienced ME/CFS advocates have signed it, as you can see from the signatories list. I'm assuming your question is asking who was consulted who is not on the list of signatories, and that's what I'm waiting for medfeb to answer.

    Why would you accuse me of an appeal to authority when the joint letter contains pages of footnotes making that same appeal?

    Well, your previous post, at least, doesn't seem to me to have any argument other than an appeal to authority (the authority of the ICC panel). I've made quite a lot of arguments that don't appeal to authority. Citing references is not the same as appeal to authority; citing references is typically backing up an argument with evidence, which is a very different thing.

    I'm not sure which of my statements you most want me to back up, but I'm prepared to do my best to oblige.

    Thanks: I guess the main ones would be
    – that the ICC panel request that CCC now be considered a CFS definition,
    – that the ICC panel disagree with the dismantling of CFS
    – that the ICC panel don't believe the CCC is good enough to help the existing scientific understanding to be developed into clear and demonstrable biomarkers

    (more accurately, you said the last two are inconsistent with the view of the panel, but I don't understand why).

  • Mark May 25, 2013, 7:15 am
    Ember

    As an aside, you write, “You know as well as I do that it's an artificial fatiguing construct that lumps patients with different conditions into one un-researchable bucket, and that the name has negative implications for perception of those so labelled. That's why you want out of it.” Please in the future do me the courtesy of asking rather than assuming that you know my motivation.

    Fair enough, I was assuming all of that, and the last sentence in particular was hasty shorthand; more accurately I'm assuming that's why you want ME patients out of that bucket. I'd also guess that you'd probably put it the other way round and say that you want ME patients in an appropriate (and homogeneous) bucket, but again you're right that's an assumption. I'd be interested to know if any part of those assumptions is incorrect, so please do correct me if I'm wrong on any of that…though I do appreciate this conversation is turning into a bit of a marathon for us both so no hurry from my POV.

  • taniaaust1 May 26, 2013, 7:13 am
    Ember

    I believe that we need to campaign for the ME-ICC because it best serves the needs of patients. The joint letter risks harming ME and CFS patients alike.

    Hi Ember, I agree completely with you that the ME-ICC best serves the needs of the patients but in reality unfortunately things take a long time to become accepted in medicine. I remember reading one study in which it was found that new scientific findings took (it was a figure) between 13-15 years before they hit mainstream.

    ME patients shouldn't have to wait any longer for an appropriate case definition. Our history doesn't suggest that moving incrementally from the CCC to the ICC would ever be easy. If

    I agree that we shouldnt have to wait but unfortunately we are currently in a very unfair biased world. At least if things did go with the Canadian consensus defination, at least then ME would be being studied even if it is still being called CFS. We need studies of this patient group more then anything, its even more important then whatever its called.

    We shouldn't wait idly by, hoping that the ICC will have its turn. The ICC is an orphan definition for an orphan disease. It's met serious opposition from entrenched interests, and it has no medical or political body paving its way. If patients don't get behind it, another independent panel of experts won't likely dedicate their efforts to our cause.

    It's there and will always be there for future use. Maybe thou with some serious study of the canadian consensus patient group even that ME ICC in the next 5 years or so may be behind times when new findings are made (that's if we can get things going forward and be using far better defintions for study).

    I dont think anyone who has ME is going to stop pushing towards the direction of the ICC while its relevent even if it may seem to you that many of us are pushing in a different direction right now. (I see it more like walking UP a winding mountain rather then trying to take a much harder maybe impossible path straight up to the goal).

  • taniaaust1 May 26, 2013, 7:28 am
    Ember

    The authors of the ICC have asked that the CCC be considered a CFS definition.

    Ember have you got a link which specifically says that? Id personally think they still consider many or maybe most who fit the CCC would also would fit the ME ICC defination.

    While people arent being taken out of the CCC by having ICC being used (as is currently the case), that means all of the ICC group will be still sitting in the CCC which would make it "mostly" ME still. (this situation would only change if the ICC people got removed from the CCC group and if the ICC says to count the ICC as a CFS defination, they would of been refering to AFTER the ME people had been removed from the group using the ICC definition).

    It would make sense thou to call the CCC a CFS defintion IF all the ME people had been removed from that defination by the ICC if it was properly accepted but as it hasnt.. this means the CCC is mostly ME people.

    edit.. lol Mark beat me too it, I hadnt seen that he'd asked this question.

  • Ember May 26, 2013, 10:29 am
    taniaaust1

    I see it more like walking UP a winding mountain rather then trying to take a much harder maybe impossible path straight up to the goal).

    I wouldn't compare this initiative to walking up a winding mountain, Tania. I think I'd compare it instead to a dead end! Expecting the American government to adopt outmoded Canadian criteria seems bizarre to me. (I say that as a Canadian.) There's something sadly surreal about this initiative. The patients are out of step (again) with the experts.

  • Ember May 26, 2013, 10:32 am
    Mark

    The only possible respect I can see in which there is any benefit to that diagnosis is legal – maintenance of medical insurance, benefits, etc – and I'm very clear that any dismantling of CFS would have to carefully take those concerns into account and ensure that those benefits are maintained.

    Mark

    The boards of the organizations and the individuals who drafted and signed the letter contain plenty of people with relevant medical and industry experience, and plenty of advocacy experience…. Regardless of what the ICC says, I stick with my view that CFS should be dismantled…. I think the letter makes it clear that those considerations must be addressed during the dismantling of CFS.

    Can you explain how medical insurance, benefits, etc. will be maintained once the CFS diagnosis is dismantled? I can't imagine DHHS accepting these marching orders:

    Include a plan to care for those patients who have received a diagnosis of “CFS” but do not meet the CCC criteria for ME (sic). These individuals should be properly evaluated and diagnosed where possible. If unexplained conditions remain, additional studies will be needed to understand these conditions and establish more appropriate names and definitions. The continued use of the overly broad “CFS” and Fukuda for these patients is not appropriate.

    How long will it take to conduct the additional studies needed to understand these conditions and establish more appropriate names and definitions? What will happen to these CFS patients in the interim?

    I don't find there to be any medical experts on the boards of these organizations. Dr. Jason may have been consulted, but he's neither a medical nor a policy expert.

  • Ember May 26, 2013, 10:37 am
    Mark

    Thanks: I guess the main ones would be
    – that the ICC panel request that CCC now be considered a CFS definition,
    – that the ICC panel disagree with the dismantling of CFS
    – that the ICC panel don't believe the CCC is good enough to help the existing scientific understanding to be developed into clear and demonstrable biomarkers

    (more accurately, you said the last two are inconsistent with the view of the panel, but I don't understand why).

    I've had to repeat myself with some of the quotations that I've provided here, Mark.

    I quoted the International Consensus Panel earlier in this thread (post #27), indicating that the ICC panel requests that the CCC be considered a CFS definition: “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.”

    That statement, published last October, clarified the original ME-ICC recommendation that ME patients should be removed from the CFS criteria. In the same post, I quoted Invest in ME:

    The authors conclude that they –

    “believe the International Consensus Criteria will help clarify the unique signature of ME” and they state unambiguously that “individuals meeting the International Consensus Criteria have myalgic encephalomyelitis and should be removed from the Reeves empirical criteria and the National Institute for (Health and) Clinical Excellence (NICE) criteria for chronic fatigue syndrome.”

    I asked in another post (post #32) whether prematurely dismantling CFS wouldn't be inconsistent with the International Consensus Panel's implementation plan: “The panel is not dismissing the broad components of fatiguing illnesses, but rather the ICC are a refinement of patient stratification. As other identifiable patient sets are identified and supported by research, they would then be removed from the broad CFS/CF category.”

    As you know, the CCC is a clinical case definition. The ME-ICC, by contrast, was written by a panel balanced between clinicians and researchers. Dr. Carruthers explained the ICC research rationale during his September 2011 presentation in Ottawa:

    While it has always been essential, it has now also become urgent to segregate the subset that we are calling ME more clearly, using the ME International Consensus Criteria, so that researchers can confirm/disconfirm their results using patients who have chronic fatigue of this clearly bio-pathological origin.

    The ME-ICC acknowledges its debt to the CCC: “The Canadian Consensus Criteria were used as a starting point, but significant changes were made.” We've discussed in this thread some of those changes, including the replacing of PEM with PENE, along with its 2 consecutive day exercise stress test. “The International Consensus Criteria (Table 1) identify the unique and distinctive characteristic patterns of symptom clusters of ME:”

    The primary goal of this consensus report is to establish a more selective set of clinical criteria that would identify patients who have neuroimmune exhaustion with a pathological low threshold of fatigability and symptom flare in response to exertion. This will enable patients to be diagnosed and enrolled in research studies internationally under a case definition that is acceptable to physicians and researchers around the world.

    The ME-ICC concludes, “The compulsory critical criteria allow comparable data to be collected in various locations and may assist in developing consistent biomarkers and further insights into the mechanism and aetiology of myalgic encephalomyelitis.”

    Dr. Broderick submitted the Panel's “Response to 'A controversial consensus'” in December 2011:

    It is precisely the issue of patient cohort heterogeneity…that we hope to address with a more specific criteria and efforts such as this one directed at improving the clinical identification of ME patients specifically. One only has to question why 5 of 15 CFS patients in recent phase II clinical trials of rituximab were unresponsive to treatment to appreciate the need for more specific criteria [3].”

    The use of patient sets selected by relevant, well-defined and consistent ICC for ME in research will…advance science, provide greater clarity of understanding and elicit more reproducible scientific results. This will also allow a selection of more homogeneous sets of ME patients, given the current knowledge, which can then be compared with other populations. Whether patients with less severe conditions represent a continuum, faulty diagnosis or different disease entities can only be determined by future studies.

    When advances in scientific technology are applied to patients who meet the more specific case definition of the ICC for ME, the current urgent need for identifying and confirming specific biopathological mechanisms and biomarkers will be facilitated, and our improved understanding of the pathophysiology can then be directed towards enhancing treatment efficacy.

    Dr. Carruthers' article on the ICC, published in the context of last year's Invest in ME Conference, sounded an optimistic note: “We can finally search for specifically directed remedies. This is the way towards scientific progress after what has been a long delay, indeed a paradigm war- not arguments between results but between opposing assumptions made before beginning observations.”

    As a replacement for the CCC, the ICC is intended by its authors to meet an urgent clinical and research need: “We all hope the International Consensus Criteria will improve recognition of Myalgic Encephalomyelitis, promote consistency in diagnosis internationally, and lead to appropriate treatment in a timely fashion.”

  • TheChronicSituation May 26, 2013, 1:51 pm

    I agree that the current situation is a bit of a mess, but I also think it is necessary to proceed with caution. CFS is an unsatisfactory title, but ME is worse. The "E" refers to Encephalomyelitis, which is a very specific term that means "swelling of the brain and spinal cord". Has anyone here ever had tests that show this particular symptom? I doubt it. ME is the term that is meaningless.
    By coincidence, I have just written a blog post on this very topic…
    http://thedamnchronicsituation.blogspot.ie/2013/05/whats-in-name-me-or-cfs.html

  • Ember May 27, 2013, 7:06 pm
    Mark

    But saying that the CCC is a 'fatiguing' definition (??) (because the ICC authors now want to call that 'CFS'?) seems a bit much.

    You take exception to my having described ME/CFS as a “fatiguing syndrome.” But don't think that my choice of words follows simply from ICC authors' having classified the syndrome as CFS. Look instead at the prominence given to fatigue in the CCC definition itself: (1) fatigue, (2) post-exertional malaise and/or fatigue, (3) sleep dysfunction, (4) pain, (5) neurological/cognitive manifestations, (6) autonomic / neuroendocrine / immune manifestations, and (7) at least six months of illness.

    In the ICC, neuroimmune exhaustion is given prominence: (1) PENE, (2) neuorological impairments, (3) immune, gastro-intestinal & genitourinary impairments, and (4) energy metabolism/ion transportation impairments. The ICC represents much more than a change in terminology. It completes a paradigm shift mandating the separation of ME from CFS.

    I find it odd that the psychologists, Drs. Jason and Friedberg, support the CCC with its greater emphasis on fatigue, while criticizing the ICC for selecting psychiatric disorders. (Unlike the CCC, the ICC clearly excludes primary psychiatric disorders and somatoform disorder.) The reason that they've given for their criticism is that the ICC includes too many symptoms. But by my count, the ICC requires fewer symptoms than the CCC. I wonder whether the CCC isn't favoured by them instead for the same reasons that the IACFS/ME has called its journal Fatigue.

  • Ember May 29, 2013, 4:13 pm
    Mark

    As I've said, I pass that over to medfeb. She's been at CFSAC (and on the way there and back) so that's why you don't have your answer yet. As I've mentioned, there have been physicians and other medical professionals involved in the drafting, as representatives of their organizations, and experienced ME/CFS advocates have signed it, as you can see from the signatories list. I'm assuming your question is asking who was consulted who is not on the list of signatories, and that's what I'm waiting for medfeb to answer.

    After two weeks of asking, I have to assume that no answers to my questions about the joint letter will be forthcoming. If I can't get my questions answered about either the process or the content, why should I assume that the early signators to the letter were any better informed? It isn't enough to expect someone else to have asked the questions. And it's undignified for you to be left holding the bag, having to write, “I think that's why the group settled on the CCC.”

    The joint letter demands a full and open partnership from DHHS, but the initiative doesn't provide an open partnership itself. It doesn't represent a consensus among patients. Jill McLaughlin presented this dissenting patient view in her testimony to CFSAC. Neither does the initiative represent a coming together of the patients and the experts. It misses a prime opportunity.

  • Nielk May 29, 2013, 5:10 pm

    I find it interesting that the following are authors of both; the CCC and the ICC

    Bruce M. Carruthers, MD, CM, FRCP(C)
    Kenny L. De Meirleir, MD, PhDNancy G.
    Klimas, MDA. C.
    Peter Powles, MRACP, FRACP, FRCP(C), ABSM

  • Ember May 29, 2013, 5:33 pm
    Nielk

    I find it interesting that the following are authors of both; the CCC and the ICC

    Add Marj van de Sande. In what way interesting?

  • Nielk May 29, 2013, 5:33 pm
    Ember

    You take exception to my having described ME/CFS as a “fatiguing syndrome.” But don't think that my choice of words follows simply from ICC authors' having classified the syndrome as CFS. Look instead at the prominence given to fatigue in the CCC definition itself: (1) fatigue, (2) post-exertional malaise and/or fatigue, (3) sleep dysfunction, (4) pain, (5) neurological/cognitive manifestations, (6) autonomic / neuroendocrine / immune manifestations, and (7) at least six months of illness.

    In the ICC, neuroimmune exhaustion is given prominence: (1) PENE, (2) neuorological impairments, (3) immune, gastro-intestinal & genitourinary impairments, and (4) energy metabolism/ion transportation impairments. The ICC represents much more than a change in terminology. It completes a paradigm shift mandating the separation of ME from CFS.
    .

    This is what it says for PENE in the ICC

    A. Post-Exertional Neuroimmune Exhaustion (PENE penʾ-e)

    Compulsory

    This cardinal feature is a pathological inability to produce sufficient energy
    on demand with prominent symptoms primarily in the neuroimmune regions.
    Characteristics are:

    1. Marked, rapid physical and/or cognitive fatigability in response to
    exertion, which may be minimal such as activities of daily living or simple
    mental tasks, can be debilitating and cause a relapse.
    2. Post-exertional symptom exacerbation: e.g. acute flu-like symptoms, pain
    and worsening of other symptoms
    3. Post-exertional exhaustion may occur immediately after activity or be
    delayed by hours or days.
    4.Recovery period is prolonged, usually taking 24 hours or longer. A relapse
    can last days, weeks or longer.
    5. Low threshold of physical and mental fatigability (lack of stamina) results

    in a substantial reduction in pre-illness activity level.

    The bolds are mine to point out that even within the PENE characteristics, there is room for physical fatiguing symptoms. That is why I am surprised when proponents of the ME only diagnosis say that ME has nothing to do with fatigue. I agree that it is much more than…but then so is CFS with the CCC criteria.

  • Nielk May 29, 2013, 5:35 pm
    Ember

    Add Marj van de Sande. In what way interesting?

    Interesting in that I don't feel that the CCC and the ICC are describing two distinct illnesses. I feel that the ICC elaborates on the CCC.

  • Ember May 29, 2013, 5:37 pm
    Nielk

    That is why I am surprised when proponents of the ME only diagnosis say that ME has nothing to do with fatigue.

    I hope that you're not quoting me as saying that ME has nothing to do with fatigue. I'm not aware of ever having said that. I quoted Dr. Carruthers above in post #88 describing PENE as "chronic fatigue of this clearly bio-pathological origin."

  • Ember May 29, 2013, 5:48 pm
    Nielk

    Interesting in that I don't feel that the CCC and the ICC are describing two distinct illnesses. I feel that the ICC elaborates on the CCC.

    Pointing out overlap between the CCC and ICC panels doesn't prove that the ICC “elaborates on” the CCC. The authors of the ICC themselves explain that the CCC "were used as a starting point, but significant changes were made." I've heard the relationship between the two definitions described as an evolution. The CCC is a transitional definition in what amounts to a paradigm shift.

  • Nielk May 29, 2013, 6:09 pm
    Ember

    Jill McLaughlin presented this dissenting patient view in her testimony

    I was reading Jill's testimony where she states:

    ME is a stand alone dx. We do not need two names. ME is a neurological illness based on CNS dysfunction. Fatigue has no more to do with ME than it does with AIDS, MS or cancer.

    I think there is a fallacy of equating Chronic Fatigue with the Chronic Fatigue Syndrome criteria of CCC.

  • Ember May 29, 2013, 6:49 pm
    Nielk

    I think there is a fallacy of equating Chronic Fatigue with the Chronic Fatigue Syndrome criteria of CCC.

    Describing the relationship between CFS and CF is difficult at this stage. These two statements by the International Consensus Panel point to that difficulty:

    “Whether patients with less severe conditions represent a continuum, faulty diagnosis or different disease entities can only be determined by future studies;”

    “As other identifiable patient sets are identified and supported by research, they would then be removed from the broad CFS/CF category.”

  • medfeb May 29, 2013, 7:03 pm

    Hi Ember
    Sorry but as Mark says, I have been away. I will need to read the thread for context and try to answer your questions as quickly as I can
    Mry

  • Ember May 29, 2013, 7:05 pm
    medfeb

    I will need to read the thread for context and try to answer your questions as quickly as I can

    Thanks!