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

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, May 14, 2013.

  1. Bob

    Bob

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    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.
  2. Ember

    Ember Senior Member

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    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.
  3. Ember

    Ember Senior Member

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    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.
  4. Bob

    Bob

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

    Mark Acting CEO

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    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.
  6. Ember

    Ember Senior Member

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    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:
    She'd prefer the cardiopulminary exercise testing from the ME/CFS Guidelines:
    Correct me if I'm wrong, but I don't see any exercise testing suggested in the ME/CFS Primer.
  7. taniaaust1

    taniaaust1 Senior Member

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    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.
  8. taniaaust1

    taniaaust1 Senior Member

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    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.
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  9. Ember

    Ember Senior Member

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    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.
  10. taniaaust1

    taniaaust1 Senior Member

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    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 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).

    #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.
  11. Mark

    Mark Acting CEO

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

    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.
  12. Ember

    Ember Senior Member

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    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?
  13. Mark

    Mark Acting CEO

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    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?
  14. alex3619

    alex3619 Senior Member

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    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.
  15. Ember

    Ember Senior Member

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    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:
    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.
  16. Mark

    Mark Acting CEO

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    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 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.


    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.
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  17. Ember

    Ember Senior Member

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    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?
    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.
    Your decision is inconsistent with that of the International Panel of Experts. Have you consulted any medical or policy experts?
    Not a trivial consideration in the context of advocacy.
    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.
    Your opinion is inconsistent with that of the International Panel of Experts.
  18. Mark

    Mark Acting CEO

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    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.

    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.

    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).

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

    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.


    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...
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  19. Ember

    Ember Senior Member

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    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.
  20. Mark

    Mark Acting CEO

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    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)?

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