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Lessons from ME/CFS: Finding Meaning in the Suffering
If you're aware of my previous articles here at Phoenix Rising then it's pretty clear that I don't generally spend my time musing upon the philosophy of the disease. I find it better to spend my time reading research and trying my best to break it down to its core elements and write...
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DHHS - soliciting for study on diagnostic criteria for ME/CFS

Discussion in 'General ME/CFS News' started by Nielk, Aug 28, 2013.

  1. Mark

    Mark Acting CEO

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    Same here: at first this sounded (to me) a lot like the solicitation for experts for the ebMW, but then it can't be because they said at CFSAC that exercise wouldn't be addressing case definitions, except that possibly indirectly that issue might come up as part of the review.

    So this seems like a separate and new exercise - and I've heard no word about it until today; they seem to have announced it with 3 days notice of the deadline. So I can only muse and speculate on what it might mean...

    Both exercises seem to have one thing in common: vagueness and tight control concerning who they are going to appoint as 'experts'. This one is particularly troubling because they say they're going to develop a new 'consensus definition', presumably under contract to the National Academies (Institute of Medicine) since they're not giving anyone else sufficient time to apply.

    However, this may not be as bad as we might fear: the only way I can explain this idea of a 'consensus' definition would be if they are soliciting here for a person with expertise in consensus development - in other words, they are asking for somebody to carry out the consultation process (under contract), and that consultation process will then consult experts on ME/CFS case definition.

    Still, we already have a couple of very good consensus definitions (CCC and ICC) so the fact they are planning a new one suggests that they are starting over and developing their own. Whether the new consensus exercise will include the ICC authors or not would seem to be the key here, but it seems likely that it will [also, or only] include other contributors with a rather different view of 'CFS', otherwise what would be the point of a fresh consensus exercise?

    My best guess at this stage is that many of the current efforts are going to take an approach that consults both ME and ME/CFS experts and also CBT/GET and 'false illness belief' proponents (which seems logical since those people also claim to be 'CFS/ME experts') with the idea being that neutral parties in the various disputes can engineer some compromise or consensus among those parties. After all, is it realistic to expect authorities in the role of neutral brokers to take sides and exclude the CBT/GET proponents from the process?

    This is clearly a worrying prospect because anything that treats stuff like the PACE trial approach as if it were science conducted by scientists is going to end up with some pretty confused and skewed conclusions. At least until those researchers finish investigating the 'mediating factors' in their treatments and end up proving that the only true mediating factor is the researchers' ability to convince patients to answer questionnaires in accordance with the researchers' own false illness beliefs, it will be garbage in garbage out to include their viewpoint.

    But I'm also afraid that some of the best ME/CFS researchers will opt out of the process because they refuse to work with something that acknowledges those CBT/GET proponents as if their work was science. Understandable though it is, it seems to me that such a purist position runs an extremely high risk: that in the development of consensus - and perhaps therefore the development of the policy agenda for the next decade or two - the exercise will be skewed towards the CBT/GET lobby by the self-exclusion from the process of some of the best researchers and advocates. We may already be seeing that pattern in the UK with respect to the membership of the new Research Collaborative.

    So although I'd like to see the bad 'science' and circular reasoning of the 'false illness belief' proponents struck from the scientific record, I doubt that's a realistic prospect at the moment (though I do think there's some possibility they may eventually end up explicitly closing their own circle and vanishing in a puff of logic), so the best I can hope for is that these new exercises will be fully inclusive, and somehow produce at least something worthwhile.
    peggy-sue and Valentijn like this.
  2. SOC

    SOC Moderator and Senior Member

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    It would be suicidal for any of our biomedical researchers to self-select out (assuming they even have a chance of being "in") of a "consensus" working group. If the US gov't creates an official research definition that is as broad or broader than the current research definition (Fukuda), no biomedical research has a chance of success.

    The whole "consensus" fad worries me. In my experience, proper consensus requires that all players operate in good faith, but many consensus-based organizations have dominating special interest subsets who wear down the rest of the committee/group with aggression and sheer stubbornness. So "consensus building" actually becomes an exercise in bullying. I can easily see a certain special interest group taking over and destroying any hope of a reasonable definition.

    OTOH, if we get a solid biomedical research definition, but the BPS lobby pushes for a broader clinical definition that includes their psychiatric burnt-out, overstressed, etc patients, I could probably live with that. It would ruin their chance of proving by "research" that their techniques have any validity in genuine ME/CFS patients, however, so I can't see them giving in easily.

    I'm still hoping that who ever is in charge of this exercise insists that this is a medical, not psychological, definition and doesn't include the psych lobby in the definition development.
    jspotila, peggy-sue and Purple like this.
  3. Ember

    Ember Senior Member

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    To set this in context, CFSAC recommended last fall to Secretary Sebelius:
    Subsequently, the NIH announced that it would convene an EbMW to address the issue of definitions appropriate to ME/CFS research. When this NIH initiative failed to satisfy certain CFSAC members, Dr. Lee responded:
    Dr. Fletcher replied, “This doesn't respond to our recommendation at all.”

    Now, “in collaboration with CFSAC ex officio agencies, OASH will request that the IOM develop consensus clinical diagnostic criteria for this disorder.” Responding presumably to the CFSAC recommendation, the Board on the Health of Select Populations of the Institute of Medicine “will establish a committee of thought leaders and stakeholders to comprehensively evaluate the current status for the diagnosis of ME/CFS."
  4. Sea

    Sea Senior Member

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    "If no capability statements are received which specifically demonstrate the ability to perform the requirements above, the Government shall proceed with negotiating a sole source contract to the National Academies (Institute of Medicine)."

    Any idea who this would be?
  5. Ember

    Ember Senior Member

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    Certainly diagnosing ALS is tragically difficult. The most recent Awaji criteria (2007) apparently improved on the El Escorial Revised document (1998): “There was a reformulation of electromygraphy, adding fasciculation with signal of neuronal damage, and inclusion new methods of diagnosis with transcranial magnetic stimulation, voxel based morphometry and diffusium tensor imaging.” Yet I can't find any mention of separate clinical and research definitions for ALS.
  6. WillowJ

    WillowJ Senior Member

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    it may be possible that in some fields researchers would simply use more exclusions in the studies where they are deemed more important, rather than having a whole separate definition.

    (I have seen competing definitions for other diseases but sometimes it's because different camps of experts cannot agree on what's important.)

    with the crossover effect in complex diseases like this, it is sometimes difficult to find patients who don't have other diseases. I have seen this discussed in some papers for other diseases.

    Finding patients who have only ME might be good practice or it might be chasing a phantom.
  7. Bob

    Bob

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    Reading it more closely, I think perhaps this is not a contract put out to general tender...

    "The Program Support Center on behalf of the Office of the Assistant Secretary of Health (OASH) within the Department of Health and Human Services intends to negotiate and award a contract to the National Academies (Institute of Medicine) on a sole source basis under the authority of FAR 6.302-1 to support a study committee to recommend clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)."

    The wording suggests that perhaps this is just a formality, and that the contract will be given to the 'National Academies (Institute of Medicine)', "on a sole source basis".

    The purpose of the contract is to 'support' a study committee to recommend clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). (So the contractor is not creating a clinical consensus itself.)

    Perhaps the proposed study committee, that was being discussed at CFSAC, decided that the best way forwards was to develop a new consensus clinical criteria? (But I'm just speculating, in a very uninformed way.)
  8. Nielk

    Nielk

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    Firestormm and Bob like this.
  9. akrasia

    akrasia Senior Member

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    There was so much resistance to evolving a new case definition at the last CFSAC meeting that this is rather startling. As SOC notes, it really depends who is on the committee.

    My hope is that this decision to evolve a "new" definition is being mediated by the imminence of Lipkin's results and the background rumors that must be accompanying them. If Fauci put his faith in Lipkin as a reliable actor for sorting out XMRV, his view of m.e. will carry some weight.

    And Lipkin's view is based on a well defined cohort drawn from m.e. specialists.

    So, while anything the government does with regard to m.e. deserves intense skepticism, and what emerges will probably involve a great deal of ass covering, which probably means including some gesturing toward the psychological interpretation, at least as a subset, this might augur well.

    I would be very surprised if what came out of this committee bore no relationship to some of the major research developments that are occurring in the private sector. On the other hand, until we know more, it's a reminder how patients have been bystanders in their own illness and dismissed as this public policy fiasco unfolded.

    Don't you wish there were a wiki leaks for m.e.?
    Iquitos, JohnnyD, Kati and 1 other person like this.
  10. Ember

    Ember Senior Member

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    Inside The Effort to Define Gulf War Illness
    6/28/2013 @ 5:10PM
    More: http://www.forbes.com/sites/rebeccaruiz/2013/06/28/inside-the-effort-to-define-gulf-war-illness/
  11. SOC

    SOC Moderator and Senior Member

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    Nielk likes this.
  12. Nielk

    Nielk

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    Why is it that we are left here in the dark wondering what is going on? Isn't there supposed to be transparency in the action s of the DHHS and specifically the OASH (Dr. Koh's office)?
    Why was nothing mentioned about this at the last CFSAC meeting when the subject of the diagnostic criteria was brought up time and time again?
    Was was this notice of solicitation sneaked out from under our noses with a week's response time - over a holiday week-end? Why not announce it to the public? I am on CFSAC's mailing list and did not receive any notice about this. Why?
    Who will serve on this committee that they don't want our input into this? Will they control the outcome which will effect our futures?
    I know that it might be pre-preemptive to make any judgement calls at this point but, anything that is cloaked in so much secrecy at the onset, does not have good intentions. IMO
  13. WillowJ

    WillowJ Senior Member

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    it's kind of a Catch-22.
  14. Firestormm

    Firestormm Senior Member

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    Nielk Are you able to perhaps ask one of your interviewees that formed a large component of your last article i.e. the chair of CFSAC? Might help - might not :)
  15. August59

    August59 Daughters High School Graduation

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    Crap! - The deadline was today! Nice of them to give the ones that are really working plenty of time to respond. Where as the psyhco-goofs that have not done anything for 10 years didn't have anything else to do.
  16. Firestormm

    Firestormm Senior Member

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    Valentijn likes this.
  17. Ember

    Ember Senior Member

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  18. SOC

    SOC Moderator and Senior Member

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    It turns out that this is a sole-source contract, which means they are deliberately hiring a specific organization. They're allowed to do this if the organization is considered "uniquely capable" of performing the contract, or (I think) if the timeframe is restricted and putting it out for open bid would take too long.

    My hope is that the organization in question, National Academies (Institute of Medecine), has "support(ed) a study committee" before and knows how do it correctly. Our first clue for how good (or bad) this is going to be will be when we find out who is selected for this study committee. If they're like Dr Lee of the CFSAC, they'll think that since PCPs are our primary medical contacts (as opposed to, say, cardiologists or rheumatologists), it should be PCPs making up the definition. :eek: In that case we're doomed. If they recognize our specialist doctors (Drs Petersen, Klimas, Rey, Kogelnik, etc) and researchers (Drs Light, Snell, etc) then we'll be in heaven. ;)
  19. medfeb

    medfeb Senior Member

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    Dr. Kenneth Shine, the former IOM president and the chair of the IOM panel developing a consensus criteria for GWI said he "could not recall when the IOM was last charged with defining a disease.” Additionally, some individuals, like the former chair of the GWI advisory council, have expressed concerns that the GWI panel contains people view GWI as a psychological disorder.
    http://www.forbes.com/sites/rebeccaruiz/2013/06/28/inside-the-effort-to-define-gulf-war-illness/

    Combined with the complete lack of transparency that Nielk talked about, its hard to see how this is going to turn out well. Not to mention a waste of time and money to develop something that already exists
    jspotila likes this.
  20. Guido den Broeder

    Guido den Broeder *****

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    With a starting point of 'ME/CFS', instead of ME, I can see only trouble ahead.

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