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Hunting down the cause of ME/CFS & other challenging disorders - Lipkin in London
In a talk to patients in London on 3rd September, Dr. W. Ian Lipkin described the extraordinary lengths he and his team are prepared to go to in order to track down the source of an illness, with examples ranging from autism to the strange case of Kawasaki disease.
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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. Nielk

    Nielk

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    https://www.fbo.gov/index?s=opportu...35096d2486592952c90cd3acee7&tab=core&_cview=0


    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).


    Clinicians and medical professionals disagree on many aspects of ME/CFS, ranging from frank disbelief in the illness to confusion about the application of clinical diagnostic criteria. In collaboration with CFSAC ex officio agencies, OASH will request that the IOM develop consensus clinical diagnostic criteria for this disorder. A widely accepted clinical definition and a clear distinction from clinical trials and research case definitions would aid in advancing clinical care, drug development, and basic and translational research for ME/CFS. This study would also demonstrate HHS' commitment and aggressive pursuit of solutions to this poorly-understood and disabling condition.

    In response to a request from the OASH, the Board on the Health of Select Populations of the Institute of Medicine will establish a study committee of thought leaders and stakeholders to comprehensively evaluate the current status of criteria for the diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

    The Committee will consider the various existing definitions for chronic fatigue syndrome and develop consensus clinical diagnostic criteria for this disorder. Widely accepted clinical diagnostic criteria and a clear distinction from case definitions for clinical trials and research will aid in advancing clinical care, drug development, and basic and translational research. The Committee will also distinguish between disease subgroups, develop a plan for updating the new criteria, and make recommendations for its implementation.

    No solicitation document is available. All responsible sources that have the requisite qualifications to perform the work described above may submit a statement of capabilities electronically to Jennifer Eskandari atJennifer.eskandari@psc.hhs.gov. Responses must be double-spaced with 1" margins on all sides and use a standard font no smaller than 12 point. The response must be sequentially numbered, beginning on the first page after the table of contents. Responses are due by August 30, 2013 by 4:00 pm EST. Responses will not be accepted after the due date. 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).
     
    Firestormm likes this.
  2. Ember

    Ember Senior Member

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    Again, why is a clear distinction needed between a clinical definition and a research case definition? The International Consensus Panel argues that “it is imperative that research for ME be carried out on patients who actually have ME.”
     
    MeSci and peggy-sue like this.
  3. OverTheHills

    OverTheHills

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    When I click on the link it appears that was issued on August 27, and they want responses by August 30th or it goes to a sole contract with National Academy Institute of Medicine. Am I misunderstanding here or does that look like a done deal.
    OTH
     
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  4. Nielk

    Nielk

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    I was thinking the same OTH. What's up with that? It doesn't seem like they really want any candidates?
     
    taniaaust1 likes this.
  5. Nielk

    Nielk

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    As far as I can see, this is major news!
     
  6. Sea

    Sea Senior Member

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    True it is necessary that the research is carried out on those with ME.

    Also it is true that we don't know enough yet to create a true line of distinction. A research definition has to include those who definitely have the illness and exclude those who have co-morbid conditions that can distort biological findings. So for example it might exclude thyroid problems, or Celiac or other autoimmune illness.

    For clinical purposes a person can have co-morbid illnesses and still have ME. It is important that they are not denied a diagnosis and appropriate treatment. Also using say Fukuda criteria as an example - what if someone is very sick but they only have fatigue and 3 other symptoms not the required 4? They may not be suitable as a candidate for a research study but they may still have ME
     
    alex3619 and Nielk like this.
  7. Mesurfer

    Mesurfer

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    Looks like they are rushing it past us.
     
    Nielk likes this.
  8. Ember

    Ember Senior Member

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    Is it common practice in the context of other illnesses for there to be two distinct definitions for clinical and research purposes? The ICC serves as both a clinical and a research definition, and it includes a more relaxed diagnosis of Atypical ME.
     
    taniaaust1 likes this.
  9. Bob

    Bob

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    I can't be certain but I think this project was discussed at the most recent CFSAC meeting.
    The FDA official/s at the CFSAC meeting were discussing holding a series of meetings with interested parties (including CFSAC committee members, patients, clinicians and others) with regards to working on a new definition.
    My understanding is that they did not make a general invitation to the public to participate, but had contacted people they met through the FDA stakeholders' meeting.
    Details were vague.
     
  10. Bob

    Bob

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    The wording in their document is strange, and concerning, and I don't understand it:
    I've heard people at CFSAC meetings discuss the difference between a research criteria and a clinical criteria.
    The way I understood the discussions is that researchers sometimes need very tightly or specifically defined cohorts.
    Such criteria could exclude borderline patients, for example, or patients who have the odd unexpected symptom, or patients with a symptom which is only occasionally apparent, or patients with a symptom which is only very subtle and not obvious, etc.
    Whereas, clinicians and patients often require a looser set of criteria so that borderline patients, etc., are not excluded from a diagnosis and therefore excluded from treatment.

    I have no idea how common it is to have separate criteria. I've not come across it before.
    It suggests to me that those discussing it simply aren't happy with the ICC being used as a clinical criteria. But that's just a guess.
     
    Sea likes this.
  11. Sea

    Sea Senior Member

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    In MS in the older criteria there were divisions for clinically definite, laboratory supported definite, clinically probable and laboratory supported probable. As more is learned the criteria are refined such that it is no longer necessary to differentiate between research and clinical.

    I think the ICC is a step along the way, but we're not there yet
     
    Bob likes this.
  12. Ember

    Ember Senior Member

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    This sounds like one MS definition that includes divisions, not like two distinct definitions for clinical and research purposes. Is Dr. Unger expecting to create a clinical definition, a research definition or both?
     
  13. SOC

    SOC Senior Member

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    Separate clinical and research definitions are pretty common for just the reasons you mentioned. For example my MIL was told by a researcher that she didn't have ALS because she didn't (at that point) have fasiculations. Her neurologist and family had a hard time convincing her she did have ALS so she would take life-improving treatments. Her ALS was not "classic", but it was ALS alright, and killed her.

    Research physicians want a very clean patient cohort, which I understand and agree with. In ME/CFS, for example, they may want to exclude all patients with any type of psychological diagnosis in the original research definition in order to avoid any confusion with MDD.

    I'm concerned that the people creating the definitions may not understand ME/CFS sufficiently well to make a definition. If they start with earlier CDC research and definitions and/or swallow the massive amount of biopsychosocial BS uncritically, we could end up with an incorrect definition. That could put us back decades.
     
  14. Nielk

    Nielk

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    Bob,

    My understanding of what they discussed at the last CFSAC meeting was the forming of a workshop to look at current evidence but not for the purpose of defining criteria.

    This is from the minutes of the meeting:


     
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  15. Nielk

    Nielk

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    It would be good to know who exactly will be working on this.
     
    SOC likes this.
  16. Bob

    Bob

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    Ah, yes, thanks Nielk, you're correct...
    You've jogged my memory, and I seem to remember the conversation going along the lines of them not specifically seeking to define a new diagnostic criteria, but they weren't ruling that out as a possible outcome of the meetings.

    So, it seems that this diagnostic criteria project is a new development.
     
    Nielk likes this.
  17. Ember

    Ember Senior Member

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    The EbMW convened by the NIH will “address the issue of definitions appropriate to ME/CFS research. However, it will not cover in detail a clinical case definition.”
     
  18. taniaaust1

    taniaaust1

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    ". All responsible sources that have the requisite qualifications to perform the work described above may submit a statement of capabilities electronically to Jennifer Eskandari atJennifer.eskandari@psc.hhs.gov. Responses must be double-spaced with 1" margins on all sides and use a standard font no smaller than 12 point. The response must be sequentially numbered, beginning on the first page after the table of contents. Responses are due by August 30, 2013 by 4:00 pm EST. Responses will not be accepted after the due date. 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). "

    I think we could do with some people doing some advocacy right now and making sure all the ME specialists know about this seeing the application responses for this are needed to by the 30th. This notice was only posted on the 27th so only giving people 3 days to respond :eek: . We've seen this ploy before in ME/CFS things, it seems they are trying to get this throu before people know about it and respond. We need to make sure the ME specialists get a chance to be on that committee. Is this a ploy so that sole contract ends up going to the Institute of Medicine? They must already have someone lined up to do this. Is this another example of corruption in ME/CFS?

    As SOC said
    .......................

    haha irronic the name "strategic acquisition service". Maybe it is strategic for some agency or whatever to bury ME further.
     
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  19. SOC

    SOC Senior Member

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    This is sometimes done when the funding organization knows who they want to do the work -- usually someone in or near the organization. That person (or organization) is aware the call is going out and is prepared to do the paperwork in the limited time frame. Everyone else gets caught on the hop or simply can't be bothered to rush through a proposal so the contract goes to the person the funding organization really wanted. It's legal, but ethically borderline. Sometimes it is for the best -- the funding organization doesn't want some screwball with minimal knowledge underbidding the knowledgeable researcher. That happens more than most people wish. In this case, it makes me a little nervous, but it could be good for us if it manages to keep the biopsychosocial loonies from low-bidding the contract just to get their viewpoint codified. :eek:

    I'm reserving judgement until I see who gets the contract. This could be great for us... or it could be a trainwreck.
     
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  20. Nielk

    Nielk

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    Exactly my thoughts!
     

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