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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. Ember

    Ember Senior Member

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    No way to guess how this will turn out…..
    Published August 29, 2013
    Apparently, the report entitled Gulf War and Health: Treatment for Chronic Multisymptom Illness includes CFS, but not ME, as a comorbid condition.
  2. Ember

    Ember Senior Member

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    No commitment has been made for this consensus committee to review either “criteria for the diagnosis of” or “existing definitions for” ME. Neither has any intent been stated to “develop consensus clinical diagnostic criteria for this disorder.” Following ICC recommendations, the committee should treat ME as separate and distinct from CFS and ME/CFS:
    According to the ICC process, “only those criteria that were agreed upon by all authors were included in the final manuscript.” How could this consensus committee, comprised presumably of clinicians, include members of the International Consensus Panel but ignore that panel's work?
  3. Nielk

    Nielk

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    If you share your concern about this proposed process, take action and send out the letter below.(see here)

    Instructions for Emailing HHS:
    1. If you are using the sample email provided below, copy the sample email into the body of an email message.
    2. Add your name to the end of the letter.
    3. Add the Subject Line “Stop the IOM Contract on “ME/CFS” Clinical Criteria”
    4. Copy the following addresses into the ‘TO” and “CC” boxes
    TO: Kathleen.Sebelius@hhs.gov
    CC: howard.koh@hhs.gov; txf2@cdc.gov; Tomfrieden@cdc.gov; Marilyn.Tavenner@cms.hhs.gov;margaret.hamburg@fda.hhs.gov; Mary.Wakefield@hrsa.hhs.gov; collinsf@mail.nih.gov; richard.kronick@hhs.gov;MEACTNOW@yahoo.com


    The CC includes the following individuals:
    HHS Assistant Secretary Howard Koh
    AHRQ Director Richard Kronick
    CDC Director Thomas Frieden
    CMS Administrator Marilyn Tavenner
    FDA Director Margaret Hamburg
    HRSA Director Mary K. Wakefield
    NIH Director Francis Collins

    The Social Security administration is not included because the agency head’s email is not available yet. The email addressMEACTNOW@yahoo.com is used to track the numbers of messages sent.


    Sample Email - To be copied into the body of an email message.

    Dear Secretary Sebelius,
    I am writing to voice my strong opposition to the HHS proposal to contract with the Institute of Medicine (IOM) to develop “clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome.” I am a member of the ME community and have witnessed firsthand the devastation of this disease. I am extremely concerned that this planned IOM initiative will gravely harm ME patients. Note that I am purposely using the term “ME” to distinguish the disease that has affected me from the overly broad “CFS”.
    I oppose this proposal for the following reasons:
    • Two peer-reviewed consensus case definitions, developed by experts in this disease, already exist – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. The CCC has been used both clinically and in research. Both are accompanied by clinical guidelines for medical practitioners, and are well regarded by patients, ME doctors, and ME researchers. Given that expertly defined and accepted consensus clinical criteria already exist, the proposed IOM contract wastes scarce taxpayer dollars and is unnecessary.

    • HHS has inexplicably refused to accept the CCC or the ME-ICC and even questions the hallmark symptoms of ME. Instead, it has promoted an overly broad view of the disease called “CFS”, which does not require the hallmark symptoms. This has confounded ME with depression, deconditioning and non-specific chronic fatigue, has severely impeded research, and is the direct cause of the medical skepticism and inappropriate or harmful treatment recommendations to which patients are subjected.

    • IOM has only been involved in one other study to define a disease, the current effort for Gulf War Illness (GWI). Advocates and the Research Advisory Committee for GWI (RAC) have criticized the IOM report that redefined GWI as the overly broad chronic multisymptom illness (CMI). They further criticized the misguided focus on psychiatric issues and the failure to staff the IOM panel with GWI experts. Given this and IOM’s inaccurate characterization of CFS in the January 2013 IOM report on treatments for Gulf War Illness patients, we have no confidence that IOM is capable of producing a clinical consensus criteria that defines ME as described by CCC, ME-ICC and most importantly, the patients themselves.

    • Ironically, the claimed intent of the HHS-IOM initiative is to develop a consensus definition but this effort has been progressed in secret, apparently for many months and without consultation with key ME stakeholders. The timing of the announcement before a holiday weekend and the short response time indicate that HHS was not looking for input from the ME experts and ME community.

    • This IOM initiative does not reflect the October 2012 CFSAC recommendation on the development of a case definition for this disease and in fact is in direct contradiction to that recommendation. CFSAC recommended that a clinical and research case definition be developed in unison, that the effort begin with the Canadian Consensus Criteria and, most importantly, that it be developed by disease experts only.

    I strongly urge HHS to abandon its plan for this ill-advised, wasteful, and unscientific initiative.

    Sincerely,
    <Name>
    Svenja and Bob like this.
  4. medfeb

    medfeb Senior Member

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    Thank you for posting this action, Neilk. Its very important that we let HHS know that we oppose this contract especially because of the GWI experience with IOM, the fact that this has been progressed in secrecy and the fact that we already have two consensus criteria, which HHS is rejecting
    Nielk likes this.
  5. Bob

    Bob

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    Email received today from the CFSAC email list:

    This email is to inform you about HHS’ ongoing efforts to address the 2011 CFSAC recommendation “to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS.” In response, NIH will be convening an Evidence-based Methodology Workshop, which would address the issue of case definitions appropriate for ME/CFS research, and that HHS was actively pursuing options for a separate effort that would result in a case definition useful for clinicians. Because the use of and audience for case definitions for research and clinical care are very different, it is important to have separate processes to develop them.

    HHS is actively pursuing a contract with the Institute of Medicine (IOM) to convene a consensus committee to develop recommendations for clinical diagnostic criteria for ME/CFS as recommended by CFSAC. The IOM is unique in the prestige and authority it possesses among U.S. clinicians, researchers and the public. The reports and recommendations released by the IOM are widely accepted and get extensive coverage in both professional and mainstream media. The IOM has a singular reputation as the gold standard for providing biomedical recommendations on difficult, complex and controversial questions in clinical medicine. As the most respected source for medical consensus, the IOM is in a position to bring together experts, the ME/CFS community, and other stakeholders to develop diagnostic criteria for ME/CFS, so that more clinicians can help patients receive the medical care they need and deserve.

    Thanks for your support.
    Firestormm likes this.
  6. Ember

    Ember Senior Member

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    Nielk and Bob like this.
  7. Bob

    Bob

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    Nielk likes this.
  8. Bob

    Bob

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  9. Nielk

    Nielk

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    The recommendation from CFSAC was talking about one workshop for both research and diagnostic criteria - in consultation with CFSAC by experts, patients and advocates.


    Why is HHS twisting the recommendation information in order to fill their need?
    The IOM might be prestigious but have no experience coming up with diagnostic criteria for diseases.
    Why not discuss their intent at the CFSAC meeting?
    Why leave everyone in the dark about this - including CFSAC members?

    The least that HHS should do at this point is postpone this action until after the next CFSAC meeting where this can be discussed with CFSAC members and ME/CFS stakeholders. If they are not willing to do that then I know where their intentions truly are.
  10. Bob

    Bob

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    A rhetorical question, Nielk?

    I think you've answered your own question...

    They've done it to fulfil their own needs! It ticks boxes.

    They can predict it will have a 'safe' outcome (safe and easy for them), and they think it will keep patients, the department secretary, and CFSAC off their back because they can say that they are doing something.

    I haven't become a bit cynical, have I?
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  11. Iquitos

    Iquitos Senior Member

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    It's not cynism -- it's realism. The unseen hand that guides the US government's efforts to disappear this illness and the patients who have it has simply acknowledged that it needs to appear to be doing something, so that is what it's doing. This is for appearances only, at best. At worst, it's an another attempt to define us and our illness out of the biomedical arena.

    The fact that there already exist perfectly good diagnostic criteria, without doing a $1million study that wastes more time and money, is our best clue that this is a stalling technique, useful only to provide the excuse that they are "doing something" about it, while jogging in place.
    Bob likes this.
  12. Ember

    Ember Senior Member

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    Jennie's comments notwithstanding, I can't imagine Dr. Unger's response in May to be about nothing more than ignorance:
    In September 2011, asked about the decision to develop the ICC and PENE, Marj van de Sande responded:
    Cort describes the Stevens Protocol as “the only test that actually documents post-exertional fatigue, and documents it so well that failing the test is virtually a slam-dunk for a disability evaluation.” He reacted to the sudden and unceremonious closure of the Pacific Fatigue Lab program writing, “Unfortunately the University of Pacific just didn’t get it (anymore) and they abruptly shut down the program recently. Maybe being the leader in a controversial field just got to be too much for them.”

    Maybe the CFSAC members who spoke out about being threatened with expulsion for expressing their views are feeling the heat of this controversy too.
    Bob likes this.
  13. Bob

    Bob

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    Some thoughts...

    I do think this is a good time to tell them that we want ME investigated separately to: chronic fatigue; unexplained chronic fatigue; idiopathic chronic fatigue; and CFS, etc.

    I've just been thinking that the idea of ME being a discrete disease might scare them intensely, so perhaps the use of wording might be important to consider carefully.

    For example, it might be easier for them to warm to the idea of ME being a distinct 'subset', with distinct symptoms.
    The word 'subset' might be more palatable for them. (Not necessarily a subset of CFS, but just a 'subset'.)

    But I don't know... That might be too ambiguous and give them too much wriggle room.

    In any case, this seems like a good time to present them with evidence that ME has very distinct symptoms and is not some vague fatiguing illness, and that fatigue is not even the most problematic symptom for many ME patients. And to discuss the significance of PEM and PENE.

    And also inform them that Fukuda is the result of a compromise that tried to incorporate unexplained chronic fatigue symptoms with ME symptoms in a single set of criteria, leading to a meaningless fudge. That's where diagnostic criteria by committee gets you. (Nowhere.)

    They need to either investigate unknown fatiguing illnesses on their own, or ME on it's own, or both separately.
    And not mix them all up in a heterogeneous broth.

    At the very least, ME has very distinct symptoms that should be investigated as such. And this is what the patient community want, and it's what the expert clinicians want.
  14. jspotila

    jspotila Senior Member

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    The contracts page was updated this morning:

    I have no idea what this means. I've got calls in to several federal offices looking for clarification. Details here as I get them: http://www.occupycfs.com/2013/09/04/dont-stop/
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  15. alex3619

    alex3619 Senior Member

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    We can hope so. Thank you for keeping us updated. :thumbsup:

    My understanding is that Fukuda criteria were always intended as a broad definition but Fukuda himself wanted it broken down further into more distinct defintions over time, which never happened.
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  16. Bob

    Bob

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    I've sent a letter, asking for ME to be investigated as a distinct entity, or a distinct set of symptoms, and I set out some of the differences between CF, CFS and ME.
    I explained why using external consultants new to the field would not result in an adequate process to get to grips with such a complex subject, where there are such subtle differences between different cohorts, explaining that most of the existing research literature is based on the muddled, inadequate and heterogeneous Fukuda definition, and will not enlighten a newcomer.
    I also asked that expert clinicians who understand the subtle and complex differences between CF, CFS and ME, lead the project.
    I also asked for patients to have a leading role in the project, pointing towards the FDA's stakeholders' meeting as a way to engage the community.
    And I discussed some other related stuff, hopefully more articulately than this post! :cool:
    rosie26, Nielk and SOC like this.
  17. jspotila

    jspotila Senior Member

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    And now the contract page has been updated again. The contract is apparently cancelled, but HHS is still working on "other mechanisms." http://www.occupycfs.com/2013/09/04/dont-stop/

    I'm still trying to get clarity from several sources.
    Firestormm, SOC, alex3619 and 2 others like this.
  18. Bob

    Bob

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    I forgot to say... Thanks to everyone for taking such impressive action on this issue so quickly... Everybody's fast efforts seem to have made a difference already! (let's hope so anyway) The quality of the work posted on this forum, on Jennie's blog and on Cort's blog is really impressive, and I'm really grateful for it. All the contact details etc made sending in an email very easy. I don't usually get heavily involved in US advocacy, but this seems like an essential time to get stuck in!!!
    jspotila, Sea, Nielk and 2 others like this.
  19. Kati

    Kati Patient in training

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    I think HHS, CDC and NIH and possibly IOM needs to be forward thinking and include a patient representative (voted by the patient population) on EVERY committee they are forming regarding our health, disease definition and else.

    "Nothing about me without me!"
  20. jspotila

    jspotila Senior Member

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    Iquitos and Sasha like this.

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