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HHS sends out a Q & A about the IOM contract through CFSAC's listserv

Discussion in 'Institute of Medicine (IOM) Government Contract' started by Nielk, Nov 15, 2013.

  1. Nielk

    Nielk

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    http://solvecfs.org/cfsac-responds-to-questions-concering-the-contract-with-the-iom/


    FAQs on an HHS contract with the IOM to recommend clinical diagnostic criteria for ME/CFS

    Who is the target audience for the Institute of Medicine (IOM) study?

    The target audience is primary care clinicians (which include physicians, nurse practitioners, and physician assistants) throughout the US. Too many providers are unaware how to diagnose myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Patients often tell us that they consult with many clinical providers before finally getting a diagnosis.

    Why did the Department of Health and Human Services (HHS) not follow the Chronic Fatigue Syndrome Advisory Committee (CFSAC) recommendation to host a workshop in consultation with CFSAC and ME/CFS experts, but instead contracted with the IOM to do a study?

    HHS relies on professional societies and medical institutions such as academic centers and the IOM to develop clinical guidelines and recommendations. The IOM has a singular reputation for providing biomedical recommendations on difficult, complex and controversial questions in medicine. It routinely brings together scientific experts, patients, and other stakeholders to develop recommendations.

    As public health professionals, we have many years of experience in disseminating health information to clinical providers in the US. Such an effort takes partnerships with medical professional societies that rely on up-to-date scientific evidence to guide the information that they disseminate. The IOM process of developing consensus recommendations is widely accepted by professional societies and other medical institutions that disseminate clinical guidelines.

    We believe that widely accepted clinical diagnostic criteria and a clear distinction from case definitions used for research and disease surveillance will aid in advancing clinical care, drug development, and basic research for ME/CFS.

    Importantly, as a direct result of the CFSAC recommendation, HHS’ contract with the IOM requires it to host public meetings and to include in the expert advisory committee ME/CFS experts (which could include members of CFSAC). HHS also provided the IOM with a copy of a September 2013 letter to Secretary Sebelius from ME/CFS experts urging adoption of the 2003 Canadian Consensus Criteria, to inform it of experts who may be appropriate for the committee.

    Can HHS, and all associated agencies, endorse the 2003 Canadian Consensus Criteria based on the recommendation of ME/CFS experts, patients and the International Association of CFS/ME? If not, why not?

    HHS often helps disseminate clinical recommendations made by nongovernmental groups, but does not generally make formal endorsements of these guidelines. Additionally, the 2003 Canadian Consensus Criteria (CCC) do not account for scientific evidence developed since 2003. In order to ensure that the IOM considers all relevant information, HHS has requested specifically that the IOM consider the 2003 CCC in its review and deliberation, in addition to other clinical criteria for ME/CFS and recent scientific evidence.

    What is the standard process that the IOM uses to develop its recommendations?

    From the IOM’s website:
    The IOM applies the National Academies’ rigorous research process, aimed at providing objective and straightforward answers to difficult questions of national importance. Our consensus studies are conducted by committees carefully composed to ensure the requisite expertise and to avoid conflicts of interest.


    The committee’s task is developed in collaboration with the study’s sponsor, which may be a government agency, a foundation, or an independent organization. However, once the statement of task and budget are finalized, the committee works independently to come to consensus on the questions raised. In fact, while committees may gather information from many sources in public meetings, they carry out their deliberations in private in order to avoid any external influence.

    As a final check for quality and objectivity, all IOM reports undergo an independent external review by a second, independent group of experts whose comments are provided anonymously to the committee members.

    … The Institute of Medicine is exempt from the Federal Advisory Committee Act except for Section 15 of that law. Applied under this section, this law governs the interactions between sponsors and the National Academies, and especially describes the public release of information concerning the study activities and results. …

    In accordance with federal law and with few exceptions, information-gathering meetings of IOM committees are open to the public, and any written materials provided to the committee by individuals who are not officials, agents, or employees of the National Academies are maintained in a public access file that is available for examination.

    IOM committees deliberate in meetings closed to the public in order to develop draft findings and recommendations free from outside influences. The public is provided with brief summaries of these meetings that include the list of committee members present. All analyses and drafts of the report remain confidential.

    Further information can be found here.

    What criteria does IOM use for selection of committee members?From the IOM’s website:
    Careful steps are taken to convene committees that meet the following criteria:


      • An appropriate range of expertise for the task. The committee must include experts with the specific expertise and experience needed to address the study’s statement of task. One of the strengths of the National Academies is the tradition of bringing together recognized experts from diverse disciplines and backgrounds who might not otherwise collaborate. These diverse groups are encouraged to conceive new ways of thinking about a problem.
      • A balance of perspectives. Having the right expertise is not sufficient for success. It is also essential to evaluate the overall composition of the committee in terms of different experiences and perspectives. The goal is to ensure that the relevant points of view are, in the National Academies’ judgment, reasonably balanced so that the committee can carry out its charge objectively and credibly.
      • Screened for conflicts of interest. All provisional committee members are screened in writing and in a confidential group discussion about possible conflicts of interest. For this purpose, a “conflict of interest” means any financial or other interest which conflicts with the service of the individual because it could significantly impair the individual’s objectivity or could create an unfair competitive advantage for any person or organization. The term “conflict of interest” means something more than individual bias. There must be an interest, ordinarily financial, that could be directly affected by the work of the committee. Except for those rare situations in which the National Academies determine that a conflict of interest is unavoidable and promptly and publicly disclose the conflict of interest, no individual can be appointed to serve (or continue to serve) on a committee of the institution used in the development of reports if the individual has a conflict of interest that is relevant to the functions to be performed.
      • Point of View is different from Conflict of Interest. A point of view or bias is not necessarily a conflict of interest. Committee members are expected to have points of view, and the National Academies attempt to balance these points of view in a way deemed appropriate for the task. Committee members are asked to consider respectfully the viewpoints of other members, to reflect their own views rather than be a representative of any organization, and to base their scientific findings and conclusions on the evidence. Each committee member has the right to issue a dissenting opinion to the report if he or she disagrees with the consensus of the other members.
      • Other considerations. Membership in the National Academy of Sciences, National Academy of Engineering, or IOM and previous involvement in National Academies studies are taken into account in committee selection. The inclusion of women, minorities, and young professionals are additional considerations.
    Does the HHS contract with the IOM specifically require the IOM to use ME/CFS experts as committee members?

    Yes.

    Does the contract require the IOM to include a patient as a committee member?

    No. The contract does require that input be sought from patients, family members, and other caregivers during public meetings.


    How can patients, family members and other advocates provide input into the IOM study process?

    The IOM has set up a listserv and website to keep stakeholders informed about the progress of the committee and opportunities for input. Interested individuals can register for the listserv at this link.


    What is the Statement of Task in this contract with the IOM?From the contract:

    An Institute of Medicine (IOM) committee will comprehensively evaluate the current criteria for the diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The committee will consider the various existing definitions and recommend clinical diagnostic criteria for the disorder to address the needs of health providers, patients and their caregivers.

    The Committee will also distinguish between disease subgroups, develop a plan for updating the new criteria, and make recommendations for its implementation. Any recommendations made by the committee will consider unique diagnostic issues facing people with ME/CFS, specifically related to: gender, across the lifespan, and specific subgroups with substantial disability.

    Specifically the Institute of Medicine (IOM) will:

      • Conduct a study to identify the evidence for various diagnostic clinical criteria of
    ME/CFS using a process with stakeholder input, including practicing clinicians and patients;

      • Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology;
      • Recommend whether new terminology for ME/CFS should be adopted;
      • Develop an outreach strategy to disseminate the definition nationwide to health professionals.
    Over the 18 months, the committee will consider 4 topic areas and produce a consensus report with recommendations. The recommendations will have a domestic focus; however, major international issues may be identified. As the committee reviews the literature, efforts that have already been completed on this topic area will be considered, including the 2003 ME/CFS Canadian Consensus Definition, the 2007 NICE Clinical Guidelines for CFS/ME, the 2010 Revised Canadian ME/CFS definition, the 2011 ME International Consensus Criteria, and data from the ongoing CDC Multi-site Clinical study of CFS. In an effort to minimize overlap and maximize synergy, the committee will seek input from the NIH Evidence-based Methodology Workshop for ME/CFS.

    Will the IOM study address treatment for ME/CFS?

    No. The Statement of Task does not ask the IOM to develop recommendations about treatment of ME/CFS nor to develop a research agenda for ME/CFS.


    What is the total cost of the IOM contract?

    One million dollars were obligated for this IOM contract. Almost all of the agencies that have efforts involving ME/CFS contributed Fiscal Year (FY) 2013 funds to this study.


    If the IOM contract is cancelled, will the contract funds go to ME/CFS research?

    HHS has a legally binding agreement with the IOM and has committed FY2013 funds to this study. There is no way for HHS to recover or repurpose these funds.


    What is the difference between the IOM committee charge and the NIH Evidence-based Methodology Workshop for ME/CFS?

    According to NIH:

    The expected outcome from the Evidence-based Methodology Workshop for ME/CFS is to identify research gaps in ME/CFS, identify methodological and scientific weaknesses in the ME/CFS field, suggest research needs that will advance the ME/CFS field, and move the field forward through an unbiased, evidence-based assessment of this complex public health issue.


    According to the HHS contract with the IOM:

    The Institute of Medicine (IOM) will:


      • Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, including practicing clinicians and patients;
      • Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology;
      • Recommend whether new terminology for ME/CFS should be adopted;
      • Develop an outreach strategy to disseminate the definition nationwide to health professionals.
    Last edited: Nov 16, 2013
  2. Ember

    Ember Senior Member

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    "HHS also provided the IOM with a copy of a September 2013 letter to Secretary Sebelius from ME/CFS experts urging adoption of the 2003 Canadian Consensus Criteria, to inform it of experts who may be appropriate for the committee.":rolleyes:
  3. Snowdrop

    Snowdrop Senior Member

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    I admit to not knowing much politically but FWIW

    Without substantial and overwhelming evidence that we are not lying/malingering/delusional/hysterical the outcome will look like whatever the h**l they want it to.

    There is after all 'evidence' out there that is pure spin.

    In the absence of more clear scientific evidence a committee like this seems inappropriate to me.

    The IOM is our Orwellian Ministry of Peace and we are the warzone.
    Izola, leela and justinreilly like this.
  4. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    This is obviously not a response from CFSAC (regardless of whether it is at some point posted on the CFSAC website by HHS), but instead by HHS. It gives flimsy excuses why HHS did not follow CFSAC's recommendation in any substantial way. CAA obviously knows this.
    Izola, beaker, leela and 1 other person like this.
  5. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Yes, this is a 'legally binding contract' which by law, at most binds HHS to recompense IoM for only the work already performed, should HHS chose to, at its whim, rescind this contract at any time! The work that would have to be paid for would basically be for Kate Meck answering emails with sometimes idiotic responses like that know-nothings must be on the panel bc know-nothings will be diagnosing patients.
    Izola and snowathlete like this.
  6. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Yesterday, PANDORA released its newsletter stating that we advocates were operating under serious misconceptions which are making us pursue impossible goals. They refused to specify what those misconceptions were, but said they would be revealed in Wanda Jones' response which would probably come today. These are many, if not all, of the same questions PANDORA asked Jones, so I guess this is basically the response PANDORA are talking about. Maybe Im missing something, but I haven't yet seen any major misconceptions we are operating under (except the fake 'misconception' that this contract can't be cancelled).
    beaker and Nielk like this.
  7. WillowJ

    WillowJ Senior Member

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    yes, multiple agencies use the CFSAC mailbox to reach the ME/CFS community.
  8. Firestormm

    Firestormm Guest

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    http://solvecfs.org/cfsac-responds-to-questions-concering-the-contract-with-the-iom/

    aimossy likes this.
  9. Nielk

    Nielk

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    So, is the IOM then considered a government group? In what way is the IOM different from the authors of the CCC in view of government or non-government groups?
  10. Nielk

    Nielk

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    But, it doesn't specify how many. The IOM could conceivably choose one or two experts to satisfy HHS' SOW.
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  11. Nielk

    Nielk

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    This explains how we can receive information.
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  12. Nielk

    Nielk

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    What does almost all of the agencies mean? Who specifically contributed how much?
  13. Nielk

    Nielk

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    Will HHS then endorse the recommendations by this workshop? If yes, why couldn't they do the same for clinical diagnostic criteria. If not, why do this work altogether?
    beaker likes this.
  14. jspotila

    jspotila Senior Member

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    I delve into the details of the FAQ, and all the important questions it does not answer. Also, the statement about the NIH workshop is inconsistent with previous statements made by HHS in writing. Here's the post:

    http://www.occupycfs.com/2013/11/18/faqchecking/
    WillowJ, beaker, Nielk and 1 other person like this.
  15. Nielk

    Nielk

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    Thank you, Jennie for this great analysis. By now, I think most of us realize that HHS is taking us for a ride. There are so many holes, inconsistencies, lies and spins in their statements and actions.

    Their answers leave more questions then we started off with. Besides, we can't even trust anything that they say. They don't even have the decency to sign off on their public statements? How lame is that? They still choose to ignore the experts' letter.

    The question is; What do we do about this?

    I feel totally frustrated that all we can do is sit here and blog/write about all these complaints yet, HHS get's away with all this?

    You state:

    I have confirmed this with a CFSAC member and the CAA just posted on Facebook that this originated from HHS. So, of course, you are right.

    I think that this statement is in anticipation as explanatory for the fact that the IOM will conceive a real 'simple' diagnostic criteria where any doctor or nurse can easily diagnose from simple bullet points.

    (my bold)

    Very well stated. In what strange world does this statement make sense? HHS can't adopt the CCC because it's a non-government group but, they could endorse the IOM criteria because...it's a non-government group???

    In addition, they stated that the CCC does not include recent research. If that is their problem with the CCC.....take the ICC then. Or just revise the CCC to include recent research/knowledge which is what the CFSAC recommendation stated; '...starting with the CCC...'. Diagnostic criteria for diseases are revised all the time to meet with current knowledge. They are not 'totally re-defined' by la people!

    They inadvertently did answer PANDORA's question without spelling it out. It obviously could be cancelled since they are talking about 'if the IOM contract is cancelled...'

    Exactly, why give such a vague answer..'almost all of the agencies..'? Is it a guessing game? I also hope, Jennie that you uncover the real answer to this.

    I agree that this is the most important question and the fact that they left it out, should send chills down our backs. This is what it's all about isn't it? Of course they can't guaranty that this won't happen because, that is exactly where they are heading. Unless, we find a way to stop this process, it is doomed.

    I also noticed this. Why is it that they left that off? That is the crucial piece of the EbMW's task. How can they leave this out?

    I have no hope that Nancy will 'enlighten' us at the CFSAC meeting. She will provide a statement re-itterating these replies. I don't see any time allocated on the agenda for discussion of the IOM topic beyond Nancy Lee's statement. Why? When this should have been the most issue on the table now. Why not allocate time for the voting CFSAC members whose recommendation has been high jacked and shredded? I am sure that they have a lot to say about it. Why have elect members to an advisory committee and then put a gag on them?

    To repeat my statement above: What are we going to do about this?
  16. jspotila

    jspotila Senior Member

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    I think you are right, Gabby. There is no indication that discussion will be permitted, and I'm sure at least some voting members have a lot to say about it. My guess is that Nancy sees no need for discussion or comment because she sees it as a done deal. Even before the IOM contract became public, they were shutting down discussion at the May 2013 CFSAC meeting, saying there would be no rehashing of the disagreements over the case definition (my words, without checking the minutes). The webinar format might make it easier for Gailen Marshall to contain discussions before they veer off track into the case definition or other topics. We still don't know how the webinar will work for the committee members - will they be sharing an open line, or will there be a way for people to "raise their hands"?
    Nielk likes this.
  17. medfeb

    medfeb Senior Member

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    Lois Ventura has posted a great letter about the IOM FAQs. She has given permission to repost

    *HHS & IOM – FAQs & Fiction
    *(Addressing the November 15, 2013 “FAQs Regarding the IOM Contract” by HHS-CFSAC listserv)

    National Alliance for Myalgic Encephalomyelitis
    November 18, 2013

    *Intro, 3 Parts, & Conclusion*
    [References below]

    *INTRODUCTION*

    It’s safe to state the obvious about the Nov 15, 2013 “FAQs Regarding the IOM Contract” put out via the HHS-CFSAC listserv (full copy below):

    *a)* We don’t know who, or how many, first person plurals and third person omniscients’ hands penned it;

    *b)* It’s pretty easy to tell that this is yet another piece of bias attempting to be passed off as absolute fact.There are myriads of variables that can influence hundreds of decisions (these are all fallible humans: we all have opinions, and ‘objectivity’ is a misnomer) – many made by non experts in the ME & CFS field, some (too many) behind closed doors – should this contract proceed as outlined.

    *c)* They raise more questions, rather than provide answers.
    There are numerous questionable ‘answers’ in this ‘FAQ’ that stand out, and others that are easily overlooked by folks like us with fluctuating cognitive impairment.So we’ll just work with the ones that stand out most to us.

    Read the entire article here:
    http://www.name-us.org/AdvocacyPages/2013HHS_IOM_FAQs_Fiction.pdf

    Lois Ventura
    www.name-us.org
  18. Izola

    Izola Senior Member

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    Did a robot give the (I forget the specific agency name) first part of that governmental explanation? It was so controlled and stilted it scared me. Yes. Orwellian. Izola

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