1. Patients launch $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
    Check out the website, Facebook and Twitter. Join in donate and spread the word!
Never Ask Us if We're Hungry -- The Answer's Always No
There are three of us here and for many years, none of us ever got hungry. When our brains would turn to mush, when our faces would go numb, and we would start the invisible vibration which is the signature dance of ME/CFS, we knew we needed to eat.
Discuss the article on the Forums.

Dr. Nancy Lee: Background and charge to the IOM Committee

Discussion in 'Institute of Medicine (IOM) Government Contract' started by Ember, Jan 29, 2014.

  1. Ember

    Ember Senior Member

    Messages:
    1,728
    Likes:
    1,781
    The P2P process is expected to be “an excellent adjunct to the discussions around the clinical definition,” according to the CFSAC minutes:
     
    Last edited: Jan 30, 2014
    justinreilly and Bob like this.
  2. Bob

    Bob

    Messages:
    8,522
    Likes:
    11,368
    South of England
    If Jennie's information is correct, then they can legally share documents as long as they are placed in the public domain.

    If Jennie's information is correct, then the IOM committee can receive any documents from the P2P process, as long as the documents are placed in the public domain

    The term "working together" could be interpreted to mean an inappropriate methodology, but it depends on what exactly it means. If it simply means sharing information, transparently, then that seems to be permissible.

    I think I see what you mean: Information is supposed to be shared with the IOM committee formally and transparently, but Klimas will be able to share information from one committee to another, informally, thus undermining the issue of transparency.

    But in practical terms, I can't anticipate much of a problem, myself.
    Nancy Klimas knows here stuff, and I can't imagine that her opinions will be influenced massively by her attendance at either committee.
    And the other IOM committee members shouldn't be influenced by any new information that Klimas is in possession of unless she shares it formally.

    But I'm pretty ignorant about the process of both committees, so these are just my casual thoughts/observations.
     
    Last edited: Jan 30, 2014
  3. jspotila

    jspotila Senior Member

    Messages:
    1,072
    Likes:
    602
    THAT is the $64,000 questions, isn't it? Especially since the IOM process was the last to be initiated of the three overlapping efforts.

    In terms of the appropriateness of two individuals serving on the P2P Working Group and the IOM committee, given that the Working Group was supposed to have met in October 2013, it seems likely to me that the Working Group was selected and these two agreed to serve. The invitation to serve on IOM came later. The Working Group serves the function of planning the P2P meeting, rather than reviewing the evidence itself. So perhaps that is why IOM did not perceive this as a conflict. But clear instructions should be given about the sharing of information and the legal restrictions on that. We have to rely on IOM and the people involved to self-police since the IOM meetings are not public.
     
    justinreilly likes this.
  4. jspotila

    jspotila Senior Member

    Messages:
    1,072
    Likes:
    602
    Just to be crystal clear, documents and information from HHS on the substance of the IOM study can only be shared with the IOM committee if it is done publicly. No documents or other information from the IOM committee can be shared with HHS at all. Period.
     
    justinreilly and Bob like this.
  5. Ember

    Ember Senior Member

    Messages:
    1,728
    Likes:
    1,781
    How can there be clear instructions and legal restrictions on sharing information with oneself?
     
    Nielk likes this.
  6. jspotila

    jspotila Senior Member

    Messages:
    1,072
    Likes:
    602
    There are legal restrictions on the sharing of information to parties outside the IOM process, specifically to HHS and its agencies. Dr. Klimas is not violating those restrictions if she keeps the information to herself. But if she discloses anything about the committee's deliberations to anybody outside the IOM process, she will be in violation of IOM policy and presumably vulnerable to removal. If she shares information from HHS with the IOM panel in a nonpublic way, she and IOM will be in violation of FACA.

    If you think that it is inappropriate for Dr. Klimas to be on both committees, that she cannot be trusted to manage these parallel information streams, you are certainly free to write to IOM and ask that she be removed from the committee because of her disclosure that she is also serving on the P2P Working Group. Personally, I do not share that view.
     
  7. leela

    leela Slow But Hopeful

    Messages:
    2,436
    Likes:
    2,952
    Couchland, USA
    I believe Klimas to be of the highest integrity, and am kind of glad she's on both commitees.
    Even though I still don't understand the real purpose of either stupid commitee!
     
    WillowJ likes this.
  8. Ember

    Ember Senior Member

    Messages:
    1,728
    Likes:
    1,781
    Dr. Klimas and the other member serving on both groups can't help but share information from HHS with the IOM panel. They comprise 13% of the panel. Why is it acceptable for HHS to share information with 13% of the panel?

    Is it an FACA violation if the committee is subject to any management or control by an agency or officer of the government but that management or control takes place in public?
     
  9. Denise

    Denise Senior Member

    Messages:
    204
    Likes:
    270

    This is the email address to use to send material, questions, concerns to IOM (NOTE -- it likely will all go into the Public Access File)
    mecfs@nas.edu
     
  10. Bob

    Bob

    Messages:
    8,522
    Likes:
    11,368
    South of England
    I think you make a good point that being on both committees makes a mockery of the rules regarding the sharing of information.
    However, as it's Nancy Klimas it doesn't both me personally.
    I'm not certain why it does bother anyone, in pragmatic terms, as I can't really see Nancy Klimas being corrupted, and suddenly turning 'rogue' on us, just because she's on two committees.
     
  11. Ember

    Ember Senior Member

    Messages:
    1,728
    Likes:
    1,781
    My concern isn't about Dr. Klimas' integrity but about the integrity of the process. (Nobody seems to know who the other member serving on both groups might be.) HHS has clearly requested that the IOM committee coordinate with two ongoing HHS efforts concerning ME/CFS in order to minimize overlap and maximize synergy. How will the fact that some members might have privileged information in this regard affect the dynamics of the consensus process?
     
    Wildcat and Nielk like this.
  12. Bob

    Bob

    Messages:
    8,522
    Likes:
    11,368
    South of England
    You've got valid questions, but I guess we won't know the answers unless we ask them directly for clarifications.

    Also, keep in mind what Jennie said about Klimas serving only on the planning part of the P2P process.
    If she isn't serving on the P2P panel that reviews the evidence, and that makes conclusions, perhaps it isn't such a conflict?
    (I don't yet understand the P2P process - I need to read up on it - So I'm just offering thoughts and observations here - Ignore me if I'm being unhelpful.)
     
    Last edited: Jan 31, 2014
    jspotila and Nielk like this.
  13. jspotila

    jspotila Senior Member

    Messages:
    1,072
    Likes:
    602
    The key thing to remember is that the P2P Panel that makes the final recommendations will have NO experts - zero ME/CFS experts - on it. Here's my writeup of the process: http://www.occupycfs.com/2014/01/06/behind-closed-doors/
     
    justinreilly and Bob like this.
  14. leela

    leela Slow But Hopeful

    Messages:
    2,436
    Likes:
    2,952
    Couchland, USA
    What I don't understand is, according to Susan MyOhMyWe'reHavingSuchFun HereToday, they've been working on the P2P thing for a year and a half. Am I the only one that had never heard of it, doesn't know what its purpose is, and cannot fathom why there is yet *another* committee reviewing an unknown quantum/selection of ME/CFS data that has no experts? Considering our collective response the IoM contract and its panel, I'm guessing this is the first time the community as a whole has heard of P2P and its expertless panel of mysterious data reviewers.

    Can someone explain then why, if this group has been underway for some time, the IoM contract was engaged?
    I am utterly confused at this point; and this may all come down to the usual chaotic disorganization of various government agencies having crap communication skills and weird budgetary regulations dictating redundant and/or useless activity.

    The big question is this: if P2P and IoM come to different conclusions, never mind that neither entity ought to be creating a disease definition--when the hell has that ever happened--what then? Is this just going to further perpetuate the myth that there is inconclusive or contradictory data to support that this is an organic physiological disease?
     
    Kati, jspotila and Nielk like this.
  15. leela

    leela Slow But Hopeful

    Messages:
    2,436
    Likes:
    2,952
    Couchland, USA
    Okay, Just read @jspotila 's excellent post about this.
    My first reaction is that those questions (thank you jennie!) are the questions that ought to be investigated by medical researchers in the field.
    How is it possible that a secretly chosen group of random individuals is given this secretly chosen task, the task that his been effectively denied to most research scientists via an almost complete lack of governmental funding in the first place?

    This has moved into theatre of the absurd.
     
  16. jspotila

    jspotila Senior Member

    Messages:
    1,072
    Likes:
    602
    The first public mention to this workshop was in a February 2013 letter from Assistant Secretary Koh to the CFIDS Association, and it was discussed by Dr. Maier at the May 2013 CFSAC meeting. At the time, the program was called an "Evidence-based Methology Workshop." The Office of Disease Prevention went through "rebranding" in 2013, so now the meeting is part of P2P.

    I cannot explain this at all. But it's also important to note that HHS started working on the concept of the IOM study in January or February 2013.

    This is the most important question. By pursuing these efforts on a concurrent rather than consecutive timeline, this is a risk. Again, important to point out that P2P is not going to be coming up with a new definition, though. Still, it is very possible that the evidence review part of the P2P process could end up different from IOM's own evidence assessment.
     
    Denise likes this.
  17. Ember

    Ember Senior Member

    Messages:
    1,728
    Likes:
    1,781
    To guard against such an outcome on the part of the IOM Committee, HSS has issued these directives:

    Statement of Work:
    Background and charge to the IOM Committee:
    Do these HHS directives amount to "any management and control by an agency or officer of the government?"
     
    justinreilly, WillowJ and Nielk like this.
  18. leela

    leela Slow But Hopeful

    Messages:
    2,436
    Likes:
    2,952
    Couchland, USA
    what a mess this all is.
     
    jspotila, WillowJ and Nielk like this.
  19. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

    Messages:
    2,490
    Likes:
    1,175
    NYC (& RI)
    Someone asked if HHS managed or controlled the IoM process publicly would that violate FACA?
    Yes it would.

    Jennie, do I have this right that there are two statutory provisions-
    One is that things submitted by HHS and others (on the substantive subject-matter?) to IoM have to be put in the public file and
    Two is the FACA provision that HHS cannot 'manage or control' the IoM process.

    If so, then there are two potential violations of provision two that HHS can't manage or control IoM:
    one is the "coordination" to create "synergy", whatever that is (presumably to include HHS sending documents from the P2P process to the panel, potentially a violation whether or not they are placed in the public file) and
    two, the existence of Klimas and the other member on both committees.

    I am a bit concerned about Klimas. Mostly she is good, but there is a reason she has always been funded by NIH and always included on HHS committees on ME. Three (of the reasons) are she recommends CBT and GET and calls the disease 'chronic fatigue.' There maybe more.

    More concerned, of course, about the unknown member.

    She and the other member are most probably being told what HHS wants from definitions and hoping they will convey this in some way, overt, covertly, consciously or subconsciously to the IoM panel.
     
    Nielk and RustyJ like this.
  20. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

    Messages:
    2,490
    Likes:
    1,175
    NYC (& RI)
    It was a little weird how Clayton jumped all over Eileen about the committee will not provide info to HHS, but didn't say anything to Maier or Lee about it.
     
    Nielk likes this.

See more popular forum discussions.

Share This Page