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ME/CFS: A disease at war with itself
We can all agree that ME/CFS is a nasty disease, particularly in its severe form, but there are abundant nasty diseases in the world. What is unique and particularly confounding about our disease is that so much controversy surrounds it, and not only surrounds it, but invades it too.
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NIH P2P Meeting (formerly the Evidence-based Methodology Workshop)

Discussion in 'Institute of Medicine (IOM) Government Contract' started by jspotila, Jan 6, 2014.

  1. jspotila

    jspotila Senior Member

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    I'm not sure if this belongs in the IOM section, but I have obtained new information about the NIH's Pathways to Prevention Workshop. This was previously called the Evidence-based Methodology Workshop, and is one of the three case definition-related efforts going on (CDC Multisite and IOM being the other two). The IOM contract specifically requires IOM to seek input from the NIH meeting.

    The Working Group that is planning the meeting is getting together today and tomorrow at NIH. NIH has refused to disclose the names of the members. They will be finalizing the study questions that will be used for the AHRQ evidence review. NIH and AHRQ have also refused to disclose those questions.

    However, I obtained the evidence review contract through a FOIA and it includes the draft questions. Surprise! There are some problems with the questions.

    I also learned that the P2P process BY DESIGN will include NO ME/CFS experts on the Workshop panel (which is different from the Working Group). This panel will oversee the Workshop and draft the final report, which will likely include recommendations on research needs and case definition use.

    This is a really big deal, and it's flying under the radar because we're all so focused on IOM. I hope you will read the full post because I think we need to pay attention, especially since this process will feed into the IOM process.

    http://www.occupycfs.com/2014/01/06/behind-closed-doors/
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  2. Ren

    Ren Primum Non Nocere

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    I myself am a highly-qualified non-expert with little-to-no knowledge in an infinite number of fields. Perhaps I too can work for NIH. :devil:

    --------------

    Thank you, Jennie, for your work in collecting and sharing this information. :angel:
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  3. Nielk

    Nielk

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    Thank you, @jspotila for acquiring and revealing this information. I will have to read it a few times to try to make sense of it but, I agree that it certainly belongs here as part of the IOM thread. As part of their activity page for the ME/CFS diagnostic criteria study, the IOM states: " In an effort to minimize overlap and maximize synergy, the committee will seek input from the NIH Evidence-based Methodology Workshop for ME/CFS."

    It seems to me that it's all one and the same.
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  4. Ren

    Ren Primum Non Nocere

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    Is this "the" contract? Has it been released? And if so, is there a link for public viewing? Thanx.
  5. medfeb

    medfeb Senior Member

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    The contract Jennie discusses is the one for the Pathways to Prevention initiative that NIH is conducting, not the contract for the IOM initiative. But as Neilk states, the IOM initiative s expected to get input from this effort.
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  6. Nielk

    Nielk

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    Jennie states the following tasks will be presented to the workshop:

    In what way are these tasks, paid for by HHS, different than the ones tasked the IOM, paid for by HHS?

    In addition, if this workshop is to share and work in tandem with the IOM, how will this satisfy IOM's self reported rule of 'independent work from the sponsors'? IOM prides itself on the fact they work independently and once work on a study has started, the sponsors of the study can not have further input into the work?

    I am very interested to see what and how the CAA and PANDORA will respond to this?

    In my opinion, a proper response to this would be a complete and unified outcry from all our organizations and advocates.
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  7. Ember

    Ember Senior Member

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    It's flying under the radar because, as you point out, “Almost the entire process of this Workshop is being conducted behind closed doors:”
    And this is a really big deal, as you say: "The only way ME/CFS experts are likely to participate is through the Working Group (IF there are any on the Working Group) and through presentations at the meeting. The extent to which members of the public will be able to participate is completely unclear."

    Why has the name of this Workshop changed? The IOM Statement of Work outlines the expected NIH coordination:
    But you commented in November on the prohibition against government management and control:
    Is the IOM/NIH coordination being surrounded by smoke and mirrors? Thanks @Ecoclimber for this quotation:
    Last edited: Jan 6, 2014
  8. Ember

    Ember Senior Member

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    Concerning the Evidence-based Practice Centre (EPC) task order, thanks @jennie for this:
    And to Robyn for this:
    How did the investigators begin their task on June 7 without their questions?
    Last edited: Jan 6, 2014
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  9. jspotila

    jspotila Senior Member

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    No, not THE contract unfortunately. The Statement of Task on the IOM website is the only official version we have.
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  10. jspotila

    jspotila Senior Member

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    I've corresponded with IOM about how the independence will be maintained in light of the requirement to meet monthly with NIH (which I was told was administrative only, not substantive) and to coordinate with this workshop. The answer was that NIH has been invited to present at the first IOM meeting. After that, it's up to the IOM panel. They cannot and will not share IOM deliberation information with NIH (or anyone else).
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  11. jspotila

    jspotila Senior Member

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    The name of the workshop changed because of rebranding of the program by NIH. From the P2P website: "Previously known as the Evidence-based Methodology Workshop (EbMW) program, the P2P program was renamed in 2013 to better reflect the overarching goal of the program."
  12. jspotila

    jspotila Senior Member

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    The contract was signed on June 7, 2013. I'm not sure what steps were taken by the EPC and now. The timeline was negatively impacted by the shutdown, and they are running behind the contractual schedule. The study questions were supposed to have been finalized in the fall.
  13. Ember

    Ember Senior Member

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    That allowing the NIH to present at the first IOM meeting satisfies the communication and coordination expectation outlined in the Statement of Work stretches credulity to the breaking point:
    In the context of ongoing parallel processes, how could a single presentation at the first meeting be expected to minimize overlap, maximize synergy and assure that relevant information is shared and that key messages are coordinated? Surely the key message won't have been formulated by the first meeting.

    Why would monthly administrative NIH/IOM meetings be needed?
    Last edited: Jan 6, 2014
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  14. Denise

    Denise Senior Member

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    As I understand it the monthly administrative meetings are for IOM to provide status updates, expenses, etc. The meetings seem to be pretty much one-sided, IOM provides updates but keeping in mind that after the initial meeting (Jan, 27th),NIH/HHS, etc can't give input to IOM unless it is done publicly...
  15. Ember

    Ember Senior Member

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    Status updates and expenses can be provided in written reports. Meetings are designed for two-way communication.
    Last edited: Jan 6, 2014
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  16. Nielk

    Nielk

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    I am really confused as to the purpose of this workshop? It is, as Ember pointed out, parallel work to the IOM with similar time frames. This workshop costs us $358,211 and the IOM study one million dollars of our taxpayer's monies. If you read the task questions carefully, you will see that they are basically what the IOM has been tasked to do.

    In addition, Jennie stated that she spoke to the IOM and the NIH will only take part in the first meeting and then they have to stay out of the study. In other words, the data obtained by the EbM workshop/NIH P2P meeting cannot be shared with the IOM or else they would impinge on the independence of the IOM study.

    In what way does this make sense? Does HHS really think that we believe any of these lies?
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  17. Denise

    Denise Senior Member

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    I agree Ember, that status reports and expenses can be provided in written reports.

    I do not know if that it standard operating procedure for IOM though. It is possible they do things differently or that the (heretofore unseen contract) stipulates in-person meetings.

    It would be good to check the IOM site http://www.iom.edu/About-IOM.aspx for more specifics and share them.

    Jennie Spotila made the IOM Statement of Work available here https://dl.dropboxusercontent.com/u/57025850/MECFS IOM SOW.pdf. I find it helps me to re-read some of these things from time to time.

    As for meetings being designed for two-way communication ---- ideally, yes, they are. But as we have seen with SOK, CFSAC etc, --- often meetings are one-way communication.
  18. Nielk

    Nielk

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    From the HHS' Statement of Work (SOW) to the IOM:

    How could this be accomplished if it's true that the NIH will not communicate with the IOM past the first meeting?
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  19. biophile

    biophile Places I'd rather be.

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    Perhaps they should also ask, how much influence has psychobabble ideology had in shaping ME/CFS research, and how much has sloppy research practices distorted the evidence base?
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  20. jspotila

    jspotila Senior Member

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    The NIH workshop (and evidence review) will look at diagnosis and treatment of ME/CFS, particularly the effect of the case definition on research as well as what the research can tell us about case definitions. At least, that's how I read the draft questions.

    The IOM study is to come up with clinical diagnostic criteria for use by primary care providers.

    Overlapping, but different to a degree. The other detail is that the evidence review contracted by AHRQ is $358,211. That is only a portion (although a significant one) of the cost of the P2P meeting (which will be covered by NIH's Office of Disease Prevention as far as I can tell). We do not know the cost of the overall meeting. I believe Susan and Beth were asked that question at the May 2013 CFSAC meeting, and an answer was never provided publicly. AND NO ONE FOLLOWED UP AT THE CFSAC MEETING. Ahem. Sorry. I'm a little frustrated that a public venue in which we could get useful information is not being used that way.
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