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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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IOM Process - four stages explained

Discussion in 'Institute of Medicine (IOM) Government Contract' started by Nielk, Nov 4, 2013.

  1. Ecoclimber

    Ecoclimber Senior Member

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    We have observe the smoke and mirrors of Sebelius Affordable Care Act.

    We have observe the smoke an d mirrors of Sebelius VA IOM Panel Contract.

    Wehave observe the smoke and mirrors of Sebelius ME/CFS IOM Contact.

    Wehave observe the smoke and mirrors of bureaucratic words with various meanings of biases.
    The scientific method is not bias, it is truth. Scientific research that is based on the scientific method which results in significant breakthroughs concerning a particular illness is not bias but scientific conclusions of fact concerning cetain disease aspects of that particular illness. With over 4000 published scientific peer reviewed papers based on the scientific method, with selected CCC cohorts, they are not biases but established scientific evidence of a particular relationship, observations or effects of the illness within a particular group of patient cohorts.

    To exclude data based on scientific evidence as they did with Research Advisory Committee on the VA IOM contract as bias, is nothing but a smokescreen of bureaucratic haze to obfuscate the bias that is in engrained in VA IOM Panel and will be in the ME/CFS IOM Panel.


    Bringing over the participants from the VA IOM Panel insures that same policies and procedures will b adhered to guarantee the same results.
    alex3619 likes this.
  2. Ecoclimber

    Ecoclimber Senior Member

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    Research and study the actions by VA IOM Panel, SOW, Contract with the final makeup of the VA IOM Panel and the personal testimonies under oath by those who were excluded from the Panel and the decision making process including members of the RAC and you will have your answer. It really isn't that difficult. Determine if they are not following the same procedure with the same language as they did with the VA IOM Panel. You will have your answer on their tatics.
  3. Firestormm

    Firestormm Guest

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    I think 'experts' will be solicited for areas relating to the operationalisation of clinical diagnostic criteria, and for 'alternate' diagnoses, and tests etc. Some non-ME experts will be considered essential. I am never clear on the experise of the IOM itself - I know this has been raised as a concern before - and I don't mean in regard to our specific condition: but I mean in relation to making these kind of recommendations. They do seem to lack experience. Then again, perhaps, at least in part this explains their reference to NICE who have of course published many clinical guidelines.
  4. jspotila

    jspotila Senior Member

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    Yes.
    justinreilly and Nielk like this.
  5. Bob

    Bob

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    This is a crucial area for the IOM to get to grips with.
  6. Andrew

    Andrew Senior Member

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    When I was diagnosed with prostate cancer, my first thought was NOT "hey, I better go out and find a urologist who has the least amount of experience with cancer because he will be less biased." What I did was find a urologist whose specialty is prostate cancer. I also found an oncologist who only works with prostate cancer. And I'm sure both of them have their own biases. But so what. Who doesn't have a bias. Every expert and non-expert has a bias. But at least an expert has a well-informed bias.

    Let me ask you this. If one of your family members was sick with a debilitating illness, would your first choice for a solution be someone with no experience.

    I'm sure the people at the IOM are intelligent and know how to read journal articles. But consider this. There are over 3000 journal articles. Do you really think every non-expert is going to sift through these. Do you think they will even bother to differentiate between Oxford Criteria Studies and Fukuda studies. If you do, name one non-expert major medical institution that does. I'm waiting to hear your answer.

    Now, maybe you are thinking "well, all we have to do is inform them what Oxford really is." Okay, fair enough. Show me one instance where this has worked. Show me one case of a major medical institution who has modified their website or information packet after being informed by advocates. I'm waiting to hear your answer.

    What the people at the IOM will do is look a smattering of research. They will make a decision based on the evidence. They will disregard the fact that most of the evidence was found using weak definitions, like Fukuda or Oxford. They will ignore the fact that you can't take weak research to create a strong definition. To do that you need to use observational science based on years of first hand experience working with patients. And they don't have this experience. But they will form an opinion in the complete absence of direct personal observation, direct examination of patients, and no field testing of the criteria.

    Is this what you want?
    RL_sparky, Delia, Purple and 8 others like this.
  7. alex3619

    alex3619 Senior Member

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    There is no doubt the IOM will be deluged with testimony and research involving the crtical issues. Its how those issues are weighted and given priority that is important. The pattern has been clear for a decade. Strong nonscientific promotion of psychogenic views, poor Cochrane reviews of these issues, a failure for medicine to grapple with unfounded psychiatric diagnoses, and the supposed evidence-base of many RCTs in CBT and other areas in psychiatry that rely on unproven diagnoses and subjective results that are within a potential bias range.
    WillowJ, Bob and justinreilly like this.
  8. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    I took that from the PANDORA paper on nominations, relaying what they were told by an IoM representative.
    http://www.pandoraorg.net/uploads/Position_on_IOM_Request_for_Nominations.pdf
    Plus all the talk on the IoM website about favoring IoM members, past IoM panelists (eg Buchwald, Vernon and Friedberg), younger people, minorities, women and people "who might not otherwise collaborate" from a diverse range of specialties, and needing to "balance" the committee. And the language in the statement of work is pretty weak on including ME experts.
    Last edited: Nov 10, 2013
    Bob likes this.
  9. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    @Andrew, Your comment really makes crystal clear the problem here. I wish everyone could see your comment! Everyone Pls repost his comment where appropriate.

    We need to remind people, to ask them those great questions-
    - If you had prostate cancer, would you go see a top-rated knee surgeon or even a great urologist with no cancer expertise?
    - What non-ME major medical organization has ever put out substantially accurate info on ME or even bothered to differentiate between Oxford, Reeves, Fukuda and CCC studies?
    - What organization has changed their website or other information after being made very well aware of the problems by advocates?
    - Look how hard it was to even get a CFS org like CAA to take down Peter White's picture and piece he wrote on the great benefits of CBT and GET. And they're supposed to be representing us.

    The fact is we have no chance with non experts, even well meaning ones.

    I have looked through (and reviewed on Amazon and elsewhere) about 200 medical textbooks that should or I thought would have something on ME. Probably half had nothing, half had substantially inaccurate (and usually tiny) pieces on "CFS" and two had substantially accurate information. One was a chapter by Charles Lapp on ME in a textbook. I forgot what the other one was. I think it was a very short, generally accurate piece in a general text.

    Two out of about 200. And among non-expert (and Wessley school) authors, one out of 200.

    Do you like those chances? One out 200 for getting it right?

    And this was for just drafting a short description of the disease, much less coming up with an entirely NEW ACCURATE DEFINITION, which is much, much more difficult.
    Last edited: Nov 6, 2013
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  10. Ecoclimber

    Ecoclimber Senior Member

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    Has anyone investigated whether HHS award or contract with the IOM violated any Code of Federal Regulations and since SS is involved, are there any exclusions for medicare and medicaid with the OIG? Has HHS violated any Federal Procedures in procurement, notification, the entire process under HHSAR? http://www.hhs.gov/regulations/hhsar/tocindetail.html http://www.hhs.gov/ohrp/. Were they required by law to make it a competitive bid or could they have the authority to award the contract to the IOM?
  11. jspotila

    jspotila Senior Member

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    FWIW, I did some basic investigation into whether the procedures around this contract violated federal law. They did not, as far as I can tell. They were not required to make it a competitive bid process.

    That's not to say my research is definitive. I am not an expert on federal contracting, nor do I know all the places to check for regulations, etc.
    justinreilly likes this.
  12. Nielk

    Nielk

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    Except for the GWI current study for a definition, is there a precedent as to HHS hiring an outside private venue with the charge of redefining a disease? This might be a completely new territory.
  13. alex3619

    alex3619 Senior Member

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    I don't know about hiring outside sources, but contracting the IOM to produce guidelines etc. is the purpose of the IOM's existence, and the HHS has been doing this for a very long time. At least that is my current understanding.

    The issue though is whether this kind of process has credibility with so much bad research that has been uncritically received, poor definitions in the first place leading to poor research, and in trying to come to grips with something that currently has no definitive biomarkers. Whether they consider the markers we already know about to be sufficient is a critical question, but I doubt they will.

    If ME and CFS were diagnostic areas with well defined biomarkers, a generation or more of well funded quality research based on a fairly robust definition, and a wide diversity of quality clinical intervention trials, then the issue would be simple. Sadly that is not what exists.
    justinreilly likes this.
  14. Nielk

    Nielk

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    The IOM has never before. except currently with GWI, been charged with finding diagnostic criteria for diseases.

    Here, you can find a list of their reports on 'consensus studies' they have developed. This will give you an idea of what their work entails.
    Ember likes this.
  15. jspotila

    jspotila Senior Member

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  16. Nielk

    Nielk

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    The big picture problem is - 'What constitutes a fair and balanced panel for a study to determine clinical diagnostic criteria for a specific disease?'

    What is considered balanced by the IOM is the panel that they have currently working on a definition for CMI (previously known as GWI. On that panel, out of 13 members, they have a few who are IOM members, a few who are pshychologists and/or psychiatrist and at most three who have some experience with Gulf War Illness veterans. This constitutes a fair and balanced panel in the eyes of the IOM and as their policy states, the IOM is the final judge of that.


    her article on Pro Health:

    "A redefinition of CFS as “chronic multi-system illness,” or any other meaningless concatenation, will not improve upon the current definition, it will not lead to effective treatment, it will not increase funding for research, and it will not lead to acceptance by the medical community. Instead, it will usher in the widespread dismissal of ME/CFS as an organic illness, and cause a halt in meaningful research. As the experts have rightly pointed out, “this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable. ME/CFS patients who have been disabled for decades by this devastating disease need to see the field move forward and there is no time to waste.”
  17. Ecoclimber

    Ecoclimber Senior Member

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    The question that I am most interested in is whether the guidelines, procedures or processes on notification to stakeholders, the public with regard to deadlines, comment periods, nominations, appointments etc. ( remember this is public funding) is in violation of HHSAR, OHRP and if so, a complaint can be lodge with the HHS, Office of Inspector General .

    What's the point in stating that advocates or organizations will monitor the HHS and IOM process during this period if one has no idea or knowledge if violations are occurring and a process is NOT in place to formally raise an objection or protest a violation to the appropriate authorities for investigation?

    As an example, (the whole process surrounding the awarding of the IOM contract and the sudden cancellation and than renewal of the contract notifications etc.), instead of complaining 'in-house' (blogs, forums etc.) are these violations of guidelines or regulations whereby parties can register a formal complaint not via petitions or emails but with HHS OIG?
    Last edited: Nov 6, 2013
  18. jspotila

    jspotila Senior Member

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    The IOM is not part of HHS. It is independent. So there's no way to lodge a complaint with the HHS OIG because that office has no authority over the IOM.

    I checked to the best of my abilities. I spoke with a contracts officer at the Federal Program Support Center (which was originally handling the contract). I spoke with an attorney. I spoke with two people who have been involved in federal contracting in professional capacities for years. I begged a source to provide me with documentation (and failed). I have not been able to find any violation of the federal contracting regulations.

    No guarantee I'm right about any of this. I'm not able to practice law, I have no special expertise in federal contracts, and I don't have access to all the materials, etc etc etc etc etc. I welcome other people putting effort into this. I am tapped out.
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  19. alex3619

    alex3619 Senior Member

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    I don't think its about experience. What the experience of Gulf War Illness tells us is they got it wrong, not why. I think the underlying process is flawed for this kind of work.

    Theyz gotz a hamma. Itz worx forz nailz. So its works for deez twisty nails with little slot on top. The very methodology used is flawed, and integrates a highly biased process that almost guarantees a flawed outcome. If the panel could work to their own methodology, and contained our experts almost exclusively, then we could wind up with an OK result. However that was already done, with the CCC then the ICC. So why do it again?

    The only point in doing it again, unless its driven by a large evidence based process (like the CDC is attempting but without the flaws the CDC is building in to the process) then you might get something better, is to drive toward a different conclusion.

    I am thinking of coining a new phrase, which is not really new but is new in this context ... hypothesis based medicine. HBM. Much of what we call EBM is based on unproven hypothesis, and the so-called evidence is actually argument and not evidence. In other words, its a house of theories. All of psychogenic medicine fits this definition.
    WillowJ likes this.
  20. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Thank you, Jennie. As Eco said, this topic really merited at least a look, so thank you for doing that for us.
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