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The Panel is out - What Now? December 23rd Deadline for Public Comments on IOM Panel

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, Dec 20, 2013.

  1. Phoenix Rising Team

    Phoenix Rising Team

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    Ahead of the December 23rd deadline for public comment on the proposed IOM panel to create clinical diagnostic criteria for ME/CFS, Gabby Klein reviews the continuing opposition to the HHS/IOM Contract and the more favorable response from some ME/CFS organizations, and offers her personal take on the controversy.

    [​IMG]

    While the mounting questions regarding the HHS/IOM contract have continued to grow and remain unanswered, the Institute of Medicine has been forging ahead with its work to create clinical diagnostic criteria for ME/CFS. On December 3rd, the IOM revealed a list of fifteen provisional panel members with a twenty day window for public comment. About half of the panel members listed have ME/CFS knowledge and experience.

    Jennie Spotila, along with a group of patient advocates, has investigated the proposed panel members and published blogs about them on her website OccupyCFS. She discusses in detail the 'knowns' (those who are familiar names to the ME/CFS community) and the 'unknowns', as well as the overall balance of the panel. Her latest blog goes into more detail in raising what the group believe are 'legitimate concerns' about three panel members: Dr. Alegria, Dr. Theodore Ganiats, and Dr. Cynthia Mulrow.

    The deadline for submitting comments is December 23rd. Comments can be submitted by accessing the 'feedback' button at the bottom of this page. If you prefer to submit your feedback as an attachment, you can do so by emailing it to mecfs@nas.edu. See the end of this article for further detail. The feedback Jennie has submitted herself is here.


    Opposition to the contract continues

    Many patients and advocates remain opposed to the contract regardless of the makeup of the panel. They argue that the commissioning of the IOM for this work, and its charge by HHS as detailed in the 'Statement of Work' (SOW), cannot result in a positive outcome for patients. They feel that the method and process of study by the Institute, coupled with the charge by the SOW to use an evidence based method of study, will have negative results for us. In addition, they highlight evidence of bias and misrepresentation by the IOM regarding ME/CFS, as evidenced by their study on GWI.

    This evidence of bias and misconduct has kept Jeanette Burmeister very busy, starting with a call on November 11th for an investigation by the Inspector General into the IOM’s conflict of interest with respect to ME/CFS.

    "Just to give a few examples, the CMI Report unconditionally accepts antidepressants (page 119) as well as cognitive-behavioral therapy and graded-exercise therapy (page 99) as recommended treatments for ME/CFS even though these 'treatments' are viewed by most, if not all, credible experts as not just unhelpful, but potentially quite harmful for most ME/CFS patients."

    Jeanette followed this up on November 17th, with a supplemental complaint to the Office of the Inspector General (OIG): "Did DHHS violate its no bid contract requirement for the IOM contract?". On November 25th, she sent out a request to investigate what appears to be a dramatic failure of HHS to follow applicable federal law and regulations regarding full and open competition in its award of the $1 million contract to the Institute of Medicine.


    CFSAC Testimony against the contract

    Mary Dimmock argues, in her testimony to CFSAC, that we really don't know which disease HHS has tasked the IOM to study. Is it the disease described by the Canadian Consensus Criteria (CCC) and the International Consensus Criteria (ICC)? Or will it resemble the broad 'chronic fatigue' term expressed by the 1994 Fukuda Criteria? Mary states:

    "Instead, HHS has wasted decades and countless millions fixated on studying medically unexplained fatiguing illnesses under the rubric of 'CFS', a man-made clinical entity that in reality is an unscientific hodgepodge of biologically unrelated conditions. A black hole guaranteed to insure that any disease in the CFS grip will remain forever medically unexplained and mistreated."

    If indeed this is the illness that will be studied, then regardless of the balance of the IOM panel, the resulting clinical criteria will not resemble ME.

    In addition, previous studies done by the IOM, with a negative slant on ME/CFS, remain a serious cause for concern. This concern was very well detailed by Andrew Bokelman in his testimony at CFSAC’s "meeting that wasn’t". Andrew argues that the IOM’s system control is flawed. He backs this up with evidence of a previous IOM study on GWI which recommended graded exercise for CFS, with the only references in support of that recommendation being three web pages that cite no research. The IOM also referenced two journal articles, but neither one says that exercise helps people with CFS, and one doesn’t even mention CFS. "The IOM points out that there will be a different panel this time", states Andrew. "But this solves very little, because the project will use the same system for quality control."

    On November 15th HHS sent out a Q & A through the CFSAC listserv mailing list. Not only did this Q & A fall short in resolving the many questions, it just added to the inconsistencies and deceit.

    Jeannette Burmeister, in her CFSAC testimony, elaborates:

    "In a letter by Secretary Sebelius to our experts, she claims that the IOM study was necessary because "HHS does not generally develop diagnostic criteria for disease conditions". When I read this, I couldn’t decide whether to start laughing hysterically or beating my head against the wall repeatedly. I mean, really? Correct me if I am wrong, but have we not been suffering tremendously for almost 20 years under the Fukuda definition developed and adopted by the CDC? In light of this reality, the letter’s assertion is outrageous."

    "I have been asked if I am 100% sure that the IOM outcome will be bad? Well, no, I am not. But I am also not 100% sure that I’d be killed if I jumped off the Golden Gate Bridge."

    My own CFSAC testimony focused on another difficulty and inconsistency with statements from the HHS:

    "HHS stated that they do not generally make formal endorsements of clinical recommendations made by non-governmental groups, as an excuse of why they will not adopt the CCC. Does this mean that HHS will not endorse the IOM definition because the IOM is a non-governmental group?".

    This is the problem when one is on a path of lies; it is very hard to get free of the web it created. HHS has also stated in their Q & A that the reason they cannot adopt the CCC is because it is ten years old. Why is it then that HHS has had no problem adopting and using the 1994 Fukuda Criteria for the past 20 years?


    Nods of acceptance from CAA, PANDORA and IACFS/ME

    Considering all the problems and issues that patients and advocates have felt and expressed, it is surprising that some patient organizations have seemed to embrace the contract.

    In their article dated December 5th, the CFIDS Association said that after reviewing the provisional panel announced by the IOM, they are optimistic that this committee will be effective in fulfilling its important mandate.

    They have reached this conclusion because they feel that the panel has:

    • Sufficient and diverse clinical experience and expertise with ME/CFS
    • Patient representation among committee members
    • Expertise in developing diagnostic criteria and outcome measures
    • Expertise in the dissemination of information in areas of unmet medical need

    In a letter dated December 4th, PANDORA's president, Lori Chapo-Kroger, outlined her organization's view regarding the intended panel members of the IOM.

    "Given previous IoM study reports on Gulf War illnesses, we understand there's a possibility that the ME/CFS IoM study results will not produce a definition for the disease that is best for patients if patient advocates and illness experts are not proactively involved in the process. But there is also the possibility that the ME/CFS definition result will be favorable, especially if patient advocates and illness experts are part of the process. This is seen in the IoM's clinical guidelines report on epilepsy. If we can get the same positive results from the IoM has happened with epilepsy, it will be a game-changer for our disease."

    Lori further lays out the plan of the "Get it Right" initiative that has been started, in which 17 people, comprised of advocates and organization representatives, have decided to work together to coordinate efforts at influencing the IoM. This group will network and work together for the 18 month duration of the IoM study.

    In their latest newsletter, the IACFS/ME’s president, Dr. Fred Friedberg, commented on the IOM study and its intended panel:

    "The new IOM CFS/ME definition committee has been nominated—which includes our own board member, Lily Chu. The committee is composed of experts from within and outside of the field in a 50/50 mix. In keeping with our focus on scientific advocacy, we hope that the committee will base their recommendations on data and empirical studies. In the last few years, fine-grained examinations of existing case definitions as well as reporting on actual symptom frequencies in CFS/ME provide a reasonable foundation to inform a case definition. As an independent scientific organization, the IOM's distinguished reputation is based on impartially weighing the evidence and forging an expert consensus on often controversial biomedical conditions. If this process is applied to new (and existing) case definitions, then IOM's recommendations hold the promise of advancing the field and increasing legitimization."


    NAME: "HHS + IOM = BORG"

    Most of the patients and advocates who oppose the HHS/IOM contract remain steadfast and refuse to participate or have any input in the process. This viewpoint was stated by the National Alliance for Myalgic Encephalomyelitis in their article titled "HHS + IOM = BORG".

    "We reject it as illegitimate. We do not recognize the committee as a whole as standing for M.E.

    By the nature of its backroom creation, objected to almost unanimously by the very community it is supposed to be serving, using our tax dollars, we deem any outcome of this ‘study’ invalid – unless the outcome is swift termination of the contract, based on many valid objections already voiced and formally submitted to authorities.

    To cooperate with this ‘study’ in any way is to validate it. Some may believe "resistance is futile." But we will not be assimilated. We will not be accomplices in ‘harming patient care’."


    My personal view

    My personal view is that this contract by HHS with the IOM is wrong. It was conceived in a deceitful, devious way. I don’t think that its intentions were positive. I feel that one cannot take this action by the HHS out of context. HHS has had a long history of malfeasance towards this disease from day one. They have been trying to ‘make it go away’. They have been successful with their aim, starting with the name they gave it, and have followed it up with meager funding and little research. These actions have continued and even mounted in recent history. Funding is diminishing. Research in serious avenues has been denied such as Dr. Lipkin’s hunt for viruses. One only needs to look at CFSAC and Dr. Nancy’s Lee’s behavior toward our community. This is really unacceptable and actually outrageous. Why is it that Dr. Unger remains steadfast in her refusal to include 2 day CPET testing in her current multi-site study? Why it is that Dr. Koh has not attended any of the CFSAC sub-committee meetings he belongs to?

    The elephant in the room is the 'hidden' contract. To be honest, I am surprised that any organization feels comfortable accepting and/or promoting this study without having a view of the contract. It is all in the contract isn’t it? Why has HHS resisted producing it?

    For all the reasons stated above I have joined the fight against the HHS/IOM contract from without and within. As long as it is going ahead, I will point out all of its issues and problems as well as I can.


    How to comment on the proposed panel

    If you would like to comment on the intended panel selection, you have until December 23rd. As per Jennie Spotila’s blog, you may

    1. Submit feedback through the form on the IOM Committee page. Scroll down to the "Feedback" button at the bottom of the page. The study director, Dr. Carmen Mundaca, told me [Jennie] via email that there is no character limit to the size of your submission.
    2. If you prefer to submit your feedback as an attachment, you can do so by emailing it to mecfs@nas.edu.
    Jennie further states:

    "I asked Dr. Mundaca if feedback is viewable by the public. She said that some feedback related to the overall balance of the panel might be placed into the “Public Access File,” a collection of documents viewable by the public. But not all feedback submitted will go into that File, so this is not like the public docket system many people used for the FDA April meeting."





    Phoenix Rising is a registered 501 (c)(3) non profit. We support ME/CFS and NEID patients through rigorous reporting, reliable information, effective advocacy and the provision of online services which empower patients and help them to cope with their isolation.

    There are many ways you can help Phoenix Rising to continue its work. If you feel able to offer your time and talent, we could really use some more authors, proof-readers, fundraisers, technicians etc. and we'd love to expand our Board of Directors. So, if you think you can help then please contact Mark through the Forum.

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    Izola, beaker, Dreambirdie and 3 others like this.
  2. Ember

    Ember Senior Member

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    "HHS...gone fishin'" [copyrighted cartoon] "...reelin' y'all in if'n yer outta line."

    Dr. Lee: “Everyone I know working to make the clinical diagnostic criteria a reality has good intentions and wants to make things better for ME/CFS patients." Posted by Wildaisy: “Insert Dr. Lee's comment about those 'inside voice' advocates 'reeling in' those advocates she thinks are too aggressive.”
    Last edited: Dec 21, 2013
  3. Nielk

    Nielk

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    @Ember - Does anyone have the exact wording that Dr. Lee used? Are there any tapes or transcript of the teleconference?
  4. Dreambirdie

    Dreambirdie work in progress

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    "The elephant in the room is the 'hidden' contract. To be honest, I am surprised that any organization feels comfortable accepting and/or promoting this study without having a view of the contract. It is all in the contract isn’t it? Why has HHS resisted producing it?"

    Yes, the elephant in the room is being courted (predictably) by CAA and PANDORA, and strangely enough by IACFS/ME’s president, Dr. Fred Friedberg. Though I do find it draining and very aggravating to see the same old crap going down, I'm glad to see the patient uprising against this contract.

    Good work, Gabby. Thanks for all your effort(s).
    beaker and Nielk like this.
  5. Esther12

    Esther12 Senior Member

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    Any quack can claim that. I'd feel more comfortable if that was "and wants to ensure that they have more power over their own lives".

    The IOM panel is less bad than I feared, but I still think that it is likely to be unhelpful for patients. There are also a number of people on there who seem to be very much the sort that I feared. That they have not been open about what was going on throughout the process is another reason for concern.
    Last edited: Dec 21, 2013
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  6. Ember

    Ember Senior Member

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    Fred Friedberg, Ph.D. Psychiatry Faculty

    Appointment: Fred Friedberg, PhD Named to Institute of Medicine Panel to Define Chronic Multisymptom Illness in Gulf War Veterans
    Last edited: Dec 20, 2013
  7. taniaaust1

    taniaaust1 Senior Member

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    Im still in complete oppisition to that panel but if its going to go ahead, I would of liked to have some someone familiar with methylation protocal stuff on that panel seeing that helps so many of us. To me its a big missed area which is important if they are going to be making any treatment recommendations.
    Nielk likes this.
  8. taniaaust1

    taniaaust1 Senior Member

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    There is only 2 days left to respond re how you feel about the OMI committee, so if you are worried we are at the last chance to express concerns ..to do so http://www8.nationalacademies.org/cp/CommitteeView.aspx?key=49592

    I've just posted my concerns of the balance.. I cant see how the non experts are going to get a good grip on ME/CFS as we all know this illness takes years to understand and get ones head around, so I think there should of been far more ME/CFS experts on the panel. I also are not happy about some on the panel.. someone who has written about neurasthenia and has an interest in that and who "may" believe this illness is just that, is highly insulting to us to have on the panel.

    As Jennie said
    "Several big names in ME/CFS are missing from the IOM panel. The biggest head scratcher is Dr. Leonard Jason, who received at least seven nominations from the ME/CFS community. Dr. Jason is the authority on ME/CFS definition assessment and comparison."

    Dr Leonard Jason should of certainly been on that panel. I think some in high places saw him as a threat to put on that panel!! As he's a psychologist but one who does understand our illness, he should be on that panel esp since he's also experienced with definitions.

    Anyway... I think they've purposely left him out due to the threat he causes of maybe having us end up with a decent definitions.
  9. taniaaust1

    taniaaust1 Senior Member

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    Well 3 of those 18mths is almost up.. this is going to one heck of a rush job. It takes YEARS of research and looking into it, to really understand this disease. How are those noobs to it going to do it. The time will ensure that they dont have time to be able to look deep into the illness.
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  10. Firestormm

    Firestormm Guest

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    Is 'noob' an Australianism? :)
  11. taniaaust1

    taniaaust1 Senior Member

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    LOL, I hadnt thought of that... it could well be. noob is someone who is completely new at something.
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  12. Valentijn

    Valentijn Activity Level: 3

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    It's short for "newbie". Though if you want to be really |33t, it should be written as "n00b".
    alex3619 likes this.
  13. Firestormm

    Firestormm Guest

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    @Valentijn If I want to be WHAT?! :wide-eyed: 33 again? I should wish :snigger:
  14. alex3619

    alex3619 Senior Member

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    n00b comes from the same group that brought you pwned. Its a computer gamer term.
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  15. Nielk

    Nielk

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  16. Nielk

    Nielk

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  17. Valentijn

    Valentijn Activity Level: 3

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    |33t! Leet!!! Like "elite" but for geeks!!!!11!!!1!!

    You lose teh internetz!!!111!!!11ONE!!!!111!!!

    :lol:
    Firestormm likes this.
  18. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    my comments:
    http://forums.phoenixrising.me/index.php?threads/occupy-cfs-my-feedback-to-iom.27152/#post-414662

    I suggest that anyone who has not yet written in simply endorse a letter or letters that they like, such as mine or Gabby's, if there is one you agree with. You can also of course say you endorse a letter with deletions (made clear by blacklining) or additions if you wish. This will save some precious energy.

    Of course, if you don't agree with our letters, pls send in your own if you think 'engagement' is appropriate.

    Anyone else who writes a letter, again, please post it on that thread so others can get ideas or simply endorse your letter to the IoM.
    Nielk likes this.

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