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TELL HHS THAT YOU OPPOSE ANY EFFORT TO REDEFINE ME

Discussion in 'Institute of Medicine (IOM) Government Contract' started by Denise, Sep 3, 2013.

  1. Denise

    Denise Senior Member

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    ME Advocacy Action: Urgent
    Tell HHS that you oppose the IOM contract – stop the proposed IOM Study!
    HHS’s proposal to contract with the IOM to “develop clinical diagnostic criteria for ME/CFS” is extremely dangerous and must be stopped.
    Why be concerned with this IOM initiative? The January 2013 IOM report on treatments for Gulf War Illness (GWI) redefined GWI as the non-specific chronic multisymptom illness (CMI) and recommended CBT, exercise and anti-depressants as treatments for severely ill and dying veterans with GWI. In addition, IOM is now conducting a study to “define a consensus case definition for chronic multisymptom illness (CMI) as it pertains to the 1990-91 Gulf War Veteran population.” This effort has come under fire by GWI advocates for failing to include sufficient expertise in Gulf War Illness on its panel.
    If the current IOM initiative to define Gulf War Illness is any indication, the “ME/CFS” IOM initiative will use non-ME experts to “define” our disease and will likely result in a definition that is even worse than Fukuda – a vague, non-science based case definition that will set ME science and treatment back for decades.
    The sample letter to HHS and the background section below provides more information on the dangers of this initiative and on the IOM initiatives on GWI.
    Immediate Actions You Can Take to Stop This Contract:
    1. Send an email to HHS voicing your strong opposition to this initiative as soon as possible but no later than by 5pm on Monday, September 9th. The email should go to HHS Secretary Kathleen Sebelius, Assistant Secretary Howard Koh, and the heads of all the CFSAC ex officio agencies. The email addresses are provided below along with detailed instructions and a sample email that you can use if you wish.

    1. Distribute this action alert to your advocacy networks and your family and friends, and urge them to send an email as well.
    The above actions are initial steps to send a strong message to HHS that the ME advocacy community opposes this effort. But we will not stop there - more actions are planned, including Congressional intervention. Stay tuned for updates and additional actions you can take. We can and must stop this destructive, anti-scientific initiative!
    If you have questions, please contact MEACTNOW@yahoo.com.
    ___________________________________________________________________________
    Instructions for Emailing HHS:
    1. If you are using the sample email provided below, copy the sample email into the body of an email message.
    2. Add your name to the end of the letter.
    3. Add the Subject Line “Stop the IOM Contract on “ME/CFS” Clinical Criteria”
    4. Copy the following addresses into the ‘TO” and “CC” boxes
    TO: Kathleen.Sebelius@hhs.gov
    CC: howard.koh@hhs.gov; txf2@cdc.gov; Tomfrieden@cdc.gov; Marilyn.Tavenner@cms.hhs.gov; margaret.hamburg@fda.hhs.gov; Mary.Wakefield@hrsa.hhs.gov; collinsf@mail.nih.gov; richard.kronick@hhs.gov; MEACTNOW@yahoo.com


    The CC includes the following individuals:
    HHS Assistant Secretary Howard Koh
    AHRQ Director Richard Kronick
    CDC Director Thomas Frieden
    CMS Administrator Marilyn Tavenner
    FDA Director Margaret Hamburg
    HRSA Director Mary K. Wakefield
    NIH Director Francis Collins

    The Social Security administration is not included because the agency head’s email is not available yet. The email address MEACTNOW@yahoo.com is used to track the numbers of messages sent.


    Sample Email - To be copied into the body of an email message.

    Dear Secretary Sebelius,
    I am writing to voice my strong opposition to the HHS proposal to contract with the Institute of Medicine (IOM) to develop “clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome.” I am a member of the ME community and have witnessed firsthand the devastation of this disease. I am extremely concerned that this planned IOM initiative will gravely harm ME patients. Note that I am purposely using the term “ME” to distinguish the disease that has affected me from the overly broad “CFS”.
    I oppose this proposal for the following reasons:
    • Two peer-reviewed consensus case definitions, developed by experts in this disease, already exist – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. The CCC has been used both clinically and in research. Both are accompanied by clinical guidelines for medical practitioners, and are well regarded by patients, ME doctors, and ME researchers. Given that expertly defined and accepted consensus clinical criteria already exist, the proposed IOM contract wastes scarce taxpayer dollars and is unnecessary.

    • HHS has inexplicably refused to accept the CCC or the ME-ICC and even questions the hallmark symptoms of ME. Instead, it has promoted an overly broad view of the disease called “CFS”, which does not require the hallmark symptoms. This has confounded ME with depression, deconditioning and non-specific chronic fatigue, has severely impeded research, and is the direct cause of the medical skepticism and inappropriate or harmful treatment recommendations to which patients are subjected.

    • IOM has only been involved in one other study to define a disease, the current effort for Gulf War Illness (GWI). Advocates and the Research Advisory Committee for GWI (RAC) have criticized the IOM report that redefined GWI as the overly broad chronic multisymptom illness (CMI). They further criticized the misguided focus on psychiatric issues and the failure to staff the IOM panel with GWI experts. Given this and IOM’s inaccurate characterization of CFS in the January 2013 IOM report on treatments for Gulf War Illness patients, we have no confidence that IOM is capable of producing a clinical consensus criteria that defines ME as described by CCC, ME-ICC and most importantly, the patients themselves.

    • Ironically, the claimed intent of the HHS-IOM initiative is to develop a consensus definition but this effort has been progressed in secret, apparently for many months and without consultation with key ME stakeholders. The timing of the announcement before a holiday weekend and the short response time indicate that HHS was not looking for input from the ME experts and ME community.

    • This IOM initiative does not reflect the October 2012 CFSAC recommendation on the development of a case definition for this disease and in fact is in direct contradiction to that recommendation. CFSAC recommended that a clinical and research case definition be developed in unison, that the effort begin with the Canadian Consensus Criteria and, most importantly, that it be developed by disease experts only.

    I strongly urge HHS to abandon its plan for this ill-advised, wasteful, and unscientific initiative.

    Sincerely,
    <Name>



    BACKGROUND

    On August 27, the Department of Health and Human Services (HHS) announced a proposal to award a contract to the Institute of Medicine (IOM) on a sole source basis to recommend consensus “clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome.” Due to federal contracting rules, HHS has given other potential contractors until September 11, 2013 to inform HHS of their interest and capabilities before HHS moves forward with signing the contract with IOM. It is likely that HHS will sign a contract with IOM immediately after the September 11 deadline.
    We have good reason to be extremely concerned that this IOM initiative will produce a definition that is as bad or even worse than Fukuda. The VA contracted the IOM to study Gulf War Illness (GWI). In January of 2013, the IOM issued a report, “Gulf War and Health: Treatment for Chronic Multisymptom Illness”. This report recharacterized GWI as chronic multisymptom Illness (CMI), defined “as the presence of a spectrum of chronic symptoms in at least two of six categories—fatigue, mood and cognition, musculoskeletal, gastrointestinal, respiratory, and neurologic—experienced for at least six months.” The creation of CMI muddied the patient cohort and in the words of Anthony Hardie, Gulf War vet, GWI patient and member of the VA Gulf War Research Steering Committee “defined [the disease] so broadly as to include nearly any human health condition.”

    Chronic multisymptom illness is even broader than Fukuda and we know how Fukuda has buried ME.

    GWI Advocates also charge that the IOM study and report obscured the science. In testimony in front of the House Committee on Veterans Affairs, Hardie further stated:

    The [IOM treatments] panel was charged by VA to conduct a literature review rather than to consult with knowledgeable medical practitioners experienced in treating ill Gulf War veterans. And nearly all of the first presenters focused on "stress-as-cause", psychological, and psychosomatic issues – all debunked years ago.”

    Not surprisingly, the IOM report recommended treatment guidelines that focused on anti-depressants, CBT and exercise. The IOM report even included a section on “CFS”, which included erroneous and outdated information and also listed CBT, exercise and anti-depressants as treatments.

    Since then, the VA has contracted with IOM to constitute another IOM panel to “develop a consensus case definition for chronic multisymptom illness (CMI) as it pertains to the 1990-91 Gulf War Veteran population.” GWI advocates have criticized the composition of the panel and its inadequate expertise in Gulf War Illness. Jim Binns, chairman of the federal research advisory committee for GWI stated “the panel includes members that “represent discredited points of view” as well as psychosomatic and mental illness experts.””

    Its important to note that Dr. Kenneth Shine, the previous president of IOM, has stated that he does not remember another time when IOM has been involved in defining a disease.

    Reading about the IOM initiative for GWI is like reading a prequel to the planned IOM initiative for “ME/CFS”. It is not a leap to surmise that if the proposed IOM project goes forward, ME will be completely obliterated and be replaced with CFS as a subtype of chronic multisymptom illness.

    Why is HHS spending the time, money and risk to come up with a new clinical criteria for ME - and the associated medical education material that will be required - when expertly developed consensus criteria and medical education already exist and are in use? Why is HHS using IOM, an organization whose single effort to define a disease has generated so much controversy with GWI advocates? What is the specific statement of work for this initiative? Will the panel be composed primarily of non-experts as was done with GWI? Why is HHS being so secretive? It appears that discussions with IOM regarding development of a case definition have been going on for months, yet HHS has not discussed the IOM initiative with ME clinicians and researchers, the members of CFSAC or the patient advocates.
    This initiative is dangerous and will hurt ME patients. We must oppose it.
    =======================================================================
    Additional Resources:

    1. HHS Announcement of the Solicitation for “Study for Diagnostic Criteria for CFS” https://www.fbo.gov/index?s=opportu...&id=7fafc35816ee932dc44d6c319937b366&_cview=1
    2. Forbes. “Inside the effort to define Gulf War Illness” 6/28/2013 http://www.forbes.com/sites/rebeccaruiz/2013/06/28/inside-the-effort-to-define-gulf-war-illness/
    3. USA Today. “Gulf War illness advocates skeptical of institute panel. 6/26/2013 http://www.usatoday.com/story/nation/2013/06/26/veterans-institute-of-medicine-gulf-war-illness/2458745/
    4. March 13, 2013 testimony by Anthony Hardie, Gulf War vet and member of the VA Gulf War Research Steering Committee, before the House Committee on Veterans Affairs, http://veterans.house.gov/witness-testimony/mr-anthony-hardie-0
    Video - http://www.youtube.com/watch?v=OuNJbPMfrYo
    1. IOM Initiative to define Gulf War Illness: “Development of a Case Definition for Chronic Multisymptom Illness” http://www8.nationalacademies.org/cp/projectview.aspx?key=49546
    2. 91outcomes.Com collection of documents related to the IOM panel to define a consensus criteria for chronic multisymptom illness. Published by Anthony Hardie. http://www.91outcomes.com/2013/06/uploads-iom-gulf-war-chronic.html
     
    Roy S and medfeb like this.
  2. Nielk

    Nielk

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    Thank you Denise and others who have worked on this.

    I sent out my e-mail. It took less than five minutes. In my opinion, probably the most important five minutes of the year.

    I hope that everyone realizes how important of an action this is. If you have been worried about the PACE trial and about the dangers of all that push the CBT/GET treatment down our throat, this could become the "official stamp" of approval for them.

    If the HHS' intentions are purely honorable and they plan on building on the CCC and/or ICC, they would have shouted this out publicly as soon as they thought of it or certainly when the diagnostic criteria kept being mentioned at the last CFSAC meeting.

    As Denise so very well described above, they are trying to sneak this past us. They will do to us what they have done to GWS.

    Please take a few minutes to send this letter out and try to share this as widely as possible. :thumbsup:
     
    medfeb likes this.
  3. Denise

    Denise Senior Member

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    Thanks Nielk!
    Like you I feel this is one of the most important actions I have been involved in to date.
    Since the announcement, I have slept a lot of time reading about the GWI IOM report debacle, concerns about gutting of the GWI advisory committee, public comment by their committee members.....It's very unsettling.
    I think we should take this DHHS/IOM proposal about clinical diagnostic criteria for "ME/CFS" very seriously and make them stop this before it gets started.
    (Just to clarify, I am the one who posted this to PR, but much of the wording was done by others than me.)
     
    Nielk likes this.
  4. Denise

    Denise Senior Member

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    WillowJ likes this.
  5. medfeb

    medfeb Senior Member

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    Thanks for posting this, Denise and for your support, Neilk. This effort is really concerning and could set us back even further than we already are. I ask everyone to please send in an email - today and every day!
     
    Nielk likes this.
  6. Nielk

    Nielk

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    Why is it that DHHS has repeatedly ignored the CCC and ICC, yet they feel comfortable with assigning the responsibility to to the Institute of Medicine who has no experience producing diagnostic criterias to illnesses?
     
  7. Sasha

    Sasha Fine, thank you

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    Denise, I have PM'ed you. :)
     
  8. Sparrowhawk

    Sparrowhawk Senior Member

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    Egads, that's a short deadline. How does one get this onto the PR frontpage as an article and call to action?
     
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  9. Bob

    Bob

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    medfeb and Sasha like this.
  10. Bob

    Bob

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    medfeb and Sasha like this.
  11. readyforlife

    readyforlife Senior Member

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    Just emailed mine just now.
     
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  12. Nielk

    Nielk

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    Great! Thank you. Please remember to e-mail every day.
     
  13. medfeb

    medfeb Senior Member

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    Yes, please email every day. We have very little time to raise our concerns. ANd please ask your networks, and family and friends to also email
     
  14. Denise

    Denise Senior Member

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  15. Sasha

    Sasha Fine, thank you

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    Sent mine. :)
     
  16. Sparrowhawk

    Sparrowhawk Senior Member

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  17. Denise

    Denise Senior Member

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    Greetings everyone.
    As of Wednesday afternoon 4 Sept 2013 the site that posted the announcement about the DHHS/IOM project has this update:
    "Synopsis:
    Added: Sep 04, 2013 4:12 pm
    This request has been cancelled. However, HHS will continue to explore mechanisms to accomplish this work."
    We are working to find out exactly what this all means.
    My own feeling is that everyone's efforts (pat yourselves on the back folks!) on this have bought us time but that we are "not out of the woods yet".
    Please know that your work is much appreciated.
    We hope to have more information on Thursday and will do our best to update and let you know what next steps need to be taken.
     
    Bob, Sasha and Sea like this.
  18. medfeb

    medfeb Senior Member

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    Thank you to everyone who sent an email to HHS! HHS has received at least 100 emails a day since Tuesday morning - more if we assume some people did not include the tracking email. The count is currently 235.

    Together we are making this happen.

    As Denise said, HHS has stopped the IOM proposal that they had announced last week but they have said that they are now pursuing other mechanisms. We need to understand what they are planning, especially when they have acted in such secrecy.

    We also need to ask why HHS is even in the ME definition business at all when experts have already defined the disease. Imagine if all the money being spent by HHS on all those definition efforts were instead being spent on targeted research to finally validate/get broad acceptance of the biomarkers that expert clinicians use today.

    Please keep sending your emails.

    Thank you!!
    Mary Dimmock
     
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  19. Bob

    Bob

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    Thanks medfeb, and everyone else involved, for all the work that's going on behind the scenes. It's obviously making a difference, and it's really appreciated.
     
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  20. Denise

    Denise Senior Member

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    As MedFeb says we continue to work to find out what DHHS's intentions are, among other things.

    It's great that we are coming together to work on this!

    I am told (thanks C for the info) that there is a Facebook event page
    https://www.facebook.com/events/705280782832088/
    that has sample letters that can be used/adapted.... These letters reflect the cancellation of the proposed solicitation.

    For those (like me) not on Facebook (I am "different" that way ;) ) I will paste the sample letters below.

    Emails should be sent to
    Kathleen.Sebelius@hhs.gov
    CC: howard.koh@hhs.gov , txf2@cdc.gov , Tomfrieden@cdc.gov , Marilyn.Tavenner@cms.hhs.gov , margaret.hamburg@fda.hhs.gov , Mary.Wakefield@hrsa.hhs.gov , collinsf@mail.nih.gov , richard.kronick@hhs.gov , MEACTNOW@yahoo.com

    There is another letter here http://speakupaboutme.wordpress.com/2013/09/05/just-say-no-to-tapioca/






    Dear Secretary Sebelius,

    I am writing to voice my strong opposition to any HHS mechanism for developing “clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome” that does not include the ME community.

    I am a member of the ME community and have witnessed firsthand the devastation of this disease. I am extremely concerned that you plan on doing this behind our backs with no input from us. Note that I am purposely using the term “ME” to distinguish the disease that has affected me from the overly broad “CFS”.

    Two peer-reviewed consensus case definitions, developed by experts in this disease, already exist – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. The CCC has been used both clinically and in research. Both are accompanied by clinical guidelines for medical practitioners, and are well regarded by patients, ME doctors, and ME researchers. Given that expertly defined and accepted consensus clinical criteria already exist, anything other than officially adopting one of these definitions wastes scarce taxpayer dollars and is unnecessary.

    HHS has inexplicably refused to accept the CCC or the ME-ICC and even questions the hallmark symptoms of ME. Instead, it has promoted an overly broad view of the disease called “CFS”, which does not require the hallmark symptoms. This has confounded ME with depression, deconditioning and non-specific chronic fatigue, has severely impeded research, and is the direct cause of the medical skepticism and inappropriate or harmful treatment recommendations to which patients are subjected.

    While you no longer appear to be seeking a contract with the IOM to develop a consensus definition, the fact remains that this effort was progressed in secret, apparently for many months and without consultation with key ME stakeholders. The timing of the announcement before a holiday weekend and the short response time indicate that HHS was not looking for input from the ME experts and ME community.

    I have no confidence in the manner in which you are handling this matter, and frankly, don't see the need for anything but the obvious: Officially adopting one of the existing, expert consensus criteria.

    Sincerely,
    <Your Name>




    second letter is below the dashed line
    ---------------------------------------------------------------------

    Dear Secretary Sebelius,

    I applaud the Department of Health and Human Services' decision not to proceed with the wasteful and unnecessary contract for the Institute of Medicine to redefine, yet again, "ME/CFS" and to develop consensus diagnostic criteria. However, I am troubled that HHS wishes to continue "to explore mechanisms to accomplish this work."

    An excellent set of consensus guidelines for the diagnosis and treatment of the specific disease was developed and published in 2003 by the Canadian Consensus Criteria panel. Unfortunately, the US Centers for Disease Control has chosen to ignore the CCC guidelines and has continued to mislead and to misinform the medical community about the disease for the last ten years. The CDC is still dispensing inaccurate diagnostic criteria and treatment recommendations based on the overly broad 1994 Fukuda chronic fatigue syndrome (CFS) research case definition.

    The CCC guidelines were updated in 2011 by the Myalgic Encephalomyelitis: International Consensus Criteria document developed by a panel of the world's leading ME experts with jointly over 500 years of clinical experience. http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full

    A useful Primer for Medical Practitioners, based on the ME ICC, has been published and is ready for distribution to doctors, hospitals, medical schools, professional medical societies, and medical support personnel. http://www.hetalternatief.org/ICC primer 2012.pdf

    Developing yet another set of diagnostic criteria will not only be wasteful but will only serve to confuse the field further. There is still a need, however, to develop standard ME research criteria with objective measures, based on the ICC, so that the scientific era in ME research can finally begin.

    I urge HHS simply to adopt the existing ME ICC guidelines as the starting point so that research, diagnosis, and treatment of the actual disease may progress.


    Sincerely,
    <Your Name>


     
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