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Newsflash: 16 new signatories on new letter to HHS--Oct 26

Discussion in 'Institute of Medicine (IOM) Government Contract' started by JohnnyD, Oct 26, 2013.

  1. JohnnyD

    JohnnyD Senior Member

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    https://dl.dropboxusercontent.com/u/89158245/Case Definition Letter final 10-25-13.pdf

    An Open Letter to the Honorable Kathleen Sebelius, U.S. Secretary of Health and Human Services

    Original Letter – September 23, 2013
    Update with additional signatures – October 25, 2013

    Dear Secretary Sebelius,

    We are writing as biomedical researchers and clinicians with expertise in the disease of Myalgic
    Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to inform you that we have reached a
    consensus on adopting the 2003 Canadian Consensus Criteria (CCC) as the case definition for
    this disease.

    The 1994 International Case Definition (Fukuda et al, 1994), commonly known as the Fukuda
    definition, was the primary case definition for ME/CFS for almost two decades. However, in
    recent years expert researchers and clinicians have increasingly used the CCC, as they have
    recognized that the CCC is a more scientifically accurate description of the disease.

    The CCC was developed by an international group of researchers and clinicians with significant
    expertise in ME research and treatment, and was published in a peer-reviewed journal in 2003
    (Carruthers et al, Journal of Chronic Fatigue Syndrome, 2003). Unlike the Fukuda definition, the
    more up-to-date CCC incorporates the extensive scientific knowledge gained from decades of
    research. For example, the CCC requires the symptom of post-exertional malaise (PEM), which
    researchers, clinicians, and patients consider a hallmark of the disease, and which is not a
    mandatory symptom under the Fukuda definition. The CCC was endorsed in the Primer for
    Clinical Practitioners published by the International Association of Chronic Fatigue Syndrome/
    Myalgic Encephalomyelitis (IACFSME). This organization is the major international professional
    organization concerned with research and patient care in ME/CFS.

    The expert biomedical community will continue to refine and update the case definition as
    scientific knowledge advances; for example, this may include consideration of the 2011 ME
    International Consensus Criteria (Carruthers et al, Journal of Internal Medicine, 2011). As
    leading researchers and clinicians in the field, however, we are in agreement that there is
    sufficient evidence and experience to adopt the CCC now for research and clinical purposes,
    and that failure to do so will significantly impede research and harm patient care. This step will
    facilitate our efforts to define the biomarkers, which will be used to further refine the case
    definition in the future.

    We strongly urge the Department of Health and Human Services (HHS) to follow our lead by
    using the CCC as the sole case definition for ME/CFS in all of the Department’s activities
    related to this disease.

    In addition, we strongly urge you to abandon efforts to reach out to groups such as the Institute
    of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for
    ME/CFS. Since the expert ME/CFS scientific and medical community has developed and
    adopted a case definition for research and clinical purposes, this effort is unnecessary and
    would waste scarce taxpayer funds that would be much better directed toward funding research
    on this disease. Worse, 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. We believe that our consensus decision
    on a case definition for this disease will jump start progress and lead to much more rapid
    advancement in research and care for ME/CFS patients. We look forward to this accelerated
    progress and stand ready to work with you to increase scientific understanding of the
    pathophysiology of this disease, educate medical professionals, develop more effective
    treatments, and eventually find a cure.

    Sincerely,

    United States Signatories

    Dharam V. Ablashi, DVN, MS, Dip Bact.
    Scientific Director of HHV-6 Foundation
    Co-founder of IACFS/ME
    Santa Barbara, California

    David S. Bell, MD, FAAP
    Researcher and Clinician
    Associate Professor of Pediatrics
    State University of New York at Buffalo
    Lyndonville, New York

    Gordon Broderick, PhD
    Professor, Center for Psychological Studies
    Director, Clinical Systems Biology Lab
    Institute for Neuro Immune Medicine,
    Nova Southeastern University
    Fort Lauderdale, Florida

    Paul R. Cheney, MD, PhD
    Director, The Cheney Clinic, PA
    Asheville, North Carolina

    John K.S. Chia, MD
    Researcher and Clinician
    President, EV Med Research
    Lomita, California

    Lily Chu, MD, MSHS (Added 10/25/2013)
    Independent Researcher
    Burlingame, California

    Todd E. Davenport, PT, DPT, OCS (Added 10/25/2013)
    Associate Professor, Physical Therapy
    University of the Pacific
    Stockton, California



    Kenny L. De Meirleir, MD, PhD
    Professor Emeritus Physiology and Medicine (Vrije Universiteit Brussel)
    Medical Director, Whittemore-Peterson Institute
    University of Nevada
    Reno, Nevada

    Derek Enlander, MD, MRCS, LRCP
    Attending Physician
    Mount Sinai Medical Center, New York
    ME CFS Center, Mount Sinai School of Medicine
    New York, New York

    Mary Ann Fletcher, PhD
    Schemel Professor of NeuroImmune Medicine
    Institute for Neuro Immune Medicine
    Nova Southeastern University
    Fort Lauderdale, Florida

    Kenneth J. Friedman, PhD (Added 10/25/2013)
    Associate Professor of Pharmacology and Physiology, New Jersey Medical School (retired)
    Research Associate, Green Mountain College
    Adjunct Instructor, Castleton State College
    Pawlet, Vermont

    Ronald Glaser, PhD, FABMR
    Director, Institute for Behavioral Medicine Research
    Kathryn & Gilbert Mitchell Chair in Medicine
    College of Medicine - Distinguished Professor
    Professor, Molecular Virology, Immunology and Medical Genetics
    Professor, Internal Medicine
    Professor, Division of Environment Health Sciences, College of Public Health
    Institute for Behavioral Medicine Research
    Columbus, Ohio

    Maureen Hanson, PhD
    Liberty Hyde Bailey Professor
    Department of Molecular Biology and Genetics
    Cornell University
    Ithaca, New York

    Leonard A. Jason, PhD
    Professor of Psychology
    DePaul University
    Chicago, Illinois

    Betsy Keller, PhD, FACSM (Added 10/25/2013)
    Professor, Department of Exercise & Sport Sciences, Ithaca College
    Ithaca, New York


    Nancy Klimas, MD
    Director, Institute for Neuro Immune Medicine
    Professor, Nova Southeastern University
    Fort Lauderdale, Florida

    Konstance Knox, PhD (Added 10/25/2013)
    Director of Research, Coppe Healthcare Solutions
    Wisconsin Viral Research Group
    Waukesha, Wisconsin

    Gudrun Lange, PhD
    Clinical Neuropsychologist
    Professor, Rutgers New Jersey Medical School
    Newark, New Jersey

    A. Martin Lerner, MD, MACP
    Professor, Infectious Diseases
    Oakland University William Beaumont School of Medicine
    Emeritus Director, Infectious Diseases, Wayne State University School of Medicine
    Master, American College of Physicians
    Reviewer, Viral Diseases, Medical Letter
    Beverly Hills, Michigan

    Susan Levine, MD
    Researcher and Clinician, Private Practice
    New York, New York
    Visiting Fellow, Cornell University
    Ithaca, New York

    Alan R. Light, PhD
    Professor, Department of Anesthesiology and Department of Neurobiology and Anatomy
    University of Utah
    Salt Lake City, Utah

    Kathleen C. Light, PhD
    Researcher
    Professor, Department of Anesthesiology
    University of Utah School of Medicine
    Salt Lake City, Utah

    Peter G. Medveczky, MD
    Professor, Department of Molecular Medicine
    College of Medicine
    University of South Florida
    Tampa, Florida

    Judy A. Mikovits, PhD
    Researcher, MAR Consulting, LLC
    Carlsbad, California

    Jose G. Montoya, MD, FACP, FIDSA
    Professor of Medicine
    Division of Infectious Diseases and Geographic Medicine
    Stanford University School of Medicine
    Stanford, California

    James M. Oleske, MD, MPH
    François-Xavier Bagnoud Professor of Pediatrics
    Director, Division of Pediatrics Allergy, Immunology & Infectious Diseases
    Department of Pediatrics, Rutgers New Jersey Medical School
    Newark, New Jersey

    Martin L. Pall, PhD
    Professor Emeritus of Biochemistry and Basic Medical Sciences
    Washington State University
    Portland, Oregon

    Daniel Peterson, MD
    Founder and President of Sierra Internal Medicine
    Incline Village, Nevada

    Richard Podell, MD, MPH
    Clinical Professor, Department of Family Medicine
    UMDNJ Robert Wood Johnson Medical School
    New Brunswick, New Jersey

    Irma Rey, MD
    Clinician
    Institute for Neuro Immune Medicine
    Nova Southeastern University
    Fort Lauderdale, Florida

    Malcolm S. Schwartz, DO, FAOCP (Added 10/25/2013)
    Clinical Associate Professor of Pediatrics, Drexel University College of Medicine
    Philadelphia, Pennsylvania
    Pediatric Endocrine LLC.
    Long Branch, New Jersey

    Christopher R. Snell, PhD
    Professor, Health, Exercise and Sport Sciences
    University of the Pacific
    Stockton, California

    Connie Sol, MS, PhDc
    Clinical Exercise Physiologist, Institute for Neuro Immune Medicine
    Nova Southeastern University
    Fort Lauderdale, Florida


    Staci Stevens, MA
    Exercise Physiologist
    Founder, Workwell Foundation
    Ripon, California

    Julian M. Stewart, MD, PhD (Added 10/25/2013)
    Director, Center for Hypotension, Associate Chairman of Pediatrics, Professor of Pediatrics,
    Physiology and Medicine
    New York Medical College
    Vahalla, New York

    Rosemary A. Underhill, MB BS, MRCOG, FRCSE
    Independent Researcher
    Palm Coast, Florida

    J. Mark VanNess, PhD (Added 10/25/2013)
    Associate Professor, Department Health, Exercise and Sport Sciences – College of Pacific
    Adjunct Professor, Department of Bioengineering – College of Computer Sciences and
    Engineering
    University of the Pacific
    Stockton, California

    Marshall V. Williams, PhD
    Professor, Departments of Molecular Virology, Immunology and Medical Genetics; Microbiology
    The Ohio State University
    Columbus, Ohio


    International Signatories

    Alison C. Bested, MD, FRCPC (Added 10/25/2013)
    Medical Director, Complex Chronic Diseases Program
    British Columbia Women's Hospital and Health Centre
    Clinical Associate Professor, Faculty of Medicine, University of British Columbia
    Vancouver, British Columbia, Canada

    Nicoletta Carlo-Stella, MD, PhD (Added 10/25/2013)
    Clinician
    Nazzani Studio
    Pavia, Italy

    Birgitta Evengard, MD, PhD
    Professor, Division Infectious Diseases
    Umea University
    Umea, Sweden

    Øystein Fluge, MD, PhD (Added 10/25/2013)
    Consultant in Oncology, Department of Oncology
    Haukeland University Hospital
    Bergen, Norway
    Malcolm Hooper, PhD, BPharm, MRIC, CChem (Added 10/25/2013)
    Emeritus Professor of Medicinal Chemistry, University of Sunderland
    Sunderland, Tyne and Wear, United Kingdom

    Sonya Marshall-Gradisnik, PhD
    Director, National Centre for Neuroimmunology and Emerging Diseases
    Griffith Health Institute
    Professor, Griffith University Parklands Gold Coast
    Queensland, Australia

    Olav Mella, MD, PhD (Added 10/25/2013)
    Professor, Director, Department of Oncology
    Haukeland University Hospital
    Bergen, Norway

    Kunihisa Miwa, MD, PhD (Added 10/25/2013)
    Director, Miwa Naika Clinic
    Toyama City, Toyama Prefecture, Japan

    Charles Shepherd, MB BS
    Honorary Medical Adviser to the ME Association
    London, United Kingdom

    Nigel Speight, MA, MB, BChir, FRCP, FRCPCH, DCH (Added 10/25/2013)
    Pediatrician
    County Durham, United Kingdom

    Eleanor Stein, MD, FRCP(C) (Added 10/25/2013)
    Psychiatrist
    Assistant Clinical Professor, University of Calgary
    Calgary, Alberta, Canada

    Rosamund Vallings, MNZM, MB BS
    IACFS/ME Secretary
    Clinician, Howick Health and Medical Clinic
    Auckland, New Zealand

    Cc:

    Dr. Howard Koh, Assistant Secretary for Health
    Dr. Richard Kronick, Director, Agency for Healthcare Research and Quality
    Dr. Thomas Frieden, Director, Centers for Disease Control and Prevention
    Ms. Marilyn Tavenner, Administrator, Centers for Medicare and Medicaid Services
    Dr. Margaret Hamburg, Commissioner, U.S. Food and Drug Administration
    Dr. Mary Wakefield, Administrator, Health Resources and Services Administration
    Dr. Francis Collins, Director, National Institutes of Health
    Ms. Carolyn W. Colvin, Commissioner, Social Security Administration
    justinreilly, Sushi, Nielk and 9 others like this.
  2. Ember

    Ember Senior Member

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    Nice to have an even 50!:balloons:
    aimossy, justinreilly, beaker and 2 others like this.
  3. leela

    leela Slow But Hopeful

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    This is really fantastic! Keep the signatures comin'!
    And profound gratitude to those who have signed, as well as those urged them to do so.
    It's quite an impressive roster.
  4. Delia

    Delia Senior Member

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    This is unprecedented in my 20 years of special education, disability and autism advocacy.

    Very few experts will go out on such a limb, even when they agree in private. It can be very hard on them professionally.

    For me, this is what makes it so clear, the advocacy strategy must be resistance to the IOM contract.
  5. Ember

    Ember Senior Member

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    So much for this statement by Dr. Vernon: "I heard from about half of the signatories. Several stood by their signature indicating the money for the contract should go to research. Others didn’t feel an IOM committee would do a good job. And yet others were hopeful that the IOM contract would be productive and effective."

    And this statement by PANDORA: “So, it was not surprising to hear of one of the experts changing her position publicly and at least one other tell us privately that he has changed his position.”

    Dr. Bateman's is the only signature to be withdrawn.
    Last edited: Oct 27, 2013
    Delia, justinreilly, Sushi and 2 others like this.
  6. leela

    leela Slow But Hopeful

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    Are Doctors Kogelnick, Lapp, Gordon, Nathan aware of this letter? I am having a brain black hole on the name of the British researcher who was rather hounded out of a job for daring to publish on ME. Begins with a K maybe? What about Maes? Hyde? So sad Rich Van K is not with us, he surely would have signed as well.

    It is such a relief and uplift to feel so supported by our medical community.

    ETA I even wonder if one ought to ask Dennis Mangan if he'd like to sign it.
    Oh and Hornig.
    Delia likes this.
  7. Nielk

    Nielk

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    I think it is there.
  8. Kina

    Kina Moderation Team Lead

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    I moved the thread to the IOM forum. :)
    peggy-sue and Bob like this.
  9. Nielk

    Nielk

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    At the October 2012 CFSAC meeting, Dr. Lee stated:

    "In general, the Federal Government isn’t in the position of telling doctors a case definition. I think a recommendation from CFSAC that the Secretary should tell people to use “X” definition will go nowhere because that’s not what we do. This is a clinical decision that has to come from the clinical community."

    "I’ve been in two or three meetings with the Secretary since I’ve been here. One of them was around this: the idea of a case definition, the need for one, and in addition, the need for a different name for the disease. She basically said that this has to be coming from the medical community. Just to let you know, that’s her belief."

    The clinical community has spoken, in unity, clearly and strongly.

    The fact that 50 experts around the world have signed this letter to the Secretary speaks volumes and if the Secretary is true to her word as Nancy lee stated at the CFSAC meeting, this decision should stand with no hesitation.

    It is clinicians who define the disease and they just have. For HHS to go against this is wrong on so many levels. How can they explain their decision to against this list of experts???
    Delia, justinreilly, Gemini and 7 others like this.
  10. Nielk

    Nielk

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    I wish the organizations that represent us could unite in the same way to send a strong message to HHS!
  11. Nielk

    Nielk

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    Notice that unlike the rumors from CAA and PANDORA, only one name has bee removed from the list - Dr. Bateman. For all those who believed that had the experts seen the announcement by HHS of their contract with IOM before they signed the letter, some would have pulled out their signature, here is your answer loud and clear.
    Delia, aimossy, justinreilly and 4 others like this.
  12. Ember

    Ember Senior Member

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    This post by Jen Brea calls for some out-of-the-box thinking:
    And here's a media suggestion by Colleen Steckel on the Canary in a Coal Mine facebook page:
    Last edited: Oct 26, 2013
  13. Ember

    Ember Senior Member

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    Which organizations represent us? The CAA and PANDORA seek to represent larger groups of patients. The CAA website uses the Fukuda case definition:
    The PANDORA website avoids mentioning case definitions altogether.

    Because the CDC uses a divide-and-conquer strategy, burying ME within a larger patient population, disunity among patients shouldn't surprise us. The experts are seeking to extricate ME, and we should follow them.
    Delia, justinreilly, beaker and 5 others like this.
  14. Ecoclimber

    Ecoclimber Senior Member

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    The patient community on a whole has asserted itself and taken the position away from PANDORA (which is a trifle small organization) as well as the CAA, and has spoken out loud and clear of their support for all the ME/CFS researchers and clincians who have written and updated an open letter to Secretaty Sebelius opposing the IOM contract in confirmed their support of CCC patient criteria. Their position opposes the actions of Vernon and the cfids.org.

    PANDORA must either stand in support of the ME/CFS community for the CCC criteria by opposing the IOM contract or stand against the 17 million stong worldwide patient community. THERE IS NO MIDDLE GROUND HERE!

    CAA opposes the interests of the patient community by their support of the IOM Contract and therefore by default does not represent nor speak on behalf of the majority of the ME/CFS patient community.

    I concur with this analysis
    Is PANDORA helpful to M.E. patients or is it an obstacle to progress?
    http://www.mecfsforums.com/index.php/topic,18166.msg155890.html#msg155890
    Last edited: Oct 27, 2013
  15. Sushi

    Sushi Moderator and Senior Member Albuquerque

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    This is great! Those "35" must have been working hard behind the scenes to increase the signatories to 50. Their amended letter is very important as we now have a clear statement from them after the IOM contract was shoved through.

    Sushi
    Delia, justinreilly, beaker and 3 others like this.
  16. SOC

    SOC Moderator and Senior Member

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    The addition of 16 new signatories is a great development!

    Patients might consider asking their current ME/CFS specialist, if s/he is not one of the current signatories, if s/he is aware of the IOM contract and this letter and whether s/he would consider adding their support.

    I can think of several expert clinicians whose names are not on this letter. I'd be interested in knowing what their reason is for not signing -- not that I'm ever likely to know. ;) Dr Bateman was honest and open about her change of position. I appreciate that transparency, although I have to admit I'd now think twice about going to her.

    Does anyone know if there's a CAA influence here? Do our "missing" docs and researchers have professional connections and/or contracts with CAA that might affect their willingness to go contrary to the CAA's stated position?

    ETA: Is their some concern among some clinicians and "advocacy groups" that using the CCC as the definition of "ME/CFS" would further marginalize the patient group within the Fukuda definition but not the CCC? That would be primarily patients with chronic fatigue but not PEM, I believe.
  17. Sushi

    Sushi Moderator and Senior Member Albuquerque

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    Cort Johnson weighs in: http://www.cortjohnson.org/blog/201...nic-fatigue-definition-controversy-continues/

    Nielk and SOC like this.
  18. Nielk

    Nielk

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    I don't know that it is so important at this point that all clinicians and researchers with ME/CFS experience actually sign this letter.

    the fact is that most big names have signed it. They have all stated that:

    They are all in agreement to adopt the CCC now. Since when do we need the signature of every clinician and researcher in the world for a consensus on diagnostic criteria?

    I wonder if any other disease has 50 signatories to their consensus criteria? This is monumental! It is the clinicians who define diseases. The clinicians have just done that. There is nothing to question anymore. What reason can HHS come up with not to agree with 50 clinicians and researchers?

    They have nothing to stand on anymore. This whole sham of a deceptive contract that was pushed through and shoved down our throat is starting to regurgitate. We have to be as clear and precise with our intentions as our experts have been.

    We will not be duped any longer and played with any longer. Like Eco said above, there is no middle ground here in my opinion. We either stand with our 50 experts or we stand with the IOM.
    Delia, beaker, alex3619 and 1 other person like this.
  19. leela

    leela Slow But Hopeful

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    'Zacly!
    Delia and justinreilly like this.
  20. SOC

    SOC Moderator and Senior Member

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    I wasn't suggesting we need the signature of every clinician and researcher. :) I think the 50 signatures is a huge statement all on it's own. However, I think even more signatures cannot hurt and is likely to be even more help, so why not encourage more experts to put their names behind this effort? Obviously, we are not going to get all of them behind it. There are differences of opinion on the subject, as Dr Bateman clearly demonstrated.

    At the same time, if my specialist -- to whom I'm giving a lot of money for treatment -- was not supportive of this letter, I'd want to know why. I might agree with their position if I knew it, or I might find that my specialist and I are not as in sync on the future of ME/CFS treatment and research as I thought.

    BTW, "consensus" by definition does imply agreement by all involved in the decision -- as opposed to a majority rule. It's not my favorite decision-making process as it often leads to watered-down useless conclusions in order to get 100% agreement from the decision-makers. It also lends itself to manipulation by individuals or groups with strong extremist positions who refuse to agree to anything but exactly what they want. But that's a side point. :D
    Last edited: Oct 27, 2013
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