ME Experts Agree on a Case Definition, Call Secretary Sebelius’ Bluff

Those of you who have followed the HHS’ CFSAC meetings know that Secretary Sebelius has, through Dr. Lee, CFSAC’s Designated Federal Official, told the patient community and CFSAC time and time again that HHS is not the proper institution to develop an official case definition for ME. Secretary Sebelius also made it very clear that she and HHS would not accept a case definition suggested by CFSAC. Instead, she insisted on a case definition that comes from the medical community.

So …. yesterday, 35 of the world’s foremost clinicians and researchers have agreed on the use of a case definition (see open letter below), the Canadian Consensus Criteria (CCC), that has been used more and more frequently for years worldwide. The CCC were adopted by an International Consensus Panel consisting of “members [who] have approximately 400 years of both clinical and teaching experience, authored hundreds of peer-reviewed publications, diagnosed or treated approximately 50 000 patients with ME.”

Well, Secretary Sebelius, the ball is in your court now. Ignoring the adoption of an ME case definition by this vast body of ME experts would confirm what most ME patients have long assumed, i.e., that you do not have any interest in advancing research and treatment options for ME. I guess the experts called your bluff. What’s your next move?

And are you really going to waste tax-payer money on the IOM contract for a disease that is absurdly underfunded for a task that is redundant? This would serve no other purpose than to continue the government’s policy and tactic of muddying the waters to prevent any meaningful progress in the field of ME, for a long time to come. You have a chance to prove the patient community wrong by pulling the IOM contract. But do you have the integrity to do so?

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

September 23, 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.

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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

Lucinda Bateman, MD
Director, Fatigue Consultation Clinic Executive Director, OFFER
Salt Lake City, Utah

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

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

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

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

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

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

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

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

International Signatories

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

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

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

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

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12 Responses to ME Experts Agree on a Case Definition, Call Secretary Sebelius’ Bluff

  1. Laurel says:

    Well said. We need to get the word out and put pressure on them to rescind the IOM contract. You’ve certainly done your part–thank you!

  2. Ok, a few thoughts:

    1. This is highly unlikely to have been pulled off by just the experts calling each other up and saying, “Let’s do this.” They are all way too busy and probably don’t all agree entirely on everything. So, there was at least one mediator involved in making this work.

    2. This most likely took a huge effort.

    3. Unlike many advocates who’d do everything to get their name out there, this person has not come forward and is, thus, a true advocate who works “just” for the cause and not for self promotion. I do not know who this person is (although I can take an educated guess), but I feel immensely grateful to him or her.

  3. Anonymous says:

    Fantastic blog, Jeannette. Very well put.

    Thank you!

  4. “Unlike many advocates who’d do everything to get their name out there, this person has not come forward and is, thus, a true advocate who works “just” for the cause and not for self promotion. I do not know who this person is (although I can take an educated guess), but I feel immensely grateful to him or her.”

    I agree, and this is such a breath of fresh air after all the months and years of so-called advocates pursuing their own goals at te expense of patients’ interests. I am most grateful to this person and I hope she or he continues to do such good work.

    Patricia Carter

  5. Kathy D. says:

    Right on to you, Jeannette for posting all of this, and to whomever organized this and to the signers. It’s about time the doctors and researchers came together in one group and advocated for us, at least the correct definition for Me/CFS. (I’ve worked on gathering endorsements; it’s a lot of work — and everyone agreeing on a statement is hard, and reaching people is also work.)
    I admit that I haven’t followed the issues and politics here, but obviously what Sec. Sibelius is doing smacks of political finagling. Internal governmental political maneuvering is at work here, but since I haven’t been reading up on this — and my brain is like a sieve with this stuff — I don’t know exactly what or why. I keep thinking that whatever the federal government is doing is meant to curtail real medical research, disability benefits and health care, from Medicare, Medicaid and private insurers.
    It’s a time of budget cuts and sequestration so medical research isn’t being well-funded. Dr. Ian Lipkin mentioned that the NIH isn’t giving out much funding for research grants, so we all need to advocate.
    I hope this effort does something that helps us all.

    • Kathy, I agree with you 100%.

      It is SO amazing to see our researchers and clinicians come together and actually strongly stand up to HHS’ shenanigans. I think this will be seen as a turning point, in retrospect, knock on wood.

      Lets keep getting organized, speaking out together and supporting the doctors to speak out!! We are making progress! I am so happy about this!

  6. Alpa says:

    Thanks for posting this Jeanette. I hope it’s a step forward for us all.

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