Open Letter to Hon. Kathleen Sebelius 9/23/2013

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


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 maor 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


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 Clincian President, EV Med Research Lomita, California


Kenny L. De Meirleir, MD, PhD Professor Emeritus Physiology and medicine (Vrije Univeersiteit Brussel) Medical Director, Whittemore-Peterson Insttute 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 Behavior 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 Medial 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 Constulting, 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 Mediine Nova Southeastern University Fort Lauderdale, Florida


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


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


Marshall V. Williams, PhD Professor, Department 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 an 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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