Monday, September 23, 2013

An Open Letter to Kathleen Sibelius, HHS

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.

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.


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
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
Fran├žois-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
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


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

No comments: