Open letter of September 23, 2013 to Kathleen Sebelius

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Last Updated: 23 January 2016 23 January 2016

For those who are following the Chronic Fatigue Syndrome Advisory Committee (CFSAC) progress, there is little. There seems to be no forward movement or recommendations that move up to Secretary of Health & Human Services Sebelius' office.

At the Spring 2013 meeting, the CFSAC committee recommended that HHS accept the Canadian Consensus Criteria (CCC) and the Primer put out by the International Association of Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (IACFS/ME).

Quietly and rather suddenly, the the Department of Health and Human Services (HHS) have put forth a contract with the Institute of Medicine (IOM) to create a definition for CFS. The problem—this organization simply looks over already published material to reach their conclusions. There might be no experts in the field of CFS involved. If there wasn't such a wealth of incorrect studies published basically on how this illness is psychiatric in nature, it wouldn't be an issue. Then, due to an overwhelming backlash from patients and advocates, the HHS seemed to back down. But in a sudden reversal of this, the HHS signed the contract with the IOM. Although HHS claims IOM will consult with CFS/ME experts, patients have been down this road before and remain skeptical at best.

Now a large group consisting of thirty-five national and international CFS/ME researchers/clinicians have signed onto an open letter sent to Secretary Sebelius pressing the requests to accept the CCC.

The signatory names are impressive and reflect years of knowledge. We sincerely hope the government agencies will listen to them. The Open Letter was first circulated on CO-CURE on 9/24/2013.  The letter was re-issued with additional signatures on October 25, 2013.

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 acceleratedprogress 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

Dr. Lipkin's ME/CFS research project pending publication

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Last Updated: 18 September 2013 18 September 2013

Soon to be published ME/CFS research project expected to provide valuable data

The Centers for Disease Control and Prevention (CDC) Chronic Fatigue Syndrome (CFS) Patient-Centered Outreach and Communication Activity (PCOCA) held its second conference call for this year, on September 10, 2013. Elizabeth Unger, PhD, MD, Branch Chief, Chronic Viral Diseases Branch at the CDC served as host for this call that featured the world-renowned scientist, Dr. W. Ian Lipkin, who spoke about "Infection and Immunity in CFS." Dr. Lipkin is the John Snow Professor of Epidemiology Professor of Neurology and Pathology Director, Center for Infection and Immunity at Columbia University Medical Center, New York, NY. He has spent the past 30 years doing high-caliber research of many infectious agents, outbreaks, and emerging infectious diseases.

Dr. Lipkin has also worked on Chronic Fatigue Syndrome (CFS) research on several occasions. Several years ago, he was asked to lead the research project that re-examined XMRV/PMV in CFS (no infections were found in CFS); however, that study revealed many of the CFS patients had evidence of immune activation which captured Dr. Lipkin's interest. In this telephone broadcast, Dr. Lipkin provided a preview of some of the findings to come from a large research ME/CFS project, prior to its publication. This project was supported by the Chronic Fatigue Initiative (funded by the Hutchins Family Foundation). Although Dr. Lipkin prefaced his report with remarks that no single agent or cause was identified for CFS, he spoke about what he considers to be valuable data and where the focus of future research should go.

Phoenix Rising provides an excellent summary of the material presented by Dr. Lipkin in the following article, Lipkin finds biomarkers not bugs. Their article incorporates the transcript from this telephone broadcast; the link appears at the top of the article (i.e, this is highly recommended reading).

Join advocates to request CPET, NK cell and viral testing in CDC multi-site study

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Last Updated: 23 January 2016 23 January 2016

Our Association was one of the signers of a July 11, 2013, letter to Dr. Beth Unger of the Centers for Disease Control and Prevention (CDC) and others, including the clinicians involved in the CDC’s multi-site research study, urging the CDC to include certain objective tests in their studies of ME/CFS patients.  The tests recommended are: Cardiopulmonary exercise testing (CPET), specifically the two-day CPET regimen known as the Stevens Protocol, and lab tests which measure Natural Killer Cell function and viral load, including enteroviruses.
 
For more background, links to the letters sent to the government officials and the clinicians, as well as a sample letter requesting the same that you can send yourself, see the excellent article “CDC Study Must Include CPET, NK Cell and Viral Testing, Advocates Insist”, by Mark Berry on Phoenix Rising.

Does Procrastination Live Among CFS and FM Patients?

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Last Updated: 06 December 2015 06 December 2015

Is there such a thing as procrastination for those with Chronic Fatigue Syndrome (CFS)/ Fibromyalgia (FM)? Do not yell all at once. For most people procrastination is a bad thing—but does it exist for us?

Having a chronic illness can force changes in the way we approach the things we want to do. No longer can we count on our body to do what we tell it to, when we tell it to do it. What is usually thought of as procrastination in healthy people can simply be in the CFS/FM population the inability to complete a task because the energy needed is simply not there.

From CFS/FM patient experience of more than 30 years: all too often when patients are having a "good day" they will subscribe to the philosophy of "I'm going to do everything I can because I don't know when I'll have another good day."

While this attitude is understandable, it is NOT helpful and can cause damage. It puts too much stress on the body—too much activity equals dead in bed for days or weeks. Using more energy than necessary ends up being counterproductive since working one's body or mind to extremes actually consumes more energy. It is much like gunning the engine on a car—one uses more gas but doesn't get there much faster. When one drives slowly and steadily and doesn't gun the engine, it uses less gas, and you still get there without wearing out the car. The analogy works with our bodies. Don't gun your body. It will help limit the number of crashes. Working towards a better balance between trying to live life and living with a chronic illness (i.e., recognizing triggers, limitations and other aspects of your health) will promote a better quality of life. It may take some practice to find this sweet spot but it is worth trying.

It is because of the crashes and the lack of predictability for accomplishing a task that many CFS/FM patients first prioritize the most essential tasks for their "good time". Next in priority are those tasks that aren't essential, but still important. But these "secondary" tasks will often get pushed down the list when new essential tasks come up. On a good day it's important to pick the one or two essential tasks, rest, and then see if one can accomplish anything more without "going down-hill." So patients are frequently forced to start, stop, prioritize and re-prioritize.

Of course, there are times when even essential tasks are too difficult to accomplish because one is simply too sick. At least the decision is made. Harder to navigate, when one is in a relapse, is the uncertainty of whether, tomorrow, one will be able to get to the doctor's appointment, or get out to buy food. This uncertainty leads to "anticipatory stress", which can make the illness itself temporarily worse.

The calculation frequently has to be made: how much do I need this to be done now; can I actually do it without really harming myself; can I get away with it with an "acceptable" pay-back.

Can all of this be called "procrastination"? No. It is the reality of living with a severe or even moderate chronic illness. Most of what healthy people call life is curtailed, and CFS/FM patients are forced to live a scaled-back existence in which time is slowed and the 2 lists of "essentials" and "necessary" are done one or two steps at a time, one day or a few at a time. And then, once and awhile, something creative or fun.

Here is where patients can help themselves—learn to practice the B word—BALANCE. It seems to be difficult for some people to manage because they are not tuned into their bodies. They can't read the signals their body sends when they have hit their energy limit, and should stop activity. (Easier to say than do.) Over the years, many patients have been told to "just learn to live with the illness" and as a result they have learned to tune-out their bodies and ignore any signals. Much like learning a language, it starts with letters, then words, then sentences, then paragraphs. Patients who are tuned into their bodies speak that language and pick up all signals, and they listen. (This does not include folks who are hypochondriacs.)

A serious chronic illness actually provides some good life lessons. (Wish they could have been learned some other way!) Patients have had to stop and assess their lives. On the positive side, they must learn to make more careful and deliberate choices as to what can be done or not, learn to conserve energy, set boundaries by learning to say no, and not take everything for granted. They also have to make a conscious choice who they want around them cutting-out or limiting exposure to toxic people. Those are excellent skills to have.

So, does procrastination live in the CFS/FM world? Procrastination is a luxury most patients don't enjoy.