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An Open Letter to the Honorable Kathleen Sebelius

Ember

Senior Member
Messages
2,115
https://dl.dropboxusercontent.com/u/89158245/Case Definition Letter Sept 23 2013.pdf
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.

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
 

Roy S

former DC ME/CFS lobbyist
Messages
1,376
Location
Illinois, USA
This is great to see but I wonder how much it's going to do.

An advisory committee for AIDS at least discussed resigning en masse to protest the poor response of the US government. Sorry for the dim memory but I think it was 1991 during a relatively short relapse for me while living on Capitol Hill. I haven't been able to find information on it online. It seems like the name of the woman chairing the committee was something like Dr. Osborn.
Perhaps the CFSAC should consider doing that now after three decades of [insert appropriate colorful descriptions of what we've been going through]. It's the sort of thing that gets attention.
 

Ember

Senior Member
Messages
2,115
Perhaps the CFSAC should consider doing that now after three decades of [insert appropriate colorful descriptions of what we've been going through]. It's the sort of thing that gets attention.
Experts would risk being co-opted if they were to participate in the IOM study. The same could be said now of their CFSAC participation.
 

Keela Too

Sally Burch
Messages
900
Location
N.Ireland
Wow! This is fantastic news - and what a list of signatories too. I have heard 3 of these individuals speak and know how much they understand and support the ME patients. Notice of this will surely be taken?

:thumbsup:
 

Ember

Senior Member
Messages
2,115
Wow! This is fantastic news - and what a list of signatories too.
Four of the seven clinicians in Dr. Unger's multi-site study have signed--Drs. Bateman, Klimas, Peterson and Podell. That should make for an interesting dynamic!

I wonder what Drs. Lapp, Kogelnik and Natelson are thinking.
 

Keela Too

Sally Burch
Messages
900
Location
N.Ireland
They do talk of re-defining as new information comes in from research - and I think this is an important point: It is the scientists involved in the studies who need to be considering the refinements to the definition. And it seems they are all happy to agree with the CCC as the starting point.
 

Hugocfs

Senior Member
Messages
121
Location
U.S.A.
This whole IOM contract doesn't make sense and doesn't pass the smell test. Something is rotten about it. Maybe I am being too pessimistic, but my gut feeling is that this open letter will be ignored and the contract will be pushed through. Time will tell.
 

*GG*

senior member
Messages
6,389
Location
Concord, NH
I wouldn't call her Honorable though, she had to be sued to let a young girl get a lung transplant from an adult, she was just going to let her die!

Remember that, these people in the Feds do not give a crap about us, on the whole. FYI

GG
 

readyforlife

Senior Member
Messages
137
Thank you Jennie for a really great article TRUST.

 
TRUST has been a long standing issue with US tax payers and the Government.
People who are sick, tired, in pain, and trying to get help from the government are going to get frustrated.

Look at any normal person who gets a kink in their neck, kidney stones, canker sores, shingles ETC. They all get frustrated and cranky from the pain and the inconvenience that it causes in their lives, but it soon goes away and they forget all about what they went through. My husband gets cranky if he is hungry and I always say that I have to go feed the monster. But when he eats something he is back to feeling good and happy.

Now back to the CFS/ME person, we are always suffering 24 hours a day, year after year. And our Government wonders why we sometimes get pissed off in our letters and they feel they don’t deserve that kind of treatment. They are right they don’t deserve to be mistreated and neither do we!! I’ve never been nasty in any of the letters that I have sent out but I can see how people could snap.

Enough is enough, It’s time for our government to listen and respond to our community. I’ve sent out a lot of emails these last few weeks and not one congressman or representative has emailed me back saying they received my email or acknowledged me in any way.

Our government is a mess. The funding for research should have priorities, like people who are suffering with out medication first!! Here are a few things our government would rather spend their money on.

It was recently revealed that the National Institutes of Health awarded a Boston hospital more than $1.5 million to figure out why nearly three-quarters of lesbians are overweight — calling the disparities a significant public health issue.

Another waste of taxpayer dollars is a study of pictures of animals in National Geographic magazines. The cost: $227,437. The grant for “Picturing Animals in National Geographic, 1888-2008,” is designed to look at how the esteemed magazine has used animal photos.

The US government via the National institutes of health awards a $181,406 to a researcher to spend on research into how cocaine enhances the sex drive of the Japanese Quail.

$682,570 in grants has been awarded to the research efforts to study a project that has shrimp running on a treadmill.

 
I’ve been sick for 20 years the last 10 have been hell. Each year that goes by something new pops up. The one thing that I always have said is thank god I don’t get headaches, like a lot of CFS/ME sufferers do. Well guess what has been popping up this year….HEADACHES. The constant pain and suffering is to much. I hide a lot of my suffering from my husband and kids because who wants to constantly hear how miserable you are…..no one.
We need change and help. How many other diseases are out there that don’t have any kind of medication available. This is inhumane.
 

Ember

Senior Member
Messages
2,115
Has Dr. Bateman forgotten that she signed the open letter to Secretary Sebelius? She writes, “I respect the opinions and decisions of my colleagues on either side of this vigorous dialogue, but feel it might be helpful to explain why I made the decision to support the IOM contract instead of advocating that we adopt the CFS Canadian Criteria as our official clinical definition.”
 

Nielk

Senior Member
Messages
6,970
Has Dr. Bateman forgotten that she signed the open letter to Secretary Sebelius? She writes, “I respect the opinions and decisions of my colleagues on either side of this vigorous dialogue, but feel it might be helpful to explain why I made the decision to support the IOM contract instead of advocating that we adopt the CFS Canadian Criteria as our official clinical definition.”


It's very interesting what a letter or cal from CAA can accomplish. Yes, she did sign the letter of 35!
 

Ecoclimber

Senior Member
Messages
1,011
I should add that not only patients should contact and write their objections and asking for a a resission of the contract to DHHS, The President, Representatives in Congress but friends, family members, basically anyone you can think of, should write. I noted that some patients have express difficulty even just writing a note but every bit helps. You could use the strategy of additional costs and more bureaucracy on an illness that has already been defined by the experts. This may sway some during this period of fiscal restraint.

It also dosen't have to be limited to only patients in the United States but to patients worldwide as funding for scientific research will come to a standstill both publically and privately. There are 17 million worldwide patients that will be affected.

With the shutdown of Congress, this couldn't happen at the least opportune time but maybe it was their strategy with Congress having no appetite to address an insignificant issue such as this.

This link provides the definition by the IOM redefining GWS into CMI, Chronic Multi-Symptom Illness. Look familiar?
http://www.med.umich.edu/1libr/aha/umcmi.htm

If you know of any patients from other communities or forums such as the Gulf War veterans, Fibromyalgia, Lyme, you should ask them to notify their member to assist you in this campaign. It will affect them as well.

Eco