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Newsflash: 16 new signatories on new letter to HHS--Oct 26

JohnnyD

Senior Member
Messages
206
https://dl.dropboxusercontent.com/u/89158245/Case Definition Letter final 10-25-13.pdf

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

Original Letter – September 23, 2013
Update with additional signatures – October 25, 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

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

Lily Chu, MD, MSHS (Added 10/25/2013)
Independent Researcher
Burlingame, California

Todd E. Davenport, PT, DPT, OCS (Added 10/25/2013)
Associate Professor, Physical Therapy
University of the Pacific
Stockton, 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

Kenneth J. Friedman, PhD (Added 10/25/2013)
Associate Professor of Pharmacology and Physiology, New Jersey Medical School (retired)
Research Associate, Green Mountain College
Adjunct Instructor, Castleton State College
Pawlet, Vermont

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

Betsy Keller, PhD, FACSM (Added 10/25/2013)
Professor, Department of Exercise & Sport Sciences, Ithaca College
Ithaca, New York


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

Konstance Knox, PhD (Added 10/25/2013)
Director of Research, Coppe Healthcare Solutions
Wisconsin Viral Research Group
Waukesha, Wisconsin

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

Malcolm S. Schwartz, DO, FAOCP (Added 10/25/2013)
Clinical Associate Professor of Pediatrics, Drexel University College of Medicine
Philadelphia, Pennsylvania
Pediatric Endocrine LLC.
Long Branch, New Jersey

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

Julian M. Stewart, MD, PhD (Added 10/25/2013)
Director, Center for Hypotension, Associate Chairman of Pediatrics, Professor of Pediatrics,
Physiology and Medicine
New York Medical College
Vahalla, New York

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

J. Mark VanNess, PhD (Added 10/25/2013)
Associate Professor, Department Health, Exercise and Sport Sciences – College of Pacific
Adjunct Professor, Department of Bioengineering – College of Computer Sciences and
Engineering
University of the Pacific
Stockton, California

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


International Signatories

Alison C. Bested, MD, FRCPC (Added 10/25/2013)
Medical Director, Complex Chronic Diseases Program
British Columbia Women's Hospital and Health Centre
Clinical Associate Professor, Faculty of Medicine, University of British Columbia
Vancouver, British Columbia, Canada

Nicoletta Carlo-Stella, MD, PhD (Added 10/25/2013)
Clinician
Nazzani Studio
Pavia, Italy

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

Øystein Fluge, MD, PhD (Added 10/25/2013)
Consultant in Oncology, Department of Oncology
Haukeland University Hospital
Bergen, Norway
Malcolm Hooper, PhD, BPharm, MRIC, CChem (Added 10/25/2013)
Emeritus Professor of Medicinal Chemistry, University of Sunderland
Sunderland, Tyne and Wear, United Kingdom

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

Olav Mella, MD, PhD (Added 10/25/2013)
Professor, Director, Department of Oncology
Haukeland University Hospital
Bergen, Norway

Kunihisa Miwa, MD, PhD (Added 10/25/2013)
Director, Miwa Naika Clinic
Toyama City, Toyama Prefecture, Japan

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

Nigel Speight, MA, MB, BChir, FRCP, FRCPCH, DCH (Added 10/25/2013)
Pediatrician
County Durham, United Kingdom

Eleanor Stein, MD, FRCP(C) (Added 10/25/2013)
Psychiatrist
Assistant Clinical Professor, University of Calgary
Calgary, Alberta, Canada

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
 

Delia

Senior Member
Messages
139
Location
Iowa
This is unprecedented in my 20 years of special education, disability and autism advocacy.

Very few experts will go out on such a limb, even when they agree in private. It can be very hard on them professionally.

For me, this is what makes it so clear, the advocacy strategy must be resistance to the IOM contract.
 

Ember

Senior Member
Messages
2,115
So much for this statement by Dr. Vernon: "I heard from about half of the signatories. Several stood by their signature indicating the money for the contract should go to research. Others didn’t feel an IOM committee would do a good job. And yet others were hopeful that the IOM contract would be productive and effective."

And this statement by PANDORA: “So, it was not surprising to hear of one of the experts changing her position publicly and at least one other tell us privately that he has changed his position.”

Dr. Bateman's is the only signature to be withdrawn.
 
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leela

Senior Member
Messages
3,290
Are Doctors Kogelnick, Lapp, Gordon, Nathan aware of this letter? I am having a brain black hole on the name of the British researcher who was rather hounded out of a job for daring to publish on ME. Begins with a K maybe? What about Maes? Hyde? So sad Rich Van K is not with us, he surely would have signed as well.

It is such a relief and uplift to feel so supported by our medical community.

ETA I even wonder if one ought to ask Dennis Mangan if he'd like to sign it.
Oh and Hornig.
 

Nielk

Senior Member
Messages
6,970
At the October 2012 CFSAC meeting, Dr. Lee stated:

"In general, the Federal Government isn’t in the position of telling doctors a case definition. I think a recommendation from CFSAC that the Secretary should tell people to use “X” definition will go nowhere because that’s not what we do. This is a clinical decision that has to come from the clinical community."

"I’ve been in two or three meetings with the Secretary since I’ve been here. One of them was around this: the idea of a case definition, the need for one, and in addition, the need for a different name for the disease. She basically said that this has to be coming from the medical community. Just to let you know, that’s her belief."

The clinical community has spoken, in unity, clearly and strongly.

The fact that 50 experts around the world have signed this letter to the Secretary speaks volumes and if the Secretary is true to her word as Nancy lee stated at the CFSAC meeting, this decision should stand with no hesitation.

It is clinicians who define the disease and they just have. For HHS to go against this is wrong on so many levels. How can they explain their decision to against this list of experts???
 

Nielk

Senior Member
Messages
6,970
Notice that unlike the rumors from CAA and PANDORA, only one name has bee removed from the list - Dr. Bateman. For all those who believed that had the experts seen the announcement by HHS of their contract with IOM before they signed the letter, some would have pulled out their signature, here is your answer loud and clear.
 

Ember

Senior Member
Messages
2,115
This post by Jen Brea calls for some out-of-the-box thinking:
Canary in a Coal Mine

Would love your ideas on how to use the energy we have right now (which is huge and growing!) for good on two fronts: 1) Karina 2) IOM.

Ideas most welcome!
And here's a media suggestion by Colleen Steckel on the Canary in a Coal Mine facebook page:
Some of us have been posting about the disastrous IOM contract, and your movie was mentioned on The Stream Al Jazeera's post asking "what stories are you following". This is the 3rd day something has been posted about CFS on there. Anybody joining in commenting or just liking the comments already posted might help Al Jazeera to do a story.
 
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Ember

Senior Member
Messages
2,115
I wish the organizations that represent us could unite in the same way to send a strong message to HHS!

Which organizations represent us? The CAA and PANDORA seek to represent larger groups of patients. The CAA website uses the Fukuda case definition:
Diagnostic Criteria / Case Definition

In 1994 an updated case definition was developed by an international working group of CFS experts. Although the criteria were designed to be used for research purposes, physicians utilize them as diagnostic guidelines for CFS. The case definition criteria calls for four of eight symptoms to be present along with fatigue that interferes with physical, mental, social and educational activities. Both the fatigue and symptoms must have occurred for [at least] a six month period. People with CFS may experience many more than the eight symptoms named in the case definition, so knowledgeable physicians will take this fact into consideration when making a diagnosis (after other possible reasons for symptoms have been ruled out).

The PANDORA website avoids mentioning case definitions altogether.

Because the CDC uses a divide-and-conquer strategy, burying ME within a larger patient population, disunity among patients shouldn't surprise us. The experts are seeking to extricate ME, and we should follow them.
 

Ecoclimber

Senior Member
Messages
1,011
The patient community on a whole has asserted itself and taken the position away from PANDORA (which is a trifle small organization) as well as the CAA, and has spoken out loud and clear of their support for all the ME/CFS researchers and clincians who have written and updated an open letter to Secretaty Sebelius opposing the IOM contract in confirmed their support of CCC patient criteria. Their position opposes the actions of Vernon and the cfids.org.

PANDORA must either stand in support of the ME/CFS community for the CCC criteria by opposing the IOM contract or stand against the 17 million stong worldwide patient community. THERE IS NO MIDDLE GROUND HERE!

CAA opposes the interests of the patient community by their support of the IOM Contract and therefore by default does not represent nor speak on behalf of the majority of the ME/CFS patient community.

I concur with this analysis
Is PANDORA helpful to M.E. patients or is it an obstacle to progress?
http://www.mecfsforums.com/index.php/topic,18166.msg155890.html#msg155890
 
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Sushi

Moderation Resource Albuquerque
Messages
19,935
Location
Albuquerque
This is great! Those "35" must have been working hard behind the scenes to increase the signatories to 50. Their amended letter is very important as we now have a clear statement from them after the IOM contract was shoved through.

Sushi
 

SOC

Senior Member
Messages
7,849
The addition of 16 new signatories is a great development!

Patients might consider asking their current ME/CFS specialist, if s/he is not one of the current signatories, if s/he is aware of the IOM contract and this letter and whether s/he would consider adding their support.

I can think of several expert clinicians whose names are not on this letter. I'd be interested in knowing what their reason is for not signing -- not that I'm ever likely to know. ;) Dr Bateman was honest and open about her change of position. I appreciate that transparency, although I have to admit I'd now think twice about going to her.

Does anyone know if there's a CAA influence here? Do our "missing" docs and researchers have professional connections and/or contracts with CAA that might affect their willingness to go contrary to the CAA's stated position?

ETA: Is their some concern among some clinicians and "advocacy groups" that using the CCC as the definition of "ME/CFS" would further marginalize the patient group within the Fukuda definition but not the CCC? That would be primarily patients with chronic fatigue but not PEM, I believe.
 

Sushi

Moderation Resource Albuquerque
Messages
19,935
Location
Albuquerque
Cort Johnson weighs in: http://www.cortjohnson.org/blog/201...nic-fatigue-definition-controversy-continues/

The thirty-five is now fifty…

Instead of being mollified by the DHHS working document, the effort by ME/CFS experts to rescind the IOM contract to produce a clinical case definition has actually gathered steam. The fifty ME/CFS experts signing the letter now include Dr. Lily Chu, Dr. Kenneth Friedman, Dr. Betsy Keller (exercise physiologist), and Dr. Van Ness and Snell (Workwell) in the U.S., and Dr’s Bested, Fluge, Mella and others from outside the U.S.
 

Nielk

Senior Member
Messages
6,970
The addition of 16 new signatories is a great development!

Patients might consider asking their current ME/CFS specialist, if s/he is not one of the current signatories, if s/he is aware of the IOM contract and this letter and whether s/he would consider adding their support.

I can think of several expert clinicians whose names are not on this letter. I'd be interested in knowing what their reason is for not signing -- not that I'm ever likely to know. ;) Dr Bateman was honest and open about her change of position. I appreciate that transparency, although I have to admit I'd now think twice about going to her.

Does anyone know if there's a CAA influence here? Do our "missing" docs and researchers have professional connections and/or contracts with CAA that might affect their willingness to go contrary to the CAA's stated position?

ETA: Is their some concern among some clinicians and "advocacy groups" that using the CCC as the definition of "ME/CFS" would further marginalize the patient group within the Fukuda definition but not the CCC? That would be primarily patients with chronic fatigue but not PEM, I believe.


I don't know that it is so important at this point that all clinicians and researchers with ME/CFS experience actually sign this letter.

the fact is that most big names have signed it. They have all stated that:

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.

They are all in agreement to adopt the CCC now. Since when do we need the signature of every clinician and researcher in the world for a consensus on diagnostic criteria?

I wonder if any other disease has 50 signatories to their consensus criteria? This is monumental! It is the clinicians who define diseases. The clinicians have just done that. There is nothing to question anymore. What reason can HHS come up with not to agree with 50 clinicians and researchers?

They have nothing to stand on anymore. This whole sham of a deceptive contract that was pushed through and shoved down our throat is starting to regurgitate. We have to be as clear and precise with our intentions as our experts have been.

We will not be duped any longer and played with any longer. Like Eco said above, there is no middle ground here in my opinion. We either stand with our 50 experts or we stand with the IOM.
 

SOC

Senior Member
Messages
7,849
I don't know that it is so important at this point that all clinicians and researchers with ME/CFS experience actually sign this letter.

the fact is that most big names have signed it. They have all stated that:



They are all in agreement to adopt the CCC now. Since when do we need the signature of every clinician and researcher in the world for a consensus on diagnostic criteria?

I wasn't suggesting we need the signature of every clinician and researcher. :) I think the 50 signatures is a huge statement all on it's own. However, I think even more signatures cannot hurt and is likely to be even more help, so why not encourage more experts to put their names behind this effort? Obviously, we are not going to get all of them behind it. There are differences of opinion on the subject, as Dr Bateman clearly demonstrated.

At the same time, if my specialist -- to whom I'm giving a lot of money for treatment -- was not supportive of this letter, I'd want to know why. I might agree with their position if I knew it, or I might find that my specialist and I are not as in sync on the future of ME/CFS treatment and research as I thought.

BTW, "consensus" by definition does imply agreement by all involved in the decision -- as opposed to a majority rule. It's not my favorite decision-making process as it often leads to watered-down useless conclusions in order to get 100% agreement from the decision-makers. It also lends itself to manipulation by individuals or groups with strong extremist positions who refuse to agree to anything but exactly what they want. But that's a side point. :D
 
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