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HHS krabbelt deels terug

op voornemen om

zelfstandig nieuwe criteria

voor "CVS" te ontwikkelen,

ME/CVS-experts schrijven open brief

en pleitten voor invoering

Canadese Consensus-criteria.








Het Amerikaanse Ministerie van Volksgezondheid en Sociale Zaken (HHS)

lijkt deels op haar schreden terug te keren om nieuwe "CVS"-criteria te doen ontwikkelen.


De plannen om het Institute of Medicine buiten iedereen om nieuwe criteria te laten uitwerken

werden duidelijk toen een op de achtergrond gesloten contract met IOM openbaar werd.


Dit leidde tot een storm van protest van patienten en een e-mail actie richting HHS.


HHS lijkt nu deels op haar voornemen te zijn teruggekomen (zie onder).


IOM gaat eigenhandig nieuwe diagnosecriteria voor CVS ontwikkelen (waarom?) en

de NIH zal een workshop organiseren om tot nieuwe research-criteria te komen (waarom?).


Een groep van ME deskundigen tekent via een open brief grote bezwaren aan (zie onder)

en pleit voor de invoering en verfijning van de Canadese Consensus-Criteria voor ME/CVS.


Deze nieuwe soap wordt ongetwijfeld vervolgd.






HHS Signs IOM Contract



The CFSAC Listserv sent out the following announcement this evening:


Monday, September 23, 2013



We are pleased to announce that

the Institute of Medicine (IOM) will begin conducting a study on

Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome this month.


This study grew out of the 2012 CFSAC recommendation to the Secretary

to convene a workshop to

“reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS.”


Because the use of and audience for

case definitions for research and clinical care are very different,

HHS decided that separate processes were needed to develop them.


The NIH is convening an Evidence-based Methodology Workshop process

that will consider case definitions appropriate for ME/CFS research and

the IOM will address the clinical diagnostic portion of the recommendation.


The Office on Women’s Health/HHS

is co-sponsoring the IOM study with several agencies

that participate in CFSAC.


A group of voting and non-voting members of the committee

participated in the development of the Statement of Work.


The IOM has agreed to perform the following tasks over the next 18 months:

  • Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS
  • using a process with stakeholder input, including practicing clinicians and patients;

  • Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians,
  • using a consensus-building methodology;

  • Recommend whether new terminology for ME/CFS should be adopted;
  • Develop an outreach strategy to disseminate the definition nationwide to health professionals.

To accomplish these tasks, the IOM has also agreed that:

  • the IOM committee will include
  • approximately 15 members with expertise in the following areas:

    epidemiology; clinical medicine/primary care and other health care fields,

    particularly with expertise in ME/CFS,

    including neurology, rheumatology, immunology, pain, infectious disease,

    behavioral health, cardiology, endocrinology; and

    scientists and physicians with experience in developing clinical case definitions.

    The IOM will ask interested parties,

    including expert clinicians, researchers and patient advocates,

    to make suggestions for nominees to the committee.

  • the IOM, in addition to the committee meetings,
  • will sponsor open meetings

    to enlist the comments and concerns of

    patients, family members and other caretakers,

    health educators, health care professionals, and advocacy groups.

    During these meetings, an open phone line and email address

    will be available to those who cannot attend in person.

  • as the committee reviews the literature,
  • efforts that have already been completed on this topic area will be considered,

    including the 2003 ME/CFS Canadian Consensus Definition,

    the 2007 NICE Clinical Guidelines for CFS/ME,

    the 2010 Revised Canadian ME/CFS definition,

    the 2011 ME International Consensus Criteria, and

    data from the ongoing CDC multi-site clinical study of CFS.

    In an effort to minimize overlap and maximize synergy,

    the committee will seek input from

    the NIH Evidence-based Methodology Workshop for ME/CFS.

  • the committee will distinguish between disease subgroups,
  • develop a plan for updating the new criteria, and

    make recommendations for its implementation.

    Any recommendations made by the committee

    will consider unique diagnostic issues facing people with ME/CFS,

    specifically related to: gender, across the lifespan, and

    specific subgroups with substantial disability.


HHS is proud to be making this investment in ME/CFS.


We have heard the advocates’ concerns and trust

that many have been addressed by the information provided in this email.


It is our hope that a widely accepted clinical definition and

a clear distinction from case definitions for clinical trials and research

will aid in advancing clinical care, drug development,

and basic translational research for ME/CFS.



The CFSAC Support Team


I wanted to get this distributed as soon as possible.


It will take us all some time to digest the news.


Please note that all those emails to HHS and Congress were not for nothing.


It appears, at first glance,

that the ME community's concerns are reflected in part in this summary.


In addition, the emails to Congress have built awareness

not only of ME but also of the problems our community is having

with the lack of transparency from 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.
  • Lucinda Bateman, MD
  • David S. Bell, MD, FAAP
  • Gordon Broderick, PhD
  • Paul R. Cheney, MD, PhD
  • John K.S. Chia, MD
  • Kenny L. De Meirleir, MD, PhD
  • Derek Enlander, MD, MRCS, LRCP
  • Mary Ann Fletcher, PhD
  • Ronald Glaser, PhD, FABMR
  • Maureen Hanson, PhD
  • Leonard A. Jason, PhD
  • Nancy Klimas, MD
  • Gudrun Lange, PhD
  • A. Martin Lerner, MD, MACP
  • Susan Levine, MD
  • Alan R. Light, PhD
  • Kathleen C. Light, PhD
  • Peter G. Medveczky, MD
  • Judy A. Mikovits, PhD
  • Jose G. Montoya, MD, FACP, FIDSA
  • James M. Oleske, MD, MPH
  • Martin L. Pall, PhD
  • Daniel Peterson, MD
  • Richard Podell, MD, MPH
  • Irma Rey, MD
  • Christopher R. Snell, PhD
  • Connie Sol, MS, PhDc
  • Staci Stevens, MA
  • Marshall V. Williams, PhD

International Signatories

  • Birgitta Evengard MD, PhD
  • Sonya Marshall-Gradisnik, PhD
  • Charles Shepherd, MB BS
  • Rosamund Vallings MNZM, MB BS