Contract Signed

This message was sent out via the CFS Advisory Committee listserv this evening:

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 hope to provide more detail and analysis tomorrow.


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7 Responses to Contract Signed

  1. Kati D says:

    NICE guidelines… Really?

  2. Roy says:

    The previous record with Gulf War Illness does not ‘xactly fill me with confidence.

  3. Janelle Wiley says:

    This is a good start (though the communication is way overdue, and I agree with Kati about NICE being misplaced), but it I’m concerned it may still put HHS as The Deciders. It’s my understanding that it’s customary for disease definitions to be written either solely by the disease experts and the disease orgs, or as an active collaboration between HHS and the disease orgs and the disease experts with all involved parties on equal footing.

    We don’t live in an imperialist society.

  4. readyforlife says:

    I was just re-reading through some of your resent post and this caught my eye. In the letter above, who ever wrote it states that the HHS is CO-SPONSORING the IOM study with several agencies that participate in CFSAC. I copied and pasted this below from the letter.
    Do we know who is co-sponsoring this study?? CFIDS???

    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.

    • Jennie Spotila says:

      I think I can clarify this. The CFIDS Association, the IACFS/ME and the NJ CFS Association participate on CFSAC as non-voting liaisons. NONE of those organizations are co-sponsoring the IOM study. Furthermore, as far as I can tell, none of those three representatives were given any opportunity to provide input on the Statement of Work.

      The funding is coming from the Office on Women’s Health, HHS agencies such as NIH (and others), and the Social Security Administration. My information is that there is only one voting member of the CFSAC who was asked to provide input into the Statement of Work. I presume that the agencies who put up the money for the study had input into the Statement of Work through their ex officio representatives on CFSAC.

  5. readyforlife says:

    Thank you for replying back. So basically how i’m seeing this is the Government agencies representatives on CFSAC all knew about this IOM contract and worked together behind our backs.
    I’m visualizing these government representatives on CFSAC getting together in secret and having a meeting about the IOM study.

    After reading and watching videos of how the Gulf War Veterans were treated trying to protests the IOM contract. I’m feeling deflated. And I think that is what are Government wants.

    • Jennie Spotila says:

      I don’t know if they physically met together (in a smoke filled room?), but my information suggests they discussed via email and other means.

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