Chronic Fatigue Syndrome Advisory Committee (CFSAC) Meeting Summary

On December 13 and 14, the Federal Chronic Fatigue Syndrome Advisory Committee (CFSAC) met in Washington DC for one of its biannual meetings. CFSAC provides advice and recommendations to the Secretary of Health and Human Services (HHS) through the Assistant Secretary for Health on issues related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

Carol Head, President and CEO of Solve ME/CFS Initiative, makes comments at most recent CFSAC meeting in Washington DC.

This meeting included an official welcome from the Acting Assistant Secretary of for Health, Don Wright, and the official announcement of three new voting members of the committee: Lucinda Bateman, M.D. Gudrun Lange, PhD and Amrit Shahzad, MBBS, MBA.

Overall, this CFSAC meeting recognized the substantial forward movement regarding our disease during this past year. Some of the previous procedural recommendations from Carol Head, Donna Pearson, and others were implemented at this meeting with positive results. The improvement of telecasting, organization, the addition of a research review, additional discussion opportunities regarding patient comments, and strong working group contributions led to a notably improved meeting function and dynamics. The key priority issues addressed by the committee included medical education and pediatric issues.

SMCI is pleased to provide the following CFSAC meeting summary for those who had difficulty watching remotely and were unable to participate.

Federal Agency Updates:

  • The Centers for Disease Control and Prevention (CDC) posted new public web content, removing CBT and GET, in June 2017, new pediatric web content in October 2017 and continues to work on content
    • CDC is aware of the concern of stakeholder input for materials before publication. The CDC held a round table to cultivate stakeholder input to drive the content. There is no public review by the community prior to posting, though the CDC does receive information input from community members – content is cleared by CDC in a specific process.
  • CDC reviewed other programming activities during the past year and provided an update on previous CFSAC recommendations: (relevant to CDC)
    • Working on center for information resources (DoE) to provide resources to parents. CDC is working with them to develop ME/CFS website specific to education needs of young patients to work with the school system to maximize education.
    • Development of treatment guidelines – not CDC specific, cannot do this alone. CDC is taking the initiative to develop a plan on how to develop these guidelines. Beginning to formulate the plan (options) for developing these guidelines and present to other ex-officios to take it forward. CDC is learning how-to create guidelines (then reviewed every 3 years)
  • The Food and Drug Administration’s (FDA) “promise investigators” are working with CDC MCAM study – looking to fill gaps in evidence and find a new patient reported outcome (PRO) – on a new fatigue scale which can be used by folks who are trying to develop new drugs. The FDA is also consulting with NIH on needs for clinical trials as requested
    • Unfortunately, the FDA cannot solicit action or investment from biopharma. The FDA met with potential drug sponsors and acknowledges that the agency will accept a large amount of risk (more than the standard isk/reward factor) because of the seriousness of the ME/CFS.
    • The FDA reports that it is a problem to motivating the monetary aspect of the bio-pharma. Easing requirements on outcome measures – even a basic survey demonstrating that patients feel better, but the FDA does not develop the outcome measures. It reviews and requires the measurement (doesn’t even have to be validated) but needs an outcome measure for each trial
    • FDA will look into the crisis in availability of medications (like saline for home use) limited as a result of the hurricane (in Puerto Rico).
  • The Social Security Administration (SSA) implements Social Security Disability Insurance (SSDI) which is a worker-based insurance program requiring payment into the system and Supplemental Security Income (SSI) a needs-based program to assist the disabled.
    • Evidence is needed to make a determination for disability. SSA collects this evidence by contacting medical providers who are providing or had provided treatment. SSA acknowledges that the poor medical understanding of ME/CFS causes difficulty. If medical evidence from patient’s treating sources is incomplete or inconclusive, then SSA will hire a consulting firm to examine patient’s health. No education protocol regarding ME/CFS for contacted exam team.
    • SSA has updated the medical criteria for disability. New neurological listings and others – currently updating muscular/skeletal listings. Revising training material for ME/CFS based on IOM report – working on “hearing operations” for judges – CMEs are provided – will provide more specifics at next meeting.
    • About 13,000 patients currently receiving disability for ME/CFS – ME/CFS is most often allowed when no secondary impairment is listed
    • SSA admits that that the “administrative backlog” is substantial – process very slow. Overall, 70% of judgements are awarded in first 2 stages of the disability process, but the rate is only 15% ME/CFS. Poorly educated medical professionals hinder process

The National Institutes of Health (NIH) reported improved ME/CFS funding levels and increased participation from institutes and offices and the Trans-NIH ME/CFS working group’s efforts on intramural and extramural research.

    • The Intramural study has seen 11 patients / 15 controls (phase 1) and is moving as quickly as capacity allows – one at a time (about one a week).
    • The Trans-NIH ME/CFS working group meets every once, 24 institutes/offices/centers (focused on extramural research) – intramural research study attends the meetings – implemented intermediate goals – now working on long-term goals.
    • Common Data Elements project – general core items, disease core items, supplemental (highly recommended), Exploratory (specific cytokine reporting example). CDE do not traditionally include members of the community – learning process to make that process open (new) – making it better, including everyone. Timeline of CDE January 31 public comment– Version 1 – with public comment – can change over time – living document that will change
    • The Collaborative Research Centers (CRCs) – Funding implemented before the fiscal year deadline (September) – Cornell, Columbia, Jackson Labs were selected. RTI selected for Data Management Coordinating Center (DMCC) – Learn more about the NIH-funded centers in the Cover Story of the Fall 2017 Chronicle, “A Significant Step Forward at the NIH: SMCI Honored to Partner on Three NIH-funded Centers.”
    • Money has been set aside by each group for collaborative projects and a steering committee for CRCs collaborative project includes NIH and program directors for each CRC
    • An MOU with Canadian partners (planning grant) and will also be attending steering committee to coordinate
    • Community engagement is part of the requirement of the CRCS – each CRC has a different community engagement approach in their application. Looking for ways to harmonize community engagement across all the CRCs/DMCC – allow for meaningful stakeholder engagement across the projects.
  • The nomination for a new ex-officio officer from the Health Resources and Services Administration (HRSA) is pending and no presentation was given from the agency
  • The Agency for Healthcare Research and Quality (AHRQ) is not a disease specific agency, but hope to continue the great work of the addendum. AHRQ operates at the process level in between NIH and CDC – health services research and the delivery of healthcare. While no disease is a specific priority, AHRQ is looking forward to a Dissemination and Implementation (D&I) initiative for the NIH to give them to something to work on. D&I – takes scientific evidence and learning how to disseminate that better in the healthcare system.
    • AHRQ is excited to see results from NIH for data-backed treatment process/recommendations so they can implement and disseminate. AHRQ Addendum – no updates or reports – request for inclusion into the annals, hundreds of pages long and cannot be printed in entirety – but the annals could include a summary version or editorial about it to provide summary/shortened version. Currently investigation options.
  • The Department of Veterans Affairs (VA) maintains a “Veterans Health Library.” Veterans’ health library is creating a patient health education material for ME/CFS – VA is partnering with NIH on the intramural study, two principal investigators with Dr. Nancy Klimas and a neuropsychologist guy– focus will be on GWI as comparison group.
    • The VA is not diagnosing people with ME/CFS – they are treating and diagnosis “Chronic multi-system illness” – the treatment for “CMSI” is established by VA/DoD – still the preferred term. The CMSI term does not preclude ME/CFS diagnosis – the clinical practice guideline may help CDC – must use peer-reviewed medical literature for treatment recommendations. The lack of literature contributed to the term CMSI – fibro/Gwi/ME/CFS – vague coding that does not capture the detail of the disease. New coding efforts – highly encourage.
    • The VA will continue to update its training and treatment guides and that process has already begun regarding ME/CFS. The treatment guidelines do not pre-empt clinician judgement and the individual decisions are made by the treating clinicians. Guidelines were not downloaded or utilized frequently.

 

Working Group Reports and Public Comments:

  • In January 2017, CFSAC established a Medical Education Working Group – charged with formulating recommendations to improve education for healthcare providers on ME/CFS. The working group presented a summary of its work and recommendations.
  • Mission of the medical education working group: 1) Provide a wide array of extensive and easily accessible ME/CFS education trainings, resources, and tools to healthcare providers (MD, DO, NP, RN, PA, Social Workers, Psychologists, Psychiatrists), 2) Disseminate clinical guidance, best practices, 3) Identify potential mechanisms to expand the base of healthcare providers able to diagnose and care for persons with ME/CFS, 4) Include continuing education options to incentivize participation and specialist support for healthcare providers inexperienced in the field.
  • Challenges – continued misunderstanding and controversy on treatment protocols for ME/CFS. Need agreement on what information is most appropriate to make available to clinicians. Expert opinion of clinician’s best information source.
  • Presented four recommendations to the committee for approval, passed recommendation #1 (a) and (b) – re: guidelines; and made modification and approved recommendation #2 (a), (b), and (c) – re: dissemination strategies
  • Public comments included: Bobbi Ausubel, Mary Dimmock, Lily Chu, Carol Head, Mark Camenzind, Eileen Holderman, and many others.
  • Public Comment Discussion: two things we hear, current system is not adequate because the clinicians deny the disease (or provide no care) – failure of clinicians to care for severe patients
  • CFSAC should clarify the workforce needs – specialists for severe cases and general practice for mild cases? What does the ideal treatment capacity for ME/CFS look like? How do we take the clinical expertise and make it standard care?
  • The Pediatric Education Working Group presented a summary of its work with accompanying recommendations including collaboration with the Parent Information Center, Department of Education and Association of School Nurses.

CFSAC Committee Business:

  • Approved the minutes from the previous meeting
  • Per previous procedural recommendations, CFSAC reviewed progress reports on previous recommendations and implemented previous procedural recommendations.
  • Received an update from the CDC regarding clinical practice guidelines, as recommended in the previous meeting
  • Provided adult and pediatric research updates (given by Drs. Jose Montoya and Ross Vallings).
  • Added a presentation from the Department of Education and is working towards adding an ex-officio to the committee from the Department of Education
  • Swore in two new members and addressed questions regarding continued vacancies; CFSAC is supposed to be composed of 13 members; currently 6 positions are vacant.
  • Announcement for nominations will be published in the Federal Register in January 2018 – members are chosen by ex-officios
  • Nicole Green of the Office of Women’s Health at Health and Human Services made welcoming comments
  • Discussed and passed most recommendations from the Medical Education Working Group and Pediatric Education Working Group
  • Committed to participation and advisement of the ICD coding meeting upcoming in March with Dr. Lucinda Bateman
  • Created a new working group on Clinical Trials and Treatments, goals and membership to be finalized before next meeting.

To view the youtube videos of the December 2017 CFSAC meeting, please visit: https://www.youtube.com/playlist?list=PLrl7E8KABz1ELEasMWqE4SqD2vHQjaCLD

To learn more about CFSAC, visit: https://www.hhs.gov/ash/advisory-committees/cfsac/index.html