The CFS Advisory Committee is charged with advising the Secretary of Health and Human Services on issues related to ME/CFS. The committee’s public meetings are highly significant for three reasons. First, the meetings require that the agencies present updates on their ME/CFS-related activities, and we learn a great deal that we otherwise might not know. Second, the committee’s recommendations put the desperate needs of ME/CFS patients on the public record. Third, the meetings provide a venue for the public to speak directly to HHS through public comment.
The CFSAC held its first meeting of 2016 via webinar on May 17th and 18th. Despite being restricted to two half-days, this CFSAC meeting was still quite substantive, with important agency updates and committee recommendations.
Highlights of Agency Updates and Announcements
The Centers for Disease Control update included a description of the Technical Development Working Group that the CDC has assembled to collect input on its ME/CFS diagnostic material. The Working Group is composed of ME/CFS experts, advocates, patients, and representatives from a number of medical associations. However, the Working Group covers material on diagnosing ME/CFS only. Their focus is not the CDC’s educational material on ME/CFS treatments (which have long been of great concern to advocates).
Dr. Suchitra Iyer from the Agency for Healthcare Research and Quality confirmed that a reanalysis of the 2014 systematic evidence review is underway. Specifically, the meta-analysis discounted the Oxford criteria as being too inspecific, and recommended patients who only met the Oxford criteria not be used in the search for effective therapies. They also are reanalyzing results with counseling studies as separate from CBT studies. Dr. Iyer stated that an addendum with this reanalysis will be published this summer.
The National Institutes of Health update from Dr. Vicky Whittemore was substantive. One of the topics of greatest interest was research funding. Dr. Whittemore said she will present a “funding concept” to the Council for the National Institute of Neurological Diseases and Stroke on May 26th. If approved, the concept will then need approval by the participating Institutes. Dr. Whittemore said the Request for Applications would hopefully be issued in June or July, with funding to begin next year. She was unable to share any information about the dollar figure or research targets.
Erin Fowler from the Health Resources and Services Administration reported that one HRSA grantee is creating a CFS educational flyer as part of a library of educational materials. Several CFSAC members expressed deep concern that there was no oversight and no clarity as to the involvement of disease experts in creating the flyer. Ms. Fowler agreed to seek more information from the project manager.
Finally, both non-voting liaison members offered updates. Carol Head of the Solve ME/CFS Initiative announced a new patient registry, funded by a grant from the Robert Wood Johnson Foundation, expected to launch in November 2016. Steve Krafchick announced the IACFS/ME conference October 27-30, 2016 in Fort Lauderdale, Florida.
Two CFSAC Working Groups presented recommendations for consideration and vote by the full committee. In both cases, the Working Groups provided extensive background and justification for the proposed recommendations.
First, the Centers of Excellence Working Group led by Dr. Gary Kaplan gave a compelling presentation on the need for Centers of Excellence. The justification for Centers is based on ME/CFS patients being an under-served population with minimal access to expert care. The Working Group found several existing NIH mechanisms for funding Centers, and also discussed the concept of “core competencies,” a model to ensure that each Center is able to provide expert clinical care, conduct research and clinical trials, and educate young researchers and healthcare providers. After discussion, CFSAC passed a recommendation that HHS fund twelve Centers of Excellence attached to academic institutions, for a minimum of five years and total investment of $60 million.
Second, the IOM/P2P Working Group chaired by Donna Pearson revisited and refined their work based on the agency responses to the August 2015 recommendations. First, the Working Group proposed that HHS commit to a review of the IOM diagnostic criteria no later than May 2019. Second, the Working Group recommended that HHS explicitly recognize ME as separate from medically unexplained fatigue or CFS without post-exertional malaise. The recognition of ME as a distinct disease should be marked by new clinical guidelines, new webpages, the new name, and a new ICD code separate from Fukuda CFS. Third, the Working Group recommended systematic collaboration for disease expert and stakeholder review of all educational materials, and that HHS revisit recommendations 8, 10 and 15 from August 2015. All three of these recommendations were adopted by CFSAC.
Dr. Faith Newton will lead a new working group on pediatrics, specifically to investigate the feasibility of collaboration between HHS and the Department of Education to provide better resources and education to school nurses and parents of school-age ME/CFS patients.
Dr. Dane Cook will lead a new working group on how the agencies can incorporate ongoing, robust stakeholder engagement in research. Interestingly, the request for this working group came from the ex officios themselves, especially Dr. Whittemore (NIH).
Finally, Dr. Jose Montoya made a request for a recommendation for a significant increase in research funding. Although this recommendation has been made many, many times before, and as recently as August 2015, Dr. Montoya made a compelling case for why such a recommendation is needed now. He agreed to lead a new working group to develop a detailed supporting case.
Running Out Of Time
Fourteen members of the public offered comments to the committee on a variety of topics, the most powerful of which were Terri Wilder’s testimony and commentary about how the history of neglect of the AIDS crisis is repeating itself with ME.
Just before the close of the meeting, Carol Head of SMCI called for greater urgency from HHS to address the many significant needs of ME/CFS patients. She acknowledged that NIH has taken some positive steps, and said she is trying to be optimistic. However, Head said that it is not clear that the federal government will make the changes demanded by the reports it has commissioned, especially an order of magnitude increase in research funding. Furthermore, in seven months there will be a new administration, and Head asked if we will have to go back to square one with new leaders. Speaking with frankness, Head commented, “Time is running out to believe in federal changes for funding.”
What happens when time runs out? That remains to be seen. But the #MillionsMissing protest may be just the beginning.
Jennie Spotila blogs at Occupy CFS, where a more detailed summary of the CFSAC meeting can be found.