The CFS Advisory Committee is charged with advising the Secretary of Health and Human Services on issues related to ME/CFS. HHS has a very patchy record in its responses to CFSAC recommendations, but the committee’s public meetings remain highly significant. 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.
Agency Updates and Announcements
The Centers for Disease Control provided an update on its ME/CFS activities, including the public Grand Rounds held in February 2016. Dr. Beth Unger described the Technical Development Working Group that CDC has assembled to collect input on its ME/CFS diagnostic material. The Working Group is composed of ME/CFS experts, advocates, patients, as well as representatives from a number of medical associations. However, the charge of the Working Group covers material on diagnosing ME/CFS only. No work will be done on CDC’s educational material on ME/CFS treatments. Dr. Unger also noted that CDC was participating in NIH’s Common Data Elements project, and that no consensus or proposal on changes to the ICD-10 code for ME/CFS has been submitted to the National Center for Health Statistics.
Dr. Suchitra Iyer from the Agency for Healthcare Research and Quality confirmed that some reanalysis of the 2014 systematic evidence review is underway. Specifically, the study authors are reanalyzing treatment studies with those relying on the Oxford definition separated out. They are also reanalyzing results with counseling studies separated from CBT studies. Dr. Iyer stated that an addendum with this reanalysis will be published this summer.
The National Institutes of Health update was provided by Dr. Vicky Whittemore. She stated that the Trans-NIH ME/CFS Working Group has completed a portfolio analysis of NIH-supported research, which will be made available on the website. To promote the interpret-ability of research, NIH will create Common Data Elements to be used in all NIH funded ME/CFS research. A plan for communication with stakeholders is also in preparation. Dr. Whittemore said that NIH will issue a Request for Information on research priorities, which will give the public a chance to weigh in on NIH’s direction. Finally, 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.
The Food and Drug Administration held two internal seminars for staff, one delivered by Dr. Lucinda Bateman and the other covering the Patient Focused Drug Development process. Dr. Janet Maynard also reported that the Pharmacy Compounding Advisory Committee recommended that D-Ribose be included on the bulk substances list for use in treating ME/CFS.
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 examples of Centers for other diseases. The Working Group also presented on 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. The need for this commitment was underscored by examination of how long the IOM process took, the IOM’s own recommendation that its criteria be reevaluated in no less than five years, and the slow realities of federal processes and meeting planning.
Next, 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. Furthermore, Oxford studies should not be used in ME-related material, as these studies include many patients without ME.
Finally, 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.
Future Directions and Unanswered Questions
Although the working group concept had been met with resistance from some CFSAC members in 2013, this approach to drafting recommendations has resulted in more detailed and better supported recommendations. Working groups are designed to tackle a specific issue, make recommendations to the full committee, and then dissolve. With completion of the Centers of Excellence and IOM/P2P recommendations, discussion turned to future working group topics.
Dr. Faith Newton will lead a 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 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 working group to develop a detailed supporting case.
One topic that received no attention at all during the meeting was the future of CFSAC. The committee’s charter is up for renewal in September 2016. While there was no discussion of the charter renewal, Designated Federal Official Dr. Nancy Lee stated that the committee would meet in October or November, so perhaps we can assume the charter will be renewed.
There was also no discussion of the committee vacancies. Rebecca Collier Patterson did not attend the meeting, presumably because her term expired the day before. Three additional members – Drs. Casillas, Corbin and Fletcher – will see their terms expire on June 13, 2016. Nominations for new members were accepted in April, but there was no word on the timeline for vetting of new members or extensions of the existing terms.
Fourteen members of the public offered comments to the committee on a variety of topics, the most powerful of which were Terri Wilder’s comments about how the history of neglect of the AIDS crisis is repeating itself with ME. But there was one more comment at the end of the meeting that summed up the views of many patients.
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. But 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.”
Time is running out in many ways. The time we will be optimistic and “stay the course” with NIH. The time to educate doctors about the new diagnostic criteria. The time to put enough initiatives in place that the change in administration will not slow progress. The time patients have to wait without treatments or competent medical care. Time is running out for us all.