CFSAC: Chronic Fatigue Syndrome Advisory Committee

Report on the November 20-21, 2006,
Meeting of the DHHS CFS Advisory Committee

The CFS Advisory Committee (CFSAC) to the Department of Health and Human Services (DHHS) met on Monday, November 20, and Tuesday, November 21, 2006 in Washington, DC. This was the Committee’s third meeting with its current membership and its 11th overall since being chartered under the Federal Advisory Committee Act in 2002. Committee chairman Dr. Nahid Mohagheghpour was unable to attend the meeting, so the new executive secretary, Dr. Anand Parekh, representing the Department’s Office of Public Health and Science, acted as meeting chair. Dr. Parekh made brief introductory comments and took a roll call, with Dr. Morris Papernik unable to attend due to a death in the family. The other nine members of the Committee were in attendance. Dr. Parekh reviewed the two-day meeting agenda and welcomed two invited guests to provide remarks to the Committee. Members of the Committee were able to question these guests and engage in dialogue with them after each presentation.

Dr. Mary Schweitzer described the onset of CFS in 1993 when she was a Villanova professor. She spoke about the difficulty of obtaining a diagnosis and the steadfast support of her family, even as their lives changed due to her disabling condition. She attributed a moderate return in function to treatment with Ampligen, which costs her family approximately $20,000 per year for the drug and related tests not covered by insurance. She restated how “lucky” she considers herself to be in comparison with others she has befriended who have CFS and fewer support systems. Dr. Schweitzer called attention to several shortcomings of federal efforts, including the CDC’s website and materials for health care professionals. She noted that her remarks were based largely on material developed for a book she is writing titled, “Slightly Alive.” Her testimony has been posted on the Internet at http://www.cfids-me.org/cfscc/cfsacf06.html

Ms. Meghan Shannon addressed the Committee next, expressing anger about the way she had been treated the last time she spoke before the Committee on December 8, 2003. She had vowed at that time never to return to a CFSAC meeting and had nearly kept that promise in spite of the invitation to offer remarks. Ms. Shannon reviewed her onset of symptoms, reporting that she was exposed to adenovirus infection in her work as a pediatric respiratory therapist, later resulting in CFS. She also mentioned poor care she had received in emergency rooms based on having CFS as her diagnosed condition. Her research and advocacy into CFS had taken her to several countries and she stated that she has been diagnosed with myalgic encephalomyelitis and postpolio syndrome. She also drew attention to material about CFS contained in the well-known book on women’s health, “Our Bodies, Our Selves.”

After a short break, Dr. Parekh turned to reports from the federal agencies. Dr. Marc Cavaille-Coll from the Food and Drug Administration (FDA) reported that the number of products under review for CFS was still small and addressed changes at FDA related to the physicians labeling rule to provide more useful information on the inserts for pharmaceutical drugs. Dr. Cavaille-Coll mentioned the Office of Special Health Issues, available to answer questions about the drug approval process, and other FDA resources. Asked his opinion about the obstacles to greater development of specific CFS treatments, he cited the lack of animal models and specific biologic targets. In response to a question about special provisions for Orphan Drug status, Dr. Cavaille-Coll indicated that the prevalence of one million Americans with CFS put CFS out of this category; however, he suggested that it was possible the case could be made that drugs to treat subsets of CFS might qualify for such classification. The use of approved products for off-label treatment of CFS was discussed, with several Committee members suggesting that off-label use of pharmaceuticals often creates problems for insurance reimbursement for these costs. Safety and efficacy in such circumstances were also concerns, and the need for more clinical trials was highlighted. Dr. Cavaille-Coll reminded the Committee that FDA does not initiate such trials and that its function is the regulation of such products. 

Dr. Eleanor Hanna reported on recent NIH activities, including the announcement of seven new CFS grants in response to proposals submitted under the special Request for Applications (RFA) issued by NIH in 2005. She reported that these investigators will be required to participate in an annual meeting to exchange information and form the basis of a collaborative research group. She offered the Office of Research on Women’s Health’s website as a resource for patients and researchers and mentioned that a new CFS flyer will become part of NIH’s Science Series. In discussing the NIH’s Roadmap Initiative, she indicated that she will be working with Trans-NIH CFS Working Group to develop a proposal for centers that would bridge basic and clinical research, as well as provide training opportunities for young investigators. This initiative would be submitted to the new Office of Portfolio Analysis and Strategic Initiatives (OPASI) for consideration as a project under the Roadmap Initiative. She suggested that it was premature to plan another consensus or state-of-the science conference and recommended that some of the new research get under way to plot promising next steps. 

Dr. Laurence Desi from the Social Security Administration (SSA) stated that physicians and consultative examiners who participate in disability decisions at the state and federal level were being encouraged to take the continuing medical education program offered by CDC and the CFIDS Association of America. He listed other CFS-related training opportunities and educational resources for staff.

Following the lunch break, Dr. William Robinson, representing the Health Resources and Services Administration (HRSA), announced his January 2007 retirement and stated that this would be his last meeting with the Committee. He introduced Dr. Deborah Willis-Fillinger, who will replace him as the HRSA representative. He then provided a history of HRSA’s involvement in CFS in the context of its mission to equalize the distribution of health care services. He commended the CDC and the CFIDS Association in supporting activities to address the Committee’s recommendations related to training health care professionals in light of the fact that HRSA has no financial resources dedicated to CFS-specific activities. He distributed a letter he had sent in August to all of the federally funded Community Health Centers which provide subsidized medical services to underserved populations in rural and urban settings, encouraging health care professionals working in those centers to use the resources developed by CDC and the CFIDS Association to become informed and knowledgeable about CFS and appropriate patient care. 

Dr. William Reeves of the Centers for Disease Control and Prevention (CDC) provided an update on research and education activities led by his group, including studies of prevalence, illness severity, medication and medical services usage, economic impact, genes implicated in CFS, changes in cognitive function, allostatic load and overlap with metabolic syndrome, and mathematical modeling of CFS. He described two new phases of an ongoing study of CFS in rural, metro and urban Georgia, including one on the clinical course of CFS patients and a pilot patient registry to be enrolled by multidisciplinary health care professionals. He also reported on the November 3 press conference hosted by CDC and the CFIDS Association as the public launch of the national awareness campaign and the media response so far. Dr. Reeves presented his logic model for how all these activities fit into a “control” strategy for CFS, a multipronged approach to decrease illness prevalence, duration, severity, impairment and economic impact. He then provided additional details on the education activities aimed at primary care professionals, including grand rounds, participation at professional conferences, continuing education programs, and evaluation of activities and project efficacy. When asked about funding for all these activities, Dr. Reeves indicated that his group’s funding had dropped to $4.4 million for the upcoming fiscal year and that some projects would be put in jeopardy at that funding level, particularly the long-term follow-up of patients identified in the Georgia study and the patient registry being piloted.

Dr. Parekh thanked all the federal representatives for their work and their reports and welcomed Dr. Lucimar Cose-Cannon, a representative of the Pan-American Health Organization (PAHO) and the World Health Organization (WHO), who was invited to present an international perspective on CFS and the education of professionals about conditions such as CFS. She provided an overview of the mission of the PAHO, indicating that a search of PAHO and WHO programs turned up little specific to CFS. She attributed this situation within PAHO, which serves countries of Mexico, Latin America and South America, to the competition for resources strapped by programs to address and control treatable and vaccine-available conditions that have high mortality rates and high prevalence in these countries. While she acknowledged the existence of and problems associated with CFS, she was candid about the challenges of initiating new activities in light of urgent realities of communicable diseases. She suggested that providers’ attitudes about CFS were likely similar to those in the U.S., yet her recent conversations with colleagues in Brazil indicated an awareness of CFS, as well as the suffering of people with it. Dr. Parekh and the Committee thanked her for her presentation and perspective.

For the remainder of the afternoon session the Committee raised and discussed a large number of tactics to expand education of health care professionals, addressing a wide range of disciplines and practice settings. Experience with other conditions or other organizations was shared, generating a large list of means by which to reach providers in training (students/residents) and providers in practice. Discussion also flowed to public awareness, with concerns raised about serving patients who don’t have access to the Internet and the missing infrastructure to provide one-on-one support to patients in need of additional resources. The appropriate balance of outreach and fulfillment was considered. The role of third party payers (including Medicare/Medicaid), on both the provider side and public side, was reviewed, as were means by which to reach these influential institutions. Throughout the days’ discussions, Kim McCleary and Terri Lupton from the CFIDS Association of America offered clarifications about public and provider education efforts and historical information pertinent to the dialogue. Dr. Parekh made helpful suggestions to guide development of recommendations and future meeting agendas. At 4:45 p.m. the first day’s session was adjourned after a review of the next day’s schedule.

Day Two:
After Dr. Parekh called the meeting to order, the Committee reviewed minutes of the April and July meetings, providing corrections and clarifications. Committee management issues were addressed in response to concerns by members about past handling of administrative issues and the lack of continuity in leadership from the department at a staffing level. Dr. Parekh handled these issues with directness and made an express commitment to improve service to the Committee through his personal involvement and oversight of other staff functions. Dr. John Agwunobi, Assistant Secretary for Health, then joined the meeting, thanking Dr. Parekh for joining his staff and accepting responsibility for supporting the CFSAC. He thanked the five outgoing members of the Committee, presenting each individual with a plaque and letter of appreciation signed by Secretary for Health Michael Leavitt. He announced that new Committee members would be named before the end of the year to replace those whose terms had been extended beyond their September 30, 2006, expiration date. Dr. Agwunobi talked with the Committee about the new schedule of two-day meetings twice per year and promised to reevaluate this if it impeded participation in the meetings or had other negative effects on productivity. He then left the meeting to attend to other commitments.

Dr. Parekh presented a letter from Dr. Agwunobi to Dr. Mohagheghpour dated November 3, 2006, a formal response to the Committee’s past recommendations. (Note: This letter will be posted to the Committee’s website at http://www.hhs.gov/advcomcfs/index.html) He reviewed with the Committee the point-by-point response and engaged discussion on several topics, including further NIH efforts to stimulate research, ICD coding issues, workshops planned by NIH and CDC, and means by which the current awareness campaign could be expanded to better serve those without Internet access. Following a short break, the Committee viewed a recording of two of the six presentations delivered at the November 3 press conference: those made by Dr. Julie Gerberding, CDC Director, and Dr. Agwunobi. The response was very favorable, sparking discussion about broader distribution of the press conference recording and the expansive media response so far. Mary Schweitzer expressed concerns about the CFS Toolkit for Health Care Professionals, but commended the media articles that had been generated. A lunch break followed.

The afternoon session was dedicated to formation of three subcommittees and drafting of four formal recommendations. Because of the turnover in Committee membership anticipated within the next six weeks, only those continuing on the Committee were assigned to subcommittees. New members will be assigned to subcommittees after their appointments to the full Committee are announced. Each subcommittee is required to have at least one federal agency participant. The following subcommittees were formed:

Research Subcommittee: James Oleske, MD, (chairman) and Rebecca Artman, with ex-officio participation from NIH (Dr. Eleanor Hanna) and CDC (Dr. William Reeves).

Education Subcommittee: Kristine Healy, PA (chairman) and Lucinda Bateman, MD, with ex-officio participation from NIH (Dr. Eleanor Hanna), CDC (Dr. William Reeves) and HRSA (Dr. Deborah Willis-Fillinger).

Patient Care/Quality of Life Subcommittee: Rebecca Artman (chairman), James Oleske, MD and Jason Neufeld, JD, with ex-officio participation from SSA (Dr. Laurence Desi).

As the Committee brainstormed topics for recommendations, several were referred to subcommittee for further exploration and discussion. Four recommendations were put forward (subject to refinement as the formal statement is prepared for transmission to Secretary Leavitt). The CFS Advisory Committee recommends to the Secretary for Health that:

1. The FY08/FY09 budgets of the CDC for CFS research be restored to at least the FY05 level in order to sustain the CDC’s remarkable momentum, including the ability to complete the Georgia study (especially its longitudinal phase).
2. The FY08/09 budgets of the CDC for public awareness/education be restored to at least the FY06 level based on the positive initial response to the November 2006 campaign launch.
3. CFS be included in the NIH’s Roadmap Initiative.
4. Based on the positive response to the Request for Applications (RFA) issued in July 2005, the Committee recommends equivalent funding for a second RFA.

Dr. Parekh then offered time to the public for brief testimony. Only Ramona Hahn addressed the Committee. She is a former IRS employee who became disabled due to CFS in 1997 and is having difficulty finding part-time employment now that she has recovered enough to work a reduced schedule. Rebecca Artman, chair of the newly formed Patient Care/Quality of Life Subcommittee, expressed her intent to address such needs through this subcommittee. With no further business on the agenda, Dr. Parekh stated his intention to begin planning for the spring 2007 meeting and to follow up on several action items identified over the course of the two days. He thanked the Committee for its work and productivity and members of the public for their participation and attentiveness. The meeting was adjourned at 3:30 p.m.