Report on the July 17, 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, July 17, 2006 in Washington, D.C. This was the committee’s second meeting with its current membership and its 10^th overall since being chartered in 2002. committee’s chairman Dr. Nahid Mohagheghpour made brief introductory comments and a roll call was taken, with Dr. James Oleske the only member of the committee’s not present. Jason Neufield, a disability attorney from NY, was introduced as a new member appointed since the last meeting (held April 24, 2006). Dr. David Rutstein acted as Executive Secretary for the committee’s in the absence of Dr. John Eckert, who was away on family business.

The first agenda item was a briefing from the Office of General Counsel on the law that governs the committee’s structure and activities, the Federal Advisory committee’s Act. The committee’s charter will expire on September 5, 2006; its renewal is at the Secretary of Health’s discretion and is based on an assessment that the committee is necessary and serving a useful purpose. More specific criteria were not given.

Before moving to invited presentations, committee’s member Dr. Anthony Komaroff asked participants to observe a moment of silence in memory of Dr. Nelson Gantz, a former member of the committee’s who passed away on June 20, 2006, ending a courageous battle with cancer.

Invited presentations
Dr. Nancy Klimas, president of the International Association for Chronic Fatigue Syndrome (IACFS) and a CFS clinician and researcher at the University of Miami, addressed the committee’s about problems and concerns related to progress in CFS research. She spoke about the burdens CFS creates for patients, their families and the community-at-large, focusing on the frustrating search for knowledgeable clinicians willing to provide care to patients. Dr. Klimas emphasized the challenges of working in the field of CFS research, where funding levels are short by at least a multiple of 10, and investigators have difficulty gaining access to large, well-characterized patient cohorts because of the lack of large research and treatment centers. She noted the difficulty of getting funded in this field, and the widespread feeling among researchers that the funding barriers are greater in CFS than other conditions. Her recommendations highlighted the need to develop creative strategies for growing the field and helping researchers adapt to changing funding priorities by NIH and other institutions. She urged the creation of CFS Centers for Excellence where clinical care is available to patients, research is conducted and training opportunities exist for providers and researchers alike. In closing, Dr. Klimas reiterated her concerns about attracting and developing the next generation of medical professionals and researchers, noting that the people she knows in the field are the same ones who’ve been involved for the past 10 years.

The second invited guest, Mr. Antonio Luna of the Madrid (Spain) CFS Association, was linked to the meeting by conference call. He shared his experience as a CFS advocate working for expanded research, improved public recognition and better treatment from health care professionals for CFS patients. He stated that in Spain, CFS is considered a psychosomatic disease or a depressive illness and there is very little support for patients. His organization is working to change these conditions by raising public awareness, promoting multidisciplinary research and engaging Parliament on matters of funding and disability policy. At the conclusion of Mr. Luna’s remarks, Dr. Komaroff noted that their challenges sounded very similar to ours in the United States.

Agency updates
Turning to the agency updates, Dr. William Reeves of the Centers for Disease Control and Prevention (CDC) structured his presentation as a direct response to the committee’s set of 11 recommendations sent to the Department on August 23, 2004. He described an international network of collaborators spanning 50 sites across 22 countries (recommendation #3), a series of workshops engaging those collaborators and a study that demonstrated the key CFS features—across cultures and languages—to be fatigue, cognitive impairment, musculoskeletal pain, inflammation-infection symptoms and sleep disturbance. He reviewed the activities of CDC’s intramural CFS laboratory (recommendation #4) and research the agency has conducted on children and adolescents with CFS (recommendation #5). He listed other workshops sponsored or attended by members of CDC’s CFS research group (recommendation #6) and the activities under way to reach health care providers with information about the diagnosis and management of CFS (recommendation #7). He addressed the national public awareness campaign (recommendation #9) and, in response to recommendation #10 regarding revision of the ICD-10 code for CFS, expressed concern that it was premature to classify CFS as a central nervous system disease without sufficient research to support this classification.

Dr. Reeves answered several questions, including queries about the postponement of the press conference scheduled for June 7 and the discrepancy in the prevalence estimate for CFS, stated as “over 4 million” in the CFS ads running in national women’s magazines and CDC estimates published elsewhere indicating that one million U.S. adults have CFS. He explained that CDC had completed its study of the prevalence of CFS in Georgia and that a manuscript describing its findings would be submitted by early August to an open-access, peer-reviewed journal. Upon publication, the press event would be held and the study methods and conclusions would be discussed in detail.

Reeves also addressed the difficulties that people expressed in obtaining copies of the research articles CDC published in the journal Pharmacogenomics. He indicated his preference for publishing in the online open-access journals, but that for this series of papers resulting from the CFS Computational Challenge, this journal had expressed interest in the group of articles and it is widely read by people working in pharmaceutical development, which he felt had merits of its own. In discussing outcomes of provider education activities, Dr. Reeves suggested that this be the focus of a future meeting, a topic the committee’s considered again later in the day. Dr. Komaroff congratulated Dr. Reeves and his group on the rigor with which they approached the study of CFS, the efforts they had made to engage new investigators from many disciplines and for changing the field through their research and publications.

Moving on to reports from other agencies, Dr. Laurence Desi from the Social Security Administration stated that physicians and consultative examiners were being encouraged to take the continuing medical education program offered by CDC and the CFIDS Association of America. He also noted that other training opportunities for staff involved in disability decisions included instruction on CFS. Dr. Marc Cavaille-Coll from the Food and Drug Administration reported that the number of products under review for CFS was still small, but that he was aware of several trials for approved products that were being tested in CFS. Asked his opinion about the obstacles to greater development of CFS treatments, he mentioned the lack of animal models and specific biologic targets. Dr. William Robinson, representing the Health Resources and Services Administration (HRSA), as in the past, noted the lack of funding at HRSA for disease-specific training initiatives, restating HRSA’s 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 recommendation related to training health care professionals and committed to working with both organizations within the resources available to him.

After a lunch break, Dr.Eleanor Hanna reported on recent NIH activities. Making reference to Dr. Reeves’ presentation, she stated that many of CDC’s collaborators were NIH-funded scientists and that each agency works within its own mission to meet research and public health needs. Dr. Hanna pointed out that NIH is undergoing significant institutional change, just as CDC has, and that Congress will be heavily involved in defining a new NIH. Remarking that change within the CFS field was not progressing as quickly as she’d like, she reported that they do continue to receive more CFS research applications with each deadline. She reviewed funding levels, stating that the only way NIH can increase funds for a given disease is to increase the number and quality of fundable applications. She also offered some history about NIH’s handling of CFS grants, referring to the years before 1999 when responsibility rested with the National Institute of Allergy and Infectious Diseases and then moved to the Office of the Director to foster a more multidisciplinary approach to CFS. Although she was not able to make an announcement about the new grants funded under the special CFS Request for Applications announced in July 2005, she informed the committee’s that seven awards were forthcoming. Dr. Hanna briefly offered highlights of currently funded investigators and responded to questions about trends in the number of CFS applications being received. When asked about the appropriateness of CFS being handled by the Office of Research on Women’s Health, she expressed her opinion that it was extremely well-placed there, given that office’s early efforts to develop cross-cutting collaborations across many NIH institutes and medical/research disciplines.

Assistant Secretary of Health participates
John O. Agwunobi, MD, MBA, MPH then joined the meeting and addressed the committee’s. Dr. Agwunobi, a pediatrician by training and the former secretary of the Florida Department of Health, was appointed by President Bush as the Assistant Secretary of Health on December 17, 2005. The committee’s charter states that it “shall advise and make recommendations to the Secretary, through the Assistant Secretary for Health.” Dr. Agwunobi’s attendance marked the first time any Assistant Secretary of Health had addressed the committee’s since its first meeting in 2003. He began his remarks with an introduction to his professional background and described his role with the Department of Health and Human Services as one of influence rather than authority. He thanked the committee’s for its work to the present and acknowledged that he was “not sure we’ve done everything to support the work of this committee’s.” Noting the 918 days left in his tenure, Dr. Agwunobi asked to be judged by his actions and then made a series of commitments. He promised to:

• attend at least half of the committee’s meetings in person
  
• appoint a permanent executive secretary to work with the committee’s and establish continuity
  
• renew the committee’s charter in an expeditious manner
  
• expeditiously name new members to replace those whose terms expire in September
  
• name a new committee’s chairman
  
• develop a process to efficiently handle the committee’s recommendations
  
• respond in writing to the committee’s past recommendations

Before taking questions, Dr. Agwunobi urged the committee’s to “keep advising us; keep reminding us of what’s important.” However, he cautioned that the Administration is working hard to contain costs for managing federal programs and that this was to difficult a time to ask for things that require new money. Although he instructed the committee’s not to restrict its recommendations to things the Department can afford, he also asked that committee’s members not be discouraged when changes do not occur as quickly as they might like.

The dialogue with committee’s members included ways to engage health care providers, the best strategies for making recommendations, the impatience of the patient community after 20 years of research without much significant progress and the need for institutional memory within the committee’s as its membership turns over. When asked what he would take back to Secretary Leavitt, Dr. Agwunobi stated that he would convey the sense of “concern, urgency, passion and frustration” that he heard about these important issues. The chair thanked him for his participation and the commitments made and Dr. Agwunobi left to attend another meeting.

The committee’s then reviewed outstanding business and discussed the timing and agenda for its next meeting. Dr. Komaroff offered to draft a letter to the Assistant Secretary summarizing progress observed and issues of concern. October 16 and 23 were proposed for the next meeting, and the topic of provider education was again discussed as a focus of that session, although there was some disagreement about whether a subcommittee should perform an initial review of activities before dedicating time by the full committee’s. The opportunity to hold a committee’s meeting in Ft. Lauderdale in conjunction with the International Association for Chronic Fatigue Syndrome’s January 2007 conference was considered, but this is apparently not possible under FACA rules. As an alternative, it was suggested that Dr. Agwunobi be invited to address the conference and provide an update on Department of Health and Human Services activities on CFS.

Public participation
During the session inviting comments from the public, Dr. Mary Schweitzer expressed her deep concerns with the apparent broadening of the CFS definition by CDC researchers and their adoption of the biopsychosocial model for CFS. She criticized the prevalence estimate of 4 million, stating that it represents the blending of CFS with other things and makes the patient population too heterogeneous. Her remarks were based on a written statement she has made available at http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0607c&L=co-cure&T=0&P=1860 .

Representing Patient Alliance for Neuroendocrineimmune Disorders Organization for Research and Advocacy (P.A.N.D.O.R.A.), Founder Ms. Marla Silverman referred to a letter she sent to Secretary Leavitt expressing concern about several issues affecting the CFSAC. She was pleased that Dr. Agwunobi had directly addressed so many of those issues and she reiterated the need to implement the committee’s recommendations, including a Center for Excellence in Florida and programs to mentor new CFS researchers and clinicians.

Ms. Kim McCleary, President & CEO of the CFIDS Association of America, addressed funding issues for CFS research, echoing Dr. Klimas’s earlier remarks that the $14.4 million being spent on CFS should have another zero added to the left of the decimal point. She referred to a report sent last week by NIH Director Dr. Elias Zerhouni to Congress and distributed an updated analysis (based on a similar study performed in September 2004) to the committee’s, showing that 35% of what NIH had classified as CFS research could not be documented as such. She asked that if distantly related studies are to be accepted as CFS research, a process should be identified to ensure that the outcomes of this research are translated to the CFS field. Finally, she suggested that the committee’s work with NIH to refine its coding instructions for CFS research so that a reliable estimate of research funded could be measured and tracked over time.

The chair thanked the witnesses for their remarks and Dr. Rutstein thanked committee’s members for their tolerance of the way the committee’s had been managed and expressed his observation that “the horizon is bright.” He added his thanks to staff member Olga Nelson for handling so many of the administrative details and the meeting was adjourned at 4:20 p.m.