Report from the Federal CFS Advisory Committee Meeting

The CFS Advisory Committee (CFSAC) to the Department of Health and Human Services (DHHS) met on Tuesday, October 28, and Wednesday, October 29, in Washington, D.C. This was the committee’s 4th meeting with its current membership and its 15th overall since being chartered under the Federal Advisory Committee Act in 2002.

Executive Secretary Dr. Anand Parekh, representing the DHHS Office of Public Health and Science, welcomed appointed members of the committee and explained committee chairman Dr. James Oleske’s absence. Roll call revealed that three members of the appointed committee were not present: Dr. Oleske, Jason Newfield and Morris Papernik. The other eight committee members were present: Rebecca Artman, Dr. Lucinda Bateman, Dr. Ronald Glaser, Dr. Arthur Hartz, Kristine Healy, Dr. Leonard Jason, Dr. Nancy Klimas and Dr. Christopher Snell. The CFIDS Association was represented at the meeting by Kim McCleary, president and CEO, Dr. Suzanne Vernon, scientific director, and Chris Revere of the Sheridan Group. Four members of the Association’s Board of Directors also participated in the meeting: Marian Dix Lemle (director-elect), Brian Smith and Amy Squires; Bateman is a member of the Association’s board as well as a member of the CFSAC.

Parekh announced that the committee’s charter had been renewed by Secretary of Health Michael Leavitt through September 2010 and that several committee members’ terms had been extended for one year to equalize the terms of all appointed members to four years. He explained that this would provide additional stability through the change of administrations that will occur after the election. His final announcement in the opening remarks was a planned change in the management and administration of the committee, moving it into the DHHS Office of Women’s Health under the leadership of Deputy Assistant Secretary of Health Dr. Wanda Jones. He introduced Jones, and she expressed her enthusiasm for working with the committee to fulfill its responsibilities.

On behalf of the Centers for Disease Control and Prevention (CDC) as its new ex-officio representative, Dr. Michael Miller, chief science officer of the National Center for Vector-Borne, Zoonotic and Enteric Diseases (NCVZED), introduced Dr. Steve Monroe, director of the Division of Viral and Rickettsial Diseases (DVRD) in NCVZED. He also noted the participation of Sarah Wiley, associate director for policy (NCVZED) and Dave Baden, a congressional legislative officer for CDC. Monroe, to whom Dr. William Reeves directly reports, provided an update on CFS research and education activities conducted in DVRD and the National Center for Health Marketing, highlighting activities that had occurred since the May meeting. Wiley pointed out that CFS program budget information for 2005-2008 was included in the committee members’ notebooks. Questions that followed from the committee focused on the CDC’s use of the “empiric” case definition in the Georgia surveillance studies and Emory clinical study, as well as the lack of investigation of the role of infectious agents in triggering and/or perpetuating CFS. Dr. Eleanor Hanna, representing the National Institutes of Health (NIH), commented that NIH does not have confidence in the new definition for CFS being used by CDC and that it had resisted using the higher prevalence figures in its materials for that reason. She conveyed her concern that the use of different definitions made it difficult to compare results from CDC-funded research and NIH-funded research, and that this would present greater problems as treatments are studied. Bateman stated that in her opinion, the CDC has made little progress toward its goal of reducing population morbidity of CFS. Dr. Nancy Klimas remarked that CDC studies of psychiatric stressors were “way behind the times” and that the “emperor has no clothes” when CDC’s long-term studies of patients don’t produce any data about the long-term risks associated with CFS. Monroe confirmed that Reeves was still actively involved in the research program and indicated that the peer-review of the program would take place November 5-7, after which CDC leadership would be making some important decisions about the future direction of the program. Miller and Monroe invited input from the committee and restated their commitment to improved transparency and communication.

Hanna presented an update on NIH activities, in particular the June 20, 2008, meeting of principal investigators funded under the 2006 Neuroimmune Request for Applications. The purpose of the meeting was for the investigators to share interim data and to establish collaborations that would build the foundation for a research network. She expressed hope that some of the ideas, tools and methods identified by the group would find financial support and she noted several existing funding announcements under which CFS investigators could apply for grants. She is working with the Trans-NIH CFS Working Group on planning a State of the Knowledge conference for CFS in 2010 and is developing an intramural fellowship opportunity for a CFS investigator. Klimas, one of the NIH-funded investigators who participated in the June meeting, seconded the “splendid” collaborative spirit and innovative presentations. Discussion that followed centered on the estimate provided by Hanna that NIH commits about $6 million per year to CFS studies, and the performance of the CFS special emphasis panel that reviews CFS grant requests submitted to NIH. Dr. Leonard Jason, chairman of the CFSAC’s research subcommittee, requested data about the success rate for CFS grants after each step in the review session; Hanna replied that she cannot provide such information without a request from Congress, and suggested that he should continue his dialogue with officials in NIH’s Center for Scientific Review (CSR).

Hanna then introduced Dr. James Baraniuk of Georgetown University, an NIH-funded investigator exploring the proteomics of CFS based on cerebral spinal fluid collected from CFS patients. Baraniuk’s presentation was titled “Transition from the Qualitative Consensus Tradition to a Qualitative Translational Hypothesis-Driven Systems Biology Strategy.”

Following the lunch break, reports were made by the three subcommittee chairmen. Education subcommittee chairman Kristine Healy spoke about the current environment in which so few health care providers feel comfortable making a CFS diagnosis or managing CFS patients. She endorsed the concept of the NIH State of the Knowledge conference noted by Hanna and thanked the two invited guests for the presentations they would soon make about the challenges of securing appropriate educational accommodations for students with CFS. Jason conveyed the appreciation of the Research Subcommittee to Miller for providing detailed budget information and to Dr. Cheryl Kitt of NIH’s CSR for meeting with them about changes that might be made to the review process to more appropriately incorporate CFS expertise in the composition of review panels. Mechanisms to encourage young investigators were discussed, with input from Kitt, who was in the audience. Speaking for the Quality of Life Subcommittee, chairman Rebecca Artman outlined the subcommittee’s primary concerns as being lack of access to health care and employment issues faced by people with CFS. She also voiced concern about the lack of patient involvement in the meetings of CFSAC.

For the next 90 minutes, the committee heard presentations from Dr. Katherine Rowe, a pediatrician in Australia who has successfully assisted her young CFS patients in securing educational accommodations and lifestyle adjustments that, in addition to symptomatic treatment, have helped them to more fully participate in academic and social activities central to their development. Attorney Barbara Comerford of New Jersey made a presentation both from the legal perspective and as a parent of a CFS patient. Because the committee operates under jurisdiction of the Department of Health and Human Services, and no Department of Education representative was present at the meeting, the committee had little to recommend following the presentations; however, Bateman expressed her strong feeling that the health agencies’ validation of CFS was an important element of patients’ ability to obtain supportive care and appropriate services.

The afternoon session concluded with presentation of public testimony by the following advocates: Deborah Friedman (New Jersey), Marian Dix Lemle (Washington, D.C.), Kim McCleary (CFIDS Association of America president & CEO), Dr. Suzanne Vernon (CFIDS Association of America, scientific director), Toni Marshall (Maryland), Amy Squires (Virginia) and Lars Ellen Morgan (Arizona). McCleary’s testimony provided a close analysis of the CDC budget figures provided by CDC, documenting the payment of millions of dollars to research contractors and the lack of evidence of outcomes delivered by those contractors since 2004. Specifically, McCleary questioned CDC leadership, accountability and performance related to three contracts the CFS research program funded totaling more than $9.8 million that produced few results in 4 years. She was invited back to the committee table to address questions posed by committee members. Wiley joined her, providing answers to questions of a financial nature. (Monroe had left the meeting prior to the beginning of public testimony and did not participate in the afternoon discussion.) McCleary stated that her testimony followed an extended series of discussions with CDC and that information about spending and obligations was provided by CDC, but it was not critically assessed by those with authority to alter the ineffective commitment of large amounts of money to unproductive contracts. She also expressed concern about the peer review and urged the committee to make recommendations that would lead to immediate corrective actions. Parekh formally adjourned the meeting for the day, although discussions continued between members of the committee, ex-officio federal representatives and members of the public.

The second day of the meeting began with reports from the remaining ex-officio representatives. Dr. Marc Cavaille-Coll from the Food and Drug Administration (FDA), made his biannual announcement that he cannot comment on the status of Ampligen or any other product under FDA review. Dr. Deborah Willis-Fillinger, representing the Health Resources and Services Administration (HRSA), reviewed the agency’s mission and major program areas. She reported that in response to the CFSAC’s request an e-mail message had been sent on October 3 to the nation’s Area Health Education Centers (AHECs) informing them about educational materials on the diagnosis and management of CFS and requesting feedback from AHEC providers about CFS. For the Social Security Administration (SSA), Dr. Laurence Desi reported that SSA had formed an ad-hoc working group to review the guidelines used by adjudicators and consultative examiners to evaluate cases involving a diagnosis of CFS. He addressed the backlog of cases that currently requires applicants to wait an average of 700 days for a hearing with an administrative law judge. The committee discussed the impact of this backlog on the applicants’ access to care and finances.

Jones was then offered the opportunity to address the committee as the incoming designated federal official assigned responsibility for managing the CFSAC. She stressed that placement in the Office of Women’s Health did not “pigeonhole” CFS as a woman’s disease, and that her office has vast experience dealing with health issues that cross sex and gender lines. She articulated her experience staffing a federal advisory committee on violence against women and the need to work across department and agency networks to engage the right people at the right time in the right ways. She also expressed her plan to keep Parekh involved as an advisor to her and the committee.

Invited guest Brownell Anderson then delivered a presentation about the education of medical students, representing the American Academy of Medical Colleges (AAMC). Anderson stated that the AAMC does not have the authority to dictate the inclusion of specific topics in curricula, nor does it impose a standardized medical school curriculum on its 130 member colleges in the U.S. As had been noted in other meetings, Anderson pointed out the opportunity present as medical schools update their approaches to education, focusing on problem solving and humanity in medicine rather than specific diagnoses. Dr. Jason then provided a review of the content of medical school texts, concluding that CFS is under-represented and that the nature of information about it varies widely from source to source. Discussion of both presentations followed. In response to a question about the role of board exams in education, Anderson indicated that the U.S. medical licensing exams drive medical school curricula. McCleary was then invited to deliver a short presentation on the outcomes achieved through the CDC-funded Provider Education Project and to introduce preliminary results from an Association-funded partnership with online CME provider Medscape. No discussion was permitted by the acting chairman.

The morning session concluded with testimony from 10 members of the public: Miriam Sobel (Utah); Dr. Mary Schweitzer (Delaware); Brian Smith (Nebraska); Carolyn Fribance(Wisconsin); Lisa Baldwin (North Carolina by telephone); Courtney Alexander (Virginia); Nancy Richardson (Pennsylvania); Loetta Vann (Maryland); Dr. Ken Friedman (New Jersey); and Marly Silverman (Florida).

Following a brief lunch break, the committee returned to formulate recommendations to Secretary Leavitt based on proposals brought forward from the three subcommittees. Five formal recommendations passed by unanimous vote and were sent to the secretary. The first recommended that DHHS develop a patient toolkit to provide accessible information about diagnosis, treatment, exercise and sleep. The second recommendation was to ensure that the CDC peer review evaluate CDC’s use of third-party contractors to provide logistical support for research projects. Next, the committee recommended that the secretary, in recognition that much can be done to ensure that every child has the best possible access to support and treatment, establish an ongoing intra-agency and interdepartmental effort to coordinate school, family, financial and health care support for children and young adults with CFS. Fourth, the committee asked that the transition report developed for the incoming secretary include all the CFSAC recommendations that have been developed over the last two chartered periods and any action taken on each one. Finally, the committee endorsed the planned NIH State of the Knowledge conference.

Remarkably absent were any recommendations generated by the Research Subcommittee, which applauded NIH and CDC for recent discussion about the review process and transparency, respectively. This forfeiture of the opportunity to send research-related recommendations was deeply disappointing to members of the public, several of whom had focused their testimony on the need for expanded federal research and a more robust search for biomarkers, diagnostics and effective treatment.

Before adjourning, the committee briefly discussed possible themes for the next meeting, including employment issues and an evaluation of the committee’s effectiveness. Again, the lack of oversight on research issues, particularly in light of the serious concerns raised about CDC’s program and the CFSAC’s purpose, was disturbing to many observers. Parekh was thanked by members of the committee for his stewardship of the CFSAC over the past two years and the meeting adjourned at 3:00 p.m.

Update on CDC Peer Review (November 21, 2008)

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