RETURN TO TABLE OF CONTENTS
Fall 2003 

CFIDS News
Keeping you up to date on recent events across the nation and around the world

In a large conference room tucked away on the Bethesda, Md., campus of the National Institutes of Health (NIH), a new era of CFIDS advocacy was quietly ushered in earlier this fall. Despite a two-year, eight-month wait, there was little fanfare as the new Department of Health and Human Services (DHHS) Chronic Fatigue Syndrome Advisory Committee (CFSAC) convened for the first time.

A handful of people gathered, waiting for the 11 committee members appointed from the public to enter the room and begin the meeting. Next door, appointees were concluding a closed-door session with the General Counsel to learn about the federal regulations that define their advisory roles. Only the placards arranged around the table gave away the committee membership. The sluggish selection process was rushed at the end to ensure that the committee met before the fiscal year ended. It was Sept. 29, 2003 and the feds had beaten the deadline with a day to spare.

The History
For advocates, the meeting marked a dubious victory. In January 2001, when DHHS announced its intent to morph the existing CFS Coordinating Committee (CFSCC) into a formal advisory committee governed by the Federal Advisory Committee Act, no one expected that it would take nearly three years to assemble the group. The extended transition of the Bush Administration, 9-11, anthrax, SARS and an overhaul of all federal advisory committee slowed the process.

Working with Congress and numerous department staff assigned for brief periods to manage formation of the committee, The CFIDS Associ-ation of America made regular inquiries about the status and structure of the new body and repeatedly reinforced the need for continuity, appropriate representation and regaining lost momentum. The advisory committee charter was signed by Secretary Tommy Thompson on Sept. 5, 2002 and the nomination process was announced on Dec. 6, 2002, with nominations due Jan. 31 of this year. The Association nominated 19 advocates, researchers, clinicians and disability experts in an effort to balance broad representation with diverse experience.

The purpose of the CFSAC is to "provide expert advice and recommendations to the Secretary of Health and Human Services on a broad range of issues and topics pertaining to CFS." The CFSCC and CFSAC differ in size — 7 appointed members of the public vs. 11 — and in the voting status of the federal representatives. Only public appointees have voting privileges on the CFSAC; it is chaired by a public appointee, whereas the CFSCC was chaired by a federal employee. The CFSAC structure is more con-sistent with other DHHS advisory committees. Changes were prompted by a June 2000 General Accounting Office report that identified incongruities in federal CFS activities.

Months passed with little more than assurances from the department that the bureaucracy wheels were turning and that our concerns were heard and understood. Verbal pledges to continue the unexpired terms of three CFSCC members and to convene the committee before Sept. 30 were regularly questioned and confirmed. Calls made by the department during the summer months to nominees to explore possible conflicts of interest were a sign that at least there was some forward progress. However, on July 9, I was informed that consideration of my nomination had ended, citing the department’s concern surrounding my dual role of Association CEO and board member and the Association’s perpetual engagement in public policy activities. Our broader interest in securing the first meeting and appropriate committee membership edged out instincts to delve more deeply into the motivations behind the decision; we elected not to protest.

With some suddenness, a Sept. 29 meeting was publicly announced in the Congressional Daybook on Sept. 17, short-changing the usual 30-day requirement for public notice. I was contacted by Dr. Larry Fields of DHHS and asked to attend and participate as an "invited guest," but told that the department could not yet announce the committee membership.

Checking in with the Association’s nominees allowed us to identify half of the committee appointees. It also revealed that there would be no carryover from the CFSCC of Dr. Leonard Jason, attorney Jeff Rabin and CFSCC co-chair (and Association board Chairman) Jon Sterling, contrary to assurances made by several different DHHS staff members during the interim period. This news compounded concerns about the hasty scheduling and inadequate time for interested parties to submit public testimony or travel to the meeting; the refusal to release the names of committee appointees or federal ex-officio members; the absence of a stated meeting agenda and overlap with the Rosh Hashanah holiday. Could a meeting held under these circumstances be productive?

The Inaugural Meeting
After a call to order, brief introductions and some opening remarks from Dr. Fields, NIH’s Dr. Donna Dean presented a historical overview of DHHS’s CFS activities, including the CFS Coordinating Committee for which she served as the last federal chairman.

Agency reports from each of the ex-officio members recounted research and education activities stretching back to early 2001. CDC’s Dr. William Reeves detailed the enormous growth in CDC’s CFS research program made possible by the restoration of $12.9 million in funds diverted to other programs between 1995 and 1998. He informed the committee about the proteomics and genomics technology being used to find a marker for CFS, a massive clinical study in its final stages in Wichita (see The CFIDS Chronicle, winter 2003) and a population study being planned for three distinct geographic regions of Georgia. He reported that for FY2003, CDC will spend $12 million on CFS – one-tenth of one percent of the annual $10 billion direct economic loss attributable to CFS, as estimated by CDC.

Dr. Eleanor Hanna of NIH’s Office of Research on Women’s Health spoke about her efforts to broaden interest in CFS across the campus to reflect the need for a multidisciplinary approach. She also reported on a June 2003 conference, Neuro-Immune Mechanisms and Chronic Fatigue Syndrome, sponsored by NIH and a Request for Applications that she is working to develop in collaboration with several institutes. Dr. Hanna reported that NIH funding of CFS studies totals $7.2 million and agreed to provide the committee with a listing of CFS grants and their total budgets at the next meeting.

FDA’s Dr. Cavaille-Coll indicated that FDA currently has applications from pharmaceutical companies for fewer than 20 products in any stage of development for the treatment of CFS. He reminded the committee that federal regulations prohibit him from disclosing any details beyond what the manufacturer has made public.

Dr. William Robinson, chief medical officer for DHHS’s Health Resources and Services Administration (HRSA), expressed his regret that as a result of significant staffing changes and reorganization of programs, HRSA’s participation in collaborative provider education efforts had ceased in 2001. He pledged his renewed commitment to identify ways in which HRSA could augment ongoing efforts.

Reporting for the Social Security Administration, Dr. William Anderson outlined efforts to better serve applicants for disability benefits arising from CFS through the publication of Ruling 99-2p for CFS and education of disability adjudicators as to the disabling features of CFS. He reported on new initiatives to identify severe impairments earlier in the process and to help those who wish to attempt a return to work.

Public comments
Question and answer periods followed each of the agency reports. After a lunch break, I was invited to address the committee to share The CFIDS Association’s priorities with the group. I conveyed the importance of this committee to the overall effort to conquer CFIDS, as well as its symbolic importance as a forum for the exchange of information and the discussion of challenging issues confronting CFIDS patients, health care professionals, researchers and policymakers. I expressed the need to improve the rigor of CFIDS research, attract more scientists to its study, better understand the impact on the body and the individual, meet patients’ health care and social service needs and raise the profile of the illness as a serious and complex public health concern.

After receiving a question about the name change working group I had served on as a member of the CFSCC, Dr. Fields suggested that Carol Lavrich and I provide our report to the committee. Carol, the chairman for the working group which had been convened by the CFSCC, referred to a draft set of recommendations that had been shaped by three years of monthly conference calls, paper and Internet surveys, open meetings at CFS conferences and discussions with advocates, health care professionals, researchers and agency staff. The recommendations called for developing a slightly less restrictive "umbrella" for chronic fatigue syndrome that would include cases that nearly meet the current 1994 "Fukuda" case definition for CFS. The larger construct would be called Neuroendocrineimmune Dysfunction Syndrome (NDS), with subgroups (including CFS and myalgic encephalopathy) falling under the NDS term. Carol asked the committee to endorse the continued efforts of this working group, allowing it time to further refine the recommendations and to hold a session in conjunction with a future CFSAC meeting to explore consequences of a name change on processes like medical coding, private insurance, HMOs, etc. Following discussion by several committee members about the timing of a name change, the impact of it on definitional and research issues and its general advisability, Committee Chairman Dr. David Bell thanked the working group for its efforts and asked that they provide to him the information collected. He informed the committee that he would summarize it at the next meeting to determine future action.

Two other advocates addressed the committee and a third presented written testimony, read by Dr. Fields. Jill McLaughlin, executive director of the National CFIDS Foundation, presented her top priorities — the name change and recognition of children with CFIDS. Mary Schweitzer, a long-term patient and activist, shared her experience with the experimental drug Ampligen and pleaded for the committee to recognize the poverty that often follows the onset of the illness due to an inability to work and the difficulty of obtaining medical and disability benefits. In her written comments, Wisconsin support group leader Pat Fero asked for greater attention to life threatening conditions that doctors overlook in long-term CFS patients. She requested that the committee "choose to do one thing and do it well."

As the meeting came to a close, committee members revisited some common themes in an effort to focus future dialogue on priority matters. The education of health care providers, increased public awareness, expanded research and committee communication mechanisms rose to the top of the working agenda. They agreed that the committee should meet frequently at first and set a target of early December for the next meeting. There was earlier agreement that a Web site and listserv be created to provide information to interested parties and to facilitate sharing between meetings. Dr. Bell made some assignments to members expressing interest in certain topics and adjourned the meeting.

First impressions
Two observers, both of whom had come on behalf of their adult children with CFIDS, felt cautious optimism after the meeting. Sandy Solomon, whose son is ill, expressed early concern: "I was disappointed that The CFIDS Association was not represented on the committee and hope that members will take advantage of Kim Kenney’s offer to be a resource. It was clear from the agency reports and the comments made by the DHHS representatives on the committee that The CFIDS Association has played a significant role, both as a collaborator and advocate, in progress made by the federal government."

Rick Baldwin, who serves as the Association’s Treasurer, shared his hopes. "There is a lot of ground to cover because of all the new members and the need to catch up after two and a half years of not meeting. I was disappointed that there was such short notice of the meeting, and that this probably contributed to three members not being present. However, I was pleased that the committee recognized the need to meet more frequently than originally expected and to use a listserv to facilitate communication. Hopefully, these actions will help to regain momentum." Rick’s daughter, Alison, has been ill since 1995.

In all, the session provided a good start for a committee long in the making. The Association remains committed to continued collaboration with the department, federal agencies and the CFS Advisory Committee. It will use the opportunities this committee creates to assess federal efforts, express concerns and make policy recommendations.

Meeting announcements and updates on the committee’s activities will be shared through the Chronicle, the Association’s Web site and the CFIDS Activist listserv. For more information, visit www.cfids.org/advocacy/cfids-activists.asp or send an e-mail message to C-ACTMembership@cfids.org.

Kim Kenney is President and CEO of The CFIDS Association of America.

Chronic Fatigue Syndrome Advisory Committee

Voting Members

David S. Bell, MD
CFS Advisory Committee Chairman
Lyndonville, N.Y.

Nancy C. Butler
Dubuque, Iowa

Jane C. Fitzpatrick
Punta Gorda, Fla.

Kenneth Friedman, PhD
Short Hills, N.J.

Nelson Gantz, MD, FACP
Boulder, Colo.

Anthony L. Komaroff, MD
Boston, Mass.

Charles W. Lapp, MD
Charlotte, N.C.

Lyle Lieberman, JD
Miami, Fla.

Nahid Mohagheghpour, PhD
San Francisco, Calif.

Roberto Patarca, MD, PhD
Miami, Fla.

Staci R. Stevens
Ripon, Calif.

Eleanor Hanna, MD
National Institutes of Health (NIH)

William Reeves, MD
Dru Barrett, MD
U.S. Centers for Disease Control & Prevention (CDC)

Marc Cavaille-Coll, PhD, MD
Food and Drug Administration (FDA)

William Robinson, MD
Health Resources and Services Administration (HRSA)

William Anderson, MD
Social Security Administration (SSA)

Larry E. Fields, MD, MBA, FACC (Acting Executive Secretary)
Office of Public Health and Science, Dept. of Health and Human Services (DHHS)