The Chronic Fatigue Syndrome Advisory Committee Update   

CFS Advisory Committee Charter Extended, Meets in D.C.

The Department of Health and Human Services CFS Advisory Committee held its fifth meeting on Monday, September 27, 2004 in Washington, D.C. The committee, chaired by Dr. David Bell, heard agency updates from the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) on their CFS research activities. Representatives from the Social Security Administration (SSA), the Food and Drug Administration (FDA) and Health Resources and Services Administration (HRSA) were on hand to answer questions about disability, drug and education issues. Committee members also reviewed and discussed a set of 11 recommendations that they had sent to Secretary for Health Tommy Thompson on August 23, 2004. 

The meeting was lightly attended by advocates, but the committee heard public testimony from seven people. Utah clinician Dr. Lucinda Bateman made a presentation on behalf of her patients who were enrolled in the double-blind study of Ampligen, a drug that she feels offers substantial clinical benefit to “carefully selected patients.” She reported that several of the patients at her site were able to return to more active lives and that there were relatively few side effects in her group. Dr. Bateman urged the FDA to approve the drug. Ampligen is administered twice weekly by IV; the 40-week study enrolled 220 patients at more than a dozen sites around the country. The manufacturer is expected to announce results of the Phase III trial at the October meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

Elsie Owings presented her own testimony and read remarks submitted by two others who were unable to travel to the meeting. She expressed her belief that CFS is “lost in a sea of fatiguing illnesses,” largely as a result of the name and diagnostic criteria. Dr. Budrose shared some of these same sentiments in her testimony. Ed Jelinski, a law student who has recovered enough to attend school full-time, spoke about the lack of resources and support systems for young people with CFIDS. Mary Schweitzer, PhD echoed Dr. Bateman’s support for approval of Ampligen, a drug that she has benefited from under special cost recovery provisions that allow her to purchase the drug although it has not yet been approved for marketing. Several of the speakers offered their appreciation for the committee’s efforts and the dedication to important issues that committee members have demonstrated in their first year of work.

During the morning session, CFIDS Association of America president & CEO Kim McCleary presented a detailed analysis of data provided by the NIH budget office on CFS research grants made from 1999 through 2003. Although NIH reported that $31.6 million had been spent on CFS during the five-year period, Ms. McCleary closely investigated the nature of the studies counted as CFS and found over $6 million lacked direct relevance to CFS. Adjusting for misclassified studies brought the total funding to $25 million and just $3.9 million for 2003, a figure only slightly higher than NIH funding in 1992. The committee asked Ms. McCleary about her methodology for the analysis, comparative figures for similar conditions and other trends and patterns she observed in preparing the 45-page report. NIH representative Dr. Eleanor Hanna responded to questions as well, informing the committee of the process used to compile the budget office’s data and difficulties in accurately capturing all the studies that NIH supports that may have outcomes important to the understanding of CFS. Ms. McCleary offered a series of recommendations and emphasized the importance of securing substantial funding for and actively distributing the Request for Applications (RFA) that NIH plans to issue before year-end. The committee returned to the issue of “relevance” in the afternoon and formed an ad-hoc task force to develop criteria for assessing whether a particular study is relevant to CFS.

The committee’s recommendations to the Secretary for Health were the primary subject of the afternoon session. Dr. Roberto Patarca and Dr. Ken Friedman urged the committee to think more expansively about where CFIDS research and education should be in the future. With renewal of the committee’s charter through September 2006, topics for future meetings were also discussed. It was decided that the committee would focus on CFS in young people at its first 2005 meeting, tentatively scheduled for January 10. At the spring meeting the committee will invite participation from several professional organizations like the American Medical Association to learn how they view CFS and what partnership activities might be possible.

For advance notice of these meetings, sign up to receive the Association’s e-mail Grassroots Action Alerts. Visit our Grassroots Action Center to voice your concerns about the steep decline in NIH funding for CFS research.