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
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.
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
Center to voice your
concerns about the steep decline in NIH funding for CFS research.