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 10th 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.
