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Summary
ME/CFS is characterized by debilitating physical and cognitive
symptoms. It is estimated to affect over 800,000 adults
in the United States.
The first National Institutes of Health (NIH) grant was awarded for the study of
the chronic
fatigue syndrome in 1987. Over twenty-three years later despite high
prevalence rates and the disabling nature of
the illness, controversy and
speculation shroud this field of scientific investigation at the NIH.
Using Freedom of Information Act requests 2000 - 2009, the newly
created NIH Report database, the Government
Accounting Office Report HEHS-00-98,
and Chronic Fatigue Syndrome Advisory Council meeting minutes, this report
examines NIH funding for CFS for the last 10 years. While institute funding and
NIH appropriations doubled over the
past decade, CFS funding is the same
in 2009
as it was in 1992. Once the three CFS research centers established in 1992
phased out about 10 years ago,
funding for new CFS grants decreased
dramatically. In addition, further analysis of detailed grant information
reveals
that a significant amount CFS research money is spent on projects where
CFS is not the primary focus.
Report
Chronic Fatigue Syndrome is a functionally incapacitating
illness. This illness has more recently been referred to as
ME/CFS (where ME
stands for either Myalgic Encephalomyelitis or Myalgic Encephalopathy). The
persistent nature of
ME/CFS often results in a reduction in work and family life
activities, as well as an increase in health care costs.
In addition to
employment loss, patients with ME/CFS often experience higher costs of health
care due to the search
for better diagnosis and effective treatment. It is
estimated that the direct and indirect costs of ME/CFS to society
in the United
States is between $18.6 billion and $23.9 billion per year. [1]
Because of the societal impact of ME/CFS, and severity of daily
illness, advocates continue to question NIH dedication
to scientific
investigation. Few papers examine ME/CFS funding patterns. In 1998, the
Government Accounting Office
issued the first official report on NIH CFS
research funding patterns. This investigation was a result of advocates’
concerns that the Centers for Disease Control and the NIH ignored congressional
mandates about the direction of
CFS research. Other reports on NIH CFS funding
presented to the Chronic Fatigue Syndrome Coordinating Committee
(1996 – 2001)
and to the Chronic Fatigue Syndrome Advisory Committee, the current federal
advisory committee on
CFS, have been informal. Several meeting reports focused
on inadequate CFS funding and decline in overall CFS
expenditures. However, NIH
budget reports show a pattern of stable or increased budget for CFS studies.
The purpose of this report is to explore NIH CFS funding
patterns over a ten-year period from fiscal year 2000 through
fiscal year 2009.
Using NIH data from several sources, the data suggests an overall pattern of few
new awards each
year for ME/CFS science. In addition data shows increased
funding for new grants categorized as CFS expenditures
where CFS is not the
primary focus.
NIH Freedom of Information Act (FOIA) requests centered on 3
areas of data collection. Table 1 shows the number
and funding amount for new
studies and renewal of existing ME/CFS science awards fiscal years 2000 - 2009.
Table 2 shows the number of Chronic Fatigue Syndrome Special Emphasis Panel
reviewed new applications from
October 2005 through October 2008, and the number
of new ME/CFS science grants funded.
The Chronic Fatigue Special Emphasis Panel (CFS SEP) is one of
hundreds of panel review groups within the
Center for Scientific Review. After
the Center for Scientific Review receives grant applications, an officer assigns
a review group that will read and score submissions and a Council that will look
at scored grants. The CFS Special
Emphasis Panel is multidisciplinary. The
majority of grants submissions are investigations of sleep, pain and fatigue
mechanisms which makes for considerable overlap as these symptoms translate to
syndromes and disease processes.
Table 2 is specific to the CFS SEP because over
99% of grant applications relating to CFS are assigned to this panel.
Information gathered from other public sources as noted is
integrated in Table 2 to provide a more comprehensive
picture of CFS funding
patterns. The NIH website < http://report.nih.gov> provides overall statistics
for NIH projects,
historical data on funding initiatives, and a vast number of
links to all NIH business. A valuable link on the NIH report,
Project Reporter,
shows specifics about grant award history, the project title, the principle
investigator, dollars
awarded, and research results in terms of publications.
The Government Accounting Office investigation of CFS (GAO/HEHS/00-98),
finalized in 2000, provides a starting
point for this report. Baseline data as
well as GAO summaries and recommendations give context to the questions on
inadequate funding for CFS. Lastly, meeting minutes from the Chronic Fatigue
Syndrome Advisory Council 2003
through 2009 show ongoing interest and troubling
questions from voting members about the level of National
Institutes of Health
interest in the pursuit of a CFS science program.
The Government Accounting Office investigation stated that the
CFS Special Emphasis panel was designed to help
facilitate the consideration and
scoring of CFS grant applications. In fact, in fiscal years 1988 through 1999,
the
funding rate for CFS was about 24% . [2] Further analysis of data from FOIA
requests made in 2006, 2007 and
2008 indicates a funding rate for CFS specific
awards at about 6%. [3]
The grant making process through the CFS Special Emphasis Panel
has not facilitated CFS scientific investigation.
A ten-year profile of ME/CFS
science grants where CFS is the primary focus reveals that there were only 25
new
awards for a total of about 8.5 million. 2 – 3 grant awards per year is
unacceptable.
Table 1. Inadequate funding: A 10-year profile of ME/CFS science
grant awards 2000 - 2009
*New studies are often 2 or 3 year grants, so for the
next several years after the award, they are
included in the renewal funding.
Thus, percentage of the total funding for new CFS studies can be
calculated
for
one year only and not as a whole. See grant details Appendix 1.
Scarcity of new ME/CFS grants is not apparent when looking at
NIH reported total CFS expenditures.
From 2000 through 2007, the Office of the
Budget reports $51 million spent on CFS investigation. [3]
In 2008 and 2009, NIH
reports an additional $9 million spent on CFS. [4] $60 million spent in ten
years does not reflect
the actual dollars spent on CFS science as indicated by
Table 1. $38 million is actual CFS science expenditure.
That leaves a $22
million dollar discrepancy between actual CFS science new awards and renewals
and what was
reported.
Because the CFS Special Emphasis Panel reviews over 99% of
grants submitted for CFS research, the number of
submissions, the number awarded
and the specifics of those awards are key to understanding at least one factor
that might explain the difference between actual spending and reported
spending on CFS research studies.
The meeting minutes of the Chronic Fatigue Syndrome Advisory
Committee (CFSAC), chartered under the Office of
the Director, Health and Human
Services, show repeated discussions from 2004 through 2009 about the efficacy of
the CFS Special Emphasis Panel. [5] Decisions about grant funding made by the
CFS Special Emphasis Panel and its
chief, the Scientific Review Officer,
continue to challenge the CFSAC.
Discussions about the CFS Special Emphasis Panel are recorded in
the CFSAC meeting minutes November 2007,
May 2008 and November 2008. In November
2007, Dr. Ron Glaser, a voting member of the CFSAC, stated that
over the last
three years only about 15% of the Special Emphasis Panel reviewers had
background related to CFS
and none of those on work about etiology. In May of
2008, the Research Subcommittee concluded that the review
process, the SEP, and
the apparent “hurdles” were out of line with a fair review process. Discussion
continued at
the November 2008 meeting.
The Research subcommittee concluded that investigators will be
discouraged by the rejection of their research
proposals, not because their
grants are poorly written, but because of inappropriate reviews. [5] Over time,
CFS
researchers and those newly intrigued by CFS science will pursue other areas
of interest that may lead to
advancement rather than a detriment in career
goals.
Numbers indicate that the CFSAC concern is founded in fact. 161
CFS Special Emphasis Panel grants were
reviewed in 2006, 2007 and 2008 by the
CFS Special Emphasis Panel. Of those 161 grants, 10 were CFS awards
for a total
of about 3 million dollars.
Grant details appear in Appendix 2
Significantly, data about the total number of CFS applications
logged in by the Center for Scientific Review and
sent to the CFS Special
Emphasis Panel for peer review is not public information through the FOIA
process.
Unread and unscored applications do not make the cut for a second
review.
These applications are sent back to the researcher. This issue
needs further investigation. It is speculative to
conclude that all returned
submissions are poorly written, ill conceived or lack innovation. This issue was
discussed
at length at the March 2004 CFSAC meeting. [5]
Another troubling fact is that many studies clearly designated
as CFS do not have CFS as a primary focus.
These have been excluded from Table 1
and have been excluded from funding details in Appendix 2.
Principal
Investigators state CFS as a priority, but grant history and research
publications do not demonstrate
use of funding for CFS. Two NIH awardees, Roy
Freeman, a Harvard researcher interested in orthostatic intolerance
and Colleen
Carney/Andrew Krystal, Duke researchers interested in behavioral treatments for
CFS insomnia,
present troubling grant histories. [6]
Inappropriate use of CFS funds is clear in the case of a 2006
award for Diane Lorton, Banner Sun City Health
Research Institute located in
Phoenix, Arizona. The intent was to develop a Fibromyalgia spinal cord and brain
tissue bank. This grant does not appear in Table 1 because CFS is not the
primary focus of the grant. In fact in
2010, the institute, “dedicated to the
study of aging and age-related diseases such as Alzheimer’s, Parkinson’s,
arthritis and prostate cancer” has not created a Fibromyalgia Biobank. [7]
Conclusion
Controversy and speculation shroud this field of scientific
investigation at the NIH. A significant amount of CFS
research money is spent on
projects where CFS is not the primary focus. The efficacy of the CFS Special
Emphasis
Panel is questionable. Overall, despite high prevalence rates, the
disabling nature of the illness, economic loss and
extreme family and community
resource hardships, scientific interest in Chronic Fatigue Syndrome at the
National
Institutes of Health is not supported by outcome data.
There are limitations to this report in gathering accurate
information over a period of ten years. Freedom of
Information Act requests must
be worded for specific information, which can, unknowingly exclude data needed
to
make accurate conclusions. NIH grant making procedures and data recording
evolve over the years. Scientific
meetings at the NIH that focus on CFS often do
not include public input, but may alter grant announcements and
the focus of CFS
research. Gathering information to review CFS funding outcomes may exclude key
decisions about
the CFS program.
A brief with charts and documentation is available upon request.
1. The Economic impact of ME/CFS: Individual and societal costs
Dynamic Medicine 2008, 7:6 doi: 10.1186/1476-5918-7-6
Leonard A Jason, Mary C Benton, Lisa Valentine,
Abra Johnson and Susan
Torres-Harding Email: Leonard A Jason - ljason@depaul.edu;
2. The General Accounting Office Report, Chronic Fatigue
Syndrome: CDC and NIH Activities are Diverse but
Agency Coordination is Limited,
(GAO/HEHS-00-98)
3.National Institutes of Health Freedom of Information Act
Requests, 2000 – 2009 # 32335, 33228, 34681,
34777, 34979, 35899
4. < http://report.nih.gov>
5.Meeting minutes 2003 – 2009 http://www.hhs.gov/advcomcfs/meetings/index.html
6. http://projectreporter.nih.gov/project_info_description.cfm
7. /www.bannerhealth.com/Innovations/Sun+Health+Research+Institute/Research+Programs/Arthritis.htm