Wednesday, April 27, 2011

Pat Fero's report on Funding

National Institutes of Health Funding for Chronic Fatigue Syndrome Grants: A Ten-Year Profile
Pat Fero, MEPD
Executive Director
Wisconsin ME/CFS Association, Inc.
3/26/2011
Bp.fero@charter.net -- contact Pat for the PDF version with the charts

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-four 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.
This report examines NIH funding for CFS for the last 10 years. CFS funding is the same in 2009 as it was in 1991. Once the three CFS research
centers established in 1992 phased out about 10 years ago, funding for new CFS research projects decreased to an average of 2 - 3 awards per
year. In addition, further analysis of detailed grant information reveals that a significant amount of CFS research money is spent on projects where
CFS is not the primary focus. In 10 years, about 36.4 million dollars has been spent on CFS science which is about $3.60 per person per year.
Background
Chronic Fatigue Syndrome is an 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 treatment that is more effective. It is estimated that the direct and indirect costs of ME/CFS in the
United States is between $18.6 billion and $23.9 billion per year. [1]
Patients question NIH support for scientific investigation. In 25 years, there has been little scientific progress on understanding the etiology of
ME/CFS, little progress on determining biomarkers and no progress on treatments to alleviate symptom severity. Patients look to public health
agencies for answers. 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, these data suggest an overall pattern of few new awards each year for CFS science. In addition,
data show increased funding for new grants that are categorized as CFS expenditures, but outcomes show that CFS is not the primary focus of
the research.
Few papers examine ME/CFS funding patterns. In 2000, the Government Accounting Office (GAO/HEHS/00-98) issued the final investigative
report on NIH and Centers for Disease Control (CDC) CFS research activities. This investigation was a result of advocates' concerns that the CDC
and the NIH ignored congressional mandates about the direction and level 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, the NIH Office of Management and Budget (OBM) charts show a pattern of stable or increased budget for CFS studies.
Further data will explain the discrepancy between decline in CFS expenditures and OBM CFS budget reports.
NIH Freedom of Information Act (FOIA) requests centered on three areas of data collection. Table 1 shows the number and funding amount for
new studies and renewal of existing CFS science awards fiscal years 2000-2009. Table 2 shows the number of Chronic Fatigue Syndrome Special
Emphasis Panel reviewed new applications from October 2006 through October 2008, and the number of new 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. This means that grant applications may be investigations of
sleep, pain and fatigue mechanisms in a multitude of syndromes and disease processes to include fatigue in cancer patients, pain in sensitivity
syndromes and any disorder with disturbed sleep. 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 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 principal
investigator, dollars awarded, and research results in terms of publications.
Report
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 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 GAO investigation stated that the CFS Special Emphasis Panel was designed to help facilitate the consideration and scoring of CFS grant
applications. The GAO report shows that in fiscal years 1988 through 1999, the funding rate for CFS was about 24% compared to 28% for all
grants across the same institutes that fund CFS research. The GAO counted only those awards where CFS was the primary focus. [2]
The grant making process through the CFS Special Emphasis Panel has not facilitated CFS scientific investigation. From Fiscal Year 2000
through fiscal year 2009 there were only 24 new awards, about 7.6 million dollars, where CFS is the primary focus. Further analysis from FOIA
requests made in 2006, 2007 and 2008 indicates a funding rate for CFS awards at about 7%. [3] Considering the numbers of people affected, the
severity of daily illness, and societal impact of ME/CFS, 2 – 3 new grant awards per year and the dramatic decline in funding rates since 2000
raises serious questions about NIH commitment to CFS science.
Table 1. A 10-year profile of ME/CFS science grant awards 2000 – 2009
Year New
Studies
New
Funding Renewed
Studies
CFS
Centers
Renewals
Renewal
Funding
Total
Funding
2000 2 $863,805 6 14 $3,414,202 $4,278,005
2001 3 $676,220 6 14 $3,876,723 $4,552,943
2002 1 $329,987 7 12 $4,269,156 $4,599,143
2003 3 $1,188,270 8 Discontinued $2,034,241 $3,222,511
2004 1 $255,301 9 $2,667,530 $2,922,831
2005 1 $641,703 6 $2,344,369 $2,986,072
2006** 6 $1,736,061 4 $2,270,107 $4,006,168
2007 3 $809,875 9 $3,283,159 $4,093,034
2008 3 $795,041 5 $1,734,886 $2,529,927
2009 1 $335,600 8 $2,852,214 $3,187,814
Totals 24 $7,631,863 $28,746,585 $36,378,448
*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. ** Bump year with 5 million 'new' money
available for CFS grants. 1.7 million was spent.
Scarcity of new 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 dollars spent on CFS investigation. [3] In 2008 and 2009, NIH reports an additional $9 million spent on CFS. [4] $60
million dollars spent in ten years does not reflect the actual dollars spent on CFS science as indicated by Table 1. $36.4 million dollars is actual
CFS science expenditure. The $23.6 million dollar difference is money spent on grants where CFS is not the primary focus as indicated by grant
history, outcomes, publications, and PI academic interests.
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. Decisions about
grant funding made by the CFS Special Emphasis Panel and its chief, the Scientific Review Officer, continue to challenge the CFSAC. CFSAC
meeting minutes show that invited speakers such as Scientific Review Officers as well as other NIH grant experts conclude that the number of
CFS applications are low and submissions are poorly written, ill conceived or lack innovation [5]
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 reviewers worked on etiology. In May of 2008, the Research
Subcommittee concluded that the CFS SEP review process and the apparent "hurdles" for new project proposals 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]
With a 7% funding rate, over time, CFS researchers and those newly intrigued by CFS science are likely to pursue other areas of inquiry that may
lead to advancement rather than a detriment in career goals.
FOIA data legitimize CFSAC concerns about the CFS SEP. 161 grants were reviewed in 2006, 2007, and 2008 by the CFS Special Emphasis
Panel. Of those 161 grant applications, 11 awards went to CFS researchers for a total of about 3.2 million dollars, a 7% funding rate. In addition,
of those 161 grant applications, 18 awards went to non-CFS researchers for a total of about 6.5 million dollars, an 11% funding rate. This means
that of the 9.6 million dollars awarded in fiscal years 2006, 2007 and 2008, about 33% of the money was for CFS and about 67% was for non-CFS
research. Grant details appear in Appendix 2.
It is troubling that many studies designated as CFS do not have CFS as a primary focus. Principal Investigators state CFS is a priority, but grant
history and research publications do not demonstrate use of funding for CFS. Inappropriate or questionable use of CFS funds is clear when a
researcher uses NIH award money dedicated to a CFS related projects, such as creating a spinal cord and tissue bank, when in fact, there is no
evidence that the project was started or completed. In other cases, the researcher is interested in and publishes on a CFS related symptom such
as hypotension, pain, sleep, and fatigue in an entirely different illness or syndrome. There is no evidence that grant money is used to investigate
that symptom in chronic fatigue syndrome laboratory studies, animal models or in clinical studies. In order to focus on CFS research these non-
CFS grants have been excluded from Appendix Table 1. However, Appendix Table 2 includes funding details for new non-CFS awards.
Conclusion
Controversy and speculation shroud this field of scientific investigation at the NIH. A GAO reported funding rate of 24% in 2000 compared to a 7%
funding rate a decade later shows a steep decline. The efficacy of the CFS Special Emphasis Panel is questionable. A significant amount of CFS
research money is spent on projects where CFS is not the primary focus. 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 existing 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 relevant data. 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 are not public information through the FOIA process thus
making conclusions inherently risky and sometimes faulty. NIH CFS focused scientific meetings often do not include the public, but decisions
made at meetings may alter grant announcements and the focus of CFS research leaving the public unaware of changes. Lastly, NIH grant
making procedures and data recording evolve over the years. This fluidity demonstrates progressive and continued NIH efforts to serve public
health interests.
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
 

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