Inadequate NIH Funding for CFS by Pat Fero, MEPD

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(Pat Fero, the Executive Director of the Wisconsin ME/CFS Association used Freedom of Information Act requests, the online NIH Report Database, minutes from the CFSAC meetings and government to uncover a startling pattern of disregard to CFS by the NIH
Some highlights:

• While the NIH’s Budget doubled over the last decade funding for ME/CFS remains at 1992 levels. That’s bad! But it’s actually even worse than that because a dollar is worth about half as much as it was 1992; in real terms the NIH is spending half as much now on ME/CFS as it did almost twenty years ago.
• The federal disregard for ME/CFS is actually even worse than than. Until Lenny Jason’s 1999 Community based study the federal government felt rates of ME/CFS were actually quite low. Now they know they are actually quite high yet funding continues on at pitiful leves
• Over three years the Chronic Fatigue Syndrome Special Emphasis Panel awarded funding for 161 grants; only of which 10 were for Chronic Fatigue Syndrome.
• Grant acceptance rates have fallen from 24% (1988-99) to 6% a year (2006-8) – Cort )

Executive Director
Wisconsin ME/CFS Association, Inc
9/27/2010
Bp.fero@charter.net

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 < https://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. 2 to 3 new CFS grants per year is unacceptable. A 6.2% funding rate is unacceptable. 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. < https://report.nih.gov>
5.Meeting minutes 2003 – 2009 https://www.hhs.gov/advcomcfs/meetings/index.html
6. https://projectreporter.nih.gov/project_info_description.cfm
7. /www.bannerhealth.com/Innovations/Sun+Health+Research+Institute/Research+Programs/Arthritis.ht

Appendix Table 1. Grant history for all CFS researchers 2000 – 2009. Shaded gray indicates new awards.

*CFS Research Center renewals **Hartz, A is included in Table 1, but not in table 2. The 2008 grant was not CFS SEP reviewed.

Appendix Table 2. CFS SEP reviewed new grants 2006, 2007, and 2008

Grant Details

*Hartz, A is included in Table 1, but not in table 2. The 2008 grant was not CFS SEP.reviewed.

Addendum

NEW and competing renewal 2010 awards as of 9/16/2010
< https://report.nih.gov>