Disease Funding and NIH Priority Setting

Disease Funding and NIH Priority Setting

97-917 STM
Updated March 26, 1998
CRS Report for Congress
Received through the CRS Web
Disease Funding and NIH Priority Setting
Judith A. Johnson
Specialist in Life Sciences
Science, Technology, and Medicine Division
Summary
Research at the National Institutes of Health (NIH) has strong political support, but
a heated debate rages over the allocation of NIH funds among various diseases. NIH
contends that decisions are made based on scientific opportunity while critics of the NIH
process charge that spending often follows current politics and political correctness.
The ongoing effort to balance the federal budget has reduced overall federal research
and development (R&D) funding. "Between FY1995 and FY1997 total civilian R&D
declined 4.1% in real terms." Although overall federal R&D spending is down over the
1
past several years, one sector of the federal R&D effort has been protected. Biomedical
research funding at the National Institutes of Health (NIH) has nearly doubled over the
last decade. The NIH budget has "stayed about 25% ahead of inflation as measured by
the Biomedical Research and Development Price Index, a special inflation index
developed for NIH to measure changes in the prices of items and services required for its
R&D activities.” The NIH FY1998 budget of $13.65 billion represents over one thir
2
d
of federal civilian spending for R&D.
Clearly, NIH has received strong bipartisan support from Congress. Advocates for
expanding biomedical research are none the less concerned that continuing pressure to
reduce the deficit will eventually result in NIH receiving only small increases or even the
flat or declining budgets experienced by the other federal R&D agencies. While funding
for NIH has been relatively generous, about 75% of the research grant proposals
submitted to NIH do not receive funding, leaving many scientists to find support
elsewhere. This situation has resulted in many young investigators leaving research for
other careers. In addition, researchers in academic health centers (AHCs--the complex
of a medical school, one or more teaching hospitals and other health professions schools)
are concerned over the fiscal side effects of managed care health insurance. Managed care
has eroded biomedical research dollars by taking away the patient care income of the
1 CRS Report 97-126, Federal R&D Funding Trends in Five Agencies: NSF, NASA, NIST,
DOE (Civilian) and NOAA, coordinated by Michael E. Davey.
2 CRS Report 95-96, The National Institutes of Health: An Overview, by Pamela W. Smith.
Congressional Research Service ˜ The Library of Congress

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centers. “AHCs have missions in teaching, research, and patient care. Patient care
revenues subsidize teaching and research to a large degree. Care in the highly specialized
AHCs is more expensive than in other settings, and the centers are increasingly finding
that they cannot attract patients who are covered by managed care insurance.”3
In this atmosphere of impending budgetary constraint, health advocacy groups find
themselves increasingly at odds with one another, lobbying congressional offices and NIH
for more research on their specific disease of interest rather than for health research in
general. Such lobbying efforts appear to have succeeded in gaining large increases for
certain diseases (e.g., AIDS and breast cancer) at the expense of others. When budget
resources are limited and not growing, adding funds to one area almost inevitably limits
funds to another. This more than likely has added to the intensity of the already fierce
lobbying for disease-specific earmarks in the NIH budget.
Those active in the lobbying effort include groups which support research on AIDS,
heart disease, breast cancer, prostate cancer, Parkinson’s disease, Alzheimer’s disease,
diabetes, and others. Advocacy groups have generated a vast and sometimes confusing
array of charts and tables comparing disease-specific research funding with statistics on
morbidity, mortality, and health care costs in order to advance the cause of their disease
over others that receive what they perceive as “too much funding.” Table 1 displays the
currently available HHS budget information for a number of the diseases that are
receiving increased lobbying attention. Funding information is incomplete for all the
diseases listed, with the AIDS budget information being the most comprehensive.
In the July 25, 1997 House report (H.Rept.105-205) on H.R. 2264 (Departments of
Labor, HHS, and Education, and Related Agencies Appropriations Bill, 1998) the House
Appropriations committee asks for extensive disease funding information from HHS
(p.130) on the following diseases: acute respiratory distress syndrome, arthritis, cancer,
chronic obstructive pulmonary disease, depression, diabetes, heart disease, HIV/AIDS,
kidney disease, liver disease, pneumonia and influenza, septicemia, and stroke. The
committee requested a functional breakdown of each disease total showing the amount
spent on research, prevention/education, and treatment as well as details on spending in
both Medicaid and Medicare, approximations for spending by insurance in the private
sector, and private expenditures by individuals afflicted with these diseases. The report
was submitted to the committee on February 23, 1998.
In response to the continuing controversy over disease funding, several congressional
hearings were held in the spring and summer of 1997 addressing how research priorities
are set at NIH. The first was held on May 1, 1997, in preparation for work on NIH
reauthorization legislation. The hearing entitled “Biomedical Research Priorities: Who
Should Decide?” was held by the Senate Labor and Human Resources Subcommittee on
Public Health and Safety. The Senate subcommittee heard from NIH Director Dr. Harold
Varmus as well as representatives of the Institute of Medicine, academia, scientific
societies, industry and advocacy groups. The June 10, 1997, hearing, “NIH Priority-
Setting,” held by the House Appropriations Labor-HHS Subcommittee
3 CRS Report 94-870, Health Care Reform: Where Does Medical Research Fit In? By
Pamela W. Smith.

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Table 1. HHS Agency Funding of Selected Diseases
($ in thousands)
FY1997
FY1998
FY1999
AIDS:
National Institutes of Health
$1,501,073
$1,607,053
$1,730,796
Centers for Disease Control
616,790
634,266
641,779
Agency for Health Care Policy Research
4,193
1,100
1,500
Indian Health Services
3,503
3,540
3,540
Health Care Financing Administration
3,100,000
3,300,000
3,600,000
Office of the Secretary
2,827
2,844
3,972
Health Resources Services Adm.
1,001,248
1,155,196
1,320,196
Substance Abuse & Mental Health Adm.
63,857
70,125
77,826
Food & Drug Administration
72,745
72,745
72,745
Total, AIDS
$6,366,236
$6,846,869
$7,452,354
Cancer:
National Institutes of Health
2,760,698
2,941,163
3,231,804
Centers for Disease Control
185,138
192,873
196,500
Agency for Health Care Policy Research
3,945
4,400
5,600
Health Care Financing Administration
16,699,000
18,502,000
20,380,000
Office of the Secretary
2,250
1,250
1,250
Total, Cancer
$19,651,031
$21,641,686
$23,814,904
Diabetes:
National Institutes of Health
319,539
373,215
414,856
Centers for Disease Control
26,277
48,977
53,788
Agency for Health Care Policy Research
2,135
2,000
2,100
Indian Health Services
41,001
41,001
41,001
Health Care Financing Administration
13,269,000
14,611,000
16,278,000
Total, Diabetes
$13,657,952
$15,076,193
$16,789,745
Alzheimer’s Disease:
National Institutes of Health
329,272
349,198
374,700
Centers for Disease Control
40
40
40
Agency for Health Care Policy Research
322
600
1,000
Health Care Financing Administration
339,000
362,000
387,000
Administration on Aging
7,099
7,299
7,494
Total, Alzheimer’s Disease
$698,733
$744,137
$770,234
Heart Disease:
National Institutes of Health
1,005,264
1,080,373
Not Available
Centers for Disease Control
5,792
14,233
Agency for Health Care Policy Research
8,392
4,983
Health Care Financing Administration
37,579,000
41,508,000
Office of the Secretary
100
Total, Heart Disease
$38,598,448
$42,607,689
Parkinson’s Disease:
National Institutes of Health
89,000
98,000
107,000
Sources: HHS Budget Office, "HHS and National Cost for Thirteen Diseases and Conditions," Feb. 20,
1998; HHS Budget Office, FY1999 Moyer Cross-Cutting Material, Feb. 1998; and, NIH Budget Office,
"NIH Research Initiatives/Programs of Interest," Mar. 1998.

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Table 2: Ten Leading Causes of Death, United States, 1995
Number of
Death Rate
% of Total
Rank
Cause of Death
Deaths
per 100,000
Deaths
All causes
2,312,132
880.0
100.0
1
Heart diseases
737,563
280.7
31.9
2
Cancer
538,455
204.9
23.3
3
Cerebrovascular diseases
157,991
60.1
6.8
4
Chronic obstructive lung diseases
102,899
38.2
4.5
5
Accidents
93,320
35.5
4.0
6
Pneumonia & influenza
82,923
31.6
3.6
7
Diabetes
59,254
22.6
2.6
8
HIV infection
43,115
16.4
1.9
9
Suicide
31,284
11.9
1.4
10
Chronic liver disease & cirrhosis
25,222
9.6
1.1
Source: Monthly Vital Statistics Report, v. 45, no. 11(S)2, June 12, 1997. p. 23.
had NIH Director Varmus as the sole witness. At both hearings Dr. Varmus gave the
same testimony on the process and principles used in making research budget decisions
at NIH.

Dr. Varmus put forth a multifaceted case against the practice of "earmarking," a term
often used for specifying increased emphasis on particular programs in report language
on appropriations bills. He pointed out that 90% of the NIH budget is already committed
to multi-year grant recipients (who receive four years of support, on average) as well as
the infrastructure of the Institutes and Centers. New scientific opportunities and earmarks
compete for the remaining 10% of the NIH budget. Dr. Varmus emphasized that the
ability to plan for scientific discovery is limited. “Science attempts to discover what is
unknown. It’s inherently unpredictable.” In his view, history has shown that when
research activity is guided by an individual scientist’s imagination, there are many
benefits for public health. Much of the basic research supported by NIH is difficult to
classify as part of a research plan against a specific disease. Yet, he observes, it is
precisely this type of fundamental research (e.g., on protein structure or cell death) which
forms the foundation for practical advances against any number of specific diseases.
When Congress and the public inquire about how the NIH budget is spent, it is often
in terms of how much money is spent for a specific disease. Dr. Varmus pointed out that
although the coding of funds by disease category may be useful for some purposes, it is
inherently imprecise. Using a series of charts, Dr. Varmus showed that there is a four-
fold difference between the number of grants directly related to Parkinson’s disease, and
the much larger number of grants (e.g., on nerve cell biology and nerve degeneration) that
are related to the fundamental understanding and treating of this disease. “So, numbers
are suspect. They are suspect in part because important discoveries also often come from
totally unexpected directions that might not be represented on this chart. For this reason,
there is no right amount of money or any right number of projects for any disease.”
Dr. Varmus pointed out that shifting scientific priorities in order to stimulate disease
breakthroughs requires more than just budgetary adjustments. “Scientific work is not a
commodity we can purchase....We need to have investigators who can do the work.” To
attract new investigators to a promising area of research, NIH often holds workshops

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highlighting under-explored medical and scientific areas and advertizes funding for
research to resolve new public health challenges. However, it takes time to attract and
train a novice researcher in a new field and for new treatments to be discovered. Congress
and the public often become frustrated with the pace of medical research. Dr. Varmus
testified that congressional directives to reroute dollars to specific diseases is not the best
solution to these frustrations. “Many fields of medical research deserve increased
financial support and could move faster with more funds. Because resources are limited,
pushing funds vigorously in one direction limits the flow in others. This situation
compels us to consider especially carefully whether proposals to enhance investments in
certain fields are justified by new scientific opportunities, [or] by public health issues.”
In his opinion, existing methods for resource allocation at NIH are preferable to
congressional directives. Dr. Varmus urged advocacy groups to adopt methods to
heighten the interest of scientists in the public benefits of their research.
One source described the outcome of the May 1 Senate hearing as follows: “The
biomedical establishment fired away at the growing boldness of disease lobbies pursuing
bigger shares of the budget of the NIH. From the reaction of their Senatorial overseers,
it appears that the bio-mandarins won on debating points, arguing that health research is
more likely to be impeded than advanced by political edicts to focus on particular
diseases. But the pressures from the so-called disease-of-the-month clubs are mounting,
and it’s by no means certain that the line can be held by NIH, which traditionally would
rather grow than fight.” In September 1997 NIH released a report entitled
4
Setting
Research Priorities at the NIH. The 17-page report is very similar to the NIH Director’s
hearing testimony and describes in greater detail how NIH management determines the
research allocations for each fiscal year.
Critics of the NIH funding process believe that it fails to focus on those diseases
which cause the highest morbidity and mortality in the United States. In their view, NIH
spending often follows current politics and political correctness, responding to media
attention focused on diseases such as AIDS and breast cancer. For example, the
Parkinson’s Action Network claims that in 1994 NIH spent more than $1,000 per affected
person on AIDS research, $93 on heart disease and $26 on Parkinson’s. The American
Heart Association contends that while overall NIH funding has increased 36% in constant
dollars since 1986, the heart program at NIH has declined 5.5%. The Juvenile Diabetes
Foundation asserts that funding at NIH’s National Institute of Diabetes and Digestive and
Kidney Diseases has increased only 53% over a ten-year period when overall NIH funding
increased 97%. The critics argue that the NIH budget of $13 billion is taxpayer dollars,
and the Congress has a constitutional duty to exercise oversight, influence direction, and
demand accountability. Population statistics are commonly used when allocating funds
for education, housing, transportation or other programs, and relevant numbers, such as
health care costs, disease incidence and prevalence, should also be considered when
making health research funding decisions.
Many representatives of disease advocacy groups claim that in the past they pushed
solely for increased overall funding for basic research at NIH. However, after years of
perceived neglect they are now intent on following the example of the AIDS and breast
4 Greenberg, Daniel S. NIH Defends Research Priorities at Senate Hearing. Science &
Government Report, May 15, 1997, pp 3-4.

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cancer lobbyists and are promoting increases for their area of interest alone. These
groups believe increased lobbying of Congress and NIH is the only way they will receive
more equitable funding and attention for their cause. Parkinson’s disease groups have
pushed for legislation which expands and coordinates such research at NIH (H.R. 1398,
The Parkinson's Research Act of 1997; and H.R. 1260/S. 535, The Morris K. Udall
Parkinson's Research Act of 1997). Similarly, advocates for diabetes research have
lobbied for legislation that mandates a diabetes research plan at NIH (H.R. 1315, The
Diabetes Research Amendments of 1997).
The Senate Subcommittee on Public Health and Safety held a second hearing on July
24, 1997, on coordination of NIH research conducted in multiple NIH institutes which
also touched on the subject of disease-specific targeting and priority setting. Like the May
hearing, the July hearing was held in preparation for the upcoming work on NIH
reauthorization legislation in the second session of the 105 Congress.
th
Research priority setting was also addressed during the NIH appropriations hearings
in April 1997. An amendment (S. Amendment 1075) to S. 1061 (FY1998 Labor/HHS
Appropriations bill) directs that a comprehensive study on NIH research priority setting
be conducted by the Institute of Medicine (IOM) and completed in the spring of 1998.
The provision requires that IOM make recommendations for improvements in NIH
research funding policies and processes and for any necessary congressional action. The
first meeting of the IOM panel that is working on this study was held on March 6, 1998.
As it has for the past several years, the House Appropriations Committee included
report language stating that in order “to enhance NIH’s flexibility to allocate funding, the
committee has attempted to minimize the amount of direction provided in the report
accompanying the bill. For example, there are no directives to fund particular research
mechanisms, such as centers or requests for applications, or specific amounts of funding
for particular diseases.” The House Appropriations Committee report on the FY1998
Labor/HHS Appropriations bill (H.Rept. 105-205) provides the following discussion on
priority setting in research funding allocations:
The factors NIH uses to decide how to allocate research funding among disease areas
have been a topic of great concern to the Committee and the outside community. The
elements the NIH leadership considers when allocating funds have been discussed
repeatedly in the Committee’s hearings this year, including a special hearing on the
subject. It is clear there is discomfort among some Members that NIH is not thought
to be paying sufficient attention to the societal and economic factors related to a
disease, such as the number of citizens afflicted with a disease, the infectious nature
of a disease, the number of cases and deaths associated with a particular disease, the
Federal and other monetary costs of treating a disease, the years of productive life lost
due to a particular disease, and trends in the way diseases affect minority populations
and different geographic areas. The Committee understands these concerns and
sympathizes with the disease advocacy groups who raise them, realizing that their
dissatisfaction with NIH decisions is grounded in a deep commitment to bettering the
lives of the patients whom they represent. The Committee does not presume to judge
which of these criteria should take precedence or carry the greatest weight in
individual funding decisions, but urges NIH to consider the full array of relevant
criteria as it constructs its research portfolio.