Medical Research Funding: Summary of a CRS Seminar on Challenges and Opportunities of Proposed Large Increases for the National Institutes of Health

Medical Research Funding: Summary of a CRS Seminar on Challenges and Opportunities of Proposed Large Increases for the National Institutes of Health

Order Code RL30483
CRS Report for Congress
Received through the CRS Web
Medical Research Funding: Summary of a CRS
Seminar on Challenges and Opportunities of
Proposed Large Increases for the National
Institutes of Health
March 15, 2000
John K. Iglehart, Contractor
Pamela W. Smith, Coordinator
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress

ABSTRACT
This report summarizes the proceedings of a CRS seminar for congressional staff on
appropriations for the National Institutes of Health (NIH), held September 23, 1999 against
a backdrop of congressional deliberations over increases in NIH’s budget. The seminar
featured journal editor John K. Iglehart as moderator, former appropriations staffer Michael
A. Stephens, newspaper columnist Daniel S. Greenberg, and patient advocate Myrl Weinberg
as panelists, and Dr. Lana Skirboll as respondent from NIH, with Pamela W. Smith as CRS
coordinator. Topics discussed included the recent funding history of NIH and current
proposals to double its budget in 5 years, ideas on what NIH could do with substantial new
resources, cautions and questions about NIH’s ability to make maximum efficient use of such
resources, the desire of patient advocacy groups to be more involved in NIH research priority-
setting, and current NIH activities responding to these various issues. This product will not
be updated. For background on NIH generally, see CRS Report 95-96, The National
Institutes of Health: An Overview, and for information on appropriations activity, see the NIH
section of CRS Issue Brief IB10051, Research and Development Funding: Fiscal Year 2001.

Medical Research Funding: Summary of a CRS Seminar on
Challenges and Opportunities of Proposed Large Increases
for the National Institutes of Health
Summary
In September 1999, Congress was struggling with the FY2000 appropriations
acts for the Departments of Labor, Health and Human Services, and Education,
including consideration of a second substantial increase in the budget of the National
Institutes of Health (NIH) to follow the 15% increase of FY1999. To help inform the
debate, CRS held a seminar for congressional staff on the challenges and opportunities
posed by proposals to further increase the NIH budget. The seminar was made
possible, in part, by a grant from the Robert Wood Johnson Foundation.
Moderator John Iglehart reviewed NIH’s long history of bipartisan support from
the Congress, manifested in discussions over how rapidly the agency’s budget should
be increased. Key legislators have favored doubling the NIH budget over the 5 year
period from FY1998 to FY2003, while the Clinton Administration has supported a
slower pace. Panelist Michael Stephens discussed how NIH spent its $2 billion
increase for FY1999, especially for more peer-reviewed grants. He also showed that
the 5-year doubling proposal, generating $13.6 billion, could accommodate substantial
increases in grants, training awards, infrastructure improvements, and inflation, and
still have an estimated $5.4 billion to devote to new initiatives. He proposed some
possibilities for innovative uses of the money: establishing another intramural campus
on the West Coast or elsewhere, investing more heavily in foreign partnerships,
helping build additional megacenters of research, expanding interdisciplinary research
with other sciences, expanding training, and developing genomics research resource
centers. He also advocated greater NIH involvement in disseminating knowledge of
new breakthroughs to patients and providers.
Panelist Daniel Greenberg was skeptical of NIH’s ability to make good use of
large sums of new money. He acknowledged the political popularity of the agency,
but called for greater congressional oversight in several areas: the productivity of the
intramural program, the conservatism of the peer review system, the lack of an
electronic system for handling grants, and the desirability of setting up a new
federally-funded research organization separate from the traditions of NIH. Panelist
Myrl Weinberg said that patient advocacy groups want more opportunities to
influence NIH’s research priorities and want NIH to make the priority-setting and
resource allocation process more understandable. She praised NIH’s recent efforts
in establishing the Council of Public Representatives (COPR) and publishing a booklet
on priority setting, but urged greater accountability for the NIH Director and more
trans-NIH planning, budgeting, and reporting. Respondent Lana Skirboll said the
NIH institutes would soon publish planning documents on their research agendas;
NIH is doing more cross-institute planning; it is funding more clinical research training
grants; COPR members could help clarify the explanation of priority setting; and NIH
is working with industry on various fronts to reap practical benefits from research.
(Final FY2000 funding gave NIH an increase of $2.2 billion or 14.2%.)

Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
NIH: Research Agency to the World . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
NIH and a Voice of Skepticism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
NIH and a Voice of Strong Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
A Response by NIH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Questions from the Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Medical Research Funding: Summary of a CRS
Seminar on Challenges and Opportunities of
Proposed Large Increases for the National
Institutes of Health
Introduction
In an era of partisan political conflict that has divided Members of Congress on
a wide variety of issues, the bipartisan support enjoyed by the National Institutes of
Health (NIH) stands out as a strong vote of confidence in the federal government’s
major health research agency. Reflecting this level of support, NIH’s budget has
grown at a time when Congress and the executive branch are locked in an ongoing
debate over future expenditures for many other domestic government programs.
What is at issue between these two branches of government appears to be not whether
to increase the budget of NIH, but how rapidly its annual spending plan should be
increased. Key legislators favor doubling the agency’s budget over the 5-year period
from FY1998 to FY2003, while the Clinton Administration has supported a timetable
that spans closer to a decade. If the enactment of a $2.2 billion increase (14.2%) in
the agency’s FY2000 budget over the previous year serves as any guide, the shorter
timetable could prevail. But how the agency should allocate this major increase in
its spending capacity remains an open question.
Indeed, it was the central question addressed in September 1999 by panelists
who participated in a symposium sponsored by the Congressional Research Service
(CRS) and made possible in part by a grant from the Robert Wood Johnson
Foundation. The audience was composed largely of staff members of legislators who
will weigh in on how NIH allocates its larger budget over the next decade. The
panelists who addressed this question and related subjects were Michael A. Stephens,
who, for 20 years, worked as a professional staff member of the House
Appropriations Subcommittee on the Departments of Labor, Health and Human
Services (HHS), and Education; Daniel S. Greenberg, a newspaper columnist and a
long-time observer of the biomedical research scene; and Myrl Weinberg, president
of the National Health Council, to which 110 national health-related organizations
such as the American Cancer Society and the American Heart Association belong.
Dr. Lana Skirboll, director of the Office of Science Policy at NIH, was invited to be
the first respondent to the formal presentations. John K. Iglehart, founding editor of
the health policy journal Health Affairs and a national correspondent to the New
England Journal of Medicine, served as moderator and rapporteur for the session.

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NIH: Research Agency to the World
Begun in 1887 as a one-room Marine Hospital laboratory, NIH has grown to
become the pre-eminent biomedical research enterprise in the world, relied on for its
innovation by countries spanning the developing and industrialized world. Today,
NIH comprises 18 institutes, 3 centers, and the National Library of Medicine. Each
institute specializes in particular diseases, areas of human health and development or
aspects of research support, and each entity receives a separate appropriation. NIH
operates 78 buildings on a 300-acre main campus in Bethesda, Maryland, and also
occupies off-campus sites in Maryland, North Carolina, Montana, and other locations.
With an FY2000 budget of $17.8 billion, NIH’s research monies flow to some 2000
institutions and 50,000 investigators, but, as Stephens pointed out, “the vast bulk of
the money goes to about 30 large institutions in this country which are the
megacenters of academic research – the Johns Hopkins’, the Harvards, the Yales and
so forth.”
Stephens, based on his experience with the House Appropriations Committee,
opened his remarks by noting the contrast between debates over maintaining
congressionally imposed budget caps on federal discretionary spending and the actions
being taken that day by the House Labor-HHS-Education Appropriations
Subcommittee that vastly exceeded the caps. The proposed doubling of the NIH
budget began in earnest with its FY1999 appropriation, which increased from $13.6
billion the previous year to $15.6 billion. That increase came on a base of several
previous years’ increases in the range of 6% to 7% annually. Stephens showed a slide
detailing how NIH was spending the $2 billion increase, including the award of about
9,100 new investigator-initiated research project grants, and a total portfolio of about
31,000 research grants, up from 28,000 in FY1998. Such grants, awarded through
a competitive, peer-reviewed process, are considered by the agency to be its “engine
of discovery,” as Stephens characterized it. He also discussed a slide on the proposed
$13.6 billion that would be gained over 5 years if the budget were doubled from the
FY1998 level, to impress upon the audience what a vast sum of money that effort
represents. Even after paying for “first priority” increases in the number and size of
grants, training for more researchers, infrastructure improvements (new and renovated
buildings, new instruments, improved clinical research capability), and inflation, there
would still be an estimated $5.4 billion available to devote to new initiatives.
Stephens mentioned several possibilities for innovative uses of the money. First,
he noted that the intramural research facilities at the Bethesda campus are already
overcrowded, and that county authorities might doubt whether additional facilities
should be constructed there. Some have suggested that NIH could establish another
large intramural campus run by the federal government on the West Coast or
elsewhere. A second idea involved investing more heavily in foreign partnerships.
Stephens said: “I think that we have dramatically underinvested in foreign partnerships
in science.” He noted that out of the very small percentage of the NIH budget going
to foreign awards, the largest portion goes to Canada. “So we have made a minuscule
investment in partnerships with other parts of the world, many of which have very
rich, albeit, undeveloped and sometimes inexpensive biomedical research enterprises
which NIH could invest in.” Other possibilities for NIH to consider, Stephens
continued, would be to help build another 25 to 30 megacenters of research, since the

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current ones cannot expand much; to develop new partnerships with the disciplines
of physics, chemistry, mathematics and computational science, an idea supported by
Dr. Harold Varmus, who directed NIH for 6 years until the end of 1999; to review the
manpower personnel needs to staff this vastly larger enterprise; and to invest in
developing four or five huge genomics research resource centers around the country
where investigators at universities could collaborate.
Finally, Stephens suggested that another opportunity NIH could address would
be to close the gap that exists between practicing physicians and the new knowledge
that researchers continue to gain through their pursuits. Myrl Weinberg also
identified this gap as “a significant problem for this country.” Stephens observed that
studies have shown that many practicing physicians do not read medical or scientific
journals on a regular basis. “Thus, the ability to disseminate new breakthroughs to
patients and providers more quickly is clearly a priority.” Indeed, this has been a
congressional priority for many years and has taken different forms. Congress created
the Regional Medical Program in the 1960s that had as one of its major charges the
rapid diffusion of medical innovations to patient care uses in the community. The
Office of Technology Assessment, before its termination in 1995, devoted resources
to this same task, as has the Agency for Health Care Policy and Research (recently
renamed the Agency for Healthcare Research and Quality). This translational activity
has never been one of NIH’s core missions. But, Stephens recounted, former Iowa
Representative Neal Smith, who was briefly the chair of the House Appropriations
Subcommittee on Labor, Health and Human Services and Education, had suggested
that Congress should consider creating a circuit-rider system of federal employees or
contract employees (much like the Agricultural Extension Service) that would inform
practicing physicians and community hospitals about new medical innovations.
NIH and a Voice of Skepticism
Dan Greenberg, a far more skeptical voice regarding NIH’s capacity to deliver
research results that approach the value of a doubling of its budget, conceded in his
opening remarks that NIH is “a revered, politically untouchable institution. No one
can speak unkindly about NIH because it’s our Pentagon of the war on disease, and
the American people are quite fearful of disease. We all want to live forever and we
want to live without pain forever. NIH promises a great deal. What’s interesting
about NIH politically is that it is probably the most under-scrutinized federal agency
in the whole large inventory of federal agencies. The Congress, which has a
responsibility for oversight, rarely ever exercises it regarding NIH. The hearings that
have been held by the Appropriations Committees generally are celebrations of NIH.
Invariably the chairmen, through some process that I can’t quite understand, who
come to head the appropriations subcommittees with responsibility for NIH, become
NIH enthusiasts. NIH is the only research institution in the world where the buildings
are named not after great scientists but after chairmen of appropriations committees.”
Greenberg identified a number of issues that he thought legislators should be
examining more closely, including whether NIH’s intramural research program is as
productive as its extramural program, how effective its peer-review system is at
identifying the research proposals with the greatest potential, why the agency has not

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yet installed an electronically-based grant application and award system, and the
wisdom of doubling the size of its budget. Greenberg asserted: “I don’t think they
can handle the money they have now .... I would seriously doubt that by doubling that
money in a relatively few years we’re going to improve their performance. I would
not establish another 30 centers under the direction of NIH .... There should be an
altogether different organization which would be far away, maybe in California,
maybe in Honolulu, but it should not be in Bethesda .... [We need] NIH-2, completely
detached from NIH with none of its traditions, none of its people. I would say that
peer review should not be ensconced or enthroned as the ultimate system.”
NIH and a Voice of Strong Support
The third presenter, Myrl Weinberg, said the National Health Council is “very
supportive of NIH” but that many of her member organizations also are frustrated by
the relatively few opportunities that consumer-based groups feel they have to
influence the agency’s research priorities. “Some of these groups truly believe that
we are just at the edge of having tremendous new potential discoveries in science and
in medicine. And that is one of the reasons they are supportive of large budget
increases, albeit with some improvements at NIH,” including making the agency more
accountable to the public.
Weinberg noted that she served on a committee convened in 1998, at
congressional direction, by the Institute of Medicine (IOM), National Academy of
Sciences, that published a report entitled, Scientific Opportunities and Public Needs:
Improving Priority Setting and Public Input at the National Institutes of Health.
Weinberg said: “The fact that the Congress mandated that such a study be done was
certainly indicative that there are some problems, or at least perceived problems, at
NIH.” The essential problem is that the march of science is a complex enterprise that
is often difficult for the general public to understand. Even patient-advocacy groups
that follow NIH’s activities very closely find it a challenge to understand how the
agency allocates its resources.
The issue revolves around a belief held by patient groups that there are too few
opportunities for them to provide “regular and meaningful input” into the NIH
decisionmaking process, in order to make the case for increased funding for particular
research areas. Some of these groups say certain institutes do quite well seeking input
from patient-advocacy organizations but, “on the whole, NIH has been, in their minds,
lacking in having opportunities that are open and meaningful for them to have input.
That sends them straight to you [legislators and their staffs] quite often because they
do feel frustrated, and so the only place they can turn, and they have every right to
turn, is to Congress to say we really feel that we’re not getting our fair share.”
Weinberg reported some NIH responses to these publicly expressed concerns.
In the fall of 1998, Dr. Varmus announced creation of a Council of Public
Representatives (COPR), a body that meets regularly to learn in greater detail of the
agency’s activities and to provide the agency feedback on those activities. In
September 1997, NIH published a booklet entitled, Setting Research Priorities at the
National Institutes of Health. The booklet describes the criteria upon which NIH sets

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its research priorities and allocates funding. The IOM committee and patient-
advocacy groups regarded the booklet as a step forward, but Weinberg said the next
step NIH must take is explaining how it actually applies these criteria in its
decisionmaking processes. Weinberg added: “Patient groups also feel that NIH
needs to improve the way it does some of the data collection and analyses it is
conducting to inform the decisionmaking process.”
Weinberg said that, in anticipation of a large infusion of funds to NIH over
several years, patient-care groups favor exploring research opportunities across
institutes and diseases. These activities should be mounted in ways that make the
NIH director more accountable for progress. She added: “I am sure most of you
know that the institutes are fairly independent .... The NIH director should be able to
receive, which is not necessarily the case now, from the directors of all the institutes
and the centers multi-year, strategic plans including budget scenarios in a standard
format on an annual basis.” With more standardized processes of planning, budgeting
and reporting, Weinberg asserted, patient-advocacy organizations and the broader
public could grasp more readily how wisely NIH spends its resources and, as a
consequence, hold the agency to greater account for its decisions.
A Response by NIH
Dr. Lana Skirboll of NIH was the invited first respondent to the views expressed
by the three panelists. She began by offering her own explanation of why the agency
has enjoyed such strong bipartisan political support. “It’s a reflection of both NIH’s
history of supporting research that leads to improvements in health, and I will grant
you it’s also a reflection of public fear. We are all afraid of ill health – morbidity and
mortality. And as the population ages, society, both from financial and social
perspectives, needs to be concerned as we baby-boomers age. We need to pay
attention to research issues that can improve both the quality and length of life, and
the extent to which chronic illness even affects society from a financial point of view.”
At a later point in the program, Stephens offered what he said was an equally
important third reason why NIH enjoys such strong bipartisan political support:
“There is both a perception and a reality of NIH as an enormously well-managed,
overall, government enterprise .... I reviewed my first NIH budget in 1975. I’ve
reviewed budgets every year since then. I did three cabinet departments, 20 related
agencies. NIH is the only government entity that I know of where the best people in
the United States, the most highly trained, most successful, most competitive, want
to work for the government because NIH is the pinnacle of biomedical research in the
world.”
After asserting that NIH engaged in a great deal of planning in relation to “that
wonderful, generous increase from Congress” of $2 billion for FY1999, Skirboll
conceded that, “we may not have been as clear as we might have been in the past
about the internal dialogues” that occurred within the agency on how that money
should be spent. In response to concerns expressed about this perceived lack of
clarity, particularly as those concerns were set out by the Institute of Medicine’s
monograph, Skirboll said the NIH institutes and centers intend to publish material in

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the spring of 2000 which will set out how each entity plans for its research agenda,
and what that agenda will be for the next few years. Skirboll noted that the
documents would not be standardized. She added: “At the moment, we have asked
each institute to use their own culture and scientific and patient advocacy groups to
develop a planning document that they think reflects where their institute needs to
go.”
Later in her remarks and in answers to questions, Skirboll also mentioned several
other methods NIH has started using to make its management and planning processes
more open. She described planning forums convened to develop research agendas
that cut across institutes in which “each institute comes forward with new initiatives
for the budget year [currently FY2002],” followed by “an overarching meeting in
which we even bring outside reviewers in to look at which of those initiatives are
cross-cutting, which are most important for NIH in toto.” NIH will use the new
Council of Public Representatives as a conduit to receive feedback on how to make
the research priority-setting process better understood. In addition, “one of the
innovations we’re trying in some arenas of clinical research is inviting patient
advocates into peer review” (that is, inviting them to participate in the system through
which the agency ranks grant applications). Skirboll also described how NIH has
applied the requirements of the Government Performance and Results Act (GPRA)
to help improve its capacity to plan. In its budget submission to Congress, NIH laid
out both administrative goals and research goals, together with performance targets
for which the agency expects to be held accountable.
In response to Greenberg’s assertion that Congress is neglecting its oversight
responsibilities regarding NIH, Skirboll said that total oversight has increased along
with the growth in NIH’s budget. She indicated that the “exponential increase in
funding” has been matched by oversight from Congress, the General Accounting
Office, and the HHS Inspector General. She added: “We expect that, we welcome
that, we think we manage our money well; we think the American public and frankly
Congress’ support is a reflection of the good product we put out.”
Questions from the Audience
At this point, the floor was opened to queries from members of the audience.
One congressional staff member, a former researcher, noted that Mike Stephens urged
NIH to “think out of the box” when it is deciding how to allocate its larger
appropriation. “One possible way to think out of the box is to fund researchers, not
research. The Howard Hughes Medical Institute does a lot of that.” He described
the difficulties and uncertainties of a career in research, particularly for physicians, and
spoke of knowing people who had to leave research careers because they failed to
obtain funding for one grant cycle. He noted that young investigators who observe
such situations with their older mentors may be discouraged from pursuing research
careers. He asserted that the most productive researchers spend more time writing
grants than working in the laboratory, and that the system encourages
“incrementalism,” where each grant “just makes the little tiniest advance because you
have to get funded to keep your job.”

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In response, Stephens said he was quite open to exploring new ways to pursue
research opportunities, but he also asserted that “there is very broad agreement that
one of the great strengths of the American system of funding life sciences vis-à-vis the
Japanese, the Europeans, and others is that NIH does not tell people what research
needs to be done. But they allow this to come from the science community .... The
engine of discovery is driven by individual scientists looking at problems and coming
up with a thousand different approaches of which some work and some do not.”
Skirboll also responded to the staff member, saying that NIH has increased
support of three new “K mechanism” grants (the NIH classification number for
research career programs) that address the needs of the individual clinical researcher.
She described two of them as awards for clinical investigators “to buy time that’s
otherwise being used up for patient care, where they have to account for every hour
in the delivery of treatment, so they can’t mentor young investigators. So we’re
buying salary time” both for mid-career mentors and for young investigators who
want to do clinical research. The third program is the Clinical Research Curriculum
Award, “a didactic program aimed at institutions to help them formally train clinical
researchers in basic research design and statistics.”
Another congressional staff member voiced a critical opinion of NIH’s funding
processes before she posed a question to Stephens. She said the major research
enterprises – “the Johns Hopkins and the Duke Universities of the world,” are the
major recipients of NIH funding “only because they [hire former NIH people] who are
able to get the grants because the grant process is so complex that you need these
people who understand the process to actually get the grants.” She asked Stephens
whether he believed that Congress could improve the value of the public’s investment
in biomedical research by pursuing alternatives to simply building onto NIH or, as she
put it, “looking into the internal workings of NIH, and doing an inside-out
modernization of NIH, if that’s necessary.” (Interestingly, this question anticipated
remarks by Dr. Varmus in his final meeting with his Advisory Committee to the
Director in December 1999, at which he proposed just such an in-depth study. Saying
that the proliferation of institutes and centers was making NIH more and more
difficult to manage, he suggested that Congress should commission a study of the
organizational structure of NIH and the role of the director, perhaps from the
National Academy of Sciences.)
Stephens responded by disagreeing with her that “you have to have worked at
NIH and come through the NIH system in order to be a successful grantor. My major
activity now is working for a group called the Federation of American Societies for
Experimental Biology, which is 66,000 Ph.D-M.D. scientists who account for about
52 % of all research project grants at NIH. I would say that probably 10% of those,
15 % of those that are under age 60, worked at NIH. It is true that going through an
NIH research training experience was sort of a credential of advancement in science
for many years, and those trainees then went off and established these megacenters.
But I don’t think that is true anymore.” Stephens did say he thought NIH could reach
out more effectively to teach researchers how to apply for the agency’s grant support.
A final question from the audience pointed out that in the quest to develop new
drugs and medical devices to treat disease, NIH only has responsibility for the initial
steps in the process. The staff member said that the patient groups that visit his office

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seem to focus only on NIH and not on the equally important roles of the Food and
Drug Administration (FDA) and the private sector. He said, “At the end of the day,
the drug companies are going to think about what’s going to be most profitable, but
how do we make it more motivating for them to do things that will bring in more new
and advanced treatment?” Weinberg commented in response that many of the patient
groups have become active in FDA-related issues. She noted, however, that “what
hasn’t happened, and what the Council is attempting to take the lead on, is putting all
those pieces together so that we talk about the research enterprise as a total.” She
also indicated that there is not total agreement within the Council, among the patient
groups versus the pharmaceutical and biotechnology company members, on some of
the issues that the industry groups feel are important, such as price controls on drugs
and tax breaks for research and development costs. Skirboll gave an “example of
NIH being much more aggressive recently in trying to work with industry” as she
described an extremely popular conference on biomarkers. The pharmaceutical
industry wants to make the clinical trial system for testing new drugs more efficient
by improving the science of clinical markers for drug efficacy, and wants NIH to
partner with FDA on the subject. Skirboll also noted, however, that the single biggest
barrier to working with industry is disputes over intellectual property rights. She
concluded, “These are complex issues not easily solved, and ones that we are trying
to set up some model systems as we partner with specific industries on initiatives.
They are ones that we all need to turn our attention to if we are going to reap the
benefits of what is about to come out of all this basic research.”
Conclusion
There is no question NIH is an esteemed institution that subsidizes biomedical
research that is of value to people the world over. But that does not remove from its
vast agenda continuing controversy over how the agency should allocate its ever
increasing appropriation. As a public agency supported through tax revenues, NIH
will, in all likelihood, face even greater scrutiny in the future. While NIH may not
always be enthusiastic about these increased demands for more information and
greater oversight, it seems to clearly recognize that they come with the territory in a
wide open democracy.