U.S. Department of Health and Human Services National Institutes
of Health
Fiscal Year 2008 Budget Request Witness appearing
before the House Subcommittee on Labor—HHS—Education
Appropriations
Elias A. Zerhouni, M.D.
Director, National Institutes of Health
March 6, 2007
Slides used during the presentation: NIH: A Vision for the Future (PDF - 1.93 MB), March 6, 2007
Richard J. Turman, Deputy Assistant Secretary, Budget
Good morning, Mr. Chairman and distinguished members of the subcommittee.
It is an honor and a privilege to appear before you today to present
the National Institutes of Health (NIH) budget request of $28.9
billion for Fiscal Year 2008, and to discuss the priorities of
NIH for this year and beyond.
I would first like to thank the Committee for your longstanding
support of NIH, including in the FY 2007 Joint Resolution that
provided additional support.
Introduction
The 21st century will be for the life sciences what the 20th century
has been for the physical sciences. Mastery of the biological world
will impact not just health, but also our ability to develop sensitive
solutions to environmental and energy challenges and will be a
key determinant of national competitiveness. One of the greatest
challenges facing our society is the unsustainable growth rate
of healthcare expenditures. NIH and its scientists deeply believe
that we are in a transformative phase of the biomedical and behavioral
sciences, where opportunities for discoveries and their translation
have expanded considerably. We believe that we are on a path to
transform medicine from the current practice of intervening often
too late in a disease process, to a new era when medicine will
be more predictive, personalized and preemptive, through a broader
scientific understanding of the fundamental mechanisms that lead
to disease years before it strikes the patient. In a relatively
constant budget, we made the tough but necessary choices to ensure
that the investment and momentum of biomedical research continues.
A more predictive, personalized and preemptive form of medicine
is no longer just a dream but a vision to strive for, because it
can reduce disease burden and its costs while improving individual
quality of life.
Last year, I discussed the return on the Nation’s investment
in biomedical research. Today, I will highlight some of the progress
we’ve made in the last 12 months and where we must be
in the future to create a sustainable environment for the discoveries
needed to transform people’s health.
The Impact of Past NIH Research
NIH-supported research of the past several decades has contributed
to dramatically improved health outcomes across many diseases and
conditions. For instance, we have made remarkable advances in coronary
heart disease, the leading cause of death in the United States
for the past 80 years. Were it not for ground-breaking research
on the causes and treatment of heart disease, supported in large
part by NIH, heart attacks would still account for an estimated
1.6 million deaths per year instead of the actual 452,000 deaths
experienced in 2004. Our Nation has had particular success in reducing
fatal heart disease in women. In February of this year, NIH’s
National Heart, Lung and Blood Institute announced that the number
of women who died from heart disease decreased by nearly 18,500
deaths from 2003 to 2004. Part of this success is attributed to
NIH’s efforts to increase awareness among women that heart
disease is their number one killer.
The mortality rates of cancer, the second-leading cause of death
in the United States, have been steadily falling. This year, for
the second year in a row, the absolute number of cancer deaths
in the United States has declined despite the growth and aging
of our population—a truly unprecedented event in medical
history. More effective therapies have also led to improved outcomes
for more than 10 million American cancer survivors. In 2006, new
clinical guidelines were announced for the treatment of advanced
ovarian cancer. And for another of our most deadly cancers, melanoma,
a new gene therapy approach resulted in sustained regression of
advanced disease in a study of 17 patients, whose own white blood
cells were genetically engineered to recognize and attack cancer
cells.
Nearly 21 million Americans have diabetes, a disease that can
damage multiple organs and lead to death. Without NIH research,
the improvements of the past two decades in the therapies for diabetes
would not have occurred, and we would have many more cases of the
dreaded complications of diabetes, including blindness and end-stage
kidney disease. Our research has shown the enormous benefits to
be gained by tightly controlling blood glucose levels in diabetes.
The NIH-funded Diabetes Control and Complications Trial confirmed
that individuals with diabetes can cut their risk for nerve disease
by 60%, and half their risk for kidney disease and cardiovascular
disease by intensively controlling their blood glucose levels.
Our diabetes research has also shown that tight glucose control
can slash the risk for eye disease by more than 75%—a critical
finding for the estimated 24,000 Americans who lose their sight
to diabetes each year. In fact, diabetic retinopathy is the leading
cause of blindness in adults under age 65.
The treatment of cognitive decline and mental disorders continues
to improve at an incredibly rapid pace. In 2006, NIH supported
the development of new strategies that helped depressed patients
become symptom-free and prevented disease recurrence in older adults
with single-episode depression.
Other noteworthy advances from 2006 included the development of
promising new drugs for tuberculosis, inflammatory disease and
muscular dystrophy, as well as exciting experimental results of
vaccines against increasingly dangerous staph infections and against
the H5N1 avian flu virus. Last year we also launched a trial for
a new and promising vaccine against HIV/AIDS, and just last month,
our scientists’discovered a unique molecular weak spot in
the armor of the HIV virus, which could have profound implications
for vaccine development.
In brief, thanks to the Nation’s investment in biomedical
research, we have learned to diminish the harmful impact of many
diseases and disabilities for all Americans. The estimated total
cumulative investment at the NIH per American over the past 30
years—including the doubling period—is about $1,334,
or about $44 per American per year over the entire period. Over
the same time period, Americans have gained over six years of life
expectancy and are aging healthier than ever before. New industries
such as biotechnology, based on NIH-funded discoveries, have led
to the creation of thousands of companies in the life sciences
with impact beyond health. The American people’s return on
their investment in NIH is truly spectacular.
Current Challenges
In short, the many scientific advances achieved by NIH-funded
researchers—over many decades—now allow our population
to live longer and healthier lives. But as our population continues
to age, a striking change becomes evident. The burden of our Nation’s
health problems has dramatically shifted from acute to chronic
diseases. Chronic diseases now consume over 75% of healthcare costs
and continue to grow at a rapid pace. Profound lifestyle changes
have led to the emergence of non-communicable diseases such as
obesity and attendant growth in the prevalence of associated conditions,
such as diabetes and heart, kidney and musculoskeletal diseases.
It is important to note that the burden of these chronic diseases
is not uniformly distributed among our population; health disparities
remain a critical health issue that requires new and continuing
efforts.
Let me now present a sobering reality. Despite medical progress,
healthcare costs in the United States have risen to more than $2
trillion, or about 16% of the Gross Domestic Product (GDP), and
they grow at a rate greater than the GDP. The average amount spent
on healthcare per person is about $7,100 today. The causes of healthcare
inflation are varied and complex, but it is clear that this growth
rate is unsustainable in the long term and will impose an enormous
burden on our people and the competitiveness of our Nation. Biomedical
research alone will not solve all of these problems, but it is
an essential component toward a sustainable future. NIH and its
scientists understand the need to reduce the impact of this great
challenge through transformative discoveries and their rapid translation
from laboratory to patients.
While seeking medical discoveries that will address ongoing concerns,
we must also be prepared to confront new and unpredictable threats.
Emerging and re-emerging infectious diseases are on the rise, as
micro-organisms develop strategies for evading our best drugs.
We face the rapid globalization of mass transportation and the
staggering worldwide threat of HIV/AIDS and other familiar foes.
We must stand ready for the threat of pandemic influenza and of
man-made bioweapons for which we have greatly expanded our investments
in the past several years. Addressing these many new threats will
require sustained scientific efforts and further breakthroughs.
Strategic Vision for the Future: From curative to preemptive
medicine
Historically, medicine has been reactive, and patients did not
seek attention until an acute event required them to seek a doctor’s
cure. Our system of care is based on managing these late events
on an episodic basis—an increasingly costly and unsustainable
approach. What then is the scientific vision for change? Our goal
at NIH is to usher in an era where medicine will be predictive,
personalized and preemptive. This trend will also require a transformation
in the fundamental relationship between healthcare providers and
patients, necessitating continuous participation of individuals,
communities and healthcare institutions as early as possible in
the natural cycle of a disease process.
Based on NIH-supported research, we now know that many of the
most prevalent diseases of our time begin silently, many years
before they inflict their obvious damage to patients. Increasingly,
we are able to identify biomarkers that are predictive of the likelihood
of developing a serious condition later in life. Just in the past
year, we have discovered genetic variations that help predict the
development of age-related macular degeneration, a major cause
of late-life blindness. We also discovered a new gene associated
with Alzheimer’s disease, a major control gene for diabetes
and a marker of genetic susceptibility to prostate cancer. The
genetic marker for prostate cancer risk came from the NIH-supported
Cancer Genetic Markers of Susceptibility (CGEMS) study. Through
the CGEMS database, genetic information about prostate cancer risk
will be shared with cancer researchers across the country. The
mining and sharing of genetic information will provide much-needed
information to help us develop new strategies for the early detection
and prevention of prostate cancers, which take the lives of nearly
27,000 American men each year and disproportionately affect African
Americans.
Just consider, for a moment, how more predictive and personalized
treatments could improve the safety and effectiveness of drugs.
We know that drugs do not fall into the “one size fits all”category.
The same drug can help one patient and harm another. Recent research
shows that we will be increasingly able to know which patients
will benefit from treatment and which patients might be harmed.
This field of study is known as pharmacogenetics. Using the latest
genomic data—acquired thanks to the doubling of the NIH budget—the
NIH established a Pharmacogenetic Research Network, which is studying
the interactions of drugs and molecules, as well as the biological
processes that eliminate compounds from the body.
As an example of emerging personalized medicine, cancer researchers
have developed a test that helps to determine the risk of recurrence
for women who were treated for early-stage, estrogen-dependent
breast cancer. This information can help a woman and her doctor
decide whether she should receive chemotherapy, in addition to
standard hormonal therapy. The test has the potential to change
medical practice by identifying tens of thousands of women each
year who are unlikely to benefit from chemotherapy, sparing them
from unnecessary and costly treatments and their harmful side effects.
Such a test is now being readied for FDA review and is being evaluated
in a long-term clinical trial sponsored by the NIH’s National
Cancer Institute.
Ultimately, this individualized approach—completely different
than how we treat patients today—will allow us to preempt
disease before it occurs. We have already benefited greatly from
these insights. For example, we know that controlling blood pressure,
cholesterol levels, weight and diet, and eliminating smoking, greatly
reduce the risk of heart disease and lung cancer. Mortality from
colon cancer has dropped because our scientists have shown that
such cancers evolve from accumulated genetic mutations in initially
benign colon polyps which, if removed, preempt the development
of lethal cancers.
Because of a hundredfold reduction in the unit cost of genomic
technology, we can now study, at affordable costs, the differences
between patients who have a disease and their normal counterparts.
These breakthroughs form the basis of our budget request for the
continuation of the Genes, Environment and Health Initiative started
in 2007 and strongly supported by Secretary of Health and Human
Services Michael Leavitt, who is also championing the concept of
personalized medicine across all of HHS. With this new initiative,
we expect to uncover—within three years—the potential
molecular causes of the 10 most common diseases afflicting the
U.S. population. As part of this initiative, we will also launch
a technology development effort that will enable scientists to
measure many types of environmental exposures at the individual
level.
Taken together, these studies will lead to better understanding
of the environmental and genetic factors that affect the development
of many diseases. Imagine that your heart rhythm, brain activity,
blood pressure and many other variables could be remotely monitored
through a device like your cell phone and sent to a secure web-based
analyzer with direct access to experts and a modern health information
system. Suppose, for example, that these technologies could identify
dangerous patterns in your heart rhythms or key biomarkers and
warn you of an impending heart event or stroke or other complications.
Imagine your doctor could tell—based on your genes—whether
you need to take preemptive action to thwart a costly or painful
disease, or whether you can avoid taking expensive medications
for life because you are not at risk. This is not some science
fiction. NIH is supporting the development of that future today.
Maintaining Momentum Toward 21st Century Medicine and Health
Building toward the future involves innovations in multiple areas,
including technology, research and training paradigms, information
interoperability, and greater knowledge and resource management.
We have seen an explosion of new discoveries and novel opportunities
for progress across all areas of science—from the most basic
discoveries to the sequencing of the human genome, to the development
of fields that simply did not exist a few years ago. These emerging
fields include proteomics, computational biology, or more recently
the discovery of RNA interference, for which two NIH-funded scientists—Drs.
Craig Mello and Andrew Fire—received the 2006 Nobel Prize
in Physiology or Medicine.
The greatly expanded scope of research and new health challenges
have necessitated a dramatic expansion of the Nation’s research
capacity, which was a primary outcome of the doubling of the NIH
budget. This remarkable growth in research capacity was accomplished
by leveraging NIH resources with private sector resources to nurture
more investigators, develop new technologies and build infrastructure.
The United States is now the preeminent force in biomedical research,
and continues to lead the highly competitive biotech and pharmaceutical
sectors, but it is also the focus of increasing challenges from
government-supported research in Europe and Asia. NIH basic research
and training programs produce steady streams of novel discoveries
and innovative people that flow into our industries, making them
more competitive. Multi-national corporations often choose to set
up facilities here, to tap into the American pool of talent and
research nexus, both largely developed through NIH funding.
NIH-funded research leads to patents and spin-off companies across
the Nation. Through the Small Business Innovation Research (SBIR)
and Small Business Technology Transfer (STTR) programs, NIH helps
to support entrepreneurs, as they bring to the international market
products that improve health and help to maintain American economic
leadership. Thus, NIH research and training dollars leverage state
and private investment, resulting in powerful academic research
centers and entire geographic regions for greater creativity and
productivity.
The American health research enterprise now has the capacity to
achieve extraordinary medical advances and economic benefits for
the Nation, and we must continue this momentum. We must sustain
the capacity we have worked so hard to build and harness its potential.
The talented scientists and institutions we have nurtured are
stepping up to the challenge. For example, NIH now receives twice
as many applications for grants than before the doubling of its
budget. Due to the marked competition for funds across so many
novel areas of research and health challenges, competition for
grants and the quality of projects submitted to NIH is better than
ever. We anticipate that the FY 2008 budget will again support
about one-fifth of applications submitted, as opposed to one-third
in FY 2003. We focused our budget request on maximizing the number
of competing grants for new and established scientists. To encourage
innovation and sustain the next generation of scientists to the
greatest extent possible, we have also developed programs for new
investigators and for pioneering high-risk/high-impact investigator-initiated
research, the mainstay of fundamental discoveries.
To achieve our vision of modern medicine, we also need research
scientists with broad expertise, from widely varied disciplines,
coming together in highly cooperative and efficient teams to answer
ever-more complex questions. To this end, NIH recently changed
a long-held policy of having only a single principal investigator
on any NIH grant to a new policy that allows, when appropriate
to the science, multiple principal researchers to apply for a grant
together. This new policy is encouraging collaboration across disciplines
and enabling academic scientists to exercise creative leadership
in a project while bringing more of the best and brightest from
physical, biological and behavioral sciences to the task of solving
the multifaceted and complex health-related problems.
As biomedical research becomes more comprehensive, and we recognize
that complex diseases come under the purview of more than one or
a few NIH Institutes and Centers, we have been stimulating collaborative
endeavors through multiple trans-NIH activities, such as the NIH
Roadmap for Biomedical Research. These trans-NIH activities focus
on providing the impetus and support for high-risk/high-impact
research through Pioneer Grants; developing tools and new scientific
teams for furthering our understanding of the complexity of biological
systems; and stimulating a large effort to re-engineer the Nation’s
clinical and translational research enterprise to support more
effective interactions between laboratory research and its clinical
translation.
In 2006, we launched the Clinical and Translational Science Awards
(CTSA) Program, which is the first in-depth redesign of our system
of applied research in 50 years. The CTSA Program is stimulating
research institutions to foster more productive collaboration among
investigators in different fields. The program also encourages
creative organizational models and programs for training the next
generation of clinician scientists, without whom much basic research
cannot be applied to human populations. Ultimately, patients will
be better served because new prevention strategies and treatments
will be developed, tested and brought into medical practice more
rapidly.
In addition, the NIH Intramural Research Program is launching
several initiatives to make even more effective use of the highly
talented scientists and state-of-the-art resources in our federal
laboratories.
We have made every effort to generate greater synergies between
NIH Institutes and Centers. For example, the NIH Strategic Plan
for Obesity Research was launched in 2003 and involves 19 Institutes.
The Neuroscience Blueprint brings together 15 NIH Institutes and
Centers and the Office of the Director, pooling resources and expertise
to confront challenges in neuroscience research that transcend
any single Institute or Center.
NIH is also taking advantage of emerging information technologies
and is making management changes in response to public health needs.
We are working to modernize our governance and improve efficiency.
For example, the Office of Portfolio Analysis and Strategic Initiatives
(OPASI) is developing a new knowledge management-based system,
which performs text mining on NIH projects for more efficient research
portfolio analysis. This tool will provide our Institutes and Centers
with the information needed to more effectively manage their large
and complex scientific portfolios, identify important emerging
scientific opportunities and public health challenges, and target
investments to those areas. OPASI will be invaluable for supporting
key trans-NIH initiatives being incubated through the NIH Common
Fund, which is a central feature of the NIH Reform Act of 2006.
We would like to take this opportunity to thank Congress for passing
this landmark legislation, which will enable NIH to modernize its
organization; incubate innovative ideas and potentially ground-breaking
research; address emerging areas of scientific opportunities; stimulate
support of cross-cutting science; and encourage collaborative efforts
while preserving the ability of Institutes and Centers to continue
their outstanding record in fulfilling their specific missions.
We are diligently working to implement this legislation.
Budget Priorities: Nurturing a New Generation of Scientists and
Sustaining Innovation
New visions require new talent. One of NIH’s highest priorities
will be to preserve the ability of new and junior scientists with
fresh ideas to enter the competitive world of NIH funding. We plan
to use the additional funding provided to NIH in the FY 2007 Joint
Resolution on these valuable initiatives. In FY 2007 and 2008,
we will make every effort to maintain an average yearly number
of approximately 1,500 new investigators receiving their first
NIH R01-equivalent grants to create the vital next generation of
scientific leaders.
Also in FY 2008, the NIH budget proposes to continue to grow fresh
talent through the new “Pathway to Independence”program
and to support 175 recently trained scientists in their quest to
become independent researchers at an earlier point in their careers.
These efforts, however, cannot come at the expense of the need
to provide continuing support to our most productive and already
established scientists. History shows that no one can predict from
whom and from where the next great discovery or life-saving breakthrough
will occur. It is therefore critical that NIH maintain a large
variety of approaches to science and continue to work hard to encourage
diversity among its scientists across all strata of our society.
We also strive to maintain the historical balance between the
critically important investigator-initiated research portfolio
and agency-driven priorities. Our successful model of research
is based on creative and unconstrained scientists who propose their
best ideas, so we can subject those ideas to rigorous and independent
peer review, and then support the most promising and high-quality
projects. Our budget targets resources to providing as large a
number of competing Research Project Grants for individual scientists
as possible. To support our vision and initiatives in the current
budget environment, we made difficult but strategic decisions,
like maintaining the average cost for competing grants at the FY
2007 level and not providing inflationary increases for direct
reoccurring costs in non-competing grants. Our budget also proposes
to reduce intramural research expenses.
Our basic science projected percentage in FY 2008 is 54.1%, and
applied science is projected at 42.1%. The percent of NIH’s
budget designated for infrastructure support will increase slightly
in FY 2008, to 3.2%. In total, the budget provides $144 million
to enhance our infrastructure stewardship to provide robust, modern,
energy-efficient, and environmentally safe and secure facilities
to conduct basic and clinical research.
Summary
In closing, let me emphasize—we are at a critical point
in biomedical research and must maintain the momentum to reach
our vision. The opportunities for significant advances exist on
virtually every front. We must not let these opportunities slip
away. We do not want to lose the scientific capacity that we have
developed in the recent past across the entire country. The transformation
of health and medicine from the curative paradigm of the past to
the preemptive paradigm of the future is within our grasp. As an
example, in the past year alone, we realized a huge victory against
cervical cancer, a disease that affects hundreds of thousands of
women worldwide—a victory that we only dreamed about 10 or
15 years ago. The discoveries of Drs. Doug Lowy and John Schiller
of NIH’s National Cancer Institute on the human papilloma
virus and the hard work of our private-industry partners have led
to the development of the first FDA-approved vaccine against cancer.
This is the kind of preventive intervention that will help us transform
medicine in this century. The development of this vaccine represents
just a small example of the NIH contribution to biotechnology and
its transfer to the bedside —in this case before the “bedside”is
ever needed.
We are also working to preempt disease through evidence-based
education that draws on the best behavioral and social science
research. Let me give you just one of the many examples of how
NIH translates research results into practical health interventions
for the public. In 2005, NIH launched the WE CAN (Ways to Enhance
Children’s Activity & Nutrition) program. WE CAN is a
behavioral intervention at the level of communities aimed at preventing
childhood obesity. The overwhelming response from around the country
has been gratifying. In less than two years, individuals and groups—ranging
from schools and youth organizations to community and recreation
centers—have joined with NIH and our partners in 36 states
to energize WE CAN. This is what I mean when we talk about the
necessary participation of communities and individuals in their
own health in a future redesigned healthcare system.
NIH also continues to expand its outreach and participatory efforts
through its website, one of the most-visited in the world. The
NIH website averages about 47 million visits each month, with more
than 330 million page views.
I ask you to consider the challenges and the opportunities before
us today in medicine and health, and the essential role of biomedical
research. We have the key elements in place for overcoming a host
of diseases and conditions and their societal burden, and momentum
is on our side. Our research efforts have ushered in revolutionary
changes in the diagnosis, treatment and prevention of disease.
Sustaining the pace of biomedical discovery is essential to realizing
a true and necessary transformation of medicine and health in our
country.
I will be happy to answer any questions you may have. Thank you.
Elias A. Zerhouni, M.D.
Director, National Institutes of Health
Elias A. Zerhouni, M.D., is the Director of the National Institutes
of Health (NIH), the nation’s medical research agency. Transforming
medicine and health through discovery, this federal agency is part
of the Department of Health and Human Services. NIH supports peer-reviewed
basic, clinical and translational scientific research at more than
3,000 universities, medical schools, hospitals, and research institutions
throughout the 50 states and overseas. Approximately 83% of the
budget supports the work of some 325,000 extramural scientists
and research staff at those sites. Additionally, NIH supports 6,000
intramural scientists in its own laboratories. The agency trains
research investigators and develops and disseminates credible health
information based on scientific discovery to scientists, medical
and health professionals, patients, families, industry, and the
public. NIH has 27 Institutes and Centers and a fiscal year 2006
budget of approximately $28 billion.
At NIH, Dr. Zerhouni has initiated the NIH Roadmap for Medical
Research, led the effort to transform the medical research enterprise,
supported trans-NIH initiatives in obesity and neuroscience research,
launched the NIH Pathway to Independence Awards designed to bridge
new scientists from mentored support to independent research careers,
established and supported initiatives to reduce health disparities,
and ensured public access to NIH-funded research results. Dr. Zerhouni
has spent his career providing clinical, scientific, and administrative
leadership. Prior to joining the NIH, Dr. Zerhouni served as executive
vice-dean of Johns Hopkins University School of Medicine. Dr. Zerhouni
earned his medical degree at the University of Algiers School of
Medicine, completing his residency in diagnostic radiology at Johns
Hopkins in 1978 as chief resident. He has won a Gold Medal from
the American Roentgen Ray Society and two Paul Lauterbur Awards.
His research in imaging led to advances in Computerized Axial Tomography
(CAT scanning) and Magnetic Resonance Imaging (MRI) that resulted
in 157 peer reviewed publications and 8 patents.
Since 2000, Dr. Zerhouni has been a member of the National Academy
of Sciences' Institute of Medicine.
Department of Health and Human Services
Office of Budget
Richard J. Turman
Mr. Turman is the Deputy Assistant Secretary for Budget, HHS.
He joined federal service as a Presidential Management Intern in
1987 at the Office of Management and Budget, where he worked as
a Budget Examiner and later as a Branch Chief. He has worked as
a Legislative Assistant in the Senate, as the Director of Federal
Relations for an association of research universities, and as the
Associate Director for Budget of the National Institutes of Health.
He received a Bachelor’s Degree from the University of California,
Santa Cruz, and a Masters in Public Policy from the University
of California, Berkeley.
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