DEPARTMENT OF HEALTH AND
National Institutes of Health
National Heart, Lung, and Blood
Fiscal Year 2006 Budget Request
Witness appearing before the
House Subcommittee on Labor-HHS-Education
March 9, 2005
Elizabeth G. Nabel, M.D., Director
National Heart, Lung, and Blood Institute
I am pleased to present the Fiscal Year (FY) 2006 President's
Budget request for the National Heart, Lung, and Blood Institute (NHLBI).
The FY 2006 budget includes $2,951,270,000, an increase of $10,069,000 over the
fiscal year 2005 enacted level of $2,941,201,000 comparable for transfers proposed
in the President's request. I come to you with pride on behalf of the NIH component
that is responsible for much of the gain in life expectancy that we have enjoyed over
the past three decades in the United States, as shown in this chart. At the same time,
however, I come with deep concern because the diseases under NHLBI responsibility still
comprise three of the four leading causes of death in this country—heart disease,
stroke, and chronic obstructive pulmonary disease (COPD).
Clearly, we have come a long way, but we have far to go.
A VISION FOR THE FUTURE OF THE NHLBI
As the NHLBI's first new director in 22 years, I would like to take this opportunity to share with the
Committee my vision for the Institute. This vision is based upon a fundamental set of values—excellence,
integrity, innovation, respect, and compassion—that will permeate all activities in the NHLBI. I believe that
scientific discovery provides the basis for progress and that the NHLBI is uniquely positioned to catalyze changes
that must be made to transform our new scientific knowledge into tangible benefits for the people of this country.
Within this framework, let me articulate four themes that will guide priority setting of our research agenda.
THEME ONE: DISCOVERY
The first theme—stimulating basic discoveries of the causes of diseases—is vital to developing new,
critically needed treatments. Basic research provides the foundation of the NHLBI portfolio and has been
one of its great strengths. The typical model of investigation—research conducted by single investigators
or small groups of investigators on projects of their own inspiration—accounts for most of the unanticipated
and major scientific discoveries in this country. I believe strongly that we must protect and nurture
investigator-initiated research. The NHLBI will continue to invest in the most talented scientists conducting
the highest caliber research. Innovation and creativity using the most advanced biomedical technologies will
be our goal.
We have an exciting opportunity to support emerging new scientific fields. Major strides are being made in
computer sciences, bioengineering, material sciences, chemistry, and other areas of study that vastly benefit
medical research, and the pace of discovery in these disciplines should be accelerated. One approach is to
develop funding mechanisms (e.g., for support of high-risk research) that encourage innovative thinkers to
turn their attention to the major current challenges in heart, lung, and blood diseases.
Another objective is to generate large, publicly available sets of reagents and data that could function
as a “tool kit” for NHLBI investigators. Gene sequences and maps, cell lines, knockouts and knockdowns of
genes in selected animals, reference sets of proteins, protein affinity reagents, and libraries of small
molecules are examples of resources that will provide our investigators with the technologies required for
THEME TWO: TRANSLATION
Our second task is to speed translation to clinical applications so that people can benefit as
quickly as possible from the basic research enterprise. Clinical research, and more specifically,
translational research (“bench to bedside”) are vital to our mission, so that we can translate basic
discoveries into the reality of better health for our country.
The NHLBI must further develop the infrastructure for clinical research so that it serves the
evolving field of scientific discovery and provides a foundation for evidence-based clinical decision-making.
Clinical research is critical to ensuring that new products and techniques are safe and effective before they
are widely applied. However, clinical research is often time-consuming and inefficient, and is increasingly
burdened by regulatory hurdles. Our challenge is to expand clinical research to complement the exciting basic
science discoveries, while making it more efficient and cost-effective.
We intend to develop a translational research agenda supported by clinical trials, clinical networks,
and clinical workforce training. Key components will focus on increasing interactions between basic and
clinical investigators and easing the movement of new tools from laboratories to clinics. We will build
upon our rich experience with clinical trials and networks to develop new partnerships among organized
patient communities, community-based physicians, and academic researchers. We will work on improving
bioinformatics and clinical databases, standards for clinical research protocols, measures of clinical
outcomes, and quality assessment. Translational research requires the expertise of many fields and
should include analysis of health education, outcomes, health-care delivery, and health-care economics. This
focus fits well with the Re-engineering the Clinical Research Enterprise of the Roadmap.
The NHLBI must cultivate a cadre of clinical researchers who have skills commensurate with the
complexity and needs of our research enterprise. Clinicians must be trained to work in the interdisciplinary,
team-oriented environments that characterize today's research efforts. We further anticipate that specific
training will be required in an array of disciplines important to clinical research, including genetics,
epidemiology, biostatistics, and behavioral medicine.
At the core of this vision is the need to develop new partnerships of research with organized
patient communities, community-based health care providers, and academic researchers. We will rely
on our partnerships to facilitate the conduct of this clinical research, to train our clinical
investigators, and most important, to achieve our common goals of improved health for the public.
THEME THREE: INTERACTIONS
The third theme is facilitating communication between scientists and physicians so that new ideas can
be generated, shared, and advanced.
Today's science is far more complex than that of yesteryear. Research, whether basic or clinical,
is now commonly done by teams of scientists wherein each individual brings specific talents and expertise
to the overall effort. We will stimulate and facilitate the conduct of interdisciplinary research, so that
advances can be made more quickly. Principal-investigator status will be granted not to just one investigator,
as is the norm, but to all key members of the research team. Integrated reviews of grants will take into
account the melding of various disciplines to address the problem at hand, and interdisciplinary teams will
be encouraged to evolve in both directed and unexpected ways.
An essential component of our efforts in research collaboration will be community-based clinical trials,
which enhance the conduct of clinical research at academic medical centers. An outstanding example is our
ALLHAT (Antihypertensive and Lipid-Lowering to Prevent Heart Attack Trial), in which physicians from many
types of medical settings—a total of 623 sites in 47 states, Puerto Rico, the U.S. Virgin Islands, and
Canada—successfully enrolled over 42,000 patients and followed them for 6 years. The physicians
participated because they believed in the importance of the scientific questions being addressed with
regard to patient care and because of the direct benefits of participation to their patients, including
free medications. These community-based physicians conducted the trial at very high standards—follow
up was over 97 percent. As part of our plan to disseminate the ALLHAT results, participating
community physicians are now working with other doctors in their local communities to treat patients
with high blood pressure.
THEME FOUR: COMMUNICATION
Our fourth task is to effectively communicate our research advances to the public to improve
understanding of new, promising science.
The NHLBI has an outstanding history of outreach in the areas of high blood pressure, cholesterol,
asthma, heart attack, obesity, sleep disorders, and women's cardiovascular health, and new
efforts are under way with respect to COPD and peripheral arterial disease. I wholeheartedly support
these programs that serve the mission of our Institute and the Nation. Education of our patients and
the public regarding prevention and treatment of heart, lung, blood, and sleep disorders is one of my
We will continue to work collaboratively with our colleagues in the DHHS, including the CDC and the FDA,
to support prevention and control programs. We also have an unprecedented opportunity to build upon our
partnerships with professional organizations, who have a large stake in developing and implementing practice
guidelines and monitoring their effectiveness, and with patient advocacy groups. One of our most gratifying
partnership programs has been The Heart Truth, which is successfully raising awareness nationwide that heart
disease is the leading cause of death among American women. The “reach” of this campaign continues to expand
as we forge additional fruitful partnerships with entities in the public and private sectors.
Disparities in health status constitute a significant global issue. Research is essential to understand the diverse
contributions of genetics, health behavior, diet, socioeconomic status, culture, and environmental exposures in the genesis
of health disparities in heart, lung, and blood diseases and to formulate, evaluate, and disseminate well-conceived, focused
intervention programs. This work will necessarily entail a vigorous effort to increase the representation of minorities in the
ranks of NHLBI researchers. We are also cognizant of the need to improve and expand programs to prevent, manage, and treat
diseases and conditions that disproportionately affect U.S. minority and underserved populations, such as cardiovascular
disease and asthma, and to evaluate the effectiveness of our research, treatment, and education programs. A full resolution
of the health disparities problem will occur only through committed and sustained efforts by many in our government, health
centers, and society.
The realization of this vision will require the efforts of many. We are engaged in a special form of public service,
that is, the promotion of patient and public health. I will work diligently to preserve public trust in the Institute,
the NIH, and the biomedical research enterprise, and to ensure that the NHLBI serves the public with the highest level
of integrity. This trust is essential for meeting our common goals of making
important new scientific discoveries and translating them to improve health in this country.
Thank you, Mr. Chairman. I would be pleased to answer any questions that the Committee may have.