DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
Fiscal Year 2015 Budget Request
Statement for the Record
Senate Subcommittee on Labor-HHS-Education Appropriations
Gary H. Gibbons, M.D.
Director, National Heart, Lung, and Blood Institute
Mr. Chairman and distinguished members of the Subcommittee:
I am pleased to present the President’s Budget request for the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH). The fiscal year (FY) 2015 budget of $2,987,685,000 includes an increase of $4,948,000 over the FY 2014 enacted level of $2,982,737,000.
NHLBI’s highest priorities for research investment are conditions that contribute substantially to the global burden of disease. Heart and lung diseases are the leading causes of death, disability, and rising health care costs from non-communicable diseases in the United States and worldwide. Research supported by the NHLBI has contributed to dramatic improvements in longevity, quality of life, and the wealth of the nation. Deaths from cardiovascular disease, for example, have dropped by 70 percent in the past 40 years. This success reflects a balanced approach to supporting discovery science that spans basic, clinical, and population research. As accountable stewards seeking to maximize the public’s return-on-investment, we are committed to continually improving our approach to strategic priority-setting and systematic evaluation of our portfolio to ensure the highest possible impact on science and health.
Reflecting upon the NHLBI’s legacy of success, many of the previous advances involved interventions at the latter stages of chronic disease. The FY 2015 budget envisions a research agenda that elucidates the underlying mechanisms of disease such that clinicians can more accurately predict at-risk individuals and tailor preventive interventions for disease long before symptoms and irreversible damage occur. Our strategic vision is guided by the breathtaking scientific opportunities at hand and public health needs, in consultation with domain-experts at the leading edge of discovery science. The FY 2015 budget continues a journey toward predictive, preventive precision medicine that holds promise for turning research-to-results, continuing the dramatic decline in the burden of chronic disease in our nation.
UNPRECEDENTED SCIENTIFIC OPPORTUNITIES
Sustained investments in fundamental discovery science have led to new tools and technologies that stand to revolutionize medical research and clinical practice. Biomedical advances in congenital heart disease (CHD), the most common structural birth defect, have led to dramatic improvements in infant survival over the past 50 years, now with more adults living with CHD than children. However, current palliative approaches that repair birth defects have limitations that compromise the length and quality of life. Recent NHLBI-supported research, applying the latest genomic technologies, has identified spontaneous genetic mutations that increase the risk of CHD. This breakthrough finding is beginning to unlock the mysteries of CHD, helping to define what goes awry during the formation of the heart and lay the foundation for preventing or fixing defects in the womb. To that end, NHLBI is investing in regenerative medicine research to enhance the capacity of the heart to repair itself. The 2012 Nobel Laureate, Shinya Yamanaka, is part of a large inter-institutional team of NHLBI-funded investigators studying how to use a child’s own cells to repair a congenital defect or create a tissue graft that could grow as a child ages.
NHLBI investments in reparative biology and tissue bioengineering may also hold promise for accelerating new drug development platforms in partnership with the private sector. For example, NHLBI-funded investigators at Stanford University are using stem cells derived from adult tissue in a laboratory to create heart cells and model diseases such as those that perturb the electrical system of the heart in atrial fibrillation. These models are being used to more efficiently screen many novel drugs to determine efficacy as well as potential toxicities, augmenting the discovery pipeline.
PREEMPTING AND PREVENTING CHRONIC DISEASE
New scientific discoveries hold promise for making public health inroads to halt chronic diseases before they become debilitating. In sickle cell disease (SCD), for example, we have made great strides in reducing complications from the disease such as penicillin to prevent fatal infections in infants, transfusions to reduce stroke risk, and hydroxyurea to reduce pain and hospital admissions. While these advances have extended lifespans from childhood into the sixth decade of life, they target complications not the disease itself—a disease that disproportionately affects African Americans (about 1 in 500 births). We recently funded a new program that we hope will lead to the next generation of SCD treatments. Particularly exciting are studies that are attempting to raise fetal hemoglobin levels (the most powerful known modifier of SCD severity) through modulation of a gene called Bcl11A that is involved in the switch from fetal to adult hemoglobin during development. These studies open the door to potential treatments that can reactivate the fetal hemoglobin gene to inhibit the sickle cell shape change of red blood cells, which could preempt disease progression.
Chronic obstructive pulmonary disease (COPD), the third leading cause of death, is a prime example of a chronic disease in which biomedical research advances have ameliorated symptoms; yet most interventions fail to dramatically alter the natural course of the disease. There is a critical need to identify at-risk individuals earlier in the disease process to prevent disease progression. NHLBI’s COPDgene study is integrating genetics and imaging studies to characterize pre-clinical subtypes of COPD. Such characterization can enable clinicians to detect subtle changes in lung function and structure long before symptoms develop, conventional clinical tests show abnormalities, or progressive lung damage occurs. This leading-edge research points to a horizon of individualized, precision medicine to preempt chronic lung disease.
TRANSLATING DISCOVERIES INTO PUBLIC HEALTH IMPACT
While basic science is the cornerstone of scientific discovery, it is the beginning of a long path to public health impact. NHLBI has been a leader in traversing this road. Noted research initiatives like the Framingham Heart Study first identified the cardiovascular disease risk factors now addressed in routine physicals, which led to basic research that won Brown and Goldstein the Nobel Prize for their research on cholesterol metabolism—setting the stage for the development of statin drugs.
We are currently amidst a similar story unfolding. The recent discovery of a mutation in the gene PCSK9 among a family with very low LDL cholesterol levels and reduced risk of heart attack has led to basic science discoveries and the rapid development of PCSK9 inhibitors by public-private partnership toward potential widespread clinical use as the next generation of cholesterol lowering drugs.
We now know, however, that we must look beyond one-size-fits-all treatments. Population science and genetics research have clearly demonstrated individual differences not only in predisposition to disease but also in treatment response. For example, 26 million Americans currently suffer from asthma—the leading cause of missed school days for children and a driver of preventable hospitalizations and emergency room visits. However, asthma disproportionately affects African Americans; African American children are twice as likely to have asthma as white children and, as adults, are two to three times more likely to die of asthma than any other racial or ethnic group. While effective treatments exist, they do not reach all of those in need. NHLBI will be seeking applications focused on identifying barriers and testing strategies to enhance the implementation of evidence-based practices in diverse communities across the nation. Beyond the current treatments, next generation therapies should target these differences to achieve maximal benefit. NHLBI’s multi-center clinical trial network, AsthmaNet, is beginning the Best African American Response to Asthma Drugs (BARD) study to compare the effectiveness of different treatments on the management of asthma in African Americans. BARD will also assess how genetics may influence an individual’s response to the treatments, which could be a paradigm shift in addressing challenges like disparities in asthma care.
We are in the midst of a very exciting period in science in which the capacity to enhance human health has never been greater. New tools and technologies are daring us to envision a future that is unburdened by chronic heart, lung, and blood diseases—not only ensuring wellness but also increasing economic productivity and reducing health care costs. For example, research shows that treating patients at moderate risk for cardiovascular disease with statin drugs to lower cholesterol can reduce annual medical spending by up to $430 million. Imagine how much can be saved by preventive interventions earlier in the disease course before symptoms begin and the costs of treatment rise dramatically. By achieving that goal, the return-on-investment of biomedical research will strengthen both the health and the wealth of the nation.
Gary H. Gibbons, M.D.
Director, National Heart, Lung and Blood Institute
Gary H. Gibbons, M.D., is Director of the National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH), where he oversees the third largest institute at the NIH, with an annual budget of approximately $3 billion and a staff of nearly 1,000 federal employees.
NHLBI provides global leadership for research, training, and education programs to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives.
Prior to being named director of the NHLBI, Dr. Gibbons served as a member of the National Heart, Lung, and Blood Advisory Council (NHLBAC) from 2009-2012. He was also a member of the NHLBI Board of Extramural Experts (BEE), a working group of the NHLBAC.
Before joining NHLBI, Dr. Gibbons served as the founding director of the Cardiovascular Research Institute, chairperson of the Department of Physiology, and professor of physiology and medicine at the Morehouse School of Medicine, in Atlanta.
Under his leadership of the Cardiovascular Research Institute, Dr. Gibbons directed NIH-funded research in the fields of vascular biology, genomic medicine, and the pathogenesis of vascular diseases. During his tenure, the Cardiovascular Research Institute emerged as a center of excellence, leading the way in discoveries related to the cardiovascular health of minority populations. Dr. Gibbons received several patents for innovations derived from his research in the fields of vascular biology and the pathogenesis of vascular diseases.
Dr. Gibbons earned his undergraduate degree from Princeton University in Princeton, N.J., and graduated magna cum laude from Harvard Medical School in Boston. He completed his residency and cardiology fellowship at the Harvard-affiliated Brigham and Women's Hospital in Boston. Prior to joining the Morehouse School of Medicine in 1999, Dr. Gibbons was a member of the faculty at Stanford University in Stanford, Calif., from 1990-1996, and at Harvard Medical School from 1996-1999.
Throughout his career, Dr. Gibbons has received numerous honors, including election to the Institute of Medicine of the National Academies of Sciences; selection as a Robert Wood Johnson Foundation Minority Faculty Development Awardee; selection as a Pew Foundation Biomedical Scholar; and recognition as an Established Investigator of the American Heart Association (AHA).