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Fiscal Year 2007 Budget Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH

Fiscal Year 2007 Budget Request

Witness appearing before the House Subcommittee on Labor-HHS-Education Appropriations

Elizabeth G. Nabel, M.D., Director
National Heart, Lung, and Blood Institute

March 16, 2006

Richard J. Turman, Deputy Assistant Secretary, Budget

Mr. Chairman and Members of the Committee:

I am pleased to present the fiscal year (FY) 2007 President’s Budget request for the National Heart, Lung, and Blood Institute (NHLBI).  The FY 2007 budget includes $2,901,012,000, a decrease of $20,745,000 over the fiscal year 2006 enacted level of $2,921,757,000.

The NHLBI was established as the National Heart Institute in 1948 with a mandate “to improve the health of the people of the United States” through research on diseases of the heart and circulation.  And that is exactly what we have done.  I believe it is no exaggeration to claim that, over the past decades, biomedical research has made more progress in cardiovascular disease than in any other major chronic health problem.  The impact on death rates alone constitutes a monumental validation of this country’s public investment in the NIH and the NHLBI.

The United States experienced an epidemic of coronary heart disease (CHD) during the twentieth century and, had the trend continued unabated, more than 1.6 million lives would be lost to CHD this year.  In actuality, the toll will be less than 500,000 deaths, reflecting a 63 percent decline in age-adjusted mortality since 1950.1  Mortality from stroke, the third most common cause of death in the United States, declined 70 percent over that time.  The effect on longevity has been remarkable— looking just at recent data, we can see that between 1970 and 2000 the life expectancy of the average American increased by 6 years, and nearly 4 years of that gain was due to reductions in deaths from cardiovascular disease.

Much of the reduction in death rates has come from improved treatments for CHD.  Not so long ago, atherosclerosis followed an inexorable course and, once an artery became occluded, blood flow could not be restored.  Increasingly sophisticated technological developments in revascularization—coronary artery bypass surgery (1968), balloon angioplasty (1977), stents (1994), and now “drug-eluting” stents—coupled with vastly improved diagnostic procedures and new medications, have literally given many patients a new lease on life.  NHLBI-supported basic and applied research studies, as well as carefully designed clinical trials, have enabled scientists to develop these interventions, to assess their utility and safety, and to determine the characteristics of patients most likely to benefit from them.  Millions of Americans suffer from cardiovascular disease, and this research has contributed enormously to our ability to help them live longer and healthier lives.

We are equally pleased to reflect on improvements that have occurred in our ability to treat acute heart attacks.  In past generations, doctors could only stand by while a heart attack ran its course and they had little to offer the patient but bed rest and a prognosis of rapid death or severely restricted life as a “cardiac cripple.”  All that changed in the 1980s when scientists determined that most heart attacks occur because of a blood clot in an artery that feeds the heart.  The development of thrombolytic—“clot-busting”—therapy followed.  NHLBI-sponsored clinical trials of thrombolysis demonstrated that the procedure could limit the area of damaged heart muscle and decrease mortality.  This was revolutionary, and it rapidly influenced how heart attack is treated.

The greatest benefit of thrombolysis, however, accrues in the initial minutes and hours after onset of the attack and, unfortunately, many patients do not reach the emergency room in time.  In the 1990s the NHLBI initiated a successful trial of community-based interventions to reduce delays in seeking and receiving treatment for heart attack symptoms.  The knowledge gained was used to develop Act in Time to Heart Attack Signs, a far-reaching public education campaign launched by the NHLBI during the NIH budget doubling.  Also during the doubling, the Institute began a pilot program at Suburban Hospital to test a new approach to diagnosing heart attack patients who may be candidates for thrombolytic therapy.  For many patients arriving at the emergency room with chest pain, diagnosis requires measurement of enzymes that appear in the bloodstream only hours after the heart attack has occurred—too late for effective thrombolysis.  The experimental program is having great success in using MRI (magnetic resonance imaging) technology to provide a diagnosis in about 35 minutes, and we believe it may form the basis for a better approach to delivering prompt therapy to patients who are likely to benefit from it.  In light of recent evidence that thrombolytic therapy may benefit patients who experience a clot-based stroke, we have also teamed up with the National Institute of Neurological Disorders and Stroke to use MRI in evaluating patients who come to the emergency room with stroke symptoms.

Let me mention some special efforts to improve treatment of coronary heart disease in a highly vulnerable population—patients with obesity and type II diabetes.   Although there is near-universal optimism that a cure for diabetes will ultimately be found, in the meantime the majority of patients are suffering and dying from cardiovascular disease.  We are working to identify approaches to prevent and treat these complications, and I am happy to note that the budget doubling enabled us to move forward with full funding of two major new clinical trials in this area.  The ACCORD trial is testing the extent to which control of blood pressure, cholesterol, and glucose levels to thresholds beyond those that are currently recommended will reduce the occurrence of cardiovascular problems.  The BARI-2D trial, focused on diabetic patients who already have coronary heart disease, is weighing the merits of revascularization versus medical treatment and, in addition, studying two different approaches to controlling blood sugar.  These trials are effortful and expensive because they involve multiple complex issues in diabetes management.  However, they address a critical public health need, given the escalating prevalence of obesity and diabetes in the United States, and many among us are likely to benefit from their findings.

Much as we celebrate these advances in treatment, let me assure you that we have never lost sight of our ultimate objective—prevention.  Indeed, we have had considerable success in identifying risk factors such as high blood pressure and cholesterol, developing and evaluating methods to control them, and translating the research findings into messages for health-care professionals, patients, and the general public.  During the budget doubling, we launched The Heart Truth, an education campaign to raise awareness that heart disease is the leading cause of death in American women and call women to take action to reduce their risk of developing heart disease.  Already we have evidence that the campaign’s message, “Heart disease doesn’t care what you wear—it’s the #1 killer of women,” has raised awareness throughout the nation.  Last June we launched We Can! (Ways to Enhance Children's Activity and Nutrition), a national education program to help children 8-13 years of age stay at a healthy weight.  We Can! offers parents and families tips and activities to encourage healthy eating, increase physical activity, and reduce sedentary or screen time.  It also provides resources to help community groups and health professionals work toward these goals.

Much of what we know about factors that put people at risk of developing cardiovascular diseases has come from the multigenerational Framingham Heart Study, begun in 1948.  I am delighted to announce that the NHLBI, in conjunction with Boston University, recently unveiled a plan to take this study to the next level.  Our new Framingham Genetic Research Study will entail up to 500,000 analyses of the DNA of 9,000 study participants.  By identifying genetic variations that relate strongly to participant characteristics (e.g., blood pressure and cholesterol levels, overweight and obesity) and to outcomes (e.g., stroke, congestive heart failure, diabetes), we hope to refine our understanding of individual risk and identify carefully focused new strategies for treatment and prevention.  We at the NHLBI share Dr. Zerhouni’s vision of an approach to medical care that is predictive, personalized, and preemptive and we believe this new endeavor constitutes a major step toward realizing that goal.

PEDIATRIC HEART AND LUNG DISORDERS

Tremendous progress has been made in treating congenital cardiovascular malformations, the most common type of birth defect in the United States.  Many of us remember when these conditions constituted a death sentence, but today we have an array of surgical and medical treatments, as well as reliable and effective methods for providing monitoring and support.  As a result, more than 90 percent of these babies live to celebrate a first birthday.  Indeed, the prognosis has improved so much that there are now more adults than children living with congenital heart defects, according to data from the Adult Congenital Heart Association.  Nonetheless, congenital heart disease is still a major contributor to infant mortality and many challenges remain.  Thanks to the budget doubling, we have been able to expand significantly our efforts in this area by funding two additional Specialized Centers of Research in Pediatric Cardiovascular Disease, establishing a clinical research network to enable rapid evaluation of new treatment approaches, and soliciting research proposals to develop devices for infants and children who experience cardiopulmonary failure and circulatory collapse. 

As recently as 35 years ago, many premature infants died within hours of birth from neonatal respiratory distress syndrome (RDS), a condition caused by lack of a substance called surfactant that keeps the lung’s air sacs open for breathing.  The NHLBI’s long-term investment in basic, applied, and clinical research has nearly relegated neonatal RDS to history.  With development of special ventilation techniques to sustain babies until their lungs matured, introduction of a prenatal test for lung maturity, and demonstration that antenatal corticosteroid treatment could accelerate lung maturation, U.S. deaths from this disorder fell 60 percent between 1970 and 1984—from 10,000 to 4,000 per year.  Then, in the 1980s, NHLBI-supported studies of surfactant structure, function, and regulation and efforts to identify the genes for surfactant proteins culminated in development of surfactant replacement products for testing in clinical trials.  Since 1990, when two surfactant treatments were approved for widespread clinical use, neonatal RDS mortality has fallen more than 75 percent, to about 1,000 deaths per year.

ASTHMA

For centuries, asthma was viewed a bronchial spasm problem and treated—with limited success—as such.  Our intensive research effort in recent years led to the realization that asthma is a manifestation of chronic inflammation and immune dysfunction.  This insight revolutionized treatment, the mainstay of which now is anti-inflammatory medications to treat the underlying disease, with bronchodilators used chiefly for quick relief of symptoms.  The NHLBI has also been a pioneer in development of self-management strategies and their application, especially for inner-city minority children; evidence indicates favorable effects on emergency room visits and school absences in this vulnerable population.  Results of all these efforts are rapidly incorporated into national guidelines that set the standard for modern asthma management.  Clinical research networks have proven invaluable for rapidly assessing new treatment strategies, and during the budget doubling we were able to renew our highly productive adult Asthma Clinical Research Network and initiate the Childhood Asthma Research and Education Network, which addresses pediatric asthma.  We also began a program focused on severe asthma.  These efforts are enabling us to make good on our promise to patients, “Your asthma can be controlled – expect nothing less.”  And we are now talking with increasing confidence about curing asthma, going beyond the initial promise of asthma control.

SICKLE CELL DISEASE

As recently as 1970, the average patient with sickle cell disease died in childhood.  Today, life expectancy is about 45 years.  NHLBI research has led to a standard of care that begins with screening of newborns, provides prophylaxis for potentially lethal childhood infections, and offers transfusion therapy to prevent stroke in high-risk children.  A clinical trial demonstrated the value of the drug hydroxyurea in preventing painful crises, acute chest syndrome (a life-threatening respiratory complication), and need for transfusions in adult patients.  With the budget doubling, we have been able to undertake a hydroxyurea trial in children, and also to assess the value of stem cell transplantation as a possible cure.  Our hope and expectation is that further gains in longevity and quality of life will be achieved.

I would be pleased to respond to any questions that the Committee may have.
            


1Data in this statement regarding mortality and life expectancy are from U.S. Vital Statistics.

 
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