The Federal Government's commitment to the National Institutes of Health (NIH) has resulted in an explosion of knowledge that promises to advance our ability to understand the biological basis of disease and unlock new and effective strategies for disease prevention, diagnosis, treatment and cures. As the 20th Century drew to a close, the existence of these unparalleled scientific possibilities, combined with a flourishing national economy, presented a unique opportunity to accelerate and transform this nation's medical research effort to address the continued health challenges facing us.

Congress responded by committing, in a bipartisan fashion, to double the NIH budget over the five-year period FY 1999 to FY 2003. The main reasons for continuing this doubling effort are discussed in this section, and include the many health needs we still face, the tremendous array of new scientific opportunities for conquering these diseases presented by the post-genomic era, and the large economic benefits to be derived from expected improvements in health.

A. Current Health Needs:

The sustained federal commitment to medical research has produced significant health benefits in the United States. However, despite the progress that has been made against many diseases, there remain critical challenges to the health of an aging and increasingly diverse population. In addition, the increasing frequency of international travel makes the United States part of a global health community, which means that diseases that emerge in foreign nations also are likely health threats in this country. Several of these important health challenges include:

Infectious diseases are the second leading cause of death worldwide, accounting for over 13 million deaths (25% of all deaths worldwide) in 1999. The economic impact of infectious diseases is also great, with an annual cost in excess of $120 billion. Twenty well-known diseases - including tuberculosis (TB), malaria, and cholera - have reemerged or spread geographically since 1973, often in more virulent and drug-resistant forms. At least 30 previously unknown disease agents have been identified since 1973 - including HIV, Ebola, and hepatitis C - for which no cures are available.

An estimated 61 million Americans have cardiovascular diseases, 35 million of whom are younger than 65 years of age. High blood pressure affects 50 million Americans. More than 12 million Americans have coronary heart disease, 4.7 million have congestive heart failure, 4.5 million have stroke, and 2 million have peripheral vascular diseases. Nearly 41 percent of all deaths in 1998 in the U.S. were attributed to cardiovascular diseases. Heart disease, alone, is America's No. 1 killer and stroke is the No. 3 killer. Both are major causes of permanent disability. The economic cost to the nation for cardiovascular diseases in 2001 is projected to be $300 billion, including $180 billion for health expenditures and $119 billion for lost productivity.

Aging - Ten years from now, 75 million Baby Boomers will begin to turn 65. By 2050, the number of Americans over 65 will more than double and the number of Americans over age 85 will increase five-fold. With increasing age comes increasing risk of disease and disability. According to a recent national survey, 60 to 70% of Americans age 60 and older have high blood pressure. Radiographic evidence of osteoarthritis - the most common form of chronic arthritis - is seen in 80% of the U.S. population over age 70. One in two older women will have a fracture due to osteoporosis. Late-onset Alzheimer's disease - the major form of this disease - is responsible for up to 4 million cases of dementia; by 2050, there could be 14 million cases.

Mental Illness - The Surgeon General released a report on January 3, 2001, announcing a "national crisis" in children's mental health. In the United States, 1 in 10 children and adolescents suffer from mental illness severe enough to cause impairment. The report calls for the further development of scientifically proven prevention and treatment services including developmental psychopathology, neural network development, and pharmacogenetics.

Allergies and asthma are major causes of illness and disability in the United States. More than 50 million Americans suffer from allergies and/or asthma. Although asthma is a disease of low mortality, its economic costs are enormous, totaling an estimated $14 billion in 1996. Health Disparities - While the overall health of Americans has improved over the past two decades, troubling disparities continue to persist in the burden of illness and death experienced by African Americans, Hispanics, Native Americans, Alaskan Natives, Asians, and Pacific Islanders. The most striking disparities include shorter life expectancy as well as higher rates of cardiovascular disease, cancer, infant mortality, birth defects, asthma, diabetes, stroke, sexually transmitted diseases, and mental illness.

Social and behavioral research - Six of the ten leading causes of death are behaviorally based: obesity, smoking, violence, substance abuse, HIV/AIDS, and unintentional injuries. Research on topics such as basic sensory mechanisms, the effects of different forms of stress on animal models, and the social and cultural factors related to diabetes, hypertension, depression, and cancer could lead to advances in many areas.

B. Emerging Scientific Opportunities and the Changing Nature of Research:

Thanks to the previous investments in NIH, there are more exciting basic and clinical science opportunities than ever before in areas such as DNA research, genomics, molecular and cell biology, immunology and auto-immunity, the neurosciences, computational biology and computer science, bioengineering, and imaging and information technologies.

On June 26, 2000, leaders of the public Human Genome Project and Celera Genomics Corporation announced that both had successfully completed the production of a working draft of the human genome. Researchers expect to complete the first high-quality reference of the human DNA sequence by 2003. Although not as refined as the final version, the working draft completed in 2003 provides the community with sequence data covering most of the genome and represents the raw data needed to find most of the human genes.

Biological science is increasingly based upon molecular genetics and DNA and protein analysis. The understanding of many diseases, ranging from cardiovascular disease, cancer and diabetes, to psychiatric illness, needs to be pursued at the level of genes and gene products. Although significant advances have been made in working with large DNA fragments, new methods and computational tools are needed for DNA analysis. The rapid pace of progress in biotechnology and molecular biology presents a challenge to pursue new computer and information science advances to collect, analyze, and make available an ever-increasing body of knowledge.

Advances in computer modeling, x-ray crystallography, combinatorial chemistry and robotics promise faster and cheaper drug discovery, more precise and effective pharmaceuticals and new drugs for diseases that have eluded treatment efforts.

Achievements in the study of growth and tissue regeneration are setting the stage for practical applications of tissue engineering, permitting a new approach to the problem of replacing tissues and organs damaged by disease or injury. In the field of dental research, continued improvements in biomaterials have resulted in composite resin polymers that are used for anterior restorations, bonding agents, cements and sealants. In eye care, research efforts are being directed toward the development of ocular biomaterials such as intraocular lenses, corneal shields, artificial tears and ocular drug delivery materials.

Explosive progress is occurring against cancer. New technologies to detect and diagnose cancer at an early stage are on the horizon. Imaging devices and techniques are being developed and tested that permit visualization of the cell with greater precision than ever before. An exciting approach to cancer treatment is immunotherapy, or treatments in which the patient's own immune system is coaxed to recognize and eradicate cancer cells.

In sum, previous scientific advances have placed us on the threshold of even more amazing scientific discoveries that promise more treatments, diagnostics, and cures than ever before. In addition, accelerated research progress and expanded opportunities in medical science sparked by NIH funding have dramatically reshaped the ways in which medical research is being conducted. Today, much of the most exciting, cutting-edge research is interdisciplinary in nature, requiring highly specialized teams of scientists with backgrounds in multiple fields. By virtue of the larger size and complexity of interdisciplinary research, it is more costly. NIH is adapting to the challenges of interdisciplinary research by implementing a variety of new funding mechanisms.

C. Research Has Economic Benefits:

While lives saved and human suffering prevented are the ultimate justification for doubling the NIH budget, there is also a dramatic economic return from our nation's investment in medical research. According to a May 2000 Congressional Joint Economic Committee (JEC) report, The Benefits of Medical Research and the Role of the NIH, public investment in NIH yields returns to the economy of 25% to 40% a year. Bottom-line returns to our economy can be seen both in the greater productivity of longer-lived and healthier citizens and the profits, employment and other economic benefits generated by the biotechnology, medical technology and pharmaceutical industries.

Economic Productivity Recovered and Health Care Costs Saved - Cardiovascular disease provides a dramatic example of the economic return possible from a disease prevented, ameliorated or cured. According the JEC, savings resulting from the reduction in cardiovascular mortality and ensuing longevity and economic productivity are estimated at $1.5 trillion a year. If one-third of this reduction in disease and resulting economic benefit can be attributed to medical research, the return on the research investment could be $500 billion annually, or nearly 25 times the size of the FY 2001 NIH budget.

A 1996 Wisconsin Association for Biomedical Research and Education study estimated that the direct cost savings from medical research totals more than $100 billion dollars a year and that the federal government's investment in bioscience is $62 per citizen, while the benefits returned to each of us are worth $5,600.

Economic Benefits - According to the JEC, the high-tech and research-driven industries, including biotechnology and the pharmaceutical industry, have contributed directly to one-third of the nation's economic growth over the past decade. At the same time, employment in high-tech industries has grown at twice the rate of private-sector job creation as a whole, and high-tech salaries are on average 82% higher than salaries in other areas of the private sector. According to a 1999 Ernst and Young study of the biotechnology industry, biotech employment grew by 9%, to 153,000 in 1998. In the same year, product sales of $13.4 billion grew by 17% and more than 80 new biotechnology products were headed for market, while more than 2500 were in clinical trials or earlier stages of development. The JEC found that of the 21 most important drugs introduced between 1965 and 1992, 15 were in part the result of federally-funded research, and seven were the direct result of NIH research. The success and prosperity of the U.S. pharmaceutical industry has long depended upon NIH-supported science for "enabling discoveries" and for training the skilled workers to exploit new knowledge that leads to cures and therapies. The revolutions in molecular biology and in genomics can only strengthen this reliance.

The economic returns that accrue from medical research, therefore, provide an additional basis for supporting increased medical research funding through NIH.