provide continued evidence of a "rising tide of mediocrity" among American youth. A 1988 international report comparing science achievement among students in 13 developed countries placed U.S. students of all grades at the bottom half. U.S. high school seniors placed 13th in biology, and 9th and 11th in physics and chemistry, respectively. Furthermore, on biology tests, the mean scores of U.S. high school seniors are a dismal 37.9 percent, well below those of 11 other countries, including Japan, Hungary, and the United Kingdom. Statistics show that this trend continues through college. Life science as a career choice for American youth has been in decline for some time. Changes in the market-share of undergraduate majors in 4-year schools reflect this fact as sciences across the board are losing, while business, social sciences, and the humanities are gaining. For example, first-time freshmen majoring in business jumped from one in five in 1978 to almost one in four in 1987, while those choosing physical and biological sciences declined. Bachelor's degree awards over the past 20 years in the biological sciences, premedicine, engineering, and the physical sciences have declined significantly, while those in business, management, and the social sciences continue to rise in popularity. Predictably, there is a similar trend in the awarding of doctoral degrees in the sciences. Also of great concern is the ever-growing number of doctoral recipients in this country who are not U.S. citizens. Many doctorates are awarded to individuals on temporary visas who must return to their countries. A major factor in the decision of Americans not to pursue careers in biomedical research is the cost associated with advanced education. Because of the large debts often accrued during their education, a large number of students, regardless of their intelligence, talent, or ability, are choosing careers that have bigger financial payoffs and not training for a career in scientific investigation. Financing an education through loans has increased disproportionally to scholarships over the past ten years. In 1983, an estimated 30 percent of student funds were in the form of scholarships, while in 1989 that number dropped to nearly 20 percent. The mean debt of senior medical students, which has steadily increased over the past decade, also reflects this increasing financial burden. On the average, a senior medical student leaves school owing close to $50,000. Unfortunately, the high risk and personal sacrifice of a career in science does not improve after those training years. It is not just that the salaries are lower in research than nonresearch fields. Due to the escalation in cost of individual grants, the NIH has seen slower growth in its portfolio of research awards in the past 5 to 6 years. Moreover, the number of principle investigators supported by the NIH has declined over the past 3 years. The research grant portfolio represents "our nation's response to opportunity"--and the principle investigators, the intellectual brain trust needed to develop this field. Perhaps of equal concern is the knowledge that our research community is aging. Of persons submitting competing research project grant (RPG) applications, those between ages 46-50 are steadily increasing while those age 35 and below are steadily decreasing. This information is both startling and worrisome. Science in particular needs its young, not just to renew itself but to do its job intellectually. There is enormous wisdom in the words of Sir Francis Bacon in his essay "Of Youth and Age": "Young men are fitter to invent than to judge; fitter for too soon, success." These words are even more powerful today--Science moves ahead because of bold questions, challenges to established dogma, and irreverence to naysayers. Science will calcify and crumble if we lose our youth. Declining Scientific Prestige Abroad Another warning sign for science and its ability to contribute to this nation's economy is the erosion of our world leadership in science and engineering. The percentage of GNP invested in civilian research and development by the United States is lagging relative to other industrialized nations, particularly Japan, West Germany, and France. These countries have been increasing their investment, while ours has remained constant. For example, nondefense R&D as a percentage of GNP in Japan rose from about 2 percent in 1977 to 3 percent by 1987, while U.S. spending in the same category remained stable (at around 1.5 percent). There is some sign for hope though, because, since 1987, the U.S. figure has increased steadily. Our world neighbors have steadily increased their market share of scientists, as a matter of focused national priority while some measures of our technical strength have declined. One example of this decline is the lower percentage of Americans registering patents in this country. We are seeing a decline in absolute numbers of patents held by American inventors. Another measure of the relative strength of our nation's biomedical research is an examination of its market share of world scientific and technical articles. Here too, we are witnessing an erosion of the U.S. preeminence. An analysis of Nobel Prizes awarded to Americans over the last five decades indicates a fluctuation in recipients with the trend also on the decline. During the decade from 1950-1959, 70 percent or 14 of the 20 total prizes were awarded to Americans. In contrast, from 1980-1989, 57 percent of 23 prizes were awarded to Americans and the first ever to a Japanese scientist. This past year, two Nobel prizes in physiology or medicine went to Germany -- and no prize to a U.S. scientist. The figures clearly suggest a global change as other countries are challenging our leadership. Is it that they are getting better, or are we getting worse? Cumulatively, the challenges to our human resource base, and its productive output, could eventually pose problems for American biomedical research, biomedicine, and biotechnology. Erosion of our biomedical research enterprise could impact, not only on our Nation's economic well being in the years ahead, but also on the quality of life of our people. Benefits of Biomedical Research The National Institutes of Health plays a major role in ensuring the health of the nation's people through the development of therapies and interventions that prevent disease and reduce suffering from disabilities. This investment also contributes to the vigor of the country's economy. We believe that biomedical research can be part of a national strategy to contain and reduce health care costs. Reductions in health care costs are best realized through prevention, cure, and effective treatment for diseases and disabilities. Cardiovascular diseases remain the leading cause of death and disability in the U.S., with costs estimated to exceed $100 billion per year. The recently completed Systolic Hypertension in the Elderly Program (SHEP) clinical trial, a collaboration of the National Heart, Lung, and Blood Institute, and the National Institute on Aging, established that pharmacologic treatment of isolated systolic hypertension, typically costing less than 25 cents per day, could result in 24,000 fewer strokes and 50,000 fewer cardiovascular events, including myocardial infarctions. This treatment could save the nation more than $200 million each year, and could likewise reduce the incidence of stroke by one third. The estimated annual cost for cancer is $100 billion, while the economic impact of substance abuse and addiction is tremendous, with alcohol use alone having an estimated annual cost of $86-113 billion. Possible future identification through biomedical research of the molecular underpinning of these diseases, and development of appropriate prevention and therapeutic intervention, have the potential for substantially reducing health care costs and the associated economic burden. Health care costs for the older population are expected to increase significantly in the coming decades. Persons over age 65 are now estimated to account for approximately one-third of U.S. health care costs. The estimated price tag of Alzheimer's disease is more than $90 billion per year; if treatments that delay the onset of the disease by five years could be developed, they could reduce the incidence of the disorder by half--possibly, reducing costs by more than $40 billion annually. One of the goals of aging research is to reduce the risk factors that lead to institutionalization and other costly, long-term care services. Better understanding of the human brain could also lead to more costeffective interventions. Neurological disorders are responsible for more hospital admissions than any other disease category, affecting 75 million Americans at an annual cost of over $300 billion. Because these disorders are typically chronic and debilitating, even a modest increase in function can mean a vast improvement in the quality of life for the patient and family, as provide continued evidence of a "rising tide of mediocrity" among American youth. A 1988 international report comparing science achievement among students in 13 developed countries placed U.S. students of all grades at the bottom half. U.S. high school seniors placed 13th in biology, and 9th and 11th in physics and chemistry, respectively. Furthermore, on biology tests, the mean scores of U.S. high school seniors are a dismal 37.9 percent, well below those of 11 other countries, including Japan, Hungary, and the United Kingdom. Statistics show that this trend continues through college. Life science as a career choice for American youth has been in decline for some time. Changes in the market-share of undergraduate majors in 4-year schools reflect this fact as sciences across the board are losing, while business, social sciences, and the humanities are gaining. For example, first-time freshmen majoring in business jumped from one in five in 1978 to almost one in four in 1987, while those choosing physical and biological sciences declined. Bachelor's degree awards over the past 20 years in the biological sciences, premedicine, engineering, and the physical sciences have declined significantly, while those in business, management, and the social sciences continue to rise in popularity. Predictably, there is a similar trend in the awarding of doctoral degrees in the sciences. Also of great concern is the ever-growing number of doctoral recipients in this country who are not U.S. citizens. Many doctorates are awarded to individuals on temporary visas who must return to their countries. A major factor in the decision of Americans not to pursue careers in biomedical research is the cost associated with advanced education. Because of the large debts often accrued during their education, a large number of students, regardless of their intelligence, talent, or ability, are choosing careers that have bigger financial payoffs and not training for a career in scientific investigation. Financing an education through loans has increased disproportionally to scholarships over the past ten years. In 1983, an estimated 30 percent of student funds were in the form of scholarships, while in 1989 that number dropped to nearly 20 percent. The mean debt of senior medical students, which has steadily increased over the past decade, also reflects this increasing financial burden. On the average, a senior medical student leaves school owing close to $50,000. Unfortunately, the high risk and personal sacrifice of a career in science does not improve after those training years. It is not just that the salaries are lower in research than nonresearch fields. Due to the escalation in cost of individual grants, the NIH has seen slower growth in its portfolio of research awards in the past 5 to 6 years. Moreover, the number of principle investigators supported by the NIH has declined over the past 3 years. The research grant portfolio represents "our nation's response to opportunity"--and the principle investigators, the intellectual brain trust needed to develop this field. Perhaps of equal concern is the knowledge that our research community is aging. Of persons submitting competing research project grant (RPG). applications, those between ages 46-50 are steadily increasing while those age 35 and below are steadily decreasing. This information is both startling and worrisome. Science in particular needs its young, not just to renew itself but to do its job intellectually. There is enormous wisdom in the words of Sir Francis Bacon in his essay "Of Youth and Age": "Young men are fitter to invent than to judge; fitter for These words are even more powerful today--Science moves ahead because of bold questions, challenges to established dogma, and irreverence to naysayers. Science will calcify and crumble if we lose our youth. Declining Scientific Prestige Abroad Another warning sign for science and its ability to contribute to this nation's economy is the erosion of our world leadership in science and engineering. The percentage of GNP invested in civilian research and development by the United States is lagging relative to other industrialized agricultural enterprises also develop "biotechnological" products. PRODUCTS IN DEVELOPMENT - There were one-third more products in various stages of development in 1990 than in 1989. APPROVED PRODUCTS -- In 1990 alone, 11 biotechnology products were approved by the FDA for therapeutic application, the same number as approved during the preceding 5 years. As of July 1991, 17 new products awaited FDA approval. PATENTS -- While our nation's share of patents has declined overall, the - The President's FY 1993 budget recognized the importance of biotechnology research by creating a Presidential initiative on this important topic. The President therefore, requested an additional $270 million for biotechnology research across the Federal government. International Competitiveness Despite these compelling figures, the international arena may prove to be the most challenging area for further consideration, both for biomedical research and for the U.S. place in the competitive world market. It is clear that other countries, notably Japan, have identified the development of their biotechnology industry as of highest priority. They, therefore, devote substantial resources (private and public) toward developing the innovative biotechnologies, critical to economic prosperity. This is indicated by the increase in the number of U.S. patents owned by Japan and selected European nations, which rose from 22 percent in 1972 to 37 percent in 1988, with Japan increasing its share from 7 percent to 21 percent. In molecular biology, medical technologies and other critical fields, Japan has demonstrated its skill in translating research discoveries into viable commercial products. is also notable that approximately 55 percent of the drugs and biologics approved by the FDA from 1987 through 1990, were originally developed in foreign laboratories. It To maintain our world leadership in biotechnology, the United States must see the support of progress in biomedical research as one of its highest priorities. The President's FY 1993 budget on biotechnology reflects such a priority. This country became an international economic power in part because our manufacturing industries were able to refine raw materials of the earth into innovative products. The biotechnology industry transforms the raw materials of life using mainly the resources of the mind. The industry is inseparably linked to the scientific creativity of individual human talent. The future of biotechnology and our nation's economic strength in no small way depends on our ability to tap the imagination of our scientists and sustain the vigor of the scientific enterprise. The Changing Face of NIH Our As I have illustrated, this era in biomedical research is one of unprecedented opportunity, a powerful new age of discovery about living organisms and the application of these discoveries to human health. challenge is to advance the technologies critical to the future, to be attentive to infrastructure and technical needs at the pace that accompanies them, and to continue nurturing and encouraging individual creativity. We are now a $9 billion public enterprise with 20 institutes, divisions, and centers. NIH has close to 15,000 Federal employees and 194 chartered advisory committees with more than 3,400 consultants. We, also partially or totally, support an estimated 100,000 people through grants and other funding mechanisms. We have five Federal facilities outside the Bethesda campus, and grants and contracts are provided to more than 1,800 institutions, including 500 small businesses. NIH grants average approximately $250,000, with some far exceeding $1 million per year. These grants cover a broader spectrum of science, and as a result, approximately 140 study sections encompassing more than 80 disciplines of science, have been established to guide their review. What this means to me is that, more than ever, we must critically examine how we are managing ourselves and our resources. This is a time when excellence in management of our resources is as crucial to the success of NIH as is scientific excellence. It is a time when public confidence and public trust have never been more important. The Need for Planning This myriad of challenges and opportunities that the national biomedical research enterprise faces, has not just been noted, but is being carefully contemplated. No nation can be prepared to meet such challenges and opportunities, and provide domestic national security without a healthy population and a plan for its future research endeavors. Since my appointment as Director of the National Institutes of Health, the academic research community has joined with the NIH leadership to embark upon a process to develop a "Strategic Plan" that will enable us to confront future challenges to the biomedical research enterprise. The intent is to join forward, corporate-style thinking with historical strengths: accomplishments, organization, mechanisms, and approaches of proven value. The purpose of planning is to achieve predictability and stability, which will allow us to capitalize on the opportunities in the burgeoning areas of biology and medicine. To advance this sophisticated and complex enterprise, it is imperative that we plan beyond the next budget year. It is important to acknowledge that planning and priority setting are not new to the NIH. Furthermore, our success today is the result of the sound strategic planning from earlier times. Key strategic decisions made in the post World War II era did much to forge the research enterprise and are largely responsible for the best of what NIH is today. We built over these years on this foundation, ensuring a stable, Federally-supported biomedical research system. That stage has now been completed. The advent of advanced technologies, such as the use of recombinant DNA and other molecular analyses, have ushered in a new era that has begun to blur the traditionally understood distinctions between disciplines. For example, basic research on cellular growth has shown us that there is an interrelatedness between the processes of uncontrolled proliferation--cancer and terminal differentiation leading to senescence--aging. As we have begun to understand these fundamental aspects of biology, we have recognized that our old approach has been a vertical growth of disease-focused disciplines. In response to what has occurred in the life sciences, and in response to what has occurred in the broader environment around us, we must now examine a horizontal, transcendent plan that will integrate these previously compartmentalized orientations. The NIH Mission In brief, our draft mission statement reflects the heart and soul of our institution and underscores our concern for the public health to pursue new knowledge to extend healthy life, and reduce the burdens of illness and disability. We are more than a science agency, more than a public health agency. We share with the American public an abiding commitment to the importance of human health and the enhancement of the quality of life for everyone. To advance our mission, we identified six draft trans-NIH objectives. As we look ahead, success in pursuit of each of these objectives is essential to being true to our mission: 1. Critical Science and Technology--To assure that critical science and technology in basic biology impacting on human health and the national economy are advanced as priorities across the NIH. Investments in critical science and technologies in basic biology will set the stage for improving health, reduce health care costs, and bolster the nation's economic well-being. The operational components of the framework that relate to and advance this objective are: molecular medicine, biotechnology, vaccine development, and structural biology. These areas transcend the categorical institute missions and contribute substantially to the understanding of most diseases and the enhancement of the nation's economic growth, productivity and competitiveness. |