National Institutes of Health - FY 2002 Testimony

The American Society for Microbiology (ASM) appreciates the continued bipartisan support of Congress for the National Institutes of Health (NIH). Through generous appropriations over the past years, Congress has brought biomedical research to the forefront of the national agenda and recognized the NIH's pivotal position in serving the American public through the support of biomedical research. Increased support for NIH not only helps to ensure the continued leadership of the United States in biomedical research, but it will also allow the United States to address the global health issues in infectious diseases that currently threaten national security.

The ASM commends President Bush's proposal for a record $2.8 billion increase for the NIH in FY 2002. This proposed increase is a major step toward meeting the bipartisan goal set by Congress of doubling the NIH budget by FY 2003, enabling the Institutes to take greater advantage of the many recent significant discoveries affecting human health.

Within the past few years we have seen exponential advances in knowledge in the biomedical sciences. The landmark advances of decoding the human genome and sequencing over 30 bacterial genomes, discovering new treatments for AIDS, and developing vaccines that can prevent meningitis and ear infections in children are only a few of the many accomplishments that have set the stage for an even more explosive growth in the benefits derived from NIH research.

The opportunities for substantial return on investment in biomedical research have never been greater, and it is essential that the NIH be supported at a level to take full advantage of promising existing and new areas of basic and clinical research. According to a report of the Joint Economic Committee, public investment in NIH yields returns to the economy of 25% to 40% per year. The development of the Hemophilus influenzae vaccine to prevent meningitis in children, for example, has saved an estimated $400 million yearly in treatment and long-term care costs.

At the same time, we are being challenged by emerging and existing infectious diseases, increasing resistance to antibiotics, and accumulating evidence pointing to an infectious cause for many chronic diseases, such as arthritis, heart disease, and some forms of cancer.

In addition, each year the cost of illness in the United States totals an estimated $3 trillion in health care and lost productivity, representing 31% of the gross domestic product. The entire NIH budget equals less than 1% of this annual health-related burden on the national economy.

The ASM, therefore, joins with the Ad Hoc Group for Medical Research in endorsing an FY 2002 budget increase of $3.4 billion (16.5%) for NIH to ensure we reach the goal of doubling the NIH budget by FY 2003. Such an increase will also enable the NIH to increase the total number of research project grants it supports, thereby pursuing a greater number of scientific opportunities, and to expand training programs, ensuring an adequate scientific workforce that can translate research discoveries into significant patient care advances.

Public Health Needs and Infectious Diseases

Past investments in medical research clearly have benefited both the United States and the world in terms of improved health care and increased understanding of disease. However, the ASM is concerned about the continuing onslaught of infectious diseases, a threat directly confronted by NIH-sponsored research. In the United States, infectious diseases remain a leading cause of death, with five of the top ten killers related to infection (pneumonia, AIDS, chronic liver disease, chronic obstructive lung disease and cancer). The estimated annual cost of infectious disease in this country exceeds $120 billion. Worldwide, infections account for more than 13 million deaths each year, potentially undermining both the political and the economic security of nations. Seven of the 20 leading causes of global death and disability are infectious diseases.

We can expect previously unknown infectious diseases - as well as old diseases with renewed virulence - to continue to imperil public health. Microbial diseases that appeared just in the last 25 years include legionnaires' disease, HIV/AIDS, Lyme disease, human cases linked to mad cow disease, airborne Ebola virus infection, and toxic shock syndrome. Medical researchers have identified nearly 40 new disease agents since 1973, some capable of massive destruction. In 1998, HIV/AIDS was the fourth leading cause of death worldwide, responsible for an estimated 2.3 million deaths that year. In the United States, pathogens such as hantavirus from rodents, the West Nile virus, and last year's new hemorrhagic fever virus (the Whitewater Arroyo virus) appeared during the past decade without warning, claiming human lives and placing new demands on our health care system. A recently described hepatitis virus, type C, infects almost 4 million Americans. Although numbers of new infections have decreased due to better public health efforts, about 9,000 die from HCV each year and many more may develop chronic liver disease. HCV is the leading cause of liver cancer and one of the major reasons for liver transplants.

In recent years there has been a resurgence of several long-time enemies of public health, historic diseases revitalized by acquired antibiotic resistance and expedited by global travel and commerce. Increasingly resistant to traditional therapeutics, malaria continues to ravage the world's populations, killing an estimated 1.1 million each year and infecting 275 million new victims. In response to such alarming statistics, the NIH is leading a multilateral initiative against malaria, hoping to maximize research against the disease in Africa. Another long-time threat, tuberculosis kills about 2 million people each year and persists as the eighth leading cause of death worldwide, with fully one-third of the global population infected with the tubercle bacterium. Once treated effectively with drug regimens, bacteria causing tuberculosis are developing multiple drug resistance. Not just a problem in developing countries, this more-virulent form of tuberculosis has now spread to several larger American cities, a disturbing trend in a health care system where antibiotics have become the second most commonly prescribed category of drugs.

Other pathogens, such as salmonella, Staphylococcus aureus, enterococci, and the gonorrhea bacterium, are similarly acquiring drug resistance, becoming more serious problems in our nation's hospitals. More than 90 percent of S. aureus found in U.S. hospitals are now resistant to penicillin and beta-lactam antibiotics, for example. In intensive care units, nearly one-third of hospital-acquired nosocomial infections are resistant to the preferred antibiotic treatment. Nosocomial infections caused by just six of the most common kinds of resistant bacteria cost the United States at least $1.3 billion annually. In response, the NIH, CDC and FDA just released the Antimicrobial Resistance Action Plan, a comprehensive, multidisciplinary collaboration with private and public groups to include surveillance, prevention and control, research, and product development. NIH will lead the research component, towards new information and technologies and support of clinical studies.

Among newly recognized infectious agents are those now believed linked to chronic disorders heretofore attributed solely to environmental or lifestyle factors, thus further complicating our efforts to improve the public's health. This new concept of infectious diseases will force a reassessment of chronic disease - one example of how NIH's focus will change in a new era of medical research. Medical experts estimate that infectious agents cause 16 to 20 percent of all cancers, and may be the underlying causes of common chronic diseases such as diabetes, multiple sclerosis, chronic lung conditions, and coronary artery disease. Specific infectious agents already have been indicted in certain conditions: for instance, Helicobacter pylori in peptic ulcers and Borrelia burgdorferi in some forms of arthritis and brain disorders. With advances in genomics, it now is possible to identify non-human genetic material in human diseased tissues, making this new field of medical research feasible. Investment of research dollars promises high returns, as suggested by estimates that more than 50 percent of stomach and cervical cancers could be avoided by preventing their suspected infectious disease etiologies.

Not only must the NIH focus on infectious diseases in this country, it also must address the cumulative burden of disease worldwide. Infectious disease agents easily cross national boundaries, creating a global health interdependence that impacts the health, economics and foreign policy of the United States. Infectious disease has become a national security issue, as we become tightly connected to the rest of the world physically, commercially and culturally. High incidence of mortality and disability can intensify social and political instability in countries where the U.S. has significant economic and political investments. Infectious diseases also raise the possibility of bioterrorism through deliberate spread of dangerous microorganisms. The NIH, through its research on diseases that primarily affect other countries - such as malaria and cholera - accepts a responsibility towards fighting global infectious disease. The ASM urges Congress to recognize the NIH's role in national security when determining the FY 2002 budget.

The Need for Basic Microbiology Research and NIH Funding

Scientific knowledge of microbes and their link with larger life has expanded exponentially in the last half of the 20th century. Scientists studying microbes discovered that DNA was the genetic material of life. Many believe that the future of humankind depends on our ability to understand microbes and how they work and to take advantage of their abilities to solve some of humanity's most difficult problems, including the prevention and treatment of infectious diseases.

The path of scientific investigation will shift in the coming decades, with new funding needed for a broader scientific base that will require much more multidisciplinary research. Genomics is just one aspect of the increasingly complex research enterprise needed to combat the diseases that afflict humankind. Conquering disease requires additional emphasis on environment and infectious disease. In particular the physiologies of organisms, that is the actual functioning of organisms from microbes to humans, requires multidisciplinary inputs. Institutes like the National Institute of Environmental Health Sciences need to do more in areas such as the environmental reservoirs and transport of pathogens so that we can understand the epidemiology of many environmentally borne infectious diseases and act judiciously to prevent them. Studies on the interactions of genetics, environment, and infectious diseases is critical for preventing and treating many human diseases.

Immediate attention is needed to reverse the decline in the field of microbial physiology or we risk losing ground in medical and environmental research and discovery. The once flourishing field of basic (prokaryotic) microbiology is no longer receiving sufficient attention. The decline in funding devoted by the NIH to bacterial physiology is compounded by the limited budgetary growth of other agencies, such as the National Science Foundation, to support the basic cellular biological studies of prokaryotes. Given that an understanding of bacterial physiology is a critical underpinning to overall cellular studies that are key to the advancement of the broader life and biomedical sciences, the NIH would be well served by coordinating with other agencies to ensure the adequacy of funding for bacterial physiology. This would be an important step for overcoming the shortage of qualified scientists with training in bacterial physiology to fill the employment opportunities available in biotechnology and biomedical research laboratories The ASM recommends that NIH recommit itself to rebuilding support for this critical area and to take steps such as training grants and requests for proposals to increase the number of laboratories, institutions, and scientists working in this area.

The ASM emphasizes the importance of providing increased support for the basic, untargeted research in the biomedical sciences supported by the National Institute of General Medical Sciences (NIGMS), which provides the fundamental underpinning for all the disease-oriented research done by other NIH Institutes. If we are to sustain the momentum of NIH research in the future-and to build upon the notable advances made in recent years - it is important to recognize that basic and clinical research both are indivisible segments of successful medical science. Basic science is at the heart of what the NIH and research institutions do best. Basic research is the engine that drives scientific creativity and productivity making sustained funding for new research projects a particularly critical issue when deciding the FY 2002 budget. There must be a high-quality continuum of not only new projects, but new scientist training programs, to keep American medical science of the future as vigorous as it is today. We also need more physician-investigators trained to translate discoveries into patient care and lives saved.

Requirements for Today's Research

Technological innovation may become the most visible hallmark of research in the 21st century, but it is just one aspect of an increasingly complex and expensive system needed to combat infectious diseases and other threats to national and global health. It is essential that financial support of the NIH includes sufficient funds for all facets of the research process, whether state-of-the-art DNA sequencing equipment or increased stipends for scientists-in-training.

New pathways to medical discoveries rely upon a complicated, interlocking framework of scientific infrastructure, which needs to be updated with an infusion of federal funding. Skilled personnel and premier research facilities are the foundation of U.S. research and make medical advances happen. The more the research landscape changes, the more researchers must have expertise outside the traditional boundaries of their disciplines, and research facilities must make this cross-pollination possible. The fields of bioinformatics, imaging, and computer science will repeatedly meld with biology and chemistry. These scientific cross-currents will require new and creative training programs to produce interdisciplinary scientists, as well as greater financial incentives to retain the best of these at federal research centers.

Research Stewardship Funding

The management and support budget of the NIH is decreasing as a percentage of the agency's entire budget, a trend that negatively affects the best administration of federal research dollars. This deficiency undermines the strength of the NIH and its promise to the American public to improve health and well-being.

Economic Benefits

Medical advances in the past have directly minimized the cost of specific diseases. The United States spent a total of $32 million over 10 years to support the global smallpox campaign. Economists estimate that, every 2½ months since the world was declared smallpox-free in 1977, the entire $32 million has been recouped in health cost savings. The ongoing anti-polio campaign promises similar results: The U.S. will save more than $230 million annually in vaccine costs, while globally, the annual savings is expected to exceed $1.5 billion. At the NIH's National Institute of Allergy and Infectious Diseases, research costing $31.8 million produced the hepatitis B vaccine, saving our health care system an estimated $73.7 million to $146.6 million each year. But the price of illness in this country will grow if we are not prepared to confront all new and costly diseases, such as antibiotic-resistant infections and the inevitable yet-unknown pathogens. The NIH, and specifically, the National Institute of Allergy and Infectious Diseases (NIAID), is at the center of a national mission to stop these diseases, a mission that must be adequately funded in the FY 2002 budget.

The American Society for Microbiology, the largest single life science society with over 42,000 scientists, appreciates the opportunity to provide these recommendations to the Senate Subcommittee on Labor, Health and Human Services and Education Appropriations and stands ready to assist the Subcommittee in any way possible.

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