National Institutes of Health - FY 1999 Testimony

Before the Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies
U.S. House of Representatives
Presented by: Gail H. Cassell, Vice President Infectious Diseases Drug Discovery Research and Clinical Investigation Lilly Research Laboratories,
Chair, Public and Scientific Affairs Board

January 29, 1998

My testimony today on the Fiscal Year 1999 appropriation for the National Institutes of Health (NIH) is presented on behalf of the American Society for Microbiology, the largest single life science society in the world with a membership of over 43,000. The ASM appreciates the opportunity to provide the following comments and recommendations on funding for the NIH.

First, I would like to thank the Chairman and members of this Subcommittee for their strong support for the NIH. As a direct result of this commitment to biomedical research, new technical advances are occurring in the biological sciences and the opportunities for translation of recent discoveries in molecular biology to the diagnosis and treatment of human diseases have never been greater. For example, new technologies have led to methods for sequencing the genomes of disease-causing microbes, revealing information that can be used to find targets for therapies, identifying antigens to incorporate into vaccines, detecting mutations that cause drug resistance and determining the factors that influence the antigenicity or virulence of a microbe. Emerging technological innovations, such as DNA chip technology and microarrays, promise further advances in science and medicine. Beyond the incredible power of biomedical research to improve human health, is its growing contribution to the nation's economic prosperity. Biomedical research is responsible for the creation of approximately 1300 biotechnology companies in the United States, employing over 118,000 people throughout the nation. The growth of the biotechnology and pharmaceutical industries is a direct result of federal investment in biomedical research that began with funding by the NIH 20 years ago. Biotechnology, structural biology, rationale drug design, gene therapy, vaccine development and fundamental biology are intimately linked with practical benefits that can be expected to spawn new industries, create jobs and stimulate the economy to grow in the future.

The ASM, however, concurs with many Congressional leaders that the United States is not spending enough on scientific research to take advantage of its full potential and recommends that Congress double the federal investment in research. In this regard, the ASM supports the recommendations of the Ad Hoc Group for Medical Research which calls for a 15 percent increase in funding for the NIH in FY 1999 as the first step toward the goal of doubling the NIH budget over the next five years. The Ad Hoc Group represents a large coalition of organizations and the ASM works with the Group each year to determine an appropriate, scientifically based level of funding for NIH that is consistent with health needs and research capabilities. It is essential that the United States develop a strategy to achieve a higher level of national investment in research to capitalize fully on scientific achievements and opportunities to respond to a growing array of public health concerns and to maintain its competitive edge and scientific leadership into the 21st century. The future health, quality of life, economy and security of Americans depend on a high level of national investment in research.

Currently, only a small fraction, 3 percent, of all the money spent on health care in this country is devoted to biomedical research, which means that only a fraction of high quality research proposals can be supported by the NIH and other research agencies. Increased investment in research would help close the gap that exists between available funding and research opportunities. Increased investment in research will help lead to faster development of more effective screening programs, new vaccines, and better drugs and treatments to combat heart disease, cancer, emerging and drug resistant infections and many other unconquered diseases. Increased investment in research reduces human suffering and has proven to be cost effective. For example, the vaccine for Haemophilus influenzae type b (Hib) introduced just a few years ago has virtually eliminated one form of childhood meningitis, the leading cause of acquired mental retardation and a major cause of deafness in children, and resulted in savings estimated at more than $400 million a year. Prior to the development of the vaccine, Hib infected one of every 250 infants; 5 percent of patients died and 30 percent suffered permanent central nervous system injury.

The ASM can best illustrate the need for and the benefits of increased investment in research in the area where it has the greatest expertise, infectious diseases. The ASM, whose members include leading scientists performing infectious disease research, is extremely concerned about the threat of new and reemerging infectious diseases. Few public health concerns today carry as great a sense of urgency and importance as infectious diseases. Each day headlines in the national news describe new diseases that are rapidly arising worldwide and "old" diseases that are reemerging as infectious agents evolve or spread and as changes occur in ecology, socioeconomic conditions and population patterns. Humans through rapid world travel and unprecedented trade have become a major vector of infectious diseases, transporting disease from one country to another, often in less than 24 hours. Infectious diseases can be spread from human and animal sources but also from "bioterrorism," the intentional release of pathogens to harm human health or the animal and plants on which humans depend. The threats posed by infectious diseases to the security and well being of the world community are now apparent, and the United States is no exception. In 1996, infectious diseases in the United States ranked as the third leading cause of death. The death rate from infectious diseases in the United States has increased almost 60 percent since 1980. Deaths due to respiratory tract infections, HIV and bloodstream infections, account for most of these increases. Serious infections are becoming increasingly resistant to antibiotics and treatment of patients is often difficult and sometimes impossible. Antibiotics that we took for granted are now failing to control common diseases such as bacterial pneumonia. Recent reports indicate that in some parts of the country as many as 40 percent of the strains of pneumococci are resistant to penicillin and other antibiotics. In addition, 90 percent of the strains of Staphylococcus aureus, one of the most common disease producing organisms in humans, are resistant to penicillin and other related antibiotics. The incidence of vancomycin resistant strains of Enterococcus, one of the most common causes of infections in hospital patients, has increased 20 fold since 1989. Foodborne disease is responsible for over 30 million illnesses in the United States each year and 9,000 deaths. Foodborne diseases account for $5 to $6 billion in medical costs and lost production each year. New foodborne pathogens have emerged over the past decade and established pathogens have developed increased virulence and antimicrobial resistance. Additional research is needed urgently to better understand the pathogenesis of these organisms, as well as to prevent foodborne diseases and to guide changes in food safety practices. Basic research is also urgently needed on AIDS, tuberculosis, malaria and sexually transmitted diseases. Since AIDS was first recognized in the early 1980s, worldwide there have been over 29 million adult and child HIV infections, and approximately 1.5 million adult and child deaths in 1996, including 39,000 people in the United States. There are over 8 million new cases of active TB each year in the world and an annual death rate of approximately 2-3 million. Recent data indicate that over 10 percent of people with tuberculosis are infected with stains of Mycobacterium tuberculosis resistant to at least one of the four first-line anti-TB drugs. Malaria continues to be a global public health problem and is occurring in the United States. The incidence of sexually transmitted diseases and the resulting complications ranging from infertility to infant morbidity and mortality is rising. The recent outbreak of "bird flu" in Hong Kong has focussed new attention on the threat of influenza which presents the most imminent viral threat to public health. Influenza reemerges worldwide each year in a new form and causes between 10,000 and 40,000 deaths yearly in the United States alone. An emerging pathogen of great concern is the hepatitis C virus (HCV), a leading cause of cirrhosis, liver cancer, and a major reason for liver transplants. Four million individuals are chronically infected with HCV in the United States and HCV-deaths number approximately 8,000 to 10,000 in the country and are projected to increase. Worldwide infectious diseases remain the leading cause of death, with over 17 million of the 52 million deaths in the world due to infectious diseases. Approximately 9 million of these deaths are among children.

In addition to the human toll, the financial burdens of infectious diseases are staggering. Approximately $120 billion, or 15 percent, of all 1992 health care expenditures in the United States were related to the direct or indirect costs of infectious diseases. Infectious diseases also account for 25 percent of all visits to physicians in the United States. Two of the largest US infectious disease health care expenses are for the treatment of TB and AIDS. Influenza is estimated to cost the United States $17 billion annually in direct medical costs and lost productivity. Research on infectious diseases is particularly cost effective. For example, since smallpox was eradicated in 1977, the total investment of $32 million has been returned to the United States every 26 days. Every dollar spent on the vaccine against measles, mumps and rubella saves $21 and every dollar spent on the vaccine against diphtheria, tetanus and pertussis saves $29.

It is apparent that the nation remains vulnerable to infectious diseases, old and new, and that they pose challenges of immense complexity. The emergence of new or altered pathogens is unpredictable, occurring as the result of microbial evolution, changes in host-parasite interactions, human demographics and behavior and other mechanisms. Basic research and discovery are urgently needed and a strong scientific infrastructure must be maintained in core disciplines such as microbiology, infectious disease and immunology. Increased funding for infectious disease research would allow the pursuit of new research opportunities, such as sequencing the genomes of medically important bacteria, determining the host factors and mechanisms involved in infections with the hepatitis B and C viruses, research on antimicrobial resistance and defining the potential role of infectious agents in chronic diseases, such as cancer. For example, over 550,000 new cases of stomach cancer per year are attributed to the bacterium Helicobacter pylori which causes ulcers and gastritis. Confirming the infectious origins of diseases such as arthritis, infertility, coronary artery disease, asthma, hypertensive renal disease, Guillian Barré syndrome and juvenile-onset diabetes could greatly reduce health care costs by treatment with antibiotics and other drugs and perhaps by prevention through immunization.

Because of recent advances in basic research, the opportunities have never been greater for new diagnostics and new therapies in the field of infectious diseases. The NIH is the lead agency to strengthen research efforts in the biology and pathology of infectious agents and to develop new tools to prevent, detect and control emerging diseases. The ASM recommends increased funding for the National Institute of Allergy and Infectious Diseases (NIAID), whose research mission in infectious diseases is of critical importance.

It is essential to emphasize that NIH and the research institutions that it sponsors will be in a position to take advantage of presenting research opportunities only if a strong research environment and infrastructure are maintained. Therefore, increased investment in research must consider the following objectives as essential to the health of the research enterprise: 1) increase peer reviewed, investigator initiated basic research; 2) increase support for current researchers and provide more opportunities for new investigators; 3) support areas of good science that have been under funded; 4) expand clinical research and clinical research opportunities; 5) strengthen research training in order to attract the best and the brightest students to biomedical research. Increase pre and postdoctoral stipends and provide adequate funding for NIH supported National Research Service Awards. Racial and ethnic minorities have long been under represented among biomedical researchers and NIH supported training programs designed to increase and expand opportunities for under represented minorities to pursue careers in biomedical research should be supported with additional funding; and 6) ensure institutional research capability by updating facilities, addressing the needs of animal facilities and supporting essential resources for biomedical research, including state-of-the art research equipment, supplies and instrumentation.

The ASM realizes the difficulty of achieving the goal of doubling the NIH budget over the next five years under the current spending limits. We encourage Congress to explore all possible options to identify the additional resources needed to support to the extent possible this level of sustained growth in funding for biomedical research. The ASM would be pleased to work with Congress to achieve this goal. The ASM recognizes the critical importance of other public health activities as well as the interdependency of research across the various disciplines of science. The ASM is particularly concerned that increased funding be provided for infectious disease activities supported by the Centers for Disease Control and Prevention (CDC), which has primary responsibility for surveillance and detection of emerging disease threats. The ASM also joins with over 100 other scientific societies in a common goal, enunciated in the "Unified Statement on Research" endorsed by the ASM, to increase the national investment in research and to ensure that research is a budgetary priority for Congress.

The ASM stresses that increased investment in research must be long-term, stable and allocated on the basis of merit. To ensure the optimal use of a multi-year 15 percent increase in the NIH budget, the scientific community and the NIH should partner in a collaborative process to plan and develop an approach to allocating significant new resources based on the identification of scientific opportunities and public health needs. The ASM is concerned that adequate funding be provided for NIH Research Management and Support (RMS). RMS funds scientific workshops and conferences, peer review of grants, oversight of research and clinical trials, outreach programs, communications activities about biomedical research, and adequate stewardship, mentoring, planning and accountability for NIH research expenditures. NIH represents a $13 billion investment by Americans based upon an expectation of substantial returns to themselves and their loved ones. This investment must be managed wisely by the NIH to ensure continued public confidence and adequate stewardship of research.

As we approach the crossroads of the new century, it is essential that the nation invest wisely in research to maintain US scientific and technological leadership and address the health, environmental and technological problems of the next century. We urge Congress to increase the nation's investment in biomedical research. Thank you for the opportunity to testify.