The American Society for Microbiology (ASM) represents over 42,000 life scientists who work in research, clinical, public health and industrial laboratories. We would like to thank Chairman Specter for his leadership and the members of this Subcommittee for their efforts to increase funding for biomedical research, especially in view of the fiscal constraints that require difficult decisions about budget allocations to federal programs.
Through the NIH, the federal government's premier institution for funding biomedical research, Congress wisely has made a long-term investment which has returned enormous dividends in scientific achievements that have improved the health of the nation's citizens as well as people worldwide. Advances in biomedical research have led to the dawn of an era of breakthroughs in medicine unprecedented in history. Federal investment in basic molecular biology research supported by the NIH has yielded revolutionary advances in medical diagnosis and treatment and launched the new biotechnology industry. The U.S. biotechnology industry has created more than 108,000 high wage jobs in less than 20 years, and biotechnology is responsible for hundreds of medical diagnostic tests that detect medical conditions at an early stage.
At the same time, despite enormous medical progress, we urgently need more research to discover new cures, preventions and treatments for a myriad of diseases that still plague humankind, such as acquired immunodeficiency syndrome (AIDS), alzheimer's disease, arthritis, cancer, depression, diabetes, heart disease, stroke, to name just a few, and a growing number of infectious diseases which we will highlight in our testimony. These diseases affect over 100 million Americans each year and cost society more than $500 billion annually in direct and indirect costs. Given the magnitude of the burden of disease and disability to society, the untold human suffering to patients and their families from disease, and the many research opportunities that are ready to be exploited, we urge Congress to continue to make basic and clinical biomedical research supported by the NIH the highest priority in order to capitalize on past research achievements and to pursue vigorously new research opportunities that are desperately needed to address current and future health needs.
To ensure that the fiscal year 1998 funding level for the NIH is sufficient to sustain ongoing research progress and to take advantage of new biomedical research opportunities, the ASM recommends that Congress attempt to increase funding for the NIH by 9 percent in the coming fiscal year. Although we recognize that a 9 percent increase for the NIH may be a difficult goal to achieve in the current budgetary climate, we hope that Congress will seriously consider such an increase because it is based on the professional judgment budget identified by scientific experts as the best estimate of needed funding for NIH in fiscal year 1998. The recommended increase of 9 percent, supported by the Ad Hoc Group for Medical Research Funding, a coalition of 200 organizations, is necessary for biomedical research to keep pace with inflation, to maintain a strong research infrastructure and to fund the range of research opportunities that are needed to improve all areas of health.
In the following testimony, the ASM would like to bring a number of issues to the attention of the Subcommittee: the need to fund peer reviewed investigator initiated research project grants; the urgent need to fund adequately research required to address threats from new and reemerging infectious diseases and the National Institute of Allergy and Infectious Diseases (NIAID), the federal government's lead agency for research on infectious diseases; the vital role of the National Institute of General Medical Sciences (NIGMS), which funds basic, nondisease specific research; adequate support for NIH research management and support (RMS), and research training and infrastructure needs.
Individual research project grants: Basic research into fundamental life processes, which is supported primarily through individual investigator initiated research project grants, is critical to continued technological innovation. To ensure that top quality research opportunities are not missed, the NIH should fund approximately 35 percent of meritorious research project grant applications. A 9 percent increase in funding for NIH would help achieve this goal. The peer review process is essential to develop scientific and budgetary priorities and should be sustained and strengthened to maintain scientific excellence.
Research required to address threats from new and reemerging infectious diseases and the leading role of the National Institute of Allergy and Infectious Diseases: In 1996, infectious diseases in the United States ranked as the third leading cause of death. Five of the ten top causes of death in 1996 were related directly or indirectly to infectious diseases (pneumonia, AIDS, chronic liver disease, chronic obstructive lung disease, and immunosuppression related to cancer chemotherapy). Data presented in the Journal of the American Medical Association (275: 189- 193, 1996) indicate that the death rate from infectious diseases has increased 58 percent since 1980. Trends in death due to respiratory tract infections, HIV, and bloodstream infections, account for most of these increases. It is estimated that 9,000 people in the United States die annually from foodborne illnesses, a number unheard of for a developed country. In 1994, 1995 and 1996 locally acquired cases of malaria have been reported in the United States, where the disease has been nonexistent for 50 years. The appearance of dengue fever in the United States, the marked increase of Lyme disease, the reemergence of tuberculosis and rabies are just a few examples of the rising tide of infectious diseases. In 1993, the largest (>400,000 cases of diarrhea due to Cryptosporidium) waterborne disease outbreak in the U.S. history occurred. An outbreak of acute, fatal respiratory distress syndrome in the Southwestern United States was shown to be due to hantavirus, a newly identified virus spread to humans in the feces and urine of the deer mouse. Initially thought to be limited to the Southwest, it appears that the deer mouse is one of the most common rodents in the country and fatal hantavirus cases have been reported as far away as Miami and New York. The virus is now known to be carried by other rodents as well and another strain of the virus has been identified.
Antibiotics are now the most commonly prescribed category of drugs. Yet the efficacy of these miracle drugs is threatened by an alarming increase in the antibiotic resistant bacteria. Although defining the precise public health risk of emergent antibiotic resistance is not a simple undertaking, there is little doubt the problem is global in scope and very serious. Today more than 90 percent of the strains of Staphylococcus aureus are resistant to penicillin and other related antibiotics. This common bacterium causes a range of infections such as boils, toxic shock syndrome, and serious diseases of the lung, heart, and bone. Enterococci (a kind of streptococcus) are the most common cause of hospital acquired infections. The antibiotic vancomycin often is the last weapon available to treat these potentially deadly microbes. According to the U.S. Centers for Disease Control and Prevention, the incidence of vancomycin resistant enterococci in the United States increased 20 times from 1989 to 1993. One of the miracles of modern medicine has been out ability to treat successfully bacterial pneumonia with penicillin. Before 1987, antibiotic resistant Streptococcus pneumoniae (pneumococci) were uncommon in the United States. Recent reports indicate that in some parts of the country as many as 40 percent of strains of pneumococci are resistant to penicillin and other antibiotics. These bacteria are a leading cause of deadly bloodstream infections, pneumonia, and meningitis in the elderly and are one of the most common causes of middle-ear and sinus infections in children.
Infectious diseases account for 25 percent of all visits to physicians in the United States, and approximately $120 billion, or 15 percent, of all 1992 health care expenditures in the United States were related to direct or indirect costs of infectious diseases. The annual financial cost of common infectious diseases in the United States is estimated by the National Science and Technology Council and the NIH as follows: Intestinal infections: $23 billion in medical costs and lost productivity; Foodborne diseases: $5 to 6 billion in medical costs and lost productivity; Sexually transmitted diseases: $5 billion in treatment costs (excluding AIDS); AIDS: at over $10 billion in costs annually now the leading cause of death among adults aged 25 to 44; Hepatitis B virus infection: over $720 million in combined direct and indirect costs; Influenza: $17 billion in medical costs and lost productivity; Otitis media: over $1 billion in medical costs; Antibiotic-resistant bacterial infections: $4 billion in medical costs.
Combating infectious diseases requires increased funding for research: Like the organisms themselves, the challenges of detecting and preventing infectious diseases are constantly evolving. A strong, stable research and training infrastructure is needed to investigate the mechanisms of molecular pathogenesis (cause of disease), the evolution of pathogenicity, drug resistance, and disease transmission. This fundamental knowledge is required to design new vaccines, discover new classes of antimicrobial compounds, and devise other novel means of preventing and treating infectious diseases.
The NIH's National Institute of Allergy and Infectious Diseases is the federal government's lead agency for funding scientific research on causes of infectious diseases, pathogenic mechanisms, host defense mechanisms, vaccines, and antibiotics. In collaboration with other Public Health Service agencies and industry, NIAID sponsors basic and clinical research that yields multiple public health and economic benefits. The following are just a few examples of persistent biomedical research efforts that have paid off in the past: Before the development and introduction of a vaccine, Haemophilus influenzae type b (Hib) was the leading cause of pediatric bacterial meningitis in the United States with more than 16,000 cases reported each year, of which 10 percent were fatal. Since the introduction of the Hib vaccine in 1989, Hib infection has decreased by 95 percent among children under age 5, resulting in savings estimated at more than $400 million per year; Protease inhibitors used in combination with other drugs such as AZT were shown to block the protease enzyme of HIV, thereby preventing HIV from replicating itself. In the past year, we have learned that many people with AIDS can experience dramatic improvement after treatment with these drugs; Chlamydial infection is the most common bacterial sexually transmitted disease in the United States, with about 4 million new cases each year at an annual cost exceeding $2 billion. If undetected and untreated the infection can lead to long-term complications such as infertility and tubal pregnancy. A highly sensitive and noninvasive urine assay that allows earlier detection of this infection even before it becomes symptomatic has been developed.
Increased funding for the NIAID is needed to address the current threats from new and reemerging infectious diseases through the development of better diagnostic tests, new drugs and vaccines. In addition, increased finding would provide new opportunities for making major advances to define the potential role of infectious agents in chronic diseases, such as cancer, that currently have no known causes. The link between infectious diseases and cancer is becoming increasingly clear. According to the World Health Report 1996, up to 84 percent of some cancer cases worldwide are attributed to viruses, parasites, or bacteria. The following are several examples:
Stomach cancer--Approximately 550,000 new cases of stomach cancer per year are attributed to the bacterium Helicobacter pylori, first isolated from humans in 1982 (in university research supported by NIH finding), this bacterium has been shown to cause duodenal ulcers and gastritis. Although other factors are likely to be involved, infection with this bacterium has been shown to lead eventually to the development of stomach cancer. More research is needed to develop effective therapy and vaccines to prevent H. pylori infections and to understand its role in cancer.
Cervical cancer--Human papilloma virus infection, a sexually transmitted infection of the cervix, involves a very high risk of developing cervical cancer. The infection is most prevalent in sexually active young adults. More research is needed to develop sensitive and specific diagnostic tests and to better establish the link between the virus and the development of cancer;
Liver cancer-- The World Health Organization estimates that globally there are about 527,000 new cases of liver cancer per year: 82 percent of which are attributable to infection with the hepatitis B and C viruses. More research is needed to determine the host factors and mechanisms involved.
In addition to cancer, there is growing evidence that other chronic illnesses may have infectious origins or "co-triggers". Research suggests that some forms of arthritis, infertility, coronary artery disease, asthma, hypertensive renal disease, and juvenile-onset diabetes are associated with infections. The autoimmune intestinal disorders--Crohn's disease and ulcerative colitis--are very likely to be triggered initially by a microbial factor. Consequently, the full costs of infectious diseases my be far greater than previously estimated. Confirming the infectious origins of such diseases would greatly reduce health care costs by treatment with antibiotics and other drugs and perhaps by prevention through immunization.
The role of NIAID research and new and reemerging infections: The ASM recommends that the following language be included in the Senate report to recognize the important role of NIAID research in addressing new and reemerging infectious diseases: New and reemerging infections--The Committee believes that it is essential that the national strategy to address the threat of new and reemerging diseases be broad based, incorporating research as well as surveillance activities. Biomedical research supported by the NIH/NIAID forms the foundation upon which surveillance and response are ultimately based, providing the basic research tools (diagnostics, vaccines and therapies) necessary to detect and limit the impact of new and reemerging infections. Ongoing research support also contributes to the scientific training infrastructure required to maintain the capability to identify and control new diseases, both nationally and internationally.
National Institute of General Medical Sciences: The NIGMS has sponsored and continues to sponsor leading edge basic research on recombinant DNA which contributes to direct payoffs in the biotechnology industry. The basic, nondisease targeted research supported by the NIGMS provides the underpinning for all the disease oriented research done by the other Institutes. NIGMS research is showing remarkable progress in areas such as new approaches to drug design, developmental biology in model organisms, understanding of cell-cycle mechanisms and control. Among areas being studied are the structures of key molecules, mechanisms by which genetic information is stored and transmitted and chemical reactions that sustain life. This research provides valuable new knowledge about disease processes and new technologies that underlie advances in disease diagnosis, treatment, cure and prevention. NIGMS research also contributes to commercial applications in the pharmaceutical and agricultural industries. One reflection of the importance of past work down by NIGMS is the frequent selection of Institute grantees for high scientific honors, including Nobel prizes in physiology and medicine.
The NIGMS also has a major involvement in ensuring a highly trained workforce which is essential for the future of biotechnology and for maintaining the future health of the biomedical research enterprise. NIGMS' role in predoctoral research training helps bring a cadre of well trained new investigators into the research system. Efforts must be continued to try to increase the numbers of minority PhD's by strengthening the capabilities of institutions to recruit and retain qualified students. The ASM urges Congress to provide increased funding for NIGMS research and training programs.
Research training and infrastructure needs: NIH support of grants and contracts to universities has a significant impact on the research and educational activities of academic institutions across the country and helps to create jobs at these institutions. This support of higher education and scientific literacy is necessary to ensure that Americans have skills to compete in the international arena. Federal investments in basic biomedical research have also produced the world's finest scientists. Adequate support for research training is necessary to build a foundation for the future to maintain U.S. preeminence in biomedical technology. Successive generations of talented young individuals bring new ideas and renewed energy necessary for continued scientific and technology discovery, which is key to the ability of the U.S. to compete internationally. Adequate finding should be provided for NIH supported National Research Service Award (NRSA) training programs for predoctoral and postdoctoral students at academic institutions.
Increased investment in NIH is also necessary for infrastructure development and enhancement of state-of-the-art research equipment and supplies. Equipment and instrumentation are increasingly expensive, but are necessary to support high caliber research. With the advances in genetics, the need for high quality research involving animal models of human diseases has never been greater. The costs associated with use of transgenic animals are increasing due to the need for disease surveillance and specialized facilities required for these animals. The NIH's National Center for Research Resource (NCRR) supports essential resources for biomedical research. The federal commitment to infrastructure needs should be long-term, stable and allocated on the basis of merit. The Shared Instrumentation and Small Grant Programs and the Comparative Medicine Program for Animal Research require additional funding to provide the necessary underpinning for research efforts.
NIH research management and support: The ASM is concerned about continued budget reductions for the RMS budget. Erosion of funding for RMS will impact negatively on science. RMS helps fund scientific workshops and conferences, peer review of grants, site visits for oversight of research programs, outreach programs, communication activities about biomedical research, and adequate stewardship, mentoring, planning and accountability for NIH research and expenditures. The communication of scientific and health information is essential to NIH's mission. It is crucial that NIH communicate effectively with many groups, including scientists engaged in biomedical research, health care practitioners, patients, the general public, the media and the Congress. 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 to ensure continued public confidence and adequate stewardship of pubic funds is critical to success. Innovative and quality managers and management systems are necessary to achieve responsible stewardship. Reductions below necessary levels for RMS could interfere with efforts to streamline and reinvent grants management and could impede program growth at NIH.