National Institutes of Health - FY 2003 Testimony

The American Society for Microbiology (ASM) fully supports the Administration's FY 2003 budget request of $27.3 billion, a 15.7 percent increase, for the National Institutes of Health (NIH).The proposed FY 2003 budget for the NIH includes new funding to expand the nation's biodefense research agenda and at the same time strengthens resources for research facilities, scientific personnel, and investigator initiated research on a vast array of diseases that continue to threaten public health.The Administration's budget request fulfills the bipartisan commitment to double the NIH budget by FY 2003, a goal supported by the ASM to take advantage of new scientific opportunities.The ASM is grateful for the bipartisan support that Congress has shown the NIH, and for the generous funding increases provided for biomedical research.

The September 11 tragedy has transformed the nation.We have seen the human toll of lives, illness and fear as the result of the deliberate use of anthrax.The capability to develop effective measures to counter the effects of a potential bioterrorism attack has never been more urgent.At the same time, we must increase research efforts to combat old and new diseases that threaten to undermine health and well-being in this country and globally.

Fortunately, investments in basic and clinical research have produced medical advances in the past year which will help the nation respond to both deliberate and naturally occurring infectious diseases, including: the elucidation of the mechanisms by which anthrax toxin destroys cells, hastening the development of new drugs to treat anthrax; clinical research that suggests it is possible to "stretch" available does of licensed smallpox vaccine by dilution; a new anthrax vaccine, based on a bioengineered component of the anthrax bacterium called recombinant protective antigen (rPA)which will soon enter human trials; a number of improved HIV/AIDS treatments; the first vaccine against a blood infection common among hemodialysis patients; a hybrid vaccine that protects mice from West Nile infection;a new DNA-based vaccine that prevents the Ebola virus infection in monkeys and is now ready for human clinical trials; and the complete genome sequencing of several pathogenic bacteria.The progress and success of microbial genomics has been a critical achievement for biomedical research, with the complete genomic sequence of five disease causing bacteria, including E.coli 0157:H7, Salmonella typhimurium, Ureaplasma urealyticum, Streptococcus pneumoniae and Streptococcus pyogenes.

Bioterrorism-related Research: Scientific Opportunities to Protect the Nation

The ASM strongly supports the Administration's budget request of $3.99 billion, an increase of $1.5 billion for the National Institute of Allergy and Infectious Diseases (NIAID), which spearheads the bioterrorism research efforts of the NIH.The NIAID supports unprecedented research opportunities in the scientific disciplines of microbiology, immunology and infectious diseases, key fields which promise better understanding of the mechanisms of infectious diseases, antimicrobial resistance, and the human immune system.

As the lead agency at NIH for infectious diseases and immunology, NIAID has developed a Strategic Plan for Counter-Bioterrorism Research and a detailed NIAID Counter Bioterrorism Research Agenda, with short-, intermediate-, and long-term goals for both basic and applied research.Research into the basic biology and disease-causing mechanisms of pathogens underpins all efforts to develop interventions to counter bioterrorism agents.The investment in research on counter bioterrorism and the genetics of microbes should have positive spin offs for other diseases and should lead to better understanding of naturally occurring infectious diseases, such as West Nile virus, dengue, influenza and multi-drug resistant infections.

The $1.75 billion proposed in total for NIH bioterrorism related research in fiscal year 2003 ($441 million for basic research and development; $592 million for drug and vaccine discovery and development; $194 million for clinical research; and $521 million for research facilities)is needed to accelerate discovery and development of knowledge and products that will rapidly increase countermeasures to control bioterrorism agents and to enhance the capability to do research on threat agents.Antimicrobial and vaccine strategies depend on breakthroughs in basic research, genomics and computer sciences.The genome sequencing of the smallpox and cholera pathogens recently was completed, that of the anthrax bacterium is nearly completed, and sequencing will be done on a host of other potential bioterrorism agents.The NIAID's ambitious research agenda includes development of new vaccines, therapeutics, and diagnostic tests for potential agents, as well as unraveling the basic biology of microbes and of human host responses to infection. Studies will be expanded on microbial genomes to sequence the genomes of the various species and strains of microbes most likely to be used by terrorists and by performing comparative analysis of these genomes and their protein products to develop new leads for the development of new and improved diagnostic devices, drugs, vaccines and forensic tools.Comparative microbial genomics and proteomics will yield new insights into the genetic basics for why different species of microbes and different strains of the same species differ from one another and their virulence and susceptibility to antibiotics. Such research will help assess preventative and therapeutic strategies using existing products.

The NIH is mounting a multi-layered assault on a long list of threatening microbes that will include expanded research resources for:extramural research project grants; expansion of the research infrastructure, in particular additional high-level biosafety laboratories; creation of ten Centers of Excellence for Bioterrorism and Emerging Infections nationwide, development of a centralized research reagent repository, expansion of research training and challenge grants to industry and academia. A major component of the research program is to enhance the research infrastructure at intramural and extramural sites to enable research efforts on pathogenic microbes and potential terrorism agents and to meet new biosecurity requirements.

Substantial and comprehensive increases in resources will be needed if this effort is to be successful in attracting and synergizing the long-term interest of academic scientists and industry in support of research to develop biomedical tools to detect, diagnose, treat, and investigate diseases caused by deadly pathogens.

New and Emerging and Drug Resistant Infectious Diseases - Threats to Public Health and Global Security

The ASM remains alarmed by the persistence of infectious diseases in this country and abroad, and by the real possibility of even greater problems in the future.Worldwide more than 13 million deaths result from infectious diseases..In the United States, infections are significant killers and cost more than $120 billion annually.The multiple threats of emerging, re-emerging and drug resistant infections mandate that we accelerate the pace of biomedical research.

Emerging and re-emerging pathogens appear at a time of increasing microbial resistance to standard therapeutics, two trends that together complicate already complex challenges for the research community. Antimicrobial resistance must be become a priority area of research efforts and new funding should be provided for the interagency Antimicrobial Resistance Action Plan released in 2001.In the United States, most Staphylococcus aureus infections acquired in hospitals are now resistant to the drug of choice.Approximately 14,000 people in this country alone are infected and die each year from a drug resistant microbe acquired in a hospital setting.Antimicrobial resistance is growing and spreading worldwide, affecting the ability to successfully treat respiratory, diarrheal, sexually transmitted, hospital-associated and other infections. Resistance to chloroquine, the main anti-malaria drug, is impairing efforts to control this disease in Africa. More research is needed to advance the field of study and develop new diagnostic, therapeutic and preventive approaches.

In his budget message to Congress, President Bush cautioned that infectious diseases "make no distinctions among people and recognize no borders."Aided by rapid travel and constant cultural exchanges, infectious diseases not only have not disappeared, they have persisted as a global problem.They exact a heavy toll not only in the United States, where infections are the third leading cause of death, but worldwide, with infectious diseases the leading cause of death for those under age 45 and particularly children.These sad statistics, and the entry into the United States of new pathogens such as the West Nile Virus two years ago, compel this nation to approach infectious disease as a global issue.