National Institutes of Health - FY 2005 Testimony

The American Society for Microbiology (ASM), the largest single life science society with 43,000 members, is pleased to provide testimony in support of the nation’s investment in the extraordinary work of the National Institutes of Health (NIH). Advances in NIH research have markedly intensified over the past 5 years during which the NIH budget has grown thanks to the foresight of Congress and the Administration. Robust funding increases have resulted in rapid strides in cutting edge research and new research tools to facilitate the development of vaccines, therapies and interventions that save and improve the lives of millions of people.

To ensure that progress is sustained, the ASM recommends that Congress make research and public health a high national priority and provide an increase of 10 percent for the NIH for FY 2005. Continued strong funding increases will enable NIH to accelerate and expand promising basic and clinical research that will lead to new preventions and treatments for tragic and costly illnesses and disabilities that continue to afflict and claim the lives of many people. The ASM encourages Congress to provide higher funding levels for research and public health that will address the alarming burden of disease in the United States and abroad and help prepare the nation for novel health threats and the next disease emergency that will inevitably occur in the future.

The public health and security of the nation depend on the continuation of strong investments in research and public health. The severe acute respiratory syndrome (SARS) epidemic of 2003 highlights the continuing need for investment in a strong biomedical and public health system that is prepared to respond to emerging diseases, whether naturally occurring or intentionally introduced. Previous NIH investment in emerging diseases research has allowed expeditious studies of SARS to identify targets for antiviral drugs, diagnostics and vaccines. Not only are people at risk for chronic diseases such as cancer, heart disease, stroke, diabetes and Alzheimer’s disease, but also from new and emerging infectious diseases, such as the HIV pandemic, highly virulent influenza viruses, West Nile Virus, hepatitis A and C, and the possibility of the deliberate release of disease by bioterrorists, which still remains a threat.

The accomplishments and investment in biodefense research, facilities and resources should also facilitate defenses against naturally occurring infectious diseases that pose a real and present danger to global public health. Infectious diseases account for 26 percent of total global mortality and are the third leading cause of death in the United States. Despite impressive advances in microbiology, old diseases remain entrenched and new ones can appear suddenly and spread quickly. Sufficient and sustained federal funding for research helps protect against these enemies to public health.

Investigator Initiated Research and Research Training

Most of the budget appropriated to the NIH each year flows outside the agency to an estimated 212,000 research personnel affiliated with approximately 28,000 organizations across the United States and elsewhere. This extramural research community competes for NIH grants through a merit based peer-review process; of the growing number of applications each year, estimated to exceed 35,000, less than one-third are projected to receive NIH funding. The proposed FY 2005 budget supports an increase in the number of new and competing grants from 10,135 to 10,393, an additional 258 grants. Investigator initiated research is the primary tool by which biomedical research is funded and conducted and requires increased funding to take advantage of scientific opportunities that lead to new knowledge and its applications to health care. NIH must also support the training of future researchers to maintain the vitality of the scientific community.

NIH Roadmap for Medical Research

Within the proposed FY 2005 budget, the NIH Roadmap for Medical Research plan would receive $237 million, an increase of $109 million over FY 2004. Announced in September 2003, this set of 27 initiatives actuates an agency wide commitment to maximize research investment through intensive, multi-disciplinary projects with high potential to solve serious health problems. The Roadmap realizes three 21st-century visions of a vigorous research enterprise: building new pathways to discovery through new technologies, databases, and other resources; creating multidisciplinary research teams better prepared to tackle the complexities of modern research; and re-engineering clinical research structures to expedite the rapid translation of discoveries from the lab to the clinic. This trans-NIH effort is an approach that promises to stimulate research advances and interventions for public benefit.

Biodefense Research

After the anthrax mail attacks of 2001, biodefense research has emerged as a major feature of the NIAID’s mission to understand the pathogenesis of disease-causing microorganisms and host responses to them. NIAID scientists now are pursuing numerous countermeasures as therapeutics, diagnostics, and vaccines. The agency mobilizes research capabilities and extramural partnerships to prepare against “deliberately emerging disease” outbreaks. The NIH and particularly the NIAID have become significant partners in the broad-based, multi-faceted U.S. homeland security program. The FY 2005 budget highlights the significance of NIAID biodefense efforts, with nearly $1.7 billion for research and infrastructure, 4.5 percent above FY 2004’s $1.6 billion.

The biodefense agenda at the NIAID reflects a new focus on science based security. Basic research forms the backbone of the NIAID counterterrorism efforts and includes microbial physiology and ecology, genomics, studies of pathogenesis and host defenses, and development of animal disease models. Strong funding appropriations by Congress and the Administration over the past two years have made possible significant progress, evidenced by the more than 50 major NIAID biodefense initiatives now in place. Most of these initiatives are new, with intramural, academic, and industrial partners investigating all aspects of bioagents and emerging diseases. Components include expansion of the nation’s biodefense laboratory infrastructure, enhanced communication and data-collecting networks, interdisciplinary studies on potential bioweapons, and investigations into basic mechanisms of disease and disease pathogens.

In 2003 NIAID and its collaborators achieved significant successes in both basic and applied areas related to biodefense. A candidate vaccine against the Ebola virus was found to protect lab monkeys against the deadly disease. Other researchers discovered that the anthrax bacterium toxin affects host cells in a previously unknown manner, which will redirect some aspects of anthrax therapeutics. Genome sequencing projects are on going for at least one strain of every bacterium, virus or protozoan considered a of priority pathogen. This vast genomics effort includes mapping of agents for such diseases as anthrax, brucellosis, Q fever, plague, smallpox, and tuberculosis. Researchers recently developed a rapid test for measuring antibodies to vaccinia that is 5 to 10 times more sensitive than standard detection techniques. NIAID has screened more than 800 compounds for antiviral activity against poxviruses and two clinical trials of a new smallpox vaccine have been completed. The search continues for vaccines against a long list of pathogenic bacteria and viruses, including next generation vaccines against smallpox and new vaccines for plague, tularemia, and other viral hemorrhagic fevers.

Current NIAID biodefense programs build upon the NIH tradition of creating networks of institutions and scientists best qualified to solve complex problems. Last year the NIAID funded eight of the 10 planned Regional Centers for Excellence for Biodefense and Emerging Infectious Diseases Research (RCEs), at a cost of about $350 million to be expended over five years. The RCEs will be responsible for a broad range of basic and applied research on disease biology, vaccines, and antibiotics, as well as development of novel computational and genomic approaches. As regional centers of excellence, they also will train new generations of science professionals in biodefense research, provide facilities for area researchers, and supply facilities and support to first-line responders in the event of a biodefense emergency. The NIH also is adding new biodefense-research facilities at its own Bethesda campus and at other NIH locations. Last fall, NIAID construction grants were awarded to leading universities for nine high-level biosafety laboratories. These state-of-the-art labs will contain special engineering and design features to prevent release into the environment of the most deadly microorganisms. The facilities also will be available to assist national, state and local public health officials when needed. Similar cooperative programs were established by the NIAID to encourage biodefense research within the pharmaceutical industry, human immunology research institutes, and computational science centers. The proposed FY 2005 budget includes continued support of these efforts, as well as funding for the final two Centers for Excellence and $150 million for an additional 20 high-level biosafety laboratories.

Infectious Disease Research and Public Health

Centuries of triumph and defeat mark the human struggle against infectious disease. Many infectious diseases persist and continue to plague us. Each year populations are beset by one or more previously unknown diseases or pathogens. The World Health Organization estimates that more than 1,600 die each hour from an infectious disease, half under 5 years of age. Others suffer with debilitating infections. For instance, an estimated 40 million people worldwide are living with HIV/AIDS. Tuberculosis, malaria, and other familiar intractable diseases kill or sicken millions annually. New outbreaks surprise and alarm nations. Being prepared to detect, treat, and prevent any infectious disease is the central, science based mission of the NIAID, with well-funded medical research.

Newly emerging and re-emerging or resurging infectious diseases constantly change the landscape of microbiological research, creating moving targets for medical intervention and prevention. West Nile virus, monkeypox, dengue, multi-drug resistant tuberculosis and malaria are current examples of what faces NIAID-supported investigators. Last year’s SARS outbreak illustrates the breadth and depth of NIAID research and response capabilities. It is a cautionary tale of how a previously unknown disease can quickly become a global news story of significant economic and public health importance. Within months the new respiratory illness had caused more than 8,000 cases and nearly 900 deaths in 30 countries, severely disrupting international trade and travel—and yet it became a triumph for science and public health efforts, in large part due to effective, well-funded NIAID research. NIAID-supported scientists in Hong Kong were the first to show that SARS was caused by a virus; within days, they and CDC investigators identified the virus as a previously unknown type of coronavirus. An ongoing NIAID-funded program of influenza surveillance then found animal carriers of the virus in food markets in China. Related NIAID-supported work quickly followed, including several genetic analyses of the virus underway, an NIAID-developed mouse model of SARS, screening of up to 100,000 antiviral compounds for anti-SARS activity, several parallel approaches to vaccine development, as well as joint projects with private industry, researchers abroad, and China’s Center for Disease Control. NIAID funding led to quick development of a rapid diagnostic test now being improved, and NIAID provides researchers with free SARS “gene chips” embedded with a reference strain of the virus for genetic screening of isolates. NIAID’s extensive and multi-layered quick response to SARS was possible largely because of previous investments in virus and respiratory disease research.

Each year NIAID responsibilities for novel diseases grow greater, not less.
Today a new threat of global potential, the so-called bird flu or H5N1 influenza, is emerging to join diseases like West Nile virus infection and bovine spongiform encephalopathy (BSE) as targets of NIAID initiatives. NIH supported laboratories are world leaders in research on transmissible spongiform encephalopathies that include BSE, Creutzfeldt-Jakob disease in humans, and chronic wasting disease in deer and elk. Last year there were more than 9,000 human cases of mosquito-borne West Nile virus infection in the United States. Since first detected in 1999, WNV has spread throughout North America and beyond. NIAID-supported scientists have developed an immunoassay to identify WNV and a new treatment already in early clinical trials.

A myriad of infectious diseases continue to take a toll on people worldwide. Infections of the respiratory tract continue to be the leading cause of acute illness worldwide. In the United States, diarrhea is the second most common infectious illness and diarrheal diseases account for 15 to 34 percent of deaths in some countries. NIAID funding supports a broad variety of basic and applied research to better understand food- and waterborne illnesses. Sexually transmitted infections (STIs) affect over 15 million people in the United States each year. NIAID-supported researchers recently discovered an unusual bacterium that may be the cause of many reproductive tract infections in women. More than 25 STIs have now been identified, and NIAID is supporting multiple projects aimed at preventing and treating STIs. Currently a new vaccine for genital herpes is in advanced clinical trials.

Together, HIV/AIDS, malaria and tuberculosis account for more than 5 million deaths each year. One of the principal goals of 21st-century medical science is the development of safe and effective vaccines against these three global killers. In the United States, more than 500,000 have died from AIDS-related illness; the CDC estimates that 850,000 to 950,000 Americans are living with HIV infection. HIV/AIDS research continues to be a significant component of NIH research: The Administration’s FY 2005 budget requests $2.9 billion for HIV/AIDS research at NIH, a 2.8 percent increase over FY 2004. NIAID investigators continue to develop new treatments, and the number of AIDS vaccines in development and testing increases steadily.

Malaria threatens more than one-third of the world’s population and kills more than one million each year. Although U.S. cases of malaria are unusual, the NIAID has become a leader in the accelerated development of malaria vaccines. The agency has initiated its first trial of a candidate malaria vaccine in Africa. One-third of the world’s population also fights tuberculosis, another major global focus of the NIAID. A new recombinant vaccine made with several proteins from the bacterium that cause TB will soon enter human trials. Scientists recently discovered genetic mutations in the tuberculosis bacterium that contribute to worrisome antibiotic resistance.

The increasing use of antimicrobials in humans, animals and agriculture has contributed to pathogen resistance to antibiotics and some diseases are becoming more difficult to treat because of the emergence of drug resistance. NIAID supports antimicrobial research and the goals of the Interagency Task Force for Antimicrobial Resistance.

In recognition of impressive NIAID contributions to public health and homeland security, the ASM emphasizes that only sustained financial investment will guarantee continued success against today’s infectious diseases, tomorrow’s unpredictable pathogens, and the growing threat of antimicrobial resistance.