The American Society for Microbiology (ASM) appreciates the opportunity to submit a written statement on the FY 2009 budget proposal for the National Institutes of Health (NIH). The ASM is seriously troubled by the continuing shrinkage of appropriations for the National Institutes of Health (NIH), with inflation-adjusted funding flat or declining since FY 2003. The President's proposed FY 2009 budget for NIH continues a disturbing trend that risks losing our scientific edge in biomedical research. With annual health spending in the United States likely to exceed $4 trillion by 2017, innovative medical research is critical to improvements in both public health and the national economy. Increasing biomedical research is key to finding new cures, treatments and preventions for infectious and chronic diseases that threaten our future. Increased biomedical research investment will also help ensure US competitiveness in medical breakthroughs and cutting edge technologies that will contribute to economic growth in the United States.
For five years the NIH budget has lost ground to biomedical research inflation, estimated at 3.5-3.7 percent. Since FY 2004 this situation has cost NIH and biomedical research approximately 11 percent in purchasing power. At the same time, annual funding has fallen far short of that needed to adequately support and build on opportunities in basic and clinical research. The FY 2008 NIH budget of $29 billion, minus the set-aside for the Global Fund for HIV/AIDS, Malaria and TB, is a meager 0.5 percent increase over FY 2007. The Administration’s proposed $29 billion budget for FY 2009 regrettably flatlines NIH funding for the sixth year in a row. This budget request will clearly weaken fiscal support for NIH, which expends more than 80 percent of its budget on research at about 3,100 institutions and is the largest single funding source for research at US universities and colleges.
Because of flat budgets and expanding research opportunities, the success rates for NIH research grant applications continue to fall. The total number of grant recipients also will decline under the FY 2009 request. This is a sobering predictor of slower technical innovation and fewer medical advances. At the National Institute of Allergy and Infectious Diseases (NIAID), the number of research grant requests rose from 1,993 in 1997 to 4,900 in 2007, while success rates slipped from about 43 percent to 23 percent. The Institute's FY 2008 funding level was 2.3 percent below FY 2007. The FY 2009 NIAID request is only 0.2 percent above FY 2008 levels, before $300 million is transferred to the Global Fund. This downward trend will continue to undercut research that is the foundation of future biomedical successes and the fight against infectious diseases.
Shrinking support for biomedical research will also reduce the numbers of talented trainees and students who choose a career in biomedical research. At risk is the next generation of biomedical scientists who would otherwise be able to capitalize on recent advances in deciphering the human genome or translating basic research into tangible improvements in human health. These setbacks to biomedical research, training and public health will continue unless the NIH budget is increased. If the Administration and Congress continue the pattern of neglect for NIH funding that has been going on for half a decade, it will be difficult for the nation’s biomedical research enterprise to recover.
The ASM Recommends the NIH Budget be Increased by $1.9 Billion
The NIH Reform Act of 2006 authorized a funding level of $32.8 billion for the NIH's FY 2008 budget, which illustrates how far the NIH budget, currently at $29 billion in FY 2008, has fallen behind congressionally authorized levels of growth. Continuing fiscal shortfalls will weaken efforts of NIH to develop new therapies, vaccines, and diagnostics for a myriad of infectious and chronic diseases. To help reverse the ongoing erosion of biomedical research, the ASM recommends that the FY 2009 NIH budget be increased by $1.9 billion, an increase of 6.6 percent. This increase will help restore purchasing power that has been eroded by five years of flat funding and would provide some measure of growth for biomedical research.
Taking Advantage of Research Opportunities to Improve Public Health and Address Infectious Diseases
Federal investment in basic and applied research has had enormous payoff in medical advances against chronic and infectious diseases. NIAID supports research on a wide array of infectious diseases, from the more familiar killers like influenza to those less common—such as dengue fever, a flu-like illness spreading in its severe hemorrhagic form into new geographic areas, including the United States/Mexico border region. The following are just several examples of the changeable nature of both pathogens and their human hosts, evidence that strong biomedical research programs must be sustained:
- Seasonal influenza kills about 36,000 Americans each year and is an ever present concern. Even more worrisome is the potential for pandemic influenza if current bird flu viruses mutate into forms easily spread from human to human. Since the avian influenza virus H5N1 resurfaced in 2003, it has spread to more than 60 countries and infected more than 350 people, with over 60 percent mortality. NIAID scientists are collaborating with others worldwide to prevent a possible pandemic. Last year, for example, NIAID researchers identified genetic changes on the H5N1 surface that could permit easier entry into human cells, thereby suggesting potential approaches to improved surveillance and vaccines. The institute has initiated funding to establish six Centers of Excellence for influenza research and surveillance.
- Widespread, sometimes indiscriminate, use of antimicrobial drugs is a growing public health concern, as mutating pathogens become resistant to increasing classes of therapeutics. Antimicrobial resistance is a significant challenge to biomedical researchers trying to understand the mechanisms involved and to develop countermeasures. Recent surveillance studies report yet another newly emerging antimicrobial resistant pathogen, a multiple-drug resistant variant of the already problematic methicillin-resistant Staphylococcus aureus (MRSA). In 2005, MRSA was responsible for an estimated 94,000 life-threatening infections in the United States and more than 18,000 deaths. The newly described variant of MRSA is resistant to even more drugs and causes more-virulent skin infections. NIAID-supported research is providing key information on resistant staph infections, like the just published studies identifying specific proteins secreted by MRSA that determine disease severity in humans. NIAID-funded scientists also have used comparative genome sequencing to reveal the origins of epidemic community-associated MRSA, a growing problem in this country. This February, an international team funded by NIH grants announced that a cholesterol-lowering drug could block staph infections in mice, an approach based on previous basic research on metabolic pathways in bacteria and in humans that might help circumvent drug-resistance in pathogens.
- NIAID’s extensive research on global killers like malaria and tuberculosis recognizes that infectious diseases can easily cross time zones and national boundaries. Every 30 seconds, a child dies of malaria. One-third of the world’s population carries the pathogen that causes tuberculosis, a disease that annually kills 1.6 million. In February, the WHO reported that multi-drug resistant tuberculosis (MDR-TB) has been recorded at the highest rates to dates, based on data from 81 countries. The WHO found that extensively drug resistant tuberculosis (XDR-TB), a virtually untreatable form of the disease, has been recorded in 45 countries, although few countries are currently equipped to diagnose it. Public health officials are finding drug-resistant strains of the TB pathogen in US populations. NIAID working groups have recently rewritten high-priority research agenda for these difficult-to-treat diseases, identifying critical areas where additional research is essential. In the past year, a promising new tuberculosis drug based on NIAID research was granted orphan drug status by US and European regulators. NIAID joined with stakeholders from industry, academia and government to announce a new partnership to focus on TB drug discovery and development. NIAID-supported TB research currently includes more than 300 projects worldwide.
- Infectious diseases, whether naturally occurring or deliberately spread, are among the greatest security challenges to the United States. Research to develop effective medical countermeasures to detect prevent and treat infectious diseases is a key responsibility of the NIAID. The NIAID has updated its Strategic Plan for Biodefense to address a broad spectrum strategy to prevent and respond to traditional and new types of threats that will require the capability to rapidly identify unknown and poorly defined agents, quickly evaluate the efficacy of available interventions and develop and deploy novel treatments. In recent years, the NIAID has expanded its basic and applied research portfolio and established a comprehensive infrastructure with extensive resources that support all levels of research. Examples of this infrastructure include the following:
- Regional Centers of Excellence (RCEs) for Biodefense and Emerging Infectious Diseases, ten centers, located nationwide, provide resouces and communication systems that can be rapidly mobilized and coordinated with regional and local systems in response to an urgent public health event.
- Cooperative Centers for Translational Research on Human Immunology and Biodefense further knowledge of human immune responses against infectious pathogens and elucidate molecular mechanisms responsible for both short-term immunity and long-term immune memory. The ultimate goal of these eight centers is to translate research on immunity to infection into clinical applications to protect against bioterrorist threats.
- National Biocontainment Laboratories (NBLs) and Regional Biocontainment Laboratories (RBLs), 2 NBLs and 13 RBLs are available or under construction for research requiring high levels of containment and are prepared to assist national, state and local public health efforts in the event of a bioterrorism or infectious disease emergency.
- Expanded Vaccine and Treatment Evaluation Units, multiple sites allow for more extensive clinical trials capacity and expertise.
- The Biodefense and Emerging Infections Research Resources Repository offers reagents and information essential for studying emerging infectious diseases and biological threats.
- Genomics and proteomics centers include the Microbial Sequencing Centers, the Pathogen Functional Genomics Resource Center, the Bioinformatics Resource Centers, and the Biodefense Proteomics Research Centers.
- The In Vitro and Animals Models for Emerging Infectious Diseases and Biodefense resource provides screening of potential therapeutics and the development of in vitro animal efficacy models for evaluating drugs and vaccines.
- The NIAID has supported a number of biodefense workshops and multiple training opportunities ranging from basic introductory courses to two-year fellowships to provide professional training in biosafety and biocontainment. These programs are available through the National Biosafety and Biocontainment Training Program, the RCEs, and NIAID Institutional Training Grants.
- The NIH routinely reevaluates its research priorities and adjusts programs to address changing disease threats, national priorities, or appropriated resources. An example is the agency-wide Roadmap for Medical Research, a strategy to leverage waning resources through interdisciplinary teams, state-of-the-art technologies, and harmonization of clinical research efforts. The NIH's singular ability to impact biomedical research broadly is epitomized by the recent launch of a new Roadmap initiative: the multi-center Human Microbiome Project to map the genomes of all microorganisms present in or on the human body, to better understand host-microbe interactions in both sickness and health. With next-generation DNA technologies, researchers will eventually sequence 1,000 microbial genomes, results to be deposited in public databases for use in designing new treatments and better methods to prevent disease.
Constant changes here and abroad, in populations, disease pathogens and vectors, climates, economies, cultures, and governments, all have potential to influence the global burden of human disease. Emerging threats like West Nile fever or Nipah virus coexist with global successes like polio or smallpox immunization campaigns. Persistent challenges like HIV/AIDS and foodborne illnesses continue to confound public health officials. It is imperative that the NIH maintain its science based agility to respond appropriately to both the anticipated and the unexpected health threat.
Biomedical Research is the Foundation of Research Competitiveness in a Global Economy
Past investments in biomedical research have returned exceptional benefits to the American people, but there are troubling indicators that our scientific edge is slipping. Globalization is now increasing worldwide competition in scientific discovery, technological innovation, and scientific talent. The US has declined to near parity with the EU-15 in recent years in biology publications. US federal support for academic R&D is falling for the first time in a quarter century. It is critical to note that the federal government supports the majority of basic research conducted by academic institutions. Basic research funded by the NIH fuels technological innovations and fosters the vitality of the US scientific enterprise. It helps create new industries and jobs, improves the quality of life of people and provides technology that contributes to national security.
The ASM strongly recommends that Congress end the past five years of fiscal neglect for NIH. It is absolutely essential that the United States increase support for biomedical research, which is an essential foundation for future US scientific competitiveness, knowledge based industries, and highly skilled jobs in this country. Biomedical innovation is key to economic competiveness and technological breakthroughs that improve our lives.
ASM Urges Congress to Increase FY 2009 Funding for NIH
The United States cannot afford to neglect greater investment in biomedical research. The continuing complacency that has led to the leveling off and erosion of support for biomedical research can diminish our defenses against both expected and unpredictable diseases. Also at risk are the nation's high quality scientific workforce, the tradition of technological innovation, and competitiveness in global markets, all nurtured by NIH supported research, laboratories and institutions. To assure continued public health benefits from biomedical research, the ASM strongly recommends that Congress increase the NIH budget by $1.9 billion for FY 2009.