The American Society for Microbiology (ASM) is pleased to submit the following testimony on the Fiscal Year (FY) 2011 appropriation for the National Institutes of Health (NIH). The ASM is the largest single life science organization in the world with more than 40,000 members. The ASM mission is to enhance the science of microbiology, to gain a better understanding of life processes, and to promote the application of this knowledge for improved health and environmental well-being.
The ASM is grateful for the support of Congress for the NIH, which is the single largest source of funding for biomedical research, with an annual budget of over $31 billion. Fiscally sustained funding for biomedical research is key to finding treatments, cures and preventions for chronic and infectious diseases. NIH supports extraordinary biomedical research successes, which are also critical to national security and a catalyst for the nation’s industrial, business, and education enterprises. To ensure continued biomedical research progress and to keep pace with the cost of conducting research, we recommend that Congress provide at least an 8 percent increase for NIH, and a higher level of funding, if possible.
NIH Funding: The Need for Increased Funding for Biomedical Research
In 2009, health care costs in the United States reached $2.5 trillion, nearly 17 percent of the gross national product and more than any other nation, yet key health outcomes need improvement. Biomedical research offers innovative individual and population based medical interventions that will improve health and productivity. In FY 2011 the NIH will support emerging technology dependent areas like computational biology and DNA sequencing, as well as basic research and trans-NIH, multidisciplinary programs. NIH has identified the following “exceptional research opportunities” to be explored in FY 2011: 1) genomics and other high-throughput technologies; 2) translational medicine to expedite the path from basic research to clinical treatments and preventives; 3) greater focus on global health; 4) use of science in support of health care reform; and 5) revitalization of medical research, including training new scientists.
In FY 2011, NIH will support research by its own 6,000 scientists and by nearly 325,000 other researchers at over 3,100 institutions, including medical schools, universities, and hospitals. About 83 percent of the FY 2011 appropriation will fund extramural research, stimulating medical innovations, local economies, and the technical workforce needed to sustain the nation’s high-tech competitiveness. The Department of Health and Human Services funds 85 percent of the country’s life sciences research, primarily through the 37,000 research project grants NIH will award in FY 2011.
Each dollar of NIH funding results in another two dollars in business activity and other financial benefits. Last year, analysts found that 20 percent of every NIH stimulus dollar spent under the 2009 American Recovery and Reinvestment Act (ARRA) purchased commercial products like software, instruments, and reagents, boosting technology-based industries and services.
ARRA has enabled NIH to invest $10.4 billion over two years in NIH programs, distributed to researchers across the nation through roughly 14,000 grants to date. ARRA stimulus funds to NIH ultimately will create or retain 50,000 jobs. ARRA funding clearly has stimulated NIH research, which until recently suffered years of stagnant or declining resources.
With stimulus funds, NIH was able to support about 20 percent of grant applicants; but in FY 2011, that figure likely will drop by half, to an historically low funding rate that will impinge medical innovation in the United States. NIH received more than 20,000 proposals last year for new Challenge grants, which specifically support high risk, high return projects, but only 229 could be funded. Increased funding for NIH in FY 2011 is essential to ensure that scientists can pursue research opportunities that will lessen the human burdens of disease and disability.
NIH Funding: Foundation for Advances in Medicine
Last September, NIH and the US Army concluded their joint clinical trial in Thailand of a new AIDS vaccine, the first vaccine candidate to elicit a protective effect in humans against HIV infection. In 2009, NIH achieved advances in the global offensive against H1N1 influenza, most notably rapid development and implementation of clinical trials for various H1N1 vaccines. The three winners of the 2009 Nobel Prize in physiology or medicine had received more than $31 million in NIH research grants, while the three Nobel winners in chemistry received over $17 million. Their respective studies on cellular aging and on the structure and function of ribosomes have transformed medical science and will continue to do so into the future.
Worldwide, communicable diseases are responsible for 51 percent of the calculated “years of life lost” each year, according to the World Health Organization (WHO). Even in wealthy nations like the United States, preventable infectious diseases persist as leading causes of morbidity and mortality.
The National Institute of Allergy and Infectious Diseases (NIAID) sponsors a range of research activity from diseases like malaria and HIV/AIDS, to immune system disorders, biodefense, and the antibiotic resistance among pathogenic microbes to drug treatments. NIAID focuses on nearly 300 pathogens that include bacteria, viruses, parasites, fungi and prions. New therapies, vaccines, diagnostics, and other products nurtured by NIAID have benefited every American and contributed in some way to global health.
Influenza Approximately 86 million Americans have received 97 million doses of 2009 H1N1 influenza vaccine largely developed and tested with the support of NIAID. Although the H1N1 pandemic has fortunately proved to be more moderate than originally feared, it still has produced an estimated 59 million US cases since April 2009; 265,000 hospitalizations; and 12,000 deaths. Stopping H1N1 requires thorough understanding of the viral pathogen’s unique features. Ninety percent of seasonal flu deaths occur in those over 65, whereas 87 percent of reported H1N1 deaths were patients under 65. In the past year, NIAID funded numerous H1N1 studies, including microscopic exams of respiratory tissue from fatal cases; lab experiments suggesting that H1N1 may outcompete seasonal flu virus strains and may be more communicable; a series of vaccine trials in different human subpopulations; and alternative vaccine production strategies, including tissue culture based vaccines and an early clinical trial of a candidate DNA vaccine, an experimental class of vaccine where a pathogen’s genetic material is injected directly into the body.
HIV/AIDS In FY 2011, The NIH will spend nearly $3.2 billion for research on HIV/AIDS, which remains one of the most intractable health challenges faced by the world. An estimated 33 million people are living with HIV worldwide, and another 2 million have died. Each year, there are 56,300 new HIV infections in the United States; of the estimated 1.1 million Americans living with HIV, 21 percent are unaware of their infection. The NIAID’s Vaccine Research Center investigates multiple approaches to new vaccine development, like how neutralizing antibodies develop during natural HIV infection, which could point to an effective vaccine. NIAID also supports other prevention strategies, such as using antiretroviral drugs to stop mother to child HIV transmission (an estimated 430,000 children became infected in 2008, mostly through birth or breastfeeding from an HIV infected mother). In 2009, NIAID outlined its “test and treat” prevention agenda, based on a WHO mathematical model predicting that universal, voluntary, annual HIV testing and immediate treatment for those who test positive could radically reduce HIV incidence within a decade, and potentially end the pandemic within 50 years.
Global Health Infectious diseases can quickly spread through the world’s populations and across national borders. Global health research at NIAID informs science based public health policies worldwide, and the institute participates in several global partnerships with entities like WHO and UNICEF. It also has interagency agreements with USAID, CDC, NASA, and the State Department to combat diseases that migrate from country to country. With its scientific expertise in major global diseases, NIAID will be a vital contributor to the Administration’s new Global Health Initiative (GHI) designed to reform and coordinate US support for international health. NIAID has established programs tied to four of the six GHI focus areas, that is, HIV/AIDS, tuberculosis, malaria, and neglected tropical diseases (also, health systems and health workforce; maternal, newborn, and child health).
Malaria threatens an estimated 3.3 billion people, nearly half of the world’s population. Each year, this age-old disease causes about 250 million clinical cases and nearly 1 million deaths, most of those deaths in and children under 5 years and pregnant women. At least four species of the causative Plasmodium protozoa are transmitted through bites from dozens of Anopheles mosquito species, all of which can develop resistance to known pesticides and antimalarial drugs and a fifth human malaria parasite was recently discovered in Asia. The complex parasite vector human host cycle ranks malaria among medicine’s grand challenges. NIAID funds basic and applied research to develop tools and strategies for the treatment, prevention, and control of this disease.
One-third of the world’s population is infected with the pathogen Mycobacterium tuberculosis. There are 9.4 million new tuberculosis cases annually and 1.8 million deaths, making TB the leading cause of global mortality after HIV/AIDS. Public health efforts against TB are often outmoded, the mostly commonly used diagnostics were developed a century ago, there have been no new drugs introduced for decades, and the last new vaccine was produced 40 years ago. Therapy is difficult at best, and the emergence of drug-resistant strains has greatly complicated treatment. TB cases classified as “extensively drug resistant” (XDR) now occur in nearly 60 nations, with mortality rates exceeding 95 percent in some areas. NIAID funding supports research to discover updated diagnostics, therapeutics, and vaccines.
The so called “neglected tropical diseases” (NTDs) like leishmaniasis, sleeping sickness, and Chagas disease cumulatively infect over one billion people and kill 534,000 per year. WHO categorizes 14 diseases as NTDs important to global health, serious illnesses that most often affect impoverished countries. Many are often fatal, usually ignored by control and treatment programs, and associated with poor surveillance tools and systems. NIAID already conducts research on selected NTDs, including ARRA funded projects awarded last year that include the following: investigating the role of immunological markers like T-cells in the pathology of Chagas disease in Bolivia; conducting a prevalence study of toxocariasis and cysticercosis in HIV patients; screening Panamanian cyanobacteria, fungi, and bacteria for potential new drugs against NTDs; and designing a detailed spatial map of the onchorcerciasis endemic areas in West Africa using satellite and epidemiological data. NIH also funds research creating models of human health impacts of climate change, including potential shifts in cholera transmission.
NIH Funding: Defense Against Emerging Infectious Diseases
The proposed FY 2011 budget increases funding for NIAID’s activities emerging infectious diseases. These diseases might migrate or evolve naturally, perhaps developing resistance to standard drug treatments, or their pathogens might be deliberately dispersed as agents of bioterrorism.
NIAID funding has created countermeasures against anthrax, botulinum toxin, and smallpox. It also supports research on diseases less well-known in the United States, such as dengue fever, prion diseases like chronic wasting disease, and chikungunya fever. Scientists at NIAID recently reported success with an experimental vaccine against chikungunya virus, a mosquito borne pathogen that infects millions in Africa and Asia and causes painful joint swelling, for which there currently is no specific vaccine or treatment. Last year, researchers identified cell components in mosquitoes and humans that dengue viruses use to multiply inside their hosts, suggesting new drug targets. At present, there are no dengue-specific drugs to treat an illness that sickens 50–100 million people each year. In March, NIAID scientists reported a new form of a prion disease in laboratory mice that causes brain damage resembling that caused by a type of Alzheimer’s disease in humans.
In recent years, alarmed public health officials have devoted increasing resources toward mitigating the social and economic impacts of antimicrobial resistance. NIAID supports multiple projects devoted to the biological aspects of this problematic phenomenon. Drug resistant pathogens of greatest concern include methicillin resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and the microbial causes of malaria, HIV/AIDS, influenza, tuberculosis, streptococcal pneumonia, and various foodborne illnesses. Many resistant infections develop in health care settings. Each year, about two million people develop infections in US hospitals, with 90,000 deaths. About 70 percent of those infections are linked to pathogens resistant to at least one drug. Data now indicate that the problem outside health care settings is greater than originally believed. In FY 2011, NIAID will fund a new initiative, Development of Therapeutic Products for Biodefense, with particular emphasis on broad spectrum products or those addressing the growing dilemma of antimicrobial resistance.
NIH Funding: Moving Forward in Biomedical Research
Federal funding for NIH centers and institutes underwrites some of the world’s most creative, most promising biomedical research. Discoveries through NIAID and NIGMS programs have fostered breakthrough tools and methods vital to sectors of the US medical enterprise, like biotechnology. Research strategies at NIH must take advantage of cutting edge technologies and modern scientific disciplines like genomics and bioinformatics. NIAID research partnerships will develop next-generation biodefense diagnostics, like those using nanotechnology-based microfluidic platforms, in vivo imaging methods, or other emerging technologies. NIH supported scientists are finding novel approaches to vaccines and therapeutics, like the bioengineered use of tobacco plants to make a nasal vaccine against norovirus and a treatment for West Nile virus infection
By supporting high risk/high return projects, NIGMS lays the foundation for future advances in disease diagnosis, treatment, and prevention. It promotes large-scale initiatives to solve complex problems through collaborative research. An example is the NIGMS pharmacogenetics research program, which integrates laboratory science and databases linking genes, medicines, and diseases. In December, NIGMS announced five new projects in its pharmacogenomics collaboration with Japan’s Center of Genomic Medicine; one will examine why antiretrovirals used to treat HIV are not effective in some people.
FY 2011 funding for NIH will support the necessary acquisition of the “forward technologies” important to intramural and extramural investigators. Examples include geographic information systems for disease surveillance, and genomics tools like cloud computing, DNA sequencing software, and single-cell technologies able to assess activities within an individual cell. NIH funding also invests in the future by building the workforce needed to sustain innovation. Each year, NIH also provides grants for STEM education across the United States, and supports pre- and postdoctoral scientists at the NIH campus or with fellowships elsewhere. NIGMS alone supports approximately 50 percent of PhD training positions at NIH.
NIH projects contribute to improving public health, local economies, and science education. NIH plays a key role in accelerating transformation of basic science into clinical tools that save lives. The ASM recommends that Congress approve at least an 8 percent increase for the National Institutes of Health.