April 7, 2011 - National Institutes of Health - FY 2012 Testimony

The ASM urges Congress to support strong federal funding for biomedical research and to provide $35 billion in funding for the National Institutes of Health (NIH) in FY 2012.  Continued investments in science and public health programs are critical to the nation’s health, economic growth, national security and global leadership. Acquiring knowledge at the frontiers of science is the basis for new technologies, medical discoveries, new industries and high value jobs.  Investments in biomedical research lead to more effective treatments, preventions and cures for chronic and infectious diseases, improving the quality of life for people everywhere. Reducing funding for research project grants will slow medical progress on a myriad of diseases, adversely affecting human life.  Attracting and retaining scientists and maintaining the vitality of the research enterprise will become more difficult if the nation does not remain committed to sustained and predictable funding for research and training.   We, therefore, urge Congress to make increased appropriations for biomedical research a national priority as the federal budget is considered for the coming fiscal year.

National Institutes of Health:  A Crucial Investment for the Future
The NIH is a primary contributor to growing the nation’s economy and ensuring US leadership in science. The NIH expends 97 percent of its annual budget on R&D activities through its 27 centers and institutes.   NIH funding helps foster innovation among more than 300,000 research personnel at over 3,000 universities and research institutions, with about 6,000 scientists working in NIH’s own laboratories.

Life saving successes in biomedical research depend on NIH support: for example, the development last year of a new two hour diagnostic test for tuberculosis and drug resistant TB bacteria; a potential drug against malaria parasites, evidence that an anti HIV treatment could also prevent infection, research suggesting a role for intestinal bacteria in obesity, and the 2010 Nobel Prize winning methods to synthesize compounds that have already proven effective against HIV and herpes virus.  NIH funded research improves the health of our communities, represents investment in local and national economic growth and advances US science and medicine. 

Investing in Scientific Innovation, Advancing Medical Knowledge
NIH funded research has repeatedly reshaped medicine and continues to enhance public health.  NIH routinely identifies new research initiatives and pursues transformative research.  NIH recently delineated five priority areas with particular promise for safeguarding our future, including:  

  • High throughput technologies – DNA sequencing, nanotechnology and other computer supported technologies can generate massive data sets that enable comprehensive approaches to disease, like the NIH microbiome project to understand how interactions with the microbes that live on and in the human body influence health and disease.
  • translational medicine – NIH programs will increasingly focus on translating basic scientific discoveries into new clinical diagnostics and treatments (bench to bedside). 
  • informing health care reform – With US expenditures on health care approaching 20 percent of our gross domestic product, NIH research areas like personalized medicine and pharmacogenomics seek cost effective solutions through disease treatment and prevention tailored to individual patients.
  • global health – In addition to NIH’s ongoing efforts against AIDS, tuberculosis and malaria, more resources will go toward combating neglected tropical diseases that devastate low income countries.
  • reinvigorating the biomedical research community – NIH is reevaluating the nation’s future scientific workforce needs in terms of its own training programs, as well as optimizing NIH’s extramural research investments to more effectively discover innovative medical solutions.

The Importance of Investigator Initiated Research
The majority of NIH funds are distributed across the country to extramural researchers through grants, contracts and fellowships. Investigator initiated, competitively awarded Research Project Grants (RPGs) are the single most effective mechanism for ensuring research innovation.   Early in the decade, an average of 1 out of 3 grant applications were funded. In recent years, the success rate has fallen to roughly 1 in 5, with only a 15 percent success rate estimated for FY 2011, despite an abundance of research opportunities.

Scientific advances require investigator inspiration and persistence often over years of research.   For example, a large share of the research awarded the 2010 Nobel Prize in Chemistry occurred in a laboratory supported since 1979 by the National Institute of General Medical Sciences (NIGMS). Success developing the DNA based TB rapid diagnostic test announced last year followed more than eight years of National Institute of Allergy and Infectious Diseases (NIAID) support.  NIH funding also enables transformative research that has a higher degree of risk for failure, but potential for huge scientific rewards, like recipients of the relatively new EUREKA program (Exceptional, Unconventional Research Enabling Knowledge Acceleration) managed by NIGMS.  Among this year’s new NIGMS grants are projects designed to decipher the genetic code in yeast and to use bacterial components to induce patient specific stem cells that facilitate gene therapy. 

At NIH, long range strategies for research success include workforce development and mentoring young researchers.  NIAID, for example, met its own target of supporting “new investigators” in FY 2009 by funding about 20 percent of those who applied for R01 grants as first time principal investigator.  NIGMS, which distributes 70 percent of its budget to research project grants, contributes an additional 10 percent to underwrite institutional training grants and fellowships that specifically fulfill its mission to train the next generation of medical scientists.  In addition, NIGMS funds approximately 50 percent of Ph.D. research training positions at NIH, including the Medical Scientist Training (M.D.-Ph.D.) program.  Additional NIH grant programs focus on K–12 education in science, technology, engineering and mathematics (STEM), to foster a future technical workforce.

The NIH regularly identifies research intended to ultimately produce public health benefits.   In FY 2009, NIAID released 33 new funding opportunity announcements that are already producing results in selected areas, including innovative approaches to vaccine development against HIV, malaria and hepatitis C, and clinical trials specifically designed to counter the threat of antimicrobial resistance among pathogens.  Research concepts reviewed periodically by NIAID advisory councils may anticipate potential research initiatives for upcoming funding cycles.  For example, concepts approved in September 2010 included research to prevent the spread of drug resistant pathogens; support for Functional Genomics Research Centers that will generate massive genetic data sets readily available to the broad scientific community; improved diagnostics for Lyme disease; and a “pluripotent approach” for sexual and reproductive health that might combine contraceptive methods with microbicides, vaccine or other disease preventives.

NIH Research to Address Threats of Infectious Diseases and Antimicrobial Resistance
Infectious diseases cause approximately 26 percent of all deaths worldwide, more than 11 million people annually.  Each year infectious diseases kill approximately 6.5 million children, most in developing countries.  These preventable diseases also greatly impact public health systems in the United States.  For example, influenza and pneumonia account for more than 56,000 deaths annually, while each year there are more than a million new cases of sexually transmitted diseases.  Despite ground breaking triumphs against infectious diseases over decades of research, both predictable and unexpected infectious agents continue to challenge medical science.  In recent years of flat funding, NIAID has had to respond to additional public health threats like bioterrorism and unforeseen infectious diseases, by steadily expanding its research portfolio and its capabilities to recognize and quickly counter newly emerging and reemerging diseases in the United States and elsewhere.   The scope and significance of NIAID sponsored research cannot be overstated. 

The emergence of drug resistant microbial pathogens seriously complicates efforts to stop or minimize infectious diseases.  The magnitude of the problem elevates the public health significance of antimicrobial resistance.  Examples of clinically important microbes that are rapidly developing resistance to available drugs include bacteria that cause pneumonia, ear infections and meningitis, skin, bone, lung and bloodstream infections, urinary tract infections, foodborne infections and infections in health care settings.  In recent years there have been dramatic examples like chloroquine resistant malaria, methicillin resistant Staphylococcus aureus (MRSA) infection and multidrug resistant and extensively drug resistant tuberculosis.  Ten percent of all hospitalized patients in this country have or develop resistant infections, adding $55 billion in annual health care costs.  The public health burden of MRSA is enormous with over 90,000 MRSA infections per year in the US. As a result, more NIH funding must be allotted to relevant research.  In 2010 NIAID announced four new contracts for large scale clinical trials (making a total of eight trials) focused on treatment alternatives for diseases for which antibiotics are prescribed most often (e.g., middle ear infections).  Also in 2010, NIAID reported a newly identified MRSA toxin, the only MRSA toxin currently known to destroy specific human immune cells and a possible target of future drugs. 

HIV/AIDS   Since 1981, when the US epidemic began, HIV/AIDS has killed more than 565,000 people in the US. Each year there are about 2 million AIDS related deaths worldwide and an additional 2.7 million become newly infected, including about 56,000 new infections annually in the United States.  An estimated 33 million are living with HIV/AIDS, over a million of those in this country.  In large part due to NIH support, medical science now offers rising hope amidst these grim statistics, as those with HIV/AIDS live longer and better.  In 2010, NIAID funded researchers reported several studies that have been called landmarks in the fight against this difficult disease: 

  • Preexposure prophylaxis (PrEP) with a daily dose of an approved anti HIV drug reduces the risk of infection among men who have sex with men; studies of other at risk populations continue.
  • After nearly 15 years of research, scientists discovered the first vaginal microbicide gel that gives women some protection against HIV infection.
  • Various research groups have discovered at least eight antibodies that can stop HIV from infecting human cells in the laboratory, which could help scientists design effective vaccines.
  • A study in Cambodia demonstrated that people coinfected with HIV and tuberculosis can benefit from starting antiretroviral therapy earlier than originally believed (antiretroviral treatment can worsen the symptoms of coinfections, so timing is critical).

Emerging Infectious Diseases   Since 2003, NIAID has had principal responsibility for NIH’s research and development of medical countermeasures against radiological, nuclear, chemical and biological terrorist threats.  NIAID’s programs on biodefense and emerging/reemerging infectious diseases are inevitably intertwined.  Researchers study hemorrhagic fevers caused by Ebola and other viruses, West Nile virus, prion diseases, influenza viruses, anthrax, and dozens of other infectious diseases, seeking vaccines, therapeutics, and diagnostics to prevent or curb disease outbreaks.  Last year, for instance, NIAID scientists announced a new, quick method called real time quaking induced conversion assay (RT QuIC) to detect prions, which cause fatal brain diseases like mad cow disease in cattle, Creutzfeldt Jakob disease in humans, and scrapie in sheep.  Other researchers discovered a new form of murine prion disease that resembles a form of human Alzheimer’s disease. 

Last August, after more than a decade of work by NIAID scientists, a dengue vaccine began human clinical testing; the virus infects about 50 million to 100 million people annually.  NIAID also awarded new contracts to private industry to develop delivery systems for new vaccines against anthrax and dengue fever; clinical trials of the three vaccines should begin within three years.  Two other experimental vaccines showed promise against Marburg virus (cause of hemorrhagic fever with a fatality rate up to 80 percent) and Ebola virus (up to 90 percent fatality).

National Security and Research  Beginning in the late 1990s and especially following 2001, funding for research in the Department of Defense related to global diseases that impact US military on foreign soil as well as protection against biothreats on US soil decreased.  This research is now primarily entrusted to NIAID and other NIH institutes, FDA and CDC.  Research related to defense is interdependent on advances in other areas of research, especially those related to emerging infections.  Reports issues recently by the Institute of Medicine and the National Biodefense Science Board emphasize the need to properly fund these agencies for medical countermeasure development.

Genomics   NIAID and NIGMS sponsor genomic research for improving human health.  At NIGMS, investigators are using human genetic information to explain and identify individuals’ reactions to certain drugs―research called pharmacogenetics, which is focused on the NIH goal of cost effective “predictive, personalized, and preemptive medicine.”  NIAID supported genomic research programs include genome sequencing centers and bioinformatics resource centers.  By the end of 2010, the Institute’s two Structural Genomics Centers for Infectious Diseases had determined 500 3-D protein structures from microorganisms on the NIAID Category A–C priority lists or otherwise considered major human pathogens.

Global Health   Infectious diseases travel easily across international borders, and the economic stability of nations can be shaken by high rates of morbidity and mortality from such diseases.  FY 2009 marked the 30th anniversary of the Institute’s International Collaborations in Infectious Disease Research (ICIDR) program. That year NIAID supported 643 international projects in 97 countries, with 72 percent of the funds invested in HIV/AIDS research.  In mid 2010, NIAID announced funding to establish 10 new malaria research centers around the world.  NIAID supported researchers recently developed a chemical that may prove to be a new malaria drug; it has more than a decade since the last new class of antimalarials became available against a disease that kills nearly 1 million people every year.  Preliminary data suggest that the new compound might be effective as a single dose, rather than the current standard treatment of multiple doses over several days.  Also last year, other NIAID grantees described a previously unknown metabolic pathway used by malaria parasites to survive inside human blood cells. 

Conclusion
For over a century, NIH funded discoveries have saved lives, stimulated private industry and fostered the next generation of scientists and physicians.  More than 130 Nobel Prize winners have received support from NIH, but more importantly, the health of millions worldwide has been improved through NIH programs.  NIH investments have also yielded remarkable financial rewards, from basic research that helped launch the biotech industry to the recent development of a highly effective meningitis vaccine that each year saves an estimated $950 million in medical costs and another $1.14 billion in patient/caregiver earnings.  The ASM strongly recommends that Congress support innovation in the medical sciences and increase funding for the National Institutes of Health in FY 2012.

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