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The American Society for Microbiology (ASM), the largest single life science Society with over 39,000 members, wishes to submit the following comments and recommendations for the record on the FY 2015 budget for the National Institutes of Health (NIH). The ASM commends Congress for passage of the FY 2014 Omnibus Appropriations Bill which represents a step in the right direction although funding for NIH remains too low in view of the gaps in our knowledge of disease and the abundance of scientific opportunities that cannot be pursued because of lack of funding. The ASM recommends that NIH receive at least $32 billion in FY 2015 as the next step toward a multi-year increase in the Nation's investment in medical research.

The ASM is very concerned about the future of biomedical research in the United States. NIH support for basic research is critical to health and security, job creation and growing the US economy. In FY 2013, the success rate for NIH research grant applicants fell to an historic low 16.8 percent. The average size of research project grants (RPGs) decreased to the lowest ever since 1999. During last year’s sequestration, there were reports of delayed research projects, enforced layoffs of technical staff and waning innovation. Such stagnation undercuts biomedical research progress in the United States at a time when the opportunities are great and other nations are growing their investment in basic and translational biomedical research.

NIH is the primary supporter of biomedical research in the Nation. In 2012 alone, NIH funding supported more than 402,000 jobs and $57.8 billion in new economic activity nationwide.Among NIH’s investments are those in the rapidly advancing field of genomics. A recent report from the nonprofit United for Medical Research (UMR) spotlighted the economics of federal investment in the human genome project, which has generated $965 billion in economic impact, more than 53,000 direct genomics related jobs and $293 billion in personal income.

Current trends in the Nation’s R&D investments clearly do not bode well for future innovation and global competition. Federal R&D expenditures declined by 16.3 percent between fiscal years 2010 and 2013, while China’s investment jumped more than 400 percent over the past decade. Since 2001, the US share of global R&D performed has decreased from 37 percent to 30 percent. The Science Coalition Report in 2013 highlighted the importance of federally funded university research in creating new companies and R&D jobs. The report profiles R&D companies launched by relatively small federal investment in university research, including NIH grants funding rapid pathogen detection technologies, vaccine development and advances in food and water safety.

Several UMR reports from last year underscore how NIH supported research can propel private sector growth and innovation. US biotech companies catalyzed by NIH funding illustrate the productive collaborations among NIH, university research scientists and the private sector. These companies are reshaping lucrative R&D sectors like gene sequencing and therapeutics for human disease, taking basic research to the marketplace. NIH support is responsible for several of Science magazine’s top ten 2013 discoveries, all expected to return huge dividends, including the “breakthrough of the year” cancer immunotherapy, the new gene editing CRISPR technique and the astoundingly important human microbiome project.

Also included was the first use of structural biology techniques to custom design a powerful immunogen with vaccine potential, in this case against respiratory syncytial virus (RSV). Worldwide, about 64 million cases of RSV infection occur each year, responsible for 160,000 deaths, making it the most common cause of severe respiratory illness in infants and young children. There is no approved vaccine, but the team led by NIAID Vaccine Research Center identified 3-D structures of attachment sites on the virus surface and potent antibodies against those sites, offering new tools to develop new or improved vaccines.

NIH investments build the scientific foundation for the Nation’s valuable biomedical R&D sector, which employs 7 million and exports $90 billion in goods and services. In 2013, all three recipients of the Nobel Prize in Physiology or Medicine and all three winners of the Nobel Prize in Chemistry had at some point received NIH funding (for a total of 144 NIH supported Nobel laureates). Four NIH funded scientists also won prestigious 2013 Lasker Foundation awards.

As the Nation’s largest funder of biomedical research, NIH leads the Nation’s efforts to discover new cures, preventions and therapies for difficult disease challenges by funding intramural and extramural projects to combat infectious diseases that kill millions of people worldwide. The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of General Medical Sciences (NIGMS) contribute to new, paradigm shifting technologies like high throughput genomic sequencing, as well as new multidisciplinary research approaches like systems biology.

NIAID funded scientists have discovered therapies, vaccines, diagnostic tests and other biomedical tools that improve human health. Lifesaving examples are vaccines for rabies, meningitis, whooping cough, hepatitis A and B, chickenpox and pneumococcal pneumonia. Developing new influenza vaccines is a high priority for NIAID, which has supported a health provider consortium for clinical trials since the 1960s. The NIAID Vaccine Research Center’s influenza research has produced multiple promising advances like a DNA vaccine against H5N1 avian influenza and it helped establish the Southeast Asia Influenza Clinical Research Network to address global influenza threats. Ongoing NIAID research is making progress toward the highly significant goal of a universal influenza vaccine that would confer decades long protection from any flu virus strain.

In February, NIAID reported on its latest contributions in the battle to halt antimicrobial resistance (AR) spreading among pathogens, which is creating ever more dangerous diseases like multidrug resistant gonorrhea and extensively drug resistant tuberculosis. Each year, there are 2 million drug resistant infections and 23,000 deaths in the United States. Annual costs are an estimated $20 billion in added healthcare and $35 billion in lost productivity. NIAID leads U.S. research against drug resistant pathogens, making major investments in basic, translational and clinical research. Results include advances in prevention, diagnosis and treatment of AR infections, as well as greater support for new drug discovery. The agency has helped support R&D of at least 25 percent of the antibiotics currently in clinical testing. Basic AR research funded by NIAID is detailing the ways that pathogens evade host defenses, to identify new therapeutic and diagnostic targets. Using the latest in technological tools, NIAID supported researchers are developing novel diagnostics platforms for more rapid and accurate detection of emerging AR infections. NIAID’s expansive AR portfolio also includes vaccine development against increasingly common AR threats like drug resistant staph and gonorrhea bacteria.

One of NIAID’s greatest challenges for the 21st century is developing defenses against familiar enemies, the world’s three greatest microbial killers, HIV/AIDS, malaria and tuberculosis. Recent research advances include the following:

  • A novel compound, from a new class of potential antimalarial drugs, appears effective against multiple life stages of the malaria causing Plasmodium parasite. Most antimalarials only target the parasite as it grows in the host’s bloodstream, giving the parasite more chances to spread and acquire drug resistance.  
  • After designing nanoparticles loaded with copies of mutated HIV selected via computerized screening, scientists have activated host immune cells to produce VRC01 neutralizing antibodies. The approach offers a new tool to potentially reverse engineer neutralizing antibodies against HIV and other viruses.
  • Using a systems biology approach, scientists have identified interactions among genetic regulators in Mycobacterium tuberculosis (Mtb), the bacterium that causes tuberculosis (TB). The results help explain how Mtb lies latent for long periods in otherwise healthy people, then becomes active and transmissible TB. About one third of the world’s population is infected, making Mtb switches between different stages crucial to public health.

Research strategies clearly rely upon previous scientific successes. Ever shifting influenza viruses and steady evolution of AR pathogens illustrate how any effort must build upon the past, respond to the present and plan for the future. New microbial threats emerge as old threats persist, the recent spread of dengue fever, detection of influenza H7N9 last year and the newly emerging coronavirus caused Middle East respiratory syndrome (MERS). First identified in 2012, MERS-CoV infection has been implicated in 181 cases (as of February 4) and 79 deaths. With high mortality and no treatments, the disease’s spread from the Middle East to Europe has health officials concerned. NIAID funded researchers now have reported some laboratory success using potential MERS-CoV therapy that combines two licensed antiviral drugs routinely used to treat diseases such as hepatitis C.

At NIGMS, microbial genetics and cell/molecular biology are principal research emphases, recognition that microbiology not only provides insights to human health and biology in general, but also stimulates innovation in US biotechnology. Each year, NIGMS awards more than 4,500 research grants and supports one fourth (~4,000) of the NIH supported technical trainees.

NIGMS funded research has generated high value technologies like PCR, high throughput DNA sequencing, and the human genome project. The latest exciting biotech tool to emerge is CRISPR technology (Clustered Regularly Interspaced Short Palindromic Repeats, DNA loci in bacterial genomes), innovation that evolved from basic research in both phage biology and advanced computing genomics. With huge potential for improved genome editing essential to the biotech industry, today the CRISPR system is increasingly used in gene cutting and other customized gene targeting.

Without sustained NIH funding in diverse fields like microbiology, ASM strongly believes there will be fewer new discoveries and innovation in the United States. We urge Congress to build on bipartisan efforts to replace the random cuts of sequestration that have been devastating to basic research in the United States and to increase funding for the National Institutes of Health. Increased investment will enable the scientific progress that is needed to improve the health, security and economic growth of the country.