ASM Responds to Senate HELP Committee on NIH Modernization
The Honorable Bill Cassidy
Ranking Member, Senate Health, Education, Labor and Pensions Committee
428 Dirksen Senate Office Building
Washington, D.C. 20510
On behalf of the American Society for °®¶¹´«Ã½ (ASM), thank you for the opportunity to provide feedback on modernization of the National Institutes of Health (NIH). ASM is one of the largest professional societies dedicated to the life sciences and is composed of 36,000 scientists and health practitioners. NIH supports the important research and discoveries of ASM members and is essential to ensuring the next generation of microbiologists has the support and training to drive the science of the future. ASM's mission is to promote and advance the microbial sciences. For example, our global public health programs enhance laboratory capacity around the globe through training and resources, and we provide a network for scientists in academia, industry, and clinical settings. Additionally, ASM promotes a deeper understanding of the microbial sciences to diverse audiences. On Sept. 29, 2023, you on ways to reform NIH with input on various questions. ASM appreciates the opportunity to respond to this request.
Building on the foundation of long-term bipartisan commitments by Congress, NIH allowed researchers to rapidly pivot when SARS-CoV-2 emerged and the race to develop tests, vaccines and therapeutics commenced. Researchers built on decades of federally funded basic science and technological advances to develop safe and effective vaccines at record speed. This is a success story and exemplifies the value of robust, sustained and predictable funding for the NIH. The U.S. continues to face threats, known and unknown, and sustaining our investments is the only way we will seize the unparalleled scientific opportunities in microbial research that lie before us, and the only way we will be equipped to address the demands that future outbreaks will place on our society. However, FY 2024 budget proposals would bring NIH funding back to 2015 levels, erasing recent bipartisan work to increase the rate of scientific discovery and translation.
Scientific breakthroughs do not happen overnight, nor can they be stopped and restarted without major setbacks when funding is interrupted. For example, the NIH of mRNA research leading vaccine development in the first 100 days of the COVID-19 pandemic, was built on the discovery of mRNA in the 1960's. This led to research on its interaction with protein cells, which then led to breakthroughs in vaccine science in the early 2000s and the successful development of Food and Drug Administration-approved mRNA vaccines for SARS-CoV-2 that saved millions of lives. The 50 years of public and private laboratory research laid the groundwork for the rapid development of these life-saving vaccines. The research into mRNA and the development of a vaccine is just one of thousands of examples of how sustained investments over time at federal research agencies produce life-saving developments. While entities like the Advanced Research Projects Agency for Health (ARPA-H) play an important role in funding high risk-high reward research that is translational in nature, this work is not possible without a strong foundation laid by fundamental research funded through NIH.
2. What specific policies or systems would better expedite open sharing of NIH-funded data and analyses?
ASM has a long-standing commitment to equity in science and recognizes that making research more widely accessible is a step in that direction. We believe that data availability and data sharing are critical to our mission to advance the microbial sciences. ASM has been an open access (OA) leader and advocate for many years and supports the fundamental principles of open science. ASM’s 15 peer-reviewed journals, 6 of which are fully Gold open access, and all of which publish open access content, are fundamental to ASM’s mission and provide a critical service not only to our members, but also to the advancement of the microbial sciences globally.
Earlier this year, ASM submitted comments to the NIH on its public access plan, commending the agency for its commitment to equity and its work to achieve equitable access to publishing and to research in setting forth this plan. We were pleased to see NIH’s commitment to convening the community throughout the process to work through these challenges and share ideas. We also expressed concerns about the unintended consequences of enacting federal policies that might shift costs to researchers, or otherwise result in significant additional costs related to publication, repositories, data management and staffing. There remains a cost to publishing good science.
It is critical that NIH policies support alternative means for funding public access. Congress can assist the agency and research community by providing financial support to address these unequal additional burdens in future spending bills and through other strategies. Investing in infrastructure and services that are directly aligned with the research mission will be critical to laying the foundation for a more open and equitable system.
ASM also supports NIH’s efforts to promote the management and sharing of scientific data generated from NIH-funded or conducted research. In the FY24 Budget Request for NIH, emphasis is given to appropriate infrastructure to ensure data can be found, accessed and used appropriately, and NIH has several ongoing efforts to enhance or modernize the data ecosystem. ASM supports these efforts and more to make NIH data more findable, accessible, interoperable and reusable (FAIR).
6. What lessons can be learned from individual NIH Institutes and Centers (ICs) related to the conduct of clinical research? How can clinical trials be conducted more efficiently and effectively?
Clinical research and trials are essential to advancing diagnostics, vaccines and therapeutics that detect, prevent and treat infectious disease. This work is particularly important given that pathogens and pathogen resistance threaten our nation’s public health and safety and can have serious economic and social ramifications. For example, seasonal influenza costs the U.S. billions annually in direct medical costs and lost productivity, and it claims the lives of thousands of Americans each year. Thanks to a specific sustained funding commitment from Congress to the National Institute of Allergy and Infectious Diseases (NIAID), scientists continue the quest for a universal flu vaccine that can offer the public longer lasting protection against multiple flu strains compared to the annual vaccine. Last month, the first Phase 1 clinical trial began to test a new investigational candidate for the vaccine at the NIH Clinical Center.
Antimicrobial resistance (AMR) is a daunting public health challenge and considered a global crisis by the World Health Organization, the G20 and the °®¶¹´«Ã½ Nations. In ASM’s recent paper titled “Policy Pathways to Combat the Global Crisis of Antimicrobial Resistance,” we call for renewed investment in the NIH-funded Antibiotic Resistance Leadership Group (ARLG). The ARLG consists of more than 100 leading experts working together to combat the antibacterial resistance crisis and improve patient care through the prioritization, design and execution of clinical research. In order to stimulate antibiotic discovery and development taken on by the private sector, we must renew and strengthen the clinical trials network on antibacterial resistance through NIH.
ASM also supports the passage of the PASTEUR Act and the STARR Act to address antimicrobial resistance. The PASTEUR Act, sponsored by Senator Michael Bennet (D-CO) and Congressman Drew Ferguson (R-GA), creates solutions for the antimicrobial marketplace by establishing a subscription model through which the federal government can enter into contracts with innovators to pay for a reliable supply of novel antimicrobials with payments that are decoupled from the volume of antimicrobials used. This allows private companies to overcome the lack of financial incentives to fund clinical trials for antimicrobials. Introduced in the previous congress as S. 3291 and H.R. 9094, the STAAR Act provides statutory authority to the National Institutes of Health’s National Institute for Allergy and Infectious Diseases (NIAID) to maintain and expand a clinical trial network focused solely on antibiotic-resistant bacterial infections, known as the Clinical Trials Network on Antibacterial Resistance.
Federal research agencies like NIH must focus on supporting programs to better recruit, develop and sustain the biomedical research workforce, including keeping current early and mid-career scientists engaged in the work, the science and the frontier of innovation related to testing, lab composition and development and efficiencies in style of work processes. Congress has a role to play by providing the funding necessary to support training and early-career opportunities at NIH.
ASM shares your concerns about the future of the microbial sciences research workforce. In order to better understand the trends and needs, ASM commissioned a study, published in June 2023 titled “Workforce Trends: The Future of Microbial Sciences,” providing the most current look at the demographic makeup, employment patterns and occupations of the microbiology discipline. Some key findings of the report include:
Increased demand for lab scientists driven by viral diseases has strained training institutions and professional societies. As the COVID-19 pandemic surged, those microbiologists unsatisfied with their jobs listed opportunities for advancement and intellectual challenges as the most common reasons. As the field evolves, investments in training are only one solution. In order to incentivize the education and training of those who choose to enter the microbiology field, the NIH must support funding for early and mid-career investigators. This is particularly relevant given that 1 in 10 individuals working as a microbiologist today is aged 65 or older and may exit the workforce at any moment. To alleviate shocks in the microbiology workforce that is so critically needed, as the next public health scare could be right around the corner, we must support all individuals who wish to enter the microbial sciences workforce. To grow the medical microbiology workforce, ASM has recommended establishing federal loan forgiveness programs, including those that focus on laboratorians in public health, including medical microbiologists and other medical laboratory scientists and creating federal training grants for medical microbiologists.
2.How might NIH’s mission, strategic goals and objectives be refined to better reflect and enable its core functions?
One practice that could be refined to better reflect and enable NIH core functions, as well as support for the biomedical research workforce, is enhancing diversity and inclusion of underrepresented groups in funding for extramural research. An essential part of ASM's mission is to embrace diversity in the STEM community. Being inclusive enhances innovation, broadens the health research agenda and furthers scientific advancement. ASM is committed to promoting and advancing the microbial sciences through the elevation, embodiment and sustainability of inclusive diversity with equity, access and accountability (IDEAA). In the NIH's recent budget request, special emphasis is given to the UNITE Initiative, with the goal of identifying and addressing structural racism within the NIH community and the greater research community. This includes enhanced extramural funding for underrepresented groups that ASM supports.
3. In your view, could NIH research dollars be better allocated within the agency’s portfolio? Are there certain areas of research that are over-funded or under-funded? What strategy should Congress and NIH take in allocating resources to specific areas?
We thank Congress for its longstanding, bipartisan support for the NIH and for its commitment to basic, translational and clinical microbial research funded through multiple institutes and centers, particularly through NIAID. Both the Senate and House have worked in a bipartisan manner over the past several years to place the NIH budget back on the path of meaningful growth above inflation. This is the best thing Congress can do to support the agency. Allocations of funding should follow the science and the opportunity, and there are mechanisms at the agency to fund cross-cutting research and innovative ideas. The NIH peer review process also works very well to help accomplish this. ASM submitted outside witness testimony in March 2023 in support of providing at least $50.924 billion for NIH, in line with the request of the Ad Hoc Group for Medical Research that would expand NIH’s capacity to support promising science in all disciplines.
5. How would you rate the success of the Common Fund, since its inception? What works well, what could be improved, and how?
The Common Fund has paid enormous dividends for the microbial sciences through a 10-year initiative focused on microbiome research called the Human Microbiome Project (HMP). In an by the NIH Human Microbiome Portfolio Analysis Team published in 2019, the initial $215 million HMP investment at NIH catalyzed microbiome research, with NIH support for human microbiome research outside of the HMP eclipsing the annual HMP investment and reached or exceeded $100M/year by FY2012.
Thanks to NIH’s cross-cutting work that the Common Fund enabled, we now have a foundational understanding of how microbial communities interact with humans, especially the human gut microbiome, and the world around us. The NIH’s leadership has paved the way for microbiome research at other agencies throughout the federal government, including the Department of Energy, the Department of Agriculture and the National Science Foundation focused on how microbial communities exist on, in, and around people, plants, animals and the environment and have symbiotic relationships that protect against disease and, in some cases, can be leveraged to treat it.
The need to leverage the microbiome as a tool to promote human, animal and plant health is now greater than ever. A coordinated effort to evaluate human, animal and plant microbiomes could propel the bioeconomy to the next level and address the most pressing concerns in health, food safety, and antimicrobial resistance. ASM urges policymakers to create a mechanism for strategic leadership, interagency coordination and support across federal science agencies on fundamental microbiome research. That is why ASM and partners issued a letter in support of the renewal of the Microbiome Interagency Working Group and an update of the Interagency Strategic Plan for Microbiome Research. The NIH leadership and mechanisms like the Common Fund are essential to driving interagency collaboration at NIH in exciting areas of science like the microbiome.
We thank you for your leadership and appreciate your interest in modernizing the National Institutes of Health. ASM and its members stand ready to assist you in this effort. If you have any questions, please contact Nick Cox, Senior Federal Affairs Officer at ncox@asmusa.org.
Sincerely,
Allen Segal
Chief Advocacy Officer
Ranking Member, Senate Health, Education, Labor and Pensions Committee
428 Dirksen Senate Office Building
Washington, D.C. 20510
Re: Request for Information from Stakeholders Regarding NIH Modernization
Dear Senator Cassidy:On behalf of the American Society for °®¶¹´«Ã½ (ASM), thank you for the opportunity to provide feedback on modernization of the National Institutes of Health (NIH). ASM is one of the largest professional societies dedicated to the life sciences and is composed of 36,000 scientists and health practitioners. NIH supports the important research and discoveries of ASM members and is essential to ensuring the next generation of microbiologists has the support and training to drive the science of the future. ASM's mission is to promote and advance the microbial sciences. For example, our global public health programs enhance laboratory capacity around the globe through training and resources, and we provide a network for scientists in academia, industry, and clinical settings. Additionally, ASM promotes a deeper understanding of the microbial sciences to diverse audiences. On Sept. 29, 2023, you on ways to reform NIH with input on various questions. ASM appreciates the opportunity to respond to this request.
Increasing the Pace of Science
1. How has the conduct and dissemination of science changed in recent years, particularly due to COVID-19? What role can NIH play in speeding up the pace of science and quickly disseminating high-quality research findings?Building on the foundation of long-term bipartisan commitments by Congress, NIH allowed researchers to rapidly pivot when SARS-CoV-2 emerged and the race to develop tests, vaccines and therapeutics commenced. Researchers built on decades of federally funded basic science and technological advances to develop safe and effective vaccines at record speed. This is a success story and exemplifies the value of robust, sustained and predictable funding for the NIH. The U.S. continues to face threats, known and unknown, and sustaining our investments is the only way we will seize the unparalleled scientific opportunities in microbial research that lie before us, and the only way we will be equipped to address the demands that future outbreaks will place on our society. However, FY 2024 budget proposals would bring NIH funding back to 2015 levels, erasing recent bipartisan work to increase the rate of scientific discovery and translation.
Scientific breakthroughs do not happen overnight, nor can they be stopped and restarted without major setbacks when funding is interrupted. For example, the NIH of mRNA research leading vaccine development in the first 100 days of the COVID-19 pandemic, was built on the discovery of mRNA in the 1960's. This led to research on its interaction with protein cells, which then led to breakthroughs in vaccine science in the early 2000s and the successful development of Food and Drug Administration-approved mRNA vaccines for SARS-CoV-2 that saved millions of lives. The 50 years of public and private laboratory research laid the groundwork for the rapid development of these life-saving vaccines. The research into mRNA and the development of a vaccine is just one of thousands of examples of how sustained investments over time at federal research agencies produce life-saving developments. While entities like the Advanced Research Projects Agency for Health (ARPA-H) play an important role in funding high risk-high reward research that is translational in nature, this work is not possible without a strong foundation laid by fundamental research funded through NIH.
2. What specific policies or systems would better expedite open sharing of NIH-funded data and analyses?
ASM has a long-standing commitment to equity in science and recognizes that making research more widely accessible is a step in that direction. We believe that data availability and data sharing are critical to our mission to advance the microbial sciences. ASM has been an open access (OA) leader and advocate for many years and supports the fundamental principles of open science. ASM’s 15 peer-reviewed journals, 6 of which are fully Gold open access, and all of which publish open access content, are fundamental to ASM’s mission and provide a critical service not only to our members, but also to the advancement of the microbial sciences globally.
Earlier this year, ASM submitted comments to the NIH on its public access plan, commending the agency for its commitment to equity and its work to achieve equitable access to publishing and to research in setting forth this plan. We were pleased to see NIH’s commitment to convening the community throughout the process to work through these challenges and share ideas. We also expressed concerns about the unintended consequences of enacting federal policies that might shift costs to researchers, or otherwise result in significant additional costs related to publication, repositories, data management and staffing. There remains a cost to publishing good science.
It is critical that NIH policies support alternative means for funding public access. Congress can assist the agency and research community by providing financial support to address these unequal additional burdens in future spending bills and through other strategies. Investing in infrastructure and services that are directly aligned with the research mission will be critical to laying the foundation for a more open and equitable system.
ASM also supports NIH’s efforts to promote the management and sharing of scientific data generated from NIH-funded or conducted research. In the FY24 Budget Request for NIH, emphasis is given to appropriate infrastructure to ensure data can be found, accessed and used appropriately, and NIH has several ongoing efforts to enhance or modernize the data ecosystem. ASM supports these efforts and more to make NIH data more findable, accessible, interoperable and reusable (FAIR).
6. What lessons can be learned from individual NIH Institutes and Centers (ICs) related to the conduct of clinical research? How can clinical trials be conducted more efficiently and effectively?
Clinical research and trials are essential to advancing diagnostics, vaccines and therapeutics that detect, prevent and treat infectious disease. This work is particularly important given that pathogens and pathogen resistance threaten our nation’s public health and safety and can have serious economic and social ramifications. For example, seasonal influenza costs the U.S. billions annually in direct medical costs and lost productivity, and it claims the lives of thousands of Americans each year. Thanks to a specific sustained funding commitment from Congress to the National Institute of Allergy and Infectious Diseases (NIAID), scientists continue the quest for a universal flu vaccine that can offer the public longer lasting protection against multiple flu strains compared to the annual vaccine. Last month, the first Phase 1 clinical trial began to test a new investigational candidate for the vaccine at the NIH Clinical Center.
Antimicrobial resistance (AMR) is a daunting public health challenge and considered a global crisis by the World Health Organization, the G20 and the °®¶¹´«Ã½ Nations. In ASM’s recent paper titled “Policy Pathways to Combat the Global Crisis of Antimicrobial Resistance,” we call for renewed investment in the NIH-funded Antibiotic Resistance Leadership Group (ARLG). The ARLG consists of more than 100 leading experts working together to combat the antibacterial resistance crisis and improve patient care through the prioritization, design and execution of clinical research. In order to stimulate antibiotic discovery and development taken on by the private sector, we must renew and strengthen the clinical trials network on antibacterial resistance through NIH.
ASM also supports the passage of the PASTEUR Act and the STARR Act to address antimicrobial resistance. The PASTEUR Act, sponsored by Senator Michael Bennet (D-CO) and Congressman Drew Ferguson (R-GA), creates solutions for the antimicrobial marketplace by establishing a subscription model through which the federal government can enter into contracts with innovators to pay for a reliable supply of novel antimicrobials with payments that are decoupled from the volume of antimicrobials used. This allows private companies to overcome the lack of financial incentives to fund clinical trials for antimicrobials. Introduced in the previous congress as S. 3291 and H.R. 9094, the STAAR Act provides statutory authority to the National Institutes of Health’s National Institute for Allergy and Infectious Diseases (NIAID) to maintain and expand a clinical trial network focused solely on antibiotic-resistant bacterial infections, known as the Clinical Trials Network on Antibacterial Resistance.
Extramural Research Program
7. What specific factors cause individuals to leave the biomedical research workforce? How could common NIH funding mechanisms be revised to better recruit and retain high-quality investigators, including young investigators?Federal research agencies like NIH must focus on supporting programs to better recruit, develop and sustain the biomedical research workforce, including keeping current early and mid-career scientists engaged in the work, the science and the frontier of innovation related to testing, lab composition and development and efficiencies in style of work processes. Congress has a role to play by providing the funding necessary to support training and early-career opportunities at NIH.
ASM shares your concerns about the future of the microbial sciences research workforce. In order to better understand the trends and needs, ASM commissioned a study, published in June 2023 titled “Workforce Trends: The Future of Microbial Sciences,” providing the most current look at the demographic makeup, employment patterns and occupations of the microbiology discipline. Some key findings of the report include:
- There has been a significant increase in microbiology degrees awarded, with most of the growth coming from bachelor’s and master’s degrees. Between 2003-2021, undergraduate degree completions increased by 57%, master’s degrees by 117% and Ph.D.s by 20%. That being said, growth has slowed relative to the early 2000s.
- The field is becoming more racially diverse, but work is needed to ensure that those trained find flourishing careers in the profession. The profession is also becoming younger and older at the same time. One in 10 microbiologists are aged 65 or older and could retire at any moment. Over 50% of the workforce is aged 45 or younger.
- More than 95% of microbiologists working in fields closely related to their degrees are satisfied with their jobs. Of those dissatisfied in 2019, a lack of opportunities for advancement was listed as the most prevalent reason followed by not being intellectually challenged at work. In 2021, being dissatisfied due to degree of independence, contributions to society, level of responsibility, job location, job security and salary all decreased. It is possible that the pandemic shifted expectations around their work, contributions and job security.
Increased demand for lab scientists driven by viral diseases has strained training institutions and professional societies. As the COVID-19 pandemic surged, those microbiologists unsatisfied with their jobs listed opportunities for advancement and intellectual challenges as the most common reasons. As the field evolves, investments in training are only one solution. In order to incentivize the education and training of those who choose to enter the microbiology field, the NIH must support funding for early and mid-career investigators. This is particularly relevant given that 1 in 10 individuals working as a microbiologist today is aged 65 or older and may exit the workforce at any moment. To alleviate shocks in the microbiology workforce that is so critically needed, as the next public health scare could be right around the corner, we must support all individuals who wish to enter the microbial sciences workforce. To grow the medical microbiology workforce, ASM has recommended establishing federal loan forgiveness programs, including those that focus on laboratorians in public health, including medical microbiologists and other medical laboratory scientists and creating federal training grants for medical microbiologists.
Organizing NIH for Success
Statutory Structure and Functions2.How might NIH’s mission, strategic goals and objectives be refined to better reflect and enable its core functions?
One practice that could be refined to better reflect and enable NIH core functions, as well as support for the biomedical research workforce, is enhancing diversity and inclusion of underrepresented groups in funding for extramural research. An essential part of ASM's mission is to embrace diversity in the STEM community. Being inclusive enhances innovation, broadens the health research agenda and furthers scientific advancement. ASM is committed to promoting and advancing the microbial sciences through the elevation, embodiment and sustainability of inclusive diversity with equity, access and accountability (IDEAA). In the NIH's recent budget request, special emphasis is given to the UNITE Initiative, with the goal of identifying and addressing structural racism within the NIH community and the greater research community. This includes enhanced extramural funding for underrepresented groups that ASM supports.
3. In your view, could NIH research dollars be better allocated within the agency’s portfolio? Are there certain areas of research that are over-funded or under-funded? What strategy should Congress and NIH take in allocating resources to specific areas?
We thank Congress for its longstanding, bipartisan support for the NIH and for its commitment to basic, translational and clinical microbial research funded through multiple institutes and centers, particularly through NIAID. Both the Senate and House have worked in a bipartisan manner over the past several years to place the NIH budget back on the path of meaningful growth above inflation. This is the best thing Congress can do to support the agency. Allocations of funding should follow the science and the opportunity, and there are mechanisms at the agency to fund cross-cutting research and innovative ideas. The NIH peer review process also works very well to help accomplish this. ASM submitted outside witness testimony in March 2023 in support of providing at least $50.924 billion for NIH, in line with the request of the Ad Hoc Group for Medical Research that would expand NIH’s capacity to support promising science in all disciplines.
5. How would you rate the success of the Common Fund, since its inception? What works well, what could be improved, and how?
The Common Fund has paid enormous dividends for the microbial sciences through a 10-year initiative focused on microbiome research called the Human Microbiome Project (HMP). In an by the NIH Human Microbiome Portfolio Analysis Team published in 2019, the initial $215 million HMP investment at NIH catalyzed microbiome research, with NIH support for human microbiome research outside of the HMP eclipsing the annual HMP investment and reached or exceeded $100M/year by FY2012.
Thanks to NIH’s cross-cutting work that the Common Fund enabled, we now have a foundational understanding of how microbial communities interact with humans, especially the human gut microbiome, and the world around us. The NIH’s leadership has paved the way for microbiome research at other agencies throughout the federal government, including the Department of Energy, the Department of Agriculture and the National Science Foundation focused on how microbial communities exist on, in, and around people, plants, animals and the environment and have symbiotic relationships that protect against disease and, in some cases, can be leveraged to treat it.
The need to leverage the microbiome as a tool to promote human, animal and plant health is now greater than ever. A coordinated effort to evaluate human, animal and plant microbiomes could propel the bioeconomy to the next level and address the most pressing concerns in health, food safety, and antimicrobial resistance. ASM urges policymakers to create a mechanism for strategic leadership, interagency coordination and support across federal science agencies on fundamental microbiome research. That is why ASM and partners issued a letter in support of the renewal of the Microbiome Interagency Working Group and an update of the Interagency Strategic Plan for Microbiome Research. The NIH leadership and mechanisms like the Common Fund are essential to driving interagency collaboration at NIH in exciting areas of science like the microbiome.
We thank you for your leadership and appreciate your interest in modernizing the National Institutes of Health. ASM and its members stand ready to assist you in this effort. If you have any questions, please contact Nick Cox, Senior Federal Affairs Officer at ncox@asmusa.org.
Sincerely,
Allen Segal
Chief Advocacy Officer
