Physical activity is one of the most powerful tools for promoting health and wellbeing. Movement is not only medicine—effective at treating a range of physical and mental health conditions—but it is also preventive medicine, because movement reduces the risk for many conditions ranging from cancer and heart disease to depression and Alzheimer’s disease. But rates of physical inactivity and sedentary behavior have remained high in the U.S. and worldwide for decades.
Engagement in physical activity is impacted by myriad factors that can be viewed from a social ecological perspective. This model views health and health behavior within the context of a complex interplay between different levels of influence, including individual, interpersonal, institutional, community, and policy levels. When it comes to healthy behavior such as physical activity, sustainable change is considered most likely when these levels of influence are aligned to support change. Every level of influence on physical activity within a social-ecological framework is directly or indirectly affected by federal policy, suggesting physical activity policy has the potential to bring about substantial changes in the physical activity habits of Americans.
Why are federal physical activity policies needed?
Physical inactivity is recognized as a public health issue, having widespread impacts on health, longevity, and even the economy. Similar to other public health issues over past decades such as sanitation and tobacco use, federal policies may be the best way to coordinate large-scale changes involving cooperation between diverse sectors, including health care, transportation, environment, education, workplace, and urban planning. An active society requires the infrastructure, environment, and resources that promote physical activity. Federal policies can meet those needs by improving access, providing funding, establishing regulations, and developing programs to empower all Americans to move more. Policies also play an important role in removing barriers to physical activity, such as financial constraints and lack of safe spaces to move, that contribute to health disparities. With such a variety of factors impacting active lifestyles, physical activity policies must have inter-agency involvement to be effective.
What physical activity initiatives exist currently?
Analysis of publicly available information revealed that there are a variety of initiatives currently in place at the federal level, across several departments and agencies, aimed at increasing physical activity levels in the U.S. Information about each initiative was evaluated for their correspondence with levels of the social-ecological model, as summarized in the table. Note that it is possible the search that was conducted did not identify every relevant effort, thus there could be additional initiatives that are not included below.
Given the large number of groups with the shared goal of increasing physical activity in the nation, a memorandum of understanding (MOU) may help to promote coordination of goals and implementation strategies.
These and other federal departments and agencies can coordinate action with state and local partners, for example in healthcare, business and industry, education, mass media, and faith-based settings, to implement physical activity policies.
The CDC’s Active People, Healthy Nation initiative provides an example of this approach. This campaign, launched in 2020, has the goal of helping 27 million Americans become more physically active by 2027. By taking action steps focused on program delivery, partnership engagement, communication, training, and continuous monitoring and evaluation, the campaign seeks to help communities implement evidence-based strategies across sectors and settings to provide equitable and inclusive access to safe spaces for physical activity. According to our analysis, the strategies of the Active People, Healthy Nation initiative are aligned with the social-ecological model. The Physical Activity Policy Research and Evaluation Network, a research partner of the Active People, Healthy Nation initiative, provides an example of coordinating with partners in other sectors to promote physical activity. Through collaboration across sectors, the network brings together diverse partners to put into practice research on environments that maximize physical activity. The network includes work groups focused on equity and inclusion, parks and green space, rural active living, school wellness, transportation policy and planning, and business/industry.
The Biden-Harris Administration National Strategy on Hunger, Nutrition, and Health, announced in September 2022, also includes strategies that are consistent with a social-ecological model. The strategy outlines steps toward the goal of ending hunger and increasing healthy eating and physical activity by 2030 so that fewer Americans will experience diet-related diseases. Pillar 4 of the strategy is to “make it easier for people to be more physically active—in part by ensuring that everyone has access to safe places to be active—increase awareness of the benefits of physical activity, and conduct research on and measure physical activity.” The strategy specifies goals such as building environments that promote physical activity (e.g., connecting people to parks; promoting active transportation and land use policies to support physical activity) and includes a call to action for a whole-of-society response involving the private sector, state, local, and territory governments, schools, and workplaces.
The Congressional Physical Activity Caucus has been active in introducing legislation that can help realize the goals of the current physical activity initiatives. For example, in February 2023, Sen. Sherrod Brown (D-OH), co-chair of the Caucus, introduced the Promoting Physical Activity for Americans Act, a bill that would require the Department of Health and Human Services to continue issuing evidence-based physical-activity guidelines and detailed reports at least every 10 years, including recommendations for population subgroups (e.g., children or individuals with disabilities). In addition, members of the Caucus, along with other members of congress, reintroduced the bipartisan, bicameral Personal Health Investment Today (PHIT) Act in March 2023. This legislation seeks to encourage physical activity by allowing Americans to use a portion of the money saved in their pre-tax health savings account (HSA) and flexible spending account (FSA) toward qualified sports and fitness purchases, such as gym memberships, fitness equipment, physical exercise or activity programs and youth sports league fees. The bill would also allow a medical care tax deduction for up to $1,000 ($2,000 for a joint return or a head of household) of qualified sports and fitness expenses per year.
What progress has been made?
There are signs that some of the national campaigns are leading to changes at other levels of society. For example, 46 cities, towns, and states have passed an Active People, Healthy Nation Proclamation as of September 2023. According to the State Routes Partnership, which develops “report cards” for states based on their policies supporting walking, bicycling, and active kids and communities, many states have shown movement in their policies between 2020 and 2022, such as implementing new policies to support walking and biking and increasing state funding for active transportation. However, more time is needed to determine the extent to which recent initiatives are helping to create a more active country, since most were initiated in the past two or three years. Predating the current initiatives, the overall physical activity level of Americans increased from 2008 to 2018, but there has been little change since that time, and only about one-quarter of adults meet the physical activity guidelines established by the CDC.
Clearly, there is a critical need for concerted effort to implement the strategies outlined in current physical activity initiatives so that national policies have the intended impacts on communities and on individuals. Leveraging provisions in existing legislation related to the social-ecological model of physical activity promotion will also help with implementation. For example, title III-D of the Older Americans Act supports healthy lifestyles and promotes healthy behaviors amongst older adults (age 60 and older), providing funding for evidence-based programs that have been proven to improve health and well-being and reduce disease and injury. Physical activity programs are prime candidates for such funding. In addition, programs under the 2021 Bipartisan Infrastructure Law and the 2022 Inflation Reduction Act are helping to change the current car-dependent transportation network, providing healthier and more sustainable transportation options, including walking, biking, and using public transportation, and are providing investments in environmental programs to improve public health and reduce pollution. For example, states can use funds from the Highway Safety Improvement Program for bicycle and pedestrian highway safety improvement projects, and funding is available through the Carbon Reduction Program for programs that help reduce dependence on single-occupancy vehicles, such as public transportation projects and the construction, planning, and design of facilities for pedestrians, bicyclists, and other non-motorized forms of transportation.
Partnering with non-governmental groups working towards common goals, such as the Physical Activity Alliance, can also help with implementation. The Alliance’s National Physical Activity Plan is based on the socio-ecological model and includes recommendations for evidence-based actions for 10 societal sectors at the national, state, local and institutional levels, with a focus on making change at the community level. The plan shares many priorities with those of the Active People, Healthy Nation initiative, while also introducing new goals, such as establishing a CDC Office of Physical Activity and Health.
With coordinated action based on established public health models, such as the social-ecological framework, federal policies can be successfully implemented to make the systemic changes that are needed to create a more active nation.
The work for this blog was undertaken before Dr. Dotson joined the Agency for Healthcare Research and Quality (AHRQ). Dr. Dotson is solely responsible for this blog post’s contents, findings, and conclusions, which do not necessarily represent the views of AHRQ. Readers should not interpret any statement as an official position of AHRQ or of the U.S. Department of Health and Human Services.
Maternal mortality is a crisis in the United States. Yet more than 60% of maternal deaths are preventable—with the right evidence-based interventions. Data is a powerful tool for uncovering best care practices. While healthcare data, including maternal health data, has been generated at a massive scale by the widespread adoption and use of Electronic Health Records (EHR), much of this data remains unstandardized and unanalyzed. Further, while many federal datasets related to maternal health are openly available through initiatives set forth in the Open Government National Action Plan, there is no central coordinating body charged with analyzing this breadth of data. Advancing data harmonization, research, and analysis are foundational elements of the Biden Administration’s Blueprint for Addressing the Maternal Health Crisis. As a data-driven technology, artificial intelligence (AI) has great potential to support maternal health research efforts. Examples of promising applications of AI include using electronic health data to predict whether expectant mothers are at risk of difficulty during delivery. However, further research is needed to understand how to effectively implement this technology in a way that promotes transparency, safety, and equity. The Biden-Harris Administration should establish an AI Center of Excellence to bring together data sources and then analyze, diagnose, and address maternal health disparities, all while demonstrating trustworthy and responsible AI principles.
Challenge and Opportunity
Maternal deaths currently average around 700 per year, and severe maternal morbidity-related conditions impact upward of 60,000 women annually. Stark maternal health disparities persist in the United States, and pregnancy outcomes are subject to substantial racial/ethnic disparities, including maternal morbidity and mortality. According to the Centers for Disease Control and Prevention (CDC), “Black women are three times more likely to die from a pregnancy-related cause than White women.” Research is ongoing to specifically identify the root causes, which include socioeconomic factors such as insurance status, access to healthcare services, and risks associated with social determinants of health. For example, maternity care deserts exist in counties throughout the country where maternal health services are substantially limited or not available, impacting an estimated 2.2 million women of child-bearing age.
Many federal, public, and private datasets exist to understand the conditions that impact pregnant people, the quality of the care they receive, and ultimate care outcomes. For example, the CDC collects abundant data on maternal health, including the Pregnancy Mortality Surveillance System (PMSS) and the National Vital Statistics System (NVSS). Many of these datasets, however, have yet to be analyzed at scale or linked to other federal or privately held data sources in a comprehensive way. More broadly, an estimated 30% of the data generated globally is produced by the healthcare industry. AI is uniquely designed for data management, including cataloging, classification, and data integration. AI will play a pivotal role in the federal government’s ability to process an unprecedented volume of data to generate evidence-based recommendations to improve maternal health outcomes.
Applications of AI have rapidly proliferated throughout the healthcare sector due to their potential to reduce healthcare expenditures and improve patient outcomes (Figure 1). Several applications of this technology exist across the maternal health continuum and are shown in the figure below. For example, evidence suggests that AI can help clinicians identify more than 70% of at-risk moms during the first trimester by analyzing patient data and identifying patterns associated with poor health outcomes. Based on its findings, AI can provide recommendations for which patients will most likely be at-risk for pregnancy challenges before they occur. Research has also demonstrated the use of AI in fetal health monitoring.
Yet for all of AI’s potential, there is a significant dearth of consumer and medical provider understanding of how these algorithms work. Policy analysts argue that “algorithmic discrimination” and feedback loops in algorithms—which may exacerbate algorithmic bias—are potential risks of using AI in healthcare outside of the confines of an ethical framework. In response, certain federal entities such as the Department of Defense, the Office of the Director of National Intelligence, the National Institute for Standards and Technology, and the U.S. Department of Health and Human Services have published and adopted guidelines for implementing data privacy practices and building public trust of AI. Further, past Day One authors have proposed the establishment of testbeds for government-procured AI models to provide services to U.S. citizens. This is critical for enhancing the safety and reliability of AI systems while reducing the risk of perpetuating existing structural inequities.
It is vital to demonstrate safe, trustworthy uses of AI and measure the efficacy of these best practices through applications of AI to real-world societal challenges. For example, potential use cases of AI for maternal health include a social determinants of health [SDoH] extractor, which combines AI with clinical notes to more effectively identify SDoH information and analyze its potential role in health inequities. A center dedicated to ethically developing AI for maternal health would allow for the development of evidence-based guidelines for broader AI implementation across healthcare systems throughout the country. Lessons learned from this effort will contribute to the knowledge base around ethical AI and enable development of AI solutions for health disparities more broadly.
Plan of Action
To meet the calls for advancing data collection, standardization, transparency, research, and analysis to address the maternal health crisis, the Biden-Harris Administration should establish an AI Center of Excellence for maternal health. The AI Center of Excellence for Maternal Health will bring together data sources, then analyze, diagnose, and address maternal health disparities, all while demonstrating trustworthy and responsible AI principles. The Center should be created within the Department of Health and Human Services (HHS) and work closely with relevant offices throughout HHS and beyond, including the HHS Office of the Chief Artificial Intelligence Officer (OCAIO), the National Institutes of Health (NIH) IMPROVE initiative, the CDC, the Veterans Health Administration (VHA), and the National Institute for Standards and Technology (NIST). The Center should offer competitive salaries to recruit the best and brightest talent in AI, human-centered design, biostatistics, and human-computer interaction.
The first priority should be to work with all agencies tasked by the White House Blueprint for Addressing the Maternal Health Crisis to collect and evaluate data. This includes privately held EHR data that is made available through the Qualified Health Information Network (QHIN) and federal data from the CDC, Centers for Medicare and Medicaid (CMS), Office of Personnel Management (OPM), Healthcare Resources and Services Agency (HRSA), NIH, United States Department of Agriculture (USDA), Housing and Urban Development (HUD), the Veterans Health Administration, and Environmental Protection Agency (EPA), all of which contain datasets relevant to maternal health at different stages of the reproductive health journey from Figure 1. The Center should serve as a data clearing and cleaning shop, preparing these datasets using best practices for data management, preparation, and labeling.
The second priority should be to evaluate existing datasets to establish high-priority, high-impact applications of AI-enabled research for improving clinical care guidelines and tools for maternal healthcare providers. These AI demonstrations should be aligned with the White House’s Action Plan and be focused on implementing best practices for AI development, such as the AI Risk Management Framework developed by NIST. The following examples demonstrate how AI might help address maternal health disparities, based on priority areas informed by clinicians in the field:
- AI implementation should be explored for analysis of electronic health records from the VHA and QHIN to predict patients who have a higher risk of pregnancy and/or delivery complications.
- Drawing on the robust data collection and patient surveillance capabilities of the VHA and HRSA, AI should be explored for the deployment of digital tools to help monitor patients during pregnancy to ensure adequate and consistent use of prenatal care.
- Using VHA data and QHIN data, AI should be explored in supporting patient monitoring in instances of patient referrals and/or transfers to hospitals that are appropriately equipped to serve high-risk patients, following guidelines provided by the American College of Obstetricians and Gynecologists.
- Data on housing from HUD, rural development from the USDA, environmental health from the EPA, and social determinants of health research from the CDC should be connected to risk factors for maternal mortality in the academic literature to create an AI-powered risk algorithm.
- Understand the power of payment models operated by CMS and OPM for novel strategies to enhance maternal health outcomes and reduce maternal deaths.
The final priority should be direct translation of the findings from AI to federal policymaking around reducing maternal health disparities as well as ethical development of AI tools. Research findings for both aspects of this interdisciplinary initiative should be framed using Living Evidence models that help ensure that research-derived evidence and guidance remain current.
The Center should be able to meet the following objectives within the first year after creation to further the case for future federal funding and creation of more AI Centers of Excellence for healthcare:
- Conduct a study on the use cases uncovered for AI to help address maternal health disparities explored through the various demonstration projects.
- Publish a report of study findings, which should be submitted to Congress with recommendations to help inform funding priorities for subsequent research activities.
- Make study findings available to the public to help build public trust in AI.
Successful piloting of the Center could be made possible by passage of an equivalent bill to S.893 in the current Congress. This is a critical first step in supporting this work. In March 2021, the S.893—Tech to Save Moms Act was introduced in the Senate to fund research conducted by National Academies of Sciences, Engineering, and Medicine to understand the role of AI in maternal care delivery and its impact on bias in maternal health. Passage of an equivalent bill into law would enable the National Academies of Sciences, Engineering, and Medicine to conduct research in parallel with HHS to generate more findings and to broaden potential impact.
The United States has the highest rate of maternal health disparities among all developed countries. Yet more than 60% of pregnancy-related deaths are preventable, highlighting a critical opportunity to uncover the factors impeding more equitable health outcomes for the nation as a whole. Legislative support for research to understand AI’s role in addressing maternal health disparities will affirm the nation’s commitment to ensuring that we are prepared to thrive in a 21st century influenced and shaped by next-generation technologies such as artificial intelligence.
As the COVID-19 pandemic has clearly shown – American health is crucial to the health of our nation. Yet American health is under threat from all angles, from escalating chronic deadly diseases like cancer to rising mental health challenges and the growing overdose epidemic. All of these threats contribute to the United States ranking 31st in life expectancy at birth, one of the lowest in the developed world, despite having the highest health spending per capita.
At the State of the Union, the Biden Administration presented a bipartisan platform dedicated to securing the health and wellbeing of the American people, from our Veterans to our youth. An agenda is a first step – unified action on public health comes next. Evidence-based science policy can bring us closer to a healthier future. Since 2020, policy entrepreneurs have developed innovative implementation-ready policy proposals through the Day One Project (D1P) to tackle some of the biggest societal problems. Here are a few that speak to the current moment:
To combat cancer…
With the median monthly cost of cancer drugs topping $10,000, many families cannot afford the costs of caring for their loved ones. Yet, there are 1,100 FDA-approved off-patent generics that could be used for treating cancer, at a fraction of the cost. Congress should appropriate $100 million into Phase III clinical trials of off-patent generics for treating a variety of cancers. This funding can go towards the National Cancer Institute and be implemented through an open-source pharmaceutical R&D framework through accelerated progress towards accessible and affordable cures.
Environmental hazards are a growing driver of cancers, and disproportionately impact rural and disadvantaged communities. Air pollution has been linked to lung cancer, the most deadly cancer for both men and women in the US. An interagency collaboration led by National Oceanic and Atmospheric Administration and leveraging funds from the Inflation Reduction Act could deploy a network on low-cost, real-time, ground-based sensors in all 300 US cities with a population above 100,000 to track particulate matter rates. Connecting this data to relevant providers in these cities, such as federally-qualified community health centers, could inform physicians of high-risk sites to target early screening interventions. Further, materials composing American homes, from housing materials to pipe materials, and even water running in the faucets, have been identified as possible sources of carcinogens. The Biden Administration should launch the President’s Task Force on Healthy Housing and Water for Cancer Prevention to coordinate research, develop the statistical database, and prepare for regulatory actions.
Finally, innovations in primary care can also catch cancer at earlier stages in disease progression. Yet, many rural and disadvantaged communities lack access to primary care. The NIH’s $23 million investment investigating telehealth for cancer care will develop the best care strategies – but labor-market, technical, financial/regulatory barriers, and data barriers will remain for scaling to the broad population. The Biden Administration and Congress will need to collaborate to unlock barriers to delivering healthcare services directly to the American home, through reforming licensure, expanding broadband access, investing in new mobile healthcare devices, expanding Medicare and Medicaid reimbursements, and ensuring data interoperability.
To strengthen mental health…
Digital mental health technologies have enormous potential to combat the growing mental health crisis, as evidenced by the Administration’s plan on mental health research and development. Yet more work remains to build a national infrastructure for successful implementation of digital mental health services. The vast majority of digital mental health technologies are unregulated, as existing FDA standards fail to cover these emerging technologies because many do not make treatment claims. Congress should authorize Health and Human Services (HHS) to develop standards for digital mental health products to ensure clinical effectiveness, data safety, and mitigate risk. Technologies that meet these standards should then be reimbursable through Medicare and Medicaid, which will require further congressional action. Finally, the Substance Abuse and Mental Health Services Administration (SAMHSA) should create a National Center for Digital Mental Health to maintain a database of approved digital products, provide training to providers, and ensure compliance of developers with national standards.
Knowing that tech platforms can be harmful to the youth’s wellbeing, the Congress and the Administration can take several steps to protect children’s privacy. Congress can expand the technological expertise at the Department of Education (ED) to protect children’s privacy and security in schools as well as appropriate $160 million funding to the Federal Trade Commission (FTC) to expand Children’s Online Protection Privacy Act (COPPA) enforcement and further investigate technology companies extracting children’s data. The Administration can commission a task force to identify ways to protect children’s data through existing legislation such as the Family Educational Rights and Privacy Act and COPPA.
To tackle the opioid crisis…
The opioid crisis is claiming thousands of lives every year, and there is bipartisan consensus on action. The Centers for Medicare and Medicaid (CMS) has sought strategies to prevent opioid use disorders – which will require reforms to the insurance reimbursement model which less generously covers preventative services. The Biden Administration should pilot a multidisciplinary study group to implement payment for prevention, using opioid use disorders as the test case. Following the guidance of the study group, CMS should provide guidelines to contracts between states and managed care organizations (MCOs) and between MCOs and providers and provide necessary technical assistance to implement these guidelines.
To deliver on care for Veterans…
Five million veterans live in rural areas, and of those, 45% lack access to reliable broadband internet, reducing access to vital health services. To ensure Veterans remain connected to healthcare services wherever they are, the Veterans Health Administration (VHA) should partner with the Postal Service and/or Department of Agriculture to pilot telehealth hubs in rural communities using existing FY23 appropriations for telehealth. An initial focus of care delivery could be on digital mental health and suicide prevention. Going forward, care delivery innovations like this one, if successful, can inspire new policies for the broader population, if the VHA’s health policy mission is expanded. VHA should be added to strategic interagency health policy coalitions such as the ACA interagency working group on healthcare quality and Healthy People 2030 to share data, develop innovative projects, and evaluate progress.
There’s more work to be done to build a healthier future for all Americans – these ideas can be jumping off points for Executive and Congressional action. FAS will continue to develop and surface evidence-based policies that can make a difference, and submissions to the Day One project are always welcome.
For the United States, the economic, societal, and national security benefits of the life sciences are vast. The U.S. bioeconomy – the part of the economy driven by the life sciences and biotech, and enabled by engineering, computing, and information science – is valued at over $950 billion. Life sciences research leads to cleaner crops through pollution-free fertilizers, and access to life-saving vaccines, like those mRNA vaccines that helped counter the devastating impacts of COVID-19. And industries built on the life sciences create good-paying jobs across the country.
The 118th Congress can adopt policy to help drive U.S. biotech and biomanufacturing to grow regional prosperity, deliver on conservation goals, and improve U.S. competitiveness and resilience. Here are some ideas.
Advancing the U.S. Bioeconomy to Create Jobs and Bolster Competitiveness. Many provisions in the bipartisan CHIPS and Science Act are intended to enable the bioeconomy. Implementation should focus on three areas: cutting-edge R&D, fundamental and publicly available tools, and biomanufacturing. To further support fundamental research, Congress could direct the National Institutes of Health (NIH) to aim to maximize returns on its massive R&D budget by piloting novel funding mechanisms with evaluation through randomized control trials, funding more high-risk high-reward research, and dedicating more funding to early-career researchers. Congress could also establish a Plant Genome Research Institute (PGRI) that would drive plant genomics research and centralize federal government activities, helping to promote crop innovation and enable a diversified, localized, and resilient food system. And to ensure all Americans benefit fully, actions should be taken to address bias in medical technology at the development, testing and regulation, and market-deployment and evaluation phases.
To promote U.S. bioindustrial manufacturing scale-up and commercialization, Congress could authorize a Bio for America Program Office at the National Institute of Standards and Technology. With appropriations, the office would house a suite of initiatives:
- A Bioindustrial Production Consortium that coordinates precompetitive efforts helping to address the measurements, tools, and standards needed for advancing both research and commercial products in the bioindustrial production space, and that collaborates with BioMADE, industry, government scientists, and other stakeholders.
- BAPO Ventures, which would seed a nonprofit partnership manager to launch a U.S. Bioindustrial Production Investment Portfolio to crowd-in additional capital from non-federal government sources and makes calculated investments in early-stage, domestic bioindustrial production companies that demonstrate credible pathways to product commercialization.
- The Bioindustrial Production Scale-up Infrastructure Group, which as an initial step would work with both the interagency and non-federal government partners to conduct a comprehensive analysis of the U.S. bioindustrial production pilot- and intermediate-scale infrastructure landscape in order to develop a precision strategy for moving forward on domestic bioindustrial production scale-up capacity.
- A Bioindustrial Production Loan Program Office that relies on partners such as the U.S. Small Business Administration to help it provide debt financing for techno-economically sound, domestic demonstration- or commercial-scale bioindustrial production infrastructure projects.
Importantly, Congress can help prepare and invite more Americans into skilled jobs that support the bioeconomy, building a better future for Americans in all 50 states – including people of color, people with disabilities, and people from economically disadvantaged backgrounds – by funding modernized biology education, establishing world-class entrepreneurial hubs for biotechnology in non-traditional regions of the country, and supporting equitable access to industry-recognized certificates and work-based training.
Biotech can also be leveraged to fast-track our nation’s capability to deliver on conservation goals, remediate contaminated habitats, and detect dangerous environmental toxins and pathogens. To that end, Congress could establish a national center to achieve several important goals:
- Provide competitive grant funding across three key tracks – carbon capture, bioremediation, biomonitoring – to catalyze comprehensive environmental biotechnology research
- House a bioethics council to develop and update guidelines for safe, equitable environmental biotechnology use
- Manage testbeds to efficiently prototype environmental biotechnology solutions; and
- Facilitate public-private partnerships to help transition solutions from prototype to commercial scale.
Safeguarding Americans Against Biological Threats. The human and economic toll of COVID-19 has shown the need to be better prepared for future pandemics and epidemics. And yet, there is currently little to no economic incentive for pharmaceutical companies to engage in vaccine research for infectious diseases that have not, and yet could, cause a pandemic. To address this market failure, the U.S. should incentivize vaccine development for priority emerging infectious diseases through federal financing. Specifically, Congress should authorize and appropriate $10 billion to the Biomedical Advanced Research and Development Authority (BARDA) over 10 years to create an investment fund that would:
- Leverage demand-pull mechanisms to purchase vaccines in bulk during future outbreaks and promote innovation in vaccine R&D
- Support manufacturing and distribution facilities
- Provide limited government guarantees, equities, and securities to investors in vaccine development.
Masks, especially high quality respirators, are disease-agnostic tools that can help reduce infections from respiratory diseases like the flu virus and RSV. In turn, this can reduce the burden on doctors and hospitals, and avoid additional healthcare. To that end, the mail delivery system used to distribute COVID-19 diagnostic tests should be augmented by the addition of a masks via mail program. The COVID-19 test mailing program should be restarted and expanded to include an option for ordering one box of 10 free N95 masks every quarter, for those Americans who wish to participate. Additionally, rotating face-mask inventory from the Strategic National Stockpile in a “first in, first out” method will prevent masks from being stored past their recommended shelf life, and promote continual replenishment of the U.S.’s stockpile. The recent National Strategy for a Resilient Public Health Supply Chain, as well as the bipartisan PPE in America Act (H.R.1436) and the bipartisan PREVENT Pandemics Act (S.3799), all advocate for a rotating stock system; however, steps must be taken to better operationalize its implementation and instate a timeline. Congress should authorize the Administration for Strategic Preparedness and Response to grant the HHS Coordination Operations and Response Element key management and distribution responsibilities for critical diagnostic and preventative measures like tests and masks.
The impact of the COVID-19 pandemic was significantly worsened by the presence of diseases that persist at relatively stable case numbers within a particular region. Additional infections paired with COVID-19 infections can lead to lower survival rates and longer hospital stays, creating a drain on resources as well as higher morbidity and mortality effects. Congress should thus authorize an initiative within the Centers for Disease Control and Prevention that enhances the reporting and tracking of regional diseases and helps reduce the data gap that prevents actions and responses to countering circulating diseases. The initiative could be incorporated into S. 3814, the bipartisan Modernizing Biosurveillance Capabilities and Epidemic Forecasting Act.
Finally, the bipartisan Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA) will expire in 2023. This law contains several integral provisions for national health security, public health preparedness, biosurveillance, and emergency medical countermeasures, as well as authorizations for BARDA and the Assistant Secretary for Preparedness and Response (ASPR). Congress should re-authorize PAHPAIA, as it forms the bedrock of America’s pandemic preparedness architecture, and consider expanding its purview to address aspects of other U.S. challenges such as wildfires and antimicrobial resistance.
Bioeconomy in CHIPS and Science. There are many provisions critical to the U.S. bioeconomy in the CHIPS and Science Law, which Congress should ensure receive robust appropriations. These include:
- Coordinating and strategy activities in Title IV, focused on Bioeconomy Research and Development;
- Title III, Subtitle G, National Science Foundation Directorate for Technology, Innovation, and Partnerships. The directorate is authorized at $3.4 billion overall in FY 2024. The list of critical technologies the new directorate is intended to advance (Section 10387) includes biotechnology, medical technology, genomics, and synthetic biology, all relevant to the bioeconomy. The directorate also funds the Regional Innovation Engines program promoting biotech partnerships and commercialization efforts across the U.S. in biotech.
- Title II, Section 10221, which directs the National Institute of Standards and Technology to conduct an array of activities in engineering biology and biometrology.
- Title I, Section 10103, Department of Energy (DOE) Biological and Environmental Research (authorized at $947 million in FY 2024), which funds an array of fundamental research in the biosciences.
- Title I, Section 10112, Office of Science Emerging Biological Threat Preparedness Research Initiative (authorized at $50 million in FY 2024), which establishes a cross-cutting program to leverage DOE analytical resources and tools, user facilities, and advanced computational and networking capabilities to support efforts that prevent, prepare for, predict, and respond to biological threats to national security, including infectious diseases.
Congress should provide robust appropriations to all activities, as close to the CHIPS authorizations as possible, to ensure a dynamic and innovative bioeconomy sector.
Bioproduct Pilot Program. The National Institute of Food and Agriculture’s (NIFA) Bioproduct Pilot Program (created in the Infrastructure Investment and Jobs Act, Sec. 70501) is intended to increase economic activity in rural areas of the U.S. while also lowering commercialization risks associated with bringing biobased products to market. The program aims to study the benefits of using materials derived from covered agricultural commodities for manufacture of construction and consumer products. The program’s work also enables the development of a more circular economy, where finite resources are not just extracted and consumed but also regenerated in a sustainable manner. Adopting a more circular economy ensures that wealth and other economic benefits in the form of jobs and other opportunities are created, and stay in, rural communities, while learnings can be shared throughout the U.S. innovation ecosystem.
A total of up to $5 million is available for the program for each of FY 2022 and FY 2023. The availability of funds for the program should be extended through FY 2028, with yearly increases to a level above $5 million per year according to the requests of NIFA/the program team.
Scaling and Regionalizing Networked Bioindustrial Manufacturing. The 2023 NDAA (Division A, Section 215) directs the Secretary of Defense to establish and expand a network of manufacturing innovation institutes and intermediate scale facilities for R&D, piloting, and scaling of innovative bioindustrial manufacturing processes and products. Support for these activities is critical to ensure the industrial base can leverage bioindustrial manufacturing processes for the production of chemicals, materials, and other products necessary to support national security and secure fragile supply chains. Congress should provide $500 million in appropriations across national security bioeconomy activities including $300 million for biomanufacturing innovation institutes, in accord with the NDAA.
Countering Global Malnutrition to Enhance U.S. Security. Due to the COVID-19 pandemic, environmental impacts, and conflicts like the war in Ukraine, global rates of malnutrition are at eight percent and are forecast to become even worse. Providing life-saving treatment around the world serves a core American value of humanitarianism, and a priority for U.S. national security – the newly released National Security Strategy dedicates an entire section to food insecurity.
In 2021 legislation, Congress directed USAID to advance programs to prevent and treat malnutrition around the world and develop a Global Nutrition Coordination Plan. That legislation also directed USAID to create the Nutrition Leadership Council, which can help elevate nutrition programs across U.S. global health interventions and foster collaboration with other sectors, development agencies, partner governments, and local actors. These are important steps to create a centralized food security program with harmonized funding – a system to deploy a more effective response to end global malnutrition and improve U.S. national security.
Congress should work with the Administration to begin scaling up global malnutrition assistance in FY 2024, in accord with the 2021 legislation.
Supporting the U.S. Emergency Response Workforce. The National Disaster Medical System (NDMS) is an integral part of the United States’ pandemic and hazards preparedness and response infrastructure. NDMS has a unique ability to coordinate and deliver emergency medical services to both federal and state, local, tribal, or territorial (SLTT) agencies. During the COVID-19 pandemic, NDMS deployed all across the country to provide training, medical care, coordinate medical supply delivery, and ensure effective communication. Additional appropriations would go toward hiring more personnel and bolstering in-person activities in the wake of COVID-19. Congress should ensure NDMS is funded up to FY 2024 request levels.
The invention of pulse oximeters in the 1980s reshaped healthcare. While tracking blood oxygen content (commonly recognized as the “fifth vital sign”) once required a painful blood draw and time-delayed analysis, pulse oximeters deliver nearly instantaneous data by simply sending a pulse of light through the skin. Today, pulse oximeters today are ubiquitous: built into smartwatches, purchased at pharmacies for home health monitoring, and used by clinicians to inform treatment of everything from asthma to heart failure to COVID-19. Emerging algorithms are even incorporating pulse ox data to predict future illness.
There is a huge caveat. Pulse oximeters are medically transformative, but racially biased. The devices work less accurately on dark-skinned populations because melanin, the chemical which gives skin pigment, interferes with light-based pulse ox measurements. This means that dark-skinned individuals can exhibit normal pulse ox readings, but be suffering from hypoxemia or other critical conditions.
But because regulations to this day do not require diversity in medical device evaluation, many pulse ox manufacturers don’t test their devices on diverse populations. And because the Food and Drug Administration (FDA) has created streamlined pathways to approve new medical devices based on technology that is “substantially similar” to already-approved technology, the racial bias embedded in ‘80s-era pulse ox technology continues to pervade pulse oximeters on the market today.
COVID-19 illustrated, in devastating fashion, the consequences of this problem. Embedded bias in pulse oximeters demonstrably worsened outcomes for patient populations already disproportionately impacted by COVID-19. Studies show, for instance, that Black COVID-19 patients have been 29% less likely to receive supplemental oxygen on time and three times as likely to suffer occult hypoxemia during the pandemic.
Similar inequities persist across the health-innovation ecosystem. Women suffer from lack of sex-aware prescription drug dosages. Minorities increasingly suffer from biased health risk-assessment algorithms. Children and those with varying body types suffer from medical equipment not built for their physical characteristics. Across the board, inequities create greater risks of morbidity and mortality and contribute to ballooning national healthcare costs.
This need not be the status quo. If health stakeholders—including patient advocates, medtech companies, clinicians, researchers, and policymakers—collectively commit to systematic evaluation and remediation of bias in health technology, change is possible.
An excellent example is eGFR algorithms. These algorithms, used to assess kidney functionality, previously used faulty “correction factors” to account for patient race. But this correction did not actually correlate with biological realities—and instead of treating patients more effectively, it increased disparities in care. Motivated by the data, advocacy and industry organizations issued broad recommendations to avoid using the eGFR calculation. Hospitals and medical systems listened, dropping eGFR from practice, and the National Institutes of Health (NIH) is now committing funding to investigate alternative calculations.
We as a society must continue to root out bias in health technology, from development to testing to deployment.
When we develop new medical tools, we should consider all the populations who could ultimately need them.
When we test tools, we should rigorously evaluate outcomes across subgroup populations, looking for groups that might fare better or worse from its use in care.
And when we deploy technologies, we need to be ready to track the outcomes of their use at scale.
Engineers, researchers, and clinicians can support these goals by designing medical devices with equity in mind. The UK just launched its evidence-gathering process on equity in medical devices, looking into the impacts of bias and ways to build more equitable solutions. The FDA’s meeting reviewing the evidence on pulse oximetry is a start to auditing technologies for their performance on different populations.
Advocacy organizations can support these goals by providing input to ongoing policy processes. The Federation of American Scientists (FAS), alongside the University of Maryland Medical System, submitted a public comment to the FDA to call for regulations that will encourage the development of low-bias and bias-free tools. FAS is also convening a Forum on Bias in Pulse Oximetry to examine the consequences of bias, build an evidence base for bias-free pulse oximetry, and look ahead to approaches to build more equitable devices.
“Do no harm”, a central oath in medicine, is becoming exceedingly difficult in our technological age. Yet, with an evidence-based approach that ensures technologies equitably serve all groups in a population and works to correct them when they do not, we can come closer to achieving this age-old goal.
Most people will experience a severe pandemic within their lifetime, and the world remains dangerously unprepared. In fact, scientists predict a nearly 50% chance––the same probability as flipping heads or tails on a coin––that we will endure another COVID-19-level pandemic within the next 25 years. Shifting America’s pandemic response capability from reactive to proactive is, therefore, urgent. Failure to do so risks the country’s welfare.
Getting ahead of the next pandemic is impossible without government financing. Vaccine production is costly, and these expenses will hinder industries from preemptively developing the tools needed to halt disease transmission. For example, the total expected revenues over a 20-year vaccine patent lifecycle would cover just half of the upfront research and development (R&D) costs.
However, research suggests that a portfolio-based approach to vaccine development — especially now with new, broadly applicable mRNA technology — dramatically increases the returns on investment while also guarding against an estimated 31 of the next 45 epidemic outbreaks. With lessons learned from Operation Warp Speed, Congress can deploy this approach by (i) authorizing and appropriating $10 billion to the Biomedical Advanced Research and Development Authority (BARDA) (ii) developing a vaccine portfolio for 10 emerging infectious diseases (EIDs), and (iii) a White House Office of Science and Technology Policy (OSTP)-led interagency effort focused on scaling up production of priority vaccines.
Challenge & Opportunity
The COVID-19 pandemic continues to wreak havoc across the world, with an ongoing total cost of $16 trillion and more than 6 million dead. Three conditions increase the likelihood that we will experience another pandemic that is just as disastrous:
- New outbreaks of infectious diseases––like ––are emerging due to population growth, increased zoonotic transmission from animals, habitat loss, climate change, and more. Over 1.6 million yet-to-be-discovered, human-infecting viral species are thought to exist in mammals and birds.
- More laboratories are handling dangerous pathogens around the world, which increases the likelihood of an accidental contagion release.
- It is easier than ever to purchase biotechnologies once reserved only for scientists. Consequently, malign actors now have more resources to develop a human-engineered bioweapon.
The United States and the rest of the world are still woefully unprepared for future pandemic or epidemic threats. The lack of progress is largely due to little to no vaccine development for these six EIDs, all of which have pandemic potential:
- Middle East respiratory syndrome coronavirus (MERS-CoV)
- Lassa fever virus
- Nipah virus
- Rift Valley fever virus
- Chikungunya virus
- Ebola virus
Failure to produce and supply vaccines doses to Americans could undermine the U.S. government’s response to a vaccine crisis. This is illustrated in the recent monkeypox response. The federal government invested in a new monkeypox vaccine with a significantly longer shelf life. While focused on this effort, it failed to replace its existing vaccine stockpile as it expired, leaving the American population woefully unprepared during the recent monkeypox outbreak.
An immediate national strategy is needed to course correct, the beginnings of which are articulated in the recent plan for American Pandemic Preparedness: Transforming our Capabilities. These overarching concerns were also echoed in a bipartisan letter from the Senate Health, Education, Labor, and Pensions and Armed Services Committees, urging the Biden Administration to re-establish a “2.0” version of Operation Warp Speed (OWS)––the government’s prior effort to accelerate COVID-19 vaccine production.
The President’s recent FY23 Budget advocates for a historic pandemic preparedness investment. The plan allocates nearly $40 billion to the Department of Health and Human Services Assistant Secretary for Preparedness and Response to “invest in advanced development and manufacturing of countermeasures for high priority threats and viral families, including vaccines, therapeutics, diagnostics, and personal protective equipment.” BARDA also declared the need to prepare prototype vaccines for virus families with pandemic potential and has included such investments in its most recent strategic plan. And, the recent calls for increased “piloting and prototyping efforts in biotechnology and biomanufacturing to accelerate the translation of basic research results into practice.”
Robust federal investment in America’s vaccine industry is especially needed since––as demonstrated by COVID-19––industries garner minimal profit from vaccine development before or during a widespread outbreak. A recent study predicted that in the unlikely scenario where 10 million vaccines are manufactured during a crisis response, pharmaceutical companies can expect to recoup only half of the upfront R&D costs. The same research states that “new drug development has become slower, more expensive, and less likely to succeed” because:
- The probability of developing a successful vaccine candidate is low.
- A lengthy investment time (i.e., a long investment horizon) is required before selling for profit is possible.
- Clinical trials are very expensive.
- To justify and overcome all costs, a high financial return is needed (i.e., there is a high cost of capital).
With clinical costs accounting for 96% of total investment, companies have a weak financial justification for investing in risky vaccine research.
To minimize these uncertainties and improve investment returns for vaccine and therapeutic production, the federal government should embrace two key lessons from OWS:
- Guaranteed government demand enables the pursuit of innovative, speedy, and effective vaccine R&D. OWS selected companies pursuing different scientific methods to develop a vaccine, each of which possessed breakthrough potential. Moderna and Pfizer/BioNTech utilized mRNA, AstraZeneca and Janssen worked with replication-defective live vectors, and Novavax and Sanofi/GSK utilized a recombinant protein. Merck is working on a live attenuated virus that may be given orally. By frequently evaluating vaccine candidates, scientists ensured that only the most promising contenders continued to subsequent regulatory phases. This workflow dramatically expedited vaccine development. Relatedly, companies were able to invest in large-scale vaccine manufacturing during clinical trials thanks to government financial support. They not only received guaranteed investment installments, but also advanced commitments to purchase vaccines. This significantly decreased the financial risk and saved tremendous amounts of time and resources.
- Public-private partnerships utilize incentives and rewards to foster highly effective and dynamic teams. OWS created a “unique distribution of responsibilities … based upon core competencies rather than on political or financial considerations.” The interests of eight pharmaceutical companies were aligned based on the potential to receive an upfront commitment from the federal government to bulk purchase vaccines. Such approaches are critical to ensuring vaccine R&D not only happens in an efficient, coordinated manner but also that such R&D yields production at scale. Moreover, it enabled a suite of approaches to vaccine development rather than one method, raising the overall probability of developing a successful vaccine.
Repeating these lessons in subsequent EID vaccine developments would generate both significant returns on investment and benefits to society.
Plan of Action
By incentivizing vaccine development for priority EIDs, the federal government can preemptively solve market failures without picking winners or losers.
First, Congress should authorize and appropriate $10 billion to BARDA over 10 years to create a Dynamic Vaccine Development Fund. This fund would build on BARDA’s unique competencies as an engagement platform with the private sector. would allow for new developments to emerge
It would also enact the following strategies, gleaned from all of which were proven to be effective in OWS:
- Advanced market commitments to purchase large quantities of vaccines in cases of an outbreak.
- Ensuring steady incremental progress in combatting the most dangerous EIDs.
- Supporting manufacturing and distribution facilities.
- Providing limited government guarantees, equities, and securities to investors funding vaccine programs for a pre-specified list of priority diseases.
As illustrated by its successful history, BARDA is well-positioned to manage a large-scale vaccine initiative. Last year, BARDA announced the first venture capital partnership with the Global Health Investment Corporation to “allow direct linkage with the investment community and establish sustained and long-term efforts to identify, nurture, and commercialize technologies that aid the U.S. in responding effectively to future health security threats.” During the COVID-19 pandemic, BARDA and Janssen shared the R&D costs to help move Janssen’s investigational novel coronavirus vaccine into clinical evaluation—a collaboration supported by their previous successes on the Ebola vaccine. The Government Accountability Office reported that BARDA had also supported scaled production by identifying additional manufacturing partners. This partnership record shows that BARDA not only knows how to manage global health projects to completion but also is particularly adept at interfacing with the private sector. As such, it stands out as an ideal manager for the Dynamic Vaccine Development Fund.
With $10 billion, this Fund could not only support the vaccine economy, but also save millions of lives and trillions of dollars. Although the price tag is admittedly hefty, it is reasonable. After all, OWS had a price tag of $12+ billion––a small investment compared to the $16+ trillion cost of COVID-19. As seen in OWS, the long-term benefits of upfront, robust financing are even more impactful. One back-of-the-envelope calculation suggests immense economic returns for the Fund:
- With a 50% chance of another $16 trillion COVID-like pandemic in the next 25 years, the expected cost over this timeframe is $8 trillion globally.
- One expected outcome of this Fund would be to prevent 31 of the next 45 pandemics, or a nearly 69% chance of preventing the next epidemic in expectation.
- A 69% chance of preventing an $8 trillion cost over the next 25 years would yield an expected value of $5.6 trillion globally.
A $10 billion down payment would allow the Fund to excel in its normal operations (see bulleted list above) and support up to 120 vaccine candidates. OWS also spawned more than just new breakthrough R&D in the use of mRNA vaccine models. It also led to a health and biotechnology innovation windfall:
“Now that we know that mRNA vaccines work, there is no reason we could not start the process of developing those for the top 20 most likely pandemic pathogen prototypes”Dr. Francis Collins, former director of the National Institutes of Health
Ten billion dollars would ensure the Fund’s impact could be similarly force-multiplied by private sector partnerships. There would be more time available and more opportunity for creative partnerships with the private sector. The Fund’s purpose is to lower financial risks and attract large amounts of capital from the bond market, whose size outweighs the venture capital, public equity, or private equity markets. Indeed, there has been growing interest in the application of social bonds to pandemic preparedness as a unique instrument for rapidly frontloading resources from capital markets. Though this Fund will assume a different form, the International Finance Facility for Immunisation represents a proof of concept for coordinating philanthropic foundations, governments, and supranational organizations for the purpose of “raising money more quickly.” With seed capital, this Fund could provide a strong signal — and perhaps an anchor for coordination — to debt capital markets to make issuances for vaccines. To this end, the targeted critical mass of $10 billion is estimated to generate both tremendous societal value by preventing future epidemic outbreaks as well as producing positive returns for investors.
Second, in executing Fund activities, BARDA should leverage investment strategies––such as milestone-based payments––to incentivize maximum vaccine innovation. When combatting EIDs, the U.S. will need as many vaccine options as possible. To facilitate this outcome, vaccine manufacturers should be rewarded for producing multiple kinds of vaccines at the same time. For example, BARDA might support the development of vaccines for a given EID by funding progress for four novel methods (e.g., mRNA, recombinant protein, gene-therapy, and live attenuated, orally-administered vaccines).
Furthermore, these rewards should come regularly during major events––or “milestones”––during development. Initial-stage milestones include vaccine candidates that protect an animal model against disease; later-stage milestones include human clinical trials. This financing model would provide companies with clear, short-term targets, reducing uncertainty and rewarding progress dynamically. Additionally, it would support the recent executive order, which calls for “increasing piloting and prototyping efforts in biotechnology and biomanufacturing to accelerate the translation of basic research results into practice.”
BARDA could expand the milestone-based financing mechanism further by employing early-stage challenges. In this scenario, it would only fund the first two of three candidates that successfully complete small-scale clinical trials. The final milestone stage––which should only be offered to a limited number of candidates––should provide an advanced market commitment to house complete vaccines within U.S. storage facilities, based on the interagency effort (described in the paragraph below). The selections process would retain sufficient competition throughout the development process, while ensuring a sustainable method for scaling up certain vaccines based on mission priorities.
Third, to support Fund activities towards late-stage clinical trials, the White House Office of Science and Technology Policy (OSTP) should coordinate a larger-scale interagency effort leveraging advanced market commitments, prize challenges, and other innovative procurement techniques. OSTP should be a coordinator across federal agencies that address pandemic preparedness, which might include: the Department of Defense, BARDA, the U.S. Agency for International Development, the National Institute of Allergy and Infectious Diseases, the Federal Emergency Management Agency, and the Development Finance Corporation. In doing so, the OSTP can (i) consolidate investments for particular vaccine candidates, and (ii) utilize networks and incentive strategies across the U.S. government to secure vaccines. Separately––and based on urgent priorities shared by agencies––OSTP should work closely with the Food and Drug Administration (FDA) to explore opportunities for pre-approval of vaccines as they develop through the trial phase.
Vaccines are among the most powerful tools for fighting pandemics. Unfortunately, bringing vaccines to market at scale is challenging. However, Operation Warp Speed (OWS) established a new precedent for tackling vaccine innovation market failures, laying the groundwork for a new era of industrial strategy. Congress should take advantage and supercharge U.S. pandemic preparedness by enabling the Biomedical Advanced Research and Development Authority (BARDA) to build a Dynamic Vaccine Development Fund. Embracing lessons learned from OWS, the Fund would incentivize companies to create vaccines for the six emerging infectious diseases most likely to cause the next pandemic.
The regulatory process for approving vaccines is even more reason to develop them ahead of time—before they are needed, rather than after an outbreak. Having access to an effective vaccine even days sooner can save thousands of lives due to the exponential rate of growth of all infectious diseases. Moreover, the FDA approval process—especially its Emergency Use Authorization Program—is extremely efficient, and is not the bottleneck for vaccine development. The main delay involved in vaccine development is the time it takes to conduct randomized clinical trials. Unfortunately, there are no shortcuts to this process if we want to ensure that vaccines are safe and effective. That is why we need to develop vaccines before pandemics occur. The idea here is simply to develop the minimum viable product of vaccines for priority EIDs that positions these vaccines to rapidly scale in the event of a pandemic.
Yes, there are several examples of vaccine initiatives using this strategy. To list a few:
- The Coalition for Epidemic Preparedness Innovations (CEPI) has a “megafund” vaccine portfolio (i.e., they have 32 vaccine candidates as of April 2022). This portfolio spans 13 different therapeutic mechanisms and five different stages of clinical development, from preclinical to “Emergency Use Listing” by the World Health Organization.
- BridgeBio, Roivant Sciences have used portfolio-based approaches for drug development.
- The National Brain Tumor Society is also leveraging this approach to finance novel drug candidates that can treat glioblastoma.
Ideally, vaccines in the final milestone stage would be stored in the United States and in line with new CDC guidance in the Vaccine Storage and Handling toolkit. This prevents the scenario where vaccines are held up in transit due to complex international negotiations and, potentially, expire during the lengthy proceedings. This exact scenario occurred when the 300,000 doses of monkeypox vaccine held in a Denmark-based facility were slowly and inconsistently onshored back to the U.S.
In addition, vaccines that are financed through the Fund would not always be final products. Instead, they would potentially be at varying stages of development thanks to the milestone-based payment strategy and frequent progress reviews. This would make it easier for the federal government to closely coordinate vaccine development with manufacturing professionals and rapidly increase vaccine production if necessary. The strategy offered in this memo lowers the risk of a similar situation occurring again.
We recommend that the executive order on biomanufacturing continue exploring this issue and investigate ways to securely store completed vaccines. The Government Accountability Office, for example, recently suggested several promising and discrete changes to update the requirements and operations of the Strategic National Stockpile.
This list was derived from justifications listed on CEPI’s website, linked here.
There are simply too many infectious diseases in nature, and most of are too rare to pose a significant threat. It would be scientifically and financially impractical––and unnecessary––to develop vaccines against all of them. However, we can greatly increase our readiness by widening our scope and developing a library of prototyped vaccines based on the 25 viral families (as called for by CEPI). Doing so would allow us to respond quickly against even unlikely pandemic scenarios.
An estimated 815 million children (one in three) around the globe have dangerous levels of lead in their bloodstream, levels high enough to cause irreversible brain damage and impose severe health, economic, and societal consequences. 96% of these children live in low- and middle-income countries (LMICs), where collectively only about $6–10 million from non-governmental organizations is available each year to address the problem. To help eliminate childhood lead poisoning worldwide, the U.S. Federal Government should (1) add blood lead level (BLL) testing to the USAID-led Demographic and Health Survey Program, (2) create a Grand Challenge for Development to end childhood lead poisoning, and (3) push forward a global treaty on lead control.
Challenge and Opportunity
Lead is a potent toxin that causes irreversible harm to children’s brains and vital organs. Elevated body lead levels result in reduced intelligence, lower educational attainment, behavioral disorders, violent crime, reduced lifetime earnings, anemia, kidney disease, and cardiovascular disease. Impacts of lead on cognitive development are estimated to cause nearly $1 trillion of income loss in LMICs annually. Adverse health effects related to lead poisoning account for 1% of the global disease burden, causing 1 million deaths annually and substantial disability.
This enormous burden of lead poisoning in LMICs is preventable. It results from a combination of sources of exposure, some of the most important being:
- Lead that is intentionally added to paint, spices, cookware, and cosmetics.
- Lead that contaminates the environment from unsafe lead-acid battery and e-waste recycling practices.
- Lead that contaminates drinking water from pipes.
These sources of lead exposure have been effectively regulated in the United States and other high-income countries, which have seen average blood lead levels in their populations decline dramatically over the last 40 years. To achieve the same success, LMICs will need to prioritize policies such as:
- Regulation limiting the lead content of paint available on the market.
- Regulation of lead-acid battery and e-waste recycling.
- Inclusion of lead parameters in national drinking-water-quality standards.
- Regulation of the use of lead compounds in other locally important sources, such as spices, ceramics, cookware, toys, and cosmetics.
LMICs generally face three major barriers to implementing such policies:
- Lack of data on blood lead levels and on the scale and severity of lead poisoning. Most LMICs have no studies measuring blood lead levels. Policymakers are therefore unaware of the extent of the problem and hence unlikely to act in response.
- Lack of data on which sources of lead exposure are the biggest local contributors. Causes of lead poisoning vary spatially, but the vast majority of LMICs have not conducted source-apportionment studies. This makes it difficult to prioritize the most impactful policies.
- Limited access to equipment needed to detect lead in paint, spices, water, other sources, or the environment. Without needed detection capabilities, regulators cannot investigate the lead content of potential sources, nor can they monitor and enforce regulation of known sources.
These barriers are relatively simple to overcome, and when they are overcome do indeed result in action. As an example, at least 20 LMICs introduced legally binding lead paint regulation after the Global Alliance to Eliminate Lead Paint and its partners helped those countries confirm that lead paint was an important source of lead poisoning. Moreover, addressing childhood lead poisoning is in line with the priorities of the Biden Administration and the U.S. Agency for International Development (USAID). The Administration has already proposed an ambitious $15 billion plan to address childhood lead poisoning in the United States by eliminating lead pipes and service lines. By contributing to global elimination efforts (for only a fraction of what it will cost to solve the problem domestically), the Administration can multiply its impact on reducing childhood lead poisoning. Doing so would also advance USAID’s mission of “advanc[ing] a free, peaceful, and prosperous world”, since a reduction in childhood lead poisoning worldwide would improve health, strengthen economies, and prevent crime and conflict.
Plan of Action
Lead poisoning, from a variety of sources, affects one in three children worldwide. This is an unacceptable situation that demands action. The United States should adopt a three-part roadmap to help LMICs implement and enforce policies needed to achieve global elimination of childhood lead poisoning.
Recommendation 1. Add blood lead level (BLL) testing to the USAID-led Demographic and Health Survey.
USAID, through its Demographic and Health Survey (DHS), is in an ideal position to address the first barrier that LMICs face to implementing anti-lead poisoning policies: lack of data and awareness. The DHS collects, analyzes, and disseminates accurate and representative data on health in over 90 countries. Including BLL testing in the DHS would:
- Make accurate and representative data on the prevalence and severity of lead poisoning in LMICs available for the first time.
- Draw national and international attention to the immense burdens that childhood lead poisoning continues to impose.
- Determine which LMIC populations are most impacted by childhood lead poisoning.
- Motivate interventions to target the most impacted populations and most important sources of exposure.
- Support quantitative evaluation of interventions that aim to reduce lead exposure.
As such, USAID should add BLL testing of children into the DHS Biomarker Questionnaire for all host countries. This could be done in DHS revision for Phase 9, beginning in 2023. Including BLL testing in the DHS is also the first step to addressing the second barrier that LMICs face: lack of data on sources of lead exposure. BLL data collected through the DHS would reveal which countries and populations have the greatest lead burdens. These data can be leveraged by researchers, governments, and NGOs to investigate key sources of lead exposure.
BLL testing of children is feasible to carry out in the context of the DHS. It was successfully piloted in 1998 and 2002 via the DHS presence in India and Uzbekistan, but not rolled out further. Testing can be carried out using finger-stick capillary sampling and portable analyzers, so venipuncture and laboratory analysis are not required. Further, such testing can be carried out by health technicians who are already trained in capillary blood testing of children for anemia as part of the DHS. The testing can be conducted while questionnaires are administered, and results and any follow-up actions can be shared with the parent/guardian immediately. Alternatively, laboratory lead tests can be added onto sample analysis if blood draws are already being taken. Costs are low in both cases, estimated at around $10 per test.
Recommendation 2. Create a Grand Challenge for Development to end childhood lead poisoning.
Childhood lead poisoning in LMICs is dramatically neglected relative to the scale of the problem. Though childhood lead poisoning costs LMICs nearly $1 trillion annually and accounts for 1% of the global disease burden, only about $6–10 million per year is dedicated to addressing the problem. A USAID-led Grand Challenge for Development to end childhood lead poisoning would mobilize governments, companies, and foundations around generating and implementing solutions. In particular, the Challenge should encourage solutions to the second and third barriers presented above: lack of data on sources of lead exposure and limited detection capacity.
Recommendation 3. Push forward a global treaty on lead control.
A global push is needed to put childhood lead poisoning on the radar of decision-makers across the world and spur implementation and enforcement of policies to address the issue. The Biden Administration should lead an international conference to develop a global treaty on lead control. Such a treaty would set safe standards for lead in a variety of products (building on the Global Alliance to Eliminate Lead Paint’s toolkit for establishing lead-paint laws) and recommend regulatory measures to control sources of lead exposure. The success of the UN’s Partnership for Clean Fuels and Vehicles in bringing about global elimination of leaded gasoline illustrates that international political will to act can indeed be generated around lead pollution.
By implementing this three-part roadmap the Biden administration and USAID can make a historic and catalytic contribution towards global elimination of lead poisoning. There is true urgency; the problem becomes harder to solve each year as more lead enters the environment where it will remain a source of exposure for decades to come. Acting now will improve the health, wellbeing and potential of hundreds of millions of children.
Though relatively little investigation has been done on childhood lead poisoning in LMICs, the studies that do exist have consistently shown very high levels of lead poisoning. A recent systematic reviewidentified studies of background levels of childhood lead exposure in 34 LMICs. According to the review, “[o]f the 1.3 billion children (aged 0–14 years) living in the 34 LMICs with acceptable data on background blood lead levels in children, approximately 632 million…were estimated to have a level exceeding the CDC [Centers for Disease Control and Prevention] reference value of 5 μg/dL, and 413 million…were estimated to exceed the previous reference value of 10 μg/dL.” Data collected by the Institute of Health Metrics and Evaluation and analyzed in a joint UNICEF/Pure Earth report published in 2020 similarly concluded that dangerously elevated BLLs affect over 800 million children worldwide.
Major sources of lead poisoning in LMICs include paint, spices, cookware, pottery, pipes, cosmetics, toys, unsafe lead-acid battery recycling, unsafe e-waste recycling, and poorly controlled mining and smelting operations. High-income countries like the United States have relatively low levels of lead poisoning due to strong regulations around these sources of lead poisoning. Most high-income countries have, for instance, banned lead in gasoline and paint, set enforceable standards around the lead content of water, and imposed strong regulations around food adulteration. As a result, median BLLs in high-income countries have declined dramatically (in the United States, from 15ug/dL in the 1970s to <1µg/dL today). LMICs generally lack many of these effective controls around lead exposure and therefore have very high levels of childhood lead poisoning.
The most important thing that can be done to tackle the scourge of childhood lead poisoning is to impose source controls that prevent lead from entering the environment or consumer products. Though the relative contributions of different sources to childhood lead poisoning differ by country, effective policies and interventions tend to include:
- Regulations limiting the lead content of paint available on the market.
- Regulation of lead-acid battery and e-waste recycling practices.
- Inclusion of lead parameters in national drinking-water-quality standards.
- Regulation of the use of lead compounds in other locally important sources, such as spices, ceramics, cookware, toys, and cosmetics.
To enforce these policies, LMICs need testing capacity sufficient to monitor lead levels in potential exposure sources and in the environment. LMICs also need BLL monitoring to track the impact of policies and interventions. Fully eliminating childhood lead poisoning will ultimately involve abatement: i.e., removing lead already in the environment, such as by taking off lead paint already on walls and by replacing lead pipes. However, these interventions are extremely costly, with much lower impact per dollar than preventing lead from entering the environment in the first place.
An extreme lack of awareness, lack of data, and lack of advocacy around childhood lead poisoning in LMICs has created a vicious cycle of inattention. A large part of the problem is that lead poisoning is invisible. Unlike a disease like malaria, which causes characteristic cyclical fevers that indicate their cause, the effects of lead poisoning are more difficult to trace back.
As the United States continues to grapple with unprecedented economic, health, and social justice crises that have had a devastating and disproportionate effect on the very communities that have long struggled most, the next administration must act quickly to ensure equitable recovery. Improving economic mobility and increasing equity in communities furthest from opportunity is more urgent than ever.
The next administration must work with Congress to quickly enact a new round of recovery or stimulus legislation. State and local governments, school systems, and small businesses continue to struggle to respond to COVID-19 and the economic and learning losses that have accompanied the resulting closures. But federal resources are not unlimited and there is little time to spare – communities need positive results quickly. It is imperative, furthermore that the administration ensures that the dollars it distributes are used effectively and equitably. The best way to do so is to use existing evidence and data — about what works, for whom. and under what circumstances — to drive recovery investments.
Fortunately, the federal government has access to unprecedented evidence and data tools that can increase the speed and effectiveness of these urgent recovery and equity-building efforts. And where evidence or data do not exist, this unique moment affords an opportunity to build evidence about what does work to help communities recover and rebuild.
Thus, one of the first priorities of the next administration’s Office of Management and Budget (OMB) should be helping agencies develop their capacity to use existing evidence and data and to build evidence where it is lacking in order to advance economic mobility across the country. OMB should also support federal agency efforts to assist state and local governments to build and use local evidence that can accelerate economic growth and help communities recover from the current crises.
Specifically, OMB should issue guidance directing federal agencies to: 1) define and prioritize evidence of effectiveness in their grant programs to help identify what works, for whom, and under what circumstances to advance economic mobility post-COVID; 2) set aside 1% of discretionary funding for evidence building, including evaluations, technical assistance and capacity building; 3) support state and local governments in using recovery funding to build their own data, evidence-building and evaluation capacity to help their communities rebuild; and 4) require that findings from 2021 evidence-building activities be incorporated into strategic plans due in 2022.
The organ-donation crisis is one of the most persistent, expensive, and yet solvable public-health challenges of our time. As of January 2020, nearly 115,000 Americans were waitlisted for an organ transplant. The vast majority have kidney failure, which, as one of the rare conditions qualifying patients for Medicare, imposes billions of dollars of costs on taxpayers. In 2016 alone, taxpayers spent an alarming $113 billion on kidney disease — more than the entire budgets of the National Institutes of Health ($39 billion), the Department of Homeland Security ($44 billion), and the National Aeronautics and Space Administration (NASA, $21.5 billion) combined. The clear solution is to shorten the organ waiting list. For every Medicare patient who receives a kidney transplant, taxpayers save $250,000 in avoided dialysis costs. This proposal presents a discrete set of actions for the federal government to take to quickly and decisively to address the organ-donation crisis.