Eliminating Childhood Lead Poisoning Worldwide

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:

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:

LMICs generally face three major barriers to implementing such policies:

  1. 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. 
  2. 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. 
  3. 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:

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. 

Conclusion

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. 

Frequently Asked Questions
How do we know that childhood lead poisoning is a global problem if there is very little data on it?

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.

Why are levels of lead poisoning so high in LMICs and what are the sources?

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.

What policies and interventions need to be in place in LMICs to eliminate 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.

Why is global childhood lead poisoning such a neglected issue despite its enormous scale?

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.

Creating Advanced Market Commitments and Prizes for Pandemic Preparedness

Summary

As part of its American Pandemic Preparedness plan, the Biden Administration should establish an interagency working group (IWG) focused exclusively on the design, funding, and implementation of advance market commitments (AMCs) and prizes for vaccine development. Under an AMC, pharmaceutical companies commit to providing many vaccine doses at a fixed price in return for a per-dose federal subsidy. Prizes can support AMCs by rewarding companies for meeting intermediate technical goals.

The IWG would immediately convene experts to identify suitable targets for ambitious vaccine-development and deployment efforts. The group would then work with stakeholders to implement AMCs and prizes crafted around these targets, offering a concrete and durable demonstration of the Administration’s commitment to proactive pandemic preparedness. As the American Pandemic Preparedness plan argues, an important part of rapid vaccine deployment is maintaining “hot manufacturing capacity”. Clear federal AMCs would create the market incentive needed to sustain such capacity, while simultaneously advancing procurement expertise within the federal government, in line with recent recommendations from a government review on the US supply chain. 

Challenge and Opportunity

Vaccines are very cost-effective medical interventions that have played a large role in reducing pathogen-induced deaths over the last 200 years. But vaccines do not yet exist for many diseases, including diseases concentrated in the developing world. Vaccines are undersupplied relative to their social benefit because their target populations are often poor and because strong political pressure for lower prices leads to low expected profits. When new vaccines are approved, scaling up production to fully supply low and middle-income countries (LMICs) can take up to 15 years. AMCs solve these issues by incentivizing vaccine development and hastening production scale-up. Prizes play an intermediate role by offering rewards for meeting technical goals along the way.


Vaccine AMCs have a track record of success. In 2007, GAVI, a public-private global health partnership based out of Geneva, launched an AMC for a pneumococcal conjugate vaccine (PCV) that covered pneumococcal strains more common in the developing world. The partnership received its first supply offers in 2009 (a fairly rapid response enabled by the fact that some PCV candidates were already in late-stage clinical trials). Compared to the rotavirus vaccine — which was developed around the same time but did not receive an AMC — PCVs achieved 3–4x greater coverage (defined as the fully vaccinated fraction of the target population). Moreover, new vaccines typically take about 10–15 years to become widely available in LMICs. PCV became available in those countries within a year. This example demonstrates the capacity of AMCs to incentivize rapid scaling. More recently, the United States (through Operation Warp Speed) and several other countries and organizations purchased substantial COVID-19 vaccine doses far in advance of approval, albeit using a more flexible AMC model that prioritized scaling production before data from clinical trials were available.

Plan of Action

To build on the progress and demonstrated success outlined above, the Biden Administration should invest in AMCs and prizes for vaccine development and deployment as part of its American Pandemic Preparedness plan. Below, we detail three specific recommendations for moving forward.

Recommendation 1. Form an Interagency Working Group (IWG) on Rapid Vaccine Innovation

Roles and responsibilities

Vaccine development and manufacturing is a multi-stage process that is too complicated for any single federal agency to manage. The Biden Administration should issue an Executive Order establishing an IWG on Rapid Vaccine Innovation.

Under emergency circumstances, the IWG would be the government hub for time-sensitive vaccine-procurement efforts. Under normal (non-pandemic) circumstances the IWG would focus on extant communicable diseases with a high disease burden and on potential future threats. This latter function would be carried out as follows.

1. Vaccine targeting. A “horizon scanning” IWG subgroup would identify priority targets for rapid vaccine development and broad deployment. The subgroup would consider factors such as pandemic potential, current disease burden, and vaccine tractability. The IWG would also consult with scientists at the VRC (whose work was essential to the rapid development of COVID-19 vaccines, and who already focus on viruses with pandemic potential) and at the CDC (which already performs pathogen surveillance) in making its determinations. Options for initial vaccine targets could include:

2. Incentive design. Once one or more vaccine targets are identified, an IWG subgroup comprising health economists and budget officers would design the AMC(s) and intermediate prizes intended to spur development and deployment of the target(s). Incentive design would (i) be carried out with substantial input from BARDA, which is familiar with the vaccine-manufacturing landscape, and (ii) consider both the technological distance of the target and market competitiveness. An output from this step would be a Vaccine Incentive Roadmap describing the different prizes and incentives that federal agencies will offer to ensure fast, consistent progress towards development and deployment of the target(s) in question. In other words, the linked prizes included in the roadmap will produce sustained incentives for continued forward progress on vaccine development. More information on this roadmap is provided below.

Structure and participation

The IWG should be structured as an integration, with each participating agency providing specific expertise on each aspect of the IWG’s charge. Participants should include senior leaders from the Biomedical Advanced Research and Development Authority (BARDA), the Centers for Disease Control and Prevention (CDC), the Department of Defense (DOD), the Food and Drug Administration (FDA), the U.S. Agency for International Development (USAID), US International Development Finance Corporation (DFC), and the Vaccine Research Center (VRC). BARDA has a track record of successful procurement of vaccines and expertise in negotiating with manufacturers. VRC’s founding mission is vaccine development and it has collaborated with manufacturers on large-scale production for multiple vaccines. They would provide expertise on vaccine tractability. Through upfront guidance on minimum efficacy requirements, the FDA will ensure vaccine standards. FDA will also work with global regulators on the possibility of regulatory reciprocity, akin to their PEPFAR program, which assists low-resource regulators in low and middle-income countries with decision-making.

The IWG should be chaired by a biosecurity expert housed at the White House Office of Science and Technology Policy (OSTP). 

Congressional notification

The IWGs recommendations (regarding both targets and AMC/prize design), once finalized, would be submitted to the Senate Health and House Ways and Means Subcommittee to request funding. Because federal agencies must notify Congress if they plan to disburse large prize sums (with agency-specific thresholds), this submittal would also serve as the required formal notification to Congress of prize amounts. 

Recommendation 2. Carry out the IWG’s Vaccine Incentive Roadmap

After the IWG has issued its recommendations on vaccine target(s) and incentive (AMC and prizes) design, implementation must follow. Where implementation support comes from will depend on the “technological distance” of the target(s) in question. 

Early-stage development focused on in-vitro or animal research should be supported with prizes from BARDA, the Department of Health and Human Services (HHS), and NIH. All federal agencies already have the authority to award prizes under the America Competes Act. Initial prizes could be awarded to vaccine candidates that successfully protect an animal model against disease. Later prizes could be awarded to candidates that hit clinical milestones such as completion of a successful Phase 1 trial in humans. We note that while agencies can theoretically pool funds for a multi-stage prize, cumbersome interagency processes mean that it will likely be easier to have separate agencies fund and oversee the separate prizes included in the roadmap. 

Later-stage development should be supported with larger prizes or purchases from USAID and DOD. Once a vaccine candidate has reached early-stage human clinical testing, larger prizes and/or different funding mechanisms will likely be required to advance that candidate to later-stage human testing. This is because costs of moving a vaccine candidate from the preclinical stage to the end of phase 2A (early-stage human clinical testing) range from $14 to $159 million dollars.

It is unlikely that a single federal agency would have the discretionary funds or willingness to sponsor a prize sufficient to incentivize participation in this process. Federal partnerships with private-sector entities and/or philanthropies could supplement federal prize funding. The promise of being a government-approved vendor of a vaccine or a DOD-supported prototype would serve as incentive for external entities to enter into such partnerships. USAID could also leverage its relationships with global health stakeholders and funders to provide incentive funding. Of course, external funding partnerships would be unnecessary if Congress appropriated sufficient designated funding for large vaccine-incentive prizes to relevant agencies.

An alternative to prize funding that would be appropriate for incentivizing later-stage R&D is use of the DOD’s Defense Commercial Solutions Opening (CSO) purchasing authority. DOD could use its CSO authority to pre-purchase vaccine doses in large quantities, effectively creating an AMC. Purchases of up to $100 million can be made through CSO authority. Early prize negotiations would use the leverage provided by becoming a government-approved vendor of vaccines (part of the CSO process) to negotiate for fair prices.  A second DOD purchase authority that could be used as an AMC-like incentive is the Other Transaction Authority (OTA), which exempts the DOD from some federal procurement regulations. OTA authority could likely be used to support vaccine research, purchase vaccine prototypes, and pay for some manufacturing of a successful prototype. OTA has also been used to fund research consortia, a possible alternative to a multi-stage prize roadmap. Purchases of up to $20 million can be made through OTA authority. In the context of diseases that affect low and middle income countries, a loan from the US International Development Finance Corporation (DFC) may be an option for supplementing an AMC.

Recommendation 3. Permanently expand BARDA’s mandate to include all communicable diseases, expand BARDA’s funding, and make BARDA the IWG’s permanent home

An IWG is a powerful tool for bringing federal agencies together. With existing prize authority and an administration that prioritizes vaccine development and deployment, much could be accomplished through only the steps outlined above. However, achieving truly transformative results requires a permanent and sustainably funded federal agency to be working consistently on advancing vaccines. Otherwise, future administrations may cancel ongoing IWG projects and/or fail to follow through. As the part of the federal government with the most expertise in therapeutics procurement, BARDA is an ideal permanent home for the IWG’s functions. 

BARDA’s mandate is currently limited to biological, chemical, or radiological threats to the health of Americans. This mandate should be expanded to include all important communicable diseases. The newly empowered BARDA would manage public-private partnerships for vaccine procurement, while  the NIH would remain the fundamental health-research arm of the U.S. government. Expanding BARDA’s mandate would require Congressional action. Congress would need to amend the Pandemic and All-Hazards Preparedness and Advancing Innovation Act appropriately, and would also need to appropriate specific funding for BARDA to carry out the roles and responsibilities of the IWG over the long term.

Frequently Asked Questions
What if we give pharmaceutical companies a bunch of taxpayer money to develop vaccine targets and they fail?

Prizes and AMCs only pay out when a product that meets pre-specified requirements is approved, so taxpayers won’t pay for any failures.

Tell me more about AMC design. What changes if a vaccine candidate is in the early-stage as opposed to the later-stage?

For technologically “close” vaccine targets with a high chance of imminent Phase 3 trial success, an AMC incentivizes rapid scale-up of manufacturing and ensures that more doses reach more people sooner. The AMC does this by circumventing a type of “hold-up” problem wherein purchasers negotiate vaccine prices down to per-unit costs. The 2007 GAVI Pneumococcus AMC was of this type. A GAS or malaria vaccine would similarly be “close” targets.


For more technologically distant targets, AMCs should incorporate “kill switches” that give future customers of the vaccine an effective veto over the AMC by way of not paying co-payments. This feature is designed to be a final check on the utility of a vaccine and avoids the difficulty of specifying standards for a vaccine many years ahead of time. An AMC structured in this way works well if a company manufactures a vaccine that meets pre-specified technical details but for hard-to-predict reasons is not useful.


For an especially distant target, a series of prize competitions could substitute for a traditional AMC. In this scenario, an initial prize could be awarded for any vaccine candidates that successfully protect an animal model against disease. A later prize could be awarded to candidates that hit clinical milestones such as completion of a Phase 1 trial in humans.


Other details of AMC and/or prize implementation depend on the market structure and cannot be determined ahead of time. For instance, the optimal AMC design is very different in monopoly versus competitive markets.

Why does this memo you propose a complicated multi-stage prize process instead of something simple like Operation Warp Speed?

Operation Warp Speed spent about $12 billion dollars on COVID-19 vaccine development and purchased hundreds of millions of vaccine doses far in advance of approval or clinical trials. While this was very effective, it is unlikely that Congress would be willing to appropriate such a large sum of money — or see that money disbursed so freely — in non-pandemic situations. A multi-stage prize process still incentivizes vaccine development and deployment but does so for a lower cost.

How can the federal government carry out these recommendations without provoking anti-vax sentiment?

The government could fund research into market segmentation for vaccines, since many who are vaccine-hesitant are avid consumers of alternative health products/supplements. There may be marketing and promotional strategies inspired by “natural” supplements that can increase vaccine uptake.

Doesn’t the federal government already fund influenza vaccine preparation? Why do we need a universal flu vaccine?

The federal government does fund influenza vaccine preparation, but that funding is only for a seasonal flu vaccine that works with 40–60% efficacy: a rate that is well below what other vaccines, such as the measles (97%) and mumps vaccines (88%) achieve. A pandemic influenza with an unexpected genetic background could still catch us by surprise. Investing in a universal influenza vaccine is essential in preparing for that eventuality.

What are the most likely points of failure for the steps outlined in this memo?

One issue is staffing. Drafting a high-quality AMC contract may require legal and economic expertise that isn’t available in-house at federal agencies, so the administration may need to engage external AMC experts. Another issue may be ensuring that activities outlined herein do not fall between interagency “cracks”. Assigning dedicated staff to oversee each activity will be important. A third issue is the potential for interagency friction. The more agencies that are involved with prize design, the longer it may take to design and authorize a given prize. One possible solution is to have only one agency administer each prize, with informal input from staff in other agencies when required.

Curing Alzheimer’s by Investing in Aging Research

Summary

Congress allocates billions of dollars annually to Alzheimer’s research in hopes of finding an effective prophylactic, treatment, or cure. But these massive investments have little likelihood of paying off absent a game-changing improvement in our present knowledge of biology. Funds currently earmarked for Alzheimer’s research would be more productive if they were instead invested into deepening understanding of aging biology at the cell, tissue, and organ levels. Fundamental research advances in aging biology would directly support better outcomes for patients with Alzheimer’s as well as a plethora of other chronic diseases associated with aging — diseases that are the leading cause of mortality and disability, responsible for 71% of annual deaths worldwide and 79% of years lived with disability. Congress should allow the National Institute on Aging to spend funds currently restricted for research into Alzheimer’s specifically on research into aging biology more broadly. The result would be a society better prepared for the imminent health challenges of an aging population.

Challenge and Opportunity

The NIH estimates that 6.25 million Americans now have Alzheimer’s disease, and that due to an aging population, that number will more than double to 13.85 million by the year 2060. The Economist similarly estimates that an estimated 50 million people worldwide suffer dementia, and that that number will increase to 150 million by the year 2050. These dire statistics, along with astute political maneuvering by Alzheimer’s advocates, have led Congress to earmark billions of dollars of federal health-research funds for Alzheimer’s disease.

President Obama’s FY2014 and FY2015 budget requests explicitly cited the need for additional Alzheimer’s research at the National Institutes of Health (NIH). In FY2014, Congress responded by giving the NIH’s National Institute on Aging (NIA) a small but disproportionate increase in funding relative to other national institutes, “in recognition of the Alzheimer’s disease research initiative throughout NIH.” Congress’s explanatory statement for its FY2015 appropriations laid out good reasons not to earmark a specific portion of NIH funds for Alzheimer’s research, stating:

“In keeping with longstanding practice, the agreement does not recommend a specific amount of NIH funding for this purpose or for any other individual disease. Doing so would establish a dangerous precedent that could politicize the NIH peer review system. Nevertheless, in recognition that Alzheimer’s disease poses a serious threat to the Nation’s long-term health and economic stability, the agreement expects that a significant portion of the recommended increase for NIA should be directed to research on Alzheimer’s. The exact amount should be determined by scientific opportunity of additional research on this disease and the quality of grant applications that are submitted for Alzheimer’s relative to those submitted for other diseases.”

But this position changed suddenly in FY2016, when Congress earmarked $936 million for Alzheimer’s research. The amount earmarked by Congress for Alzheimer’s research has risen almost linearly every year since then, reaching $3.1 billion in FY2021 (Figure 1).

This tsunami of funding has been unprecedented for the NIA. The seemingly limitless availability of money for Alzheimer’s research has created a perverse incentive for the NIH and NIA to solicit additional Alzheimer’s funding, even as agencies struggle to deploy existing funding efficiently. The NIH Director’s latest report to Congress on Alzheimer’s funding suggests that with an additional $226 million per year in funding, the NIH and NIA could effectively treat or prevent Alzheimer’s disease and related dementias by 2025. 

This is a laughable untruth. No cure for Alzheimer’s is in the offing. Progress on Alzheimer’s research is stalling and commercial interest is declining. Of the 413 Alzheimer’s clinical trials performed in the United States between 2002 and 2012, 99.6% failed. Recent federal investments seemed to be paying off when in 2021 the Food and Drug Administration (FDA) approved Aduhelm, the first new treatment for Alzheimer’s since 2003. But the approval was based on the surrogate endpoint of amyloid plaques in the brain as observed by PET scans, not on patient outcomes. In its first months on the market, Aduhelm visibly flopped. Scientists subsequently called on the FDA to withdraw marketing approval for the drug. If an effective treatment were likely by 2025, Big Pharma would be doubling down. But Pfizer announced it was abandoning Alzheimer’s research in 2018.

The upshot is clear: lavish funding on treatments and cures for a disease can only do so much absent knowledge of that disease’s underlying biological mechanisms. We as a society must resist the temptation to waste money on expensive shots in the dark, and instead invest strategically into understanding the basic biochemical and genetic mechanisms underlying aging processes at the cell, tissue, and organ levels.

Plan of Action

Aging is the number-one risk factor for Alzheimer’s disease, as it is for many other diseases. All projections of an increasing burden of Alzheimer’s are based on the fact that our society is getting older. And indeed, even if a miraculous cure for Alzheimer’s were to emerge, we would still have to contend with an impending onslaught of other impending medical and social costs. 

Economists and scientists have estimated extending average life expectancy in the United States by one year is worth $38 trillion. But funding for basic research on aging remains tight. Outside of the NIA, several foundations in the United States are actively funding aging research: the American Federation for Aging Research (AFAR), The Glenn Foundation for Medical Research, and the SENS Foundation each contribute a few million per year for aging research. Privately funded fast grants have backed bold aging projects with an additional $26 million. 

This relatively small investment in basic research has generated billions in private funding to commercialize findings. Startups raised $850 million in 2018 to target aging and age-related diseases. Google’s private research arm Calico is armed with billions and a pharmaceutical partner in Abbvie, and the Buck Institute’s Unity Biotechnology launched an initial public offering (IPO) in 2018. In 2021, Altos Labs raised hundreds of millions to commercialize cellular reprogramming technology. Such dynamism and progress in aging research contrasts markedly with the stagnation in Alzheimer’s research and indicates that the former is a more promising target for federal research dollars.

Now is the time for the NIA to drive science-first funding for the field of aging. Congress should maintain existing high funding levels at NIA, but this funding should no longer be earmarked solely for Alzheimer’s research. In every annual appropriation since FY2016, the House and Senate appropriations committees have issued a joint explanatory statement that has force of law and includes the Alzheimer’s earmark. These committees should revert to their FY2015 position against politically directing NIH funds towards particular ends. The past six years have shown such political direction to be a failed experiment.

Removing the Alzheimer’s earmark would allow the NIA to use its professional judgment to fund the most promising research into aging based on scientific opportunity and the quality of the grant applications it receives. We expect that this in turn would cause agency-funded research to flourish and stimulate further research and commercialization from industry, as privately funded aging research already has. Promising areas that the NIA could invest in include building tools for understanding molecular mechanisms of aging, establishing and validating aging biomarkers, and funding more early-stage clinical trials for promising drugs. By building a better understanding of aging biology, the NIA could do much to render even Alzheimer’s disease treatable.

Frequently Asked Questions
How did Congress get so interested in Alzheimer’s disease? What recent actions has Congress taken on funding for Alzheimer’s research?

In 2009, a private task force calling itself the Alzheimer’s Study Group released a report entitled “A National Alzheimer’s Strategic Plan.” The group, co-chaired by former Speaker of the House Newt Gingrich and former Nebraska Senator Bob Kerrey, called on Congress to immediately increase funding for Alzheimer’s and dementia research at the NIH by $1 billion per year.


In response to the report, Senators Susan Collins and Evan Bayh introduced the National Alzheimer’s Project Act (NAPA), which was signed into law in 2011 by Barack Obama. NAPA requires the Department of Health and Human Services to produce an annual assessment of the nation’s progress in preparing for an escalating burden of Alzheimer’s disease. This annual assessment is called the National Plan to Address Alzheimer’s Disease. The first National Plan, released in 2012, established a goal of effectively preventing or treating Alzheimer’s disease by 2025. In addition, the Alzheimer’s Accountability Act, which passed in the 2015 omnibus, gives the NIH director the right and the obligation to report directly to Congress on the amount of additional funds needed to meet the goals of the national plan, including the self-imposed 2025 goal.

Why is treating Alzheimer’s so hard?

Understanding diseases that progress over a long period of time such as Alzheimer’s requires complex clinical studies. Lessons learned from past research indicate that animal models don’t necessarily translate into humans when it comes to such diseases. Heterogeneity in disease presentation, imprecise clinical measures, relevance of target biomarkers, and difficulty in understanding underlying causes exacerbate the problem for Alzheimer’s specifically.


Alzheimer’s is also a whole-system, multifactorial disease. Dementia is associated with a decreased variety of gut microbiota. Getting cataract surgery seemingly reduces Alzheimer’s risk. Inflammatory responses from the immune system can aggravate neurodegenerative diseases. The blood-brain barrier uptakes less plasma protein with age. The list goes on. Understanding Alzheimer’s hence requires understanding of many other biological systems.

What is the amyloid hypothesis?

Alzheimer’s is named after Alois Alzheimer, a German scientist credited with publishing the first case of the disease in 1906. In the post-mortem brain sample of his patient, he identified extracellular deposits, now known as amyloid plaques, clumps of amyloid-beta (Aβ) protein. In 1991, David Allsop and John Hardy proposed the amyloid hypothesis after discovering a pathogenic mutation in the APP (Aβ precursor protein) gene on chromosome 21. Such a mutation led to increased Aβ deposits which present as early-onset Alzheimer’s disease in families.


The hypothesis suggested that Alzheimer’s follows the pathological cascade of Aβ aggregation → tau phosphorylation → neurofibrillary tangles → neuronal death. These results indicated that Aβ could be a drug target for Alzheimer’s disease.


In the 1990s, Elan Pharmaceuticals proposed a vaccine against Alzhiemer’s by stopping or slowing the formation of Aβ aggregates. It was a compelling idea. In the following decades, drug development centered around this hypothesis, leading to the current approaches to Alzhiemer’s treatment: Aβinhibition (β- and γ-secretase inhibitors), anti-aggregation (metal chelators),  Aβ clearing (protease-activity regulating drugs), and immunotherapy.


In the last decade, the growing arsenal of Aβ therapies fueled the excitement that we were close to an Alzheimer’s treatment. The 2009 report, the 2012 national plan, and Obama’s funding requestsseemed to confirm that this was the case.


However, the strength of the amyloid hypothesis has declined since then. Since the shutdown of the first Alzheimer’s vaccine in 2002, numerous other pharmaceutical companies have tried and failed at creating their own vaccine, despite many promising assets shown to clear Aβ plaques in animal models. Monoclonal antibody treatments (of which aducanamab is an example) have reduced free plasma concentrations of Aβ by 90%, binding to all sorts of Aβ from monomeric and soluble Aβ to fibrillar and oligomeric Aβ. These treatments have suffered high-profile late-stage clinical trial failures in the last five years. Similar failures surround other approaches to Alzheimer’s drug development.


There is no doubt these therapies are successful at reducing Aβ concentration in pre-clinical trials. But combined with the continuous failure of these drugs in late-stage clinical trials, perhaps Aβ does not play as major a role in the mechanistic process as hypothesized.

Maintaining Military Medical Readiness Today Saves Lives Tomorrow

Summary

Advances in military medicine are hard won during war but easily lost during peace. Though mortality rates of U.S. troops on the battlefield have improved significantly since World War II, the battlefield mortality rate at the beginning of a war often exceeds the battlefield mortality rate at the end of the previous war. Researchers attribute this phenomenon to erosion, during interwar years, of military readiness to provide combat healthcare. The Perelman School of Medicine at the University of Pennsylvania estimates that better maintaining military medical readiness could have prevented more than 100,000 combat deaths over the past 80 years.1

Loss of life following survivable injury is not unique to the military. Tens of thousands of U.S. civilians succumb to potentially preventable trauma-related deaths every year.2 Since military medical advances are frequently adopted by the civilian healthcare sector,345the White House,working with key federal agencies, should expand military-civilian partnerships (MCPs) in trauma care to achieve a national goal of eliminating preventable deaths. Such an initiative will save lives on the battlefield and the home front — with the ultimate goal of reaching zero preventable deaths.6

Challenge and Opportunity

An unprecedented percentage of service members wounded on the battlefields of Iraq and Afghanistan over the past 20 years made it home to their loved ones. This success is due to the professionalism of our uniformed healthcare providers and their innovations in responding to combat trauma — innovations that include moving blood products closer to the battlefield to lessen the effects of immediate and severe blood loss, deploying resuscitative surgical-system teams close to troops in enemy contact, splitting operations of forward surgical teams in two to increase coverage, and distributing tourniquets to every deployed service member.7

During times of peace, though, our military medical community loses its readiness to save life and limb on the battlefield. Statistics from the “War on Terror” illustrate the tragic consequences that arise when military medical readiness erodes during interwar years. Between October 2001 and June 2011, 4,016 U.S. combat troops died before they reached a military hospital. Of those, 976 (almost 25%) died from what are assessed to be battlefield-survivable injuries.8 A survey of general surgeons who provided deployed casualty care between 2002 and 2012 found that the majority of respondents felt underprepared to meet the demands of battlefield injuries.9

A key reason for interwar deterioration of military medical readiness is that during times of peace, Department of Defense (DoD) priorities shift from treating combat trauma to ensuring the general wellness of active-duty service members, their families, and other beneficiaries at Military Treatment Facilities (MTF) administered by the Defense Health Agency. While beneficiary care is an essential personnel benefit that should not and must not be diminished, it is also essential to recognize that the MHS does not provide sufficient training opportunities to maintain the proficiency of military medical personnel in treating battlefield trauma.10 An independent study conducted by the Institute for Defense Analysis found alarming misalignment between the top ten diagnoses on the battlefield in Iraq and the top 10 diagnoses in MTFs: while the former encompassed a variety of combat-related traumas, the latter were generally less serious (consistent with what one would expect for a predominantly young and healthy patient population). This divergence suggests that the primary missions of uniformed healthcare providers — (1) treating complex combat-related traumas, and (2) serving the needs of a family health practice — are not mutually supportive.11

Recognizing that the MTFs were not providing the necessary trauma-related training to maintain battlefield medical readiness, Congress has directed DoD to establish partnerships with civilian medical academic institutions and major metropolitan hospitals that host level I trauma centers. These partnerships are intended to ensure that the military’s wartime medical specialists12 are continually exposed to the volume and types of complex trauma necessary to ensure they are trained and prepared to rapidly deploy to an area of armed conflict.

These MCPs currently include the U.S. Army Trauma Training Center at Miami Dade Ryder Trauma Center in Florida, California’s U.S. Navy Trauma Training Center at USC/LA County, and the three U.S. Air Force Centers for Sustainment of Trauma and Readiness Skills located at the University of Maryland, the University of Cincinnati, and St. Louis University.13 While individually admirable, these MCPs constitute a patchwork that does not substitute for a coordinated national approach to curbing loss of military and civilian life from potentially survivable injuries. Because of this concern in Congress, section 757 of the FY 2021 NDAA directs DoD to conduct a systematic review of its MCPs to enhance the readiness of the military medical force to provide combat casualty care. The White House, working with the Departments of Defense (DoD), Health and Human Services (HHS), Homeland Security (DHS), and Veterans Affairs (VA), should build on results of the review and move quickly to expand military-civilian partnerships (MCPs) in the context of a national goal of eliminating preventable deaths.

Plan of Action

In 2016, the National Academies of Science, Engineering, and Medicine published a report14 explaining the need to establish a coordinated military/civilian national trauma-care system and presenting an action plan for achieving this goal. Below, we outline an updated, four-part version of the National Academies action plan. These actions will collectively shore up our nation’s military medical readiness, with benefits for American troops and American civilians alike.

Part 1

The White House should reaffirm its commitment to maintaining the quality of healthcare received by DoD beneficiaries, while also establishing national goals of (1) achieving zero preventable deaths from trauma-related injury and (2) minimizing trauma-related disability. It should be clear that these goals align both with the DoD’s mission of ensuring that uniformed medical personnel are prepared to provide battlefield healthcare and with HHS’ objective of strengthening the civilian healthcareworkforce to meet American needs. The White House should encourage partnerships between military and civilian trauma-care units to help achieve this goal.

Part 2

Within six months, the White House should establish a “Zero Preventable Deaths” task force overseen by the White House Office of Science and Technology Policy and cochaired by the HHS Assistant Secretary for Preparedness and Response and the Joint Chiefs of Staff Surgeon. The task force should be responsible for:

Part 3

The combatant commanders establish the medical requirements for their battle plans and the secretaries of the military departments are responsible for training and equipping their branch’s healthcare professionals to meet these demands. It’s the role of the Secretary of Defense to hold them accountable. The defense secretary does this by:

Part 4

The Secretary of Health and Human Services should position the Assistant Secretary for Preparedness and Response of HHS to lead civilian efforts of the task force. This role includes:

Frequently Asked Questions
1. Why is now the time to establish a national goal of zero deaths to survivable injuries?

We have just ended our country’s longest period of war and our military doctors are at their best. If we do not act now, much of what they have learned will be lost and some number of troops will die needlessly on future battlefields.

2. Would expanding MCPs improve the quality of healthcare provided to civilians?

Yes. During every armed conflict, the uniformed medical community makes incredible advances in preventing the deaths of our troops on the battlefield. MCPs ensure that civilian healthcare providers benefit from those advances.

3. Does expanding MCPs break faith with servicemembers and other DoD beneficiaries by weakening the quality of their healthcare?

No. The only priority more important than providing DoD beneficiaries access to the highest-quality healthcare available while the force is in garrison is saving the lives of our soldiers, sailors, airmen, marines, and guardians while the force is on the battlefield. And as discussed above, improving the readiness of military healthcare providers improves quality of care for all Americans.

4. Do DoD beneficiaries have access to quality healthcare at the MTFs?

Yes. But we should ask ourselves if the quality of some of the care delivered in the MTFs could be better. The medical community recognizes that high caseload volumes increase provider experience, which equals better outcomes for patients. But with a few exceptions (usually associated with newborn care, pregnancy, and maternal health), high volumes of work are not characteristic of the MTFs. For example, the consulting group CNA found that the best outcomes for knee replacements are observed in facilities that do 200 or more procedures a year. Only 13% of all knee replacements conducted in MTFs were conducted at MTFs that did 200 or more a year.

FAS Organ Procurement Organization Innovation Cohort Shares Data to Advance Organ Recovery Research

WASHINGTON, D.C.– Today the Federation of American Scientists (FAS) announced that the Organ Procurement Organization (OPO) Innovation Cohort is opening up ten years of data to engage in research to increase the rates of lifesaving organ donations every year.

Data from the U.S. Department of Health and Human Services (HHS) indicate that improvements in organ recovery practices will lead to at least 7,000 additional lifesaving transplants every year.

Bipartisan Congressional leaders have highlighted the need for accelerated data-driven reforms given COVID-19’s ravaging effects on organs. According to a July 19, 2021 letter led by the Senate Finance Committee and the House Committee on Oversight and Reform:

“The COVID-19 pandemic is exacerbating the need for organs now and creating an urgent health equity issue, as communities of color are disproportionately impacted by the failures of the current organ donation system and the effects of COVID-19.” 

Historically, OPO accountability and data-driven improvement has been hindered by opacity coupled with self-interpreted and self-reported performance data. The OPO Innovation Cohort will make public a trove of data regarding OPO performance, operations, finances, and governance with the goal of informing ongoing federal policymaking toward improving OPO performance and addressing health inequities. The first tranche of data released will be shared with MIT’s Healthy ML Lab and Wilson Lab, and will include case-level performance data, including all unstructured case notes, allowing for never-before-possible analysis of the organ donation process. Detailed data to be shared as part of the OPO Innovation Cohort can be found here. A visualization of OPO performance can be found here.

MIT’s Healthy ML Lab, led by Dr. Marzyeh Ghassemi, will review the de-identified case notes of seven OPOs, representing one-sixth of the country, to better understand where and how potential donors are lost, including by race and ethnicity. Dr. Ghassemi’s groundbreaking work will include using natural language processing and sentiment analysis of case notes to better understand the ways variation in care, communication and context might impact organ procurement and utilization. The Wilson Lab, led by Dr. Ashia Wilson, will target estimation of risks and opportunities for organ placement by OPOs to improve utilization and fairness of the organ transplant system. Dr. Wilson’s work specializes in using optimization to improve the efficiency and fairness of machine learning systems, and will bring this expertise to look for opportunities to increase the availability of organs for all demographic groups.

“Working with this data is a first step towards making better decisions about how to save more lives through organ procurement and transplantation. We have an opportunity to use machine learning to understand potential issues and lead improvements in transparency and equity,” said Dr. Marzyeh Ghassemi.

“Patients deserve transparency, and this research is even more important given what we are learning about COVID-19’s effects on organs,” said Jennifer Erickson, Senior Fellow, Federation of American Scientists.

The seven organ procurement organizations who are leading in opening up their data include: Donor Network West, Life Connection of Ohio, LiveOn New York, Louisiana Organ Procurement Agency, Mid-America Transplant, OurLegacy, Southwest Transplant Alliance. They have publicly committed to:

###

Federal Approval of Over-the-Counter Birth-Control Pills

Summary

Women have a right to contraception, regardless of circumstance. But this right has recently come under threat. Starting in 2016, multiple federal and state regulations pulled critical funding to reproductive and family-planning services. The COVID-19 crisis amplified the challenges Americans face while attempting to receive basic healthcare resources like birth-control pills. To reverse this worrying trend and ensure universal access to contraception in the United States, the federal government should approve over-the-counter (OTC) birth-control pills — thereby removing the need for a prescription to protect women’s health and prevent unintended pregnancies.

Specifically, the Biden-Harris Administration should commission the Food and Drug Administration (FDA) to create an OTC Monograph for oral contraceptives (i.e., birth- control pills). An OTC Monograph is a rulebook established by the FDA that gives specific instructions on the manufacture, distribution and marketing of non- prescription, OTC drugs. Circumstances are right for this action. 2020’s CoronavirusAid, Relief, and Economic Security (CARES) Act established the OTC Monograph Reforms, creating a new and efficient process to produce OTC drugs. The CARES Act also provided the FDA’s Department of Non-prescription Drugs with $110 million over five years1 to produce more OTC drugs. Oral contraceptives are ideal OTC candidates, having been proven safe and effective for 60 years. It is time for the United States to follow the example set by more than 100 countries to date and provide women with OTC birth-control pills.

Empowering Healthy Eating in America

Poor diets present elevated health risks, and Americans need help finding the time and resources to eat nutritiously

Americans get bombarded with promotions for unsubstantiated diet fads on the internet, are exposed to dubious weight-loss branded foods in grocery stores, and often struggle to eat nutritiously. The Dietary Guidelines for Americans recommend a balanced diet of two and a half cups of vegetables, two cups of fruit, six ounces of grains, three cups of dairy, five and a half ounces of protein, and 27 grams of oil every day. This diet is well-balanced, but it is neither practiced by, nor accessible to, all Americans (Figure 1).

Increasing numbers of Americans do not eat healthful diets. In 2018, the National Health and Nutrition Examination Survey found that one in three Americans eats fast food on any given day. Moreover, both rural and urban Americans report that lack of time and access to nutritious foods prevents them from cooking healthy meals. Indeed, a 2017 study indicated that the higher prices of healthy foods – nearly double those of unhealthy foods – can play a role in the U.S. population’s failure to achieve a nutritious diet. When healthy food cost even 14 percent higher than unhealthy food, there was a 24 percent decrease in consuming a high-quality diet. Unfortunately, an unhealthy diet can lead to a variety of health issues, such as obesity, type-2 diabetes, heart disease, and an increased risk of some cancers. To reverse poor health metrics such as the 42.4% of American adults over 20 years of age who suffered from obesity in 2018, policymakers and health experts alike hope to make healthy diets more accessible to all Americans.

Figure 1.

On average, people in the U.S. score between 56 and 60 (out of 100) when evaluated for healthy eating. The maximum test score of 100 points indicates adherence to the American Dietary Guidelines. Figure reproduced from Dietary Guidelines for Americans, 2020-2025.

To empower people to develop more nutritious eating habits, some experts recommend:

For some, the transition to eating a well-balanced diet will require learning how to cook, carving out time to prepare meals, or gaining an understanding of the nutritional value of various foods. In the U.S., there is no justifiable reason people should not be supported by their local, state, and federal governments in efforts to eat healthy.

To improve American dietary habits, policymakers can learn about and implement public health initiatives for nutritional education, as well as break down systemic barriers to healthy eating lifestyles.

This CSPI Science and Technology Policy Snapshot expands upon a scientific exchange between Congressman Bill Foster (D, IL-11) and his new FAS-organized Science Council.

American Rescue Plan Funding: A Playbook for Efficiently Getting the Lead Out

Summary

Lead is a neurotoxin that continues to harm communities across the country. Though new uses of lead in paint, gasoline, and pipes have been banned for several decades, lead in legacy products and materials remains in communities, posing an ongoing threat to human and economic development. Anywhere from 6 to 10 million residential lead service lines (LSLs), for instance, are still in use nationwide.

Funding included in American Rescue Plan (ARP) grant programs gives cities and states the opportunity to finally eradicate lead contamination in water lines. These steps outlined in this memo (and summarized in the figure below) represent a data- driven approach to rid American communities of the pernicious effects of lead contamination in water systems. This approach builds on research from the University of Michigan and subsequent implementation by BlueConduit in more than 50 cities in the United States and Canada.

Ensuring Good Governance of Carbon Dioxide Removal

Summary

Climate change is an enormous environmental, social, and economic threat to the United States. Carbon dioxide (CO2) emissions from burning fossil fuels and other industrial processes are a major driver of this threat. Even if the world stopped emitting CO2 today, the huge quantities of CO2 generated by human activity to date would continue to sit in the atmosphere and cause dangerous climate effects for at least another 1,000 years.1 The Intergovernmental Panel on Climate Change (IPCC) has reported that keeping average global warming below 1.5°C is not possible without the use of carbon dioxide removal (CDR).2 While funding and legislative support for CDR has greatly increased in recent years, the United States does not yet have a coordinated plan for implementing CDR technologies. The Department of Energy’s CDR task force should recommend a governance strategy for CDR implementation to responsibly, equitably, and effectively combat climate change by achieving net-negative CO2 emissions.

Establish a $100M National Lab of Neurotechnology for Brain Moonshots

A rigorous scientific understanding of how the brain works would transform human health and the economy by (i) enabling design of effective therapies for mental and neurodegenerative diseases (such as depression and Alzheimer’s), and (ii) fueling novel areas of enterprise for the biomedical, technology, and artificial intelligence industries. Launched in 2013, the U.S. BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative has made significant progress toward harnessing the ingenuity and creativity of individual laboratories in developing neurotechnological methods. This has provided a strong foundation for future work, producing advances like:

However, pursuing these ambitious goals will require new approaches to brain research, at greater scale and scope. Given the BRAIN Initiative’s momentum, this is the moment to expand the Initiative by investing in a National Laboratory of Neurotechnology (NLN) that would bring together a multidisciplinary team of researchers and engineers with combined expertise in physical and biomedical sciences. The NLN team would develop large-scale instruments, tools, and methods for recording and manipulating the activity of complex neural circuits in living animals or humans — studies that would enable us to understand how the brain works at a deeper, more detailed level than ever before. Specific high-impact initiatives that the NLN team could pursue include:

The BRAIN Initiative currently funds small teams at existing research institutes. The natural next step is to expand the Initiative by establishing a dedicated center — staffed by a large, collaborative, and interdisciplinary team — capable of developing the high-cost, large-scale equipment needed to address complex and persistent challenges in the field of neurotechnology. Such a center would multiply the return on investment in brain research that the federal government is making on behalf of American taxpayers. Successful operation of a National Laboratory of Neurotechnology would require about $100 million per year.

To read a detailed vision for a National Laboratory of Neurotechnology, click here.

Support Electrification at Regional Airports to Preserve Competitiveness & Improve Health Outcomes

Summary

The Biden-Harris Administration, Congress, and state legislatures should adopt measures to reduce the substantial health and environmental impact of America’s 5,000+ public airports while improving the competitiveness of American aviation. Aviation is our largest non-agricultural export industry, but we are losing our technological advantage to countries that have prioritized sustainable aviation technologies. Because our airports and aircraft use outdated technology, they disproportionately pollute the often-disadvantaged communities adjacent to them, causing health externalities while providing few benefits and job opportunities to local residents. Fixing this public health problem should start with the immediate phaseout of leaded aviation fuel, which is the largest source of lead emissions in the U.S. This should also be coupled with incentivizing advancements in sustainable aviation technology. The phaseout and innovation incentivization can be accomplished through regulatory agency mandates, new fees collected from combustion aircraft users, reprioritization of existing recurring federal funds for aviation, and allocation of additional funding—such as from the proposed national infrastructure plan—towards sustainable solutions. The focus of this funding should be comprehensive electrification of the entire aviation ecosystem, including airports, ground vehicles, support equipment, and aircraft. Electrification will remove the lead concern while also reducing other pollution and creating jobs. Funding for pollution mitigation and green job creation should be directed toward disadvantaged communities located near airports and U.S.-based small businesses developing green aviation technologies. These actions must be taken immediately, lest our public health continue to suffer, and lest we jeopardize the future of the U.S. aviation industry.

Challenge and Opportunity 

Small aircraft are the largest source of environmental lead pollution in the US. Blood lead levels are significantly elevated for children living within 0.6 mi (1,000m) of airports where leaded aviation fuel (avgas) is used. An estimated 16 million Americans are at risk of elevated blood lead levels because they live near a regional airport, where the majority of flight operations are undertaken by small piston engine aircraft burning leaded fuel. Lead is a neurotoxin for which there is no safe level of exposure, as determined by both the Centers for Disease Control (CDC) and the Environmental Protection Agency (EPA). However, the EPA has continued to permit over 2 grams of lead content per gallon of aviation gasoline, which is aerosolized into extremely dangerous microscopic particulate matter (PM) when burned in an aircraft piston engine. When inhaled, small PM is capable of directly entering the bloodstream. This lead exposure is especially dangerous for fetal development and for cognitive development in children. The science behind these effects is very well established because of decades of research into the effects of leaded automotive gasoline; this resulted in a complete ban of leaded gasoline in 1996, although aviation successfully lobbied for a special temporary exemption.

Monthly average child blood lead levels vs. sum of piston engine aircraft takeoffs and landings over time. This data was collected from over 1 million children living within 6.2 miles of 27 airports in Michigan with piston aircraft traffic. It is clear that blood lead levels rise and fall in concert with piston aircraft traffic.

Zahran et al., 2017.

Although most attention has been focused on about 30 large hub airports in the U.S., lead pollution occurs primarily at smaller regional airports due to their reliance on piston-engine aircraft. There are over 10,000 airstrips and over 5,000 public airports in the U.S., or a public airport within a 16-minute drive of the average American. The nearly 200,000 leaded-fuelburning aircraft operating from these airports are incapable of readily switching to unleaded fuel due to their outdated engine technology and the lack of availability of unleaded gasoline at most airports.

How widespread is this problem?

This is a map of regional airports where leaded avgas and other polluting fossil fuels are used. There are over 5,000 public airports in the US — or one within a 16-minute drive of the average American.

For both economic and technical reasons, a widespread, drop-in replacement for leaded aviation gasoline (avgas) has failed to emerge, despite the fact that leaded fuel was fully eliminated on our roads decades ago. Because of limited unleaded fuel supply, reduced power output, safety concerns, and pilot retraining needs, even engines theoretically capable of switching to unleaded fuel continue to use leaded fuel almost exclusively. However, simply switching to planes that use diesel or jet fuel is not the answer. Unlike cars, aircraft have no emissions control systems, and there is no existing way to install such systems. As a result, even aircraft that do not burn leaded fuel emit very high levels of PM and other forms of pollution detrimental to human health. For example, LAX alone produces nearly as much particulate pollution as all LA-area freeways combined, and LAX is just one of 39 airports in the local air district. It is critical to American public health that any policies to phase out leaded avgas concurrently foster adoption of reduced-emission and reduced-fuel-burn technologies (such as electric propulsion), rather than encourage switching to fuel-hungry and high-pollution unleaded gasoline engines, diesel engines, turboprops, and jet engines. 

This is also critical to American economic health: European and Asian companies are beating the U.S. at developing efficient unleaded-fuel engines and electric propulsion technology, winning market share in regions traditionally dominated by US-built light aircraft (e.g. where leaded fuel is unavailable or expensive). We need to invest in sustainable propulsion systems to maintain U.S. competitiveness, and lack of supportive policy action has hampered technological advancement. 

Zero funding, for example, has been allocated in the proposed American Jobs Plan to deal with dangerous aerosolized lead pollution from aviation, even though the plan dedicates $45B toward replacing lead pipes. Combating aviation pollution, however, offers a significant opportunity to pursue electrification, with a wide variety of shovel-ready airport project locations. The U.S. workforce can electrify airport infrastructure, ground vehicles, and aircraft domestically using existing and proposed federal funding as well as revenue from fees targeted at polluting aircraft. Shared charging infrastructure should be a special priority. Installing basic charging infrastructure at every one of the 5,000 public airports in the U.S. — focusing first on the 500 most heavily-used airports located closest to populated areas and in disadvantaged communities — is a highly achievable near-term goal at moderate expense. For instance, installing a 30-60 kW DC fast charger, which could charge small electric planes or ground vehicles, at the 500 highestpriority airports would cost less than $25M and could be completed in 2-3 years with sufficient federal backing.

Transitioning to biofuels or other so-called “sustainable” fuels can play a role, but should not be considered a substitute for fuel use reduction via electrification because their emissions can still be harmful. Both the biofuel supply chain and burning of biofuels, for example, emit a wide range of pollutants. Even green hydrogen, currently a tiny fraction of the world’s mostly fossil-fuel derived hydrogen supply, would still lead to emissions of water vapor. Water vapor is a powerful greenhouse gas when emitted at high altitude, and in some proposed implementations (such as direct hydrogen turbine combustion) hydrogen aircraft could also lead to significant high altitude nitrogen oxide pollution.

Electrification also offers an opportunity to better integrate airports into both urban and rural transit networks, provide clean energy and charging services to local communities (e.g., charging buses overnight), and improve resilience to power outages by offering grid storage. Electrification infrastructure at airports could include, for example, solar panels and grid storage doubling as power backup systems at airports. This would serve not just airport power needs but also those of surrounding communities, especially in remote areas prone to outages. This power system resilience is especially critical in disaster situations, where airports often serve as hubs for emergency responders.

In the near term, electrifying aviation entails plugging planes into gate power instead of burning fuel, using electric power to taxi to the runway, and operating electric tugs and ground equipment. Electrifying aviation also means investing in R&D, scaleup, and adoption of electric trainer aircraft, hybrid electric short-range cargo and passenger planes, and eventually longerrange commercial planes. As batteries and electronics improve, larger and larger planes will become more and more electric over time. To facilitate these technological advances in electric aviation and maximize public benefit, federal funding should focus on promoting adoption of electrification on routes not currently serviced or readily serviceable by rail or other alternative rapid, sustainable forms of transportation.

Plan of Action 

Infrastructure Funding 

Reprioritize existing funding sources, such as the Federal Aviation Administration (FAA) Voluntary Airport Low Emissions Program (VALE) program, to focus on sustainable infrastructure such as solar, storage, and chargers at both public airports and military airports. Supplement this funding by dedicating at least $10B of the proposed $25B of airport funding in the American Jobs Plan, or $20B of the proposed $56B Republican counter-offer, towards electrification across airports of all sizes. Initially prioritize: 

  1. The 500 most heavily-used airports located closest to populated areas and in disadvantaged communities,
  2. Regional airports that have far fewer logistical barriers to infrastructure projects than congested hubs, and
  3. Airports supporting routes not currently serviced or readily serviceable by rail.

R&D Funding 

Reprioritize existing federal research funding toward technologies aimed at reducing fuel burned by aircraft, such as significantly expanding current hybrid and electric aviation initiatives at the National Aeronautics and Space Administration (NASA), Department of Defense (DOD), Department of Transportation (DOT), and Department of Energy (DOE).1 Additional funding paid for by fees on polluting aircraft should be added to these existing pools of research dollars (see “Plan of Action” items 4-6). To remain competitive with accelerating civil and defense aviation technology development overseas, the government should direct a minimum of $2B in annual federal funding to electric aviation R&D. Funding should prioritize the development of US-designed and manufactured electric and hybrid electric aircraft technologies, including both retrofit and new-build planes, ground equipment, and ground vehicles. At least 50% of funds should be dedicated to small businesses.

The U.S. is currently the world leader in small aircraft production, but we are falling far behind Europe and Asia on electrifying fixed wing aircraft, funding development of new efficiency technologies, and implementing relevant policies. U.S. companies have instead focused primarily on low-capacity “flying cars” for carrying high-net-worth individuals short distances over traffic. The lack of funding and policy support for practical, high-impact innovation poses a significant threat to future U.S. competitiveness and jobs, especially in the export market.

Regulations 

The EPA should issue its final endangerment finding banning leaded fuels, and the Biden-Harris Administration should issue an executive order instructing the EPA and FAA to work together to eliminate lead pollution. This includes immediately implementing a 10-year phaseout mandate for the sale of leaded fuel, with use of leaded fuel banned after 2030 except for a limited number of historic aircraft. This phaseout timeline should be extended to 2040 in Alaska, due to the disproportionate impact on the greater than 80% of Alaskan communities reliant on small planes for year-round access. During the Obama Administration, an attempt was made to phase out leaded avgas, but it stalled largely because of the perceived impact on mobility in Alaska. It is critical to ensure that a phaseout plan recognizes Alaska’s needs and funds sustainable solutions suitable for an arctic operating environment.

It is not enough to simply ban lead, because this may incentivize switching to other highly polluting technologies like dirty unleaded gasoline engines, diesel engines, and far less fuelefficient turboprop or jet engines. Thus, it is critical that a leaded fuel ban be accompanied by the immediate implementation of a fuel efficiency mandate for aircraft that are based in or that regularly fly to the U.S. Inspired by the federal automotive Corporate Average Fuel Economy (CAFE) Standards program, this efficiency mandate should utilize multiple aircraft size categories with targets based on maximum takeoff weight (e.g., <1,000 lb, 1,000-5,000 lb, 5,000- 19,000 lb, 19,000-75,000 lb, 75,000-250,000 lb, and 250,000 lb+ categories). Efficiency targets should take into consideration typical missions and technical difficulty in reducing fuel burn for various types of aircraft. For instance, <19,000 lb aircraft are readily able to use hybrid electric propulsion — and, in some cases, pure electric propulsion — with existing technology and regulations. The largest aircraft flying long distance routes, on the other hand, will initially need to focus on smaller steps such as more efficient flight patterns, plugging into gate power/HVAC, electric taxi (either onboard or via tug), etc. until future technologies are developed; therefore, larger aircraft should have less aggressive targets (similar to less aggressive CAFE standards for larger vehicles). Technologies piloted in smaller electric aircraft will eventually make their way to larger aircraft, initially as high-power subsystems. Thus, these technologies are key early targets for federal funding and mandates. The overall “CAFE” goal should be a 25% reduction in overall U.S. aviation fossil fuel burned per passenger by 2030, and a 50% reduction by 2040.

Taxes

The following programs offer pathways for making electrification programs financially sustainable beyond the initial infusions of funding for infrastructure transformation and R&D.

Immediately implement a national $10 per flight hour use tax on all aircraft with 19 passenger seats or below. This should include an additional $2 per flight hour tax on leaded fuel burning aircraft and on any other aircraft burning more than 4 gallons of fuel per seat per flight hour. It is essential to avoid solely targeting leaded fuel piston aircraft, which would incentivize a switch to less fuel-efficient turboprop aircraft and business jets. 100% of tax revenues should be dedicated to the aviation industry and airports, and at least 50% of funds should go to small businesses. Tax revenues should be allocated toward: 

  1. The electrification of airports
  2. A “cash for clunkers” program to retire or retrofit polluting aircraft, with commercial and government operators receiving priority for funding. This funding should only be provided for US-manufactured or US-retrofit electrified aircraft. 
  3. Jobs training and career development for airport-adjacent communities. 

This would not be an undue burden on air travelers, because the owners and users of small aircraft are generally affluent. The Aircraft Owners and Pilots Association reports that the net worth of its average member is over $1.6 million. Aircraft operating in Alaska should be exempt from this tax until 2030. Revenue should exceed $260M/year based only on the base $10 fee, assuming pre-pandemic flight hour totals.

Immediately implement a $10 “Clean Skies Fee” per passenger for all international flights on planes with more than 19 passenger seats, excluding flights within North America, to be collected by air carriers from passengers at the time air transportation is purchased. The September 11 Security Fee offers a precedent for this type of fee.

An optional “Clean Skies Fund” contribution with suggested donations of $5, $10, $25, and $50 should also be offered at time of purchase for all flights on planes with more than 19 passenger seats—both domestic and international—to allow passengers an opportunity to further fund pollution-reducing technologies across the aviation ecosystem and to offset their personal environmental impact from flying. This fund is modeled after optional federal contributions such as the Presidential Election Campaign Fund.

A portion of collected funds should be provided to airlines and travel booking services in order to implement and maintain this contribution mechanism, which must be prominently featured in the booking process. Carriers will remit the fees to federal programs promoting reduction in fuel use, airport electrification, and jobs training. At least 50% of funds should go to small businesses. Revenue should exceed $2.34B/year assuming pre-pandemic international flight passenger demand.

For planes with more than 19 passenger seats, implement a similar $0.25/mile per passenger fee on all domestic and North America region flights effective in 2030 to fund fuel burn reduction and airport electrification. At least 50% of funds should go to small businesses, and all funds should be dedicated to projects that directly benefit airports and aviation, as well as increasing accessibility to all Americans.

Jobs 

The actions above should be immediately implemented in order to preserve the millions of U.S. jobs in the aerospace industry. Aircraft are the largest non-agricultural U.S. export product and one of the largest domestic manufacturing industries. As of 2018, the aerospace industry was directly responsible for over 2.4 million primarily high-paying U.S. jobs, many of which are union jobs or in STEM fields. Airlines directly employ nearly 500,000 Americans, and a wide variety of indirect jobs in travel agencies, airports, construction, and related industries are reliant on aviation. Although we support expanded low-emissions rail transportation, continued modal shift away from aviation towards automobiles would be devastating to the airline industry and increase overall emissions.

The U.S. currently leads the world in aviation manufacturing, but we are falling behind in electric aviation technology, including both airport-based ground vehicles and aircraft. We are headed towards an inflection point that will determine the future of the U.S. aviation industry. Either U.S. policy will promote adoption of more efficient technologies for aircraft as well as airport vehicles and equipment, thereby maintaining U.S. world leadership in aviation, or the U.S. will lose this market to other nations in Asia and Europe. The only way to preserve aviation jobs is by investing in efficiency and by enacting smart policies that promote private investment in and adoption of cleaner technologies. 

Not only can aviation jobs be preserved, but electrification of the aviation ecosystem will serve to create new green jobs related to air travel. This will include jobs in charging infrastructure installation, solar and storage construction, as well as related industries, which must be based locally and use U.S. labor. Further, if the U.S. leads in developing aviation electrification, there will be substantial export opportunities as other nations look to reduce aviation emissions and improve mobility. Potential clean aviation technology markets include countries such as Norway, which has committed to an electrified aircraft fleet by 2040 for all flights under 90 minutes duration, and Scotland, which has committed to a zero emissions airspace. Numerous other countries are actively considering similar policies, creating a significant opportunity for U.S. products.

Conclusion 

Aviation emissions, especially lead, are a clear and present danger to the health of Americans and the global climate. Failing to develop and deploy more efficient technology represents an equal danger to U.S. jobs and competitiveness. Thankfully, practical solutions exist today and even more are being developed to mitigate these dangers. To advance this mitigation, the Biden-Harris Administration and legislators should ensure that existing and new federal funding prioritizes holistic electrification of the aviation ecosystem, in addition to enacting legislation and regulations that ensure the success of this transition.

Federally-supported initiatives aim to reduce maternal mortality and shed light on the effects of therapeutics on pregnant and lactating women

Each year about 700 women die from pregnancy or birth complications in the U.S., the worst maternal mortality rate out of all industrialized countries. The need to improve U.S. rates of maternal mortality, as well as bolster research on the safety of prescription drugs for the health of pregnant and lactating women, were both raised during last week’s House Appropriations Committee hearing about the National Institutes of Health (NIH) future research and funding priorities.

The maternal mortality crisis

The rate of maternal deaths has been rising in the U.S. since 2000, taking a serious toll on families from all different backgrounds. Maternal mortality is defined as any deaths during a pregnancy or within 42 days of the end of the pregnancy from “any cause related to or aggravated by the pregnancy or its management.” More than half of maternal deaths occur after the day of birth, and one third occur during the pregnancy. The most common causes of death are cardiomyopathy (weakened heart muscles), blood clots, hypertension (high blood pressure), stroke, infection, and hemorrhage (heavy bleeding). This crisis is also exacerbated by disparities experienced by people of color: Black women are 2.5 times more likely to die than White women and three times more likely to die than Hispanic women.

Reducing maternal deaths, particularly among communities of color, is a top priority for  Diana Bianchi, the director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Just last year, the NIH established the Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) Initiative. It aims to “mitigate preventable maternal mortality… and promote health equity” by using “an integrated approach to understand biological, behavioral, sociocultural, and structural factors.” The IMPROVE initiative has already awarded over $7 million in grants to address disparities in maternal mortality.

The lack of knowledge about safe drugs for pregnant and lactating women

While there are several active efforts to address maternal mortality, one aspect of women’s health that has not received as much attention: there is a significant lack of knowledge as to which drugs are safe for pregnant and lactating women to use. While this problem has existed for a long time, it is brought into clear focus when examining the recent clinical trials for COVID-19 treatments. Out of 927 clinical trials worldwide, only 16, less than 2%, evaluated the effectiveness of a treatment on pregnant women and their fetuses. More than half of the clinical trials excluded pregnant women specifically. Both Representatives John Moolenaar (R-MI) and Lois Frankel (D-FL) raised the knowledge gap in safe treatments for pregnant and lactating women during the hearing. 

The exclusion of pregnant women from clinical trials largely stems from the thalidomide and diethylstilbestrol (DES) tragedies in the mid-1900s. DES entered the market in 1938 and was promoted as a way to prevent miscarriages and premature births, but almost 40 years later, researchers found the drug actually caused rare cancers in the daughters born to mothers who took it, as well as structural changes to the reproductive tract, and infertility. It also elevated risks of breast cancer in the mothers. Thalidomide was used during the late 1950s and early 1960s to treat morning sickness. Researchers found, however, that the drug caused devastating birth defects in babies. After these tragedies, the Food and Drug Administration (FDA) published guidelines in 1977 that prevented pregnant women from participating in phase I and phase II clinical trials.

Though it is now possible for pregnant women to enroll in clinical trials due to the passage of the NIH Revitalization Act of 1993, the researchers may only recruit them if the clinical trials adhere to strict regulations. Current regulations require conducting preclinical studies with pregnant animals and clinical studies with nonpregnant women prior to enrolling pregnant women. The clinical trials must also ensure the “least possible” risk to achieve objectives of the research, among other obligations. Because these requirements add time and cost to clinical trials, as well as necessitate the recruitment of sufficient numbers of pregnant women, many researchers opt not to include them. The Centers for Disease Control and Prevention estimate that 70% of pregnant women take at least one prescription drug. Nevertheless, the fact that researchers rarely include pregnant women in clinical trials results in these women not having clear information about what drugs are safe for them and their babies. One study found that 90% of drugs approved by the FDA between 1980 and 2000 had no data about the drugs’ potential effects on pregnant women and their fetuses. Drug manufacturers now choose to track possible side effects after a drug’s release via self-reported registries. However, the requirement for pregnant women to report their own symptoms can skew the data toward only severe reactions, and omit any milder, but still clinically important, symptoms.

As part of the 21st Century Cures Act, NIH established the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) to provide recommendations and an implementation plan on how to integrate pregnant and lactating women into drug safety research. The task force has already had a positive effect on the work at NIH, and helped launch the Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub. The goal of the hub is to establish a center of knowledge  that explains what drugs pregnant and lactating women can take safely, and the effects of medicines on babies.

More to be done

The initiatives NIH has launched so far are vital to reduce maternal mortality and support the health of pregnant and lactating women. These topics will likely continue to be priorities of the Biden Administration and Congress. If you have ideas on how the federal government can support further research in maternal health, we encourage you to serve as a resource for Members of Congress and their staff.