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.

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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.

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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.

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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:

• Building on the MCP efforts of the DoD by convening federal agencies (including DHS, the VA, and the Joint Chiefs of Staff) and other governmental, academic, and private-sector stakeholders to identify intermediate objectives, policies, and actions needed to achieve zero preventable deaths.
• Assigning accountability and responsibility for
  • Ensuring development of best practices, data standards, and research across the continuum of trauma care,
  • Evolving a data-driven research agenda to support trauma care,
  • Overcoming any policy or legislative complications resulting from the establishment of the military/civilian national trauma-care system, and
  • Executing a strategic communications plan for the effort.
  • Securing appropriate congressional appropriations and private sector funding to support the goals of eliminating preventable deaths and minimizing preventable disabilities.

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:

• Designating the Joint Chiefs of Staff Surgeon to be his representative to the task force.
• Ensuring that military department’s train and equip their forces to the combat- casualty-care personnel and system-support infrastructure requirements of combatant commanders.
• Confirming that the Undersecretary of Defense for Personnel and Readiness and the Assistant Secretary of Defense for Health Affairs have established medical-readiness policy and oversight consistent with the goals of the task force.
• Institutionalizing the military departments support for the military/civilian national trauma-care system.

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:

• Coordinating with governmental (federal, state, and local), academic, and private-sector partners to establish a national approach for improving trauma care preparedness for mass-casualty incidents.
• Integrating military/civilian trauma-care partnerships into the American College of Surgeon’s Verification, Review, and Consultation Program.
• Developing and implementing guidelines for establishing an appropriate number, level, and location of MCPs within a region based on the needs of the population and the training requirements of the military departments.
• Taking the leadership role for trauma-care research.
• Developing measures of effectiveness and measures of performance for themilitary/civilian trauma care system.

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.

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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.

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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.

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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.

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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:

• Transparency: public sharing of data/analysis in order to set a standard to which all OPOs can be held;
• Accountability: support for the OPO final rule, and any efforts to move up implementation date so all parts of the country can be served by high-performing OPOs as soon as possible in 2024; and
• Equity: commitment to analyzing/publishing data to ensure all parts of community served.

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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.

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:

• Teaching better practices for caloric intake, which can increase life expectancy;
• Incentivizing healthy eating with financial rewards, such as coupons, when purchasing fruits and vegetables;
• Teaching and encouraging adults to buy and prepare their own meals; and
• Enabling mutual aid initiatives such as community fridges, food banks, and free breakfast programs for those who are food insecure.

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.

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.

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. 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.

Challenge and Opportunity 

There is overwhelming scientific consensus that climate change is a dangerous global threat. Climate change, driven in large part by human-generated CO2 emissions, is already causing severe flooding, drought, melting ice sheets, and extreme heat. These phenomena are in turn compromising human health, food and water security, and economic growth.

Figure 1. Data collected from observation stations show how noticeably atmospheric CO2 concentrations have risen over the past several decades. (Data compiled by the National Oceanic and Atmospheric Association; figure by Klaus S. Lackner.)

Morton, E.V. (2020). Reframing the Climate Change Problem: Evaluating the Political, Technological, and Ethical Management of Carbon Dioxide Emissions in the United States. Ph.D. thesis, Arizona State University.

CO2 concentrations are higher today than they have been at any point in the last 3 million years. The contribution of human activity is causing CO2 emissions to rise at an unprecedented rate — approximately 2% per year for the past several decades (Figure 1) — a rate that far outpaces the rate at which the natural world can adapt and adjust. A monumental global effort is needed to reduce CO2 emissions from human activity. But even this is not enough. Because CO2 can persist in the atmosphere for hundreds or thousands of years, CO2 already emitted will continue to have climate impacts for at least the next 1,000 years. Keeping the impacts of climate change to tolerable levels requires not only a suite of actions to reduce future CO2 emissions, but also implementation of carbon dioxide removal (CDR) strategies to mitigate the damage we have already done.

The IPCC defines CDR as “anthropogenic activities removing CO2 from the atmosphere and durably storing it in geological, terrestrial, or ocean reservoirs, or in products.” While becoming more energy efficient can reduce emissions and using renewable energy causes zero emissions, only CDR can achieve the “net negative” emissions needed to help restore climate stability.

Five companies around the world — two of which are based in the United States — have already begun commercializing a particular CDR technology called direct air capture. Climeworks is the most advanced company, and can already remove 900 tons of atmospheric CO2 per year at its plant in Switzerland. Though these companies have demonstrated that CDR technologies like direct air capture work, costs need to come down and capacity needs to expand for CDR to remove meaningful levels of past emissions from the atmosphere.

Thankfully, the Energy Act of 2020, a subsection of the 2021 Consolidated Appropriations Act, was passed into law in December 2020. This act creates a carbon removal research, development, and demonstration program within the Department of Energy. It also establishes a prize competition for pre-commercial and commercial applications of direct air capture technologies, provides grants for direct air capture and storage test centers, and creates a CDR task force.

The CDR task force will be led by the Secretary of Energy and include the heads of any other relevant federal agencies chosen by the Secretary. The task force is mandated to write a report that includes an estimate of how much excess CO2 needs to be removed from the atmosphere by 2050 to achieve net zero emissions, an inventory and evaluation of CDR approaches, and recommendations for policy tools that the U.S. government can use to meet the removal estimation and advance CDR deployment. This report will be used to advise the Secretary of Energy on next steps for CDR development and will be submitted to the Senate Committee on Energy and Natural Resources and the House of Representatives Committees on Energy and Commerce and Science, Space, and Technology.

The Biden administration has clearly shown its commitment to combating climate change by rejoining the Paris Agreement and signing several Executive Orders that take a whole-of-government approach to the climate crisis. The Energy Act complements these actions by advancing development and demonstration of CDR. However, the Energy Act does not address CDR governance, i.e., the policy tools necessary to efficiently and ethically steward CDR implementation. A proactive governance strategy is needed to ensure that CDR is used to repair past damage and support communities that have been disproportionately harmed by climate change — not as an excuse for the fossil-fuel industry and other major contributors to the climate crisis to continue dumping harmful greenhouse gases into the atmosphere. The CDR task force should therefore leverage the crucial opportunity it has been given to shape future use of CDR by incorporating governance recommendations into its report.

Plan of Action

The Department of Energy’s CDR task force should consider recommending the following options in its final report. Taken together, these recommendations form the basis of a governance framework to ensure that CDR technologies are implemented in a way that most responsibly, equitably, and effectively addresses climate change.

Establish net-zero and net-negative carbon removal targets.

The Energy Act commendably directs the CDR task force to estimate the amount of CO2 that the United States must remove to become net zero by 2050. But the task force should not stop there. The task force should also estimate the amount of CO2 that the United States must remove to limit average global warming to 1.5°C (a target that will require net negative emissions) and estimate what year this goal could feasibly be achieved. Much like the National Ambient Air Quality Standards enforced by the Environmental Protection Agency, there should be a specific amount of CO2 that the United States should work toward removing to enhance environmental quality. This target could be based on how much CO2 the United States has put into the atmosphere to date and how much of that amount the United States should be responsible for removing. Both net-zero and net-negative removal targets should be preserved through legislation to continue progress beyond the Biden administration.

Design a public carbon removal service.

If carbon removal targets become law, the federal government will need to develop an organized way of removing and storing CO2 in order to reach those targets. Therefore, the CDR task force should also consider what it would take to develop a public carbon removal service. Just as waste disposal and sewage infrastructure are public services paid for by those that generate waste, industries would pay for the service of having their past and current CO2 emissions removed and stored securely. Revenue generated from a public carbon removal service could be reinvested into CDR technology, carbon storage facilities, maintenance of CDR infrastructure, environmental justice initiatives, and job creation. As the Biden administration ramps up its American Jobs Plan to modernize the country’s infrastructure, it should consider including carbon removal infrastructure. A public carbon removal service could materially contribute to the goals of expanding clean energy infrastructure and creating jobs in the green economy that the American Jobs Plan aims to achieve. 

Planning the design and implementation of a public carbon removal service should be conducted in parallel with CDR technology development. Knowing what CDR technologies will be used may change how prize competitions and grant programs funded by the Energy Act are evaluated and how the CDR task force will prioritize its policy recommendations. The CDR task force should assess the CDR technology landscape and determine which technologies — including mechanical, agricultural, and ocean-based processes — are best suited for inclusion in a public carbon removal service. The assessment should be based on factors such as affordability, availability, and storage permanence. The assessment could also consider results from the research, development, and demonstration (RD&D) program and the prize competitions mandated by the Energy Act when making its determination. The task force should also recommend concrete steps towards getting a public carbon removal service up and running. Steps could include, for instance, establishing public-private partnerships with prize competition winners and other commercialized CDR companies.

Create a national carbon accounting standard.

The Energy Act directs the RD&D program to collaborate with the Environmental Protection Agency to develop an accounting framework to certify how much carbon different techniques can remove and how long that carbon can be stored. This may involve investigating the storage permanence of various carbon storage and utilization options. This may also involve creating a database of storage lifetimes for CDR products and processes and identification of CDR techniques best suited for attaining carbon removal targets. The task force could recommend to the Secretary of Energy that the framework becomes a standard. A national carbon accounting standard will be integral for achieving carbon removal targets and verifying removal through public service described above.

Ensure equity in CDR.

While much of the technical and economic aspects of carbon removal have been (or are being) investigated, questions related to equity remain largely unaddressed. The CDR task force should investigate and recommend policies and actions to ensure that carbon removal does not impose or exacerbate societal inequities, especially for vulnerable communities of color and low-income communities. Recommendations that the task force could explore include:

• Establishing a tax credit for investing in CDR on private land. This credit would be similar to existing credits for installing solar and selling electricity back to the grid. Some or all of proceeds from the credit should go to help communities previously harmed by environmental injustice (i.e., “environmental justice communities”).
• Launching a CDR technology deployment program that gives environmental justice communities a tax credit or other financial benefit for allowing a CDR technology to be deployed in their communities. This “hosting” compensation would be earmarked for local environmental remediation.
• Incentivizing design of CDR technologies that deliver co-benefits. For instance, planting trees not only helps remove carbon from the atmosphere but also creates shade, provides habitat, and helps mitigate urban heat-island effects. Industrial direct air capture plants can be surrounded by greenspace and art to create public parks.
• Interviewing environmental justice communities to understand their needs and how those needs could be met through strategic implementation of CDR.

Include CDR in international climate discussions.

Because CDR is a necessary part of any realistic strategy to keep average global warming to tolerable levels, CDR is a necessary part of future international discussions on climate change. The United States can take the lead by including CDR in its nationally determined contribution (NDC) to the Paris Agreement. The U.S. NDC most recently submitted in April 2021 does discuss increasing carbon sequestration through agriculture and oceans but could be even more aggressive by including a broader suite of CDR technologies (e.g., engineered direct air capture) and prioritizing pursuit of carbon-negative solutions. The CDR task force could recommend that the Department of Energy work with the Special Presidential Envoy for Climate and the Department of State Office of Global Change on (1) enhancing the NDC through CDR, and (2) developing climate-negotiation strategies intended to increase the use of CDR globally.

Conclusion

Global climate change has worsened to the point where simply reducing emissions is not enough. Even if all global emissions were to cease today, the climate impacts of the carbon we have dumped into the atmosphere would continue to be felt for centuries to come. The only solution to this problem is to achieve net-negative emissions by dramatically accelerating development and deployment of carbon dioxide removal (CDR). As one of the world’s biggest emitters, the United States has a responsibility to do all it can to tackle the climate crisis. And as one of the world’s technological and geopolitical leaders, the United States is well positioned to rise to the occasion, investing in CDR governance alongside the technical and economic aspects of CDR. The CDR task force can lead in this endeavor by advising the Secretary of Energy on an overall governance strategy and specific policy recommendations to ensure that CDR is used in an aggressive, responsible, and equitable manner.

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:

• 3-D microscopy and ultra-fast imaging that enables real-time observations of brain-cell activity in intact tissues: key data for understanding circuit principles underlying human behavior.
• A sophisticated genetic method that could be helpful for finding new druggable targets that could be engaged to manage pain effectively, helping avoid the risks and harms of opioid drug addiction.
• A portable backpack supporting (i) simultaneous recording from a stimulator implanted into a human subject’s brain (part of an early-stage clinical trial), (ii) measurement of other biomarkers, and (iii) recording of the subject’s positions and movements within their environment. This integrated and comprehensive dataset is helping researchers understand links between neural-circuit activity and behavior in humans.

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:

• Developing a multibeam, large-scale electron microscope to map the wiring of neural circuits.
• Determining the molecular components of each cell of the brain.
• Fabricating a diverse array of implantable and wearable devices.
• Conducting supercomputer-enabled mining of large datasets to support neurotechnology development.

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.

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.

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.

To help catalyze innovation in the health and biomedical sciences, research and development (R&D) paradigms with a track record of producing ‘moonshot’-scale breakthroughs – such as the Advanced Research Projects Agency (ARPA) model – stand at the ready. The Biden Administration has recognized this, proposing the establishment of an ARPA for health (ARPA-H) as part of its fiscal year 2022 budget request. Done right, ARPA-H would be created in the image of existing ARPAs – DARPA (defense), ARPA-E (energy), and IARPA (intelligence) – and be capable of mobilizing federal, state, local, private sector, academic, and nonprofit resources to directly address the country’s most urgent health challenges, such as the high cost of therapies for diseases like cancer, or antimicrobial resistance. During a recent House Energy and Commerce Committee hearing, Chairwoman Anna Eshoo (D-CA) raised the Administration’s proposal for ARPA-H with Department of Health and Human Services (HHS) Secretary Xavier Becerra, expressing her interest in exploring how to best position a potential ARPA-H for success.

Keys to the ARPA model

The success of the ARPA model is attributed in part to the high level of autonomy with which its program leaders select R&D projects (compared to those at traditional federal research agencies), a strong sense of agency mission, and a culture of risk-taking with a tolerance for failure, resulting in a great degree of flexibility to pursue bold agendas and adapt to urgent needs. Policymakers have debated situating a potential ARPA-H within the National Institutes of Health (NIH), or outside of NIH, elsewhere under the umbrella of HHS. Regardless, it is essential that ARPA-H retain an independent and innovative culture.

The first ARPA – DARPA – was established in 1958, the year after Sputnik was launched, and is credited with developing GPS, the stealth fighter, and computer networking. DARPA continues to serve its customer – the Department of Defense – by developing groundbreaking defense technologies and data analysis techniques. Nevertheless, DARPA operates separately from its parent organization. This is also true of ARPA-E, which was launched in 2007 based on a recommendation from a National Academies consensus study report which called for implementing the DARPA model to drive “transformational research that could lead to new ways of fueling the nation and its economy,” and IARPA, created in 2006, to foster advances in intelligence collection, research, and analysis.

If ARPA-H is organized within NIH, it is essential that it maintain the innovative spirit and independence characteristic of established ARPAs. NIH already has some experience overseeing a partially independent entity: the National Cancer Institute (NCI). Compared to other NIH institutes, NCI’s unique authorities include:

• Direct access to the president;
• A requirement to submit a completely separate budget proposal to the president each year without getting approval from NIH or HHS; and
• The ability of the NCI director to form new cancer centers and training programs, establish advisory committees, and independently collaborate with other federal, state, and local entities.

This level of independence has contributed to NCI achieving a number of significant milestones in cancer treatment, including developing a chemotherapy treatment to cure choriocarcinoma (a rare type of cancer that starts in the womb), publishing the now-widely-used Breast Cancer Risk Assessment Model, and creating an anticancer drug for ovarian cancer that was unresponsive to other treatments.

If the NCI model were to be used as the foundation for the launch of ARPA-H, insulation from political considerations, whether those of Congress or the Executive Branch, would be critical. With DARPA-like autonomy, a potential ARPA-H could help push the boundaries of enrichments to human health.

Antimicrobial resistance as a case study for an ARPA-H

An example of a grand challenge that an ARPA-H could take on is addressing antimicrobial resistance, a worsening situation that, without intervention, will lead to a significant public health crisis. Antimicrobial resistance occurs when “bacteria, viruses, fungi, and parasites change over time and no longer respond to medicines, making infections harder to treat and increasing the risk of disease spread, severe illness, and death.” Microbes have the potential to gain resistance to drugs when not all of the pathogens or parasites are killed by a treatment, either because the treatment was the not correct option for the illness (like using antibiotics for viruses), or refraining from completing a prescribed course of an antimicrobial drug. The organisms that are not killed, presumably because they harbor genetic factors that confer resistance, then reproduce and pass along those genes, which make it harder for the treatments to kill them.

The most immediate concerns regarding antimicrobial resistance come from bacteria and fungi. The CDC considers some of the biggest threats to be Acinetobacter, Candida auris, and C. difficile, which are often present in healthcare and hospital settings and mainly threaten the lives of those with already weakened immune systems. Every year in the U.S., almost 3 million people are infected with antimicrobial-resistant bacteria or fungi, and as a result, more than 35,000 people die. While the toll of antibiotic resistance in the U.S. is devastating, the global outlook is perhaps even more concerning: in 2019, the United Nations warned that if no action is taken, antimicrobial resistance could cause 10 million deaths per year worldwide by 2050.

Developing new and effective antibiotics can help counter antimicrobial resistance; however, progress has been extremely slow. The last completely new class of antibiotics was discovered in the late 1980s, and developing new antibiotics is often not profitable for pharmaceutical companies. It is estimated that it takes $1.5 billion to create a new antibiotic, while the average revenue is about $46 million per year. In addition, while pharmaceutical companies receive an exclusivity period during which competitors cannot manufacture a generic version of their drug, the period is only five to ten years, which is too short to recoup the cost of research and development. Furthermore, doctors are often hesitant to prescribe new antibiotics in hopes of delaying the development of newly drug-resistant microbes, which also contributes to driving down the amount pharmaceutical companies earn for antibiotics.

Early last year, the World Health Organization reported that out of 60 antibiotics in development, there would be very little additional benefit over existing treatments, and few targeted the most resistant bacteria. Moreover, the ones that appeared promising will take years to get to the market. This year, Pew Research conducted a study on the current antibiotic development landscape and found that out of 43 antibiotics under development, at least 19 have the potential to treat the most resistant bacteria. However, the likelihood of all, or even some of these products making it to patients is low: over 95 percent of the products in development are being studied by small companies, and more than 70 percent of these companies do not have any other products on the market.

There is both a dire need for new innovations in the space, such as using cocktails of different viruses that attack bacteria to treat infections, and a gap between the research into and commercialization of new antibiotics – a perfect opportunity for a potential ARPA-H to make an impact. With this new agency, experimental treatments could be supported through the technology transfer process and matured to the point that the private sector is able to take the baton and move a new antimicrobial to market. This would be revolutionary for public health, and, combined with improved messaging around best practices for the use of antibiotics, save many lives.

Moving forward

The need for, structure, and possible priorities of a potential ARPA-H will continue to be discussed over the course of the congressional appropriations process, with consultation between the Legislative and Executive Branches. We encourage the CSPI community to serve as a resource for Members of Congress and their staffs to ensure that the new agency will be properly positioned to contribute to significant advances in human health and biomedical technologies.

WASHINGTON, D.C. — Today, the Federation of American Scientists (FAS), with financial support from Schmidt Futures, announced that six organ procurement organizations (OPOs) have joined the FAS Organ Procurement Organization Innovation Cohort, committing to use data science and transparency to accelerate improved patient outcomes and to inform ongoing, data-driven policy development. 

This follows the finalization of the bipartisan, scientifically-informed OPO rule that can save more than 7,000 lives each year, and which has been highlighted by both Senate and House leaders as an urgent equity issue. Given COVID-19’s potential to affect and attack organs, coupled with its disproportionate impact on communities of color, the need for reform is only intensifying.

Through the Federation of American Scientists, the OPO Innovation Cohort will share data to establish open and transparent lines of communication between OPOs as nonprofit government contractors and the public they serve, including branches of the federal government, in an effort to build trust and support further reforms that will save patient lives. (See data visualization from the OPO final rule here.)

Working with alumni from the United States Digital Service, over the next 12 months the Innovation Cohort will leverage the most granular OPO data ever shared with external researchers to inform ongoing policy development at the U.S. Department of Health and Human Services (HHS) and in Congress. During a transformative period in the organ procurement industry, the Innovation Cohort will help shape the future of organ recovery in America, improving OPO practice and informing OPO policy. Most importantly, the Innovation Cohort will help return OPOs to their core mission by singly focusing on striving toward new heights of operational excellence in order to increase organ transplants in an effort to best serve the public, organ donors, donor families and patients waiting for transplants.

In the coming months, the FAS OPO Innovation Cohort will share additional de-identified, retrospective data with the Federation of American Scientists to be published openly – including all referrals for donation made to the OPOs with every outcome documented, audits of hospital-level deaths, OPO financials (including organ acquisition charges), procurement and organ recovery data from organ recovery centers, and staffing models – and will work actively to source data science partners and researchers to mine these datasets for performance improvement insights.

“COVID-19’s ravaging effect on organs has further increased the urgency of accelerating accountability for the government’s contractors in organ donation. Transparency is a critical first step, and the Federation of American Scientists applauds today’s commitments from six OPO leaders to break from their peers and prioritize patients and the public interest.”

Federation of American Scientists Acting President Dan Correa

“So many of the problems and inefficiencies of the organ waiting list are solvable, but we need a new, data-driven approach. We look forward to seeing how the OPO Innovation Cohort, paired with interdisciplinary talent, can bring transformational change to a sector in dire need of it.”

Schmidt Futures Managing Director and Head of Partnerships Kumar Garg

 

The six OPO CEOs below have underscored their commitment to the following principles:

• Transparency: public sharing of data/analysis in order to set a standard to which all OPOs can be held;
• Accountability: support for the OPO final rule, and any efforts to move up implementation date so all parts of the country can be served by high-performing OPOs as soon as possible in 2024; and
• Equity: commitment to analyzing/publishing data to ensure all parts of community served.

Diane Brockmeier, Mid-America Transplant

Helen Irving, LiveOnNY

Ginny McBride, Our Legacy

Patti Niles, Southwest Transplant Alliance

Kelly Ranum, Louisiana Organ Procurement Agency

Matthew Wadsworth, LifeConnection of Ohio

 

Further, as the House Committee on Oversight and Reform is investigating “poor performance, waste, and mismanagement in organ transplant industry”, the OPOs in the FAS OPO Innovation Cohort offer themselves as a resource for Congressional staff, noting their commitment to transparency, accountability, and equity, setting a standard to which all OPOs should be held. The participating OPOs have informed AOPO that they are leaving AOPO, noting the Committee’s investigation into AOPO’s “lobbying against life-saving reforms.”

A full visualization of the final rule from Bloom can be viewed here.