Number one. That was the ranking given to the United States’ ability to respond to a pandemic by the 2019 Global Health Security Index from Johns Hopkins University. The report highlighted the United States’ relative advances in terms of its healthcare workforce, laboratory capacity, and emergency planning to explain why the country could contain a major pandemic. In the last few months, however, a nearly opposite scene has played out. America has 10 million coronavirus cases, the highest total in the world. The country has gone through a first, second, and now third wave of coronavirus cases, which have caused over 240,000 deaths and devastated the economy. Worst yet, the pandemic still threatens to overwhelm the American healthcare system, with nearly 60,000 COVID-19 hospitalizations occurring across the country.
These images are a far cry from the predictions of a highly effective American response and thus pose an important question: How did a wealthy country, famous for its medical prowess, end up being hit so hard by the disease? How did America fail to contain the pandemic like other nations in Europe and Asia?
There are no simple answers to these questions. Many factors, from wealth and racial inequalities to the accessibility of healthcare and more, all played a role in causing the American coronavirus pandemic to reach this scale. But one factor few have considered, yet which may have had the largest impact, may be what could be called the “structural fragility” of American scientific and governing institutions.
Structural fragility refers to the idea that America’s scientific and governing institutions may be incredibly effective in some cases, often those in which the government has expertise, from eradicating known diseases to expanding access to healthcare. But they are also institutions that are heavily reliant on a precise confluence of political, economic, and societal factors to function, and when these factors are changed, these institutions can struggle to adapt. When the coronavirus pandemic hit, this exact problem happened, with the virus testing and exploiting the structural fragility of American institutions to devastate the country.
A Delicate Dependence
The best place to view this structural fragility may be the defining relationship in the American system of government: federalism. Federalism refers to the division of power between the states and the federal government, where Washington has certain roles, such as conducting foreign relations or regulating interstate commerce, and the states have others, such as raising state taxes and more. As a result, the regulation of many national issues requires a delicate and often fragile degree of cooperation between the two branches; they must work together to harmonize and pass laws to regulate everything from the environment to education and more.
Due to its division of powers and reliance on intergovernmental cooperation, the federalist system has long-been hailed as a check against tyranny by one level of government. However, the system’s delicate and fragile dependence on the balance of power between Washington and the states gives it vulnerabilities, ones that the virus was all too happy to exploit, as described by Professor Donald Kettl, a leading scholar of federalism at the University of Texas.
In an interview with the HPR, Kettl described that the federal government and the Trump administration, at the beginning of the pandemic, decided “it did not want to own the solutions” to the virus. Instead, Washington made what Kettl describes as a “conscious policy decision to shift the balance of power in dealing with this national crisis to the states.” He described how that shift and that lack of federal leadership allowed “some states to be more aggressive” in controlling the virus, but other states chose to “hang back” and limit mitigation efforts.
However, the problem with that approach is that pandemics do not respect or heed state boundaries — they spread everywhere. As a result, the federal abdication of leadership, according to Kettl, has “prolonged the virus” and “made it that much more difficult for the country to respond.” He cited how inconsistencies across the states allow “the virus to spread more quickly in some places, and that in turn, has spilled out over lots of other communities.”
Normally, under a federalist system, resolving these inconsistencies is a key role of the federal government. Washington could have enforced national standards for coronavirus testing, or coordinated lockdowns across regions, and more. In fact, Kettl noted how other federal systems, like Canada and Germany, have managed to contain the virus and lower death rates by having their federal governments play a key role in coordinating the various virus mitigation measures taken by different sub-federal actors.
Rather, what Kettl describes is a problem intrinsic to the American implementation of federalism, where the federal government disrupted the precise, fragile balance of power needed for the federalist system to function and tackle the issue. Without this proper federal role, states were left to fend for themselves, resulting in the inconsistencies that allowed the virus to spread. In this way, the virus exploited the structural fragility of federalism: its dependence on good-faith cooperation between two levels of government, without which the system could not cope.
A Faltering Trust
Beyond federalism, however, this structural fragility problem manifests across other key components of the federal government, including many of its chief scientific agencies, like the Centers for Disease Control and Preventionand the Food and Drug Administration. Much like how effective coronavirus response depends on the fragile balance of power and action between the states and federal government, this response also relies on the fragile balance of trust between scientific agencies and the broader U.S. population. Although scientific agencies like the CDC may set guidelines, it is up to private actors to follow them.
Luckily, for several decades, the CDC and other scientific agencies have been widely lauded leaders in the field of public health, causing many to widely trust and follow their guidelines. However, during the pandemic, this trend has worryingly begun to change. Increasingly large shares of the public have begun to worry that the CDC and FDA are becoming politicized institutions subject to the whims of the executive branch. Citing CDC flip-flops on testing guidelines, questionable FDA emergency-use authorizations for convalescent plasma, and more, many have lost faith in the organization, threatening the fragile balance by which federal scientific agencies can function.
However, despite appearances that the CDC’s politicization is a product of the pandemic, some experts believe that their politicized role is due to their inherent function, as explained by Gil Eyal, a professor of sociology at Columbia University. Eyal told the HPR that the CDC is often politicized because it is engaged in “regulatory science,” what he calls “a hybrid of science and policy” where various agencies “set thresholds” to regulate certain behaviors. For example, Eyal describes agencies setting “thresholds” for “the safe level of mercury in seafood.”
But, as Eyal said, these thresholds beg the question of what is “safe” and it is at this point that politicization begins to occur. While safety questions are rooted in scientific research, different individuals may have a different “calculus” to determine what is “safe,” as Eyal explained, because they may accept different levels of risk based on factors like individual “values” or “political feasibility.” In this way, these “thresholds” are “always a hybrid of science and policy,” which makes them vulnerable because the policy calculations may change.
According to Eyal, this issue with thresholds and safety plays out with the pandemic, especially in terms of a coronavirus vaccine. Eyal described how the vaccine has only been tested on a “small cohort” of people, so it may have “rare side-effects” that “may not appear in a small study,” when billions get the vaccine, “they may appear.” This conflict leaves anyone approving the vaccine with a dilemma — to approve the vaccine quickly regardless of these possible negative side effects, or wait until more data appears at the cost of further viral spread?
Eyal clarified that, in some cases, the final calculus may strongly support one point, like getting a vaccine out as quickly as possible given the damage caused by the coronavirus. But making such decisions, whether about the acceptable safety threshold for a vaccine or any other health decision, is thus inherently political. Depending on an individual’s values and beliefs, different levels of risk may be tolerated, and it is here where the structural fragility problem manifests once more.
These political decisions, as Eyal describes, are inevitable in any regulatory science process. However, we do not have a pandemic every year, so most members of the public or politicians remain aloof of the process, allowing scientific experts to take the lead and give these agencies apolitical reputations. But when COVID-19 appeared, CDC decision-making became center-stage, so the underlying “political calculus” and differing “values” were more widely scrutinized in public society, making the agencies appear more politically-influenced. In a sense, the pandemic altered the circumstances and made the perception of political interference more widespread, leaving the agency unable to adapt and disrupting the fragile trust needed for individuals to follow guidelines.
A Question of Regulatory Adaptation
But this issue of the structural fragility in governmental agencies is not just limited to their public perception, but rather to how these organizations themselves function. As described above, scientific agencies, such as the FDA and the CDC, among others, must compare various costs and benefits to develop an effective course of action on an issue. For decades, the FDA and other agencies have been hailed as leaders in this regulatory capacity, approving medical items within an adequate time-frame while also maintaining high safety standards.
But this system of regulation based on balancing both speed and safety suffers from the same fragility problem, according to Dr. Aaron Kesselheim, a professor of Medicine at Harvard Medical School. Kesselheim described how, in the past, with outbreaks like SARS or Ebola, “the testing apparatus, initially at least, goes through the FDA and the CDC” due to their histories as “centers of expertise for developing novel tests” against new infectious diseases. So following this precedent, all initial COVID-19 clinical testing was funneled through the CDC to ensure “testing was as high-quality as possible.”
However, this strategy had some faults. First, the CDC test kits had an error due to the contamination of some of the reagents needed for it. Moreover, however, Kesselheim said that COVID-19 was a “faster-moving pandemic” than the other viruses, so the FDA’s lack of flexibility in “letting private labs replicate the evolving knowledge about testing” limited the United States’ ability to detect the virus, allowing it to spread rapidly throughout the country.
According to Kesselheim, however, the FDA soon recognized this issue and changed course as they “did start letting local labs do their tests.” Unfortunately, however, the FDA’s new changes went too far, allowing the organization to become “so flexible in allowing emergency use authorizations” for coronavirus tests that they approved several “that did not have the levels of sensitivity and specificity” needed to effectively detect the virus. In short, Kesselheim characterized the FDA as taking an excessively flexible approach in response to its initial lack of flexibility, and it is here where we see this same fragility problem manifest.
The FDA, CDC, and other scientific agencies are structurally very good at dealing with diseases that are either previously-known or largely resemble currently known diseases. For example, they readily designed and implemented measures to limit the spread of Ebola, a previously known disease. However, when a virus pushes the bounds of known knowledge, such as COVID-19, a pathogen which is more infectious than viruses like the flu and is capable of spreading via asymptomatic individuals, these agencies’ apparatus failed to cope with the extreme level of spread as they continued to centralize testing.
To resolve the problem, therefore, would require a myriad of structural changes to make the system more resilient and adaptive to unseen disruptions. For example, to resolve federalism issues, it might be incipient to have the U.S. strengthen and centralize the federal Public Health Service while also giving it a degree of jurisdictional independence, as enjoyed by agencies like the NIH. Doing so would create an agency to centralize pandemic response across the country, ensuring the maintenance of federal leadership on this issue.
In fact, Kesselheim also suggested this approach could solve the problems surrounding the FDA and CDC’s capabilities to adapt and respond to new diseases, as a centralized service could better ensure a lock-step, uniform response to national public health crises. Meanwhile, for regulatory agencies to overcome the perception of politicization, Eyal suggested the creation of a “mediator” body, capable of funneling extra information from academics, experts, and other relevant organizations. The mediator thus helps the FDA and CDC collect input from society while also giving them a level of independence, helping them maintain their regulatory roles. Whether or not these solutions or others are implemented, it is important to tackle this important structural fragility problem. Doing so would permit future pandemic responses to be quicker, less damaging to the economy, and ultimately help save lives.
Image Credit: “Sign of the times…” by Billie Grace Ward is licensed under CC BY 2.0.
