Squandering America’s Strength
Answers abound. But one that informs both media coverage and policy analysis is that our bungled response to the pandemic may be blamed on our inefficient and decentralized political system. Faced with a public health crisis, so the argument goes, our system — with its competing branches of government, undue deference to states and local governments, patch-work health care structure, sprawling and heterogeneous research establishment, and lack of strong, centralized leadership — was sluggish, ad hoc, uncoordinated, and ultimately ineffective.
This stands in unhappy contrast to those seemingly more centralized or technocratic governments who were able to act more swiftly and effectively. Thus, as a New York Times piece explains, Germany benefited not only from a “robust public health care system,” but also “rational decision-making at the highest level of government combined with … trust [in] the government.” A DW News article notes that, thanks to better crisis management, “citizens in ‘unfree’ Asian states like Singapore enjoy more freedom” during the pandemic than those in the West that “locked up their citizens.” Wired speculates that this may be in part because countries like Singapore “have social structures and traditions that might make … surveillance and control a little easier than in the don’t-tread-on-me United States.” And a Jacobin piece proclaims that Cuba is “putting other countries, even rich countries, to shame” when it comes to its pandemic response.
According to this line of thinking, the solution for us is clear: If we are to be better prepared for the next pandemic, we need a more centralized and rationalized political system, including “integration of services in the health system,” “centralized public health policy,” and perhaps even a new government agency for pandemic prevention. The coronavirus crisis should spell the end of the populist revolt against expertise, portending a new era in which government experts decide on national public policy.
This solution is backwards. Our country’s early failure to respond effectively to the crisis suggests that centralization is not the solution — it was one of the main problems.
The Testing Debacle
Two federal agencies, the CDC and the FDA, both within the Department of Health and Human Services (HHS), have been at the forefront of the government’s response to Covid-19. Few would deny that these agencies should be a vital line of defense against a massive public health threat. But neither the interests of our citizens nor of science were well served by having those agencies be the only line of defense.
The Achilles heel in the American pandemic response was diagnostic testing — and the CDC and the FDA deserve much of the blame for this. As the crisis was unfolding, the FDA gave the CDC emergency authorization to undertake diagnostic testing for the novel coronavirus, granting the CDC a monopoly on testing. For its part, the CDC decided to develop its own test, instead of using the World Health Organization’s test developed in Germany. Once they were ready, the test kits were rolled out to select laboratories across the country to begin testing patients who met certain criteria set by the CDC.
However, those testing criteria proved too strict, so that many patients who wanted or should have been tested were not. In one instance, testing was initially denied to a patient who may have been one of the first cases of community infection.
An even bigger problem was that soon after the CDC test kits were distributed, they were discovered to be flawed due to a faulty reagent (a necessary ingredient in this type of diagnostic test). According to the FDA, the CDC had violated its own manufacturing protocols, which led to contamination in two of its Atlanta laboratories. This meant that the results of those tests that had been administered up to that point were unreliable. The test kits were recalled while the CDC tried to fix the problem, causing a delay of three critical weeks. Meanwhile, non-CDC laboratories, eager to join the fray, including the now famous virology lab at the University of Washington, were prohibited from conducting their own tests to diagnose new patients, even if they had already developed tests, and needed to seek FDA permission.
What Happened to Emergency Use?
Under normal circumstances, many non-CDC laboratories could likely have employed their own tests without the go-ahead from the FDA, as they are already regulated by the states in which they operate and by the Centers for Medicare and Medicaid Services. Diagnostic testing is a murky area of regulation. The FDA regulates medical devices, including many laboratory tests, but is not allowed to regulate the practice of medicine itself. These are not neatly separate domains, and it is a matter of ongoing dispute which lab-designed diagnostic tests fall into one or the other. In practice, the FDA exercises “enforcement discretion,” deciding whether or not to enforce its requirements in a given case. (In 2010, the agency announced that it intended to reconsider this policy; the debate is ongoing.)
When HHS Secretary Alex Azar declared the pandemic a public health emergency in late January, a different regulatory system kicked on: To ensure the quality of new diagnostic tests for the virus, anyone developing them had to get permission from the FDA. The procedure for issuing such “emergency use authorizations” (EUAs) during times of emergency was established by the Project BioShield Act of 2004. The law allows the FDA to “facilitate availability and unapproved uses” of emergency medical products. EUAs do not do away with FDA oversight, but rather provide an official mechanism in exceptional circumstances for sidestepping the standard, slower approval process.
EUAs have been used effectively by the FDA in the past, notably during the H1N1 epidemic in 2009. During the current crisis, however, they proved to be a stumbling block. Granting the CDC emergency authorization for developing a test meant that non-CDC labs had to stop their own test development and seek authorization from the FDA — a burdensome process that in some cases required that, in addition to an electronic submission, hard copies be mailed together with a digital copy on a CD or thumb drive.
In late February, roughly a month after Alex Azar declared a public health emergency, the CDC finally loosened its testing criteria, and the FDA tweaked the EUA process to allow “certain laboratories who develop validated tests for coronavirus [to] begin using them right away prior to FDA review,” according to Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. By this time, the CDC had administered a mere 459 tests, compared to 65,000 in South Korea, while China was capable of administering 1.6 million tests per week. This is what the New York Times has called the “lost month,”
when the world’s richest country — armed with some of the most highly trained scientists and infectious disease specialists — squandered its best chance of containing the virus’s spread.
Inadequate testing during these crucial weeks meant that health experts lacked vital information about the nature and scope of the outbreak in the United States, including how many had been infected and how many of those were asymptomatic. “The basic tenet of public health is to know the situation so you can deal with it appropriately,” said Harvard epidemiologist Marc Lipsitch. “If you don’t look, you won’t find cases.” “Testing,” said Dr. Nahid Bhadelia of Boston University, “is the crack that split apart the rest of the response, when it should have tied everything together.”
The resulting data gap has left officials struggling to get a fine-grained picture of the pandemic in different regions across the country. This would not only have positioned us to respond more rapidly early on, it would also allow for more effective mitigation strategies right now, and it could enable a more targeted approach to lifting social distancing restrictions.
A Single Point of Failure
Each of the agencies’ early blunders — the CDC’s mistakes in developing its tests and setting testing criteria, and the FDA’s implementation of the EUA process that prevented non-government labs from testing — might have been more or less excusable on their own. Taken together, they were deadly: Our government’s crisis response mechanism had a single point of failure, resulting from too much centralization, not too little.
As Brian H. Shirts, a molecular pathologist at the University of Washington, put it:
The real problem was the arbitrary monopoly…. The FDA slowed innovation at a time when rapid innovation was critically important.
Clearly, our government’s response would have been much more effective had non-CDC labs been allowed to develop and deploy their own tests much sooner — whether through the use of FDA’s enforcement discretion or an expedited EUA process similar to the one now in place.
Giving Away Our Greatest Strength
All of this raises a broader question about centralization — and about the proper role of executive agencies. During a public health emergency, agencies such as the HHS, the FDA, and the CDC have broad discretion, including to declare an emergency and to interpret and implement emergency use authorizations.
A typical rationale for giving these agencies such leeway is that they are best positioned to respond rapidly and effectively. Yet, the initial response from the CDC and the FDA to the coronavirus threat was neither rapid nor effective. While the goal was to provide speedy access to tests while ensuring quality, what we got was delayed and flawed testing. Rather than leveraging our vast and resourceful research establishment — with its pluralistic array of public, private, and nonprofit research institutions, labs, and hospitals — the CDC and the FDA monopolized power and controlled when, where, and how to allocate resources.
Everything hinged on these agencies’ performance, with costly results. As University of Washington virologist Keith Jerome put it, “the great strength the US has always had, not just in virology, is that we’ve always had a wide variety of people and groups working on any given problem.” So “when we decided all coronavirus testing had to be done by a single entity, even one as outstanding as CDC, we basically gave away our greatest strength.”
The contrast case of Germany corroborates this diagnosis. The impression that Germany was especially successful in its response to the pandemic because of a “rational,” top-down approach is misleading. Although the country, unlike the United States, has a universal multi-payer health care system, its research and medical systems are in some ways more decentralized than ours. As Christian Drosten, director of the Institute of Virology at Charité hospital in Berlin, put it,
We have a culture here in Germany that is not supporting a centralized diagnostic system. So Germany does not have a public health laboratory that would restrict other labs from doing the tests.
The country’s public health services are controlled not by a single federal office but by over 400 offices operating in various regions and at various levels of government. As a piece in the Guardian on Germany’s “devolved logic” notes, “such an environment allows for a variety of laboratories — some attached to universities or hospitals, others privately run, medium-sized businesses — which act largely autonomously of central control.”
In other words, it was not centralization but rather Germany’s decentralized political and laboratory system that enabled it to respond swiftly and effectively to the pandemic.
There are lessons here for policymakers as they try to determine what went wrong and consider proposals to prevent such failures in the future. Does it make sense to give executive agencies so much authority during public health emergencies? Or should our regulatory framework for emergencies have more decentralization and pluralism baked into it, perhaps taking a cue from Germany? What’s the proper role of the FDA in regulating diagnostic testing?
The VALID Act, introduced in Congress in March, seeks to reform the regulation of laboratory diagnostics by creating a new category of medical products subject to FDA oversight, which would include lab-developed tests. Although earlier versions of the bill predate the coronavirus crisis, its proponents believe it could help prevent future delays in the government’s response to public health threats. Reform is clearly needed, but recent events suggest that giving the FDA more authority over diagnostics is likely not the answer. (It’s worth noting that the FDA played a role in drafting the VALID Act.)
None of this means that decentralization is a cure-all or should be pursued without limit. Federal agencies such as the HHS, the CDC, and the FDA have important roles to play, especially during a public health emergency. Still, our government’s response to the outbreak — and the counterexample of Germany — illustrate the problems of centralization and ought to make us skeptical of proposals that would strengthen it.
In addition to practical reasons, there are well-known political reasons to be wary of centralization. Government responses to the crisis in Hungary, the Philippines and elsewhere — securing broad authority for rulers to enforce lockdown measures and punish dissenters — serve as a reminder that crises afford governments the opportunity to consolidate power through emergency protocols that curb civil liberties. The most extreme of such measures are unlikely to take root on American soil. But it is worrisome that many of the proffered solutions to the current crisis have stressed the role of central authority — such as increased government access to private data and the creation of a new federal agency devoted to pandemic response — to the exclusion of decentralized approaches.
Rather than being more centralized, our approach should be sufficiently decentralized so as to include within it the wide range of experts and institutions that possess relevant knowledge and resources. We squandered our wealth of expertise during the early weeks of the pandemic. But it remains critical as researchers in public and private institutions work to develop a vaccine and antiviral medications, and as policymakers consider ways to improve techniques for data collection and sharing, and for evaluating the varying impacts of outbreaks on local communities and their hospital capacities. Even something as seemingly rote as data collection of new cases and deaths must rely on ground-level reporting and the testimony of doctors and nurses in the field — in short, dispersed and local knowledge.
There is no question that technical expertise is central to public policy, especially during a health crisis. The question is how best to integrate that expertise into our political system — how to harness the impressive breadth and scope of knowledge and know-how our nation possesses. Considering America’s testing debacle, a more centralized approach seems foolish.