How Governments Botched COVID-19 Testing, Reinforcing Destructive Lockdowns and Massive “Relief” Spending

By Lawrence J. McQuillan and Jonathan Hofer

The most glaring governmental failure during the COVID-19 experience in the United States has been the botched testing strategy because it allowed government authorities to “justify” devastating lockdowns and massive “relief” spending.

But the lockdowns and spending could have been avoided had better testing been pursued from the start—testing rooted in private property rights, autonomy of the individual, entrepreneurship, and incentives. Unfortunately, this approach was thwarted from the earliest days of the pandemic by four governmental failures regarding COVID-19 testing.

Failure #1. The federal government initially created and distributed faulty COVID-19 test kits and then covered it up.

On February 7, 2020, the federal Centers for Disease Control and Prevention (CDC) began sending diagnostic kits to local public health laboratories, kits that the CDC designed. But many of the test kits did not work properly.

As late as July 2020, Robert Redfield, then CDC director, blamed the problem on a manufacturing glitch. But according to an internal CDC review, obtained by National Public Radio and reported on November 6, 2020, poor quality control in the CDC laboratory was the true culprit for the faulty tests, not a manufacturing problem.

Even more troubling is that CDC microbiologists knew the kits failed 33 percent of the time, yet the agency allowed the kits to be distributed without notifying recipients and instead of recalling the kits. All those problems delayed the start of reliable testing nationwide by more than a month—until March 2020—a critical loss of time that forced people to fly blind as fear increased.

Failure #2. The federal government initially blocked competing COVID-19 test kits.

While the CDC was distributing faulty test kits, private laboratories were prepared to use test kits but were blocked by the U.S. Food and Drug Administration (FDA). In Seattle, for example, a project sponsored by the Bill and Melinda Gates Foundation was ready to test, but in a move labeled “bizarre” by a distinguished scientist, the FDA shut down the project pending more data. Not only was the FDA involved in testing oversight (and still is), but the federal Centers for Medicare & Medicaid Services (CMS) also imposed a gauntlet of regulations that had to be satisfied before a new test could be used on the public.

Along with the problem of deploying accurate tests quickly was the problem of having adequate laboratories to process the tests. The CMS, FDA, and state health departments each have roles in the certification, regulation, and accreditation of laboratories, whether public or private. Depending on the lab, one or more of the agencies determine whether and when a lab can legally process COVID tests. Many labs waited for government approval before they could process tests, losing more valuable time.

Dr. Helen Chu, one of the researchers involved in the Seattle-based center, had been collecting swabs from symptomatic persons for an unrelated flu study. When she tried to repurpose her team’s flu test for COVID-19 infection surveillance, she was unable to do so because the new COVID test lacked formal government approval. As reported by the New York Times, “The Seattle Flu Study illustrates how existing regulations and red tape—sometimes designed to protect privacy and health—have impeded the rapid rollout of testing nationally, while other countries ramped up much earlier and faster. Faced with a public health emergency on a scale potentially not seen in a century, the United States has not responded nimbly.”

Though private sector manufacturing and administration of tests would have expanded capacity considerably, the FDA initially mandated that testing kits be approved by them, stopping private actors from rolling out tests for about a month and a half. Valuable time was lost, while the CDC peddled its knowingly faulty test kits.

Failure #3. The federal government and state governments went all-in on useless PCR COVID-19 testing.

From the beginning, the federal government favored prescription-based polymerase chain reaction (PCR) testing rather than over-the-counter (OTC) antigen testing. In contrast to antigen testing, PCR tests were administered by healthcare professionals and analyzed using sofa-sized machines in certified laboratories. PCR tests are nearly 100 percent accurate, but useless to contain the spread of the disease because obtaining results took too long.

For example, a survey issued to California’s 58 counties found that of the “33 counties that provided information about test results, 94 percent said it often took more than two days to confirm results, while 58 percent of counties reported results taking as much as a week.” When people receive test results after significant delays, they unknowingly can infect others as they await results.

Dr. Michael Mina, an assistant professor of epidemiology at Harvard University, said that delays of up to a week “frankly makes these high-quality PCR laboratory tests complete garbage, completely useless. . . . If you’re waiting for five days to get a test result back, it’s not even worth getting the test.” Yet this was the approach that federal government officials favored, and state governments deployed, for about a year, rather than fighting the FDA for a better approach (more on this below).

California Gov. Gavin Newsom (D) led in PCR testing. He signed contracts totaling nearly $2 billion with PCR-testing companies. Mass testing sites, such as Dodger Stadium in Los Angeles, were featured regularly on the nightly news with cars shown snaking around parking lots and down roadways as people lined up for testing. But from a public health surveillance and containment perspective, it was useless COVID theater.

Since slow PCR tests were effectively worthless for containment, outbreaks raged, which Newsom and other government officials across the country then used to justify endless lockdowns and widespread social controls. A better testing paradigm would have made revolving lockdowns, contact tracing, and widespread social distancing and masks unnecessary.

As an aside, California’s testing database also failed. As part of the state’s testing endeavor, the California Department of Public Health (CDPH) relied in part on the California Reportable Disease Information Exchange (CalREDIE), an electronic infectious disease reporting database. Test results and other information were to be accessible in real time and be available for health officials around the clock. But after hundreds of thousands of tests became backlogged, the goal of accurate real-time infectious surveillance was not achieved.

Partially responsible for the slow processing of tests and the associated backlog were extensive technical difficulties in the CalREDIE system, which could not handle the large quantity of data, leading to data failures and backlogs. In mid-July 2020, the CDPH switched to a tiered list to alleviate some of the bottlenecking. Testing delays were so long, however, that results were useless for isolating and effective contact tracing.

Failure #4. The FDA delayed the legal distribution of more effective antigen COVID-19 test kits.

Many public health experts agree that the coronavirus could have been crushed by late spring or early summer 2020 if the FDA had not blocked legal distribution of inexpensive, nonprescription, self-administered antigen testing strips, which give results in minutes. With individuals self-testing two or three times per week, it would have been possible to identify their status, isolate those who test positive for a few days, and focus restrictions, treatment, and support services on truly contagious people, not everyone. Lockdowns, contact tracing, masks, and social distancing could have been avoided (watch a discussion here). Personal risks could have been assessed more accurately soon after the emergence of COVID-19.

COVID-19 antigens were identified as early as March 2020, but regulatory hurdles blocked the legal distribution of antigen testing kits. Federal, state, and local government officials should have lobbied aggressively for the FDA to lift regulatory barriers, but they were silent and wedded to useless PCR testing.

In the United States, compliance with an antigen testing regime could have been achieved through strong incentives, voluntarily implemented, such as requiring a current negative test result as a condition of entering workplaces and businesses, attending schools or churches, living in a congregate facility, flying on airplanes, or attending movies, concerts, gyms, and sporting events. A swipe of a “digital passport” on a smartphone would gain admittance. The economy would have stayed open.

The University of Illinois Urbana-Champaign pioneered a similar approach, for example, and the university stayed open for in-person classes throughout the pandemic. Many music festivals have also used similar approaches, including the summer 2021 Lollapalooza music festival in Chicago, which attracted 385,000 attendees over four days, and none of these events became “superspreaders” of COVID-19. In fact, there were fewer coronavirus infections that emerged from these events than were expected based on positivity rates in the corresponding communities.

The FDA required the same sensitivity for antigen tests as for diagnostic PCR kits. But in public health testing, the goal of testing is to detect people with viral loads heavy enough to be contagious and to isolate these people for very short periods, not to detect all positive individuals or remnants of coronavirus RNA. Also, frequent antigen testing identifies false negatives quickly. And rigorous competition among test developers would have driven entrepreneurs to quickly calibrate the sensitivity of antigen tests to the optimal level.

Not until December 15, 2020, more than a year after the first COVID-19 case, did the FDA finally authorize a nonprescription rapid self-administered antigen test. Manufactured by Ellume, an Australian company, test results were delivered in as few as 20 minutes via the individual’s smartphone. Today, more OTC antigen self-test kits are available including Abbott’s BinaxNOW and Quidel’s QuickVue. Each was originally authorized for public use only with a prescription from a licensed physician (see here and here), but both are now direct-to-consumer products.

The slow authorization of rapid OTC tests was a costly mistake, contributing to endless lockdowns, economic destruction, unnecessary deaths, and multi-trillion-dollar government “relief” packages. Dr. Peter Chin-Hong, a professor of medicine and infectious diseases at the University of California, San Francisco, told the San Francisco Chronicle in December 2020, “Everything is too late, unfortunately. We should have had [rapid self-]testing long ago. . . . We’ve had this technology forever. This is like basic stuff if you talk to the scientists.” But the FDA prevented it until December 2020.

Summary and Conclusion

Early in the COVID-19 outbreak, it became clear that communities needed rapid, inexpensive, frequent testing. Yet procuring tests was a disaster from the start. The CDC created and distributed faulty test kits and hid its mistakes. At the same time, the FDA initially blocked competitors from offering tests to the public. It was a heavy-handed, micromanaged, centralized, and botched approach to testing.

The federal government favored, and state governments deployed, slow PCR testing, which was useless for effective public health surveillance and containment of coronavirus infections. Also, the federal government delayed the legal distribution of inexpensive, nonprescription, self-administered, rapid antigen test kits. Frequent antigen testing driven by private-sector incentives could have crushed the coronavirus by late spring or early summer 2020. Instead, governments chose to mop up the mess using lockdowns and massive “relief” spending instead of turning off the COVID-19 spigot relatively cheaply and quickly with frequent antigen testing—frequency is key.

Government red tape prevented effective public health testing, which would have saved lives, kept the economy open, and avoided the snowballing government debt our children and grandchildren will have to pay. The federal government alone approved more than $5 trillion in COVID-19 “relief” spending.

It would have taken discipline, driven by private sector incentives and personal self-interest, to successfully implement an antigen testing strategy. But by mid-spring 2020 people saw clearly what the alternative looked like: government-enforced lockdowns, economic devastation, mass unemployment, government infringement of basic personal liberties, despair, and diminished physical health and mental wellbeing—an end to life as we knew it. The motivation to implement an antigen strategy would have been strong. An incentives-driven antigen testing approach would have been an effective middle ground between “let it rip” and “lock it down.” But government authorities prevented it.

 

Lawrence J. McQuillan, PhD, is a senior fellow and director of the Center on Entrepreneurial Innovation at the Independent Institute, Oakland, Calif., where Jonathan Hofer is a policy research associate. They are coauthors of COVID in California: How Government Regulations Created Critical Healthcare Shortages.

Lawrence J. McQuillan is a Senior Fellow and Director of the Center on Entrepreneurial Innovation at the Independent Institute. He is the author of the Independent book California Dreaming.
Posts by Lawrence J. McQuillan | Full Biography and Publications
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