Why Rapid COVID Tests in the US Are Harder to Find (and More Expensive) Than in Europe

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A new ProPublica report provides further confirmation that federal bureaucracy not only failed to meet the public health challenge posed by SARS-CoV-2, the novel coronavirus, but actively served to hamper the response. In particular, the report identifies “overzealous regulation” on the part of the Food and Drug Administration (FDA) as a paramount factor in explaining the lack of rapid COVID tests in the United States.

The Beginning: Early 2020

It all began in early 2020. After the virus’s genome was sequenced, commercial laboratories, universities, and biotech companies began developing tests that would determine to a high degree of accuracy whether an individual had COVID. The American federal bureaucracy, however, was not having any of it. The Centers for Disease Control and Prevention (CDC) erected countless barriers such as lengthy and insurmountable approval procedures that did not take into consideration the gravity of the public health situation. In doing so, the CDC, as well as other agencies, effectively barred these non-government researchers from developing COVID tests to be put out to market, preventing their dissemination to hospitals, clinics, and individuals.

In resisting widespread testing while the pandemic was raging, the CDC made the problem far worse than it otherwise would have been. The CDC insisted on using its own testing kits, which turned out to be complex, faulty, contaminated, and frequently returned erroneous results. With this act of hubris – a quality, along with systemic dysfunction, which typifies the CDC – precious time was lost.

The Present Day: Nearly Two Years Later

Fast forward to today – nearly two years later – and we can see that many of the same bureaucratic inefficiencies have been allowed to persist.

“Where are the tests?” inquired David Leonhardt of The New York Times in September 2021. Where indeed? They have been mired in the labyrinth of the vast, bureaucratic state, which too often resembles a chasm where the potentially lifesaving initiatives of private laboratories seeking regulatory approval go to die. Regulatory delays and the associated feet dragging are literally life-threatening as the cases of pharmaceutical drugs and the COVID vaccines show.

In addition to distributing faulty tests and blocking competing COVID tests from private laboratories and charitable organizations, Lawrence McQuillan of the Independent Institute writes that the federal government sidelined antigen testing in favor of PCR tests. Although the accuracy of PCR tests may be second-to-none, they are practically “useless to contain the spread of the disease because obtaining results took too long.” By contrast, antigen tests could be made available over-the-counter, and individuals could use them to determine whether it would be safe to go to their workplace or attend certain events. In lieu of rapid testing, governments decided to implement lockdowns and other interventions, which carry significant economic and public health costs of their own.

Someone with the sniffles or other flu-like symptoms, the new ProPublica report suggests, should be allowed to use antigen tests to determine whether they are currently infected with the virus.

“No need to go to a clinic or wait days for results. Just pick up a pack of tests at a local pharmacy whenever you want, swab your nose and learn within 15 minutes if you’re likely to pass the virus along,” write reporters Lydia DePillis and Eric Umansky.

Epidemiologists such as Harvard’s Michael Mina and public health experts such as Brown’s Stefanie Friedhoff have lamented America’s shortage of rapid testing capacity. In a country that prides itself on medical freedom and innovation, we can do better.

The problem becomes clearer and more revealing when viewed in comparison with other nations of the developed world. ProPublica notes that in western European nations – the United Kingdom, France, Germany, the Netherlands, and Belgium, to name five – “at-home tests are ubiquitous and as cheap as a decent cappuccino.” The United States, on the other hand, has stymied progress by subjecting laboratories and researchers to onerous requirements which cost billions and still often do not follow through with approval of the tests.

Examples abound. To name just one, WHPM, Inc., a California business, created a COVID test and submitted data from a clinical trial to the FDA. An FDA reviewer got back to the company in May, sending a cryptic email, claiming that the firm failed to provide all the requisite information. WHPM replied that it had submitted all relevant data. The back-and-forth continued with the FDA repeatedly alleging that WHPM’s tests and trials were deficient and incomplete. In the end, WHPM’s tests were “deprioritized.” Millions of dollars, the brainpower of WHPM’s researchers, and valuable time were squandered.

The Nature of Bureaucracy

Why has the United States failed to adopt reforms that would enable low price availability of rapid tests like those seen in other nations?

Economist Alexander Tabarrok, a frequent critic of FDA bureaucracy, refers to this attitude as “regulatory nationalism.” Under the guise of maintaining an abundance of caution, American bureaucracies stubbornly refuse to adopt even the simplest of reforms. Synchronizing emergency approvals with other developed nations would be a good first step to avoid the harsh consequences of well-intentioned, but harmful, regulation. This is particularly important as countries like the United Kingdom have approved molnupiravir, an antiviral pill which shows great promise for treating mild to moderate cases of COVID. Doctors such as Johns Hopkins surgeon Marty Makary have argued that the FDA should authorize Merck’s drug under “compassionate use.” Lives indeed depend on quick action.

Bureaucracy has hindered individual, charitable, and private sector efforts to curtail the consequences of COVID. The examples of red tape, and the resultant “invisible graveyard” created in its wake, are too numerous to list. Why then has government not responded in a timely fashion?

The answer lies in the incentives facing government. Federal bureaucracy is insulated from accountability and has no incentive to respond to rapidly changing conditions like a private company would.

Echoing this point, Norman Borlaug, the Nobel Peace Prize winner who pioneered the Green Revolution, said “One of the greatest threats to mankind today is that the world may be choked by an explosively pervading but well camouflaged bureaucracy.”

How right he was.

* This article was originally published here

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