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The coronavirus crisis has exposed how the federal health bureaucracy (i.e., the CDC and the FDA) has stymied progress and a quick response over and over again.
Crucial to understanding and potentially preventing a virus' spread is having a sufficient stock of diagnostic test kits. If tests are plentiful and used properly, infected persons can be properly quarantined and treated, and health officials may begin monitoring those with whom infected patients were in close contact during the incubation period. For SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2, the virus causing the coronavirus disease) the incubation period can range anywhere from two to fourteen days (with a mean of 5.1), making it of special importance that patients showing respiratory symptoms be tested as soon as possible.
Early Failures at the CDC
The US Centers for Disease Control and Prevention (CDC) began working on a test within the first few weeks of the virus' global outbreak in conjunction with the Food and Drug Administration (FDA). With the federal government in control, all the country's eggs were placed in a single basket—any mistakes were bound to carry wide, rippling effects.
On January 21, all plans and anticipations were suddenly brought to term when the US confirmed its first case of the virus—a thirty-five-year-old Seattle man who had recently visited Wuhan, China. This “patient zero” had checked into an emergency care center two days prior, which was able to send clinical samples from his nose, throat, and bloodstream on an overnight flight to the CDC lab in Atlanta. By the following afternoon, the lab had reported that the test had come back positive, and by nightfall the patient was being moved to a small containment unit originally built to house ebola patients. Despite these measures, the virus managed to infect others through some unknown carrier. The crisis, at last, had breached mainland America.
On January 24, the CDC digitally published information on its tests, essentially providing a blueprint for manufacturing them. It was clear that clinical and public health labs had to be capable of testing in case the virus became widespread.
But on January 31, the Department of Health and Human Services designated the coronavirus a “public health emergency, and four days later declared this condition just cause for the FDA to authorize the emergency use of diagnostic tests. Emergency use authorizations bypass the years-long approval process and accelerate the pace at which medical products reach labs and hospitals—the FDA at its most flexible. However, the layers of red tape still in force during such an emergency were thick and tangled.
Labs could only use tests that they had developed themselves if granted an emergency use authorization—which was given solely to the CDC on February 4. All other labs were prohibited from using their own tests, though many were already in the process of manufacturing them.
The CDC’s kits used polymerase chain reaction (PCR) testing, a common and inexpensive diagnostic method that’s been used for decades. As long as state and clinical labs could ensure the uberclean lab conditions required to develop coronavirus PCR primer (short DNA strands complementary to the SARS-CoV-2 viral sequence) there would be no trouble manufacturing test kits—they were fully capable. Giving the CDC the sole power to manufacture tests, on the other hand, would ultimately mean that fewer would be made and of a lower quality. But—against the interests of public health and practicality—production was centralized with the CDC anyway.
Slowing Everything Down
For more than two weeks, all testing had to be conducted via mail-in samples sent to the CDC, as with “patient zero.” On February 6 and 7, the CDC finally sent public health labs the test kits they’d been anxiously awaiting. At the time, this was a total of only ninety tests, though each one could process 700–800 patient samples—a suitable capability for the time, but one which would have to be expanded as the virus spread further.
After receiving the tests, the labs began to check them to ensure that they would produce valid results. However, nearly all of the labs ran into a problem with one of the test’s negative control reagents (mixtures used in chemical analysis). The test's reagents contained genetic material unrelated to SARS-CoV-2 and that was not supposed to react; that’s how the labs would have been able to validate the tests’ accuracy. But in most labs, one of these reagents—called N3—did react, causing a stir of panic that the tests were defective.
The CDC publicly recognized its blunder on February 12 and committed itself to making quick amends. At that point, only the three labs not facing reagent problems (out of more than one hundred) were allowed to continue testing. All other labs had to again send their samples to the CDC's Atlanta lab, delaying results by up to two days (which would have otherwise taken four to six hours to produce) at a time when knowledge of the virus’ spread was crucial.
To address its failure, the CDC initially planned to manufacture new, operative copies of N3 to send to the labs that had had difficulties, but this never came to fruition. Instead, for the next few weeks CDC officials continuously declared that they were working on the problem, ultimately helping to equip only an extra nine public health labs with the ability to test. A cocktail of bureaucratic incompetence and FDA lethargy left all the other labs without usable tests as the virus spread undetected across the country.
Finally, on February 26, the CDC announced its grand solution—that labs could simply disregard the faulty N3 reagent and otherwise continue using the tests as originally sent to them. That means that there was never anything fatally defective about them in the first place and that testing could have continued uninterrupted for the prior couple of weeks.
The real issue at hand was not with the tests, but with changing the test protocol to reflect what many virologists already knew—that having a third reagent was superfluous to begin with. That’s not even to mention the five public health labs that experienced problems with reagents besides N3, to which the CDC failed to propose a solution.
But just when most labs had at last resumed testing, a new—though unsurprising—problem presented itself: test kits were in short supply. The amount of kits distributed at the beginning of February was nowhere near enough to confront the hordes of patients requiring testing by the end of the month. Without sufficient ability to diagnose patients over the course of the month, the crisis quietly intensified.
Feds behind the Curve
CDC data records only twenty-four confirmed cases of coronavirus in the US by the end of February—a seemingly manageable number. But it was later learned that by that time a whopping 597 infected individuals had already begun to show symptoms. Each of these cases required testing, as did the thousands more who mistakenly feared themselves to be infected.
Virologists knew the reality of the matter to be much worse than the official figures were reflecting. Scarier yet, it’s likely that—without knowing it—the US had in excess of seventeen hundred cases by February 29 when asymptomatic carriers are taken into account—a far cry from the mere twenty-four that had been confirmed by that date. Much testing was needed right away, even if that wasn't immediately apparent.
But then, at a moment of critical importance, the FDA updated one of its emergency testing policies, allowing certain certified labs to use their own tests before FDA review—a deus ex machina in the diagnostics narrative. The same day, a test from New York's Wadsworth Center was also granted an emergency use authorization. The approval of many more tests beginning in mid-March followed.
The FDA could only salvage the testing situation by releasing its tight stranglehold over it. After all, the whole debacle had originated and then further worsened under the federal government's watch—it was simply unable to manage the crisis correctly.
But even after giving innovation more room to operate, shortages did not immediately disappear. The first few weeks of a virus’ spread are always the most pivotal, making it very difficult to catch up if that precious time is squandered. The insufficiencies in diagnostics experienced early on allowed the coronavirus to spread more quickly and widely, causing an untold number of deaths later.
If the FDA had properly vetted the CDC's tests before distributing them, everything might have been different. If public health labs had not, for weeks, been barred from using the tests sent to them, everything might have been different. If clinical labs could have used their own tests from the beginning, everything might have been different. But none of that happened—in fact, the worst of the worst happened when it came to test kits—and the blame for that lies solely with the federal government.
