Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic

by Scott Gottlieb

Owing to mistakes in how we deployed diagnostic tests for COVID, we left ourselves blind to the virus and allowed it to spread widely and largely unchecked, so we were never able to trace its early spread and contain

Testing would be a major gap in our response and the most visible symptom of the capabilities that we lacked in confronting a public health crisis of this magnitude.

Without access to the viral samples, it made it more difficult for other nations to fashion diagnostic tests and to begin work on drugs and vaccines.

COVID wasn’t caused deliberately, but it was enabled and nurtured by the intentional quashing of information.

Chu’s idea is to create a biospecimen repository, where certain respiratory samples would be routinely held for a few months after patients underwent routine testing in outpatient settings.

Rules governing informed consent should be amended to address a declared public health emergency.

The federal government lost trust and credibility early, by its inability to accurately convey the true scope of the hazard. The lack of reliable information on COVID’s spread, and the inability of people to access testing, degraded the integrity of the response.

The timing of the introduction of SARS-CoV-2, arriving in the US just as we were experiencing a flu epidemic, was absolutely optimal for keeping it hidden.

“The public health people on the task force were saying that there was no spread, or we’d see it in the ILI,” one White House official who sat in on the task force meetings told me.

Two of the biggest failures was the CDC’s overestimation of the risk of spread from contaminated surfaces, and its underestimation of the risk from asymptomatic transmission. The two errors were mutually dependent.

Without a way to test for SARS-CoV-2, to diagnose community cases, to understand how COVID established itself, and to uncover the asymptomatic spread, the US had no way to know for sure if it was spreading.

By January 16, a German manufacturer had started producing these kits in bulk.

The CDC also wanted to include in its FDA authorized labeling that whenever the test generated an inconclusive or positive result, the lab performing the test would be required to send the specimen to the CDC, which would run the sample in its own lab to confirm the finding. But the CDC’s central lab in Atlanta could only handle a few hundred tests a day.

when those tests finally shipped, they didn’t work.

The US government had made no assurance that a successful test would be purchased. There were no promises of minimum buys and no promises of reimbursement.

A final quality check showed that the test kit could fail 33 percent of the time. For reasons that have not been fully explained, the CDC decided to ship the kits anyway.5

In an ideal system, the CDC would have contracted with commercial manufacturers from the outset and wouldn’t have tried to make test kits on its own, even for the public health labs.

The next day, Politico reported that the CDC planned to distribute a second, corrected test to the labs. The report caught the FDA by surprise because the CDC hadn’t yet put forward a corrective plan.

only three of the more than one hundred public health labs had figured out how to get the CDC test to work.

The public health labs already had the kits in hand. They just had to be told they could start using the tests without N3.

the CDC sent the FDA an email telling the regulators that it wouldn’t allow the public health labs to run the test with just the N1 and N2 components of the previously distributed kits

The contract manufacturer shipped kits in such massive quantities that they became the backbone of the nation’s testing supply for weeks. The episode showed the merit in turning to a contract manufacturer, and the early opportunity that was lost when the CDC decided to do these things in-house.

only to suffer a low-level contamination that ruined some of the MERS test kits the agency had manufactured

even if the CDC had distributed its kits flawlessly, the US would always have needed a way to manufacture massive quantities of tests for the rest of the clinical market.

The FDA provision gave HHS emergency powers to advance medical products to combat SARS-CoV-2. Now, products intended to address the crisis would be able to come to market under an emergency use authorization. However, there was also now a Catch-22 when it came to getting more tests into the market.

companies like Quest or LabCorp, or by academic institutions, are free to fashion their own laboratory developed tests, known as LDTs, for detecting a viral pathogen. These LDTs are subject to the FDA’s oversight, but for most of these tests, the agency has exercised “enforcement discretion” and has chosen not to apply regulatory requirements—so long as the LDTs are run inside the sophisticated labs that assembled them and vouch for their quality and precision, and the tests are not turned into kits and resold to other labs. But when it came to COVID testing, things changed once the public health emergency was declared and section 564 was invoked.

any test for it subject to FD...

Labs could then start using their tests with patients so long as they could self-certify that they met those standards.

That same day, de Blasio would use Twitter to urge again that “we need the FDA to approve faster, more efficient testing. The faster the results, the faster we can limit the spread.”

“I would be careful promoting widespread testing,” the CDC editor noted, according to drafts of the manuscript.

The CDC’s single biggest breakdown in its response to COVID was the abortive rollout of its COVID test.

Upon its approval on August 26, 2020, it was made available in massive quantities owing to investments Abbott had made in manufacturing.

unused. A federal survey found that about 30 percent of thirteen thousand facilities that were provided the rapid tests hadn’t used the equipment.

The federal government had sent the antigen tests to the one place where they shouldn’t have been used.

HHS could have jump-started this market in January or February and paid commercial manufacturers to make kits in large volumes, prioritized the clearance of tests that could run on the widest array of instruments, and guaranteed reimbursement to the commercial labs for the tests by agreeing to buy a certain volume of testing in advance.

At one point the FDA, along with BARDA and the Department of Defense, stepped in to arrange a military transport out of Aviano Air Force Base in Italy, just to get shipments of swabs from Italy to the US.

Under this approach, the purchases done by federal agencies like the Department of Defense, the Department of Veterans Affairs, or the Indian Health Service, can be placed through the stockpile and sourced using domestic manufacturing sites that the federal government preferentially contracts with as a way to support US-based production of these materials. It might cost more, but the money would help guarantee that we have a domestic source for critical supplies.

The stockpile, at any one time, might hold a year’s worth of supply and then pull from this rotating inventory to satisfy the collective demand of all of these healthcare agencies. The inventory can be kept at government warehouses or held on location at the manufacturing sites. Take the example of masks. Buyers would receive masks drawn from this stash. As soon as some N95 respirators leave the warehouses to support a hospital’s immediate needs, a new supply comes into stockpile, where it will sit for twelve months before being distributed later. In this way, the US will always have a twelve-month inventory on hand that can be forward-deployed, all at once if necessary, in the event of a crisis.

“There was an assumption that CDC was going to develop a test and it was going to go to every hospital in the U.S. and that was never going to be the case.

President Bush read a new book, John M. Barry’s The Great Influenza, while on vacation at his ranch in Crawford, Texas.

A bird flu, by its very nature, kills poultry. It could wipe out the chickens. The same

Few cities maintained the interventions for longer than six weeks.

The simulation, dubbed Crimson Contagion, was a joint exercise conducted from January to August 2019 that aimed to test the capacity of the federal government and twelve states to respond to a severe pandemic flu originating in China.

There were shortages of protective gear like N95 respirators and ventilators. States went their own way on mitigation, with some states refusing a CDC directive to close schools as a way to limit spread.

So, instead of relying on testing, tracing, and isolation, the plan urged vulnerable Americans to stay home, and everyone else to essentially self-quarantine.

By the fall, General Motors and Ford had delivered more than eighty thousand ventilators to the US government.

Since the CDC believed that SARS-CoV-2 spread like flu, however, they discounted the role of asymptomatic transmission.

Americans wrongly shunned food deliveries, wiped down their groceries unnecessarily, and focused limited effort and resources on mitigating the wrong drivers of spread.

That’s what the 2005 pandemic plan had prepped for. It envisioned that mitigation would be directed to places where there was active spread, with the strictest measures reserved for cities where the virus was already out of control.

People were done with the closures of businesses and limits on large gatherings. As befits a free society, governors mostly followed the public’s inclinations.42 States such as Florida, Texas, and Arizona would have benefited from tougher mitigation once they faced epidemics in the summer, but there was no backing for the measures.