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

by Scott Gottlieb

Even when the shortcomings became obvious, the Centers for Disease Control and Prevention (CDC) continued to rely on its systems for monitoring and responding to influenza, insisting even into 2021 that its flu-based interventions were the right tools in the fight against COVID. We didn’t pursue an approach that closely tied our efforts to track and contain the spread of SARS-CoV-2 to the characteristics of the virus. This central shortcoming explains many of the gaps in our response to the pandemic we actually faced.

When COVID struck, all eyes turned to the CDC, which, it was assumed, would quarterback our response. However, the agency doesn’t have an operational capability to manage a crisis of this scale.

China ignored commitments it had made for sharing information in a public health crisis. It grudgingly revealed incomplete material only after the risks were largely apparent. China never shared samples of the early strains of SARS-CoV-2.20

These high-profile political shortcomings—the inconsistent messaging and shifting fortitude from the White House—get much of the public attention when we think about the problems with the federal government’s response. But a lot of corrosive failures were at the agency level, inside an ill-prepared bureaucracy.

Operation Warp Speed was a bright spot: one of the greatest public health achievements in modern times. The unprecedented research effort helped to deliver safe and effective vaccines and to secure new efficiencies in manufacturing.

The US Centers for Disease Control and Prevention already had evidence, in the form of clusters of cases that occurred in the same families, to suggest that the virus was spreading between people. Yet several days earlier, on January 14, the World Health Organization (WHO), relaying China’s assurances, tweeted that there was “no clear evidence” of human-to-human transmission.4

White House staff told me that, up until that point, they had little sensitive information to inform themselves on the scope of the risks. They were relying mostly on open-source material that they were pulling off the Internet and reports from friends on the ground. More ominously, they didn’t have a reliable plan to work from. For all the talk of a pandemic playbook that was purportedly on the shelf, initiated in the George W. Bush administration and refined under the administration of President Barack Obama, it was written for a pandemic involving a novel strain of influenza.

Whatever reassurance policymakers held that the virus could be contained, it would be shaken a day later, on Thursday, January 23, when China imposed a cordon around Wuhan, a city of 11 million people—a full lockdown restricting movement into and out of the city that would last two months.

The US travel ban that was ultimately announced, which went into effect on February 2, would deny entry to foreign nationals who had visited China in the fourteen days prior to their arrival to the US.17 The World Health Organization would largely endorse China’s lockdown of Hubei Province (where Wuhan is located), one of the most sweeping travel restrictions in modern times by any major economy, and yet the WHO would be critical of the restrictions imposed by the US, and other countries, on foreign nationals traveling from China.18 In other words, Chinese nationals couldn’t move around inside China, and the WHO approved of that policy. But if these same individuals somehow managed to get on a plane and travel to the US, and were subsequently not permitted entry into America, the WHO found that policy objectionable.

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.

Once inside a host, often a virus will have a specific “tissue tropism,” meaning it has a fondness for infecting and replicating inside a certain part of our body. Some viruses can infect many types of cells. Other viruses live primarily inside a certain organ.14 The rabies virus travels along our neurons. Hepatitis hides in our livers. SARS-CoV-2 likes to live in the lining of our respiratory tract.

Often the harm from a virus results from the injury it causes directly to these tissues. In other cases, the peril it brings owes to how our immune system responds to it. The same inflammatory response that our body mounts as a way to attack a virus can also damage our organs if that process gets out of whack. That’s true in hepatitis. It’s the inflammation that hepatitis triggers in our liver that does much of the damage.15 It was also true with COVID. For many patients, the most severe consequences of COVID weren’t the direct effect of the coronavirus on their lungs, but rather the exaggerated immune response their bodies unleashed to kill the virus. Because the SARS-CoV-2 virus was novel, meaning that human beings had never encountered it before and thus had no established means to combat it, the human immune system tended to overreact. In the most severe cases, it could trigger a “cytokine storm,” a cascading activation of immune cells, which in turn excrete small proteins called cytokines. In the normal sequence of our body’s functions, cytokines help coordinate our response to viral invaders and recruit other immune cells to the site of an infection. But if all the cytokines get dumped into our blood simultaneously, too many immune cells can get recruited to the site of the infection, creating an abrupt and severe hyperinflammation that can damage organs.16 It was a cytokine storm that ended up killing many people from COVID.

Yet local officials initially withheld information from the central government in Beijing about the outbreak.20 An employee of one Chinese genomics company said that on January 1 an official at the Hubei Provincial Health Commission instructed the company to stop testing samples related to the Wuhan outbreak and destroy all of the lab’s remaining specimens. The impulse to contain the troubling results eventually spread to officials in Beijing. Two days later, on January 3, the country’s top health authority, the National Health Commission, ordered the local genomics labs not to publish any sequencing information related to the novel coronavirus.21 News of the outbreak would be shared through the postings of anxious doctors who took to social media to exchange the sequencing information.

The hashtag “Wuhan SARS” was quickly suppressed on the Weibo platform by Chinese officials, and the original post put Li in the crosshairs of local authorities, who were still working to curb the news flow. On January 3, police from the Wuhan Public Security Bureau interrogated Li and censured him for “publishing untrue statements.”

“Rumor is a kind of virus that is worth more of our attention than real viruses sometimes,” the state-run People’s Daily wrote on its website.

Yet certainly by mid-December, local officials became aware of an outbreak, and started to zero in on the culprit.31 It became clearer that the episode met the bar for international reporting. These obligations were part of the revised International Health Regulations put in place in 2005, in part as a response to global concerns that China had put other nations in danger by withholding information about the SARS-1 outbreak for too long. Countries promised to be more transparent in the setting of future outbreaks. The new regulations required all 196 countries party to the agreement to improve systems for detecting and reporting dangerous pathogens.32 The agreement also widened the circle of viruses that require immediate reporting to world health authorities.33 One of the central features of this agreement is a stipulation that countries invest in systems to detect outbreaks and report events that may constitute a potential Public Health Emergency of International Concern, or PHEIC as it has come to be known. The CDC explains that under the global compact, a PHEIC is declared by the WHO when two of four criteria are met: Is the public health impact of the event serious? Is the event unusual or unexpected? Is there a significant risk of international spread? Is there a significant risk of international travel or trade restrictions?

Until COVID, there were six species of coronaviruses that were known to infect humans. Four of these caused a largely benign illness in healthy people that, for most, amounted to little more than a common cold. In rare cases, these coronavirus strains could cause pneumonia. Two of the species originated from bats (alpha coronaviruses) and two from rodents (beta coronaviruses). Together these four viruses account for as many as 30 percent of upper respiratory infections in adults.45 In more recent years, two new and more fearsome human coronaviruses had emerged: SARS-1 and MERS. The new virus spreading in Wuhan appeared to be a seventh entrant to this species.

All the while, the WHO—afraid to jostle Chinese officials, afraid to confront them, afraid to lose its limited access—would maintain that it was in constant dialogue with the Chinese government. As a technical matter, they were in dialogue. But the interchange was not productive.

Had the Chinese government been more forthright at the outset, there was a chance that the virus could have been contained there. Later, in the US, the effort to find effective tactics and therapies to stop the virus would also suffer from a lack of reliable information as we struggled to establish a truth standard about what would be most effective, and to agree on a reliable set of actions for containing spread. In a public health crisis, reliable information is a vital currency for decision making. The spark of transmission was lit amid the suppression and distortion of key facts.

We can no longer depend largely on global cooperation and the competency and transparency of other nations. COVID wasn’t caused deliberately, but it was enabled and nurtured by the intentional quashing of information.

We need more active efforts to gather information when there are signs of troubling outbreaks. We will have to rely more on our tools of national security, including our intelligence services.

Dangerous…

The US proved uniquely challenged in applying and maintaining respiratory precautions for its citizens at work and recreation.

If you look for cases only among people coming from Wuhan, you will find cases only among people coming from Wuhan.

polymerase chain reaction, or PCR.

These limitations have stirred some criticism of PCR as a diagnostic tool.20 Often, if a patient has any detectable virus by PCR, they’re judged to be positive for coronavirus and are treated as if they’re infectious. Sometimes labs will adjust the cycle thresholds needed to call a test positive and exclude results that are reached only by repeatedly cycling the machines, say forty or more times.21 The challenge is that a high Ct value can mean that the patient has largely cleared the infection and is no longer contagious, but it can also mean that the person is newly infected, and the virus has just started to take its grip on them and hasn’t had time to replicate itself widely.22 So counting the number of cycles isn’t always a reliable way to judge whether a person is indeed contagious.

There were ways that the CDC could have given high-quality labs an easier path to advance tests in the setting of the crisis. But they jealously guarded this turf. When the team’s lab reported its first positive hit, shortly thereafter the CDC told the lab to stop testing their samples.

It meant that doctors around the country had to forward samples to the CDC for testing. Physicians would first have to call the CDC and convince the agency to agree to take a sample for evaluation. It was a cumbersome process that limited the flow of specimens. By that point, there were far more people in America with unusual respiratory symptoms whose doctors wanted to test them, but the CDC’s criteria still required that patients have all the signs and symptoms of COVID along with a history of travel to Wuhan or known exposure to someone who was already infected. This created a situation similar to when China’s CDC required some contact with the Wuhan food market to be considered as a possible COVID case. It was only after Robert Redfield had suggested to George Gao that the Chinese CDC broaden its criteria that Gao revealed that the outbreak was probably out of control. Now, nearly two months later, the US CDC’s requirements seriously narrowed who could qualify to be tested in America.35 On March 1, the CDC’s official tally of COVID cases rose from fifteen to seventy-five. Models developed later by researchers at Northeastern University show that by this date, the US probably had 28,000 infections.

But without a widely deployed test, there was no way of knowing where the virus was spreading and where it wasn’t already epidemic. There was no way to target our interventions.

To make such a system robust, we’ll need a mechanism in place to test specimens for a novel pathogen even if we don’t have the explicit permission from the patients who gave those samples. Rules governing informed consent should be amended to address a declared public health emergency. We need to safeguard privacy concerns and make sure results are shared confidentially. But the imperative is to rapidly identify emerging outbreaks with novel pathogens.

Hmmm….

Until that point, the US had not recorded a single case of coronavirus infection in New York, which seemed improbable to some of the task force members. How could a city as dense and porous as New York not have a single case of the novel virus? “It was like the dog that didn’t bark,” this person told me. “It was a sign to a lot of us that we were way behind the curve. That’s when some of us started to get even more nervous. We were never going to make it.” By the time that New York City reported the first person who was positive for SARS-CoV-2 infection, the City had only conducted 32 tests on patients. It wasn’t even enough testing to serve as a tripwire.

You have to admit what you do not know. Government officials often make the mistake of trying to answer every question. Sometimes, when you lack data, when you’re confounded, the most reassuring message is to admit what you do not know. It builds trust, and building public trust is critical in a crisis. Public officials also make a mistake telling the public “not to panic.” When people hear the phrase “There is no need to panic,” the first thing that many people will ask themselves is: “Should I panic?”

In a public health crisis, eventually, you’ll need to ask the public to do hard things, and the public will have to trust the integrity of your appeals. You cannot advance policies or appeal for collective action if the public isn’t on board. Once you pursue a policy, and get met with public rejection, or noncompliance, your capacity to implement future actions is eroded. If the public refuses to follow guidance in a public health crisis, if there’s widespread opposition or protest, it becomes difficult or even impossible to advance additional measures, to take strong actions.

During the spring 2020 COVID wave, it’s likely that we were diagnosing only about one out of every ten or fifteen actual infections.

“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. “It wasn’t until the week of March 6 that you saw a clear separation, and that was retrospective that you saw the separation. Until then, we were never told the ILI was picking up anything weird ever, we were told they were using the ILI network and it’s not detecting coronavirus spread. . . . CDC was telling us we have a surveillance system and it’s the [influenza-like illness surveillance] network and that we’re in good shape and that was totally untrue.” That same week, on March 5, the assistant secretary for health at HHS, Dr. Brett Giroir, told a group of reporters at a Capitol Hill press briefing that the “best estimate” of the overall mortality for COVID might be as low as one-tenth of 1 percent, which would have put it in the range of flu, to which he explicitly compared it. And it certainly wasn’t higher than 1 percent, he said. The best estimates of the case fatality rate that spring put COVID’s mortality higher than 1 percent. But in linking it to the death rate from flu, it was a measure of how much some health officials were still viewing COVID through the lens of influenza. By that point, others in HHS had a firmer grasp on the virus’s true pathogenicity. Anthony Fauci had sent an email to a Wall Street Journal columnist three days earlier, on March 2, alerting them that for COVID...

For a long time, without adequate testing and with no emphasis on diagnosing asymptomatic cases, the CDC was attributing a lot of the transmission it was seeing, and that it couldn’t explain, not to asymptomatic infections but to “fomites”—a circumstance where someone touches a surface that had become contaminated with the respiratory secretions of an infected patient and then touches his or her own nose, eyes, or mouth. The CDC saw a whole bunch of cases where they couldn’t trace patients back to a sick contact, and so the agency wrongly assumed that the transmission chain must have been lit by touching a surface that was contaminated with respiratory secretions. Instead, it was probably through direct contact with an asymptomatic person.

These failures caused the perceived risk of fomites to be overestimated, and the perceived value of better respiratory precautions, like the use of masks, to be underestimated. We put far too much emphasis on cleaning surfaces, when we should have been taking more steps to improve airflow and filtration in confined indoor spaces and to get N95 respirators to individuals at high risk of bad outcomes.

Compounding the error, the CDC wouldn’t share its methodology, so those who might have been able to uncover the shortcomings and correct for the CDC’s faulty assumptions had no way to fully understand how the agency made its projections.

The point here isn’t that the federal health officials were wrong. The point is that they were working with faulty tools, and from faulty data sets.

Screening programs and travel bans were long known to have limited effect in preventing or even slowing epidemics.28 One widely cited modeling study, which examined the impact of travel bans in the setting of a pandemic flu, found that implementing strict travel bans that reduced infections by 99.9 percent would delay the peak of a hypothetical US pandemic by just six weeks.

Taken together, the CDC’s restrictions would limit how much testing would initially be done. Those constraints would be overshadowed, however, by a tragic failure. As I’ll detail later, when those tests finally shipped, they didn’t work. Instead, the entire country remained tethered to the CDC’s single lab for all of the nation’s testing, because it was the only place in the US that had a workable test. The CDC had prevented other labs from developing their own tests and now, its own kit was defective, and the CDC’s Atlanta lab was the only facility that could get the test to work. By March 1, the CDC had tested fewer than 3,600 samples. Senior HHS officials would tout this figure in a way that implied that 3,600 Americans had been tested for COVID.13 But even that small figure overstated the agency’s throughput. (“Throughput” refers to a lab’s capacity to run a lot of tests in short periods of time.) Under questioning at a Senate hearing on March 3 by Senator Richard Burr, the CDC’s deputy director, Dr. Anne Schuchat, revealed that many of these were multiple tests conducted on the same patients who were being serially tested for the virus, not tests on 3,600 unique patients. In fact, far fewer than 3,600 different patients had been tested for the virus.14

From January 18 to March 7, the CDC tested only 3,869 specimens for the virus.

Among the findings in a 2017 report, the GAO would write: “CDC developed the first two authorized diagnostic tests for the Zika virus and offered these tests to public health laboratories, but not to some manufacturers. Some manufacturers did not have access to the authorized CDC tests and encountered difficulty acquiring authorized tests from other manufacturers. Without a clear and transparent process for distributing CDC diagnostic tests, the agency may not be able to develop the capacity of the commercial sector to be able to meet the needs during an outbreak.”38

The CDC wasn’t a manufacturer. 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 CDC eventually reached out to contract manufacturers around February 10, but agreements to enlist the help of commercial companies to make the testing components weren’t completed for about ten days, due to complex issues that would arise in the contracting process. Among other contracting matters, the CDC was trying to assure protection of the agency’s intellectual property around its test design.

But then there were still a third group of labs that had persistent problems with both N1 and N3. For these labs, the interim solution wouldn’t work, because the tests would be generating inconclusive results. They had to wait for the remanufactured kits to arrive, and in the meantime send their samples to the CDC and see if the agency would agree to test them. The public health labs in New York City and New York State were in this third group, and they were effectively out of the testing business until the CDC was able to replace its faulty kits with ones that worked.

The IDT kits would fill the void that had been left by the CDC’s sequential failures with its own kits.17 By mid-March, IDT had a sufficient number of primer and probe kits, authorized by FDA, to make it possible to manufacture about 10 million tests that followed the CDC’s protocol. Most people assumed that the testing hole was filled when the CDC finally got its own test working. In reality, it was IDT kits that supplied the market.

A later federal review would conclude that the CDC had failed to exert proper quality control over the kits in spite of “anomalies” that were discovered during the manufacturing process and were known to the CDC staff in charge of the program.

I had used Twitter repeatedly to call on vaping companies like Juul to take specific actions to curtail youth abuse of their products.

The CDC was also exerting its intellectual property rights over its test design. If labs wanted to develop their own tests, they would need to copy the CDC’s design, which the agency said was proprietary. Negotiating a right of reference to the CDC’s recipe added additional complexities and delays, especially for the commercial manufacturers that wanted to be able to market kits to laboratories. Taken together, these layers of obstacles and intricacies froze out of the market solutions that could have filled some of the void left by the CDC’s own stumbles.

5 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.

By 2021, Puritan had used a $75 million investment from the Department of Defense to renovate yet another factory, and by the spring it was making another 100 million swabs a month.13 Puritan had cornered the US market. It took a year, but swab supply was finally keeping up with demand.