In late January, South Korean health officials summoned representatives from more than 20 medical companies from their lunar New Year celebrations to a conference room tucked inside Seoul’s busy train station.
One of the country’s top infectious disease officials delivered an urgent message: South Korea needed an effective test immediately to detect the novel coronavirus, then running rampant in China. He promised the companies swift regulatory approval.
Though there were only four known cases in South Korea at that point, “we were very nervous. We believed that it could develop into a pandemic,” one attendee, Lee Sang-won, an infectious diseases expert at the Korea Centers for Disease Control and Prevention, told Reuters.
“We acted like an army,” he said.
A week after the Jan. 27 meeting, South Korea's CDC approved one company’s diagnostic test. Another company soon followed. By the end of February, South Korea was making headlines around the world for its drive-through screening centers and ability to test thousands of people daily.
South Korea’s swift action stands in stark contrast to what has transpired in the United States. Seven weeks after the train station meeting, the Koreans have tested well over 290,000 people and identified over 8,000 infections. New cases are falling off: Ninety-three were reported Wednesday, down from a daily peak of 909 two weeks earlier.
The U.S., whose first case was detected the same day as South Korea’s, is not even close to meeting the demand for testing. About 60,000 tests have been run by public and private labs in a country of 330 million, federal officials said Tuesday.
As a result, U.S. officials don’t fully grasp how many Americans have been infected and where they are concentrated – crucial to containment efforts. While more than 7,000 U.S. cases had been identified as of Wednesday, as many as 96 million people could be infected in coming months, and 480,000 could die, according to a projection prepared for the American Hospital Association by Dr. James Lawler, an infectious disease expert at the University of Nebraska Medical Center.
“You cannot fight what you cannot see,” said Roger Klein, a former laboratory medical director at the Cleveland Clinic and previously an adviser to the U.S. Department of Health and Human Services on clinical laboratory issues.
How the U.S. fell so far behind South Korea, according to infectious disease experts, clinicians and state and local officials, is a tale of many contrasts in the two nations’ public health systems: a streamlined bureaucracy versus a congested one, bold versus cautious leadership, and a sense of urgency versus reliance on the protocol.
The delayed and chaotic testing in the U.S. will cost lives, potentially including those of doctors and nurses, many medical experts predict. Already more than 100 people have died overall, and fears of rampant spread have led to extraordinary restrictions on social interaction, upending the U.S. economy, schools, hospitals and everyday life.
"It makes me feel like I’m living in a farce,” said Dr. Ritu Thamman, a cardiologist and clinical assistant professor at the University of Pittsburgh School of Medicine. Even hospital staff who may have been exposed can’t get a test, she said. “We are a rich country but we don’t have these kinds of things?”
The administration of President Donald Trump was tripped up by government rules and conventions, former officials and public health experts say. Instead of drafting the private sector early on to develop tests, as South Korea did, U.S. health officials relied, as is customary, on test kits prepared by the U.S. Centers for Disease Control and Prevention, some of which proved faulty. Then, sticking to its time-consuming vetting procedures, the U.S. Food and Drug Administration didn’t approve tests other than the CDC’s until Feb. 29, more than five weeks after discussions with outside labs had begun.
Meanwhile, in the absence of enough kits, the CDC insisted for weeks on narrow criteria for testing, recommending it only when a person had recently been to China or other hot spots or had contact with someone known to be infected. As a result, the federal government failed to screen an untold number of U.S. citizens and missed opportunities to contain the spread, clinicians and public health experts say.
South Korea took a risk, releasing briskly vetted tests, then circling back later to spot check their effectiveness. By contrast, the U.S. FDA said it wanted to ensure, upfront, that the tests were accurate before they went out to millions of Americans.
“There are always opportunities to learn from situations like this one,” FDA Commissioner Stephen Hahn, who has been on the job only three months, told Reuters. “But one thing I will stand firm on: We cannot compromise on the quality of the tests because what would be worse than no tests at all is wildly inaccurate test results.”
In a statement, CDC spokesman Benjamin Haynes said, “This process has not gone as smoothly as we would have liked.” But he said, “more and more state labs have come online, increasing our public health system’s ability to detect and respond to cases.”
Bombarded by criticism amid a re-election campaign, Trump vowed on Friday to ramp up production of test kits in partnership with private companies and to make the diagnostic tests more widely available at hospitals and in-store parking lots. This week, the FDA said more than 35 universities, hospitals and lab companies had begun running their own tests, under the agency’s revised policy.
But it may be weeks before enough tests are on hand to fill the need.
“The idea of anybody getting (tested) easily the way people in other countries are doing it, we’re not set up for that,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases told a House committee last week. “That is a failing. Let’s admit it.”
It’s a problem many Americans, accustomed to hearing they have the most advanced medical care in the world, find hard to fathom.
“I don’t know how we messed this up so badly,” said Ruth Blodgett, 65, whose husband of the same age couldn't get a coronavirus test on Saturday in an urgent care clinic outside Rochester, New York, even though he was coughing and the doctor ordered one for him. "We got caught flat-footed. For America, that’s unacceptable."
'Hurry up and develop the kits'
At the pivotal Jan. 27 meeting at the Seoul train station, South Korean government leaders told companies they were cleared for takeoff.
“They were told that the ‘emergency use authorization’ would be coming, so hurry up and develop the kits,” said Lee Hyukmin, head of the coronavirus task force at the Korean Society for Laboratory Medicine, who was at the meeting.
One of the companies was Kogene Biotech Co Ltd, whose test kit was the only one to work initially. The government announced its approval on Feb. 4.
“The government acted quickly,” said Myoah Baek, an executive director at Kogene. The Korean CDC “disclosed information on test methods so test kit makers were able to speed up development.”
Lee Hyukmin of the Korean laboratory society said the government was swift – but not reckless.
“Of course, a kit that’s approved in one week isn’t as good as one that goes through a year of clinical trials,” he said. So in the early days, Lee said, the government cross-checked cases to ensure the tests were working properly.
Cross-checking involved verifying that labs got the same result the government did on an initial pool of patient samples. As of last week, nearly 100 labs were available to perform tests nationwide, according to government figures.
South Korea’s rapid response to the new coronavirus resulted from scars of the past.
In the aftermath of the 2015 outbreak of Middle East Respiratory Syndrome (MERS), critics slammed then-President Park Geun-hye and her administration for a slow response and a lack of transparency. Public confidence waned in Park, who was impeached in 2017 following an unrelated corruption scandal.
The country had 186 MERS cases, more than anywhere outside the Middle East, including 38 deaths.
“We can't ever forget the incident. It is engraved in our mind,” the Korean CDC’s Lee Sang-won said. “We were hurt so much, and we felt remorseful.”
'A real foul up'
On Jan. 31, only days after the Seoul train station meeting, the U.S. Department of Health and Human Services (HHS) declared the novel coronavirus a public health emergency, citing a similar pronouncement from the World Health Organization (WHO).
HHS oversees the separate operations of the FDA and CDC, key agencies involved in responding to the pandemic. The CDC was responsible for developing the initial test kits for the virus. Then, under longstanding protocols, the FDA needed to approve the test before it could be sent to state and local labs around the country. Private labs and large hospitals could develop their own tests or work off the CDC version.
On Feb. 3, amid the preparations to address the emergency, the FDA hosted an all-day conference at its headquarters in Silver Spring, Maryland, which had been scheduled well before the outbreak. Regulators, researchers and industry representatives gathered to discuss the general process for putting diagnostic tests cleared under emergencies on the path to permanent approval by the FDA.
Though coronavirus was now the hottest topic in global medicine, a broadcast of the meeting conveyed little sense of urgency about the epidemic sweeping the globe. It was mentioned in passing but regulators mostly stuck to their Powerpoint presentations.
In his remarks, Dr. Timothy Stenzel, who oversees the FDA’s review of diagnostic tests, spoke broadly about the agency’s mission to protect public health, “It's our goal to be first in the world wherever possible to authorize new tests.”
Carolyn Hiller, a program director at the Medical Device Innovation Consortium, which hosted the event alongside FDA, said there were discussions with the agency about postponing the meeting because of the coronavirus outbreak, but both sides opted to go ahead.
"The whole coronavirus thing blew up in real time while this was happening,” she said.
Stenzel did not respond to a request for comment. In a statement, the FDA acknowledged that the coronavirus was not a “specific topic on the agenda.” But it said the agency already was talking to test developers and “the conference was timely and addressed issues important” to firms and institutions looking to produce a test.
The following day, Feb. 4, the FDA greenlighted a CDC test kit for the virus.
Weeks of chaos would follow.
By Feb. 8, some states and other public labs were complaining that the CDC’s test wasn’t working because of a flawed component that gave inconclusive results. Three days later, the CDC told the labs that it was manufacturing a new component.
As of mid-February, the federal government remained stuck in first gear. The CDC was the primary supplier of tests across much of the country, and other labs couldn’t immediately deploy their own without the FDA’s blessing.
HHS said it has assigned a team of outside scientists to examine what went wrong with the CDC’s initial batch of tests, such as whether there was a manufacturing defect, flawed design or contamination in the agency’s lab. The precise problem has not been identified.
The CDC didn’t send out new test kits until late February. Meanwhile, public health experts say, a crucial window was closing on containing the virus, which by then was known to have infected more than 60 people.
The U.S. emergency declaration issued in late January created additional hurdles that hindered a wider expansion in testing, according to former federal officials and lab professionals.
The declaration eased the way for drugmakers to pursue vaccines and antiviral treatments for COVID-19. But public health experts said that the same declaration made it harder to expand diagnostic testing outside the CDC.
That’s because the declaration required diagnostic tests developed by individual labs, such as those at hospitals or universities, to undergo greater scrutiny than in non-emergencies – presumably because the stakes are higher.
"Paradoxically, it increased regulations on diagnostics while it created an easier pathway for vaccines and antivirals," said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security. “There was a real foul-up with diagnostic tests that has exposed a flaw in the United States' pandemic response plan.”
Dr. William Schaffner, a professor of preventive medicine and infectious diseases at the Vanderbilt University School of Medicine, said the CDC and FDA stuck to their conventional playbook for too long.
“Traditional public health thinking is,‘Don’t create widespread panic and don’t go over the top. Keep the testing narrow in a precision rifle approach rather than a mass, shotgun approach,’” Schaffner said. “That failed in this instance. This virus acted differently and it overwhelmed the U.S. system. South Korea had a much better sense of what was happening.”
In a statement Tuesday, the CDC said: “After finding out that some labs could not fully verify the test, CDC began working on a solution and identifying the source of the problem... CDC, in conjunction with FDA, determined how to move forward and shared this information immediately with public health labs.”
The CDC statement also suggested that the agency was not exclusively responsible for testing delays.
The CDC was “not an impediment” to getting large-scale commercial testing started, according to the statement. That was the role of the FDA, and as the initial U.S. cases were being detected in late January and early February, CDC director Dr. Robert Redfield highlighted the need for that agency to act, according to the CDC statement.
Alberto Gutierrez, who led the FDA’s office overseeing diagnostic testing from 2009 to 2017, said the agency proceeded with caution because it saw itself as the last line of defense against opportunistic companies looking to cash in on threats to public health. “There is money to be made in an emergency, and a lot of people try to take advantage of that,” Gutierrez said. "The problem the FDA faces is, do you let it become the Wild West?”
“The FDA had good intentions,” he said.
Ramping up
As U.S. efforts faltered, South Korean officials cleared a test from a second company, Seegene Inc, on Feb. 12.
With many more tests in hand, health officials were well-armed to attack a fast-moving virus and aggressively track down people who may have been exposed. This testing-backed offensive helped South Korea reduce the number of new cases over a matter of weeks, serving as a model for other countries grappling with the pandemic.
In mid-February, cases spiked at a secretive church in the southeastern city of Daegu. On Feb. 26, Daegu city officials said they would test every single member of the church, including those without symptoms.
As of March 10, Daegu said that it had tested almost all of the 10,000 members of the church in that area, and about 40% came back positive. The city, which now accounts for about three-quarters of total infections in South Korea, has seen new cases sharply drop. On Wednesday, officials announced 46 new cases compared to a peak of 741 cases on Feb. 29.
The country went from two approved test makers on Feb. 18 to five as of last week, according to the Korean CDC.
“To my surprise, test kit makers were able to boost production quickly,” Korean CDC’s Lee Sang-won said.
Pleading with Washington
By Feb. 24, state and local labs in the U.S. were pleading with the FDA to relax its rules so the nation no longer had to rely so heavily on the CDC for testing. They asked Hahn, the FDA commissioner, for “enforcement discretion” so they could use their own lab-developed tests.
“We are now many weeks into the response with still no diagnostic or surveillance test available outside of CDC for the vast majority of our member laboratories,” Scott Becker, chief executive of the Association of Public Health Laboratories, and Grace Kubin, lab services director at the Texas Department of State Health Services, wrote to Hahn on Feb. 24 in a letter reviewed by Reuters.
In an interview, Becker, whose group represents more than 100 state and local health laboratories, called the letter a “Hail Mary” pass, an act of desperation.
“The entire lab community was really coming unglued. We knew we could develop tests and were very capable of doing that, but we felt hamstrung,” Becker told Reuters.
He said labs wanted FDA to make more tests available so they could run more patient samples at a faster pace.
Two days after receiving Becker’s letter, the FDA commissioner said his agency was ready to approve new outside tests quickly – if its requirements for accuracy were satisfied.
“False diagnostic test results can lead to significant adverse public health consequences,” Hahn wrote to the Association of Public Health Laboratories in a Feb. 26 letter, “not only serious implications for individual patient care but also serious implications for the analyses of disease progression and for public health decision-making.”
Under increasing pressure, the FDA relented and removed many of the bureaucratic obstacles. On Feb. 29, the agency said public and private labs, including academic medical centers, could start using their own tests before the FDA had completed its full review. Laboratories had 15 business days to submit a completed application, which could be approved retroactively.
That same day, the Trump administration confirmed the first death in the U.S. from the coronavirus, a man in his 50s in Washington state.
On March 2, Stenzel at the FDA’s diagnostic testing office hosted a webinar for lab test developers, highlighting additional challenges, including a shortage of viral samples needed for validation of test results. Some labs also have reported shortages of other key supplies and ingredients, as well as the need for more trained personnel.
As U.S. regulators rewrote their policies, South Korean municipalities were opening roadside testing facilities across the country, collecting samples in minutes while people sat in their cars.
At a closed-door meeting last week in Congress, U.S. Representative Raul Ruiz, a Democrat from California and an emergency-room physician who treated patients during the 2009 H1N1 influenza outbreak, pressed the FDA commissioner and other members of the Trump administration on why South Korea was lapping the U.S. in its response.
“Why don’t we have drive-through testing like South Korea?” Ruiz asked leaders of the president’s coronavirus task force.
Ruiz told Reuters the officials said they were working on it. On their own, some hospitals and communities have begun offering drive-through testing in Colorado, New York, Texas and elsewhere.
In recent days, as the public criticism grew louder, Trump appointed a testing czar to improve coordination across agencies. The FDA launched a 24-hour hotline for laboratories needing help to accelerate testing, approved two company applications for higher-volume testing and granted states the flexibility to authorize new tests so labs can bypass the FDA.
Despite the new moves, Ruiz said he fears the U.S. is still weeks away from approaching what South Korea has accomplished. “I think months have been lost here,” Ruiz said. “Maybe we should look into purchasing South Korea’s tests.”
That may happen. Both Kogene and SolGent Co, two of the COVID-19 test-makers approved in South Korea, said their companies have an eye on the U.S. market.
“The FDA asked us to proceed with applications quickly,” Kogene executive Myoah Baek said.
