The first coronavirus case in the U.S. and South Korea was detected on the same day. By late January, Seoul had medical companies starting to work on a diagnostic test — one was approved a week later. Today, the U.S. isn’t even close to meeting test demand
SEOUL - 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.
The United States, whose first case was detected the same day as South Korea’s, is not even close to meeting 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. The delayed and chaotic testing in the United States 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.
South Korea took a risk, releasing briskly vetted tests, then circling back later to spot check their effectiveness. By contrast, the United States’ FDA said it wanted to ensure, upfront, that the tests were accurate before they went out to millions of Americans. It’s a problem many Americans, accustomed to hearing they have the most advanced medical care in the world, find hard to fathom.
“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.”“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.
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. 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.
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. 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.
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.
“To my surprise, test kit makers were able to boost production quickly,” Korean CDC’s Lee Sang-won said.By Feb. 24, state and local labs in the United States 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.
He said labs wanted FDA to make more tests available so they could run more patient samples at a faster pace. That same day, the Trump administration confirmed the first death in the United States from the coronavirus, a man in his 50s in Washington state.
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