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Special Report: How Korea Trounced U.S.
in Race to Test People for Coronavirus
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https://www.nytimes.com/reuters/2020/03/18/world/asia/18reuters-health-coronavirus-testing-specialreport.html
THEY STILL ARE NOT SCREENING US, only if SICK with SYMPTOMS WHEN ITS TOO LATE, sooner testing could allow for sooner treatment.
"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.
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.
PLEADING WITH WASHINGTON
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.
"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.
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 Americans and missed opportunities to contain the spread, clinicians and public health experts say.
"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.
https://www.nytimes.com/reuters/2020/03/18/world/asia/18reuters-health-coronavirus-testing-specialreport.html
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.
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 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.
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.
How the United States 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 a reliance on protocol.
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.
"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 Americans 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 United States' 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."
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