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SEOUL – representation In late January, South Korean health officials called from more than 20 medical establishments of their Chinese New Year celebration to the conference room tucked away in a busy train station in Seoul.
One of the highest state officials of infectious diseases convey an important message: South Korea effective immediately necessary tests to detect the new coronavirus, then rampant in China. He promised the company a quick regulatory approval.
Although there are only four known cases in South Korea at the time, “we were very nervous. We believe that it could develop into a pandemic, “one participant, Lee Sang-won, an infectious disease expert at the Korea Centers for Disease Control and Prevention, told Reuters.
“We act like an army,” he said.
A week after 27 Jan meeting, South Korea CDC approved diagnostic test of the company. Other companies soon followed. In late February, South Korea was making headlines around the world for the drive-through screening centers and the ability to test thousands of people every day.
South Korean swift action stands in stark contrast with what has happened in the United States. Seven weeks after the meeting of the railway station, Korea has tested more than 290,000 people and more than 8,000 infections were identified. new cases fall: Ninety-three was reported Wednesday, down from the intraday peak of 909 two weeks earlier.
United States, the first case was detected the same day as South Korea, was not even close to meeting the demand for testing. About 60,000 tests have been carried out by public and private laboratories in the country of 330 million, federal officials said Tuesday.
As a result, US officials do not fully understand how many Americans have been infected and where they are concentrated – essential for containment efforts. While more than 7,000 US cases have been identified as Wednesday, as many as 96 million people may be infected in the coming months, and 480,000 could die, according to projections prepared for the American Hospital Association by Dr. James Lawler, an infectious disease expert at the University of Nebraska Medical Center.
“You can not fight what you can not see,” said Roger Klein, a former director of a medical laboratory at the Cleveland Clinic and the previous US adviser Department of Health and Human Services on issues of clinical laboratories.
How does the United States fell so far behind South Korea, according to infectious disease experts, doctors and officials of the state and local, is the story of many contrasts in the public health systems of both countries: the bureaucracy efficient than the dense, thick compared careful leadership and a sense of urgency versus reliance on protocol.
The test was delayed and muddled in the United States will be the cost of living, potentially including doctors and nurses, many medical experts predict. Already more than 100 people were killed as a whole, and the fear of the spread of rampant causing tremendous restrictions on social interaction, upending the US economy, schools, hospitals and day-to-day lives.
“It makes me feel like I’m living in a joke,” said Dr. Ritu Thamman, a cardiologist and assistant clinical professor at the University of Pittsburgh School of Medicine. Even the hospital staff who may have been exposed can not get the test, he said. “We are a rich country but we do not have such things?”
The administration of President Donald Trump was tripped by government rules and conventions, former officials and public health experts say. Instead of beginning the preparation of the private sector to develop the test, as did South Korea, US health officials rely, as is customary, the assays were prepared by the US Centers for Disease Control and Prevention, some of which proved to be defective. Then, stick to the examination procedure that takes time, the US Food and Drug Administration did not approve the test other than the CDC to 29 February, more than five weeks after discussion with the outside laboratory has begun.
Meanwhile, in the absence of sufficient kit, the CDC insisted for weeks narrow criteria for testing, recommended only when someone 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 filter out an untold number of Americans and a lost opportunity to prevent the spread, doctors and public health experts say.
South Korea to take risks, releasing the rapid test is checked, then circling back later to spot check their effectiveness. By contrast, the United States FDA said it wanted to make sure, in advance, that the tests are accurate before they go to millions of Americans.
“There is always a chance to learn from a situation like this,” FDA Commissioner Stephen Hahn, who has been on the job only three months, told Reuters. “But one thing I will stand firm on: We can not compromise on the quality of the test because of what would be worse than no test at all is wildly inaccurate test results.”
In a statement, CDC spokesman Benjamin Haynes says, “The process did not go as smoothly as we would have liked.” But he said “more and more state laboratory has come online, improving our public health system’s ability to detect and respond to cases.”
bombarded by criticism in the midst of a reelection campaign, Trump pledged on Friday to increase the production of test equipment in partnership with private companies and to create diagnostic tests more widely available in hospitals and in the store parking lot. This week, the FDA said more than 35 universities, hospitals and corporate labs start running the tests themselves, under the revised policy body.
But it may be weeks before sufficient tests on hand to fill a need.
“The idea of anyone getting (tested) with ease the way people in other countries do, we are not set up for it,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases told a committee of House last week , “It is a failure. Let’s admit it. ”
This is a problem many Americans, accustomed to hear they have the most advanced medical care in the world, find it difficult to understand.
“I do not know how we screwed up so badly,” said Ruth Blodgett, 65, whose husband the same age can not get the test coronavirus on Saturday at a clinic urgent care outside of Rochester, New York, although he was coughing and doctors ordered one for himself. “We were caught flat-footed. For the Americans, it is not acceptable. ”
On the crucial January 27 meeting in Seoul train station, South Korean government leaders said their companies cleared for takeoff.
“They were told that the ‘emergency use authorization’ would come, so fast and develop the kit,” said Lee Hyukmin, coronavirus head a task force in the Korean Society for Laboratory Medicine, who was at the meeting.
One of the companies that Kogene Biotech Co. Ltd., which test kit is the only work initially. The government announced its approval on February 4.
“The government has to act quickly,” said Baek Myoah, an executive director at Kogene. Korea CDC “disclosing information about test methods so test kit maker is able to accelerate development.”
Lee Hyukmin of community laboratory Korea said the government was quick – but not reckless.
“Of course, the kit is approved in one week is not as good as the one that passed the one-year clinical trials,” he said. So in the early days, Lee said, the case of cross-checking the government to ensure the test is working properly.
Cross-checking involved verifying that the laboratory gets the same results the government is doing at the pool early patient samples. In the last week, nearly 100 laboratories available to conduct a national test, according to government figures.
South Korea quick response to the new coronavirus generated from the scars of the past.
In the aftermath of the 2015 outbreak of mer, short for Respiratory Syndrome Middle East, critics slammed the then President Park Geun-hye and her administration’s slow response and lack of transparency. shrinking public confidence in the Park, which was dismissed in 2017 following a corruption scandal linked.
The country has 186 Mers cases, more than anywhere outside the Middle East, including 38 deaths.
“We can not forget what happened. It is etched in our minds, “CDC Korean Lee Sang-won said. “We hurt so much, and we feel sorry.”
On January 31, just a few days after the meeting of the Seoul railway station, the Department of Health and Human Services (HHS) declared a novel coronavirus public health emergencies, citing a similar statement from the World Health Organization.
HHS oversees a separate operation from the FDA and CDC, key agencies involved in the response to the pandemic. CDC is responsible for developing the initial testkits for the virus. Then, under the old protocol, the FDA is required to approve the test before it could be sent to state and local laboratories across the country. private laboratories and large hospitals can develop their own tests or work outside the CDC version.
On February 3, in the midst of preparations for dealing with emergencies, the FDA hosted the 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 placing a diagnostic test cleared under the state of emergency on the road to permanent approval by the FDA.
Although coronavirus now the hottest topics in the global medical, broadcast meetings delivered little sense of urgency about the epidemic sweeping the world. It was mentioned in passing but regulators largely stuck to their Powerpoint presentation.
In his speech, Dr. Timothy Stenzel, who oversees the review FDA diagnostic tests, spoke extensively about the mission of the agency to protect public health: “It is our goal to be the first in the world as far as possible to authorize a new test.”
Carolyn Hiller, director of the program in Medical Device Consortium for Innovation, which hosted the event along with the FDA, said there was discussion with the agency about the delay the meeting because of an outbreak of coronavirus, but both sides chose to go ahead.
“The whole thing exploded coronavirus in real time as this is happening,” he said.
Stenzel did not respond to requests for comment. In a statement, the FDA acknowledged that the coronavirus was “not a specific topic on the agenda.” But the agency said it has been talking with developers test and “conference was timely and discuss important issues” for companies and institutions seeking to generate test.
The next day, February 4, FDA greenlighted CDC test kits for the virus.
Weeks chaos will follow.
Feb 8, several states and other common laboratory tests complain that CDC does not work because of the defective part that gave inconclusive results. Three days later, the CDC said the lab that it manufactures new components.
In mid-February, the federal government remains stuck in first gear. CDC is the main supplier of test in many countries, and other laboratories can not immediately deploy their own without FDA approval.
HHS said it has assigned a team of scientists outside to check what was wrong with the initial batch CDC tests, such as whether there are manufacturing defects, design defects or contamination in the laboratory entities. Exact problem has not been identified.
The CDC does not send a new test instrument until the end of February. Meanwhile, public health experts say, the important windows shut at containing the virus, who was known to have infected more than 60 people.
US emergency declaration issued at the end of January created additional hurdles that hinder broader expansion in testing, according to former federal officials and professional lab.
The declaration eased the way for manufacturers to pursue vaccines and antiviral treatments for COVID-19. But public health experts say that the same declaration makes it more difficult to expand beyond CDC diagnostic tests.
That’s because the necessary declaration of diagnostic tests developed by individual laboratories, such as in hospitals or universities, to undergo greater scrutiny than non-emergency – perhaps because the stakes are higher.
“Paradoxically, increased regulation of the diagnosis while it creates easier access to vaccines and antiviral,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security. “There is a real-up offense diagnostic test that has exposed a flaw in the US pandemic response plan.”
Dr. William Schaffner, a professor of preventive medicine and infectious diseases at Vanderbilt University School of Medicine, said the CDC and FDA stick to their conventional guidelines for too long.
“traditional public health thinking, ‘Do not create panic and do not go to the summit. Keep testing narrower approach than mass precision rifle, shotgun approach, ‘ “said Schaffner. “It failed in this regard. This virus acts differently and it overwhelmed the US system. South Korea has a lot of better sense of what happened. ”
In a statement Tuesday, the CDC said: “After learning that some can not fully verify laboratory tests, the CDC began working on solutions and identify the source of the problem …. CDC, in conjunction with the FDA, determined how to come forward and share this information immediately to the public health laboratory. ”
Statement CDC also recommends that the agency is not exclusively responsible for the delay test.
The CDC is “no obstacle” to obtain large-scale commercial testing began, according to the statement. That is the role of the FDA, and as the early US cases were detected in late January and early February, CDC director Dr. Robert Redfield highlighted the need for agents that act, according to the CDC statement.
Alberto Gutierrez, who heads the FDA’s Office oversees diagnostic tests 2009-2017, the agency said proceed with caution because it sees itself as the last line of defense against opportunistic companies looking to cash in on the threat to the public health. “There’s money to be made in an emergency, and a lot of people trying to take advantage of it,” said Gutierrez. “The problem facing the FDA, do not you let it be a Wild West?”
“The FDA has good intentions,” he said.
efforts like the US faltered, South Korean officials cleared the test of the second company, Seegene Inc., on February 12.
With many more tests in hand, health officials are well-armed to attack virus moves quickly and aggressively track down people who may have been exposed. This supported the testing of offensive help South Korea reduce the number of new cases for several weeks, serving as a model for other countries grappling with the pandemic.
In mid-February, cases spiked in a secret church in the southeastern city of Daegu. On February 26, Daegu city officials said they will test every member of the church, including those without symptoms.
On March 10, Daegu says that it has tested nearly all of the 10,000 member churches in the area, and about 40% came back positive. The city, which now accounts for about three-fourths of the total infections in South Korea, has seen a sharp drop of new cases. On Wednesday, officials announced 46 new cases compared to 741 cases peak on Feb. 29
This country went from two test makers agreed on Feb. 18 to five in the last week, according to the CDC Korea.
“To my surprise, the test kit maker can increase production quickly,” CDC Korean Lee Sang-won said.
With Feb 24, state and local laboratories in the United States who pleaded with the FDA to relax the rules so that the people no longer have to rely so heavily on the CDC for testing. They asked Hahn, commissioner of the FDA, to “enforcement discretion” so that they can use self-developed laboratory tests.
“We are now a lot of weeks to respond with still no diagnostic or test surveillance beyond that available from the CDC for most laboratories of our members,” Scott Becker, chief executive of the Association of Public Health Laboratory, and Grace Kubin, services laboratory director at the Texas Department of State Health ministry, 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 laboratory, called the letter “Hail Mary” pass, an act of desperation.
“All the lab community really came unglued. We know we can develop tests and are very capable of doing that, but we felt hamstrung “Becker told Reuters.
He said the lab wants the FDA to make more tests are available so that they can run more patient samples at a faster pace.
Two days after receiving a letter Becker, commissioner of the FDA said it is prepared to approve the new test out quickly – if the requirements for accuracy are satisfied.
“The results of diagnostic tests False may cause public health consequences of significant harm,” Hahn wrote to the Association of Public Health Laboratory in the February 26 letter, “not only serious implications for the treatment of individual patients but also serious implications for analysis progression of the disease and for public health decision-making. ”
Under the increased pressure, the FDA relented and removed many bureaucratic obstacles. On February 29, the agency said public and private laboratories, including academic medical centers, can begin to use their own tests before the FDA has completed itsfull review. The laboratory has 15 working days to submit an application is complete, which can be approved retroactively.
On the same day, government Trump confirmed the first death in the United States of coronavirus, a man in his 50s in Washington state.
On March 2, Stenzel office diagnostic test the FDA host webinars for developers of laboratory tests, highlighting additional challenges, including lack of virus samples needed to validate the results of the test. Some laboratories also have reported shortages of other important equipment and materials, as well as the need for more highly trained personnel.
As US regulators rewrite their policies, South Korea city that opens the roadside test facilities around the country, collecting samples in minutes while people sit in their cars.
At a closed meeting last week in Congress, US Representative Raul Ruiz, a Democrat from California and an emergency room physician who treated patients during the pandemic influenza H1N1 2009, pressing the FDA commissioner and other members of the administration of Trump on why Korea pounded southern United States in its response.
“Why we do not have a drive-through tests like South Korea?” Ruiz asked for coronavirus presidential task force leader.
Ruiz told Reuters officials said they were working on it. Alone, some hospitals and communities have started to offer drive-through testing in Colorado, New York, Texas and elsewhere.
In recent days, as public criticism grew louder, Trump appointed czar testing to improve coordination across agencies. FDA launched a 24-hour hotline for laboratory needs help to speed up the testing, approved two applications for the company’s higher-volume testing and the country given the flexibility to authorize new tests that could bypass FDA laboratories.
Despite the new measures, Ruiz said he fears America is still weeks away from approaching what has been achieved South Korea. “I think the moon has been lost here,” said Ruiz. “Maybe we should look into buying a test of South Korea.”
That may happen. Both Kogene and SolGent Co., two of COVID-19 test approved maker in South Korea, said that their companies have an eye on the US market.
“The FDA asked us to proceed with an application quickly,” said executive Kogene Myoah Baek.
Chad Terhune reported from Los Angeles; And Levine and Jane Lee reported from San Francisco and Hyunjoo Jin of South Korea. Contributing which Julie Steenhuysen, Josh Smith, Sangmi Cha and Aram Roston; Editing by Michele Gershberg and Julie Marquis
All quotes are delayed at least 15 minutes. View of exchanges and delays.
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