COVID-19

One Month Delay in Testing Coronavirus Led to Epidemic in the United States

The US reaction for nearly two months before the outbreak occurred struggling and delayed. Without timely extensive testing, the United States is in the biggest health crisis in history.

In the early days of the outbreak, a group of federal government officials responsible for protecting the United States from the new strain of coronavirus met daily in the Situation Room in the White House, plunged in constant crises.

They struggled with the plan to evacuate the US consulate in Wuhan, forbid people who had ever been to China to enter, and evacuated American citizens from Diamond Princess and some other yachts.

The coronavirus response task force usually spent only 5-10 minutes, mostly at the end of the meetings, to discuss testing, according to the disclosure of a number of participants.

The Centers for Disease Control and Prevention (CDC) at that time developed its own diagnostic model and will soon implement it in the first step against epidemics, or at least that is what the agency leaders promised to remaining members in the group.

However, when an epidemic from China spread to the United States, spreading rapidly across the country from late January to early March, widespread testing to detect infected people did not occur.

It is the result of technical flaws, “impassable” administrative barriers and a lack of leadership at many levels, as revealed by many health officials, government officials, and scientists and business leadership with the New York Times.

Missed the golden opportunity

The richest country in the world, with the hands of leading infectious disease scientists and experts, has spent nearly a month preparing and ruining the best opportunity to control the spread of the virus. Instead, Americans are largely blind to the scale of the public health disaster that is coming.

According to former CDC director Thomas Frieden, the failure to test until it is too late indicates failures in many parts of the government.

Jennifer Nuzzo, an epidemiologist at Johns Hopkins, reviews President Donald Trump’s government misjudging the impact of the epidemic. Meanwhile, former leader of the US Food and Drug Administration (FDA) Margaret Hamburg said the passive period has led to “cumulative growth of cases” in the US.

A week after Washington state reported the first case of coronavirus in the United States on January 21, the Wall Street Journal published comments from two former top health officials of the Trump administration calling for immediate action to block disease outbreak.

Luciana Borio, former director of health policy and biological defense at the National Security Council, and Scott Gottlieb, former leader of the US Food and Drug Administration (FDA), outlined the urgent steps to take. America avoids medical catastrophes. A top priority is that the federal government must work with the private sector and develop a “quick, easy-to-use diagnostic test kit”. That’s exactly what Korea did in the first two weeks after the first case was discovered, just a day before Washington’s historic announcement.

It was not until February 29, more than a month after the appeal of Borio and Gottlieb, and nearly 6 weeks after the first case in the US was discovered, that the Trump administration realized this. Hospitals and laboratories across the country are finally allowed to conduct the Covid-19 test themselves to speed up the detection of infected people.

On March 26, the United States surpassed 82,000 cases of coronavirus infection nationwide and became the country with the highest number of Covid-19 patients in the world. Only three days later, this figure in the US exceeded 121,000 walls with more than 2,000 deaths.

More than a quarter of patients were discovered in New York City, now a new focus of the global pandemic. The development curve of the epidemic in the US continues to increase steeply, with the number of infections / cases getting bigger and bigger, approaching the risk of exceeding the endurance of the national health system.

“The way America copes will be viewed by many generations as a classic example of catastrophic failure. What happened in Washington is clearly a near total failure, ”said Ron Klain, former 2014 Ebola virus coordinator, under former President Barack Obama.

By the time federal officials are being notified of large-scale testing adjustments, everything is too late. Control measures no longer matter. The remaining coping tools in the hands of the government are blockade, social intervention and drastic treatment in the hope of limiting the consequences of the disease.

In a hearing with the House of Representatives, Dr. Anthony Fauci, the leading government scientist in the battle with the virus, admitted that not promoting early testing was a weakness in the deadly pandemic response.

According to sources familiar with the matter, there are three agencies in the US government responsible for detecting and responding to threats such as Covid-19 but unable to catch the pandemic. Although scientists soon followed the Chinese situation and set off the alarm, none of the three leaders of the agency urgently mobilized full protection for the American people.

CDC Director Robert Redfield, 68, former veteran military physician and AIDS pandemic researcher, believes his scientists can develop the world’s most accurate coronavirus test and tissue sharing this diagnostic image of state laboratories. When he discovered that the test kit was flawed and did not produce reliable results in February, he promised to fix it quickly, but CDC took several weeks to come up with a solution.

Leading health agencies in the United States also limit the scope of karma review and delay the conduct of epidemiological surveillance at the community level, a basic practice for detecting the spread of a virus. If the United States can trace the earliest developments of the disease and identify hot spots at risk of outbreaks, local isolation may have worked.

At the same time, the Food and Drug Administration (FDA) leader Stephen Hahn again enforced regulations that prevented hospitals, private clinics and businesses from running diagnostic tests. While some countries are successful in mobilizing the private sector, jointly conducting tens of thousands of tests every day, the average number in the US before the outbreak is less than 100 tests per day.

Overseeing the activities of both agencies is Secretary of State Alex Azar, head of the US Department of Health and Human Services, and is responsible for coordinating the U.S. government’s response strategy to the pandemic. Although aware of the frustrations of the Covid-19 test, Minister Azar could not urge the CDC and FDA to accelerate.

The 52-year-old minister was the leader of the coronavirus task force until the end of February, before being taken over by Vice President Mike Pence. Mr. Azar himself has also encountered disagreements with the White House on a number of other issues for months before the coronavirus became a global problem. The liaison between the task force and President Trump is the White House Chief of Staff Mick Mulvaney, a voiceless figure in the group of officials close to the leader.

Lacking high-level attention and the need for urgent action, the testing problem is forgotten and has disastrous consequences.

Science loses its voice

President Trump at the end of January dodged talking about the severity of the threat. On January 30, when the World Health Organization (WHO) declared the coronavirus outbreak to be a global emergency, President Trump continued to reassure people that “the situation will not be as bad as people think.” .

“We think things are very well controlled. We think things will end well for us. I can assure you that, ”he said.

In the early stages of the lost “golden month”, when the US government should still have time to act before the coronavirus outbreak, President Trump was again distracted with impeachment in the Senate. Lo economic influence, he denied the risks that the US health system is facing. By the end of the month, the leader was confident that the virus was about to evaporate from the United States.

“It will disappear. One day, miraculously, it will disappear,” he emphasized in a speech in February.

The United States now has more than 312,237 cases with deaths exceeding 8,501, making it the world leader in the scale of the disease. Many cities froze, the economy went into recession, and the daily lives of people turned upside down. Even so, many Americans still cannot get tested even if they have the disease.

The subjective psychology of the White House before all scientific warnings became familiar during President Trump’s term.

Many experienced and highly specialized personnel and officials, fully aware of what the government needs to do with scientific information, have left office recently. As revealed by former senior administration official with the Guardian, the level of expertise and leadership “has eroded at many important levels within the government.” He shared that federal agencies have difficulty finding qualified quality personnel because “no one wants to work there.”

Before the worrying developments of the epidemic in Korea and Italy, Dr. Messonnier on 25/2 suddenly warned the American people that “the disturbance in daily life can be very serious”. That statement made President Trump furious when he returned from India. Some sources said he was screaming during a call with Minister Alex Azar because he was unhappy with the impact of the warning on financial markets.

On the same day, the head of the US Department of Health and Human Services had to correct Ms. Messonnier, who noted that people “began to think about what could happen to their lives”. The phrase “maybe” was repeatedly emphasized by him

The indifference of the White House to the epidemic is evident in the proposal to cut 16% of the budget for the CDC, which President Trump made on February 10, just 11 days after WHO recognized the corornavirus as a problem emergency medical. Schaffner said the leading US health agency was marginalized during a period when the White House should have made the most of it to prepare for a pandemic.

The voices of many veteran, respected and in-depth officials in scientific expertise are overwhelmed by President Trump’s messages. Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, is a rare case of a scientific voice respected by the White House when the coronavirus storm hit the US . He must regularly make corrections on television and provide accurate scientific information after the White House coronavirus press conferences.

Mr. Fauci himself spoke openly about the annoyance of the leader’s arbitrary speech habits. In the interview, Jon Cohen, a writer in Science magazine, wondered how Fauci could stand still with President Trump at every press conference and hear the leader give confusing information to the public. Typically the statement of a ban on entry from China stopped the coronavirus.

“I understand, but what do you want me to do now? In fact, what else can I do? ”, The top US health official shared.

Mr. Trump calls himself a “war president”. If true to the title itself, his “strategy” is causing too much controversy. The problem with the federal agencies in dealing with the disease is further amplified with the way President Trump organizes the government’s task force.

The government’s special task group on the coronavirus was reformed in late February, then assigned Vice President Mike Pence to lead it. The White House’s second character soon appointed Ambassador Deborah Birx, the US special envoy for global health diplomacy, to be the coronavirus response coordinator. The Federal Emergency Management Agency (FEMA) again controls many key areas of the response campaign. White House adviser and President-in-law of President Trump, Jared Kushner, also set up a private team implicitly impacting policy as in many other crises.

“Responsibility does not go anywhere. Constantly changing. No one has solved the problem, ”the former official revealed.

No consensus in senior government agency

ccording to Bruce Aylward, a senior adviser at the World Health Organization (WHO), who led the team that sent a delegation to China to study a new strain of the virus, testing plays a crucial role in the study of how to defeat the disease. . Measures to help identify the disease, the degree of pathology and especially its development direction in the population.

“You need to know if the disease has occurred or not. You need to know whether people around you are infected or not. Because only then can you prevent it,” he said.

This urgent step was delayed in the US because of the miscalculation of the CDC and the FDA, two agencies that are extremely important in disease prevention.

The first time CDC Director Robert Redfield heard about the severity of the coronavirus was from his Chinese colleagues in early 2020, when he was on New Year’s holiday. He spends so much time making phone calls that people in the house rarely see him. One of the most gloomy conversations was when George Gao, the director of CDC China, burst into tears on the other side of the call.

His agency acted aggressively in the beginning. On January 7, the CDC built a “case management system” for the coronavirus and recommended citizens who came to Wuhan to be cautious. By January 20, about two weeks after Chinese scientists shared the virus genome sequence, CDC had developed its own test model and deployed the first case detection in the United States.

Assessing viruses is a major challenge. The virus strain is so new and mysterious, so scientists don’t have much information to act. China provides limited data, while also rejecting a request from the US government to send CDC experts to the field. The virus does not cause symptoms but still has the ability to spread, making it difficult to understand the disease in the early stages.

Attempts to track viruses have stalled at the most urgent time. By mid-February, the entire US conducted an average of 100 tests per day, according to CDC data. However, Mr. Redfield still underestimated the severity of the problem during meetings and talks with Minister Alex Aza, emphasizing that the error will be rectified soon, according to the disclosure of some government officials.

Because of its limited capacity, the CDC offers a rigorous set of criteria for those who need testing: Only those who have been to China or have been in contact with patients who have found positive for the virus.

CDC on February 14 announced plans for testing in five high-risk cities, New York, Chicago, Los Angeles, San Francisco and Seattle. The measure to provide an “early warning signal to promptly change the response strategy” was not finally implemented.

“If there were more tests in the first place and early detection of cases, we would have been in a very different situation,” says epidemiologist Jennifer Nuzzo.

The consequences of false steps gradually became apparent in late February. The Seattle area, where the first case was detected in the US, first detected a corona-positive patient outside the test criteria. Virus alarm researchers have been spreading in Seattle and elsewhere for weeks. Without knowing the complete picture of the infected person, epidemiological investigators could not conduct “contact tracing”. They cannot search for people at risk of the disease and carry out quarantine to cut off the chain of infection.

Meanwhile, CDC still resolutely refuses to apply the WHO testing model. They are confident when the private path is still effective. The test gives accurate results in a CDC laboratory. Deputy Director Anne Schuchat later admitted that she did not think they needed an external testing model when the WHO-recommended test kit had not yet passed the US approval process.

On February 24, a letter signed by 49 deputies called for speeding up testing in the states.

Difficulty in testing

While the CDC struggled with developing test kits, the FDA became a legal barrier to national testing efforts.

Stephen Hahn’s first working session with the FDA leadership began when the coronavirus epidemic was approaching the US threshold, nearly 6 weeks after the US Department of Health and Human Services declared a medical condition emergency in late January. Former leader of the MD Anderson Cancer Research Center in Houston was tasked with driving the FDA to build a network of academic and private laboratories across the country to deal with “invisible enemies.” “, but they became obstacles.

The private sector should quickly become America’s next line of defense after the CDC completes its mission of conducting tests through public laboratories.

Typical example is Korea. The Seoul government since early February has been meeting with 20 medical equipment manufacturers, easing management and speeding up testing. Stephen Hahn again chose a cautious approach. He does not proactively use CDC and FDA scientists but adheres to the rigorous testing approval standards.

According to the New York Times , it was Minister Azar’s declaration of emergency medical conditions that inadvertently set rigid rules forcing Hahn and the FDA to follow.

The statement at the end of January was made for pharmaceutical companies to develop vaccines and therapies more quickly during a crisis, instead of spending more than a year waiting for FDA approval.

However, the text also creates a barrier to hospitals and laboratories to develop diagnostic tests for people infected with coronavirus.

Researchers in the US have soon developed the test models that can diagnose Covid-19, but most need to approval at the FDA.

Many test kits are waiting in laboratories across the country, among them Stanford. Researchers at the world’s leading prestigious university have completed effective testing since February, based on information provided by WHO. WHO, after co-operating with Germany, developed the Covid-19 assay, which has supported more than 250,000 test kits to about 70 laboratories around the world.

BioMérieux, a French medical diagnostic firm, faces the same difficulty with the FDA. Its BioFire test system is used to detect influenza and many respiratory diseases at more than 1,700 hospitals in the United States. This technology is capable of delivering results in 45 minutes. Mark Miller, the company’s chief medical officer, said the FDA’s “emergency use” process was too time-consuming and time-consuming.

In mid-February, the airline received an emergency license for BioFire, effective from March 24.

Miller said the US government was responding too slowly, especially in terms of logistics, such as providing sufficient testing supplies for facilities that needed BioFire.

Lack of leadership

When declaring a state of emergency in late January, Minister Alex Azar showed his confidence. During a press conference at the US Department of Health and Human Services building in Washington, he said the coronaviurs epidemic was still under control.

“I know the tactics very well,” the minister recalled the senior positions he held during the SARS response phase in 2003 and other infectious disease risks.

Graduating from law at Yale University, Mr. Azar was a leading legal adviser to the US Department of Health and Human Services. He also has about 10 years of experience in leadership of Eli Lilly, one of the largest pharmaceutical companies in the world.

It is worth noting that Minister Azar was most interested in President Trump because of non-medical aspects. After graduating from law school, he worked as a secretary for the most conservative American judges in the United States, including Supreme Court Judge Antonin Scalia. He also spent two years as a deputy to Special Prosecutor Ken Starr in an independent investigation of President Bill Clinton.

Mr. Alex Azar was appointed as the second Secretary of Health and Human Services during President Trump’s presidency in early 2018. The top priority at the time was lower drug prices and the fight with painkillers.

When the Covid-19 epidemic broke out sharply in China and many other countries in the first 2 months of the year, Minister Azar was under pressure from public scrutiny and the relationship was not very smooth with the leaders of some direct agencies, according to some well-informed sources. He has persistent disagreements with Seema Verma, the leader of the federal insurance program Medicare and Medicaid. He also did not include Director Stephen Hahn as part of the coronavirus response team, even though the meetings were attended by FDA representatives.

The disagreement between the minister and CDC Director Robert Redfield increased around testing strategy. Two people exchange by phone dozens of calls every day. By the end of February, when the CDC test kit revealed a flaw, Minister Azar said that his leading medical agency had provided false information for him to disclose to the people.

Typically, the number of more than 3,600 people tested was announced by Mr. Azar on March 1 on CBS. The actual number as of that time was significantly lower because many patients were tested many times. This error was corrected by CDC in a hearing before the House of Representatives thereafter.

Another source said that Azar, who is committed to testing by the CDC, will be available within 7-10 days after development, but a week later still receive the same promise.

By the end of February 27, US health officials agreed that the FDA would need to loosen regulations so that hospitals and independent laboratories could quickly conduct separate tests. But by then the US coronavirus epidemic response apparatus had changed. President Trump unexpectedly appointed Vice President Mike Pence to replace Secretary Alex Azar as head of the task force. The decision was so sudden that even top White House health officials came to the news to watch the announcement.

The previous presidents always acted urgently in the face of disease risk. Response efforts come from within the White House, starting with the appointment of a “commander” to coordinate everything.

“If you review the history of responding to similar challenges in the US, from HIV to any other epidemic, they always remove all obstacles in the system for effective response,” the epidemiologist said. WHO study Bruce Aylward shared.

However, in the face of the coronavirus pandemic, President Trump did not choose personnel at the White House to steer the planning of the response. This was only conducted nearly 2 months after the outbreak.

Nearly a year ago, in an effort to reform the National Security Council, President Trump also dissolved the global health security unit set up by his predecessor. For nearly two months, the task force’s biggest weakness was that they did not have a person inside the White House who had the authority to force agencies to act.

After Vice President Pence intervened, the test was speeded up with nearly 100 laboratories and other medical facilities participating. On March 27, Abbott Group, the healthcare giant, announced it had received emergency approval to produce a mobile test kit, capable of identifying cases of coronavirus in just 5 minutes.

President Trump proudly declared that the US “has created a new system” and is conducting tests “in an unbelievable amount”. He emphasized that the United States over the past eight days has conducted tests on a larger scale than what South Korea has done in eight weeks.

In fact, hospitals and clinics across the country are still in a state of refusal to test for suspected mild symptoms. The test is intended for the most serious cases. Mild illness usually takes a week to receive results.

Silently acknowledging the shortage, President Trump earlier this week spoke to his Korean counterpart, Moon Jae In, to ask for support for the test kit. South Korea is producing nearly 100,000 units / day, with testing capacity now higher than national demand.

Community health experts responded positively when testing capacity was strengthened. However, the ability to diagnose the disease up to 3 months after China revealed the newly established epidemic only adds to the regret that the process was not completed earlier to minimize the number of deaths.

“Testing is a crack that breaks the rest of the coping effort, while it should be tied together,” said Nahid Bhadelia, Medical Director at the University of Boston School of Medicine Special Unit of Diseases. , identify.

“It affects every aspect of the coping effort, affecting us all. The delay in testing has affected the overall coping strategy, ”she stressed.

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