from the Washington Post website – free – https://www.washingtonpost.com/politics/2020/03/30/11-100000-what-went-wrong-with-coronavirus-testing-us/
Graphics on-line are worth looking at.
11 to 100,000: What went wrong with coronavirus testing in the U.S. |
The Fact Checker
Testing for the novel coronavirus is a crucial part of slowing the spread of the disease.
Here’s how the U.S. failed to provide tests that worked quickly.
By — Meg Kelly, Sarah Cahlan and Elyse Samuels
March 30, 2020 at 3:00 a.m. EDT
[Please Note: The Washington Post is providing this story for free so that all readers have access to this important information about the coronavirus. For more free stories, sign up for our daily Coronavirus Updates newsletter.]
“We have it totally under control.”
— President Trump, in an interview, on Jan. 22
“We’re in great shape in our country. We have 11, and the 11 are getting better. ”
— Trump, in remarks, on Feb. 10
“You may ask about the coronavirus, which is very well under control in our country.”
— Trump, in a news conference, on Feb. 25
“It’s going to disappear. One day — it’s like a miracle — it will disappear.”
— Trump, in remarks, on Feb. 27
“Anybody that needs a test, gets a test. They’re there. They have the tests. And the tests are beautiful.”
— Trump, in remarks at the Centers for Disease Control and Prevention in Atlanta, March 6
[This article has been updated with a response from the Food and Drug Administration.]
When the first U.S. case of the novel coronavirus was confirmed, President Trump assured the American people that the situation was “totally under control.” Cabinet officials, the vice president and the president repeated that refrain throughout February. By the end of that month, as global financial markets and the American public started to quiver, Trump held firm: “You may ask about the coronavirus, which is very well under control in our country.”
With the clarity of hindsight, it is obvious the situation was very much not under control. In reality, a lack of testing gave a false picture of how many people across the country were infected.
Through government documents, testimony, news reports and interviews, The Fact Checker video team has reconstructed events that left the government blind to the virus’s spread, and examined how those errors opened the door for 11 confirmed cases to balloon to more than 100,000 in less than six weeks.
The novel coronavirus was first detected in early December in Wuhan, China. Chinese officials reported the pneumonia-like disease to the World Health Organization (WHO) at the end of December, but neglected to mention growing evidence that the virus could spread by human-to-human transmission through airborne droplets.
Still, China’s previous failures to be forthcoming about public health crises meant that public health officials elsewhere already were wary of its government’s official statements. As reports of the mysterious virus increased, the Centers for Disease Control and Prevention (CDC) warned Americans against traveling to China and activated an emergency management tool used to direct operations, deliver resources and share information.
Despite the alarm bells and increased intelligence briefings, Health and Human Services Secretary Alex Azar struggled to get Trump’s attention for weeks.
January: Make the test
One of the first things that any government needs to track and manage any disease’s spread is the ability to test for it. Because covid-19 is a disease caused by a novel strain of coronavirus, that meant developing a new test.
China developed its own test. The WHO adopted a test from German researchers and published testing protocols in mid-January. Those protocols could be adopted by other countries to produce their own tests or countries could use tests provided by the WHO. The CDC publicly shared the details of the test it designed on Jan. 24 — three days after the first case of coronavirus was confirmed in Washington state.
The CDC’s decision to develop its own test is not unusual. “The CDC will develop their own test that is suited to an American health-care context and the regulations that exist here,” Jeremy Konyndyk, a senior policy fellow at the Center for Global Development, explained. “That’s how we normally would do things. A lot of countries don’t have the capabilities that we have here. And so they need to rely on the WHO to provide tests to them. We don’t have to do that in the United States.”
Even though the United States had cases in the single digits in late January, some public health officials were increasingly worried. Luciana Borio, the former head of medical and biodefense preparedness at the National Security Council, and Scott Gottlieb, who led the Food and Drug Administration (FDA) from May 2017 to April 2019, wrote a prescient op-ed in the Wall Street Journal, warning that if the virus is widespread, “the CDC will struggle to keep up with the volume of screening. Government should focus on working with private industry to develop easy-to-use, rapid diagnostic tests that can be made available to providers.” Borio told NPR on Jan. 30: “The most important and effective way to control epidemics is to identify patients who are infected, exposed to the virus, and isolate them.”
In other words, the government needed to prepare to test Americans on a large scale.
But the government did almost the exact opposite of what Borio and Gottlieb proposed. CDC issued narrow guidance on which patients qualified for a test — only those with recent travel to Wuhan or those who had come into contact with an infected person.
On Jan. 31, Azar declared a “public health emergency,” announcing travel restrictions — including barring noncitizens who had recently visited China from entering the United States — in an effort to curtail the virus’s spread inside the country. The declaration triggered emergency testing protocols, which increased restrictions on which labs could make a coronavirus test. Any lab would be required to acquire an Emergency Use Authorization (EUA) from the FDA to perform testing for covid-19. The FDA granted the CDC the first EUA.
The overall plan was simple. The CDC would use the science it had developed for the test, do the bulk of the testing, and distribute test kits to qualified state labs. This would safeguard against potential bad results and ensure an accurate count.
The EUA requirement meant that other labs, including sophisticated labs that developed tests based on the genetic sequence available and that under normal circumstances could have begun testing, were not able to do so until they received special permission.
February: Distribute the Test
On Feb. 2, Gottlieb tweeted, “Since CDC and FDA haven’t authorized public health or hospital labs to run the tests, right now #CDC is the only place that can. So, screening has to be rationed. Our ability to detect secondary spread among people not directly tied to China travel is greatly limited.”
The conundrum Gottlieb described quickly amplified. The CDC-manufactured kits were sent to state labs on Feb. 6 and Feb. 7. Some labs had problems with the test. By Feb. 12, the CDC announced that the test was providing inconclusive results. By then, the United States had reported 11 cases.
The low case count dampened concern among some in the administration. And Trump touted those comparatively low numbers on Feb. 10: “We’re doing great in our country. … We only have 11 cases, and they’re all getting better.”
By then, a self-perpetuating cycle had formed. Few people qualified to be tested, and even if they did qualify, the CDC was essentially the only place that could do those tests. (A total of 12 other labs received EUAs by late February.) That meant relatively few tests were performed, and thus few people tested positive for the virus.
By Feb. 16, the CDC and state public health labs tested nearly 1,600 specimens. As a rule of thumb, two specimens are required per person, meaning that in total, only about 800 people had been tested. That’s roughly 2.4 tests per million people in the United States. In contrast, South Korea, which found its first case on the same day as the United States, had tested nearly 8,000 people, or 154.7 tests per million.
COVID-19 tests per million residents
“The testing issue was not something that any single agency could resolve,” Konyndyk said. “CDC had their piece of it, which was their own test, but CDC didn’t have the authority to tell other private labs: Go ahead. You’ve got a green light. FDA had to do that.”
The New York Times reported that Azar was “unable” to get either the CDC or the FDA to “speed up or change course.” Moreover, he “had been at odds for months with the White House over other issues” and was communicating primarily with acting White House chief of staff Mick Mulvaney, who was in the process of being forced out.
Azar testified that he intended to implement a pilot program, adding coronavirus surveillance to the existing flu surveillance networks on Feb. 13. But it never came to fruition. There were not enough tests to make it happen.
By the following week, it became clear to local public health officials that the virus had spread in communities and become endemic in other countries. Public health labs, frustrated by their inability to test, became frantic. Still, the CDC warned labs not to test without emergency authorization from the FDA — regardless of whether protocols they planned to use came from the WHO or the CDC or had been developed in-house.
(Correction: An earlier version of this article incorrectly attributed this warning to the FDA.)
On Feb. 24, state public health labs made an unusual plea for the agency to open testing. That same day, Trump tweeted, “The Coronavirus is very much under control in the USA.”
The next day, Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, told reporters: “Ultimately, we expect we will see community spread in the United States. It’s not a question of if this will happen, but when this will happen, and how many people in this country will have severe illnesses.”
One section of Messonnier’s remarks was especially stark: “I had a conversation with my family over breakfast this morning, and I told my children that while I didn’t think that they were at risk right now, we as a family need to be preparing for significant disruption of our lives.”
According to news reports, Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, was growing concerned about the slow pace of testing. But Trump’s cheery assessments continued. On Feb. 27, he said, “It’s going to disappear. One day — it’s like a miracle — it will disappear.”
March: A new strategy
Two days later, on Feb. 29, the FDA lifted restrictions on labs, issuing a new set of significantly less restrictive protocols. On March 3, the restrictions on who qualified for a test were dissolved. At that point, 13 people in the United States were recorded as having died of covid-19.
Still, tests were hard to come by. Five days after both restrictions were removed, the United States reported 518 cases and had completed 3,099 tests, according to the Covid Tracking Project. That is roughly 9.5 tests per million people. South Korea had 7,314 cases after performing 188,518 tests, or 3,682 tests per million. Yet, Trump claimed on March 6 that “anybody that needs a test gets a test.”
As of March 28, exactly four weeks after the FDA loosened the rules for testing, the United States still performed only 2,250 tests per million — two-thirds of what South Korea did almost three weeks earlier. The death toll in the United States was 2,198 — and climbing rapidly.
South Korea’s death toll that day was 144, a rate of 3 per million people. The rate for the United States was more than double — 7 per million people.
Konyndyk put the failure simply: “The reason [the lack of testing] has been such a damaging shortcoming in the U.S. response is it basically left us blind to the spread of the virus in our country for about six or seven weeks.”
The White House, the CDC and other federal agencies did not respond to requests for comment.
Stephanie Caccomo, spokeswoman for the FDA sent this statement: “The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. The FDA has been extremely proactive and supportive of test development by all comers—laboratories, and large and small commercial manufacturers—offering our expertise and support to speed development and to quickly authorize tests that the science supports.”
The Bottom Line
The president spent nearly two months issuing confusing and contradictory signals — leaving the bureaucratic machine of the U.S. government to chart the course for the coronavirus response.
The CDC designed its own test. The FDA picked a conservative testing strategy, allowing labs to use only the CDC test. When those tests failed, neither a new strategy nor a new test was available for more than two weeks. Azar failed to push the agencies to change direction, and the president didn’t intervene.
Even then, widespread testing was not immediately available. It’s not just the number of tests that are the problem — it’s getting the materials to do the tests and the personal protective medical equipment for providers to give those tests. That means we may never have a true count of how many Americans contracted the virus.
The missteps that went unmanaged were ignored by leaders at the highest level of government and allowed cases to go undetected, contributing to the spike in the virus’s spread.
Meg Kelly produces video and reports for the Fact Checker. She previously covered the 2016 election for NPR where she was a visual producer. Follow
Sarah Cahlan edits and produces videos for the Fact Checker at The Washington Post. Follow
Elyse Samuels is a digital video editor focused on verifying viral video, reporting on misinformation and manipulated video that spreads online. She joined The Washington Post in October 2016 as a producer for the Facebook Live team. She then transitioned to the universal desk where she focused on editing breaking news content.