How The Trump Administration Hindered The Creation Of Efficient Testing For Covid-19

By Theodore Shoebat

In January of 2020, officials in the Chinese government revealed that the reason why there was a boom in cases of pneumonia in Wuhan was because of a novel coronavirus, now known as sars-CoV-2. On January 10th, a team of Chinese scientists uploaded a copy of the virus’s genome to an online collection of documents for virologists around the world to observe in order to develop tests to find out who is infected with the disease. On January 21st, a German scientist named Christian Drosten (who was amongst the scientists to have discovered the sars virus in 2003), put out a paper giving the details on a protocol for testing for sars-CoV-2. This protocol would provide the foundation for the test given early on by the World Health Organization. Also on January 21st, Nancy Messonnier, the director of the National Center for Immunization and Respiratory Diseases, announced that the CDC had completed the creation of its own test which would be used to discover the US’ first case of covid-19 on February 5th, 2020. 

The day before this, February 4th, Alex Azar, the Secretary of Health and Human Services, declared a public-health emergency. This triggered a policy of regulation in which the FDA would have full authorization to the CDC and that any lab that wanted to create its own tests for the new coronavirus would first have to get something called an Emergency Use Authorization (EUA) from the FDA. The purpose of this, according to Joshua Sharfstein, a former principal deputy commissioner of the F.D.A., was to prevent confusion. In his words: “You certainly wouldn’t want to say, ‘Any lab can advertise a coronavirus test.’ Because then it’s going to be chaos. There are a lot of people who will sell things that may or may not work.” Sharfstein signed the first EUA during the H1N1-flue epidemic in 2009. He recounted in an interview with the New Yorker how:

“I met with the lawyers to explain to me the E.U.A. process, and they basically said, ‘It’s whatever we think it is. We can make it up to fit the time.’ If you tell me I’ve got twelve hours, I could get some very smart people on the phone to do our best to figure out something that’s going to work. The E.U.A. process is supremely flexible.”

But, Keith Jerome, the director of the University of Washington Virology Lab in Seattle, has a different perspective on the regulation policy triggered by Azar: it hindered the making of an efficient testing system by prohibiting the reporting on the testing of patience. It also slowed things down by requiring that researchers mail a physical copy detailing their work directly to the FDA: “Here we are in this sars-CoV-2 crisis, and you have to send them something through the United States Postal Service. It’s just shocking.” Because of this hinderance, the FDA has since dropped the requirement of sending a CD-rom or USB drive with a copy of the application. The F.D.A.’s exclusive authorization to the C.D.C. to conduct covid-19 tests ended up starting, in the words of Jerome, “what you’d think of as an agriculture monoculture. If something went wrong, it was going to shut everything down, and that’s what happened.”

The Seattle lab began testing 300 people for coronavirus, and found two people who tested positive. “We didn’t find anything on those three hundred until, I believe it was, February 29th,” said Jerome. “And then we got a specimen from one of the people who were the two original cases in Washington.” But the EUA regulation triggered by Azar did something shocking, as was reported by the New Yorker:

The E.U.A. regulations, however, prohibited the lab from reporting the results to the doctors who had ordered the tests for their patients. To work around the prohibition, Jerome’s lab called officials at the state lab and told them, “You’ve got to get this patient and test.” (As it happened, the patient’s specimen was already being studied for covid-19.) In effect, Jerome said, the lab was able to perform at least some surveillance of the outbreak, despite the lack of tests from the C.D.C. “If we’d been able to test a thousand people or two thousand people, maybe we would have found something sooner,” he told me. “But it does show that it wasn’t like everyone had it through those last two weeks of February.”

Labs like Jerome were trying to create an efficient test in a time when the CDC did not have one for the coronavirus. The first case of coronavirus was discovered on February 5th, 2020. The man was a Seattle resident who had visited Wuhan, China, to see relatives. After his diagnosis, the Center for Disease Control started testing people for coronavirus. Out of 500 people tested at various CDCs in Atlanta,12 had coronavirus. The CDC in Atlanta started sending diagnostic tests to a network of about a hundred public health laboratories in various cities and counties, so that people could be tested without having to get screened by the CDC.

Testing kits then arrived on February 7th at more than fifty state and local public health labs. These testing kits were made to screen fifty thousand patients. But there was a problem, in order for a state or local laboratory to actually run the CDC tests, they needed to verify that they would work the same way that they did in Atlanta. Only about six to eight labs that received the testing kits reported that they had worked the way they were suppose to. But about thirty-six labs, including in New York City and New York State, reported problems with two kits. On February 8th, the CDC received several reports from labs on problems with the testing kits.

Messonnier stated: “we hoped that everything would go smoothly as we rushed through this,” and said that verification problems were “part of the normal procedures.” Until a consistent testing system was established, all coronavirus testing needed to be done at CDCs. This caused a three week delay in distributing a viable testing kit.

What made the situation unstable was the fact that the CDC was, in the words of Robert P. Baird, “never intended to provide widespread testing in the event of a pandemic.” There was no point in conducting the procedures that are to be done during the early stages of an outbreak — contact tracing, isolation, and individual quarantines — without an efficient means of testing. The hurdle and delay that was caused by the CDC made it impossible to get a clear picture as to how fast the virus was spreading. In fact, this is what allowed COVID-19 to spread undetected for several weeks in Seattle which became a hotspot for coronavirus in the country. Alberto Gutierrez, the former head of the F.D.A. Office of In Vitro Diagnostics and Radiological Health, said: “The problem was that containment was not done very well. At this point, we’re looking at exponential growth, and we need to figure out how to meet an exponential demand.” The COVID-19 tests use a highly sensitive chemical system that reacts very quickly to contamination. Consistency for the reagent is thus requisite for a viable test. In the words of Baird:

“The covid-19 tests use polymerase chain reaction, or PCR, a technology for whose invention the biochemist Kary Mullis won the Nobel Prize, in 1993. PCR is highly sensitive to contamination and other faults, which is why the verification step is necessary to insure accurate results. And yet while the reagent problems were, in their way, a fairly ordinary technical hiccup—Messonnier, at the C.D.C., was not spinning the situation—the cascading effects that they’ve had on the country’s covid-19 preparations suggest a much larger problem with the way the United States has structured its pandemic response.”

During the weeks long void made by the CDC, laboratories like the one in Seattle were trying to come up with a test were hindered by EUA regulation triggered by Azar.

The hindering of the creation of tests was also seen by Scott Becker, the C.E.O. of the Association of Public Health Laboratories ( APHL), a nonprofit organization that represents and coördinates a hundred and fifty state, county, and city public-health laboratories.

When the CDC were dealing with the problems of their testing kits, the CDC told labs to not do any tests until new kits could be made. But, the CDC also refused to specify when those kits would be ready. “You’re just thinking, any day it’s going to show up,” Becker said. “We really felt this enormous pressure to begin testing any way we could. … Not only pressure, but responsibility.”

On February 26th, The FDA told Becker that they were willing to consider an E.U.A. that would allow all of the labs in the APHL’s network to begin testing. This was after Becker and the APHL’s president, Grace Kubin, sent a letter on February 24th to the FDA requesting that with “the gravity of the current COVID-19 situation across the globe,” that the F.D.A. commissioner allow the A.P.H.L.’s member laboratories to “create and implement a laboratory developed test (LDT) for the detection of SARS-CoV-2 (COVID-19).” The letter went on: “While we appreciate the many efforts underway at CDC . . . we are now many weeks into the response with still no diagnostic or surveillance tests available outside of CDC for the vast majority of our member laboratories.” The FDA told the APHL that they were considering to “streamline the process to facilitate the protocol that you propose.”

The state of New York, where the Wadsworth Center, the state public-health laboratory, had created its own working covid-19 test based on the C.D.C. protocol, filed an E.U.A. application on Friday, February 28th. The next day, the F.D.A. approved the test for use by both New York City and State. As the New Yorker reports: “A week and a half later, at the request of New York State, the F.D.A. expanded the E.U.A. to allow the Wadsworth Center to do its own authorizations of laboratories that sought to use its test.”

On February 29th, the same day that the F.D.A. permitted New York tests, the agency also put out a new policy that gave permission to any facility that had been certified to deal with so-called high-complexity testing to conduct its own covid-19 tests. According to Becker, about five thousand virology labs in the country, including the one at the University of Washington, met the standard. Back in Seattle, Keith Jerome and his team at the Virology Lab in the University of Washington, could now for the first time since February 4th, conduct clinical covid-19 tests. “That changed everything,” Jerome said. “We didn’t have to wait to get the forms in and then wait for the response.”

On March 13th of 2020, Trump gave a Rose Garden press conference where he announced that commercial firms were finally ready to commence testing for covid-19. When Trump was asked by a reporter if he felt any responsibility for the delay in producing proper testing, the president replied:

“Yeah, no, I don’t take responsibility at all … We were given a set of circumstances and we were given rules, regulations, and specifications from a different time. It wasn’t meant for this kind of an event with the kind of numbers that we’re talking about.”

Trump was also asked about his administration dismantling, in 2018, an Obama era National Security Council directorate made for pandemic and bioterrorism planning, established after the Ebola epidemic four years earlier. “I just think it’s a nasty question,” the President replied. “I don’t know anything about it.”

On the same day Trump took to Twitter to bash the CDC and blame Obama:

“For decades the @CDCgov looked at, and studied its testing system, but did nothing about it. It would always be inadequate and slow for a large scale pandemic, but a pandemic would never happen, they hoped. President Obama made changes that only complicated things further.”

Alberto Gutierrez, the former F.D.A. official, replied to the president: “That’s not fair … If a general who’s lost a war says, ‘I don’t take responsibility because the army that was built for me was an army for a different area’? No. It is part of the obligation of the government to figure out what is needed, and what’s changing, and how to change to meet those demands.”

What we do know is the CDC delayed the creation of an adequate testing system for three week, and that the EUA regulations triggered by Azar prohibited virologists from reporting the results to the doctors who had ordered the tests for their patients. 

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