The Infuriating Story of How the Government Stalled
Coronavirus Testing
How one young doctor at a Seattle lab tried to get out in
front of the coronavirus crisis by inventing his own test. And why the
absurdity of his struggle should make us all afraid.
BY JULIA
IOFFE
March 16, 2020
Alex Greninger was watching it all from the start. An
epidemiologist and expert in laboratory medicine, Greninger spent the first few
weeks of the year paying close attention to China, where a new SARS-like virus
was burning through the city of Wuhan at an alarming rate. He watched as
Chinese officials struggled to contain the virus, locking down the giant city
of 11 million people, going door-to-door to test its citizens. He watched as
the virus evaded their grasp. More than most people, Greninger could guess at
what was coming for America. And more than most people, he was in a position to
do something about it.
The key to getting an outbreak like the
current one under control, say medical professionals, is implementing proper
testing protocols. Testing for the virus allows doctors to pinpoint and isolate
those who are carrying the virus and prevent them from spreading it. Aggressive
testing allowed China, eventually, to get the outbreak in Wuhan under control
and bring the number of new infections down dramatically. It’s been central to
the strategy that Singapore and South Korea have used, too: test and isolate.
And yet, two months since the first case of COVID-19 was confirmed in the U.S.,
tests for the novel coronavirus are still exceedingly hard to find.
How did the U.S. fumble its response to the
coronavirus so colossally, even with so much lead time? Why, with the number of
diagnosed COVID cases in the U.S. climbing toward 4,000, do we still not have
nearly enough tests?
A large part of the blame lies with President
Trump, who has not wanted widespread testing, apparently out of an obsession with
keeping the number of confirmed COVID cases low. It’s why he waffled so long on
whether to let the Grand Princess cruise liner, where COVID infections were
spreading rapidly, dock in the United States. “I would rather have them stay on
[the ship], personally,” Trump said earlier this
month. “I don't need to have the numbers double because of one ship that wasn't
our fault.” His administration turned down tests
provided by the World Health Organization and instead wasted precious time
having the Centers for Disease Control create its own test. While that was
underway, the president denounced the spread of the disease as a Democratic hoax,
giving the public a dangerously false sense of complacency just as a pandemic
was getting underway.
In the meantime, a more prosaic and
bureaucratic tangle of frustrations ensnared those on the front lines of the
fight—those like Dr. Greninger, whose struggles offer a window into how the
rollout of testing has been bungled, and why the situation isn’t likely to
improve any time soon.
Back in January, while Greninger was studying
the outbreak in China, officials there helpfully published the viral genome of
the SARS-CoV-2 virus, which causes the COVID-19 illness. Greninger immediately
took the information and used it to start developing a test. He knew that he’d
need to get FDA approval to use the test on patients, but if there was an
outbreak coming, he hoped that wouldn’t be a problem.
It was. The FDA had granted permission to make
testing kits to only one lab: the CDC. Many of those kits had, by early
February, been sent to public health labs across the country—and the tests, it
turned out, didn’t work. By then,
cases of COVID-19 in Washington state were beginning to crop up just north of
Seattle. The bottleneck for testing patients began to grow. And those patients
fortunate enough to get tested were forced to wait for their results. In the
case of a typical illness—say, flu or strep—doctors and nurses can order tests
and have the results processed in-house, especially if they work at a big
teaching hospital, like the medical center at the University of Washington.
Now, mysteriously ill patients, some of them critically sick, had to wait days
for doctors to send their swab to their local public health department, which
had the CDC tests, and then wait for the result to come back.
Greninger decided to keep going in his effort to create a test
that the University of Washington could use in-house. On February 18, he
submitted a request to the FDA for a preliminary Emergency Use Authorization
(EUA), or permission to develop and use his own coronavirus test. Even though
he kept quietly working on the test while waiting for permission to come, he
understood why the FDA regulated such things: you don’t want bad tests
circulating in the healthcare system, giving people false positives of negatives,
especially in the midst of a pandemic. Bad tests could be just as dangerous as
no tests at all.
What followed, however, went far beyond
quality control—and into the realm of the absurd.
After emailing his application to the FDA,
Greninger discovered that it was incomplete. It turned out that in addition to
electronically filing it, he also had to print it out and mail a physical copy
along with a copy burned onto a CD or saved to a thumb drive. That package had
to be shipped off to FDA headquarters in Maryland. It was a strange and onerous
requirement in 2020, but Greninger complied. He had no choice. On February 20,
he overnighted the hard copies of his application to the FDA.
Four days later, the FDA responded with its
guidance. It needed some more information and wanted Greninger to conduct a few
more tests. According to Greninger, the FDA wanted him to run his SARS-CoV-2
test against some older viruses in his lab to make sure his test didn’t
cross-react with them. The officials at the FDA instructed him to test his test
against the MERS and SARS viruses, which are also coronaviruses. It wasn’t a
terrible idea, Greninger thought. Why not develop a test that catches all these
deadly coronaviruses all at once? It did seem strange, however, that the FDA
was asking for this in an emergency use application: by this
point, COVID-19 cases had appeared in six states. (The FDA did not
respond to a list of questions about the process.)
Still, Greninger complied. He called the CDC
to inquire about getting some genetic material from a sample of SARS. The CDC,
Greninger says, politely turned him down: the genetic material of the extremely
contagious and deadly SARS virus was highly restricted.
“That’s when I thought, ‘Huh, maybe the FDA
and the CDC haven’t talked about this at all,’” Greninger told me. “I realized,
Oh, wow, this is going to take a while, it’s going to take several weeks.”
By this point, there were already over 50 confirmed cases of COVID-19 in
the United States and still, nobody but the CDC was permitted to conduct
testing. The Association of Public Health Labs sent a letter to the FDA, pleading
with regulators to loosen restrictions and allow labs to start developing their
own test—and was rejected. And yet, here was Greninger, who already had a test,
chasing after the genetic material of a different virus so he
could secure the permission he needed to use it. In the meantime, he had
drafted a letter to Congress, begging them to relax the restrictions, and was
collecting signatures from colleagues at labs all over the country.
Finally, after days of searching, Greninger
found some coronavirus RNA at a lab in Galveston, Texas. It wasn’t ideal, but
after consulting with scientists at the FDA, Greninger says they allowed it.
“It was the bare minimum for the EUA,” he says. The Galveston lab put ten
microliters of the frozen genetic material into a vial, packed it in dry ice,
and shipped it overnight to Greninger on February 28. That afternoon, Seattle
got its first confirmed cases of COVID-19. “The virus beat FedEx,” Greninger
says.
The same day Greninger received his vial, a woman who had been
diagnosed with COVID-19 died in Washington
state. It was the first official casualty of the novel coronavirus in the
United States. That day, the FDA removed the regulatory hurdles that Greninger
had been trying to clear for weeks, and allowed individual labs to begin
testing for the novel coronavirus. Greninger and his colleagues at the
University of Washington's Virology Lab were ready.
While Greninger was scrambling to meet the
FDA’s rigid requirements, the Virology Lab had been quietly testing the
coronavirus test Greninger had developed. It worked, so on March 2, they
decided to begin using it to test patients in the University of Washington
hospital system. They immediately got positives.
To keep pace with the rising demand for tests
in the Seattle area, the Virology Lab scaled up its operation to 1,000 tests a
day in a little over one week. It was an enormous feat, and they stood out in the field.
No one, save for the big state public health labs and corporate giants like
LabCorp, was able to begin testing for the coronavirus so quickly and in such
large quantities.
That was because UW’s Virology Lab had
advantages that most other hospital labs didn’t have. For one thing, they had
the test ready to go as soon as the FDA announced on February 29 that
individual labs could make use of their own tests. That was when most other
labs started their processes of developing a test. (Another
University of Washington lab, working independently of Greninger’s, the Seattle
Flu Study, began testing samples
that they received as part of their study on February 25. But they were a
research lab and therefore strictly prohibited from doing clinical testing of
the kind the Virology Lab was licensed to do. As a result, the FDA demanded
that they shut down their testing.)
The Virology Lab was also blessed with vast
resources. Realizing that the hospital was at the center of a COVID-19 hotspot
in Washington state, the university hospital’s administrators gave the
lab carte blanche to do what was necessary to test, test,
test. “We basically have a blank check,” Greninger told me. But it went deeper
than that. The Virology Lab is part of the university’s larger Department of
Laboratory Medicine, which has 55 faculty and over 1000 staff. This is huge
compared to most other clinical university labs. Moreover, Geoffrey Baird, who
teaches at the University of Washington’s School of Medicine and is the
Department of Laboratory Medicine’s interim chair, says the department has been
getting a steady stream of resources for decades to develop the kind of
infrastructure needed for the work Greninger and his virology colleagues do.
Since the coronavirus outbreak, the University
of Washington and the state government have opened their wallets even further.
“We have been throwing money at the problem,” Baird told me. “We spent $4
million in the last two weeks, purchasing instruments, hiring staff, buying
space.” Baird understands how his lab was uniquely positioned when the FDA
finally allowed testing. “We were ready to go,” he says. “We had the test
already. We have an infrastructure for testing, we have a lot of highly
dedicated and genius people working here.”
They had other advantages, including the
resources they were able to marshal. Dozens of highly skilled volunteers from
across the department and the hospital have volunteered their time to help run
the intricate testing process. A grad school friend of Greninger’s even offered
to drive up from San Francisco. Makers of the testing equipment donated
high-tech, expensive instruments. Suppliers were handing over, free of charge,
equipment valued in the six-figures, including the chemical
solutions—reagents—needed to run the test. A couple of in-house informatics
specialists spent a weekend building an interface that would allow the lab to
enter and process the test data more quickly, shaving another hour or so off
the time needed to process results. It was an all-hands-on-deck situation, and
scores of people were pitching in to not only to help the operation run quickly
and smoothly, but to help the Virology Lab scale in proportion to the
ballooning demand for coronavirus tests.
Looking ahead, they intend to continue to grow. The UW lab has
purchased empty industrial space to expand its testing as it tries to ramp up
to 8,000 tests a day. Still, there are big hurdles to reaching that number. For
one thing, the new equipment is large and complex and sensitive, and it takes
days to set up. For another, the testing still requires a lot of manual labor
and cannot be fully mechanized. There are only so many trained pairs of hands
in the UW system. Then there is the issue of how one can even handle samples of
the SARS-CoV-2 virus. Because the biohazard level on the novel coronavirus is
higher than for other infectious agents, a very specific kind of hood with a
very specific kind of ventilation is required to work with this highly
contagious bug. How many of these hoods can the University of Washington get in
the next week? Are there enough for the whole country?
Moreover, not everyone knows how to work with these hoods. The number of lab workers trained to use them correctly is also limited. Still, the Virology Lab is lucky, and Baird and Greninger told me labs in other states haven’t been as fortunate. Many have reached out to them for help in the last two weeks.
Moreover, not everyone knows how to work with these hoods. The number of lab workers trained to use them correctly is also limited. Still, the Virology Lab is lucky, and Baird and Greninger told me labs in other states haven’t been as fortunate. Many have reached out to them for help in the last two weeks.
In the midst of what he calls “an existential
crisis”—there are nearly 800 confirmed cases in
Washington state—Baird has also taken the time to write long emails with tips
and pointers that he blasts out to a listserv of pathology departments around
the country. These departments run their hospitals’ clinical laboratories, and
Baird hopes to prepare his colleagues for what he knows will soon befall them.
His department has sent out test kits to over 50 labs around the country. But
even as other hospitals—Johns Hopkins, Yale,
George Washington University, the University of Nebraska—are finally going live
with their own tests, they are encountering the same problem Baird has run up
against: the supply chain.
The more tests the University of Washington
runs, the more help Greninger and Baird offer their colleagues across the
United States, the more the finite supply of the reagents needed to run the
tests are used up. The same goes for the swabs used to swab patients’ noses and
throats, the plastic vials of liquid—known as transport medium—they’re put in,
the reagents used to separate out and cut the viral RNA, the other, special
plastic vials into which all this is poured and distributed in the lab. There
are finite stocks of all of these supplies, and neither their manufacturers nor
the hospitals purchasing them were counting on a black swan event like a global
pandemic. And though we are still in the pandemic’s early stages, hospitals are
already running out of supplies.
Spurred on Friday by the Trump administration,
the manufacturers of these vital supplies are apparently working in overdrive
to make more. But the reason stocks of these supplies were so low to begin
with? Trump’s trade war with China. On
March 5, the Trump administration issued an exemption on
these made-in-China products—including protective gear for healthcare workers,
which is already scarce—but many fear it was too little, far too late.
“As I speak, we’re running out of supply
chains now so I don’t know what our capacity will be in the short term,” Baird
told me on Friday afternoon, just as the President was beginning his Rose
Garden address declaring a national emergency. Baird said he wasn’t planning on
watching; he had too much to do and he asked me if I could hear the panic
straining his voice. I told him I could, and asked him what he’d tell President
Trump if he had the opportunity to speak to him, if he knew that everything he
asked for would be granted. Baird hesitated. He started a few sentences, each
of which devolved into raw anger that he asked me to scratch from the record.
Finally, he took a breath and said, “An immediate recognition of the primacy of
fact and reason. That’s all.”
Though it was not the only university lab able
to get testing online quickly—the University of Nebraska’s lab also had a test
early on—the University of Washington’s Virology Lab was extremely fortunate.
It was blessed with a combination of timing, circumstances, and assets that
will be nearly impossible to replicate elsewhere to tide us over until mass
production of tests can adequately address demand. Long before the Seattle area
became a COVID hotspot, the lab had tremendous resources and the right
infrastructure to do this kind of work and to do it at scale. In the two months
that the Trump administration wasted precious time dragging its feet, a
38-year-old virologist had the foresight and gumption to develop a test anyway
all while lobbying Congress and navigating the FDA’s regulatory labyrinths. And
he had the full backing of his bosses to do so.
Once the FDA allowed them to use their test, the
lab was lucky again. They operated in a state where the governor, the
progressive Jay Inslee, was highly receptive to their needs, showering the lab
with even more resources. This will likely not be the case in red states like
Oklahoma, where the governor openly, proudly flouted the advice of the
scientific establishment to avoid crowded places and practice social
distancing.
Still, there is only so much in the coffers of
the state of Washington, and only so much that money can do. “At the current
burn rate, we’ll run out of money,” Baird says. “This is a gigantic financial
hole. We need immediate investment. I can’t continue to spend $4 million every
two weeks. And there are problems we can’t throw money at. What do I do if
people who work here get sick and have to stay home? Or if the schools are
closed and they don’t have childcare? These are decisions they have to make on
their own.”
In the meantime, manufacturers like Roche, a
massive biomedical manufacturer freed by President Trump’s move to lift
restrictions on testing, said it was racing
to get hundreds of thousands of test kits out to healthcare providers. Still,
it takes time to fill a vast and growing need: it takes time to ship the kits,
and once they arrive, they have to be tested to make sure they work before they
can be used on patients. In the meantime, demand is skyrocketing. Early on
Saturday morning, the Virology Lab processed its 10,000th sample, while
thousands more flooded in.
Over the weekend, Baird plotted the numbers:
it was a neat, geometric progression. This was alarming. “Our supply chain
doesn’t double every few days,” Greninger said. Experts were citing South Korea
as a model for widespread testing of its population, but it is a much smaller
country than the United States, and, at its maximum, it was
running 15,000 tests per day. That’s not nearly enough for a country of over
330 million people spread over six time zones. South Korea was also testing
before the virus exploded into Europe. Now that it has, European countries are
also clamoring for tests and the supply chain is strained to the breaking
point.
I spoke to Greninger again on Sunday evening.
The day’s batch of tests was almost done. It wasn’t looking good. A consistent
eight percent of the samples they were testing were positive for SARS-CoV-2.
“That’s very high,” Greninger explained. Over the last four days, they had
diagnosed over 120 COVID cases per day. The backlog was starting to build up,
and their turnaround time was creeping up. “We’re still in the early phases of
this,” Greninger fretted. Of all the viruses Greninger had worked with, this
was a really bad one, with a long incubation period but highly contagious, making
it that much harder to track and hard to control. “We foresee high demand for
months, based on what’s going on in other countries,” he said. “And we haven’t
learned all the lessons from what happened in China.”
And he still had more paperwork to do. It
turned out that the FDA hadn’t fully lifted its requirement that individual
labs get permission for testing. The FDA had merely given them a grace period:
labs still had to apply for the Emergency Use Authorization within 14 days of
when they started testing. Given the President’s Friday press conference and
how quickly the situation was changing, Greninger kept hoping the FDA would
waive that requirement and spare him a new round of bureaucratic and regulatory
games at a time like this. It didn’t. His deadline was Monday.
Julia Ioffe is
a GQ correspondent