Coronavirus and You - Page 19

Dr. Helen Y. Chu, an infectious disease expert in Seattle, knew that the United States did not have much time.

In late January, the first confirmed American case of the coronavirus had landed in her area. Critical questions needed answers: Had the man infected anyone else? Was the deadly virus already lurking in other communities and spreading?

As luck would have it, Dr. Chu had a way to monitor the region. For months, as part of a research project into the flu, she and a team of researchers had been collecting nasal swabs from residents experiencing symptoms throughout the Puget Sound region.

To repurpose the tests for monitoring the coronavirus, they would need the support of state and federal officials. But nearly everywhere Dr. Chu turned, officials repeatedly rejected the idea, interviews and emails show, even as weeks crawled by and outbreaks emerged in countries outside of China, where the infection began.

By Feb. 25, Dr. Chu and her colleagues could not bear to wait any longer. They began performing coronavirus tests, without government approval.

What came back confirmed their worst fear. They quickly had a positive test from a local teenager with no recent travel history. The coronavirus had already established itself on American soil without anybody realizing it.

“It must have been here this entire time,” Dr. Chu recalled thinking with dread. “It’s just everywhere already.”

In fact, officials would later discover through testing, the virus had already contributed to the deaths of two people, and it would go on to kill 20 more in the Seattle region over the following days.

Federal and state officials said the flu study could not be repurposed because it did not have explicit permission from research subjects; the labs were also not certified for clinical work. While acknowledging the ethical questions, Dr. Chu and others argued there should be more flexibility in an emergency during which so many lives could be lost. On Monday night, state regulators told them to stop testing altogether.

The failure to tap into the flu study, detailed here for the first time, was just one in a series of missed chances by the federal government to ensure more widespread testing during the early days of the outbreak, when containment would have been easier. Instead, local officials across the country were left to work in the dark as the crisis grew undetected and exponentially.

Even now, after weeks of mounting frustration toward federal agencies over flawed test kits and burdensome rules, states with growing cases such as New York and California are struggling to test widely for the coronavirus. The continued delays have made it impossible for officials to get a true picture of the scale of the growing outbreak, which has now spread to at least 36 states and Washington, D.C.

Dr. Robert R. Redfield, director of the Centers for Disease Control and Prevention, said in an interview on Friday that acting quickly was critical for combating an outbreak. “Time matters,” he said.

He insisted that despite the rocky start, there was still time to beat back the coronavirus in the United States. “It’s going to take rigorous, aggressive public health — what I like to say, block and tackle, block and tackle, block and tackle, block and tackle,” he said. “That means if you find a new case, you isolate it.”

But the Seattle Flu Study illustrates how existing regulations and red tape — sometimes designed to protect privacy and health — have impeded the rapid rollout of testing nationally, while other countries ramped up much earlier and faster. Faced with a public health emergency on a scale potentially not seen in a century, the United States has not responded nimbly.

The C.D.C.’s own effort to create a system for monitoring the virus around the country, using established government surveillance networks for the flu, has not yet built steam. And as late as last week, after expanding authorizations for commercial and academic institutions to make tests, administration officials provided conflicting accounts of when a significant increase in tests would be available.

In states like Maine, Missouri and Michigan, where there are few or no known infections, state public health officials say they have more than enough tests to meet demand.

But it remains unclear how many Americans have been tested for the coronavirus. The C.D.C. says approximately 8,500 specimens or nose swabs have been taken since the beginning of the outbreak — a figure that is almost certainly larger than the number of people tested since one person can have multiple swabs. By comparison, South Korea, which discovered its first case around the same time as the United States, has reported having the capacity to test roughly 10,000 people a day since late February.

As soon as the genetic sequence of the coronavirus was published in January, the C.D.C.’s first job was to develop a diagnostic test. “That’s our prime mission,” Dr. Redfield said, “to get eyes on this thing.”

The agency also released criteria for deciding which individuals should be tested for the virus — at first only those who had a fever and respiratory issues and had traveled from the outbreak’s origin in Wuhan, China.

The criteria were so strict that the sick man in the Seattle area who had visited Wuhan did not meet it. Still, worried state health officials pushed to get him checked, and the C.D.C. agreed. Local officials sent a sample to Atlanta and the results came back positive.

Officials monitored 70 people who were in contact with the man, including 50 who consented to getting nose swabs, and none tested positive for the coronavirus. But there was still the possibility that someone had been missed, said Dr. Scott Lindquist, the state epidemiologist for communicable diseases.

Around this time, the Washington State Department of Health began discussions with the Seattle Flu Study already going on in the state.

But there was a hitch: The flu project primarily used research laboratories, not clinical ones, and its coronavirus test was not approved by the Food and Drug Administration. And so the group was not certified to provide test results to anyone outside of their own investigators. They began discussions with state, C.D.C. and F.D.A. officials to figure out a solution, according to emails and interviews.

Dr. Scott F. Dowell, a former high-ranking C.D.C. official and a current deputy director at the Bill & Melinda Gates Foundation, which funds the Seattle Flu Study, asked for help from the leaders of the C.D.C.’s coronavirus response. “Hoping there is a solution,” he wrote on Feb. 10.

Later, Dr. Lindquist, the state epidemiologist in Washington, wrote an email to Dr. Alicia Fry, the chief of the C.D.C.’s epidemiology and prevention branch, requesting the study be used to test for the coronavirus.

C.D.C. officials repeatedly said it would not be possible. “If you want to use your test as a screening tool, you would have to check with F.D.A.,” Gayle Langley, an officer at the C.D.C.’s National Center for Immunization and Respiratory Disease, wrote back in an email on Feb. 16. But the F.D.A. could not offer the approval because the lab was not certified as a clinical laboratory under regulations established by the Centers for Medicare & Medicaid Services, a process that could take months.

Dr. Chu and Dr. Lindquist tried repeatedly to wrangle approval to use the Seattle Flu Study. The answers were always no.

“We felt like we were sitting, waiting for the pandemic to emerge,” Dr. Chu said. “We could help. We couldn’t do anything.”

As Washington State debated with the federal officials over what to do, the C.D.C. confronted the daunting task of testing more widely for the coronavirus.

The C.D.C. had designed its own test as it typically does during an outbreak. Several other countries also developed their own tests.

But when the C.D.C. shipped test kits to public labs across the country, some local health officials began reporting that the test was producing invalid results.

The C.D.C. promised that replacement kits would be distributed within days, but the problem stretched on for over two weeks. Only five state laboratories were able to test in that period. Washington and New York were not among them.

By Feb. 24, as new cases of the virus began popping up in the United States, the state labs were growing frantic.

The Association of Public Health Laboratories made what it called an “extraordinary and rare request” of Dr. Stephen Hahn, the commissioner of the F.D.A., asking him to use his discretion to allow state and local public health laboratories to create their own tests for the virus.

“We are now many weeks into the response with still no diagnostic or surveillance test available outside of C.D.C. for the vast majority of our member laboratories,” Scott Becker, the chief executive of the association, wrote in a letter to Dr. Hahn.

Dr. Hahn responded two days later, saying in a letter that “false diagnostic test results can lead to significant adverse public health consequences” and that the laboratories were welcome to submit their own tests for emergency authorization.

But the approval process for laboratory-developed tests was proving onerous. Private and university clinical laboratories, which typically have the latitude to develop their own tests, were frustrated about the speed of the F.D.A. as they prepared applications for emergency approvals from the agency for their coronavirus tests.

Dr. Alex Greninger, an assistant professor at the University of Washington Medical Center in Seattle, said he became exasperated in mid-February as he communicated with the F.D.A. over getting his application ready to begin testing. “This virus is faster than the F.D.A.,” he said, adding that at one point the agency required him to submit materials through the mail in addition to over email.

New tests typically require validation — running the test on known positive samples from a patient or a copy of the virus genome. The F.D.A.’s process called for five. Obtaining such samples has been hard because most hospital labs have not seen coronavirus cases yet, said Dr. Karen Kaul, chair of the department of pathology and laboratory medicine at NorthShore University HealthSystem in Illinois.

She said she had to scramble to obtain virus RNA from a laboratory in Europe. “Everyone is trying to figure out what we can get to help us gather the data that we need,” she said.

The F.D.A. has disputed that it moved too slowly, saying that it provided emergency authorization for two laboratory-developed tests within 24 hours of a completed submission — one was the C.D.C.’s test and the other a test developed by New York’s Wadsworth laboratory after it had trouble verifying the C.D.C.’s test.

On the other side of the country in Seattle, Dr. Chu and her flu study colleagues, unwilling to wait any longer, decided to begin running samples.

A technician in the laboratory of Dr. Lea Starita who was testing samples soon got a hit.

“I’m like, ‘Oh my God,’” Dr. Starita said. “I just took off running” to the office of the study’s program managers. “We got one,” she told them. “What do we do?”

Members of the research group discussed the ethics of what to do next.

“What we were allowed to do was to keep it to ourselves,” Dr. Chu said. “But what we felt like we needed to do was to tell public health.”

They decided the right thing to do was to inform local health officials.

The case was a teenager, in the same county where the first coronavirus case had surfaced, who had a flu swab just a few days before but had no travel history and no link to any known case.

The state laboratory, finally able to begin testing, confirmed the result the next morning. The teenager, who had recovered from his illness, was located and informed just after he entered his school building. He was sent home and the school was later closed as a precaution.

Later that day, the investigators and Seattle health officials gathered with representatives of the C.D.C. and the F.D.A. to discuss what happened. The message from the federal government was blunt. “What they said on that phone call very clearly was cease and desist to Helen Chu,” Dr. Lindquist remembered. “Stop testing.”

Still, the troubling finding reshaped how officials understood the outbreak. Seattle Flu Study scientists quickly sequenced the genome of the virus, finding a genetic variation also present in the country’s first coronavirus case.

The implications were unnerving. There was a good chance that the virus had been circulating silently in the community for around six weeks, infecting potentially hundreds of people.

On a phone call the day after the C.D.C. and F.D.A. had told Dr. Chu to stop, officials relented, but only partially, the researchers recalled. They would allow the study’s laboratories to test cases and report the results only in future samples. They would need to use a new consent form that explicitly mentioned that results of the coronavirus tests might be shared with the local health department.

They were not to test the thousands of samples that had already been collected.

The same day, the F.D.A. said it would relax its rules and allow clinical labs to begin using their own coronavirus tests as long as they submitted evidence that they worked to the agency. Under that new policy, according to an agency representative on Tuesday, it had heard from 14 labs, with 10 already beginning patient testing.

On March 2, the Seattle Flu Study’s institutional review board at the University of Washington determined that it would be unethical for the researchers not to test and report the results in a public health emergency, Dr. Starita said. Since then, her laboratory has found and reported numerous additional cases, all of which have been confirmed.

As new samples came in, Dr. Starita’s laboratory also worked their way backward through some older samples that had been sitting in the freezers for weeks, finding cases that date back to at least Feb. 20 — seven days before public health officials had any idea the virus was in the community.

The scientists said they believe that they will find evidence that the virus was infecting people even earlier, and that they could have alerted authorities sooner if they had been allowed to test.

But on Monday night, state regulators, enforcing Medicare rules, stepped in and again told them to stop until they could finish getting certified as a clinical laboratory, a process that could take many weeks.

On March 11 2020 15:45 Danglars wrote:
California (as I gather the rest of the country) has been having trouble testing patients that pass the several step screenings. Also, the screening in hospitals that I have seen mainly focus on people that have recently been in contact with someone from outside the country who appeared sick, or people currently showing symptoms. No in-community transmission screening, and no nonsymptomatic people recently returned from foreign countries. That's just my very small sample size.

The big story around here is the NYT's recent compilation of bureaucratic failures leading to shutdowns in labs currently testing for COVID19. The odd duck in the chain of mishaps is the FDA. The regulations intended to protect patients, prevent scares, and make orderly progress in situations like this, ended up slowing everything down and needlessly burdening researchers. The story is a bit long.
+ Show Spoiler +
NYT

On March 11 2020 16:43 Harris1st wrote:
Germany is building Drive-In centers for testing.

You drive there and stay in your car the whole time while someone comes and does the test. Then you drive home and wait there for the results which should be available in the next 7 seven days or something.

On March 11 2020 20:59 Geo.Rion wrote:
Well, things went from 0 to 100 real quickly here (Romania).
There arent any deaths, there are about 25 cases (0 in my county), the following precautions were made:
1. Events with 1000+ people banned.
2. Schools, pre-schools and some universities closed.
3. Some public places like markets, arenas, swimming pools etc closed.
4. There's a red list for places (including the whole of Italy, parts of China, South Korea, Spain, Germany etc), if u come from there 14 days special quarantine, if u come from yellow zones, then 14 day self quarantine.
5. There are police cars now at the border that follow people till they get home (no idea how many of them, no way they have enough people to do it for everyone)
6. Some businesses are sending their workers home if they can do home-office. My employer offered it as an option.

All this was instituted in the past 24-48 hours, when the government found out that tens of thousands people are returning (have returned) from Italy, most of them went unchecked (lied about their stay, avoided checkpoints etc).

I dont think it's an overreaction, since the health infrastructure is quite underdeveloped, so the best (or only if i want to be honest) strategy is to try and contain/minimize the spread. Cuz if there's gonna be suddenly thousands of cases, there s absolutely 0 chance that the current capacity of the hospitals could hold up.

Needless to say, my Barcelona trip is a goner, I got a full refund from the airbnb, cant really get a refund for the airplane and train tickets. Maybe if there's a forced cancellation, then i might get the price of the plane-tickets back.

On March 11 2020 21:42 Harris1st wrote:


But why? I can somewhat understand US Citizens because their health care is shit and everyone knows it.

Why lie? Why not get tested? Don't people wanna know? I don't get it

On March 11 2020 16:42 Silvanel wrote:
There has not been a single case reported yet in my city but as preventive measures local government has ordered all theaters, operas, cinemas, fairs and philharmonic to shut down. At the same time Church is increasing number of services....it is retarded.....
It is hard for me as i go to philharmonic every week, i think i will miss at least two concerts. I know it isnt much really but this is something really important for me. Anyway it feels like creeping *something*. Since it was observed in Italy every day it is getting closer and is affecting me in stronger way. I am worried about my mother who is already in retirment age but is still working and on top of that in public administration so has conatct with plenty of people every day.

On March 12 2020 01:24 Wombat_NI wrote:

It’s frustrating, everything feels a bit over the top, least over here.

There are not a huge amount of restrictions on shopping/working commutes etc over here, just on the arts and sport and social activities.

Is it serious or is it not? Will London’s Underground running as normal with people confined in cramped spaces, many of whom probably aren’t 100% heathy really be less of a risk than x sporting event going ahead?

On March 12 2020 01:46 Gorsameth wrote:
Metro systems look like a massive area for infection. But shutting it down will have a big economic impact on everything while shutting down sporting events is much more limited.

Its not about containing the virus, its about trying to limit economic damage. But I can't help but wonder if the economic cost isn't lower if you shut down the country for 2 weeks, stop it from spreading and give everyone that is infected time to show symptoms so they can quarantine themselves and then start back up.
Taking half measures that we know have already failed elsewhere just leads to the same result, it spreads like wildfire anyway and you still need to shut down the country but now many more people are infected. See Italy.