This article is long and I haven't copied all of it. For those concerned about the slowness and lack of testing, it explains a lot.
From the New York Times: Mar 10
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.
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.
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.
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.
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.”
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.
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