Red Tape Stopped Early Coronavirus Testing
03/12/2020
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America isn’t ready for a fix-the-Yorktown type emergency push for many reasons, including that we have a lot of rules and regulations for privacy, safety, and other agreeable reasons. From the New York Times:

‘It’s Just Everywhere Already’: How Delays in Testing Set Back the U.S. Coronavirus Response
A series of missed chances by the federal government to ensure more widespread testing came during the early days of the outbreak, when containment would have been easier.

A research project in Seattle tried to conduct early tests for the new coronavirus but ran into red tape before circumventing federal officials and confirming a case.

By Sheri Fink and Mike Baker
March 10, 2020

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. …

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. …

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.

It’s difficult to know the optimal way to balance off worthy considerations in normal times versus emergencies. It’s also hard to know when is an emergency.


[Comment at Unz.com]

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