The CDC botched the coronavirus test. The FDA took weeks to allow others to fix it. Those delays contributed to the current crisis.
The coronavirus epidemic this week reached Beadle County, South Dakota. A single case tied to travel has exploded into 14 infections and counting, with no way to know how many were exposed while supply shortages forced the entire state to briefly suspend testing.
Story continuesThen, public and private lab directors felt rebuffed by the FDA when they first offered to help troubleshoot the problem by developing their own tests. The agency, through its emergency authority, had placed restrictions on labs that can apply in emergencies but not in normal circumstances.
“That was a bald-faced lie,” said Wadford. At that point, she was waiting four to five days on test results for samples she had sent to the CDC. Caccomo denied that the FDA was overly restrictive at the onset of the outbreak and then slow to adapt to the"unprecedented public health emergency.” The time lost in February was critical to containing the outbreak and helping hospitals prepare, experts say. With each delay, the virus spread undetected as people likely unaware of an infection attended conferences and weddings, frequented bars and restaurants and took long-planned cruise vacations.
The crisis may soon be just as dire in rural communities. As of mid-March, Dr. April Abbott, the microbiology lab director at the largest hospital chain in southern Indiana, said she could not get equipment to run her own tests, in part because the federal government does not consider her area a priority like New York or California.
“Below Indianapolis, our state has virtually no functional testing capability,” Abbott wrote to a diagnostics company on March 16. “I cannot overemphasize the lack of testing available in our region.” “The infrastructure has failed us,” Abbott said in an interview. As of mid-week, Indiana had confirmed just 645 cases of coronavirus.
She fears the community was broadly exposed by these kinds of comings and goings while tests were backlogged.Federal testing push falls behindSince early January, a virus raging in China had the attention of public health experts. A coronavirus, it was the newest member of a large family of viruses whose evils include the common cold. The name refers to how it looks under a microscope, with crown-like spikes on its surface.
“When you see a disaster coming, you want to go big and go now,” said Dr. Tara O’Toole, who helped develop pandemic response plans in the Department of Homeland Security under former President Barack Obama.On Jan. 31, after Americans began returning stateside from the outbreak’s origin in Wuhan, China, Health and Human Services Secretary Alex Azar declared a public health emergency, but called the threat to this country “low.
“The response has been backwards,” said Sharfstein, now vice dean for public health practice and community engagement at Johns Hopkins University, who advocates for more regulation during non-emergencies and less in urgent situations like this one. Flawed test, then flawed responseThe federal emergency declaration allowed the CDC to begin distributing test kits to state health department labs across the nation in early February.
The CDC promised to quickly fix the test. But for two weeks, the agency offered temporary solutions — such as creating a new “surge” lab and offering to receive samples at CDC headquarters in Atlanta. Around the same time, more than 100 scientists in private labs and universities penned a similar letter to Congress.
Experts criticize the agency, however, for moving slowly given the magnitude of the health epidemic unfolding. Dr. Jim Dunn, director of medical microbiology and virology at the hospital, had developed lab tests for the Zika virus for weeks before the FDA stepped in. He said the restrictions this time prevented Texas Children’s from getting out in front of COVID-19.
Clinicians burned through supplies, using four nasal swabs to run testing for COVID-19 and other respiratory concerns. The protocol was eventually scaled back to one swab per nostril, then one per patient. Lacking a crucial chemical used to process the test, in short supply nationally, South Dakota’s public testing lab posted a notice online last Wednesday that it had temporarily suspended testing.
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