Inside the Early Virus Test Delays and Failures at the CDC and FDA — 100 Hours Spent Filling Out Paperwork and FDA Would Not Accept It Because it was sent Via Email
On Feb. 8, when lab technicians for New York City’s health department ran the test on samples that contained the virus, they saw on their computer screens a logarithmic curve sloping upward, indicating the virus was present. The problem was, they saw something similar when they ran the test on distilled water that contained no trace of the virus.
When they finally gave up that evening, the technicians called their director, Rakeman. Shortly before midnight, she relayed the bad news in an email to local health authorities. “The issue will need to be investigated and could result in significant impact to testing availability at the CDC and across the country until the issue is resolved,” she wrote.
New York state lab officials also passed on the news, according to documents and interviews. “There is a technical problem in one of the reagents which invalidates the assay and will not allow us to perform the assay,” the lab director of New York state’s Wadsworth Center, Jill Taylor, wrote to state health officials in an email that same night.
“I am sorry to not have better news,” she wrote. “It is a bummer.”
Word that some labs were having problems with the test quickly made its way back to the CDC.
“Is this something to worry about?” Daniel Jernigan, a leader of the CDC’s coronavirus response, wrote to the Association of Public Health Laboratories the next morning as he prepared to board a plane.
It was, he was told.
Later that day, Scott Becker, chief executive of the association, raised concerns to another CDC official. “The states and their governors are going to come unglued,” he wrote, adding later, “If CDC doesn’t get ahead of this it will be a disaster.”
As they struggled to make the test kit work, many of the public health labs realized they might succeed by eliminating one of its three main chemical components. But under the FDA’s emergency rules, they could use the test only as it was approved. The flaw meant they could not use it at all.
“The silence from CDC . . . is deafening,” Joanne Bartkus, the Minnesota health department’s lab director, wrote to Becker on Feb. 10. “What is going on? We are getting questions from our governor’s office and other labs are getting media requests asking when we will be starting.”
By Feb. 12, a total of 2,009 tests had been conducted in the United States, according to CDC data.
“We’re screwed from a testing standpoint if this thing takes off in the US,” Susan Butler-Wu, director of medical microbiology at the Los Angeles County and University of Southern California Medical Center, warned in a Feb. 13 email to fellow scientists.
…The Mayo Clinic created its first-ever rapid response team. A third of the 15 members were devoted solely to the FDA’s data and paperwork demands. Like others on the team, they worked 15-hour days for three weeks.
“It’s unlike anything we’ve ever done before,” said Matt Binnicker, a director of clinical virology at Mayo.
He said they decided to persist because, in a worst-case scenario, the public health labs alone could not test on the scale that would be needed. “The public health infrastructure is really not set up to handle a pandemic,” he said.
At the University of Washington, Greninger and his fellow scientists were initially baffled by an FDA process they viewed as baroque. They had always worked under strict guidelines, aimed at protecting patients and guaranteeing quality. But the EUA was a bureaucratic puzzle they had never encountered.
“The most pernicious effect of the current regulatory environment is that it kneecaps our ability for preparedness should a true emergency emerge,” Greninger wrote to colleagues on Feb. 14.
Greninger channeled his energy into the paperwork problem, spending more than 100 hours filling out forms and collecting information needed for the application, he told The Post. But when he finally submitted the material, an FDA official told him the agency could not accept it – because he had emailed it.
“We received your email and attachments regarding the UW 2019-nCoV assay pre-EUA,” an FDA official wrote on Feb. 20. “However, we have not received the official submission through DCC.”
“What is the DCC?” Greninger wrote back.
“The Document Control Center,” came the reply.
“What is the Document Control Center?”
Greninger then learned about another requirement. Under FDA rules, he was supposed to digitally copy the electronic documents he had emailed to the FDA, burn the copies onto a disk and mail the hard disk to an office in suburban District of Columbia.
Greninger shared his exasperation in a Feb. 20 email to a colleague: “repeat after me, emergency.”