If you’ve been on Twitter lately you’ve probably noticed an increasing number of people on the left are claiming that President Trump has blood on his hands. Even those who aren’t going quite that far are eager to blame Trump for a “lost month” in February during which the government failed to ramp up testing. For instance:
The most economically, scientifically, and technologically advanced country on the planet is ranked 38th in tests per person. Donald Trump had to work hard to screw up such a massive advantage. His trust in China lost months, as did his belief COVID-19 would magically go away. https://t.co/2jkbagnu3N
— Joe Scarborough (@JoeNBC) April 19, 2020
Like a lot of partisan claims, there is some truth to this one. It’s true that February could have been a moment to ramp up testing in order to see more clearly how quickly the virus was spreading and it’s true that didn’t happen. Why it didn’t happen is another matter.
Over the weekend the Washington Post published a deep dive on the problems at the Centers for Disease Control which cost the U.S. about a month of progress. Effort by the CDC to create a coronavirus test began in mid-January after China published the genetic sequence of the virus:
Those familiar with the events said the design efforts were led by Stephen Lindstrom, an accomplished respiratory virus specialist who was a co-inventor of seven earlier CDC tests for strains of the flu…
The test kits featured two components that focused on separate regions of the virus’s genome, a standard approach. However, the CDC also outfitted the kits with a third component, a pan-coronavirus segment. That addition sought to identify a wider family of coronaviruses, of which covid-19 is the most recent strain to be observed in humans. Tests that were being developed abroad under sponsorship from the World Health Organization did not include this extra feature.
In essence, the CDC-designed test kit included and extra segment that would have allowed users to include people who had SARS or similar coronaviruses. It’s not clear what the point of this third segment of the test was but the important point is that only the first two segments of the test kit were needed to identify COVID-19.
The addition of the third test segment might not have mattered except that it wound up creating a significant problem. The CDC decided to manufacture the test kids “in house” rather than rely on outside labs. And during that process, the reagents used in the third segment of the test became contaminated. We know this because when the CDC sent out the initial batch of test kits, nearly all of them gave false positives on the third segment. Here’s what happened:
In the fourth week of January, the CDC shipped out the kits to more than two dozen public health labs scattered across the country, from Albany, N.Y., to Richmond, Calif…
The labs were instructed by the CDC to demonstrate that the test would work before analyzing samples from patients.
But when those facilities began using the kits to analyze a negative control sample — highly purified water supplied by each lab and free of any genetic material — the tests wrongly signaled the presence of the coronavirus.
The third segment of the test was supposed to detect a whole range of coronaviruses. But in order to make sure the test was working properly, the labs were running the test with pure water. The test should have reliably given a negative result since there was no virus in the water. Instead, all of the labs got false positives, which indicated one of the reagents provided by the CDC had been contaminated during production.
Exactly how this contamination happened still isn’t clear but as a result the public labs were in limbo. They had a test showing a false positive. However, the false positives were only appearing on the third, unnecessary segment of the test. In theory, the labs could have continued to use the test without that problematic third segment but that would require special permission from the FDA. Until that was granted, the labs had to use the test as designed. In mid February it seems the CDC plan was to re-manufacture the one contaminated reagent [emphasis added]:
The first public hint of trouble with the test came during a Feb. 12 press briefing in which the CDC’s Messonnier mentioned unspecified “issues” bedeviling the public health labs. At the time, most American clinics and hospitals remained unable to test for the coronavirus…
“We think that the issue at the states can be explained by one reagent that isn’t performing as it should consistently, and that’s why we are remanufacturing that reagent,” she said.
At the public health labs, officials struggled to figure out what was wrong. Some labs determined that the test would work without the third component. But under the CDC’s emergency instructions, health officials had to use the test as it had been designed.
On February 23, a top FDA official named Timothy Stenzel finally went to the CDC lab in Atlanta to sort out what was going on.
During his visit in Atlanta, Stenzel determined that the problems with the coronavirus test were caused by the CDC’s manufacturing, not the design, according to the FDA. The shortcomings with the test kits were attributable to what the FDA described as a “manufacturing issue.’’
Stenzel advised CDC officials to stop making the kits in-house…
The FDA on Feb. 26 informed the CDC by email that the labs could begin testing samples while skipping the third component.
To sum all of this up, we had a test designed and manufactured by late January, but initial validation showed one segment of the test had been contaminated. That third segment wasn’t necessary to test patients for COVID-19 but only the FDA could allow the labs to perform tests without using the third segment. For some reason, it took the FDA nearly a month to get to the bottom of the problem. Why was that exactly?
There’s one paragraph in the story which states, “Stenzel for nearly a month could not determine, based on information provided by the CDC, whether the kits were failing because of a ‘design or manufacturing issue.’’’ That’s pretty thin but it’s not hard to imagine there were frequent calls between the FDA and the CDC in February. The CDC was saying, hey, we think we’ve got this figured out just give us a few more days. And the FDA was on the other end of those calls saying, hey, we’re in a hurry, can’t we run the tests without the third segment? Finally in the last week of February the FDA got tired of the BS, showed up at the lab, said no more in-house manufacturing of tests and allowed labs to run the tests without the 3rd segment.
But this wasn’t the only problem. While all of this was happening, competent outside labs were stalled in creating their own alternative tests because once the U.S. declared a public health emergency, which it did in late January, the FDA had to approve any outside tests. Anyone who wanted to create their own test would face reams of FDA paperwork to secure an “emergency use authorization,” something many hospital labs didn’t begin to know how to get:
Academic hospitals, which have laboratories that routinely develop tests to use on their patients, began to get increasingly anxious about the nation being dependent on the CDC lab. They considered pursuing FDA approval for their tests but complained they didn’t have the resources or expertise — or access to crucial materials such as the virus itself — for the complicated application process required during a public health emergency.
“When the CDC test was delayed, then the cases started appearing outside of China, there should have been a quicker response to get diagnostic testing going” by easing regulations on hospital labs, said Melissa Miller, director of the clinical molecular microbiology laboratory at the University of North Carolina at Chapel Hill School of Medicine.
During the Zika outbreak, some laboratories developed their own tests and got letters from the FDA notifying them that their tests had not been approved. Even as coronavirus testing remained limited nationwide, the CDC reminded hospitals on Feb. 18 that they shouldn’t do their own testing without an “emergency use authorization” from the FDA.
So the FDA not only didn’t sort out the mess at the CDC quickly, it also warned everyone else to stay on the sidelines unless they’d gone through a laborious approval process. The outcome of all of this is that we had very little testing happening in February.
A combination of mistakes and red tape cost us at least several weeks when we should have been moving forward with testing. That may be President Trump’s fault in the “buck stops here” ultimate sense but blaming him directly for a series of missteps by highly trained professionals seems to overlook the real problem: Bureaucracies don’t respond well, or quickly, to new challenges.