Report: Officials feared lab where CDC coronavirus test kits were being made was "contaminated"

This Axios story is vague on the nature of the contamination. They don’t mean — I hope — that the lab was contaminated (or at risk of contamination) by coronavirus itself. What they mean, I think, is that some chemical that wasn’t supposed to be part of the test kit was at risk of being accidentally introduced into it, leading to false positives. Local health authorities have been at their wits’ ends over the past week or two because the CDC couldn’t manage to put together a workable test for the illness, even though countries like China and Italy are testing many thousands of people every day. The delay was so exasperating that the FDA decided to let state labs start producing their own tests to ease the bottleneck. The CDC has supposedly finally worked out the bugs and will be sending out functioning kits this week, but in the meantime coronavirus has had weeks to spread in American communities with doctors and scientists almost completely blind to its presence.


What the Axios story tells us is that the CDC’s incompetence might be even worse than suspected. Even now, they’re being conspicuously tight-lipped about the nature of the “contamination.” An HHS official told Politico that there was a “problem with lab test cleanliness” but there are no specifics beyond that.

And that’s only the tip of the iceberg in how the agency has screwed up, as you’ll see.

The big question: It was not immediately clear if or how possible contamination in the Atlanta lab played a role in delays or problems with testing. Nor was it clear how significant or systemic the contamination concerns may be; whether it was a one-time issue that’s easily resolved, or a broader concern involving protocols, safeguards or leadership…

[FDA official Richard] Stenzel was alarmed by the procedures he witnessed in the Atlanta laboratory and raised concerns with multiple CDC officials, per a source familiar with the situation in Atlanta.

Stenzel is a highly-regarded scientist and diagnostics expert. He was on the ground in Atlanta to deal with technical issues and happened to stumble upon the inappropriate procedures and possible contaminants. He is not a laboratory inspector and thus was not charged with producing an inspection report on the lab conditions.

Stenzel wasn’t even supposed to be there. He was dispatched to the lab to help work out the bugs in the test and recognized some sort of contamination problem that apparently hadn’t been noticed by CDC personnel. Those concerns were deemed sufficiently credible that manufacturing of the test kits was moved out of the CDC lab altogether, to a third-party contractor. Why didn’t the CDC just use the test kits that the WHO has been supplying to other countries, you ask? Good question. Politico asked around and no one could say for sure, although some believe the agency feared the WHO kits weren’t sensitive enough in distinguishing coronavirus from other viruses like flu.


But it gets worse. An update from the mayor of San Antonio:

They released an asymptomatic patient after two straight negative tests — only to have him test “weakly positive” on a third test. You can let them slide on that if you like on grounds that they can’t be expected to know with certainty how long a novel virus takes to incubate, but why wouldn’t they err on the side of caution when it’s still (sort of) possible to prevent community spread? Especially when, for the moment, they had some reason not to trust their own tests?

But wait. There’s more:

Several US patients have recovered from coronavirus, but so far, the CDC has shared detailed clinical information about only one of those patients. That information includes what treatments the patients received and how they fared…

That means doctors who now unexpectedly find themselves treating new coronavirus patients aren’t able to benefit from the findings of doctors who preceded them.

“It’s a medical truism that it’s absolutely essential that physicians with experience with a particular condition disseminate information to others,” said Dr. Irwin Redlener, director of the National Center for Disaster Preparedness at Columbia University.

Not sharing such information is “is inexplicable and inappropriate,” Redlener added.


Doctors who specialize in infectious disease can’t understand why that information isn’t being shared expeditiously. There are papers co-authored by the CDC that are awaiting publication but time is obviously of the essence in limiting contagion while the number of infected Americans is still small.

This list of CDC screw-ups isn’t exhaustive either. Screening protocols continued to focus exclusively on China even after the outbreaks in Italy and Iran. (If you want to lump in HHS screw-ups here too, don’t forget this.) These people are under tremendous pressure, obviously, and can’t be expected to perform perfectly in every instance, but “we need a few more weeks to get our act together on tests” and “we can’t share information right now on how to successfully treat patients” seem like momentous errors that’ll cost lives. Potentially many lives.

I don’t know why people aren’t angrier about it. Matt McCarthy, a doctor at Weill Cornell Medicine, called the bottleneck on tests a “national scandal” on CNBC this morning, as you’ll see below. I think part of the reason the public is blasé — for the moment — is because the official number of infected people is so low. It’s something like 90 people nationally as I write this. But that’s only because so few people have been tested, thanks to the CDC’s incompetence. That was the point of yesterday’s post too. There are probably thousands of undetected cases in the U.S. right now — watch Scott Gottlieb’s comment on that in the second clip below — and there’ll be thousands more soon because the genie is too far out of the bottle to shove it back in. I wonder too, though, if the CDC is inadvertently being shielded politically by the fact that critics of the Trump administration usually strain to find reasons to tie government incompetence to Trump himself. Every story in the Trump era is a “Trump story,” and Trump did himself no favors with the happy talk recently about how few people were infected. But to all appearances, the coronavirus spread isn’t a “Trump story.” It’s a CDC story. He trusted them to be on top of this out of the gate. So did everyone else. Oops?


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