WaPo: “A glaring scientific breakdown at the CDC”

“The impact was devastating to the country.”
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Today, the Washington Post published a scathing report that details how the scientists at the CDC screwed up the launch and deployment of C-19 testing … leaving the medical community and policy-makers flying blind in the early stages of of the US coronavirus spread … and, information-short as the nation tries to transition back to re-opened normalcy.

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WaPo’s general conclusion:

The CDC’s performance with the test kits marks an unparalleled low in the 74-year history of America’s heretofore premier institution for combating the spread of catastrophic disease.

More specifically, WaPo reports a disastrous mix of scientists’ hubris,  protocol violations, slow reactions, and missed commitments.

Here are some details ….

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So, what’s the story?

First, there was the unbridled hubris of the CDC scientists, who thought that they were not just the smartest people in the room, but the smartest scientists on the planet.

They refused to seriously consider piggy-backing on a WHO-developed test that was already being used successfully in Japan and other countries.

Seeking a “higher quality” test that could “identify a wider family of coronaviruses” the CDC scientists “chose complexity over simplicity in the test’s design” … and, that decision backfired.

While an audit by the FDA eventually “exonerated the test’s scientific design“, they concluded that the added complexity required a complicated  manufacturing process and that “substandard manufacturing practices” made the test kits. vulnerable to contamination.

That vulnerability materialized when “the CDC did not manufacture its test consistent with its own protocol.”

So, the kits did get contaminated and quality control processes were too lax to catch the problem before the kits were released to labs.

“Rigorous validation and record-keeping should have detected the contamination before the CDC distributed the kits.”

A competent laboratory would not have that problem – where was the adult supervision?”

Labs immediately reported a major problem: false positives. Almost all samples — even test samples of “highly purified water, free of any genetic material“ – were testing positive for the coronavirus.

The culprit was traced to the “unnecessary test component” that was being added to the test design other countries were using.

There was an apparent workaround for the problem.

Some labs determined that the test would work without the third component. But under the CDC’s policies, the labs were required to run the test as it had been designed, so they couldn’t just skip the problematic step.

Note: In late February, the FDA & CDC relaxed the policy and the labs were allowed to begin testing samples while skipping the third component.

Rather than “promptly jettisoning the problematic test .. the CDC just kept doubling down on what they knew was a poor performing assay.”

Publicly, the CDC portrayed the problem as a “minor, correctable manufacturing issue” that would be promptly remedied.

The CDC initially kept the troubled processes in-house, steadfastly refusing to leverage the private sector … and repeatedly missed deadlines for resolving the problems.

Finally, the CDC swallowed their pride and outsourced test kit development to a contractor — Iowa-based Integrated DNA Technologies – which attacked the problem effectives, at warp speed,

“The test manufactured by IDT has encountered no issues.”

But, valuable testing time has been lost and the US is still in catch-up mode —  behind the curve.

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I was surprised that the Washington Post was willing to touch a “3rd rail” and expose the scientific community.  Wondering what their motive was…

Now that the door has been opened, I expect more articles that pile on the scientist community.

I was also surprised that WaPo didn’t lay the whole testing mess on Trump’s doorstep. In the long article, there was only one reference to the “Trump administration” … and no direct references to Trump himself.

I doubt that going light on Trump will be a reporting trend…

One Response to “WaPo: “A glaring scientific breakdown at the CDC””

  1. April 20: C-19 UPDATE | The Homa Files Says:

    […] News & Views on Marketing, Economics & Politics « WaPo: “A glaring scientific breakdown at the CDC” […]

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