If there is any sort of a silver lining in the aftermath of the Wuhan virus thrashing our economy and reducing the progeny of the men and women who conquered the wilderness, beat the British in two wars, destroyed slavery, and eradicated the Axis to sniveling, hand-scrubbing, bemasked serfs it may very well be that the role and basic competence of some federal agencies will be examined in excruciating detail.
At the center of just about every delay and misstep in this sorry saga one does not find politicians or even political appointees, rather one finds the incompetent, turf-conscious, implacable bureaucrats in two of the agencies directly responsible for public health: the CDC and the FDA. In particular, the FDA seems to be at ground zero as a lackadaisical workforce used to being kowtowed to by Pharma and the medical device industry suddenly found itself under intense pressure to at least pretend it cared about what it was supposed to be doing.
This is a great thread that lays out the critical missteps by both CDC and FDA. I don’t agree with some of the views this guy has. For instance, testing at the early stages of this crisis took about 5 days to get results, making it less data than a Trivial Pursuit answer. But the overall picture he paints is not only accurate but damning:
Thread by @AlecStapp:
1/ I wrote 3,000 words for The Dispatch on what exactly went wrong with coronavirus testing in the US
2/ The first coronavirus case in the US and South Korea was detected on January 21.
South Korea quickly ramped up widespread testing.
Why did the US fail to do the same?
In short: the FDA dropped the ball.
3/ There have been 3 major regulatory barriers to scaling up testing
- obtaining an Emergency Use Authorization (EUA)
- being certified for high-complexity testing under CLIA
- complying with HIPAA Privacy Rule and the Common Rule related to protection of human research subjects
4/ HHS Secretary Alex Azar declared a public health emergency on Jan 31.
That action initiated a new requirement — labs that wanted to conduct their own coronavirus tests must first obtain an emergency use authorization (EUA) from the FDA.
5/ EUAs were intended to speed up the normal authorization process.
But in this case, labs that were already conducting their own tests needed to cease operations until they were granted an EUA.
By not waiving the EUA requirement, the FDA was actually slowing down testing.
But in this case, labs that were already conducting their own tests needed to cease operations until they were granted an EUA.
By not waiving the EUA requirement, the FDA was actually slowing down testing.
6/ And obtaining an EUA was no easy task.
FDA required:
- validation by testing at least five known positive samples
- mailing a physical application on CD or thumb drive
- testing the protocol against MERS and SARS viruses
FDA required:
- validation by testing at least five known positive samples
- mailing a physical application on CD or thumb drive
- testing the protocol against MERS and SARS viruses
7/ On Feb 4, the FDA issued an EUA to the CDC for its testing protocol.
The FDA wouldn't issue another EUA to any other entity until Feb 29.
By only issuing a single EUA in the month following the emergency declaration, the FDA was putting all its eggs in one basket.
The FDA wouldn't issue another EUA to any other entity until Feb 29.
By only issuing a single EUA in the month following the emergency declaration, the FDA was putting all its eggs in one basket.
8/ And then they dropped the basket and all the eggs broke.
The CDC protocol failed when state and local public health labs tried to validate it.
The exact cause of failure is still under investigation, but a faulty reagent is suspected.
The CDC protocol failed when state and local public health labs tried to validate it.
The exact cause of failure is still under investigation, but a faulty reagent is suspected.
9/ On Feb 24, an association of more than a 100 state & local public health labs sent the FDA a letter begging for enforcement discretion.
The FDA said they should apply for an EUA instead.
5 days later, the FDA reversed its position & exempted advanced labs from the EUA req.
The FDA said they should apply for an EUA instead.
5 days later, the FDA reversed its position & exempted advanced labs from the EUA req.
10/ But this exemption applied only to “laboratories that are certified to perform high-complexity testing consistent with requirements under CLIA.”
One researcher estimated 5,000 virology labs in the country met this standard.
Context: US has ~260,000 laboratory entities.
One researcher estimated 5,000 virology labs in the country met this standard.
Context: US has ~260,000 laboratory entities.
11/ On March 16, the FDA expanded the EUA exemption to all commercial manufacturers and labs (not just those certified to perform high-complexity testing under CLIA) & devolved regulatory oversight to the states.
"The FDA sped up the process by removing itself from the process."
12/ The FDA did the right thing when it expanded the EUA exemption to all labs and manufacturers and devolved regulatory oversight to the states.
The Department of Health and Human Services did the right thing when it waived certain provisions of the HIPAA Privacy Rule.
The Department of Health and Human Services did the right thing when it waived certain provisions of the HIPAA Privacy Rule.
13/ But these actions were six weeks too late.
Speed, not perfection, must be the focus of pandemic response.
A distributed approach would be much more resilient to the inevitable mistakes and accidents inherent to crisis management.
14/ Instead, in this crisis, the FDA bet big on a single testing protocol from the CDC and burned its ships.
And when the “perfect” test failed spectacularly, everyone was left wishing for a way to retreat.
Over and over, you see President Trump and political leadership at federal and state level stepping in to remove barriers to clinical trials, to agitate for therapies that seem to have been proven in use in Europe to be pushed to the head of the line (here I’m talking specifically about the combination of hydroxychloroquine and the antibiotic Zithromax that Trump has touted and now is undergoing a massive clinical trial at the direction of New York Governor Andrew Cuomo), promising tests were moved to the head of the line and the way cleared for home testing by major commercial labs.
One would think this public shaming would have galvanized the FDA into action and inspired them, in Twitter SJW vernacular, to ‘do better.’ You would be wrong.At this very moment, stockpiles of masks, hand sanitizer, and other supplies are sitting in warehouses waiting for FDA inspectors to get around to them. Where other nations are expediting these deliveries, trusting proven suppliers in their deliveries, the FDA has resorted to its favorite fetish: bureaucratic lethargy.The problem here is not simply that the FDA is insisting that its box-checking comes before exigent needs of public health, but also that the agency doesn’t have enough inspectors to get the job done quickly.I spoke to one significant medical supplier who talked to me on the condition of anonymity, for fear of FDA retaliation. In one location on the Pacific coast, this supplier has had more than 20 pallets of coronavirus-specific medical supplies waiting in a warehouse for five days. Yes, five days.At another depot in the south-central United States, this same supplier has had 500,000 level-three or level-four masks sitting in a warehouse for two days now. They expect the FDA delays to continue indefinitely.And get this — some of what the supplier is delivering is supposed to be gifted to a hospital. But even in that case, the FDA has warned that the supplies cannot even be unpacked until an inspector arrives. If they are broken down before then, even if only to expedite delivery once the inspector’s approval is given, fines are threatened to follow.
The FDA has a role in keeping the medical supply chain safe and ensuring devices and drugs are effective. It is not, however, a gatekeeper. And in times like this it must work hand-in-glove with industry and research facilities to ensure things that work get to the public fast while making sure snake oil gets stopped. Right now, the FDA seems to have a business as usual attitude and they are in urgent need of a ‘tune up’ by President Trump.