What is the holdup with test kits in the USA?

It’s amazing how we can’t seem to view anything except through a partisan lens. The guy sitting at the FDA saying sorry, we can’t process this application until the paper mail lands on my desk, he’s there saying the same thing whether we’re in a Trump or Obama or Clinton or Sanders presidency. It’s in the same family of bureaucratic inflexibility to botched the rollout of Healthcare.gov for example. Obama escaped a lot of grief for his Ebola response because the epidemic eventually was contained but if you talk to epidemiologists at the time, there were egregious errors made there too.

The guy saying “Stop testing” to the UW researcher, he’s not saying it because Trump is breathing down his neck, he’s saying it because they were violating HIPAA and HIPAA is a big scary law that everyone up and down the government has been trained you never want to ever step an inch over in any possible circumstance because the people who will judge you for it after the fact have no room for looking at extenuating circumstances. It doesn’t matter if a million extra people die, at least HIPAA wasn’t violated!

One thing I’ve noticed that is a particular specialty of American discourse is that the question “Why did something happen?” and “Who do we blame for something happening?” get resolved into the same question, possibly because the main reason we ever ask why something happens is to figure out who to sue. I’m absolutely happy to blame Trump for 100% of the consequences coming from this because his response has the direct opposite in every way of what should be happening and part of the burden of being a leader is that you take on the responsibility of everything that comes your way.

But if we want to look into the specifics of why it happened, it feels far more plausible to me that it was a result of incompetence, not malice. The conspiracy theories of “Trump wants to keep the numbers low” don’t hold much water to me, even if Trump wanted the numbers high, all of the standard bureaucratic SNAFUs would have still been SNAFUs. If you’re saying Trump didn’t put the right people in charge, then I 100% agree but Obama arguably did put a lot of the right people in charge and they still produced fuckups like this.

I’m also not saying Trump deserves 0% of the blame for this, different actions at different points in time affect the probability spectrum of different actions for sure. But we need to be aware that one of reasons the testing response was botched so badly was because some bureaucrat somewhere had a checkbox that said I need to receive a document in the paper mail before I act and he patiently waited by the mailbox while the world fell apart, and that bureaucrat had, in all likelihood, worked for multiple administrations.

Thanks for the responses so far. It sounds like there are many factors but much of the problem is inflexible bureaucracy throughout the system. If so, that is really alarming - I’ve read that effective case tracing is extremely important in minimizing the impact of a pandemic - but step one is to test and have a good take on the situation.

Countries that are capable of ramping up effective responses quickly (looking at you South Korea) seem to be able to get this crisis under control. I know the US has the educated professionals as well as resources to ramp up an effective response - but it seems more and more likely that the front line efforts are going to be hamstrung.

We have an administration hostile to science that doesn’t benefit its corporate pals; that fired the nation’s pandemic response team; that heads critical agencies with connected know-nothings; that muzzles experts whose warnings are politically inexpedient; that broadcasts deliberate falsehoods; that relies on insightful intestines. These are known facts, not partisan opinions.

Why the USA hoidup on COVID test kits? Lack of preparation and coordination because bureaucracy, yes, but also because an administration, never organized as a functioning team, was occupied with internal battles. High-level indifference to public health, yes. It boils down a lack of political will. The buck stops… where? At.The.Top. Them’s the facts.

Actually, at least on one point you are only kind of correct. Trump (well, Bolton) did fire Tom Bossert and forced Timothy Ziemer and his team to leave, but this team was the White House pandemic response team, not the nations. They were part of a team to coordinate response between the White House and other agencies, so not sure how much or how little that hurt us. I don’t think it had much, if anything to do with the test kit hold up.

A lot of what you say is correct, in that Trump et al’s response have been, as usual, chaotic and at cross purposes. Trump often says (or Tweets) things that are completely contrary to what the rest of his team is saying or doing…as seems to be the norm for this administration. In this case, it has most definitely had a negative impact on our response, though time will tell what that translates into. I find it ironic that you talk about muzzling experts and some of the rest of that, as this is exactly what the CCP has been and continues to do, and I don’t see that so much from Trump as that he contradicts what the experts are saying or says something completely off the wall.

I do agree with the last part there completely…this cluster fuck is definitely going to be on Trump’s head, he’s not going to be able to deflect this if it goes as far south as some are predicting. I seriously doubt his administration will survive it if this gets to even the level of Italy, let alone if it is as bad as it could be. :frowning: It will be cold comfort, however, when people start dying in the thousand or 10’s or even 100’s of thousands.

Let me guess:
the WHO test, developed by a government (UN) agency is in the public domain. Whereas in the US, the development of another test is contracted out to private drug company researchers, so when this test is developed, it will be privately owned (& patented), so the Big Pharma company can sell it at high prices.

I’d rejoice if someone with inside knowledge shows I’m wrong here. But I’m very afraid that I’m right about how the American health care ‘system’ works.

"But it’s also important to know that the work of setting up testing for a new virus can be difficult. Laurie Garrett, the science journalist who won a Pulitzer Prize for her reporting on the Ebola outbreak in 1995, said China’s most-used tests have had false negatives nearly half the time."

““Everybody is having trouble with the sensitivity/specificity issues” with the coronavirus, Garrett said. But the slow start to testing in America, compounded by the problematic test kits that were first sent out into the field, has set back the US response.”

A test with poor sensitivity but good specificity, or the reverse, is still useful, as long as you know that it does, and especially if you have multiple tests with different sensitivity/specificity.

Actually, the problem wasn’t getting authorization from the government, it was getting authorization from the patients who were being tested. Dr. Chu was doing research on flu, and she couldn’t get the government to approve a re-purposing of the program for coronavirus. Apparently the problem was that she didn’t get explicit consent from the subjects, which is a big deal.
Federal and state officials said the flu study could not be repurposed because it did not have explicit permission from research subjects; the labs were also not certified for clinical work. While acknowledging the ethical questions, Dr. Chu and others argued there should be more flexibility in an emergency during which so many lives could be lost. On Monday night, state regulators told them to stop testing altogether.
So patients had consented to have samples taken for flu testing, and Dr. Chu ended up testing for coronavirus without consent. That’s why it had to be shut down. She has an ethical argument to go ahead without patient consent, but she should have at least brought that argument before an ethics board before doing so.

~Max

Dang. I originally wrote “their” team, not “the nation’s”, but the latter looked better on my flat screen. Silly me. I should know the White House’s interests aren’t the nation’s.

Requiring all federal health communications be approved by a vice-president who has praised prayer as the treatment for AIDS looks to me like muzzling. Yes, the Chinese muzzled medics, unto death. Rogue US PHS doctors haven’t been arrested. Yet.

And an additional factor is that the CDC would not have wanted to compete with the rest of the world for the potentially limited supply of test kits. The USA has not just a desire to run a rigorously policed medical system, it has a kind of international obligation to do so.

Which in this case has let to the USA demonstrating again the third-world standard of it’s public health system. (As distinct from the medical system, which is what you normally argue about)

From the Washington Post:

Public health labs had received tests for up to 75,000 people by Friday. As of Friday night, more than 1.1 million tests had been shipped to nonpublic health labs including academic medical centers and commercial laboratories, officials said. The administration said 4 million more tests will be shipped in the next several days.

Mass producing the tests is already in the works. It would have been nice if we got a heads-up from China in December but that cruise ship has sailed.

Keeping people out of the hospital until it’s necessary will be the biggest task going forward. Otherwise it’s just a bunch of incubators looking for people to infect. One of the ideas that will certainly go into effect is drive through testing. Pull up to a check point and get swabbed. If you test positive AND need medical attention then the goal would be a negative-pressure hospital room so it isn’t spread throughout the building.

Kind of OT but not really.

Dr. Fauci says the vaccine is a year to year and a half away even with expedited rules. At least a vaccine is possible.

I went to the VA (just a clinic) to see what I had and they said that they couldn’t test me (no test kits) and that I would have to go to the ER at a local hospital.

Have you ever been to a ER in a major city … full of people with mask on and little sick children and takes hours to make sure you have insurance to get treated.

PS This was just nine (9) days ago

IOW, developing the vaccine in weeks has already occured. Proving it to be safe and effective is what takes a year +. Two different definitions of when a vaccine could be developed.

There were very few tests available in the US as recently as 9 days ago.

The governor of Connecticut was just on MSNBC and he said that they had labs ready to do testing but they were waiting for approval from the federal government to start testing. There was no followup question so I can’t clarify exactly what that meant, or whether they actually had tests in hand, etc.

Things are changing by the hour. Here is a report about new test equipment and new emergency approvals.

[Moderating]

And this after Colibri’s note. Yup, that’ll be a Warning.

RioRico, this is a pattern for you. Change that pattern, or we will change it for you.

In a situation like this, would you run the high sensitivity/low specificity as a first pass then use the low sensitivity/high specificity test second? Are there other parameters to tests?

Well, you’d like your tests to be cheap, and quick, and harmless. A cheap high-sensitivity low-specificity test that killed 1% of all people tested might be used if the diseases infected 98% of everybody exposed, and killed 30% of all those infected.

Real tests aren’t like that, but most real diseases aren’t like that either: the point is just that many tests (chest x-rays for TB) do cause harm, and are only used if the harm caused is less than the harm prevented. Even a harmless throat swab will have an expected mortality figure, depending on where and how it is done by who in what circumstances.

“Cheap” and “quick” are also real considerations that really do affect what tests are used and in what order. Also, how important the answer is: if it’s just medical tourism, an expensive, slow, low-sensitivity high-specificity test might be offered first just because it’s expensive