Why are we letting FDA regulations limit our number of coronavirus tests?

Since CDC and FDA haven’t authorized public health or hospital labs to run the [coronavirus] tests, right now #CDC is the only place that can. So, screening has to be rationed. Our ability to detect secondary spread among people not directly tied to China travel is greatly limited.

That is from Scott Gottlieb, former commissioner of the FDA, and also from Scott:

#FDA and #CDC can allow more labs to run the RT-PCR tests starting with public health agencies. Big medical centers can also be authorized to run tests under EUA. For now they’re not permitted to run the tests, even though many labs can do so reliably 9/9 cdc.gov/coronavirus/20

Here is further information about the obstacles facing the rollout of testing.  And read here from a Harvard professor of epidemiology, and here.  Clicking around and reading I have found this a difficult matter to get to the bottom of.  Nonetheless no one disputes that America is not conducting many tests, and is not in a good position to scale up those tests rapidly, and some of those obstacles are regulatory.  Why oh why are we messing around with this one?

For the pointer I thank Ada.

Comments

Corruption is superior to rule of law in unusual situations, because rule of law is sclerotic.

In places where rules are often bent, you can just bribe a bureaucrat to look the other way, where you really need a sensible result in an extraordinary situation. But if everyone is a stickler for the rules, that can't happen.

See Posner on torture use and the ticking time bomb thought experiment.

Delete this comment. Because you are afraid of what those little virus creatures want, and you do not want to hear from people like me who know what they want.

Please please please try to do what is right.

Your ordinary virus is not a conscious creature, whereas the most miserable creatures we see day to day - the cockroaches, the rats, the voracious insects - have much more in common with us than they do with the viruses.

Please do what is right, and do what you need to do to make the conscious creatures succeed in their battle with the viruses.

Trust me, there are many people who know what needs to be done.

MAGNA EST VERITAS ET PRAEVALEBIT

Removing regulatory obstacles to enable more testing seems like an obvious thing to do. What could explain the inaction? The most likely explanation is (as typical) incompetence. However, we should also consider the possibility that this inaction is intentional. We know that many high-ranking people within the government want to use the coronavirus to place further restrictions on interactions between Americans and Chinese people (Ross and Navarro have said so openly). They have a strong incentive to prevent testing for coronavirus, because expanded testing would allow infected individuals to be identified and isolated individually, thus removing the justification for restricting travel and trade with all 1.4 billion people in China. Such an internal decision to prevent or delay testing would be very easy to pull off and very difficult to discover, because all it would require is inaction.

Identifying and isolating infected individuals individually, you say? How do you propose to do that when their numbers climb exponentially.

The horse is out of the barn and all hell is breaking loose even as we speak. This is not the time for lame conspiracy theories. It's time for great big bonkers conspiracy theories. I say Comet Borisov crop-dusted us with panspermic pesticide.

I think Zaua might be on to something. There are a good number of people in positions of influence who would let thousands die to not be called a racist.

What people are those? Can you point to any quotes from officials saying that thousands of people should die so they won’t be called racist? Whereas, there are actually quotes from officials saying coronavirus is an opportunity to move supply chains out of China.

Moreover, saying that the alternative to discrimination is thousands of people dying is a false and fearmongering dichotomy. It is racist to target Chinese people when 99.99%+ are not affected and many provinces of China have not had new cases in a while (and you know the travel restrictions are based on politics rather than infection risk because travel is not restricted from places like South Korea, Singapore, or even Hong Kong, which have had more cases recently than many provinces in China). Targeting all Chinese people is also less effective than individual screening at controlling the disease—notice how Italy was the first European country to restrict travel from China and is now experiencing an outbreak, whereas countries like the UK, France, and Canada that have taken a more targeted approach are not.

"Can you point to any quotes from officials saying that thousands of people should die so they won’t be called racist?"

Trumpians dream of them every night.

Like Rotherham and Rochdale never existed.

Very funny. I mean, it is totally classic for a political paranoid to reach across space and time for an example to shore up irrational fear.

Not America. Not our political system. Not our Constitution. Not our model of immigration integration.

Waaaay across time, all the way back to Jan 15th.
https://www.foxnews.com/world/manchester-asian-grooming-scandal

And yes we have the same problems. In the US, we cannot even discipline children acting up in school without considering racial makeup.

"quotes from officials saying coronavirus is an opportunity to move supply chains out of China." I haven't heard 'opportunity', but sure have heard it as a good reason, which would be prudent.

It’s not a conspiracy theory, just pointing out motive and opportunity. In fact, no conspiracy is required—just inaction.

Many people on this site seem to not understand anything about what is going on. The FDA is allowing individual labs to develop their own tests, which is a relaxation of regulations. Normally, a test that may result in a patient being subjected to potentially dangerous treatments (and treatment for Wuhan Flu are dangerous) needs to be approved to make sure the test works. That is a long process. The CDR has developed a test but it is the only one authorized to use it. Now the FDA has through emergency powers authorized private labs to develop their own tests. They still have to get FDA approval, but they don't have to go through a long approval process. (Presumably, someone at the FDA with knowledge can just sign off that the test makes sense, i.e., it works like the CDC test.) That is a good thing. More testing will now occur. This is the regulator allowing more testing not the other way around

No, wrong. The FDA has not yet made the emergency declaration it needs to make to allow private labs to test.

Clearly this is wrong, because No labs in the US are testing but the CDC. And it's testing rate has been so glacially slow as to invite conspiracy theories.

The CDC, has to date, tested 426 people. China, Japan, S Korea, etc have run thousands of tests on much smaller budgets.

https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html

This is probably just shear incompetence by the CDC. But it's disturbing to see this level of competence at a time when the US needs their ability to smoothly function.

Saint John Chrysostom is my least favorite saint, but, long ago in a time that is not that much different from our time, he wrote a few words about how God knows - and loves - each of his creatures including the most "meager" of such creatures (I posted the quote here earlier tonight, in the kindness of my heart because I know what we are going through, but it was deleted - sad!) ---- well, there are a lot of people alive today who need your prayers, because if you do not pray for them this coronavirus is going to kill them.

Often my comments are deleted, and I am fine with that, but seriously, I want you to know ----

God listens to your prayers.
A virus is not a conscious creature.

A virus cannot pray.

You, my young friend, can pray,

Trust me there is almost no likelihood that you are gonna find a vaccine, or that you are gonna do anything practical to protect your countrymen from this pandemic: but you can pray.

God loves us all, and I am praying for everyone you care about.

I know the statistics and I know the numbers, but more importantly, I know how to pray.

God bless you my friends.

It is working as designed. This is what a financial guy said:

I’ve noticed a massive difference in how much people who deal in risk care versus those who don’t on #Covid_19

My VC & Wall St trader friends are prepping like mad.

My friends who work for bureaucracies just sort of shrug, waiting for someone else to tell them what to do.

Bureaucracies reward inaction. If it gets out of control the CDC will get increased funding and esteem.

Robin Hanson suggested preemptive infection, where the virus is spread here and there with the idea that everyone is going to get sick so you might as well even out the effects. Nassim in his typical way suggested that Robin should have some skin in the game. Robin said he would place a bet with real money. Nassim suggested no, you infect yourself first.

Of course, it is working as designed. It cannot do more than the powers it is given. A bureaucracy that does too much is in danger of overstepping its bounds and infringing on the rights of others.

Very very soon this virus will be all we talk about, here and elsewhere. Looking at recent topics covered on MR, much of it now seems trivial and beside the point.

We could speculate endlessly about how the world changes now. One silly example I just thought of: Nearly all new movies made from now on will be CGI. Live-action will be gone because of no travel, no crowded film sets, and outright deaths of prominent cast members of franchises.

Prominent people will have a higher mortality rate, because they have been shaking more hands, meeting more people, posing for selfies, attending more social functions. That wasn't the case during the Spanish influenza.

Democratic presidential candidates are especially vulnerable. How do you conduct an election campaign without any actual campaigning? What's the reaction when Bernie drops dead?

Please, this drama is unnecessary. The disease is basically the flu in many ways (with many more people having been infected and dying from the flue since December 2019), but due to its being new, we let novelty overrule any reasonable perspective.

Of course no one wants to deal with a new disease spreading. On the other hand, a decade down the road, the current reaction will likely be seen as a sign of hysterical overreaction. That the Chinese were ineffective in containing it at the and of 2019/beginning 2020 is a different lens.

The incubation rate is longer than the flu. The observed death rate is 20 times that of the flu. There is not and has never been a vaccine for any coronavirus. No human population has antibodies for this coronavirus because it is novel. It is spreading at an exponential rate. NOT A FLU.

Let us know when it reaches the extent of the Spanish Flu, will you? Until then, it has a long ways to go before it reaches the observed deadliness of a novel flu virus (which pretty much describes a not tiny number of flu variations).

Isn't that the point of this whole conversation? We can't know it isn't at the level of the Spanish Flu because we aren't looking for it because testing is strangely limited for obscure reasons.

Now, I agree we have not yet seen bodies in piles large enough to justify a comparison with the Spanish Flu... but without testing being done, we can't know those piles are not about to emerge in our city streets until the either do or some number of months pass by and no bodies appear.

The lessons of Italy and other such places is, absent testing and surveillance, you have some number of weeks or months of invisible plague spreading and then *wham* piles of sick people that will lead to dead people in the following weeks.

Here is some guy on Reddit making the counterargument why it's not just "the flu". (https://old.reddit.com/r/Coronavirus/comments/f8k2nj/why_sarscov2_is_not_just_the_flu_with_sources/)

+1, excellent response.

So excellent that the Spanish Flu is not mentioned at all, just seasonal flu. Seems we forget what the flu is capable of. For example, the CFR of Spanish Flu is the same as Covid19 at around 2.5%. Or that r0 of Spanish Flu is quite comparable to that of Covid19.

And the reason everyone wears face masks in such situations is the Spanish Flu.

If we can so easily forget what an actual pandemic with mass fatalities looks like, no wonder people can write that the flu is somehow not a proper comparison.

The ironic thing is that most of the generations long planning for another deadly flu will serve very well when dealing with Covid19.

+1 for the reference

-1 for yet another episode of “Pointlessly Pedantic with Prior”

+1, Indeed, another example of:

Pedantic Passive Aggressive Attacks by Prior

It's a freaking flu. Did you freakout when SARS, MERS, avian, swine, ebola, and zika made the rounds? Just spend a few days catching up on your hopelessly large Netflix queue and chill out.

I don't understand this reaction. It's not a flu at all, it's a coronavirus. Those aren't the same. Furthermore, this has already killed far more people than the SARS or MER coroaviruses. Has a far higher mortality rate than Avian or Swine flu. And Ebola was mostly localized to a small area. So, by a rational metric, it's worse than any of these.

People shouldn't panic, but your reaction is just as irrational as someone who is in a panic.

Assuming Steve dies, let us know if Covid19 manages to beat out the 20th Century and still reigning modern pandemic champion, the Spanish Flu.

Really? If your Wall Street trader friends are prepping like mad, it’s not showing up in stock prices. Even Chinese stocks are down by less than when Trump announced his first round of tariffs.

Italy and Korea wake-up calls happened over the weekend, and on the first trading day of the week the S&P 500 fell 3.35% today. European stocks had their worst day since 2016.

Daily stock fluctuations are not necessarily indicative of anything, but you yourself chose to trumpet it as an indicator.

and for the record, yes, I have spent year after year trying to understand what a virus wants, in its little virus heart.

God bless you my friends.

No, I am not suffering from TDS. I suspect that no bureaucrat wants to say or do the wrong thing. The chances of being fired or demoted are too great. This is hunker down time. The feds responded much more visibly to Ebola and SARS

Pearls before swine, eh?

Not at all, that is not the way I think.

"Why are we not calling for a national day of prayer" is more along my line of thinking.

(there are very very smart people working on this - I am not one of them; none of them regularly post here).

There are a lot of very smart people working on the flu, and yet every year, the flu appears, infecting many, and killing a significant number.

Prayer has nothing to do with it.

Actually houses of worship have been a very effective channel for the coronavirus to spread forcing many of them to close for the time being:

https://www.financialexpress.com/lifestyle/health/no-handshakes-coronavirus-outbreak-spooks-temples-churches-and-mosques/1868827/

They even stopped public mass in Venice, Italy:

https://www.nzherald.co.nz/travel/news/article.cfm?c_id=7&objectid=12311035

"For the pointer I thank Ada."

I thank Ada too but she's not as excellent as me. I'm the most excellent.

This sounds exactly the sort of situation that a company like Theranos could handle. Especially if the government would support such free market innovation, instead of shutting it down.

"Hospitals could advance these tests as Laboratory Developed Tests or LDTs, meaning they develop them in house. But since HHS declared a public health emergency related to #Coronavirus, hospitals are now expected to get FDA permission to use their own tests"

My first reaction was "how does this make any sense" but it looks like the PCR tests being advocated aren't reliable so the question of scale becomes moot and it does make sense for the HHS to exercise emergency powers to concentrate efforts to come up with a more reliable system. Having each hospital come up with its own bespoke diagnostics seems very shoddy and downright authoritarian when the personal risk of a false positive from a bad test means a half month quarantine.

The problem is regulatory only in the sense that Trump has gutted the CDC and DHS epidemic personnel while cutting their funding. The problem is political in the sense that Trump is more concerned with the political consequences of an outbreak than the health consequences. https://nymag.com/intelligencer/2020/02/what-we-know-about-the-trump-admins-response-to-coronavirus.html

So the problem, then, is too *little* regulation, since Trump gutted all the agencies.

Trump is a magical character on both sides of the aisle.

That would seem to argue for letting more organizations do the testing, not the ongoing restrictions.

'many labs can do so reliably 9/9': what does '9/9' mean?

It’s #9 in a Twitter thread.

Thank you.

"Why oh why are we messing around with this one?"

For the same stupid reason regulations require hospitals and nursing homes to feed diabetic patients high sugar/high carb foods.

RN wife says it’s not that high sugar/carb diets are required. In nursing homes if the patient demands them, the facility must provide them. In hospital settings it is dependent on blood sugar levels, but staff cannot prevent family/friends from bringing sugary food to the patient.

That's my understanding as well, and it makes sense. Suppose, for example, you are terminal. Why not have the right to eat what you want? Should the government prevent you? That's really a nanny state.

By having the regulation, it also shields nursing homes from getting sued for providing what the customer (the patient) wants.

Butler T. Reynolds, what regulations are those?

Okay, as someone who formerly worked in the medical diagnostics industry, I think Tyler has horribly set this up wrong. From the article:

"In the United States, efforts to expand use of the CDC test have struggled after one of the three reagents upon which the test depends delivered inconclusive results during quality checks, said Kelly Wroblewski, APHL's director of infectious diseases. Samples that test positive at any of the three labs are still being sent to CDC for retesting."

That means essentially that there is no test. It is *the* problem in chemical diagnostics that you have reagents that work and are shelf-stable. They must be shelf-stable for years in a commercial product.

This is not an economic problem, unless you think magically "more centers" will produce a test that works reliably.

And frankly I'm not convinced by the economic argument that since there is only "one place" it cannot scale. Didn't FedEx famously scale with one transshipment center?

Always interesting to find the correct common buried, that explains the outrage in a more reasonable fashion. I also work the PCR industry. You can’t just snap your fingers and develop the method, or do a tech transfer instantly to a new lab. Details like specificity take time to work out.

Think about what you know about the background of this, and how wrong and off base all of this discussion is, and think, could this be the case for all journalism?

Thats a pretty common reaction by people who see reporting about topics or events they actually know something about. Even assuming best efforts (which is a very big assumption), most of the "journalists" are quite poorly educated, glaring so in areas outside their every day experience (e.g. technical, military, business). They don't even know the questions to ask, and in any event disdain 5W straight reporting.

That is a well known phenomenon (it has a name which escapes me). I find it hard to believe the former FDA commissioner has no idea how medical diagnostics are developed. He was a nontraditional appointee admittedly, but I assume he's not a complete idiot. So who's right here?

Good comments. But I do believe there's indecision in the Trump administration, in part because the president has made clear that the coronavirus will be over by spring and nobody in the administration wants to contradict the president, and in part because Trump dismissed key personnel at CDC and DHS and hasn't replaced them. As markets fall, one would think that the administration would want to get out front on this and provide reassurance that the administration is on top of this, but fear of angering Trump seems to have caused the administration to have been caught flat footed and nobody is willing to take charge While Trump basks in the glow of adulation in India.

I am a Trump supporter, but I second most of rayward's comment.

also, anonymous at 8:31 am - you don't comment here often, do you?

When I worked in the industry, one of my buddies actually was one of the top reagent designers in the industry. I remember him telling me that his skill was so rare that there were only three companies he could ever work for. FYI.

Looking at the CDC link, seems odd that there is no mention of specimen disposal requirements.

Perhaps such specimens are kept forever or something.

Haven't seen any data on number of tests actually run, time from sample to result, test kit availability, test kit production rate, false positive rate, false negative rate.

"Samples that test positive at any of the three labs are still being sent to CDC for retesting."

This implies that they think they only have false positives. Let's hope so.

Per the CDC, number of tested = 426

https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html

By the way, on the subject of "hurry up and do something,"

https://www.businessinsider.com/disinfectant-control-coronavirus-triggers-mass-die-off-animals-china-2020-2

Public spraying of disinfectants makes great television, but it is actually very scary.

CODX has a test far superior to the CDC test... CODX tests use co-primers.

But no approval for use in the US.

http://codiagnostics.com/technology/coprimers/

Well the good news is that what the media calls the "Climate Crisis" is getting all sorts of drop in CO2 emissions from this coronavirus. Flights in China are down 80%, and energy consumption down roughly 40%. Greta should be thrilled! And her media cheerleaders. If only every day could be a coronavirus lockdown day for the next 12 years, the earth could be "saved"!

How dare you!

The boys only tease you because they have hopeless crushes on you, Greta.

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