Why the Hell Has the FDA Not Approved Cheap Rapid COVID-19 Self-Tests Yet?
If they're good enough for Europeans, surely they're good enough for Americans.
Above is a photograph of my stash of five at-home COVID-19 tests. After participating a conference in South Dakota in July where a lot of folks were ostentatiously unvaccinated, I used one so that if I tested positive I could quarantine myself to prevent infecting other people. Since I have been fully vaccinated since early March, I hoped that the results would be negative. Fortunately, they were. The cost of my test stockpile is $149.95.
Below is a photo showing a bin of at-home rapid Flowflex COVID-19 tests for sale for about $3.50 apiece at a supermarket in the Netherlands. The test is manufactured by a company headquartered in the U.S., but the Food and Drug Administration (FDA) has not approved it for sale here. In the bin below the Flowflex test, you'll see another COVID-19 self-test offered by Roche. You can buy it in the Netherlands for about $5.90 per test. It too is not approved by the FDA.
The picture was tweeted by the Tufts Medical Center pediatrician Mark Dexter, who quite reasonably observes, "I don't understand why we *still* don't have these in the US!"
The answer is simple: From the beginning of the pandemic 20 months ago, hypercautious federal bureaucrats have massively bungled COVID-19 diagnostic testing. Way back in March 2020, I argued that the FDA should get out of the way of rapid at-home COVID-19 testing. Instead, the agency prevented private companies and academic labs from developing and deploying any COVID-19 tests. It especially took its sweet time approving at-home diagnostic tests. The first real at-home COVID-19 wasn't finally approved until mid-December.
Making cheap, fast COVID-19 self-testing widely available could have dramatically reduced cases and deaths and enabled Americans to safely work, shop, travel, and entertain themselves just a few months into the pandemic. Bureaucratic incompetence ensured that this didn't happen.
Demand for the expensive at-home COVID-19 tests approved by the FDA has outstripped in-store supplies as delta variant infections surged. Even at this late date, rolling out cheap rapid self-tests could significantly reduce transmission of the virus. If cheap rapid COVID-19 self-tests are good enough for Europeans, surely they are good enough for Americans.
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When the FDA fast tracks something, like the vaccine, then it’s experimental and must be avoided.
When the FDA goes through their usual drawn out process people die because of their negligence.
It must be both ways. No matter what they do they’re wrong.
put this in your arm. it stays and you may suffer ill effects.
put this in your nose. it does not stay and you will not suffer.
One of those two things is not like the other.
Isn’t that what sarc is pointing out?
Heads they win. Tails you lose.
If they’re good enough for Europeans, surely they’re good enough for Americans.
Just like lockdowns.
Because taking away peoples’ freedom is the same as approving a test that would allow them freedom. Good catch.
I’m assuming Diane? Paul? wasn’t actually making an argument about rapid COVID-19 tests, but thought it would be funny (if not particularly relevant) to make a snarky remark about Europeans and lockdowns.
I guess I’m assuming that because I can’t believe anyone could be against rapid COVID tests — but you never know what partisan-inspired talking points against the tests will crop up.
(Not saying Diane? Paul? is a partisan. She? He? seems to be a civil, fairly behaved commenter.)
(Not saying Diane? Paul? is a partisan. She? He? seems to be a civil, fairly behaved commenter.)
Yeah. Soaring above the fray.
I know I lost my edge when people started saying nice things about me.
It’s like when Ray Davies of the Kinks was inducted into the Rock and Roll Hall of Fame.
“so I’m respectable now… damn…”
Yeah yeah, I know, “Ray Davies was a friend of mine, you’re no Ray Davies”
Ray Davies is my absolute favorite lyricist.
met a girl named Lola and took her back to my place feeling guilty feeling scared hidden cameras everywhere.
Oh yeah? Well… Ummm… I can’t tell if you’re Paul or Diane! So there!!!
That’s about as confrontational as I can get with you. Weak.
Public information is 4.6 million deaths and 223.7 million cases. We know that the number of cases is likely higher probably by a factor of ten. Odds of dying is 0.2%, more so for some people than others.
The Hong Kong flu epidemic of 1968-1970 also has a similar number of deaths (varies according to source) and the world population was at least half of what it is today.
We over panicked, and we know it.
We over panicked, and we know it.
And Ron is asserts, entirely baselessly, that objective evidence will, somehow, prevent us from rather than induce us to over panic.
they know I would only test myself @casa and they want statistics.
Tangentially related: Idaho is now rationing care by triage standards, essentially. Live free and die! Wooooooo! Good thing blue state Washington is next door to bail them out. I’m sensing a pattern…
https://www.king5.com/article/news/health/coronavirus/what-does-idahos-crisis-standards-of-care-mean-for-washington-hospitals/281-e40b932b-aadb-4b1b-a7cd-d66f46700ea3
didn’t someone note this interesting trend yesterday, that we’re 300% worse on hospitalizations and 86% worse on deaths than we were last year at this time, and that’s WITH A VACCINE?
Umm, northern Idaho is a hotbed of conservative anti-vaxxerism, so it is not going to be a good example of that hypothesis.
Yes, but this trend as noted yesterday was nation-wide. And 100% of the country was unvaxxed at this time last year, so that is an excellent example of the hypothesis.
And we still have huge numbers of unvaccinated people, for some dumb reason, and they are primarily the ones getting hospitalized and also serving as a breeding ground for variant mutations.
You need better sources….
Most hospitals are having mainly vaccinated people, NOT non-vaccinated. Your media choices lie.
The biggest reason people do not want the vaccine is because they have had covid and are better protected than with a semi-risky vaccine that is barely 50% effective , according to the Israelis who are 85% vaccinated.
Largest groups of non-vaccinated are Blacks(democrat supporters) and health care workers, NOT the republicans your media choices lie to you about.
The breeding ground for mutants is 100% within the vaccinated crowd……..DUH read more sources! Understand why!
The unvaxxed are truly dying in droves. Oh well…
Exactly, why do we care? I’m vaccinated. Why can’t I return to normal and stop wearing my mask?
We care because many people are having their own life saving treatments delayed because of these morons overwhelming the medical system.
Allow hospitals to turn away covid-19 patients who are unvaxxed and this will solve itself. Unfortunately, that will not happen.
Don’t fund hospitals with public money and require them to provide service to the public at large in the first place. Taxing anti-vaxxers (or anyone) and subsequently refusing them service is taking.
That’s been my opposition to the vaccines since Trump paid for them up front.
Also, variants are an existential threat to humanity, vaccinated or not, unless they’re killing conservative anti-vaxxers. Then, the unequivocal rules of Science! that could save all of humanity don’t apply.
One reason we can’t get back to normal is that delta has figured out how to (sometimes) colonize a vaccinated person’s nose and spread before the vaccine-trained immune system eradicates it. I’m sticking with my mask until/unless overall infection levels drop. Or until we get a nasal spray vaccine that triggers mucosal immunity.
WITH A VACCINE really isn’t in play here because the people flooding hospitals didn’t take it.
Yup, the anti-vax conservatives in the Coeur d’Alene area lean on Spokane hospital to bail them out of the trouble they get into because of their poor choices.
But, hey, freedom to be an idiot and risk your own health for no good reason just because you don’t want to do anything liberals want you o do.
FYI, Spokane is a hotbed of conservative anti-vaxxers. How could Spokane possibly help them out when they’re overwhelmed too?
Relative to Coeur d’Alene, Spokane looks like a liberal pro-vaccination city.
This is very rapid google search and research I just did, so take this for what you will.
Spokane county vaccination rates:
As of June 1 (admittedly)
The Spokane Regional Health District’s map of vaccination rates by zip code in Spokane County shows several pockets where some areas barely reach 30 percent.
•99009: 25.0%
•99018: 25.9%
•99012: 26.7%
•99001: 28.3%
•99006: 29.6%
•99025: 29.6%
•99030: 30.3%
Coeur d’Alene, ID metro:
40.5%
Admittedly that’s not comprehensive, I admit its cherry picked, but based on my impressions, I would be very surprised if Spokane were “way higher” than Idaho.
Didn’t Washington decriminalize drugs? So you’re free to shoot up heroin in the street and OD but not free to not get vaccinated?
I’m too lazy to find the link again, but the Times printed a head scratcher wondering why the homeless population (hint: The least sanitary, least locked down, most unhealthy, highest comorbidity-having population in the solar system) wasn’t being hit very hard by Coronavirus.
Outdoor living and generally not going to the doctor for any reason. And if they die, I don’t think anyone bothers to autopsy them.
That was Oregon, not Washington.
It’s still legal to put everyone around you at risk by not getting vaccinated. You may find some employers unwilling to give you paychecks, though.
Idaho: 66% full
Washington: 76% full
https://protect-public.hhs.gov/pages/hospital-utilization
Thought this was worth posting again here:
The CDC’s website, definition of terms surrounding ‘immunity, vaccine’ etc.
This represents a change that has been up on the CDC website for a very long time. Web archive, August 26th:
Tell me the CDC is gaslighting us.
Yawn… who cares what definition of vaccines is up on the CDC website. It’s a very, very good idea to be vaccinated against COVID-19 and we are collectively seeing bad shit happening again because too many people are making the dumb choice of not getting vaccinated.
If the CDC’s definition of “vaccine” suddenly morphs (after years… decades?) from “it provides immunity” to the disease to “it lessens the symptoms of polio and diphtheria” then I would call that a significant and important shift in thinking.
I thought we have all caught in that the CDC is not a good source of reliable guidance.
Its not really a shift in thinking, we’ve known vaccines aren’t 100% effective since the invention of the first vaccine. CDC just updated their decade-old definition with century-old information
Oh, and I forgot to bold the definition of “vaccination” which is the most important shift.
Vaccines used to be dead viruses, or a similar virus that the body could easily defeat. Technology has moved on. So should the definition, right?
My cats get a rabies vaccine that is dead viruses. Pfizer isn’t inoculating us with dead viruses. It’s some RNA stuff I don’t pretend to understand, other than to see it’s not the same thing. So why shouldn’t the definition change as well?
*shrug*
Perhaps there should be a new category. Leave “vaccine alone” and produce a new word for stuff that just keeps your polio down to a few aches and pains compared to the thing that keeps you from getting Polio.
Perhaps “immunizing vaccine” vs “symptom-mitigating vaccine”.
Or is this whole thing devolving the way everything else in western society is devolving: Things we used to know that we now pretend to not know.
Perhaps there should be a new category.
aye
The problem is that you are talking about “getting it”: there really isn’t such a thing. You seem to think that a vaccine prevents any of the virus in question from ever entering your body, but that can’t be true: vaccines can only work on something that has entered your body. So there is no “binary” state of “getting it” vs “didn’t get it.” It is more meaningful to think of “how much of the virus” do you have. Zero is great, of course, but that can only happen by physically preventing transmission of the virus (isolation, masks, etc are attempts to do this). Once one or more of the viruses get into your body, the question is how many and how fast do they reproduce. If the answers are “not much and not very”, then there aren’t enough of the critters to cause you problems, e.g. you don’t have symptoms and you aren’t “ill”. This is probably what you think of as “not getting it”, but indeed you did get “it” if “it” is “the virus entered my body”, you just squashed their reproduction fast enough to keep them from doing damage. So that is what vaccines do. Note that while the population of virus may not increase enough to do you damage, it might still increase enough so that some of the beasties sneak *out* of you and thus potentially into others. E.g., you can be a carrier even if you are “asymptomatic”, which is really just another word for “didn’t get ill.”
There are many, many viruses and bacteria that enter your body all the time and move on to others, but because they don’t *make you sick*, we really don’t care. We are literally walking around all the time carrying communicative but not-harmful “diseases.”
For instance, what’s the drug that keeps your HIV from developing into full-blown AIDS? The thing that makes it so HIV is no longer a death sentence? They’re VERY careful to not call that a vaccine.
I don’t pretend to understand it the way the geniuses who developed it do, but for anyone curious there’s some good information out there. One of my fellow nerds has a web page explaining what the Pfizer/Biontech vaccine does in the body and what each part of its RNA sequence does:
https://berthub.eu/articles/posts/reverse-engineering-source-code-of-the-biontech-pfizer-vaccine/
” Technology has moved on. ”
“Moved on” is not the same as “doesn’t actually do what those other things do.”
I get that you are ok with goalpost shifting. The rest of us are not.
Sometimes goalposts move.
Few, if any, vaccines have ever been 100% effective. So it absolutely “does what the other things do” and does it better than some. If you want to make new categories “immunizing vaccine” is going to be a pretty empty group
Masks aren’t 100% effective. That means they’re 0% effective. Same with every other measure to slow the spread. Just like QI won’t solve every problem with the police. That means it’s just fine the way it is.
Come up with a 100% solution or go home. I bet you voted for Biden, masturbate to Ashli Babbitt’s death and want the government to force everyone to get vaccinated. Prove me wrong! You can’t! Guilty on all counts!
If you want to make new categories “immunizing vaccine” is going to be a pretty empty group
This contradicts decades of FDA science and your own definitions. Defintiively, the two categories would be ‘immunizing’ and ‘protecting’ and, in line with longstanding FDA practice, the most recent vaccine would be judged against a gold standard and not itself definitive of either category.
I get that you are ok with goalpost shifting. The rest of us are not.
He’s pretty much admitting that COVID vaccines are definitively different than (e.g.) the polio vaccine. The polio vaccine produces immunity, the COVID vaccine produces protection. Definitively.
“The polio vaccine produces immunity, the COVID vaccine produces protection. ”
You say this like it is wisdom, but it is not. How exactly do you think polio vaccines work? Do you think they create a plastic bubble around a person preventing any polio beasties from entering your body? Maybe it’s a little set of laser-equipped satellites circling at body-stationary orbit?
All vaccines work the same at a high level: they make it so that when the offending beasties enter your body, they cannot reproduce enough or fast enough to cause enough damage to make you “sick”. They simply cannot work another way. There are different mechanisms by which a vaccine might prepare the body for this defense, and different ways for that defense to attack the beasties, but they *all* share the characteristic that *the beasties have entered your body*. It is all “protection”.
If polio vaccines are *better* at protection, great, but that’s a matter of degrees, not types.
You say this like it is wisdom, but it is not.
No, I don’t. I say it with the definitions given. The required wisdom is 3rd grade reading comprehension.
If polio vaccines are *better* at protection, great, but that’s a matter of degrees, not types.
I didn’t change the definition and this statement incorrectly asserts that there’s only one means by which vaccines can be judged or varied and that the COVID-19 vaccinations aren’t a different type of vaccination than the polio vaccine. There are a wide number of ways to typify viruses and vaccines. I simply did so (or proposed it) with the two definitions given.
We use these tests at work. It’s what allowed my hyper-risk-averse company to allow employees to come back. We all get tested once a week. Quick swab up the nose and away we go. It’s mildy annoying, but it lets us get back to work.
I have some of these same tests at home. I don’t use them much because I’m already being tested weekly. But they’re same tests one can get at the local grocery store.
And they say in big bold letters, “FOR USE UNDER AN EMERGENCY USE AUTHORIZATION ONLY”.
The Federal government clearly doesn’t want us to be using these tests. But who gives a shit, they’re available everywhere. The results aren’t good enough to get you into an SF or NYC restaurant though. Maybe that’s the fear? That government worried that people will use these tests to show they are virus free? Well duh, that’s the point!
FYI, Nick Gillespie appeared on a libertarian podcast.
Man bites dog
The real problem is the hysteria people have with Covid. The solution isn’t to turn yourself into a latter day Howard Hughes, constantly being in fear of getting infected
We’re all going to get it, maybe more than once. Thankfully it’s not particularly serious, unless you are obese or really old. It’s almost nothing if you are a kid, much less serious than a flu.
We need to stop panicking, and the media needs to stop pushing the panic
As Jonah Goldberg stated, we beat the pandemic, the emergency is over, now COVID is endemic and we need to treat it as endemic.
It’s a bad flu. A VERY bad flu. But like the flu most people who catch won’t die of it. Mostly it will be the elderly and those with comorbidities, but also the occasional healthy teen. Which is why we get our flu shots! Why we get our flu shots!
I don’t understand why so many people are refusing COVID vaccines. We could put this thing behind us if we would just get vaccinated. We’re going to have yearly vaccinations just like we do for the flu, but so many people have their heads in the ground. Fuck, I’ll get the flu vaccines just so I don’t shit my pants when I catch the bad flu. It’s worth it just for that. But people still mumbling about Bill Gate’s microchips and shit not realizing how fucking dumb they look.
Which is why we get our flu shots! Why we get our flu shots!
Never once had one. Could probably count the number of times I’ve had the flu, as an adult, on one hand.
There is a long-held and widely-applied gaming of stochastic systems, from evolutionary bottlenecks to market downturns, the one solution that contains all solutions: diversify. Don’t force the vaccine on me, best of luck with your diversification options.
I have a daughter that works in a Covid ICU. I’m not going to argue with you because your politics make your mind not changeable, but what you are saying about only the obese and only the old is completely false. Particularly as to delta.
I have a daughter that works in a Covid ICU.
No you don’t.
It’s serious enough to be the #1 cop killer now, ahead of violence and car crashes.
https://www.odmp.org/search/year/2021
Even if approved there is nothing that says they would be priced as cheaply here as they are over in Europe.
Differentials in prescription drug pricing here to there tending to indicate that they would be more expensive here.
These aren’t prescription. You can get them now today in the US over the counter. They just have an EUA on them.
That happens across the board, the US subsidizes their defence and health sector
Well, Ron, why don’t you follow the money and tell us why?
Weekly at-work testing would enable unvaccinated people to avoid vaccination mandates. If the FDA feels that it’s mission is to get everyone vaccinated, allowing testing outside of the medical system would therefore interfere with its mission.
Easily available at-home testing would also tend to give comfort to the unvaccinated, as they could immediately take treatments like ivermectin at the earliest stage, when they are most effective. But the FDA wants the unvaccinated to feel UNCOMFORTABLE.
I think it has to do with the government wanting to know who has Covid. If you need to see a doctor or pharmacist, or you seek reimbursement from your insurance, CDC and state and local health departments know whether or not you have Covid. But, if kits are OTC and $5 a piece, a lot of people will learn if they have Covid, but government agencies won’t know.
I’ve told my wife that I will not be tested or seek treatment for Covid. The government knows I’m vaccinated, and I’m fine with that. After all, my grade school, high school, college, and law school had my vaccination records. But, the government doesn’t need to know whether or not I have Covid.
Nah, it’s simpler than that. If you are a bureaucrat who holds up release of a product, no one can tell who was harmed by the delay. If you release it and something bad happens it comes right back at you. So nobody in government is willing to commit a possible sin of commission, but always feels safe committing those of omission.
See it everywhere in government.
I use over the counter tests when I can get them, and I’ve been fully vaccinated for quite a while.
Vaccines and testing work together well. Imagine Provincetown, but with most of the sick people finding out within days and isolating. The vaccines were pretty good at keeping people out of the hospital and prevented an unknown number of cases, but it’s better not to have the infection sources in the first place.
Speaking of Provincetown, maybe with massive testing and vaccination both we could have crowds again. South Korea did it for months with massive testing alone.
There’s a Harvard epidemiologist, Dr. Michael Mina, who’s explained in depth what a difference frequent population-wide testing could make. He’s put some information on rapidtests.org and Google will find at least one op-ed from him.
Here’s what I think part of the problem is. I bounced off a state legislator who has a health care education when I suggested a massive rapid antigen testing program. The problem my lawmaker had may be the one that the FDA has. There’s a paradigm shift between providing care for an individual (use a PCR test) and public health screening (go for fast and cheap). She was stuck on antigen tests being less accurate. They are, but they’re plenty good enough to reduce spread.
see Hanlon’s razor
There’s a hole in your logic: bureaucrats are never held liable for their decisions, no matter how bad they are.
Exactly this. The thalidomide lesson from Europe locked this into US gov’t decision making many years ago.
Bureaucracies are never held liable for their decisions. If a bad decision makes its way back to one, some bureaucrat, generally exactly one and generally one who had nothing to do with the actual decision, will be made to suffer.
Stupid response to a stupid post outlining your meaning you, GG stupidity.
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I guess Idaho regularly asks Washington to transfer their patients there? I guess Idaho regularly triages health care?
No. This is not normal. Nice attempt to use the standard modern “conservative” response to anything: “I don’t like it. I don’t have an answer for it. Therefor it does not exist.”
Are you sure of that? Most rural areas send patients to bigger hospitals to get better care. Is this a case of Washingtonians being smarter and more sophisticated, or a case of there being bigger hospitals on the Washington side of the border. I haven’t done any digging, but since you keep riding that horse, you should know the answer.
> Less accurate
So are home pregnancy tests, but piss on a stick or two and if it comes up positive or inconclusive you go to the doctor.
Seems a reasonable trade off. Catches a hell of a lot more a lot earlier even if you get an occasional false negative. If you get an occasional false positive, well, you should be getting a PCR test after a positive or real symptoms normally. THe quick, cheap test can pre-screen people without that PITA and expense of a doctor or testing site visit. In the aggregate, that’s good, and good for public health. And there’s nothing stopping you from getting a PCR if you prefer.
FDA bureaucrats trying to further their careers by getting credit for denying something harmful has caused delays killing many thousands. We need a WW2 mentality. When people are dying every hour speed counts and some fish is justified.
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