FDA Reminds Public It's Raining

Thursday, December 17, 2020

The FDA's recent announcement that it has finally "authorized" a rapid antigen test has to be read to be believed.

Tests like this have been available since since at least April, according to an essay titled, "An At-Home Contagiousness Test for COVID-19 Already Exists. Why Can't We Use It?"

In light of that fact, the announcement reads like some kind of sick joke:

Red tape can be deadly, and false advertising is illegal. And yet the FDA keeps pushing red tape. (Image by Paul Kapischka, via Unsplash, license.)
Similar to other antigen tests, a small percentage of positive and negative results from this test may be false. Therefore, for patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible. This is especially true if there are fewer infections in a particular community, as false positive results can be more common when antigen tests are used in populations where there is little COVID-19 (low prevalence).

The FDA reminds patients that all tests can experience false negative and false positive results. Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.
If only this were just a sick joke.

The FDA reminds patients...

Let that sink in for a moment.

Many people are already familiar with how this test works. Indeed, the test available in April (and perhaps this one, too, for all I know) is like a home pregnancy test.

Depending on whether a couple is excited or terrified by the prospect of a pregnancy, I can guarantee you that the last thing they will need to focus on the implications of a result and to place it in proper perspective is to be patronized by a bureaucrat.

Credit the manufacturer with providing instructions and the customers with a grain of common sense. (The failure to do just this -- on the part of millions of people who tacitly approve of what is going on, or won't challenge it -- is the underlying reason for the entire existence of the FDA and every agency like it that has ever existed or will exist.)

In any event, a test nobody was ever going to confuse with a definite diagnosis and that everyone would have been able to use, was kept away from us for months while a virgin soil epidemic raged, worsened by a severe and chronic shortage of diagnostic testing. People died or lost loved ones -- or were thrown out of work as politicians panicked (or ran with the excuse) and forced people to stay home because they might be contagious.

That last would be wrong, test or no test, but most people having even just a good guess as to whether they might be contagious could have taken all the wind out of the lockdown sails.

But the FDA would have us remain as ignorant of that, just as we are (because of it) of our own infectious status and the actual extent and severity of the pandemic.

Instead, the FDA will remind us not to treat a test result like a bolt of truth from the blue -- despite people showing for decades that they can use such a test and consider its results appropriately. And it will pepper its announcement with scientific-sounding jargon -- that it lifted from the forms it got some of the heroes of this pandemic to copy, like schoolchildren being punished, into its forms. And it will crow about of how it has "strongly support[ed] innovation" all along -- apparently by forbidding willing volunteers to try it, or scientists to test their ideas, or backers to see a profit. And it will claim to have "worked tirelessly" -- such as by pausing, when two game-changing vaccines were ready.

At least the vaccines are beginning to be deployed now -- despite the wait for public (read, non-expert) comment before approval and a "paperwork" (!) delay. But the rapid antigen test -- which I would have loved to purchase? It's being shipped in January and it looks like it will be in short supply:
[G]iven the pent-up demand for such a test, ... there remain questions about how much of a difference it would make unless available in large quantities and also how to prevent people and companies from hoarding such a test by buying in bulk. [bold added]
You might not know it from the deafening sounds of the FDA slapping itself on the back and reminding you that you are supposed to be an incompetent judge when it comes to potentially life-and-death medical advice: But this agency has all but rendered rapid antigen testing moot -- as it has already done with the vaccine, as least as far as a quarter million souls and counting are concerned.

-- CAV


Dinwar said...

This whole thing has been a giant referendum on the FDA.

Every time I hear someone complain that the vaccine, testing, or whatever is dangerous because the FDA rushed it, I ask what specific problems they think will arise, and what specific evidence leads them to this conclusion. So far, not one has been able to respond with anything coherent. The best is "There may be as-yet unknown rare side effects." Remember, vaccine trials have taken place all over the world and have included hundreds of thousands of participants; any side effect would have to have a rate lower than 0.001% or so to remain undetected. Also remember that 2,000 people (mostly elderly) are going to die each day waiting. Further, remember that industrial, first-world nations--including one of our closest allies--have approved vaccines. Yet because the FDA hasn't approved it, therefore it's not safe.

I'm a scientist, and this isn't "following the science". Scientists are supposed to fearlessly look at the evidence and follow where it leads, regardless of who they upset. Scientists have been banished, have been disowned, have died because they refuse to allow politics to dictate their conclusions. What the FDA is doing is pure magical thinking. Specifically they are engaging in something that's been termed Occidental Ceremonial Magic: the ritual must be completed precisely, as it always has been done, or else it will lead to disastrous consequences. There's no evidence suggesting that these vaccines or tests are more harmful than many others that are in use; it's all about the ritual of getting that bureaucratic sigil attached to the sacred document.

The CDC and FDA have proven themselves to be entirely political animals. They are not, in any way, scientific organizations. They are so fossilized in their policies that they are unwilling to recognize realty despite the death toll they were established to prevent.

Gus Van Horn said...


I love the term "Occidental Ceremonial Magic."

You also remind me of a great quote from medicinal chemist Derek Lowe, regarding that new Corona fad, Vaccine Panic:

Specifically, if you take 10 million people and just wave your hand back and forth over their upper arms, in the next two months you would expect to see about 4,000 heart attacks. About 4,000 strokes. Over 9,000 new diagnoses of cancer. And about 14,000 of that ten million will die, out of usual all-causes mortality. No one would notice. That’s how many people die and get sick anyway.

The FDA has delayed everything it hasn't killed altogether. Our willfully ignorant and attention-hungry mass media will gleefully and cluelessly try to do the rest when this stuff starts happening.


SteveD said...

The FDA's recent announcement that it has finally "authorized" a rapid antigen test has to be read to be believed.

Is this test more or less accurate than the PCR test already in use? The present test generates large numbers of false positives and low positives in which viral levels are too low for the person to be infectious.

Also it is interesting that the Moderna vaccine was created in 2 days between Jan 11 and Jan 13, 2020, more than a week before the first case of Covid19 in the US.


Anonymous said...

Hi Gus,

"Specifically, if you take 10 million people and just wave your hand back and forth over their upper arms . . ."

Well, this just shows the power of Democracy. It used to be you had to be a King or Shaman or Priest to get that effect!

Vox Populi Vox Dei - or something like that. ;^)

I have to admit that Occidental Ceremonial Magic is a very funny term. And appropriate given our Cargo Cult Education Mentality.

c andrew

Gus Van Horn said...


That article is good and makes a similar point to the one here.

The tests are different and are made with different purposes in mind. I have heard that the rapid antigen test -- whose purpose is to let you know you might be contagious -- is less accurate than the PCR test, whose purpose is diagnostic. Of course, there have been plenty of reports of recovered people popping positive on the PCR test due to unviable viral remnants that get amplified just like the virus. And then there has been controversy around the number of rounds of amplification, which I would have no trouble believing are too high, resulting in false positives.

Ironically, the FDA has been fixated on the fact that the rapid antigen test might be prone to false negatives. So, based on its actions, everyone being completely ignorant beats lots of people knowing they might be contagious, with a few here and there slipping through.


Gus Van Horn said...


Lord! How could I forget about the Cargo Cult!


Dinwar said...

I must admit, the term isn't mine. I got it from a Wiccan. And even he viewed such magic with contempt.

Gus Van Horn said...

Heh. Even a magic eight-ball can appear to be correct, sometimes...