FDA Reminds Public It's Raining

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