The Big Gov Pretty Much Ruins Everything It Touches

Next in the news: water is wet and fire will burn you.  Film at 11. 

The general topic can be said as the title puts it.  The big Fed.gov screws up everything it touches.  We used to say the only things they're good at are killing people and breaking things, but with stories coming in from various incidents around the world I'm not even sure they're good at those anymore.  Well, they seem to break their own stuff pretty regularly.

Tonight's tale is about the response to the SARS-CoV-2 novel coronavirus pandemic.  Not the vaccines - there's not enough ink - um, not enough pixels, electrons or whatever in the universe to cover that screw-up.  No, this one is about the simpler question: why aren't there rapid, cheap, COVID testing kits everywhere in the US?  

The story starts at ProPublica ("Investigative Journalism in the Public Interest") called, "Here’s Why Rapid COVID Tests Are So Expensive and Hard to Find."  I got the lead to ProPublica from FEE - the Foundation for Economic Education - who almost used the same title but added (Than in Europe) to it.  

I'll bet you already know the answer: the problem is the FDA.  The problems are cronyism and the bureaucrat's default decision-making that I've written about many times; in this case, it's better to deny approval to a test that might do lots of good than to approve one that might cause harm.  In denying the good test, the bureaucrat is also harming people through inaction.  Nobody ever seems to care about harm done through inaction.  Except the families.  In the second case, harm by action - by actually doing something - might well get them a seat in front of a congressional investigation.  

FEE sums it up this way:

The Beginning: Early 2020

It all began in early 2020. After the virus’s genome was sequenced, commercial laboratories, universities, and biotech companies began developing tests that would determine to a high degree of accuracy whether an individual had COVID. The American federal bureaucracy, however, was not having any of it. The Centers for Disease Control and Prevention (CDC) erected countless barriers such as lengthy and insurmountable approval procedures that did not take into consideration the gravity of the public health situation. In doing so, the CDC, as well as other agencies, effectively barred these non-government researchers from developing COVID tests to be put out to market, preventing their dissemination to hospitals, clinics, and individuals.

As an aside, I covered the CDC test mess back in March of '20.  

Here's where it's worth switching to the deeper story at ProPublica.  Their article mentions that when the FDA opened up applications for Emergency Use Authorizations for screening tests, the FDA balked at the idea of Over The Counter solutions, saying they were afraid of false negatives.  

“To mitigate the impact of false results, all Covid-19 tests authorized to date have been made available only by prescription, so that clinicians can interpret results for patients,” wrote Shuren and his deputy Dr. Tim Stenzel in an October 2020 column in The New England Journal of Medicine.

"Shuren" is Dr. Jeff Shuren, head of the FDA’s Center for Devices and Radiological Health, which authorizes tests. Dr. Tim Stenzel is ...

a microbiology Ph.D. who in 2018 became director of the office that authorizes diagnostic tests, holds the most day-to-day power over whether a test gets approved. He worked at biotech companies for most of his career before coming to the FDA, leading some to wonder if those prior relationships played a role in determining which testmakers became the most important players in the market.

Among Stenzel’s former employers were Abbott and the San Diego-based Quidel Corporation, the first two companies to sell self-administered, prescription-free COVID tests in large volumes.  Predictably, Quidel (the smaller company) had a tremendous increase in both revenues and market capitalization once their test was on the market.  

While saying that Stenzel worked at those two companies is suggestive of why they were approved early, according to ProPublica his disclosures of any outside conflicts of interests have always said he has no relationships with them, but his having worked at the two major test manufacturers and the slow pace of authorizations for other companies’ at-home tests drew a letter from an anti-monopoly think tank, the American Economic Liberties Project, calling for an investigation.

This is a good example of why bureaucrats do their best to not end up under investigation.  The rest of the article shows good examples of why all of the FDA should be under investigation.  For one example:

Nanōmix, a diagnostics designer based in Emeryville, California, developed a rapid test with the help of a federal grant and submitted it to the FDA in February. In early June, an FDA reviewer sent back a list of questions, giving Nanōmix a deadline of 48 hours to respond. The company couldn’t provide answers that quickly, so it was sent to the back of the line.

“We start development on a set of guidance,” said Nanōmix CEO David Ludvigson. “Then they change the guidance after we’re done, and expect us to have conformed to their revised guidance.”

Reuters Photo from the Voice of America, just to show what these tests look like.

At every level, the US Fed.gov is an arthritic bureaucracy that can't get out of it's own way.  You've seen how people talk about being ungovernable?  Are they governing or just obstructing everything?