Fumble Delay Abet

This is scandalous.

Brian H. Shirts, M.D., is a molecular pathologist at the University of Washington. He writes: We’ll see more shortages of diagnostic tests if the FDA has its way

“February was a frustrating month for my laboratory. We wanted to make tests to detect the virus that causes Covid-19. My virology colleagues had great ideas and solid testing platforms. The Food and Drug Administration told us to stop. [That link is worth reading!]

Why? Because of a quirk in FDA regulations. Diagnostic tests are currently regulated in one of two ways, and there’s no clear rule to determine which one applies to coronavirus tests. This uncertainty is a big part of why test shortages have caused a national crisis.

This uncertainty is no accident. James Bovard, at Mises Institute:

“Dr. David Kessler, who became FDA commissioner in 1990, quickly sought to intimidate the companies that his agency regulates. A laudatory Washington Post article concluded, “What he cannot accomplish with ordinary regulation, Kessler hopes to accomplish with fear.” Kenneth Feather of the FDA’s drug advertising surveillance branch boasted: “We want to say to these companies that you don’t know when or how we’ll strike. We want to eliminate predictability.”

See the notes at the end of this post.

Now, back to Dr. Shirts:

“The VALID Act, introduced in Congress in early March, aims to address the confusion about who regulates diagnostic testing, but it would make the situation worse. If the VALID Act passes, we would see shortages in diagnostic tests for even more diseases than Covid-19, including cancers.

Under one system of regulation, laboratory directors are licensed by their states to develop tests through a set of rules called the Clinical Laboratory Improvement Amendments (CLIA). When a CLIA-licensed lab creates a test and documents that it works, doctors can order that test.

Diagnostic testing, and interpreting those tests, is considered the practice of medicine. The FDA is not allowed to regulate the practice of medicine. Yet it is responsible for regulating medical devices. Diagnostic tests use machines, sample tubes, and other tools that are clearly medical devices.

Here’s where the second system comes in: The FDA approves devices — not the lab that produces it — on a case-by-case basis. So which diagnostic tests are devices regulated by the FDA and which are laboratory-developed tests regulated through CLIA?

The FDA gets to choose…

The VALID Act will give the FDA power to create more monopolies on diagnostic tests. CLIA-licensed labs will be shut out of producing new tests that perform as well as FDA-approved versions — or better than them. The result will be higher costs and periodic shortages…

The VALID Act was created because large pharmaceutical companies wanted to have monopolies on cancer tests…”

If you recall, the FDA granted a monopoly to the CDC for CCP virus test kits. The kits were quite late, few, and didn’t work.

With the VALID Act, the FDA is going to be able to create a public/pirate partnership – making private industry more like the CDC.

Notes. Thoughts on complex and uncertain ‘law’ in the hands of unaccountable bureaucrats.

“After having thus successively taken each member of the community in its powerful grasp and fashioned him at will, the supreme power then extends its arm over the whole community. It covers the surface of society with a network of small, complicated rules, minute and uniform, through which the most original minds and the most energetic characters cannot penetrate, to rise above the crowd. The will of man is not shattered, but softened, bent, and guided; men seldom forced by it to act, but they are constantly restrained from acting. Such a power does not destroy, but it prevents existence; it does not tyrannize, but it compresses, enervates, extinguishes, and stupefies a people, till each nation is reduced to nothing better than a flock of timid and industrious animals, of which the government is the shepherd.”
-Alexis de Tocqueville

“We’re after power and we mean it… There’s no way to rule innocent men. The only power any government has is the power to crack down on criminals. Well, when there aren’t enough criminals one makes them. One declares so many things to be a crime that it becomes impossible for men to live without breaking laws. Who wants a nation of law-abiding citizens? What’s there in that for anyone? But just pass the kind of laws that can neither be observed nor enforced or objectively interpreted – and you create a nation of law-breakers – and then you cash in on guilt. Now that’s the system, Mr. Reardon, that’s the game, and once you understand it, you’ll be much easier to deal with.”
-Ayn Rand.


At Quillette:
Motivated Reasoning Is Disfiguring Social Science

A good criticism of the state of social science, a field closely engaged in tarnishing the meaning of the word “science.”

I will make 3 points. First, an excerpt:

The second is the culture of institutions. From my experience and perspective, these tend to function on a corporate structure… they do not appear to foster an appropriate level of critical thinking, skepticism, caution, or solicitation of opposing views… This is a recipe for conformity and groupthink. (… APA policy appears to forbid scholarly special interest groups under its fold from taking public positions that differ from its own central stated positions…consistent with a business but not an academic or scholarly model.)

The classic model of a capitalist business actually forces critical, creative thinking, or the business dies. The academic model has baked in incentives and protections for the groupthink we observe. “The University,” could only survive as a respectable institutional concept so long as diversity of thought was critically valued. It isn’t anymore. In fact, the opposite is true.

Groupthink came before the abandonment of “critical thinking, skepticism, caution, or solicitation of opposing views,” and was necessary for that abandonment.

I think the parallel here is better described by the words “corporatist” and “bureaucratic” than by “business.” Academia displays, on average, less “critical thinking, skepticism, caution, or solicitation of opposing views,” than “business.”

Now, you may accurately point to Google’s treatment of James Damore as a business exemplifying advanced hardening of the categories, but this is also only possible where diversity of thought is suppressed – and where amoral business practices are hidden from customers. That may be business, but it will not be good business in the long run.

IAC, I’ll posit that even Google fosters a higher level of freedom of conscience than your average sociology department.

As to “ignoring entire fields of research,” and “task force[s] appear[ing] … stacked with people who had taken prior … views,” we can see this rot in the social sciences penetrating the hard sciences. The IPCC folks serve as a clear example.

Looting and Freedom

Whether political freedom or economic freedom is more important is a moot question.

The most basic property right is self-ownership. To the degree that right is compromised, so is freedom. A commenter at the linked article above noted this:

“I propose in the following discussion to call one’s own labor, and the equivalent exchange of one’s own labor for the labor of others, the ‘economic means’ for the satisfaction of needs, while the unrequited appropriation of the labor of others will be called the ‘political means’.”

   – Franz Oppenheimer, The State. New York: Free Life
      Editions, 1908 (1975), pp. 24-25

Beyond the unabashed wealth redistributionism of a Bernie Sanders, ‘unrequited appropriation of the labor of others’ includes all forms of rent-seeking: Regulation favoring entrenched business (from tariffs to requiring hair braiders to take hundreds of hours of training, to subsidies for solar panels, movies, art, mortgages, etc., etc., etc.); union shops; civil asset forfeiture and eminent domain; and zoning laws.

We may agree politically to give some portion of some of those freedoms to the State, but we will, by definition, be less free; and bureaucracies will always take more than is granted.

Principled resistance to the looting is a requirement of freedom.


Is free speech under assault on college campuses? Well, some people, including President Trump, think not.

Most of those skeptics promote a distinction between free speech and “hate speech,” a term Mr. Zuckerberg has yet to define for us; but he’s working on an AI to apply the definition he comes up with: Once all those messy linguistic, contextual, semantic issues humans can’t even deal with are programmed.

That is, he dreams of automating enforcement of Silicon Valley values conforming to regulation he’s requested from our technology-naive and Constitutionally slipshod Congressional placeholders. They’ll be looking to erect an emanating penumbra since: No, there’s no “hate speech” exception to the First Amendment. They have to help Mr. Zuckerberg add one.

We can look to George Orwell for insight into how that public/pirate partnership is likely to work out.

“The mind should develop a blind spot whenever a dangerous thought presented itself. The process should be automatic, instinctive. Crimestop, they called it in Newspeak.”
-George Orwell, 1984

A model is already apparent. Google fired James Damore for failure to crimestop. On campus, they’re calling it “self-censorship.”
The Skeptics Are Wrong Part 2: Speech Culture on Campus is Changing

Click to enlarge.

Very Liberal students care far less about giving offense than about being judged. That is, they worry more about tribal membership in-good-standing and find it implausible their opinions would offend anyone. A collectivist approach.

Conservative students are much more concerned about campus thought police than Liberal students. I would have liked to see them less concerned about giving offense to peers as an indication of individualism, but they know they are surrounded by a great number of people who easily take offense. And they are probably just more polite.

I’m sure you can infer other interesting theories yourself, but the result is not good for any of these students: The Stifling Uniformity of Literary Theory

One wonders whether the students that the academy is producing today could if asked to, provide the arguments of their ideological or political counterparts, without resort to crude caricature or ad hominem…What might a course look like if a race theorist such as Derrick Bell was studied alongside someone like Thomas Sowell? For about thirty years both Bell and Sowell were consistently among the top five most cited black scholars in American Academia according to The Journal of Blacks in Higher Education.12 However, as with so many prominent intellectuals, while Sowell is revered among classical liberals, libertarians and conservatives, he is practically unheard of on the left, despite his pioneering work on the economics of race and ethnicity.13 To borrow Jonathan Haidt’s phrase, liberal intellectuals are in danger of being ‘blind’ not only to the other side’s moral taste buds, but also to their most important thinkers.14

Here’s another post I think helps explain why Liberals don’t like free discussion of ideas. They mean well, but can’t be bothered to examine consequences in their quest to perfect the rest of us.


A very short history of US steel making after WWII.

How the U.S. Squandered Its Steel Superiority

In the early 50’s the Europeans were rebuilding their steel industry with new technology:

“The cost of building steel mills using the basic-oxygen furnaces was 40 to 50 percent lower than conventional open-hearth factories; operating costs were 25 percent lower, though some studies suggested even greater cost savings.

But it was the productivity gains associated with the new process that should have really raised eyebrows. One factory that made the shift could produce 40 tons of steel per hour using the open-hearth process, but after installing basic-oxygen equipment, it managed to quadruple that figure.

Unfortunately, Big Steel was too proud to notice Europe gaining ground. In a typical advertisement from the era, U.S. Steel claimed it was a company “where the big idea is innovation.” But this claim — much like so many of the braggadocios claims of today — could not hide a more disturbing reality.

Indeed, throughout the 1950s, as Europe’s steelmakers built new factories around the basic-oxygen process and simultaneously demolished its remaining open-hearth furnaces, Big Steel made endless excuses. Representatives of the Big Three — Bethlehem, U.S. Steel, and Republic — repeatedly claimed that the jury was out on the new method, all evidence to the contrary.”

And by the 60’s little mammals were nipping at the heels of the Big Steel dinosaurs. It’s quite ironic that one of the biggest corporatists now whining for protection is Nucor, whose success was profiled by Clayton Christensen in Innovator’s Dilemma (2011).

Nucor and others started out making re-bar, which is easy. Bethlehem, U.S. Steel, and Republic saw no money in re-bar, and let Nucor have the business. The upstarts climbed the market chain by recycling scrap steel (with “mini-mills,” which don’t use blast furnaces), and eventually achieved continuous strip steel casting; the high margin product. They ate Big Steel’s lunch.

“But there’s a final twist to this tale that highlights the absurdity of Trump’s strategy. In the 1960s, a man named Ken Iverson took over a conglomerate that acquired a stake in the steel business that became Nucor. Iverson then bet the firm’s future on making steel using the electric arc process, building the first American facility in 1969. It began growing at an exponential rate, competing rather effectively with foreign producers, to say nothing of other American producers.

As other steel producers begged for protectionist trade policy, Iverson mocked the idea. In an interview in 1986, Iverson noted that protectionist measures already instituted hadn’t had the desired effect. “As soon as prices began to rise so that the steel companies began to be profitable, they stopped modernizing,” he said. “It’s only under intense competitive pressure — both internally from the mini-mills, and externally from the Japanese and the Koreans — that the big steel companies have been forced to modernize.””

Nucor is now the largest US steel maker. They used to understand the definitions of innovation, capitalism and competition.

Lack of innovation and unwillingness to compete – sustained by protectionism – is what toppled the big guys from overwhelming superiority. Maybe if Reagan hadn’t ordered “voluntary restraint agreements” in 1984 to reduce steel imports, and Dubya hadn’t put steel tariffs in place in 2002, US steel companies would by now have had an epiphany.