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.

Federalism, not what it used to be

The President has tweeted:

“For the purpose of creating conflict and confusion, some in the Fake News Media are saying that it is the Governors decision to open up the states, not that of the President of the United States & the Federal Government. Let it be fully understood that this is incorrect. It is the decision of the President, and for many good reasons. With that being said, the Administration and I are working closely with the Governors, and this will continue. A decision by me, in conjunction with the Governors and input from others, will be made shortly!”

In “It is a decision of the President,” he is unequivocally, Constitutionally wrong.

However, have you checked how SCOTUS interprets the Commerce Clause since FDR?

Or, does anybody remember how we came to have a national 55 MPH speed limit?

Oil crisis? Federal road funding? Gas saving and lives saved predictions that were totally wrong?

In other words, the much of Federalism was blown up long ago. In practical terms, therefore, the President has a point.

The same point Hillsdale makes in refusing all Federal funds.

Update 1:02PM
Comment seen at Instapundit, “Trump is showing himself as a political genius here. He has found a way to get the democrats to defend federalism.

Chekists

Well before some functionary, with career advancement too much on his mind, decided I could be held criminally negligent for my sons’ use of seat belts and the precise dimensions of their car seats when they were under a certain arbitrary height and weight…

“I don’t want you to forget, or think of it as optional, because then you won’t have done it when it might matter. I want you to get to the point where I trust you to follow the rule, and I won’t have to check to see if you’ve done it. My job is to get you there.”

That’s how I explained to my sons, then 8 and 10, why they had to fasten their seat belts when we were only driving a couple of miles. Their response, and the cause of the glitch, “Mom doesn’t make us do that!”

“Well,” I said, “Mom and I agreed before that you should always do it, and she’s wrong if she lets you off. I just told you why she’s wrong.”

After a couple of dozen seconds sitting silently in the unmoving car, they complied. I didn’t have to remind them again after that, and soon stopped checking.

But what happens when some functionary applies that principle to free adults?

The FDA happens. They never stop checking. Checking is what they get paid for. So they constantly find new things to check and more ways to check the old things.

Bureaucrats aren’t concerned about YOUR welfare, they’re concerned about their own. Uncertainty is their friend – because, unlike an actual parent, they aren’t interested in having nothing to enforce.

It’s Time to Track the FDA’s Death Toll Emphasis mine:

The Food and Drug Administration helped turn the coronavirus from a deadly peril into a national catastrophe. Long after foreign nations had been ravaged and many cases had been detected in America, the FDA continued blocking private testing. The FDA continued forcing the nation’s most innovative firms to submit to its command-and-control approach notwithstanding the pandemic…

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.”…

The FDA’s stonewalling of new medical devices was sometimes politically motivated. A 1994 report by the Medical Device Manufacturers Association noted, “It is not unusual for [FDA] reviewers to express the position that excessive requests [for additional information] are made because of a concern or fear about how a particular member or members of Congress will react” to the approval of a new device. Sacrificing lives was a small price to pay for bureaucrats to avoid bothersome interrogatories from Capitol Hill…

[I]n 1991 Dr. Kessler prohibited pharmaceutical companies from informing doctors of new uses for approved drugs. He announced that the FDA would enforce the ban with seizures, injunctions, and prosecutions. Though the agency never finalized its proposed regulations, it warned companies that they would face its wrath if they violated the draft proposals. Dr. Kessler, in a speech before the Drug Information Association, said: “I would urge all members of the pharmaceutical industry to take a long and hard look at their promotional practices. I do not expect companies to wait until this guidance becomes final to put their advertising and promotional houses in order.” The question of off-label treatments is becoming a key issue again as doctors search for effective treatments for the COVID-19 coronavirus…

Dr. Kessler declared in 1992: “If members of our society were empowered to make their own decisions…then the whole rationale for the [FDA] would cease to exist.” Kessler derided “freedom of choice” as an illusion unless people are presented only with government-approved choices. But the FDA “liberated” people by shielding them from information, devices, and drugs that could have saved their lives.

How far removed from Constitutionality and actual legislation is a DRAFT proposal from a government agency managed by mandarins and staffed with non-elected officials?

The FDA’s mission is to protect the power of the FDA. Not your ignorant, childish ass.

RTWT

Also:

The COVID-19 Crisis Is the Result of Decades of FDA Misrule

The COVID-19 pandemic is exposing how the US Food and Drug Administration puts Americans at increased risk of sickness and death. Decades of killing medical innovation and forcing industries offshore made this inevitable.

The real debate should be over how best to downsize or abolish the FDA, which contributed greatly to the vulnerable state in which America now finds itself…

[T]hanks largely to its treatment in the media, many Americans have never imagined how the country might benefit from doing away with the bureaucracy. That may change now.

Imagine there’s no bureau
It’s easy if you try
No hell in freedom
Above us, an ally
Imagine all the people living for themselves

Emperors undressed

The Rise of the Ungovernables

2019 marks the thirtieth anniversary of Francis Fukuyama’s seminal essay for the National Interest “The End of History?” Its central hypothesis was that we were witnessing “the end point of mankind’s ideological evolution and the universalization of Western liberal democracy as the final form of human government.” That looked plausible in 1989, particularly when the Berlin Wall fell just months after the essay’s release. Thirty years later—not so much.

To be fair to Fukuyama, he never suggested that the world had seen the end of geopolitical conflict or that democracies would experience no more of Macmillan’s “events.” Today, he continues to view liberal democracy as the best form of government, but he is less optimistic about its robustness. It’s hard to disagree with him. The Brexit chaos, the Trump presidency, the collapse of support for centrist parties across Europe, and the pervasive rise of populism and nationalism, all point to the growing fragility of liberal democracy.

Why is this happening now? The usual response is to blame it all on the politicians. Leaders like Orban and Trump are subverting the institutions at the heart of liberal democracy. Political parties like Alternative für Deutschland and the National Rally are promoting illiberal and xenophobic policies. If only we had better leaders, democracy would flourish—so goes the argument.

That last sentence is exactly the same excuse Socialists and Communists use for state failures in the Soviet Union, Cuba, Venezuela, Cambodia, North Korea, et. al.. A majority of voters in this country agree with it, even as they are split on policy.

That last sentence describes the danger of the Imperial Presidency – something that connects Obama and Trump (they’re hardly alone, but it became an art form under their tender care).

That last sentence describes voters’ aspirations.  It explains Bernie Sanders, Ocasio-Cortez, and Donald Trump.  Not that they all share policy ideas, but that a sufficient number of voters see them as saviors.  This is a terrible way to think about public employees.

The Obamaists and the Trumpists both revere the Man, not the Law.  Their Emperor’s ideas are fully clothed in their own narcissism.

Read the whole article, it presents some good ideas about cultural changes contributing to the problem and the related role of social media.

Areopagitica Lost

The current state of the country and the current state of political and intellectual conversation depresses me in a way that it never has before. You have to understand — I’m never happy with the state of the country — that’s the inevitable fate of holding an ideological position that rarely gets any traction — I’m a classical liberal who’d like government to be dramatically smaller than it is now…

Maybe it’s paranoia but it’s been a long time since I felt the thinness of the veneer of civilization and our vulnerability to a sequence of events that might threaten not just the policy positions I might favor but the very existence of the American experiment.

The main way I’ve been dealing with this feeling of despair is to stop paying close attention. I don’t know what depresses me more — the stupidities and dishonesty and tolerance of darkness that come out of the President’s mouth or the response from those that oppose him. Given that I don’t like the President, you’d think I find the response of his enemies inspiring or important. But the responses scare me too, the naked hatred of Trump or anyone who supports or likes him. And of course, it goes way beyond Trump and politics. The same level of vitriol and anger and unreason is happening on college campuses and at the dinner table when families gather to talk about the hot-button issues of the day. Everything seems magnified.

Read the whole thing, it’s very good. Russ Roberts: The World Turned Upside Down (and what to do about it)

I agree 100% with Roberts’ intro, it feels like he wrote for me. He doesn’t mention some things that cause my angst, why “it’s different this time,” but I think he’d agree with them.

I suppose I shouldn’t be, but I’m surprised at the durability of the vehement response to Donald Trump. I get that Progressives are angry and depressed, but it’s hard for me to imagine they’re more angry and depressed than I was at Barack Obama’s re-election. That was a very dark day and an excruciating 4 more years. You can examine this blog for my criticisms of Barack Obama, but you’ll find nothing like what we hear daily from CNN, MSNBC, or (?) ESPN, or from the hegemony of far left celebrity Twitterers.

I’m not surprised, but I am disappointed at the contrast in the treatment of Antifa with that of the tea party. When the tea party left one of its demonstration sites, the area was cleaner than when they arrived. No fires, little to no profanity, no smashed windows, no beaten Obama supporters. Still, the tea party people were vilified by the media and Democrats, including the charges of racism and Nazism they’ve raised lately to screaming rants. It’s not just free speech, but freedom of assembly, freedom of religion and petitioning for redress of grievances that is under attack – with the implicit support of the very press who wish to preserve their First Amendment right. Apparently, as the only remaining First Amendment right.

When Donald Trump appointee Betsy DeVos comes out in favor of due process, it’s a sexist apocalypse. When Trump rejects the Paris Climate Accord, “we’re all gonna die!” When he removes a few draconian regulations, we can see the Four Horses on the horizon. When Trump turns responsibility for Obama’s unconstitutional DACA executive order over to Congress, it’s Nazism, racism, white supremacism, patriarchal and traitorous. Dial it back people. But they can’t.

Back to Russ Roberts. Given the above, his prescription:

1-Don’t be part of the positive feedback problem. When someone yells at you on the internet or in an email or across the dinner table, turn the volume down rather than up. Don’t respond in kind to the troll. Stay calm. It’s not as much fun as yelling or humiliating your opponent with a clever insult, but it’s not worth it. It takes a toll on you and it’s bad for the state of debate. And you might actually change someone’s mind.

2-Be humble. Shakespeare had it right: There are more things in heaven and earth than are dreamt of in your philosophy. You’re inevitably a cherry-picker, ignoring the facts and evidence that might challenge the certainty of your views. The world is a complex place. Truth is elusive. Don’t be so confident. You shouldn’t be.

3-Imagine the possibility not just that you are wrong, but that the person you disagree with could be right. Try to imagine the best version of their views and not the straw man your side is constantly portraying. Imagine that it is possible that there is some virtue on the other side. We are all human beings, flawed, a mix of good and bad.

…suffers from the fact that the center and the right have been more polite and civil than the left for decades – and see where that’s gotten us.

Donald Trump is crass, undisciplined and devoid of principle; but it is primarily the exquisite sensibilities of the intersectionality cadre who blame America for every evil that make his actual content inflammatory. They say they can identify “dog whistles” in Trump’s rhetoric, forgetting that it’s only the dog who can hear the whistle.

Is Trump complicit in this? Certainly. His comments on Mexican illegal immigrants are similar to this:

“You cannot go to a 7-11 or Dunkin Donuts unless you have a slight Indian Accent.”
“I mean you’ve got the first sort of mainstream African-American who is articulate and bright and clean and nice-looking guy.”
-Joe Biden

…but “that’s just Joe.” Still, Trump’s a piker compared to the rest of Democrat leadership:

“Republicans… [would] rather take pictures with black children than feed them.”
-Donna Brazile

“I’ll have those n*ggers voting Democratic for the next 200 years.”
-Lyndon Johnson

“[T]ypical white people,”
“clinging to their guns and religion.”
-Barack Obama

“basket of deplorables”
“You f*cking Jew b@stard.”
-Hillary Clinton

Those aren’t distant historical examples, which would be far worse (Woodrow Wilson, for example, the Progressives’ Progressive). Those aren’t dog whistles, they’re fog horns; but, on the left, nobody’s knickers got twisted. That rhetoric is how we got Trump.

As far as the hoi polloi are concerned, on one side of protest demonstrations we see a marginalized group promoting white supremacy, who have with very few exceptions been non-violent except in self defense. On the other, we see a larger group, promoting black supremacy, that uses violence regularly and indiscriminately. Criticizing the latter group either brings charges of being a “Nazi sympathizer” from mainstream Democrats, or silence, as classical liberals attempting to exercise freedom of speech are under physical attack at our nation’s universities; in collusion with university administrators and local governments who order police to “stand down.”

Which group is actually a threat to freedom? The group trying to use their right to free speech, or the group routinely using violence to shut down free speech?

I’m reminded of this passage from Alan Bloom’s (1987) The Closing of the American Mind: “I have seen young people, and older people too, who are good democratic liberals, lovers of peace and gentleness, struck dumb with admiration for individuals threatening or using the most terrible violence for the slightest and tawdriest of reasons. They have a sneaking suspicion that they are face to face with men of real commitment, which they themselves lack. And commitment, not truth, is believed to be what counts.

Bloom is writing about people avoiding the messy distractions of understanding their own ‘ideas,’ because “[C]commitment, not truth, is believed to be what counts.” Their rhetoric is excused by their commitment to no more than having unexamined good intentions.

Ronald Reagan had sub-human intelligence. Barry Goldwater was called a Nazi 50 years ago. The KKK is blamed on Republicans when, in fact, it was the action arm of the Democrats. Similarly, racial discrimination by the State: It was, in fact, outright eugenicists and open racists like Woodrow Wilson who reversed integration in the civil service. Even the far left editors at Vox admit this.

Culturally, we’re debating whether your biological sex is dispositive regarding bathroom facilities, while the left insists that any discussion of differences between men and women is absolutely not allowed. Facebook gave up when the number of “gender” choice check boxes available in your profile reached 58, but men and women are indistinguishable.

If you write a polite, scientifically factual memo questioning Google’s discriminatory hiring practices, you get fired. Meanwhile, Google downranks results from websites not fitting their political views.

Meanwhile, we waste blood and treasure half-heartedly defending poppy farmers in Afghanistan, because “homeland security,” while the territory you can visit in Europe is continually eroded by “no-go” zones and our courts plunk down on the side of unrestricted immigration.

And now I’m back to agreeing with the author’s intro, but you can’t remain silent in order to get along. That’s a complete oversimplification of Roberts’ advice, but it’s hard to remember that when some antifa thug is spraying spittle.

This is how you get more Trump. If that isn’t depressing, what is? Well, the thought of Hillary as President may be one thing.