Category Archives: culture

A Medical Man Demands Slow Approvals

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In his letter to The Wall Street Journal‘s Letters section, Todd Lorenz, a Stanford University employee degreed as a Medical Doctor, pushed for FDA to continue to pass on the efficacy of a new drug as a condition for approving it, never minding that that would drastically slow approval and subsequent availability.

There is no way to know for certain if drugs work without doing efficacy studies in humans. Preclinical and animal studies, while helpful, can’t predict with confidence which drugs will be useful. Most investigational cancer drugs that go into the clinic have been shown to work in animal models. Most don’t work in patients.

In a truly competitive free market, those that don’t work won’t stay in the market for long. Delaying approval until efficacy can be “proven,” though, denies cancer patients access to those drugs that do work, unnecessarily—unconscionably—risking their lives. Lorenz closed with this:

The answer, then, is to approve drugs after they’ve been demonstrated to be safe. Yet no drug is completely safe; some can lead to substantial adverse reactions. It may be acceptable to prescribe drugs with such profiles if the diseases they are intended to treat are serious enough to warrant the risk. The choice to use any drug in a particular patient always depends on such a cost-benefit analysis. Without an objective assessment of efficacy, no such determination is possible.

No drug is ever completely efficacious, either. Even so, Lorenz contradicted his call for a cost-benefit analysis with that repeated demand for an objective assessment of efficacy. He ignores the simple fact that that cost-benefit analysis is best done—is most effectively done—by the patient and his doctor, not by Government. The benefits and costs of a particular drug treatment can only be assessed empirically by those two critical analyzers acting in a medical drug market that is competitively fed by safe drugs. Those empirically collected use and outcome data will determine efficacy, and they will do so far faster and far more thoroughly than can a government agency populated by bureaucrats who happen to have medical degrees of one sort or another, and who hold out for repeated trials with sample sizes that are miniscule relative to the target population, even if those sample sizes argued to be statistically significant.

UCLA Emeritus Professor James Meyer, also the proud possessor of a degree as a Medical Doctor, complemented Lorenz with his own non sequitur.

Messrs Hooper and Steiner [Deregulation Can Make Medications Cheaper] argue that the cost of new drugs could be greatly reduced if the FDA focused only on their safety. Maybe so. But this overlooks that the federal government has had a major and increasing interest in efficacy since the passage of Medicare (1965), the growing responsibility for veteran care since the Vietnam War (1965) and the passage of ObamaCare (2010).

You bet it does. Those agencies have burgeoning populations of bureaucrats to keep employed and to keep expanding. Never mind that bit about denying access to safe drugs by those who need them until a collection of bureaucrats gets around to approving “efficacy.”

A Solid Proposal

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John Early, of the Cato Institute and ex-Assistant Commissioner of the Bureau of Labor Statistics (two times), has a thought on how to further remove unconstitutional race considerations from Federal government tolerance and behavior. Expanding on Chief Justice John Roberts’s observation that “the way to stop discrimination on the basis of race is to stop discriminating on the basis of race[,]” he offers this:

One simple way that the Trump administration can promote these objectives is by revising the Office of Management and Budget’s Statistical Policy Directive 15, which specifies the kind of data on race and ethnicity government agencies must collect. The current directive is unconstitutional, discriminatory, and scientifically unsound.
If OMB revised the directive to prohibit the collection of racial data, it would make it more difficult for regulators and attorneys to devise schemes for government to discriminate by race.

He’s mostly right on this. There is no need for the Federal government to collect race or ethnicity data under a couple of axes. One is that it’s barred by the 14th Amendment, which requires all of us to be treated equally under law. That makes race irrelevant. The other axis is that we’re all American citizens—see that 14th Amendment, again. We’re all the same in every way that matters to law.

There is, thus, no need for the Federal government to collect any data on persons present in our nation beyond the number of American citizens and the number of non-citizens actually present. I’d break that last into two categories, but not doing so wouldn’t be a deal breaker: the number of resident aliens and the number of illegal aliens. That last subcategory would, of necessity, be a guess, but DHS and Interior have the resources with which to make reasonably educated guesses.

“Mostly right:” there’s little need to collect ethnicity data either: the ethnicity of us American citizens is American. Full stop. There might be interest in collecting ethnicity data regarding non-citizens present in our nation, but that centers mostly on the illegal aliens so we know the first option regarding where to deport them. Ethnicity data regarding these, though, can be identified as the illegal aliens are caught; there’s no real need to collect the data as a matter of course.

Education Parity

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There are two paths for achieving some sort of “parity” in education. One path is through pushing for equality of opportunity. This path is exemplified by New York City’s gifted and talented programs that identify gifted children before they reach school age and try to funnel them into educational programs that are tailored to enhance their giftedness and encourage them to learn more and faster—to excel. This is a reflection of Theodore Roosevelt’s each man shall be guaranteed the opportunity to show the best that there is in him. Roosevelt was speaking economically, but the guarantee applies just as surely to education systems. That equality of opportunity makes each person—each student—equally capable of reaching his full potential, however large or small that might be from student to student.

The other path for education parity—it really is binary—is to push for—parity—in educational outcomes. This is the path Progressive-Democratic Party New York City Mayoral candidate Zohran Mamdani espouses. Mamdani promises to eliminate the city’s gifted and talented program under the fiction that children will benefit more from experiencing the breadth of ability in their peers than they will be harmed from being held back to the pace of their peers. Mamdani’s claim extends to insisting that the gifted children will, in the end, be unharmed from being restrained.

Oh, sure, Mamdani gussies up his move:

Mr Mamdani argues that New York City’s gifted programs have produced racially inequitable outcomes, and therefore all students should remain in the same classrooms, regardless of ability.

This is a Mamdani paraphrasing Woodrow Wilson: [removing gifted and talented programs] is not a humiliation but a benefit, and ought to be so regarded by you [parents]. This is deeply insulting to those parents and to their children. This is Mamdani saying in so many words that black children and brown children are intrinsically inferior to white children and Asian children, they cannot hope to compete in school, and so they must get the protections of holding back the white and Asian children.

It’s inconceivable to Mamdani and his fellow Progressive-Democrats that blacks and browns could easily compete did they have the same access to opportunity as their white and Asian fellow children.

“Stable Climate”

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Alex Flint and Kalee Kreider, posing as pro-climate adapters rather than as climate mitigators, want us to move toward adapting to our changing climate rather than attempting to mitigate our climate’s changes. That would seem to be a step in the right direction.

However.

Around the world, people are giving priority to higher living standards, economic security, and access to affordable energy above a stable climate.

This is a false dichotomy, leading to their false premise. In truth, we do have a stable climate—stable over human-level time frames—and we have it in conjunction with the potential for higher living standards, economic security, and access to affordable energy. These are not mutually exclusive.

For one thing, the plain fact is that our climate is stable over generations of humans, and that flows from the equally plain geologic fact that our climate is warming predictably, if noisily over thousands- to multi-million year cycles.

Since the end of the last glaciation, some 11,000 years ago, our climate has varied over narrow temperature ranges from the warming period that roughly coincides with the rise of human civilization and persisted into the period of the Roman empire to the Little Ice Age that ran from the early 14th century into the early 19th century. That variability, too, leaves us today still a couple degrees cooler than the geologic warming rate of our planet.

The other thing is that geologic warming rate. Our climate has been warming since the earth formed and stabilized as a solid body because our sun has been warming since it coalesced gravitationally and lit off its core fusion furnace. That warming is governed cyclically by our planet’s not quite circular orbit around the sun, which moves us closer and farther from the sun—not by much but by measurable temperature effects—on a cycle that harmonizes with our planet’s rotational axis precession, a cycle that points our norther hemisphere toward our sun in some seasons and away from our sun in the six months later seasons, a precession that points our northern hemisphere toward the sun in summer, roughly 6,500 years later has our northern hemisphere pointing away from the sun in summer, then after another 6,500 years points it back toward the sun in summer again for a complete cycle of about 13,000 years. That precessional cycle harmonizes with our orbit’s behavior over some hundreds of thousands of years.

Around that lockstep cycling, our climate varies noisily from the presence of an atmosphere that maintains a more stable temperature across days and months—and centuries—while being intermittently impacted by volcanism and meteor strikes. The outcome of those orbital and rotational mechanics and the interactions of volcanism and meteor strikes has produced the geological record of epochs much warmer and colder than today with life being lush in the warm periods, along with epochs of atmospheric CO2 being much higher and much lower than today, with life being lush in both higher and lower CO2 epochs—life has been lush when it was warmer independently of CO2 concentrations with no correlation between the CO2 epochs and the warmer and cooler epochs.

Mitigation always has been a scam to draw Federal funding for pet research projects.

Even though this op-ed’s excuse for shifting to adaptation comes from that false premise, it’s still a welcome step toward economic prosperity and sanity.

Personal Responsibility

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This is a core tenet of our federal republican democracy—the concept that us American citizens are the ones primarily—and most often solely—responsible for the outcomes of our decisions and our actions. This is a tenet that applies just as firmly in our fundamentally capitalist economy to our businesses. In particular, for this post, it applies to our banks, large, small, and in between.

Or, it should apply. Dangerously, our banks, particularly our small and mid-sized banks, would be relieved of that responsibility under legislation that Tennessee Republican Senator Bill Hagerty, who should know better, and Maryland’s Progressive-Democrat Senator Angela Alsobrooks, who is merely acting on her party’s big and bigger government bent, are proposing. That legislation would raise the FDIC’s deposit guarantee from $250,000 per depositor’s account to $10 million.

The editors of The Wall Street Journal have the right of it on this one.

The truth is that a higher insurance limit will increase moral hazard and make the banking system less sound, which will hurt all Americans.

Because

It would also encourage more risk-taking since banks will have to worry less about runs.

Massachusetts’ Progressive-Democrat Senator Elizabeth Warren as recently as 2023:

We have to do this because these banks are under-regulated, and if we lift the cap, we are requiring—or relying even more heavily on the regulators to do their jobs.

Here is the monarchist Party’s purpose revealed and now pushed by Alsobrooks: an ever more intrusive and controlling central government.

The proposed legislation is an idea whose time never will be, and the proposed legislation needs to be scotched in committee, if not before.