Tag Archives: regulation

A Medical Man Demands Slow Approvals

Posted on by
Reply

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

Posted on by
Reply

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.

Personal Responsibility

Posted on by
Reply

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.

They Won’t Sign

Posted on by
Reply

The lede has it.

Major media outlets including the New York Times, the Washington Post, The Wall Street Journal, and CNN have said they won’t agree to a new Defense Department policy restricting journalists’ communication with military sources.
Those who don’t sign on to the new policy must forfeit their Pentagon press badges and won’t be issued new ones.

Among the restrictions being applied by DoD internally is

military personnel need approval before sharing information with the media, even if it isn’t classified. It says members of the media should be aware that agency “personnel may face adverse consequences for unauthorized disclosures.”

That should always have been the case. For far too long, there has been inconsistent, even contradictory, messaging coming out of DoD as a result of leaks, to say nothing of security failures in too many of those leaks. The journalism guild, of course, is spilling its collective ink pots over this.

The policy drew rebukes from press-rights organizations, which have highlighted the role journalists have played in revealing wasteful spending, conflicts of interest and misconduct.

This is self-serving and disingenuous. Pressmen should go back to doing original reporting instead of repeating each other’s rumors and printing leaked “information.” Pressmen surely understand—as the rest of us do—that leaks and their leakers are unreliable sources, and pressmen should rely instead on whistleblowers and other sources with the integrity of speaking on the record.

Their disingenuousness extends: the news outlets aren’t even being required to signify their agreement with the policy limiting DoD personnel’s interactions with the press; their signatures would merely indicate their understanding of the policy and the implications for DoD personnel.

News outlets don’t have an intrinsic right to wander the halls and poke into rooms in the Pentagon, nor do they have any need to do so, accosting any DoD personnel they happen on. Not even their self-proclaimed specialness gives them that.

It’s entirely appropriate, since the outlets won’t sign, to confine their writers to the various services’ public affairs offices, and it’s entirely appropriate to require all DoD personnel, military and civilian, who are encountered by a news writer, to refer those pressmen to the PAO and to refuse further interaction with the pressmen.

There are far too many leaks from government agencies, and those from DoD can have particularly dangerous national security implications. There are, also, far too many pressmen who don’t care a fig about national security, only about their personal bylines and notoriety.

Part of the Problem

Posted on by
Reply

The Department of Defense, first under the Biden administration, but continuing under the Trump administration, is having far too much trouble deploying “AI weapons,” even figuring out how to use those it has deployed. An illustration of this is this:

The Pentagon has also struggled to find software that can successfully control large numbers of drones, made by different companies, working in coordination to find and potentially strike a target—a key to making the Replicator vision work.

This isn’t so much a software commonality or interoperability problem as it is a problem with bureaucrats giving too much weight to the desires of contractors and their lobbyists, each of whom insist on their own proprietary software. What’s needed here isn’t more money (although sometimes that helps), it’s an operational officer, one fresh in from a combatant command that’s facing current conflicts, being put in charge of AI development and programs. This officer, independent of the lobbyists, needs to write a better requirements document, one that specifies the standards of commonality (not merely interoperability—this is software, not hardware) that each contractor and contractor wannabe must meet in order for their AI package to be considered.

Beyond that, this AI OIC must open his Requests for Proposals far beyond the major contractors and take in RFPs from small businesses and startups—that’s where the ideas and agility exist—then push the development and acquisition pace, eliminating the layers of bureaucrats’ reviews.

Finally, this AI OIC must be willing to spend money on mistakes and dead ends rather than demanding (near) perfection at one stage before moving on to the next.

That’s just the development side. The AI OIC also must have four or five teams of operational officers—again, fresh in from combatant commands—working on tactics and strategies that make use of the four or five leading AI weapons candidates to investigate best uses for integrating these weapons into a combatant command unit’s (at all levels) existing suite of weapons. That tactics and strategies development effort should also lead to adjustments in those units’ existing tactics and those commands’ existing strategies, even their existing suites of weapons.

There’re just too much bureaucracy and too little operational consideration in the currently extant DoD. SecDef is making progress on the bureaucracy qua bureaucracy, but he’s got a long way to go. It’s time for him to zero in on lethality.