Category: Entrepreneurship

Alternatives to Government F.D.A.: Private “High-Quality Third-Party Seals of Approval”

The many label inaccuracies found in the “2022 study” (Crawford et al. 2022) mentioned below would seem to bode ill for the supplement consumer. But if you look at the “new study” you will find that NONE of the 30 supplements they examined had “a third-party certification seal.” This leaves open the plausible possibility that prudent consumers could do well for themselves by limiting their supplement purchases to those with a private third-party certification seal. It would be very useful if someone does another study–this one to confirm or refute my hypothesis that supplements with third-party certification seals had many fewer label inaccuracies. Confirmation would be evidence that the consumer could do well without the F.D.A.’s governmental regulatory mandates.

The relevant quotation from the “2022 study” (Crawford et al. 2022) is:

“No product had a third-party certification seal (ie, naming the third-party company), such as BSCG (Banned Substances Control Group), NSF (National Sanitation Foundation)International, Informed Sport, or USP (US Pharmacopeia), presented on the label” (Crawford et al. 2022, pp. 3 & 5 [all of p. 4 was a table]).”

(p. D7) Supplements claiming to support immunity often contain vitamins and minerals necessary for the immune system. So it isn’t unreasonable to believe that these products could help you sidestep common viral infections or lessen symptoms once you’ve become sick.

In fact, some nutrients such as vitamins A, C, D and zinc are needed to protect against germs, and deficiencies in them raise your risk of becoming sick, said Dr. Mahtab Jafari, a professor of pharmaceutical sciences at the University of California, Irvine.

. . .

It’s hard to firmly state the benefits of immune system supplements because there are few high-quality randomized clinical trials, the gold standard of medical research, assessing their effectiveness, said Dr. Pieter Cohen, an associate professor at Harvard Medical School who studies dietary supplement safety.

And dietary supplements aren’t approved by the Food and Drug Administration before hitting the market.

This means companies can sell products containing ingredients that haven’t been rigorously tested to offer benefits, Dr. Cohen said, and they generally don’t have to prove to the F.D.A. that their products contain what they claim.

A 2022 study analyzing 30 supplements marketed to support the immune system found that more than half had inaccurate labels, 13 were misbranded and nine contained ingredients not listed on the label.

. . .

“You need to have a really healthy dose of skepticism when you’re pulling something off the shelf,” Dr. Ben-Aderet said.

But if you want to give supplements a try, check for high-quality third-party seals of approval from organizations such as U.S. Pharmacopeia or NSF, which test the quality of dietary supplements, Dr. Jafari said.

For the full story see:

Katie Mogg. “Supplements and Claims of Improved Immunity.” The New York Times (Tuesday, February 25, 2025): D7.

(Note: ellipses added.)

(Note: the online version of the story was updated March 3, 2025, and has the title “Can Vitamin C and Zinc Actually Boost Your Immune System?”)

The “2022 study” mentioned above is:

Crawford, Cindy, Bharathi Avula, Andrea T. Lindsey, Abraham Walter, Kumar Katragunta, Ikhlas A. Khan, and Patricia A. Deuster. “Analysis of Select Dietary Supplement Products Marketed to Support or Boost the Immune System.” JAMA Network Open 5, no. 8 (2022): e2226040-e40.

Signed Anti-Tariff Declaration and Would LIKE to Sign PRO-Deregulation and PRO-Government-Downsizing Declarations

My friend Tom Chappelear posted a response to my posting, and I responded:

You may be right, but I am inclined otherwise. How much of the off-shoring is due to other countries’ protectionist policies, and how much is due to the U.S. over-regulating manufacturing, so that labor is cheaper and more flexible abroad? I disagree with Oren Cass’s support for protectionism and industrial policy, but I found his chapter on environmental regulations eye-opening. Ever-more-onerous environmental regulations don’t do anything to make the air and water healthier, but do a lot to make manufacturing in the U.S. more expensive and less nimbly adaptive. Our labor regulations also make it much harder for U.S. entrepreneurs to hire U.S. laborers, and to deploy them in innovative ways.

Breakthrough Innovations Often Reach Success Through Incremental Improvements

After 130 days, the patient with the longest (so far) transplant of a pig kidney decided to have the transplant “explanted” and return to dialysis. Her surgeon explained that this should not be viewed as a failure of the basic innovation. The patient had the option to continue improvisations to keep the pig kidney alive, but decided that for her the risks had become too high.

The surgeon, Dr. Robert Montgomery said:

“All this takes time,” he said. “This game is going to be won by incremental improvements, singles and doubles, not trying to swing for the fences and get a home run.” (p. A24)

The pig kidney transplants follow the pattern of many other medical innovations, where on-the-fly adjustments, when the protocol allows them, lead to longer duration successes with fewer side effects. Emil Freireich found this with his chemo cocktails for childhood leukemia. Early human heart transplants also followed this pattern.

We should not allow early setbacks to push us to overregulate the incremental progress that can eventually leads to success.

My source is:

Roni Caryn Rabin. “Pig Kidney Is Removed From an Alabama Woman After Organ Is Rejected.” The New York Times (Sat., April 12, 2025): A24.

(Note: the online version of the article has the date April 11, 2025, and has the title “Pig Kidney Removed From Alabama Woman After Organ Rejection.”)

How a Progressive, About to Pretend to Be a Conservative, Dropped the Pretense

How does a person totally change from one viewpoint to a totally different viewpoint? A thought-provoking case study was presented in a full page article in The New York Times.

In 2020 Xaviaer DuRousseau was a black progressive scheduled to appear on “The Circle,” a Netflix reality contest show in which his role was to sometimes attempt to fool the other participants into thinking that he was a conservative. To prepare himself to effectively deceive, he started studying conservative popular media, including the video clips of PragerU and of black social media pundit Candace Owens.

As he worked through the arguments he planned to make as a faux conservative on “The Circle,” he gradually realized that he was more and more agreeing with them, and eventually could no longer honestly be a “faux” conservative. So DuRousseau dropped the “faux” and resigned from the Netflix show.

Now Xaviaer DuRousseau is a full-fledged conservative, himself making popular videos for PragerU.

A surprising story in a surprising venue.

The full-page article in The New York Times is:

Kellen Browning and Mark Abramson. “How a Black Progressive Became a Conservative Star.” The New York Times (Thurs., April 10, 2025): A12.

(Note: the online version of the article was updated April 3, 2025, and has the title “How a Black Progressive Transformed Into a Conservative Star.”)

Both Homocysteine and Cholesterol Are Actionable Causes of Atherosclerosis

Alan Donagan taught a thought-provoking graduate course on Action Theory when I was a philosophy student at the University of Chicago in the mid to late 1970s. Some of the course related to how we think about causes in the social sciences and in policy debates.

Often we seek THE cause of what we want (or what we want to avoid). But most results have multiple causes. Which cause is most important, and so to some appears to be THE cause, depends largely on which cause is most easily actionable, which can change based on our knowledge or our constraints.

The obituary passages quoted below tell the sad story of how Kilmer McCully found that an amino acid called homocysteine was one cause of atherosclerosis, a cause that was actionable (could be countered) by eating foods containing various of the B vitamins. Kilmer’s career was canceled by powerful academics committed to the dominant view that cholesterol was THE cause of atherosclerosis.

McCully’s Harvard lab was moved to the basement, and eventually he was pressured out of Harvard.

Later studies, including the large, influential, and continuing Framingham study, eventually vindicated McCully’s claim.

We know the wrongly-cancelled pay a price for deviating from the dominant view. But how often do the cancellers pay a price for wrongly cancelling?

(p. B6) Kilmer S. McCully, a pathologist at Harvard Medical School in the 1960s and ’70s whose colleagues banished him to the basement for insisting — correctly, it turned out — that homocysteine, an amino acid, was being overlooked as a possible risk factor for heart disease, died on Feb. 21 [2025] at his home in Winchester, Mass. He was 91.

. . .

Dr. McCully didn’t think cholesterol should be ignored, but he thought it was malpractice to disregard the significance of homocysteine. His bosses at Harvard disagreed. First, they moved his lab below ground; then they told him to leave. He struggled to find work for years.

. . .

Presenting the case of homocystinuria in a 9-year-old girl, doctors mentioned that her uncle had died from a stroke in the 1930s, when he was 8 and had the same disease. “How could an eight-year-old have died the way old people do?” Dr. McCully wrote, with his daughter, in “The Heart Revolution” (1999).

When Dr. McCully tracked down the autopsy report and tissue samples, he was astounded: The boy had hardened arteries, but there was no cholesterol or fat in the plaque buildup. A few months later, he learned about a baby boy with homocystinuria who had recently died. He also had hardened arteries.

“I barely slept for two weeks,” he wrote.

In 1969, Dr. McCully published a paper about the cases in The American Journal of Pathology. The next year, in the same journal, he described what happened after he injected rabbits with high doses of homocysteine. “The aortas of all 13 of the animals injected with homocysteine were moderately thickened,” he wrote, “compared to the controls.”

. . .

The medical profession responded with “stony silence,” Dr. McCully told The Times.  . . .

. . .

“I felt for him, and I admired him,” J. David Spence, a professor emeritus at the University of Western Ontario who studies homocysteine, said in an interview. “He was neglected more than he ought to have been. It was sad.”

That began to change in the early 1990s, when large-scale, long-term studies of the risks for heart disease revealed that Dr. McCully had, in fact, been heading down the right path when Harvard relegated him to the basement.

. . .

As a teenager, Kilmer was enthralled by “Microbe Hunters,” Paul de Kruif’s 1926 book about Pasteur, Walter Reed, Robert Koch and others who investigated infectious diseases. He knew almost immediately that he wanted to become a scientist.

. . .

At a medical school reunion in 1999, his classmates presented him with a silver platter.

It was inscribed, “To Kim McCully, who saw the truth before the rest of us, indeed before the rest of medicine, and who would not be turned aside.”

For the full obituary see:

Michael S. Rosenwald. “Kilmer S. McCully Is Dead at 91; Fueled Debate on Heart Disease.” The New York Times (Monday, March 24, 2025): B6.

(Note: ellipses, and bracketed date, added.)

(Note: the online version of the obituary has the date March 21, 2025, and has the title “Kilmer McCully, 91, Dies; Pathologist Vindicated on Heart Disease Theory.”)

The book by McCully and his daughter, mentioned above, is:

McCully, Kilmer, and Martha McCully. Heart Revolution: The Vitamin B Breakthrough That Lowers Homocysteine Levels, Cuts Your Risk of Heart Disease, and Protects Your Health. New York: HarperCollins Publishers, 1999.

The book that inspired a teenage McCully to become a scientist is:

Kruif, Paul de. Microbe Hunters. New York: Harcourt, Brace and Company, 1926.

Hackman Was the Inspiring Hero of The Poseidon Adventure

I was surprised to see a commentary on Gene Hackman by Ben Stiller, so I started reading. He wrote that one Hackman film had mattered to him a lot.
I doubted that we liked the same film, but I read on, feeling a bit of hope and suspense. I admit I felt a tingle of triumph when I read that we both liked the same film–The Poseidon Adventure.

Stiller said that at age 7 he watched it in the theatre about 10 times. I don’t remember if I ever saw it in the theatre, but I have watched it more than once and I think about it fairly often. What I think about is what the passengers do when the ship is flipped over by a mammoth wave. Almost all of the surviving passengers start hobbling toward the top deck of the ship, hoping for rescue. But the small band of misfits who had been sitting at Reverend Gene Hackman’s table, plus the cruise singer, are convinced by Hackman that the only hope for rescue is to go in the opposite direction, because the hull is now the highest point of the ship.

He convinces them and he leads them in the right direction. At a key moment he acts to save them. The movie had hope in the face of disaster, perseverance paying off, courage when almost everyone else is going in the wrong direction.

Stiller says that the movie, and Hackman’s character in it, inspired him to want to be an actor. When Stiller acted as Hackman’s son in The Royal Tenenbaums, he finally worked up the courage to tell Hackman how much Hackman’s performance in The Poseidon Adventure had meant to him. Hackman smiled at him and simply said “money job.” Then Hackman got up when they called for them to shoot their last scene together. Stiller stayed sitting for several seconds, seeming stunned. In their scene Stiller tells Hackman that he has gone through a lot recently. Hackman looks at him with great empathy, puts a hand reassuringly on his neck and says “I know.” He says it was the same sincerity that he saw in Hackman’s performance in The Poseidon Adventure, and he doesn’t think it was a money job.

Just now I watched a YouTube interview of Hackman by Johnny Carson on the filming of The Poseidon Adventure. Hackman has a modesty to him, and a sense of humor. He talks about the filming being fun, but also talks of being disappointed that they cut a scene in which he did a difficult stunt. He could have just let the stuntman do it, but he chose to do it. When he was doing the movie he took it seriously.
My take is that as a modest man, when he said “money job” he might have been deflating the awkward intensity of what Stiller had told him, and it might not have been the whole truth.

For Stiller’s full commentary see:

Ben Stiller. “Gene Hackman’s Simple Truth.” The New York Times (Sat., March 1, 2025): A19.

(Note: the online version of the commentary has the date Feb. 28, 2025, and has the title “Ben Stiller on Gene Hackman’s Simple Truth.”)

Global Warming Allows German Wine Entrepreneurs to Grow a “Superb” Chardonnay

In my Openness book, I argue that the costs of global warming have been exaggerated, partly because environmentalists forget that entrepreneurs can adapt, either lessening the costs, or sometimes even creating benefits. A case of creating benefits is apparently now the growing of “superb” chardonnay wine in Germany:

(p. D4) What accounts for the arrival of . . . German chardonnays? Certain wine regions like Rheinhessen, the Pfalz and the Obermosel have limestone soils, which chardonnay has a special affinity for, but the warming climate has made it possible to ripen chardonnay sufficiently to make superb wines.

Climate change influenced decisions to plant chardonnay in other ways as well.

“Climate change for us does not just mean it’s getting warmer and warmer, it means everything is getting more extreme — frost risk, weeks without rain, hailstorms,” said Klaus Peter Keller, . . . . “Therefore, we must spread the risk a bit more than we would 30 or 40 years ago. Rather than 100 percent riesling we have now 70 percent riesling, 15 percent pinot noir, 10 percent chardonnay and 4 percent others, and we think that will be the structure for the coming 30 or 40 years.”

Mr. Keller said he had wanted to plant pinot blanc rather than chardonnay but that their son Felix had pushed for chardonnay.

“Felix was right,” he said. “Chardonnay is much better adapted to climate change, with thicker skins, and it transmits the soil much better than pinot blanc.”

Felix Keller said by email that his grandfather had tried planting chardonnay in 1988, but that the timing had been wrong.

“Back then, it didn’t ripen every year,” he said. “It took us until 2018 to try again. We believe chardonnay has a bright future in Germany because we now have the climate that used to be in Burgundy in the early ’90s.”

For the full commentary see:

Eric Asimov. “The Pour; A Surprise From Germany: Chardonnay.” The New York Times (Weds., March 5, 2025): D1 & D4.

(Note: ellipses added.)

(Note: the online version of the commentary was updated March 4, 2025, and has the same title as the print version.)

My book mentioned in my initial comments is:

Diamond, Arthur M., Jr. Openness to Creative Destruction: Sustaining Innovative Dynamism. New York: Oxford University Press, 2019.

Innovative Entrepreneur Bill Gates Believes He Is “on the Autism Spectrum”

In my “Openness” book I argue and present some evidence that toleration for those who think different, including those on the Autism spectrum, will allow more innovative entrepreneurs to flourish, bringing benefits to us all. In the first volume of his autobiography, innovative entrepreneur Bill Gates speculates that he is on the Autism spectrum.

(p. A17) Mr. Gates was, he says, a “happy boy,” according to family lore. He had a wide grin, excess energy and a tendency to rock his body when he was deep in thought. Mr. Gates speculates that today he “probably would be diagnosed on the autism spectrum.”

For the full review see:

David A. Shaywitz. “Bookshelf; A Life of DOS And Don’ts.” The Wall Street Journal (Tuesday, Feb. 4, 2025): A17.

(Note: the online version of the review has the date February 3, 2025, and has the title “Bookshelf; ‘Source Code’: A Life of DOS and Don’ts.”)

The first volume of Bill Gates’s autobiography is:

Gates, Bill. Source Code: My Beginnings. New York: Alfred A. Knopf, 2025.

My book, that I mention in my opening comments, is:

Diamond, Arthur M., Jr. Openness to Creative Destruction: Sustaining Innovative Dynamism. New York: Oxford University Press, 2019.

Nvidia Entrepreneur’s Work-Life Imbalance: Ferocious Hard Work

(p. A15) Mr. Kim’s book is nothing like Walter Isaacson’s portraits of tech geniuses Steve Jobs or Elon Musk. It is more prosaic, focusing on the technical and human ground war of building a company. Even so, there is drama in Nvidia’s remarkable rise, and Mr. Kim’s reporting offers plenty of incident and portraiture.

. . .

As a teenager, we are told, Mr. Huang was a formidable table-tennis player and earned money by cleaning tables and bathrooms at a local Denny’s, a toughening experience that prepared him for life as a tech CEO. As a business sage, Mr. Huang says that work is simply perseverance in the face of difficult odds and that character is the source of greatness. Asked how to be successful, he will respond: “I wish upon you ample doses of pain and suffering.”

. . .

By . . . -the late 1990s—Mr. Huang had figured out a particular way of building and managing his company. The bedrock precept was ferociously hard work. New employees were told that the culture was “ultra-aggressive.” Mr. Huang demanded that they work at the “speed of light,” constrained (as Mr. Kim puts it) “only by the laws of physics—not by internal politics or financial concerns.”

. . .

Does all of this success make Mr. Huang happy? Apparently not. After one especially successful quarter, he began a review meeting by saying: “I look in the mirror every morning and say, ‘you suck.’ ” He still enjoys publicly dressing down employees, saying that humiliation is a small price to pay for group learning. He believes that he can “torture” his people “into greatness.” When employees begin to ramble in his presence, he will start to murmur “LUA,” a warning to the speaker. The abbreviation means: “Listen to the question. Understand the question. Answer the Question.”

For the full review see:

Philip Delves Broughton. “Bookshelf; The Hard Work Of Tech Mastery.” The Wall Street Journal (Monday, Dec. 16, 2024): A15.

(Note: ellipses added.)

(Note: the online version of the review has the date December 15, 2024, and has the title “Bookshelf; The Nvidia Way’: The Hard Work of Tech Mastery.”)

The book under review is:

Kim, Tae. The Nvidia Way: Jensen Huang and the Making of a Tech Giant. New York: W. W. Norton & Company, 2024.

Idaho Cut or Simplified 95% of Regulations by a “Sunset” Review

In my Openness book, I argue that government regulations bind entrepreneurs and reduce innovation. As part of an antidote, I suggest that “sunset laws,” where regulations automatically expire, if not renewed. Later, at a small conference on Adam Thierer’s latest book, I was discouraged to hear a couple of participants grant the plausibility of the “antidote,” but report that in actual practice it does not work because almost all old regulations get renewed. Some hope returned when I read a report from James Broughel of a successful sunset review process:

Idaho has proved deregulation is possible. The state repealed and revised its administrative rules code through a sunset review process in 2019. The results were dramatic. Since then, 95% of state regulations have been eliminated or simplified. The sky didn’t fall. Most regulations, when subject to genuine scrutiny, fail to justify their existence.

I will keep my eyes open on this issue, looking for more evidence.

James Broughel’s commentary is:

James Broughel. “Recipe for a Regulatory Spring Cleaning.” The Wall Street Journal (Tues., Nov. 26, 2024): A13.

(Note: the online version of the commentary has the date November 25, 2024, and has the same title as the print version.)

My book mentioned above is:

Diamond, Arthur M., Jr. Openness to Creative Destruction: Sustaining Innovative Dynamism. New York: Oxford University Press, 2019.

Adam Thierer’s book mentioned above is:

Thierer, Adam. Evasive Entrepreneurs and the Future of Governance: How Innovation Improves Economies and Governments. Washington, D.C.: Cato Institute, 2020.

Off-Label Drug Use Shows F.D.A. Phase 3 Trials Could Be Dropped, Adding New Cures and Lowering Costs

The F.D.A. allows physicians to prescribe drugs for “off-label” use. These drugs were originally approved for a different “on-label” use. For that approval the drugs had to pass through Phase 1 and Phase 2 clinical trials, mainly to show safety, and massively expensive Phase 3 clinical trials to show efficacy for the on-label use.

When off-label use is allowed, that shows that the F.D.A. is accepting drugs for a use where efficacy has NOT been shown.

This is a proof of concept for my suggestion (that I originally heard from Nobel-Prize-winner Milton Friedman) that F.D.A. regulation should be pared back to just Phase 1 and Phase 2, for safety. Since the Phase 3 trials are usually far more expensive than the Phase 1 and Phase 2 combined, this would allow far more new drugs to be developed.

If the development of new drugs was cheaper, Fajgenbaum and others would not need to spend N.I.H.’s 48 millions of taxpayer dollars to comb through already-approved drugs to see if one can be jury-rigged as a therapy for a different disease.

(p. A6) [Dr. David Fajgenbaum, an immunologist at the University of Pennsylvania and . . . Castleman patient who studies the disease] . . . has matched rare-disease patients with drugs that are already in pharmacies for other conditions for over 10 years, starting with himself.

. . .

Every Cure, a nonprofit Fajgenbaum helped found in 2022, received funding on Wednesday [Feb. 28, 2024] that could surpass $48 million from the federal Advanced Research Projects Agency for Health. Fajgenbaum and his team will spend the money to build a drug-repurposing database and algorithms that patients, doctors and researchers can use to find drugs for untreated diseases.

There are over 10,000 known rare diseases and most don’t have a drug approved to treat them. The FDA said it has approved over 19,000 prescription drugs.

The notion of finding new uses for existing drugs has been around for a long time. Once the FDA approves a drug, doctors can prescribe it off-label to patients with other conditions they think it will help. Ozempic, originally approved for people with Type 2 diabetes, is now used by millions of people without the disease for weight loss.

The National Institutes of Health and research institutions have invested over the years in drug repurposing, hoping it would be faster and less costly to find new uses for drugs that have already made it to market, a process that can take more than a decade and cost $2 billion. But systematically matching approved treatments to unmet needs has been hard.

. . .

“Our end goal is not FDA approval. Our end goal is giving patients maximum access to medications,” said Tracey Sikora, co-founder of Every Cure.

For the full story see:

Amy Dockser Marcus. “Repurposed Drugs Give People With Rare Diseases New Hope.” The Wall Street Journal (Thursday, Feb. 29, 2024 [sic]): A6.

(Note: ellipses, and bracketed date, added.)

(Note: the online version of the story has the date February 28, 2024 [sic], and has the title “This Doctor Found His Own Miracle Drug. Now He Wants to Do It for Others.”)

For more on Fajgenbaum’s story, read his autobiographical account:

Fajgenbaum, David. Chasing My Cure: A Doctor’s Race to Turn Hope into Action; a Memoir. New York: Ballantine Books, 2019.