Regulations – artdiamondblog.com

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.

New York Times Says Trump “Has Waged a Multipronged Assault at Regulations” on Environment

The passages quoted below are further evidence apropos my dialogue with my libertarian friends who argue that the Trump administration’s efforts to deregulate and downsize have failed.

(p. 1) With a flurry of actions that have stretched the limits of presidential power, Mr. Trump has gutted federal climate efforts, rolled back regulations aimed at limiting pollution and given a major boost to the fossil fuel industry.

. . .

To achieve such a wholesale overhaul of the country’s climate policies in such a short time, the Trump administration has reneged on federal grants, fired workers en masse and attacked longstanding environmental regulations.

. . .

(p. 31) [Trump] has waged a multipronged assault at regulations designed to curb pollution, immediately sweeping some rules to the side and circumventing the normally lengthy rule-making processes. At the same time, Mr. Trump has declared an energy emergency, giving himself the authority to fast-track the construction of oil and gas projects as he works to stoke supply as well as demand for fossil fuels.

. . .

The administration and Republicans in Congress plan to use a legislative maneuver to quickly erase California’s authority to ban the sale of new gasoline-powered cars in the state by 2035. That authority has never before been challenged in this way, and critics say the maneuver is illegal. But it would be much faster than trying to overturn the California ban through the standard process that requires months of public notice and comment.

“They’re doing all the things I thought they would do, and they’re doing other things that I only dreamed they might do,” said Myron Ebell, a conservative activist who led the E.P.A. transition team during Mr. Trump’s first term.

. . .

And in a move that could have far-reaching implications for government efforts to regulate industry, Lee Zeldin, the administrator of the E.P.A., has recommended that the agency reverse its 2009 finding that greenhouse gas emissions endanger human health and welfare, according to three people familiar with the decision. That would eliminate the legal basis for the government’s climate laws, such as limits on pollution from automobiles and power plants.

“We’re talking about undoing 50 years of environmental regulation and accelerating the extinction crisis and risking the health of the American people,” said Ben Jealous, the executive director of the Sierra Club. “There’s so much shocking news every day. People are struggling to process all of it.”

. . .

Much of the damage to the country’s environmental regulatory apparatus may be long-lasting.

. . .

On Wednesday [Feb. 26, 2025] Trump said he believed Mr. Zeldin, the E.P.A. administrator, would be cutting about 65 percent of the agency’s more than 17,000 jobs. Mr. Zeldin later said that he thought the E.PA. could cut at least 65 percent of its budget and make cuts to its work force.

For the full story see:

David Gelles, Lisa Friedman and Brad Plumer. “Undoing Years of Climate Policy in a Few Weeks.” The New York Times, First Section (Sunday, March 2, 2025): 1 & 31.

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

(Note: the online version of the story has the date March 2, 2025, and has the title “‘Full on Fight Club’: How Trump Is Crushing U.S. Climate Policy.”)

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.”)

Trump Deregulates Biden’s Logging and Mining Bans on Public Lands

Trump’s agriculture secretary announced the deregulation of logging on 113 million acres of public lands–logging is now allowed on those lands. The Agriculture Department also announced the deregulation of mining on 264,000 acres of public lands, in order to “boost production of critical minerals” (p. A19).

Source:

Lisa Friedman. “White House Reverses Biden Limits on Drilling and Mining on Public Lands.” The New York Times (Thurs., April 10, 2025): A19.

(Note: the online version of the article has the date April 8, 2025, and has the title “Trump Administration Opens More Public Land to Drilling and Mining.”)

Trump Orders That Regulations Include “Sunset” Provisions

Several of my free market or libertarian friends are extremely upset about Trump’s tariff policies. I am confused and discouraged about them too. But I have said to my friends that while we criticize the tariff policies we should also find time to praise the Trump policies reducing regulations and downsizing government.

The response from several libertarians has been that nothing significant has been achieved on deregulation and downsizing. So I have resolved that at least for the next few weeks I will be alert to evidence on this issue, and occasionally run a post when I find some.

For instance, the NYT reported on Saturday that last week Trump instructed 10 federal agencies to add “sunset” clauses to most of their regulations saying that they will expire by October 2026. If the agency decides a regulation should be kept, they are to add a clause that the regulation will expire in five years unless reapproved. Trump also told all of his cabinet secretaries that within 60 days they are to have plans on which of the regulations in their areas should be repealed.

Trump also ordered the specific repeal of regulations limiting water flow in shower heads. (I like this one. Let’s Make America Clean Again (MACA) or at least let’s let people be free to choose to be clean.)

My source is:

Brad Plumer and Lisa Friedman. “Trump Deploys Shortcuts As He Moves to Eliminate Many Federal Regulations.” The New York Times (Sat., April 12, 2025): A15.

(Note: the online version of the article has the date April 11, 2025, and has the title “Trump’s New Way to Kill Regulations: Because I Say So.”)

Healthcare Under ObamaCare’s “Affordable” Care Act Is Neither Popular Nor Affordable

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:

(p. A17) Well, well. Progressives are at last acknowledging that ObamaCare is a failure. They aren’t doing so explicitly, of course, but their social-media screeds against insurers, triggered by last week’s murder of UnitedHealthcare CEO Brian Thompson, suggest as much. “We’ve gotten to a point where healthcare is so inaccessible and unaffordable, people are justified in their frustrations,” CBS News medical contributor Céline Gounder said during a Friday segment on the roasting of health insurers.

A Gallup survey released Friday [Dec. 6, 2024] affirms the sentiment, finding that only 44% of Americans rate U.S. healthcare good or excellent, down from 62% when Democrats passed ObamaCare in 2010. A mere 28% rate the country’s insurance coverage highly, an 11-point decline. ObamaCare may rank as the biggest political bait-and-switch in history.

Remember Barack Obama’s promise that if you like your health plan and doctor, you could keep them? Sorry. How about his claim that people with pre-existing conditions would be protected? Also not true. The biggest howler, however, was that healthcare would become more affordable.

Grant Democrats this: The law has advanced their political goal of expanding government control over insurers, in return for lavishing Americans with subsidies to buy overpriced, lousy products.

. . .

At the same time, ObamaCare’s perverse effects are fueling public rage against insurers and support for a single-payer system that would eliminate them. Mr. Obama and Peter Orszag, the law’s chief architect, must be smiling. Mr. Orszag, now CEO of the financial-services firm Lazard, has dined out on advising health insurers on mergers he says were spurred by the law’s regulations. How convenient.

. . .

If the goal were to help Americans with costly health conditions, it would have been far simpler and less expensive to boost subsidies for state high-risk pools. But that wouldn’t have accomplished Democrats’ actual goal, which is to turn insurers into de facto public utilities and jerry-rig a halfway house to single-payer healthcare. What a con.

For the full commentary see:

Allysia Finley. “Life Science; UnitedHealthcare and the ObamaCare Con.” The Wall Street Journal (Mon., Dec. 9, 2024): A17.

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

(Note: the online version of the commentary has the date December 8, 2024, and has the same title as the print version.)

The Gallup poll results mentioned above can be viewed at:

Brenan, Megan. “View of U.S. Healthcare Quality Declines to 24-Year Low.” Gallup, Inc., Dec. 6, 2024 [cited March 27, 2025]. Available from https://news.gallup.com/poll/654044/view-healthcare-quality-declines-year-low.aspx.

Doctors Burnout from Spending Less Time with Patients and More Time Arguing with Insurance Firms

Government policies have increased the paperwork that physicians must process and the time they must spend arguing with insurance companies on behalf of their patients. The policies have increased the need for back-office staff to handle the regulations, and so increased the overhead of private practice. So more and more physicians have given up private practice and become employees. They find their work less fulfilling and face burnout. Patients suffer when more of their physicians are bitter and burned-out.

(p. A1) There’s a question dividing the medical practice right now: Is being a doctor a job, or a calling?

. . .

(p. A2) Physicians work an average of 59 hours a week, according to the American Medical Association, and while the profession is well-compensated—the average physician makes $350,000, a recent National Bureau of Economic Research analysis found—it comes with high pressure and emotional strain.

. . .

Among physicians under age 45, only 32% own practices, down from 44% in 2012. By comparison, 51% of those ages 45 to 55 are owners.

Owners have more autonomy, but also increasing overhead costs. Vaughan, who sold his private practice in 2011, saw his malpractice insurance premiums increase to $65,000 a year.

Dr. Joseph Comfort, 80, sold his anesthesiology practice in 2003, frustrated by rising billing tussles with insurance companies. He now works part time as an internal medicine doctor at a small concierge clinic in Sanford, Fla.

“We’ve been ripped down off our pedestals,” he says.

For generations, Comfort says, doctors accepted being at the mercy of their pager and working long hours as the cost of doing business. “We took it because we considered ourselves to be masters of our own fate,” he says. “Now, everything’s changed. Doctors are like any other employee, and that’s how the new generation is behaving.”

They also spend far more time doing administrative tasks. One 2022 study found residents spent just 13% of their time in patient rooms, a factor many correlate with burnout.

. . .

In San Francisco, Dr. Christopher Domanski—a first-year resident who had his first child earlier this year—says he’s interested in pursuing a four-day workweek once he’s completed his training.

“I’m very happy to provide exceptional care for my patients and be there for them, but medicine has become more corporatized,” says Domanski, 29. Though he’s early in his medical career, he’s heard plenty of physicians complain about needing to argue with insurance companies to get their patients the treatments they need.

“It’s disheartening,” he says.

For the full story see:

Te-Ping Chen. “Younger Doctors Balk at Medicine’s Workaholic Culture.” The Wall Street Journal (Monday, Nov 04, 2024 [sic]): A1-A2.

(Note: ellipses added.)

(Note: the online version of the story has the date November 3, 2024 [sic], and has the title “Young Doctors Want Work-Life Balance. Older Doctors Say That’s Not the Job.”)

Public Health “Experts” Rebuffed Renegades Who Saw Covid Spread in Aerosols

Steven Johnson’s The Ghost Map shows how rigid adherence to the miasma theory of disease shut out alternatives. And an alternative was indeed needed to explain the spread of cholera. But the defeat of the miasma theory for cholera may have been too complete, prejudicing scientists to oppose theories of disease-spread through the air, which turn out to be important for some diseases, such as Covid-19.

(p. C9) In early 2020, as word spread of a frightening new respiratory outbreak in China, the World Health Organization and the Centers for Disease Control and Prevention were pressed for advice. Both initially counseled social distancing, guided by the assumption that the disease was spread by large, boggy droplets that fell rapidly to the ground after being expelled by coughing or sneezing.

By avoiding such projectiles and keeping surfaces clean, the reasoning went, infection could be avoided. Yet this advice ignored—with tragic consequences—nearly a century of science suggesting that many respiratory diseases can spread via microdrops that are exhaled during normal breathing and can remain suspended in the air for hours.

In “Air-Borne,” the New York Times science writer Carl Zimmer seeks to explain how public-health officials could have overlooked such an important mechanism of the Covid-19 contagion. He begins his meticulous history with the ancient Greek physician Hippocrates, who taught that illness could be caused by “an invisible corruption of the air,” which he termed a “miasma.”

. . .

While the field of aerobiology may have entered the new millennium stuck on a “stagnant plateau,” as one journal article lamented, hope was starting to emerge. Advances in technology led to a more complete characterization of the aerobiome. A range of scientists from around the world, meanwhile, re-examined the possibility of airborne transmission and discovered the evidence against it wanting.

Following the emergence of Covid-19, many of these researchers were appalled by the seemingly reflexive—“mind-boggling,” in the words of one scientist—rejection of airborne transmission by public-health agencies. At first, these renegades individually struggled to have their work published but were largely rebuffed.

After an early Covid-19 outbreak among a choir in Washington state was initially attributed to large-droplet spread, a more detailed analysis by a unified group of skeptical researchers suggested that airborne transmission was far more likely. On Dec. 23, 2021—nearly 21 months after tweeting “FACT: #COVID19 is NOT airborne”—the WHO “finally issued a clear public statement that the virus was airborne,” Mr. Zimmer writes. A triumph for persistent scientists, perhaps, but also a pointed reminder of the complexity, fragility and deeply human dependencies of evolving science.

For the full review see:

David A. Shaywitz. “Microbes in the Mist.” The Wall Street Journal (Saturday, March 15, 2025): C9.

(Note: ellipsis added.)

(Note: the online version of the review has the date March 14, 2025, and has the title “‘Air-Borne’: The Microbes in the Mist.”)

The book under review is:

Zimmer, Carl. Air-Borne: The Hidden History of the Life We Breathe. New York: Dutton, 2025.

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

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.

A Fluoridate Water “Warning Sign”

When I was a child, my family opposed the government-mandated fluoridation of the water supply of South Bend, Indiana, my hometown. We were not anti-science. We believed fluoride was a poison and that individual citizens had a right to make their own judgement whether to consume it. I still believe we were right.

(p. D6) A small study published Monday [May 20, 2024] suggested that higher levels of fluoride consumed during the third trimester of pregnancy were associated with a greater risk of behavioral problems in the mothers’ children at 3 years old. The authors of the study, which was funded in part by the National Institutes of Health and the Environmental Protection Agency and published in the journal JAMA Network Open, believe it is the first to examine links between prenatal fluoride exposure and child development among families living in the United States, where fluoride is often added to community water supplies to prevent dental cavities.

The study’s authors and some outside researchers said that the findings should prompt policymakers to evaluate the safety of fluoride consumption during pregnancy.

“I think it’s a warning sign,” said Dr. Beate Ritz, an environmental epidemiologist at the U.C.L.A. Fielding School of Public Health.

For the full story, see:

Alice Callahan and Christina Caron. “Fluoridated Water and Pregnancy.” The New York Times (Tuesday, May 28, 2024): D6.

(Note: bracketed date added.)

(Note: the online version of the story has the date May 22, 2024, and has the title “Is Fluoridated Drinking Water Safe for Pregnant Women?”)

The small published study mentioned above is:

Malin, Ashley J., Sandrah P. Eckel, Howard Hu, E. Angeles Martinez-Mier, Ixel Hernandez-Castro, Tingyu Yang, Shohreh F. Farzan, Rima Habre, Carrie V. Breton, and Theresa M. Bastain. “Maternal Urinary Fluoride and Child Neurobehavior at Age 36 Months.” JAMA Network Open 7, no. 5 (2024): e2411987-e87.

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.