Regulations – Page 12 – artdiamondblog.com

A Drug’s Lack of Randomized Clinical Trials Does Not Imply the Drug Lacks Efficacy

(p. D5) In 2013, the American College of Cardiology and the American Heart Association issued a series of statin recommendations for primary prevention, relevant to adults up to age 75 who have high cholesterol or diabetes, or who for other reasons face an estimated 7.5 percent risk or greater of developing heart disease within 10 years.

Last year, the United States Preventive Services Task Force similarly recommended statins for primary prevention in people aged 40 to 75 who had risk factors like high cholesterol, diabetes, high blood pressure or smoking, with a 10-year disease risk of 10 percent or greater.

But for people over age 75, both panels agreed, there was not sufficient evidence to reach a conclusion. As with many clinical trials, the major statin studies mostly haven’t included patients at advanced ages.

. . .

But Dr. Paul Ridker, a self-described “statin advocate” who directs the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, gets irked at the argument that we don’t know enough to give statins to older patients without heart disease.

“I don’t believe there’s any doubt that statin therapy is effective for primary prevention in older adults,” Dr. Ridker said. He cites a recent reanalysis of data from two major studies showing that patients over age 70 taking statins experienced the same reductions in cardiovascular events and mortality as younger ones.

Dr. Orkaby and her Harvard colleagues hoped to help resolve such questions with their recent study, published in the Journal of the American Geriatrics Society, comparing physicians over age 70 who took statins for primary prevention with those who didn’t.

The team matched each group for 30 variables and found that over an average of seven years, statin-takers had an 18 percent lower death rate, though not a statistically significant reduction in cardiovascular events.

In the same issue, though, an editorial co-authored by Dr. Rich called statin use for primary prevention in older patients “an unresolved conundrum.”

The physician study was observational, so can’t establish causes, he pointed out.

For the full story see:

Paula Span. “The New Old Age; If You’re Over 75 and Healthy, Are Statins for You?” The New York Times (Tuesday, January 9, 2018 [sic]): D5.

(Note: ellipsis added.)

(Note: the online version of the story has the date January 5, 2018 [sic], and has the title “The New Old Age; You’re Over 75, and You’re Healthy. Why Are You Taking a Statin?”)

The article on the effect of statins on older physicians, co-authored by Orkaby and mentioned above, is:

Orkaby, Ariela R., J. Michael Gaziano, Luc Djousse, and Jane A. Driver. “Statins for Primary Prevention of Cardiovascular Events and Mortality in Older Men.” Journal of the American Geriatrics Society 65, no. 11 (Nov. 2017): 2362-68.

Government Sugar Quotas Increase Demand for Harder-to-Metabolize Corn Syrup, Making Americans Fatter

For decades on the last day of every micro principles class I discussed the causes and effects of U.S. government sugar quotas. Government sugar quotas reduce the quantity of sugar that can be imported into the U.S., increasing the price of sugar. If the price of one substitute (sugar) rises, the demand for the other substitute (corn syrup) increases. As a result Americans consume more corn syrup which is harder to metabolize and easier to overconsume. Government sugar quota regulation thus increases obesity, and obesity-related diseases such as diabetes, heart disease, and cancer.

(p. D5) To clarify the effects of our high-sugar diet, I consulted an expert, Kimber L. Stanhope, a researcher in nutritional biology at the University of California, Davis, whose work is free of industry support and funded primarily by the National Institutes of Health. In a comprehensive 34-page review of research published in Critical Reviews in Clinical Laboratory Sciences in 2016, she linked consumption of added sugar to metabolic disease — cardiovascular disease, Type 2 diabetes and nonalcoholic fatty liver disease — as well as high blood levels of uric acid, a risk factor for kidney stones and gout.

In studies done in her lab among young adults consuming their normal diets, the risk for developing heart disease and kidney stones rose in direct proportion to the amount of high-fructose corn syrup they consumed.

. . .

“Fructose and glucose are not metabolized the same way in the human body,” which can account for the adverse effects of fructose, Dr. Stanhope said. Glucose is metabolized in cells throughout the body and used for energy. Fructose is metabolized in the liver, resulting in fat production and raising the risk of heart and fatty-liver disease. In addition, she explained, “fructose doesn’t stimulate the satiety-promoting substance leptin,” prompting some people to overconsume it, especially in soft drinks containing high-fructose corn syrup, and other tempting foods as well.

For the full story see:

Jane E. Brody. “The Sharp Bite of a Sweet Tooth.” The New York Times (Tuesday, July 23, 2019 [sic]): D5.

(Note: ellipsis added.)

(Note: the online version of the story has the date July 22, 2019 [sic], and has the title “The Downside of Having a Sweet Tooth.”)

The review article on the effect of sugar consumption on metabolism and obesity, mentioned above, is:

Stanhope, Kimber L. “Sugar Consumption, Metabolic Disease and Obesity: The State of the Controversy.” Critical Reviews in Clinical Laboratory Sciences 53, no. 1 (2016): 52-67.

Constraints and Incentives Help Explain Useless Medical Procedures

(p. D4) Researchers surveyed 2,106 physicians in various specialties regarding their beliefs about unnecessary medical care. On average, the doctors believed that 20.6 percent of all medical care was unnecessary, including 22 percent of prescriptions, 24.9 percent of tests and 11.1 percent of procedures. The study is in PLOS One.

Nearly 85 percent said the reason for overtreatment was fear of malpractice suits, . . .

. . .

More than 70 percent of doctors conceded that physicians are more likely to perform unnecessary procedures when they profit from them, while only 9.2 percent said that their own financial security was a factor.

“This study is essentially the voice of physicians about the problem,” said the senior author, Dr. Martin A. Makary, a professor of surgery at Johns Hopkins. “We’re told that there are too many operations done for narrowed blood vessels in the legs. Spine surgeons say that a quarter of all spine surgery may not be necessary. Half of stents placed may be unnecessary. These are significant opportunities to improve quality and lower costs.”

For the full story see:

Nicholas Bakalar. “Doctors: Overtreatment Weighed.” The New York Times (Tuesday, September 12, 2017 [sic]): D4.

(Note: ellipses added.)

(Note: the online version of the story has the date Sept. 6, 2017 [sic], and has the same title “Overtreatment Is Common, Doctors Say.”)

The academic study in PLOS One mentioned above is:

Lyu, Heather, Tim Xu, Daniel Brotman, Brandan Mayer-Blackwell, Michol Cooper, Michael Daniel, Elizabeth C. Wick, Vikas Saini, Shannon Brownlee, and Martin A. Makary. “Overtreatment in the United States.” PLOS ONE 12, no. 9 (2017): e0181970.

After a Century an Important Serendipitous Health Hunch Is Pursued

All of us (you, me, dogs, and physicians) observe patterns all the time. Some of the patterns, if pursued, could make the world much better. When a physician observes a pattern, even one they cannot articulately describe or justify, they could change their practices, curing more patients, saving more lives. But they are constrained from deviating from mainstream protocols by government regulations, insurance company rules, hospital administrators, and potential lawsuits. How many serendipitous discoveries that would help us flourish are delayed a century, or even totally snuffed out?

(p. C2) . . . my eye was drawn to a new study in the New England Journal of Medicine finding that hysterosalpingography cured some cases of infertility. Hystero refers to the uterus. Salpingo, I knew, relates to the fallopian tubes that funnel eggs to the uterus. Ography relates to imaging—but how could taking a picture of reproductive organs cure anything?

Doctors use hysterosalpingography to see if there are blockages that could be causing fertility problems.

. . .

To look at blockages, technicians have to introduce a teaspoon or two of a dye that’s opaque to X-rays. How that material is introduced, it turns out, is the key to the procedure’s effect on childlessness.

. . .

Smaller studies had given the scientists an idea of what to do next. They randomly chose half of the women to get the X-ray-opaque dye dissolved in oil, while the other half got the dye in water.

. . .

In an average of three months, whether treated or not, about 40% of the women receiving the oil-based dye material became pregnant, while only 29% of the women who got the water-based dye material conceived.

Hysterosalpingography is exactly a century old this year. Luckily, some astute doctors guessed that the method of taking a picture was having an unintended fertility effect, and now research has backed this up. Such serendipity in medical progress is neatly captured by a saying of the great French biologist Louis Pasteur about the need to be ready to see the unexpected: “In the fields of observation, chance only favors the prepared mind.”

The realization that supposedly inert oil could help to fulfill some couples’ dreams has built slowly. No one knows exactly how it works.

For the full commentary see:

Melvin Konner. “Mind & Matter; Can Just Taking a Picture Help to Treat Infertility?” The Wall Street Journal (Saturday, July 29, 2017 [sic]): C2.

(Note: ellipses added.)

(Note: the online version of the commentary has the date July 26, 2017 [sic], and has the same title as the print version. The Latin words in the first quoted sentence appear in italics in the original version.)

The New England Journal of Medicine article discussed in the passages above is:

Dreyer, Kim, Joukje van Rijswijk, Velja Mijatovic, Mariëtte Goddijn, Harold R. Verhoeve, Ilse A.J. van Rooij, Annemieke Hoek, Petra Bourdrez, Annemiek W. Nap, Henrike G.M. Rijnsaardt-Lukassen, Catharina C.M. Timmerman, Mesrure Kaplan, Angelo B. Hooker, Anna P. Gijsen, Ron van Golde, Cathelijne F. van Heteren, Alexander V. Sluijmer, Jan-Peter de Bruin, Jesper M.J. Smeenk, Jacoba A.M. de Boer, Eduard Scheenjes, Annette E.J. Duijn, Alexander Mozes, Marie J. Pelinck, Maaike A.F. Traas, Machiel H.A. van Hooff, Gijsbertus A. van Unnik, Cornelia H. de Koning, Nan van Geloven, Jos W.R. Twisk, Peter G.A. Hompes, and Ben W.J. Mol. “Oil-Based or Water-Based Contrast for Hysterosalpingography in Infertile Women.” New England Journal of Medicine 376, no. 21 (May 25, 2017): 2043-52.

“Common Practice of Excluding Former Cancer Patients From Clinical Trials”

Phase 3 randomized double-blind clinical trials (RCTs) are very expensive and often fail. When they do the drug company loses their investment in the new drug. As a result they have a big incentive to design the RCT to maximize the chances of success. One way is to exclude weak patients who are less likely to survive the new drug, for example in the passages quoted below, by excluding patients who have a past history of cancer. But the result is that the RCT does not provide evidence about the efficacy of the new drug in helping one of the groups we would like to help.

(p. D5) In a recent report in JAMA Oncology by researchers at the University of Texas Southwestern Medical Center in Dallas, approximately 25 percent of Americans 65 and older and 11 percent of younger adults who were previously treated for cancer were subsequently found to have one or more new cancers in a different site. Depending on the type of original cancer and the person’s age, the risk of developing a second unrelated cancer ranged from 3.5 percent to 36.9 percent. The study covered 765,843 new cancer diagnoses made between 2009 and 2013 and recorded in a population-based national registry, the Surveillance, Epidemiology and End Results (SEER) program.

. . .

The Texas researchers, led by Caitlin C. Murphy, an epidemiologist, undertook the study of new cancers in cancer survivors in hopes of changing the common practice of excluding former cancer patients from clinical trials when they develop another cancer.

“This exclusion is not evidence-based,” Dr. Murphy said in an interview. “Patients with a prior cancer do not necessarily have a worse prognosis than those without a cancer history. They should be allowed to participate in clinical trials, which may be one of their only treatment options. If they’re excluded, a lot of patients are left out from what may be the best available treatment.”

For the full commentary see:

Jane E. Brody. “When Cancer Strikes Twice.” The New York Times (Tuesday, December 26, 2017 [sic]): D5.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date Dec. 25, 2017 [sic], and has the same title as the print version.)

The academic report mentioned above is:

Murphy, Caitlin C., David E. Gerber, and Sandi L. Pruitt. “Prevalence of Prior Cancer among Persons Newly Diagnosed with Cancer: An Initial Report from the Surveillance, Epidemiology, and End Results Program.” JAMA Oncology 4, no. 6 (June 2018): 832-36.ds

Allowing Entrepreneurial Physicians to Improvise Can Save Patient Lives, Especially for Rare Conditions

The article quoted below makes the case, by example, that drugs that would be rejected based on early randomized double-blind clinical trials, can be revived by clever trial-and-error adjustments. Such improvisations saved the life of Magglio Boscarino, whose body began to develop antibodies that attacked the medicine that had been successfully treating his rare Pompe disease. Emil Freireich used trial-and-error adjustments to develop the chemo cocktail that cured many of childhood leukemia. He mentored Vincent DeVita who used trial-and-error adjustments to develop the chemo cocktails that cured many of Hodgkin’s lymphoma. Another approach, advocated by Dr. Ridker in a passage below, is to learn which patients will be able to take the drug with developing resistance to it–a form of personalized medicine that does not seem easily compatible with the oft-claimed “gold standard” of randomized double blind clinical trials.

(p. D1) The miracle treatment that should have saved Becka Boscarino’s baby boy almost killed him.

Doctors diagnosed her newborn son, Magglio, with Pompe disease, a rare and deadly genetic disorder that leads to a buildup of glycogen in the body. Left untreated, the baby would probably die before his first birthday.

There is just one treatment: a series of infusions. But after the boy received his fifth dose, he turned blue, stopped breathing and slipped into anaphylactic shock.

The problem? Eventually doctors discovered that Magglio’s body was producing antibodies to the very drug saving his life.

. . .

In a paper published in March [2017] by The New England Journal of Medicine, Pfizer reported that in the final phase of testing a new drug to lower cholesterol, many of the 30,000 patients taking it had stopped re-(p. D6)sponding to it.

Their cholesterol levels, which had plunged when they began taking the drug, were rising again. As it turned out, the subjects had begun making antibodies to the drug.

Pfizer was forced to stop the trial and pull the drug after investing billions of dollars.

. . .

By the time Magglio was 6 months old, he was weak and lacked muscle tone. Then came the diagnosis of Pompe disease and the beginning of his treatments, infusions with an enzyme his body was failing to make.

At first, Magglio improved. Within a few months, he was learning to sit up and to use his arms. His enlarged heart was shrinking. But his fifth treatment was a disaster.

He fell into anaphylactic shock and stopped breathing.

. . .

Magglio was hardly alone: Most babies with Pompe disease who received the only available treatment soon produced antibodies that rendered it useless.

“We tried everything, but these babies did not make it,” said Dr. Priya Kishnani, a professor of pediatrics at Duke University.

Dr. Kishnani realized she had to find a way to trick the immune system so it would leave the infused protein alone. Her idea was to give the babies a chemotherapy drug, rituximab, that wipes out cells that develop into antibody producers.

Along with it, she tried giving the children methotrexate, which destroys many of the body’s white blood cells, and infusions of antibodies from pooled donors’ serum so the children would have a way to fight off infections.

And for babies like Magglio, who already were making antibodies that blocked the drug they need, she added another drug — bortezomib — to eliminate those antibody-producing cells.

As the children’s immune systems were brought under control, the treatments began to work again. “It was breathtaking,” Dr. Kishnani said. “We were able to rescue these babies.”

. . .

At Brigham and Women’s Hospital in Boston, cardiologist Dr. Paul Ridker, who directed the Pfizer study, is taking a different tack.

He wants to do a large genetic study to see if he can predict which patients will develop antibodies to the Pfizer drug and perhaps to other drugs that the immune system might see as foreign.

“We probably have the best opportunity ever afforded to understand the cause of these antibodies,” Dr. Ridker said. “That would be very valuable for the development of future drugs if you could say, ‘This one patient out of 20 should not take this drug.’”

It would mean, too, that drugs that might have been abandoned could be developed for the patients who can tolerate them.

For the full story see:

Gina Kolata. “When the Body Rejects the Treatment.” The New York Times (Tuesday, May 16, 2017 [sic]): D1 & D6.

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

(Note: the online version of the story has the date May 15, 2017 [sic], and has the title “When the Immune System Thwarts Lifesaving Drugs.”)

The 2017 paper reporting the failed Pfizer clinical trial and mentioned above is:

Ridker, Paul M, Jean-Claude Tardif, Pierre Amarenco, William Duggan, Robert J. Glynn, J. Wouter Jukema, John J.P. Kastelein, Albert M. Kim, Wolfgang Koenig, Steven Nissen, James Revkin, Lynda M. Rose, Raul D. Santos, Pamela F. Schwartz, Charles L. Shear, and Carla Yunis. “Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab.” New England Journal of Medicine 376, no. 16 (April 20, 2017): 1517-26.

Covid Loan Programs Passed by Congress Were “Comically Easy to Scam”

In a WSJ op-ed, I tell how a fraudster received a $42,200 Covid-19 Economic Injury Disaster Loan in my name for an alleged “Arthur M.D. Potato Farm.” As discussed in the NYT passages quoted below, there was also massive fraud in other related Congress-funded Small Business Administration Covid boondoggle programs. The NYT article blames the Trump Administration, but in my struggle to clear up the potato farm fraud case, a S.B.A. official told me that the Congress in 2020 put enormous pressure on the S.B.A. to get the money out the door as quickly as possible. The House of Representatives, which takes the lead in spending legislation, was controlled by the Democratic Party.

In the passages quoted below, “P.P.P.” means “Paycheck Protection Program” and “E.I.D.L.” means “Economic Injury Disaster Loan.”

(p. B4) An emergency relief program hastily rolled out in the early days of the pandemic had such poor fraud protections that it improperly doled out nearly $4.5 billion to self-employed people who said they had additional workers — even those who made wildly implausible claims, like having one million employees.

The $20 billion program, called the Economic Injury Disaster Loan Advance, offered small businesses immediate grants of up to $10,000 in the months after the pandemic shuttered much of the economy. But hundreds of thousands of the grants it made were inflated because there was no system to catch applications with “flawed or illogical information,” Hannibal Ware, the Small Business Administration’s inspector general, wrote in a report released on Thursday [Oct. 7, 2021].

. . .

. . . the S.B.A. skipped an obvious safeguard: It did not require sole proprietors claiming to have employees to enter their Employer Identification Number, instead allowing them to use their Social Security numbers.

. . .

Some of the claims were outright absurd. Hundreds of applicants received the maximum grants after saying that they employed more than 500 workers, a number that would generally make them ineligible for the small business program. Fifteen said they had one million employees — a figure that would put them in league with Amazon and Walmart.

The Small Business Administration “never requested additional information from these sole proprietors to verify the number of employees cited on their grant applications before approving and disbursing the grants,” Mr. Ware said in his report.

. . .

. . . a Bloomberg article last year described how almost comically easy it was to scam the system. It cited how-to videos that circulated on YouTube with titles like “$10k SBA Loans & GRANTS Got The STREETS Going CRAZY!”

. . .

The Justice Department has already prosecuted hundreds of cases involving fraudulent claims across the government’s $1 trillion small business pandemic relief programs, reclaiming more than $600 million.

But that is only a sliver of the amount lost to bogus claims. A March memo by the House Select Subcommittee on the Coronavirus Crisis identified an estimated $84 billion in suspected fraud in the P.P.P. and E.I.D.L. programs after the Trump administration “refused to implement basic controls.”

Mr. Ware told a House committee in April [2021] that his office had opened more than 400 cases involving the agency’s assorted relief programs.

“Fraud investigations will be a decades-long effort,” he said.

For the full story see:

Stacy Cowley. “S.B.A. Paid $4.5 Billion on Bogus Grant Claims.” The New York Times (Friday, October 8, 2021 [sic]): B4.

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

(Note: the online version of the story has the date Oct. 7, 2021 [sic], and has the title “S.B.A. Overpaid $4.5 Billion on ‘Illogical’ Small Business Grant Claims.”)

Europeans Tire of Costly and Ineffective Climate Transition Policies

(p. A15) The 2015 Paris Agreement aspired to “reduce the risks and impacts of climate change” by eliminating greenhouse-gas emissions in the latter half of this century. The centerpiece of the strategy was a global transition to low-emission energy systems.

. . .

U.S. and European governments are trying to induce an energy transition by building or expanding organizations and programs favoring particular “clean” technologies, including wind and solar generation, carbon capture, hydrogen production and vehicle electrification. Promoting technological innovation is a worthy endeavor, but such efforts face serious challenges as costs and disruptions grow without tangible progress in reducing local, let alone global, emissions. Retreats from aggressive goals are already under way in Europe, with clear signs of mandate fatigue. The climbdown will be slower in the U.S., where subsidies create constituencies that make it more difficult to reverse course.

. . . It means that today’s ineffective, inefficient, and ill-considered climate-mitigation strategies will be abandoned, making room for a more thoughtful and informed approach to responsibly providing for the world’s energy needs.

For the full commentary see:

Steven E. Koonin. “The ‘Climate Crisis’ Fades Out.” The Wall Street Journal (Tuesday, June 11, 2024): A15.

(Note: ellipses added.)

(Note: the online version of the commentary has the date June 10, 2024, and has the same title as the print version.)

Koonin’s commentary, quoted above, is related to his book:

Koonin, Steven E. Unsettled: What Climate Science Tells Us, What It Doesn’t, and Why It Matters. Dallas, TX: BenBella Books, 2021.

Charter School Founder Stood Up to “Education Bureaucrats”

The NYT ran an inspiring obituary for Joseph H. Reich last Tuesday. Reich and his wife were pioneers in the Charter School initiative. The obituary quotes them as saying that they were able to afford to send their own children to private school, but poor parents who want better for their children than what is on offer by the government public schools could not afford a similar option. They were quoted as saying “We recoil against this injustice.” They created one of the first charter schools and also donated $10 million for general support of charter schools. The obituary says that they stood up against “vigorous pushback from education bureaucrats.”

For the full obituary see:

Trip Gabriel. “Joseph H. Reich, 89, Pioneer of New York City’s Charter Schools, Dies.” The New York Times (Tuesday, October 15, 2024): A21.

Trust Ventures Engages in “Trench Warfare” Against Regulations Binding the Firms It Finances

(p. A15) Another “Ghostbusters” movie is in theaters, but what we need are regulation busters. I spoke with Salen Churi and Brooke Fallon from Trust Ventures, a $500 million Texas-based venture-capital firm. It’s almost as if they are wearing plasma proton packs.

. . .

Trust Ventures came together, Mr. Churi said, because no one thinks “ ‘I hate innovation,’ except perhaps for incumbents. We have crises in the most human of industries—energy, healthcare, housing. Everyone thought I was nuts. They’re like, ‘Why would you invest in companies with regulatory problems?’ ” Good question.

Most venture capitalists invest and help startups with new strategies and hiring a team. Mr. Churi describes what he does as “trench warfare,” fighting with regulators and incumbents deal by deal.

. . .

Mr. Churi explains that “when you get a great new technology that’s fundamentally different, regulators just want to shove you in the old box, right? Our challenge is to say, ‘Well, actually, this needs a new box.’ Otherwise, it’s going to sit on the shelf.”

Eye exams are a great example of an old box. The American Optometric Association is powerful, and many states banned online vision tests. “Regulators don’t care about all those single mothers who have to pay three times as much or that people in Central Illinois have to drive three hours,” Mr. Churi says.

The pandemic loosened telehealth rules, providing an opening to test your eyes with your own smartphone. As lockdowns ended, Trust Ventures worked with the startup Visibly in several states to legalize online eye exams permanently. They got help from their investors network—some of their limited partners “are great American families,” Mr. Churi says. Visibly’s Food and Drug Administration-approved online eye tests, now in 36 states, cost as little as $35 instead of three times as much at LensCrafters or box-store-located optometrists.

For the full commentary see:

Andy Kessler. “Inside View; America’s New Regulation Busters.” The Wall Street Journal (Monday, April 15, 2024): A15.

(Note: ellipses added.)

(Note: the online version of the commentary has the date April 14, 2024, and has the same title as the print version.)

People Thinking about the Rules They Have to Obey, Are Not Thinking about the Problems They Have to Solve

(p. A18) . . . I looked into the growing bureaucratization of American life. It’s not only that growing bureaucracies cost a lot of money; they also enervate American society. They redistribute power from workers to rule makers, and in so doing sap initiative, discretion, creativity and drive.

Once you start poking around, the statistics are staggering. Over a third of all health care costs go to administration. As the health care expert David Himmelstein put it in 2020, “The average American is paying more than $2,000 a year for useless bureaucracy.” All of us who have been entangled in the medical system know why administrators are there: to wrangle over coverage for the treatments doctors think patients need.

. . .

In every organization I’ve interacted with, the administrators genuinely want to serve the mission of the organization, but the nature of their jobs is to enforce compliance with this or that rule.

Their power is similar to what Annie Lowrey of The Atlantic has called the “time tax.” If you’ve ever fought a health care, corporate or university bureaucracy, you quickly realize you don’t have the time for it, so you give up. I don’t know about you, but my health insurer sometimes denies my family coverage for things that seem like obvious necessities, but I let it go unless it’s a major expense. I calculate that my time is more valuable.

As Philip K. Howard has been arguing for years, good organizations give people discretion to do what is right. But the trend in public and private sector organizations has been to write rules that rob people of the power of discretion. These are two different mentalities. As Howard writes, “Studies of cognitive overload suggest that the real problem is that people who are thinking about rules actually have diminished capacity to think about solving problems.”

. . .

. . ., Mark Edmundson teaches literature at the University of Virginia. The annual self-evaluations he had to submit used to be one page. Now he has to fill out about 15 electronic pages of bureaucratese that include demonstrating how his work advances D.E.I., to make sure his every waking moment conforms to the reigning ideology.

In a recent essay in Liberties Journal, he illustrates how administrators control campus life . . .

. . .

Organizations are trying to protect themselves from lawsuits, but the whole administrative apparatus comes with an implied view of human nature. People are weak, fragile, vulnerable and kind of stupid. They need administrators to run their lives. They have to be trained never to take initiative, lest they wander off into activities that are deemed by the authorities to be out of bounds.

The result is the soft despotism that Tocqueville warned us about centuries ago, a power that “is absolute, minute, regular, provident and mild.” In his Liberties essay, Edmundson writes that this kind of power is now centerless. Presidents and executives don’t run companies, universities or nations. Power is now held by everyone who issues work surveys and annual reports, the people who create H.R. trainings and collect data. He concludes: “They are using the terms of liberation to bring more and more free people closer to mental serfdom. Some day they will awaken in a cage of their own devising, so harshly confining that even they, drunk on their own virtue, will have to notice how their lives are the lives of snails tucked in their shells.”

Trumpian populism is about many things, but one of them is this: working-class people rebelling against administrators. It is about people who want to lead lives of freedom, creativity and vitality, who find themselves working at jobs, sending their kids to schools and visiting hospitals, where they confront “an immense and tutelary power” (Tocqueville’s words) that is out to diminish them.