Category: Regulations

Medical Oversight Boards Jeopardize Patient Safety by Ignoring or Forgiving the “Egregious Misconduct” of Healthcare Providers

(p. C7) In her excellent book, “The Licensing Racket,” the Vanderbilt law professor Rebecca Haw Allensworth presents plenty of cases of hair braiders, barbers and interior decorators who have been prevented from working by license restrictions that inflate prices without improving safety or quality. But Ms. Allensworth has bigger targets in mind.

Most people will concede that licensing for hair braiders and interior decorators is excessive while licensing for doctors, nurses and lawyers is essential. Hair braiders pose little to no threat to public safety, but subpar doctors, nurses and lawyers can ruin lives. To Ms. Allensworth’s credit, she asks for evidence. Does occupational licensing protect consumers? The author focuses on the professional board, the forgotten institution of occupational licensing.

. . .

(p. C8) You might hope that boards that oversee nurses and doctors would prioritize patient safety, but Ms. Allensworth’s findings show otherwise. She documents a disturbing pattern of boards that have ignored or forgiven egregious misconduct, including nurses and physicians extorting sex for prescriptions, running pill mills, assaulting patients under anesthesia and operating while intoxicated.

In one horrifying case, a surgeon breaks the white-coat code and reports a fellow doctor for performing a surgery so catastrophically botched that he assumes the practitioner must be an imposter. Others also report “Dr. Death” to the board. But Ms. Allensworth notes, “at the time of the complaints to the medical board, [Dr. Death] was only one third of the way through the thirty-seven spinal surgeries he would perform, thirty-three of which left the patients maimed or dead.” The board system seems incapable of acting decisively and Dr. Death’s rampage is only ended definitively when he is indicted—the initial charges include “assault with a deadly weapon,” the scalpel—and eventually imprisoned.

No system is perfect, but Ms. Allensworth’s point is that the board system is not designed to protect patients or consumers. She has a lot of circumstantial evidence that signals the same conclusion. The National Practitioner Data Bank (NPDB), for example, collects data on physician misconduct and potential misconduct as evidenced by medical-malpractice lawsuits. But “when Congress tried to open the database to the public, the [American Medical Association] ‘crushed it like a bug.’”

One of the most infuriating aspects of the system is that the AMA and the boards limit the number of physicians with occupational licensing, artificially scarce residency slots and barriers preventing foreign physicians from practicing in the U.S. Yet when a physician is brought before a board for egregious misconduct, the AMA cites physician shortage as a reason for leniency. When it comes to disciplining bad actors, the mantra seems to be that “any physician is better than no physician,” but when it comes to allowing foreign-trained doctors to practice in the U.S., the claim suddenly becomes something like “patient safety requires American training.”

. . .

I agree that licensing boards have failed to effectively discipline their members, but I think we should eliminate restrictions on supply. The adage “any physician is better than no physician” should not be a shield for negligent doctors, but it underscores an essential truth. The real harm lies in the scarcity created by licensing.

. . .

Voluntary certification can effectively replace many occupational licenses. Consider computer security, one of the most critical fields for consumer safety. Instead of requiring occupational licenses, professionals in this field rely on certifications such as the CISSP (Certified Information Systems Security Professional) to demonstrate expertise and competence.

. . .

The medical profession is unlikely to be delicensed, but as Ms. Allensworth’s book shows, we shouldn’t let the AMA dictate the terms of medical education. Many European countries offer combined undergraduate and medical degree programs that take only six years, compared to the eight or more years required in the U.S.

Advances in artificial intelligence, which Ms. Allensworth doesn’t explore, may also catalyze reform. AI is already transforming fields such as legal research and medical diagnostics, automating tasks once reserved for licensed professionals. As these technologies advance, they can reduce reliance on rigid licensing systems by ensuring quality and safety through innovative tools.

For the full review see:

Alex Tabarrok. “Permission To Join The Field.” The Wall Street Journal (Saturday, Feb. 8, 2025): C7-C8.

(Note: ellipses added.)

(Note: the online version of the review has the date February 7, 2025, and has the title “‘The Licensing Racket’: There’s a Board for That.”)

The book under review is:

Allensworth, Rebecca Haw. The Licensing Racket: How We Decide Who Is Allowed to Work, and Why It Goes Wrong. Cambridge, MA: Harvard University Press, 2025.

Land Use Regulations Slow Home Building

Productivity in manufacturing in the U.S. between 1930 and 2020 has increased, with stagnation for the last 10 years. In contrast, residential construction productivity increased, with more variability, from 1930 until the 1970s, and then stagnated or decreased. Starting in the 1970s an increase in land use and environmental regulations caused the stagnation.

So if we want more and better and cheaper housing, the key is less government regulation.

The study I summarize above is:

D’Amico, Leonardo, Edward L. Glaeser, Joseph Gyourko, William R. Kerr, and Giacomo A.M. Ponzetto. “Why Has Construction Productivity Stagnated? The Role of Land-Use Regulation.” National Bureau of Economic Research Working Paper No. 33188, Nov. 2024.

Feds Set Up Perverse Incentives in Healthcare; Health Insurance Companies Do Not Rise Above the Incentives

Vertical integration is admirable when it results in efficiencies of production that in the end benefit the consumer. But the federal government has set up an opaque healthcare system with unintended perverse incentives for health insurance firms to vertically integrate–where the firms own pharmacies, pharmacy benefit managers (P.B.M.s), hospitals, and doctors practices. Reimbursement rates for drugs are set by P.B.M.s. So the insurance company’s in-house P.B.M. reimburses its in-house pharmacy generously, but reimburses outside independent pharmacies stingily–often so stingily that the outside independent pharmacies go bankrupt, increasing the customer flow to the insurance company’s in-house pharmacy. Consumers do not benefit.

I mainly blame the government. But I do not praise the insurance firms. Libertarian philosopher Robert Nozick in Anarchy, State, and Utopia argued that profit maximization was ethical and served the common good, as long as it was done subject to ethical side-constraints. The three big health insurance firms, and especially United Health, have NOT set a conspicuous example of following Nozick’s advice.

What a pitiful, frustrating, inefficient, unfair mess.

(p. D3) The small-town drugstore closed for the last time on a clear and chilly afternoon in February. Jon Jacobs, who owned Yough Valley Pharmacy, hugged his employees goodbye. He cleared the shelves and packed pill bottles into plastic bins.

Mr. Jacobs, a 70-year-old pharmacist, had spent more than half his life building his drugstore into a bedrock of Confluence, Pa., a rural community of roughly 1,000 people. Now the town was losing its only health care provider.

Obscure but powerful health care middlemen — companies known as pharmacy benefit managers, or P.B.M.s — had destroyed his business.

This has been happening all over the country, a New York Times investigation found. P.B.M.s, which employers and government programs hire to oversee prescription drug benefits, have been systematically underpaying small pharmacies, helping to drive hundreds out of business.

The pattern is benefiting the largest P.B.M.s, whose parent companies run their own competing pharmacies. When local drugstores fold, the benefit managers often scoop up their customers, according to dozens of patients and pharmacists.

The benefit managers’ power comes from two main sources. First, the three biggest players — CVS Caremark, Express Scripts and Optum Rx — collectively process roughly 80 percent of prescriptions in the United States. Second, they determine how much drugstores are reimbursed for medications that they provide to patients.

Pharmacies buy those drugs from wholesalers, in the hope that P.B.M.s will reimburse them at a profit when the medications are provided to patients. But the largest benefit managers have strong incentives to set those rates as low as possible. A key reason: They make money in part by charging employers more for certain drugs than what the P.B.M.s pay pharmacies for them.

P.B.M.s frequently pay the pharmacies at rates that do not cover the costs of the drugs, according to more than 100 pharmacists around the country and dozens of examples of insurance paperwork and legal documents.

To take just one example: For a month’s supply of the blood thinner Eliquis, several pharmacists in different states said, the big three P.B.M.s routinely paid them as much as $100 less than what it cost the pharmacies to buy the medication from a wholesaler.

By contrast, the P.B.M.s sometimes pay their own pharmacies more than what they pay local drugstores for the same medications.

Independent pharmacies are powerless to fight back. As the unprofitable transactions pile up, some are unable to stay afloat.

. . .

(p. 26) The evidence that P.B.M.s pay their own pharmacies more than independent drugstores for the same medications is not just anecdotal. One study, paid for by a pharmacy association, found that the markup that P.B.M.s were charging on brand-name drugs was 35 times higher when the drugs were sold through their own mail-order pharmacies than when the drugs were sold by independent drugstores.

Government studies have identified a similar phenomenon.

Those extra costs are borne by taxpayers or employers and can be passed on to patients in the form of higher premiums — at odds with the benefit managers’ mandate of lowering drug costs.

. . .

(p. 27) In Mississippi, . . ., the state board that regulates pharmacies said this month that Optum Rx paid independent pharmacies less than it paid itself to dispense generic drugs. On a single day in 2022, Optum Rx paid itself 22 times what it paid six independent drugstores to fill generic Prilosec, a heartburn medication. Optum Rx declined to comment on the audit.

For the full story see:

Reed Abelson and Rebecca Robbins. “Powerful Firms Driving Out Local Pharmacies.” The New York Times, First Section (Sunday, October 20, 2024): 1 & 26-27.

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

(Note: the online version of the story has the date Oct. 19, 2024, and has the title “The Powerful Companies Driving Local Drugstores Out of Business.” Where the wording of the two versions differs (sometimes considerably), the quotes above follow the online version.)

The academic article co-authored by Evans is:

Wu, Lingfei, Dashun Wang, and James A. Evans. “Large Teams Develop and Small Teams Disrupt Science and Technology.” Nature 566, no. 7744 (Feb. 2019): 378-82.

Davos Worries Innovative European Firms Will Relocate to U.S. for Fewer Regs and “Kinder” Trump

Many of those with the passion to persevere in overcoming the necessary and unnecessary (regulatory) obstacles to medical innovation, do so because they have a sense of urgency due to skin in the game–they or a relative is directly affected by the disease they are passionate to cure. Dr. Edward Scolnick whose story I quote below, is a great example. In the story, we find another example, Ted Stanley, who donated $100 million to Scolnick because Stanley’s son is also suffering mental illness. And perhaps an indirect example? Rienhoff does not directly have skin in the game, but he is playing a key role because of Scolnick’s passion, and Scolnick’s passion is due to his skin in the game.

If we want more cures we will reduce the unnecessary (regulatory) obstacles so that those with less skin in the game (and so less passion to persevere) will also innovate.

[“Skin in the game” has been emphasized by Taleb in his book with that title.]

(p. A2) The U.S. was outperforming much of the world before Trump was elected.

His agenda could extend that outperformance by making the U.S. the preferred destination for foreign investment via lower taxes and regulation and even cheaper energy, while his promised tariffs hurt others’ exports.

. . .

Many at Davos blamed Europe’s dismal outlook on the failures of its own leaders, not on Trump.

European scientists are making progress on technologies that use genetically engineered microbes to solve any number of problems, said Kasim Kutay, the chief executive of Novo Holdings, which manages the assets and wealth of the foundation that controls Danish pharmaceutical company Novo Nordisk.

It takes seven to eight years, however, to get such a product approved by European regulators, compared with two to three in the U.S., he said: “A lot of that innovation is happening in Europe, but the companies ultimately seek funding in the U.S.”

One particular source of anxiety in Europe is that its top companies will move to the U.S. in search of higher stock valuations, less regulation and kinder treatment by Trump.

Rich Nuzum, global chief investment strategist for investment consultants Mercer, said Trump’s deregulatory drive might jolt Europe into action.

“If the U.S. economy continues to power ahead, if every company wants to be headquartered in the U.S. and traded in the U.S. because of a lighter regulatory burden…European C-suites will say to European policymakers, ‘Do something, or we’re going to move overseas.’”

The U.S. accounted for 44% of Swedish telecom equipment giant Ericsson’s net sales in the third quarter of 2024, up from 31% a year earlier. Chief Executive Börje Ekholm has criticized excessive regulation for discouraging the upgrading of Europe’s networks. Asked if Ericsson would move its head office to the U.S., Ekholm said: “We are Swedish based. But I think every company in Europe will need to think about this going forward.”

Like Europe, China faces headwinds; tariffs would be just one more.

China’s problem “is not Trump,” said Keyu Jin, a British-based economist specializing in the Chinese economy. “It’s the unemployment numbers. So many companies going under. So much debt the government owes to the private sector. The problems with young people. The ‘lying flat’ problem.”

For the full story see:

Greg Ip. “Davos Dissects Risks, Rewards of Trump.” The Wall Street Journal (Thursday, Jan. 23, 2025): A2.

(Note: ellipsis between paragraphs, added; ellipsis internal to a paragraph, in original.)

(Note: the online version of the story has the date January 22, 2025, and has the title “Trump’s Arrival Brightens U.S. Outlook, Darkens Everyone Else’s.”)

Innovative Research Is More Likely to Come from Small Teams

The incentives and constraints of doing research in medicine make the process very expensive, which leads it increasingly be a large group activity.
The article below suggests that large group research tends to be less innovative. We should reduce the costs by reducing regulations, including the mandate that no drug can be sold without an F.D.A.-approved Phase 3 clinical trial to prove efficacy.

(p. D3) In the largest analysis of the issue thus far, investigators have found that the smaller the research team working on a problem, the more likely it was to generate innovative solutions.  . . .

The new research, published on Wednesday [Feb. 13, 2019] in the journal Nature, is the latest contribution from an emerging branch of work known as the science of science — the study of how, when and through whom knowledge advances.

. . .

In the study, a trio of investigators led by James A. Evans, a sociologist at the University of Chicago, mined selections from three vast databases: . . .

. . .

When the team correlated this disruption rating to the size of the group responsible for the project or paper, they found a clear pattern: smaller groups were more likely to produce novel findings than larger ones. Those novel contributions usually took a year or so to catch on, after which larger research teams did the work of consolidating the ideas and solidifying the evidence.

“You might ask what is large, and what is small,” said Dr. Evans. “Well, the answer is that this relationship holds no matter where you cut the number: between one person and two, between ten and twenty, between 25 and 26.”

. . .

Psychologists have found that people working in larger groups tend to generate fewer ideas than when they work in smaller groups, or when working alone, and become less receptive to ideas from outside.

. . .

The new study suggests that a different kind of funding approach may be needed, one that takes more risk and spends the time and money to support promising individuals and small groups, Dr. Evans said.

“Think of it like venture capitalists do,” he said. “They expect a 5 percent success rate, and they try to minimize the correlation between the business they fund. They have a portfolio, one that gives them a higher risk-tolerance level, and also higher payoffs.”

For the full story see:

Benedict Carey. “Is Bigger Better? Not in This Case.” The New York Times (Tuesday, February 19, 2019 [sic]): D3.

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

(Note: the online version of the story has the date Feb. 13, 2019 [sic], and has the title “Can Big Science Be Too Big?”)

The academic article co-authored by Evans is:

Wu, Lingfei, Dashun Wang, and James A. Evans. “Large Teams Develop and Small Teams Disrupt Science and Technology.” Nature 566, no. 7744 (Feb. 2019): 378-82.

Otherwise “Savvy Consumers,” Mistakenly Trusting the F.D.A., Let Down Their Guard on Drug Quality

(p. 6) In the fall of 2012, a young consumer safety officer at the Food and Drug Administration volunteered for a job that few of his colleagues wanted: inspecting the Indian manufacturing plants that make many of America’s low-cost generic drugs.

In a world of drab auditors, Peter Baker stood apart.

. . .

America needs generic drugs. They make up 90 percent of the American drug supply. Without them, every large-scale government health program — the Affordable Care Act, Medicare Part D, the Veterans Health Administration, charitable programs for the developing world — would be unaffordable.

. . . what Mr. Baker uncovered in six years of doing foreign inspections exposed the dangerous compromises behind the production of generic drugs, and the F.D.A.’s limits as a global regulatory agency.

. . .

. . ., first in India and then in China, he uncovered fraud or deceptive practices in almost four-fifths of the drug plants he inspected. Some of the plants used hidden laboratories, secretly repeated tests and altered results to produce fake data that fundamentally misrepresented drug quality, then submitted that data to regulators.

. . .

The F.D.A. declares that “Americans can be confident in the quality of the products the F.D.A. approves.” Because of that reassurance, even savvy consumers — the sorts of people who are well versed in the quality distinctions between Velveeta and artisanal Cheddar — don’t think about how and where their drugs are made when they head to a pharmacy. Their only question usually is: Can they afford, or will their insurance cover, the drug being dispensed?

The F.D.A., which approved more than 1,000 new generic drug products last year, faces a vast challenge in safeguarding these medications. Nearly forty percent of all our generic drugs are made in India. Eighty percent of active ingredients for both our brand and generic drugs come from abroad, the majority from India and China. America makes almost none of its own antibiotics anymore.

. . .

In the United States, F.D.A. investigators typically show up unannounced to inspect plants. But overseas, the F.D.A. has opted to announce the vast majority of its foreign inspections in advance. Overseas plants even “invite” the F.D.A. to inspect; the investigators then become the company’s guests and agree on an inspection date in advance. Plant officials have served as hosts and helped to arrange local travel.

The F.D.A. has defended this system as the best way to ease the complex logistics of getting visas and ensuring access to the plants. But the resulting inspections are largely “staged,” say a number of F.D.A. staff members. With advance notice and low-cost labor, the plants can make anything look like anything. “You give them a weekend, they’ll put up a building,” as one F.D.A. investigator put it.

. . .

And there was an additional negative consequence to the F.D.A.’s system of advanced notice. With the companies serving as travel agents, F.D.A. investigators spoke of inappropriate perks: hotel upgrades, for which the investigators would never see a bill; golf outings, massages, and trips to the Taj Mahal. The result was what some F.D.A. employees referred to as “regulatory tourism.” The F.D.A. said in response that “any allegations of improper conduct by F.D.A. personnel are investigated.”

A new head of the F.D.A.’s India office, Altaf Lal, arrived in mid-2013. To tame the twin problems of company fraud and compromised investigators, Mr. Lal made a novel pitch to agency officials. He proposed a pilot program to make all inspections in India either on short notice or unannounced. By December 2013, he had a green light. The results were instantaneous.

In January 2014, the F.D.A. was planning an unannounced inspection at a plant in northern India on a Monday. Fearing that plant officials had heard they were coming, Mr. Baker and his colleague went a day early, unannounced. They proceeded to the quality control laboratory, expecting it to be quiet on Sunday morning. Instead, they were stunned to see a hive of activity. Dozens of workers hunched over documents, backdating them. On one desk, Mr. Baker found a notebook listing the documents the workers needed to fabricate in anticipation of the inspectors’ arrival. There were Post-it notes stuck to some surfaces, noting what data to change.

In large swaths of India’s generic drug industry, the pilot program uncovered a long-running machinery dedicated not to producing perfect drugs but to producing perfect data. At one plant, Mr. Baker went straight to the microbiology laboratory and found the paperwork for testing the sterility of the plant in perfect order: microbial limits testing, biological indicators, all the samples with perfect results. Yet most of the samples didn’t exist. The plant was testing almost nothing. The laboratory was a fake.

At the vast majority of the unannounced inspections, the investigators found things the plants no longer had time to fix: Infestations of birds and insects. A pile of critical manufacturing records, tossed in a trash bin. An employee bathroom near a sterile manufacturing area in one plant lacked drainage piping, so urine puddled directly onto the floor.

(p 7) Under the pilot program, the rate of inspections resulting in the F.D.A.’s most serious finding, “official action indicated,” increased by almost 60 percent, according to my own analysis of F.D.A. records. Before long, drugs from numerous plants in India had been banned from the United States market. Given these results, it seemed logical for the F.D.A. to make unannounced inspections or short notice the norm around the world. But in July 2015, F.D.A. officials decided to terminate the program and return to largely pre-announced inspections in India. When asked why, the agency declined to explain its reasoning and stated that “after evaluation of the pilot a decision was made to discontinue the pilot.”

For the full essay see:

Katherine Eban. “Can You Trust Generic Drugs?” The New York Times Sunday Opinion Section (Sunday, May 12, 2019 [sic]): 6-7.

(Note: ellipses added.)

(Note: the online version of the essay has the date May 11, 2019 [sic], and has the title “Americans Need Generic Drugs. But Can They Trust Them?” In the original of both print and online versions, the word “anything” is in italics both times it appears. In the quotes above where the online and print versions differ, the quotes follow the somewhat more detailed online version.)

The essay quoted above is adapted by Eban from her book:

Eban, Katherine. Bottle of Lies: The inside Story of the Generic Drug Boom. New York: Ecco, 2019.

F.D.R.’s Wage Controls Created a Wedge Between Patients and Doctors, With Awful Unintended Consequences

Under F.D.R.’s wage controls, firms competed for workers through perks, like healthcare benefits, since they could not legally compete by offering higher wages. That resulted in the first middlemen (in this case firms) between the customers (patients) and the suppliers (doctors). The result of adding the middlemen, and also adding a variety of regulations, is a “market” that is opaque, inefficient, and slow to innovate. Rather than drain the swamp, the response has been to add more middlemen (Medicare, Medicaid, Obamacare, and Pharmacy Benefit Managers, aka PBMs), that have only thickened the mire.

(p. B11) The roots of today’s fragmented system can be traced back to a quirk in U.S. history. Unlike most high-income countries, which created centralized government systems to ration care in the 20th century, the U.S. followed a different path shaped by historical circumstances. During World War II, wage controls prompted employers to offer health insurance as a tax-free benefit to attract workers.

Medicare and Medicaid, followed decades later by Affordable Care Act exchanges, were added over time to cover those who couldn’t get insurance through their job, creating a highly decentralized and convoluted system.  . . .

. . . the pressure to increase their earnings means insurers have looked for ways to overbill the government and skimp on patient care, always staying a step ahead of regulators. In recent years, they have become vertically integrated conglomerates, controlling doctors, pharmacies and payment-processing systems.

. . .

One of the most frustrating aspects of the system is a tactic called prior authorization, a process requiring providers to obtain insurer approval before delivering certain services. While that might be disagreeable, there is little public data on how often insurers deny care. This lack of transparency allows insurers to wield prior authorization aggressively, particularly when expensive treatments are recommended.

For the full commentary see:

David Wainer. “How to Fix Health Insurance.” The Wall Street Journal (Saturday, Dec. 21, 2024): B11.

(Note: ellipses added.)

(Note: the online version of the commentary has the date December 20, 2024, and has the title “How American Health Insurance Got So Infuriating.”)

Almost $2 TRILLION in Compliance Costs for Biden’s 1,213 New Regs over 10 Years

I am queasy about Trump’s tariffs but hopeful about his deregulation. Besides attacks on freedom of speech, regulations are currently the most binding constraint on innovation and flourishing in the U.S. I hope that the tariffs will be a bargaining ploy that in the long run will result in less protectionist policies for both us and our trading partners. But even if my hope is dashed and higher tariffs become a sustained policy, I believe (but cannot prove) that heavy regulations are the greater evil.

(p. A13) By the time Mr. Biden left office, his administration had issued 1,213 new regulations, according to the American Action Forum. The Washington think tank tracks federal regulations, their cost and added paperwork hours on its Regulation Rodeo website. Mr. Biden’s red tape will result in $1.9 trillion in compliance costs over the first 10 years the new rules are in effect, according to AAF.

By comparison, in Mr. Trump’s first term, his administration issued slightly more regulations—roughly 1,340—but many reduced costs to businesses and consumers. In total, they cost only $64.7 billion, less than 4% of Mr. Biden’s total.

Mr. Biden’s regulatory regime was far more expensive than even Barack Obama’s. Over two terms, the Obama administration issued 2,997 regulations, at a price tag of $870.5 billion. That’s less than 46% of the regulatory cost Mr. Biden racked up in four years.

For the full commentary see:

Karl Rove. “Trump Sets Out to Break Burdensome Rules.” The Wall Street Journal (Thursday, Jan. 23, 2025): A13.

(Note: the online version of the commentary has the date January 22, 2025, and has the same title as the print version.)

Tainted Sulfa Drugs Led Feds to Mandate Drug Safety Tests

Note that the impetus for the creation of mandated drug licensing was an episode of tainted sulfa drugs. The motive of the mandate was to assure safety. The later impetus for the strengthening of mandated drug licensing was the thalidomide episode. Again the motive was to assure safety.

Economists annoyingly emphasize trade-offs. If we stuck to regulation for safety, we could vastly reduce the costs of drug development, allowing more and faster drug innovation.

A case can even be made for doing away with safety regulation. Firms have incentives to produce safe drugs, and private certifying organizations provide information, for instance Consumer Reports. And there are many examples of F.D.A.-approved drugs that turned out to be unsafe (e.g., Vioxx). Mandated safety regulations reduce consumer freedom to choose, and slow the amount and speed of new cures. Mandated efficacy regulations reduce them even more.

(p. C6) Between the late 1930s and the late 1940s, every major class of antibiotics was developed, as William Rosen meticulously recounts in “Miracle Cure: The Creation of Antibiotics and the Birth of Modern Medicine.” Rosen’s highly informed retelling captures the drama of scientists’ quest, against long odds, to find and produce bacteria-killing drugs—and the egos, ambitions, brilliance and resolve that drove them.

. . .

It is a strength of “Miracle Cure” that Rosen places its many tales of discovery in their larger contexts, explaining for instance the near-complete lack of drug-safety regulation that prevailed when the Tennessee-based S.E. Massengill Co. began selling Elixir Sulfanilamide in October 1937. To make the drug more palatable, the company’s chief chemist had dissolved it, along with raspberry flavoring, in a toxic chemical also used in brake fluid. At least 73 people died. The Federal Food Drug and Cosmetic Act became law the following year. Companies would no longer be able to market new drugs without government licensing. And the government would have to ensure that they were safe.

This book is not for the casual reader. At some points Rosen gets into weeds so thick that only aficionados will find a way through. Still, it’s an important contribution to a still-germane yet fast-receding history. And it’s all the more impressive that Rosen, formerly a book editor and publisher, wrote it as he was battling his own intractable disease. An aggressive cancer took his life in April 2016. He left behind a history worth reading.

For the full review see:

Meredith Wadman. “Medicine’s Age of Wonders.” The Wall Street Journal (Saturday, May 20, 2017 [sic]): C6.

(Note: ellipsis added.)

(Note: the online version of the review has the date May 19, 2017 [sic], and has the same title as the print version.)

The book under review is:

Rosen, William. Miracle Cure: The Creation of Antibiotics and the Birth of Modern Medicine. New York: Penguin Books, 2018.

Dog Health Insurance Is Simpler and More Transparent Than Human Health Insurance

Why is dog health insurance simpler and more transparent than human health insurance?

Dog healthcare is mostly provided in a true marketplace, while human healthcare is provided in a hyper-regulated mishmash of market and government. Because there are more regulations and more risks of malpractice for human healthcare, more and more providers work for large healthcare firms. It’s much easier to have a small independent veterinary practice than a small independent human healthcare practice. So we find more competition in veterinary practices, resulting in prices that are lower and more transparent.

For humans the mega-providers gain with lack of transparency. Insurers are vertically integrated with hospitals, doctor practices, and obscure middlemen called Pharmacy Benefit Managers (PBMs). I would like to confirm my strong guess: few dog health insurance firms own veterinary practices.

(p. A24) I rushed around the patient as he lay motionless with his eyes closed in the emergency room. He was pale and sweaty, his T-shirt stained with vomit. You didn’t have to be a health-care worker to know that he was in a dire state. The beeps on the monitor told me his heart rate was dangerously slow. I told the man that he was going to be admitted to the hospital overnight.

After a pause, he beckoned me closer. His forehead furrowed with concern. I thought he would ask if he was going to be OK or if he needed surgery — questions I’m comfortable fielding. But instead he asked, “Will my insurance cover my stay?”

This is a question I can’t answer with certainty. Patients often believe that since I’m part of the health-care system, I would know. But I don’t, not as a doctor — and not even when I’m a patient myself. In the United States, health insurance is so extraordinarily complicated, with different insurers offering different plans, covering certain things and denying others (sometimes in spite of what they say initially they cover). I could never guarantee anything.

. . .

The killing of Brian Thompson, the chief executive of UnitedHealthcare, the country’s largest health insurer, has reignited people’s contempt for their health plans. It’s unknown if Mr. Thompson’s tragic death was related to health care, and the gleeful responses have been horrifying. But that reaction, even in its objectionable vitriol, matters for how it lays bare Americans’ deep-seated anger toward health care. Around the country, anecdotes were unleashed with furor.

Among these grievances is the great unknown of whether a treatment recommended by a doctor will be covered. . . .

Unsurprisingly, despite my platitudes, my patient did worry. Instead of resting on the stretcher, he and his wife began calling his insurance company. To keep him from leaving, I tried to be more persuasive, even though I didn’t know what kind of health plan he had: “I’m sure your insurance will pay. I’ll document carefully how medically necessary this admission is.” I added that social workers and other advocates could also assist in sorting out his insurance once he was admitted. And worst-case scenario, if they couldn’t, I crossed my fingers that the hospital’s charity care would help.

I said what I could to get him to stay, but I understood why he wanted to be certain. The average cost of a three-day hospital stay is $30,000.

. . .

My one family member with solid insurance is my dog. He got elective surgery recently, and I was astounded by the straightforward nature of his insurance. Once we meet the deductible, everything is simply covered by 80 percent. This is clearly described in a packet I received when I first signed him up. It’s an imperfect comparison to insurance for humans — I pay in full first, then get reimbursed — but it’s incredible to think that insurance for pets and possessions is easier to navigate and more consumer-friendly than insurance for people.

For the full commentary see:

Helen Ouyang. “What I Know About Americans’ Anger at Health Care.” The New York Times (Thursday, December 12, 2024): A24.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Dec. 8, 2024, and has the title “What Doctors Like Me Know About Americans’ Health Care Anger.”)

Allow Those with Skin in the Game to Help Find Quicker Cures

The New York Times devoted more than two and half full pages to the article that I quote from below. Very very few articles receive that much space. The story is meant to inspire and it does. Linde has a terrible genetic disease, as did her mother and grandmother, as do her two sisters, and as might her two daughters. She is uncredentialled, but determined. She reads scientific articles, gives talks at scientific meetings, creates a foundation to raise funds, and with her sisters gave samples from her skin to create cell lines that can be used for research to find a cure. Linde, both literally and figuratively, has skin in the game.

In the article, victims of the disease wish that there were more clinical trials to test more possible cures. If the price of clinical trials were lower, more of them would be supplied. One way to reduce the price would be for the F.D.A. to only mandate testing for safety, not to mandate testing for efficacy. After all, it was concerns over the safety, not the efficacy, of thalidomide, that first accelerated the F.D.A.’s clinical trial mandates. Testing only for safety (Phase 1 and Phase 2 clinical trials), would hugely reduce the price, resulting ultimately in more and quicker cures.

(p. A1) Linde Jacobs paced back and forth across her bedroom, eyeing the open laptop on the dresser and willing the doctor to appear. Her husband was dropping off their older daughter at school. Their younger daughter was downstairs, occupied by a screen. Linde wanted to be alone when she learned whether she carried the family curse.

Linde’s mother, Allison, had died just four weeks before, after a mutant gene gradually laid waste to her brain. In her 50s, Allison transformed from a joyful family ringleader into an impulsive, deceptive pariah. She drove like a maniac on cul-de-sacs. She pinched strangers, shoplifted craft supplies and stole money from her daughter.

Now, on this morning in September 2021, Linde would find out if she had inherited the same vile genetic mutation.

. . .

The doctor finally popped up on the computer. Wasting no time on pleasantries, she shared her screen and zoomed in on one line of laboratory paperwork: POSITIVE.

. . .

Soon, Linde’s husband, Taylor, pulled into the garage and opened the car door. He could hear her sobbing.

. . .

Linde looked at Taylor. “I don’t want you to feel stuck with me,” she said.

(p. A12) Leaving had never crossed his mind. Allison’s miserable experience, he told Linde, did not have to be hers. “You have all this time,” he said. “Do something about it.”

Even as they spoke, scientists were working on projects that might one day help her. Some had discovered how to cure grave conditions with gene editing. Others were tinkering with patients’ skin cells to test experimental drugs. And pharmaceutical companies were developing new Alzheimer’s therapies, one of which happened to target the rare defect in Linde’s brain.

Linde didn’t know any of that yet. But she decided to take Taylor’s advice. She would use the time she had, somehow, to find influential scientists and make them care about what was happening to her — and what might happen to her girls.

Linde and Taylor scoured the internet for any scrap of hope about treating frontotemporal dementia, or FTD. There was little to read.

Taylor remembered a Netflix documentary about a new way to edit genes. The method, called CRISPR, had cured some children with sickle cell disease. He searched “FTD treatment CRISPR” and found the website of Dr. Claire Clelland, a neurologist at the University of California, San Francisco. She had collected skin cells from patients with FTD, reprogrammed them into neurons and tried to edit the faulty genetic code within.

The website listed a phone number. Taylor called and left a message — a Hail Mary, he figured.

Within a day, Dr. Clelland responded by email. “Happy to help if I can,” she wrote.

. . .

(p. A13) “Could I ask a question?” one young scientist said. How much risk, she wondered, was Linde comfortable taking on an experimental treatment? Editing genes with CRISPR was new, after all, and could come with serious side effects.

“Sign me up, patient zero, sounds good,” Linde said.

“What choice do I have,” she added, “if I don’t want the same future for myself as my mom had, and her mom?”

When she wasn’t working or coaching her daughter’s soccer team, Linde threw herself into the scientific research on MAPT — a niche but growing subfield. The gene provides the instructions for cells to make tau, a protein in the brain.

One day she came across news of a project investigating how tau can go awry. She wrote to the scientist leading the work, Dr. Kenneth Kosik of the University of California, Santa Barbara, describing her family and asking to talk.

Dr. Kosik was sitting in his home office when her note landed in his inbox. “It was the second time in my life that I realized, I’ve got to get back to this person in, like, a nanosecond,” he recalled.

. . .

Dr. Kosik told Linde that an elite group of researchers, known as the Tau Consortium, would gather in Boston in a few months for its annual meeting. Dr. Clelland would be there, as would other “Michael Jordans” in the field. We should try to get you there, he said, so the scientists can be reminded of the human toll of tau-related diseases.

A few weeks later, Linde received an invitation to be the keynote speaker. Jenica and Ashlyn could come, too.

She texted her sisters, “Holy shit.”

One morning in Boston in June 2023, Linde and her sisters got all dolled up, only to arrive in a grand hotel ballroom filled with 100 scientists in oxfords and sneakers.

Dr. Kosik introduced Linde to the members of the Tau Consortium. Too nervous to look anyone in the eye, she stared at a screen showing her slides and read from her prepared remarks.

“You will notice the lack of credentials following my name,” she began. But she said her life had brought her other titles: Caregiver. Jail-Bailer. Carrier. She was the heartbeat, she said, of the cells they studied.

. . .

After the Boston talk, Linde received a flurry of invitations to tell her story. She was interviewed on YouTube by Emma Heming Willis, the wife of the actor Bruce Willis, the most famous person known to have frontotemporal dementia. She came face to face with monkeys that carried MAPT mutations in Madison, Wis. And though she detested the crowds and grime of big cities, she flew to places like Philadelphia and Washington, D.C., to at-(p. A14)tend scientific meetings.

Linde, who by then had moved to River Falls, Wis., always returned home exhausted. But the trips were also fortifying. Learning about the latest research quelled her anxiety — and her husband’s.  . . .

During her travels, Linde met other families with MAPT mutations. They were all frustrated by the lack of clinical trials for their genetic glitch, especially because several promising treatments were in the pipeline for other dementia genes. Linde and the others started a global survey of people with MAPT mutations. If an opportunity came along for a clinical trial, they would make it as easy as possible for scientists to find volunteers.

. . .

A few months later, Linde and the group started a nonprofit, called Cure MAPT FTD. They have since found more than 500 people with confirmed or possible MAPT mutations in 10 countries, all of whom have expressed interest in participating in future clinical trials.

In March of this year, Linde got an astonishing offer from Dr. Clelland. Along with collaborators at Washington University and the Neural Stem Cell Institute in New York, she wanted to collect skin cells from Linde and her sisters and turn them into clusters that divide infinitely, known as cell “lines.”

“We propose to make new lines that can be shared with academics and also with industry so that people can do drug screening” and CRISPR projects, Dr. Clelland wrote.

. . .

Based on what happened to Allison and Bev, Linde figures she has at least 10 more years before she starts showing symptoms. But there’s no guarantee; some MAPT carriers begin to change in their 20s. Whenever Linde tells a joke a little too loudly, or has a dulled emotional response to a dramatic event, she worries: Is this tau?

That anxious metronome never shuts off. It compels her to fill any moment of downtime reading the latest study or sending another email. She has spent thousands of dollars and hundreds of unpaid hours on travel. But sometimes, like when she finds herself alone in a hotel room, FaceTiming her daughter about a rough day at school, she questions whether these scientific pursuits are really the best way to run out the clock.

. . .

Dr. Clelland said designing a CRISPR molecule that could precisely excise the MAPT mutation from a cell’s genome was not the hard part. The major unsolved challenge is delivering those molecular scissors into the brain. Still, she and her colleagues at U.C.S.F. have set an ambitious goal of getting MAPT therapy into clinical trials within four years.

For the full story see:

Virginia Hughes. “A Mother’s Race to Beat a Genetic Time Bomb.” The New York Times (Wednesday, December 25, 2024): A1 & A12-A14.

(Note: ellipses added.)

(Note: the online version of the story was updated Jan. 2, 2025, and has the title “Fighting to Avoid Her Mother’s Fate, for Her Daughters’ Sake.” I have omitted a few subhead titles that appear in both the online and print versions.)