Category: Health

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.

Noncredentialled Intense Outsider Duggan Brings Two Blockbuster Cancer Drugs to Market

(p. B11) There is a myth that making money in biotechnology stocks requires an advanced degree. But Bob Duggan, an avid surfer who never graduated from college, has proven that notion wrong. Twice.

Duggan’s latest investment, Summit Therapeutics SMMT 9.25%increase; green up pointing triangle, has become one of the industry’s greatest bets in recent years. The stock is up more than 1,000% in the past 12 months thanks to data from a late-stage trial that showed that its drug, Ivonescimab, beat Merck’s blockbuster cancer drug Keytruda in patients with a form of lung cancer. Duggan, who was already a billionaire before the Summit investment, is now worth about $16 billion, according to Forbes data.

There is much still to be worked out with the drug, which Summit licensed from Chinese biotech Akeso in 2022. For starters, investors are eager to see how it performs in global trials outside of China. What is remarkable about Summit’s success so far, though, is that this isn’t even Duggan’s first time making billions in biotech.

About 20 years ago, Duggan, a member of the Church of Scientology, began acquiring shares in a little-known biotech company called Pharmacyclics. He was drawn to the company’s cancer drug Xcytrin because of a personal loss: his son’s death from brain cancer. Pharmacyclics ultimately dropped the development of Xcytrin after multiple setbacks but went on to develop leukemia blockbuster Imbruvica. In 2015, AbbVie paid $21 billion for the company.

. . .

Nathan Vardi, author of “For Blood and Money,” which chronicles the development of Imbruvica and a competitor molecule, says that during his research he noticed that many people in biotech circles thought Duggan simply got lucky. While luck certainly plays a big role in the binary world of drug development, few would stick to that argument now.

So what is his secret? One thing Vardi points to is the ability to know when to retreat and when to go all in on an investment. “Duggan has a lifetime of experience making big bets with his own money on the line and figuring out when to hold or fold,” he wrote in an email. “Nobody gets these things completely right, but I think we have to admit he’s doing really well.”

Duggan, who built successful businesses in baking and robotics before jumping into biotechnology, suggests that the naivete of an outsider, combined with the intensity he brings to whatever he does, allowed him to try unconventional things. Nathan Vardi, author of “For Blood and Money,” which chronicles the development of Imbruvica and a competitor molecule, says that during his research he noticed that many people in biotech circles thought Duggan simply got lucky. While luck certainly plays a big role in the binary world of drug development, few would stick to that argument now.

So what is his secret? One thing Vardi points to is the ability to know when to retreat and when to go all in on an investment. “Duggan has a lifetime of experience making big bets with his own money on the line and figuring out when to hold or fold,” he wrote in an email. “Nobody gets these things completely right, but I think we have to admit he’s doing really well.”

Duggan, who built successful businesses in baking and robotics before jumping into biotechnology, suggests that the naivete of an outsider, combined with the intensity he brings to whatever he does, allowed him to try unconventional things.

For the full commentary see:

David Wainer. “Heard on the Street; An Outsider Crashes the Biotech Party.” The Wall Street Journal (Saturday, Sept. 24, 2024): B11.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date September 23, 2024, and has the title “Heard on the Street; How a Surfer Who Never Finished College Became a Biotech Billionaire.” The sentence starting with “Léon Bottou” appears in the online, but not the print, version. Where there are small differences between the versions, the passages quoted above follow the online version.)

The book by Vardi mentioned above is:

Vardi, Nathan. For Blood and Money: Billionaires, Biotech, and the Quest for a Blockbuster Drug. New York: W. W. Norton & Company, 2023.

Dogs Pass a Smell Test–Locating Ancient Buried Human Remains

(p. D1) On a sunny summer day in Croatia several years ago, an archaeologist and two dog handlers watched as two dogs, one after another, slowly worked their way across the rocky top of a wind-scoured ridge overlooking the Adriatic Sea.

. . .

Panda, a Belgian Malinois with a “sensitive nose,” according to her handler, Andrea Pintar, had begun exploring the circular leftovers of a tomb when she suddenly froze, her nose pointed toward a stone burial chest. This was her signal that she had located the scent of human remains.

Ms. Pintar said the hair on her arms rose. “I was skeptical, and I was like, ‘She is kidding me,’” she recalled thinking about her dog that day.

Archaeologists had found fragments of human bone and teeth in the chest, but these had been removed months earlier for analysis and radiocarbon dating. All that was left was a bit of dirt, the stone slabs of the tomb and the cracked limestone of the ridge.

. . .

(p. D6) . . . the experiment in Croatia marked the start of one of the most careful inquiries yet carried out of an unusual archaeological method. If such dogs could successfully locate the burial sites of mass executions, dating from World War II through the conflicts in the Balkans in the 1990s, might they be effective in helping archaeologists find truly ancient burials?

. . .

That “test run” was the beginning of a careful study on whether human-remains detection dogs could be an asset to archaeologists. Setting up a controlled study was difficult. Dr. Glavaš had to learn the scientific literature, such as scent theory, far outside the standard confines of archaeology; the same was true for Ms. Pintar and the field of archaeology.

. . .

“I think dogs are really capable of this, but I think it’s a logistical challenge,” said Adee Schoon, a scent-detection-animal expert from the Netherlands who was not involved in the study. “It’s not something you can replicate again and again. It’s hard to train.”

And, as Dr. Schoon noted, dogs are “great anomaly detectors.” Something as subtle as recently disturbed soil can elicit a false alert from a dog that is not rigorously trained.

Nonetheless, the team returned to the necropolis for the first controlled tests in September 2015, and again a full year later. Both times, they used all four of Ms. Pintar and Mr. Nikolić’s cadaver dogs: Panda, Mali, a third Belgian Malinois and a German shepherd. They worked them on both known and double-blind searches, in areas where nobody knew if tombs were located.

The dogs located four tombs new to the archaeologists. Dr. Glavaš had suspected that a fifth site might hold a burial chest, and the dogs’ alerts, combined with excavation, proved her suspicion correct.

In September 2019, the Journal of Archaeological Method and Theory published the results of their study: “This research has demonstrated that HRD dogs are able to detect very small amounts of specific human decomposition odor as well as to indicate to considerably older burials than previously assumed,” Dr. Glavaš and Ms. Pintar wrote.

Dr. Schoon, who researches and helps create protocols to train scent-detection animals worldwide, said the Iron Age necropolis study was nicely designed and “really controlled.”

. . .

Cadaver dogs are also helping archaeologists at some especially challenging sites. Mike Russo and Jeff Shanks, archaeologists with the National Park Service’s Southeast Archeological Center, had created at least 14 test holes near a promising site in northwest Florida that had been flattened during an earlier era of less diligent archaeology. They found nothing.

“We knew where it should be, but when we went there, there was absolutely no mound,” Mr. Russo said.

They then asked Suzi Goodhope, a longtime cadaver-dog handler in Florida, to bring her experienced detection dog, Shiraz, a Belgian Malinois, to the site in 2013. Shiraz and Ms. Goodhope worked the flat, brushy area for a long time. Then, Shiraz sat. Once.

“I was pretty skeptical,” Mr. Shanks said.

Nonetheless, the archaeologists dug. And dug. They went down nearly three feet — and there they found a human toe bone more than 1,300 years old.

Passing sniff tests

What is the future of using human-remains detection dogs as a noninvasive tool in archaeology?

Some archaeologists, forensic anthropologists, geologists, scientists — and even H.R.D. dog handlers who know how challenging the work is — say they have great potential. But challenges abound.

Although researchers are learning ever more about the canine olfactory system, they are still trying to pinpoint what volatile organic compounds in human remains are significant to trained dogs.

. . .

Detection dogs also must be trained for archaeology with more consistency. Often humans are the limiting factor. Sometimes, Dr. Schoon said, she can almost see a dog thinking, “Is that all you want me to do? I can do much more!”

For the full story see:

Cat Warren. “Sniffing Out New (Old) Digs.” The New York Times (Tuesday, May 19, 2020 [sic]): D1 & D6.

(Note: ellipses added.)

(Note: the online version of the story was updated May 25, 2020 [sic], and has the title “When Cadaver Dogs Pick Up a Scent, Archaeologists Find Where to Dig.”)

The academic article documenting that dogs are able use their hypercapable noses to smell ancient human remains is:

Glavaš, Vedrana, and Andrea Pintar. “Human Remains Detection Dogs as a New Prospecting Method in Archaeology.” Journal of Archaeological Method and Theory 26, no. 3 (Sept. 2019): 1106-24.

Refrigeration Preserves Three-Quarters of Food Americans Eat

(p. 10) Consider the improbable fact of the supermarket banana. In “Frostbite,” an exploration of the vast system known as the cold chain, the journalist Nicola Twilley follows the banana through a “seamless network of thermal control.” This series of refrigerated trucks, rail cars, shipping containers and warehouses ends in the ripening room, with its temperature gauges and gas immersion baths, all to meet our demand for ripe tropical fruit in all seasons. “Produce is a labor of love,” a warehouse owner tells her. “I tell people that working here is like a face tattoo — you’ve got to be really sure you want it.”

Twilley is a food and health reporter who has studied cold and refrigeration for many years.

. . .

The home refrigerator is barely a century old. Twilley is shown how simple it is to build one, and then tells us just why it took so long to figure out. Early efforts were bent toward making ice with giant and dangerous machinery; breakthroughs in the use of vacuum pumps and compressors “cut out the middleman” of the ice itself.

. . .

One story leads into another. A technology invented to dry photographic film at Eastman Kodak led first to the extraction of fish oil and, eventually, bagged salad.

. . .

. . .; I found this book hard to put down. The startling statistics — the cold chain preserves almost three-quarters of the food Americans eat; American households open the fridge door an average of 107 times a day — separate tales of unsung scientists. We meet the self-taught engineer Fred Jones, who invented the first mobile mechanical refrigeration unit, expanding the speed and size of the cold chain. Twilley also introduces the physicist Barbara Pratt, who perfected the refrigerated shipping container by traveling the world in one.

For the full review see:

Sallie Tisdale. “Freeze Frame.” The New York Times Book Review (Sunday, August 4, 2024): 9.

(Note: ellipses added.)

(Note: the online version of the review has the date June 24, 2024, and has the title “Have Refrigerators Spoiled Everything?”)

The book under review is:

Twilley, Nicola. Frostbite: How Refrigeration Changed Our Food, Our Planet, and Ourselves. New York: Penguin Press, 2024.

Florence Nightingale Used Early Infographics to Improve Hospital Hygiene

(p. A15) As she tended soldiers during the Crimean War, a British nurse found herself appalled by the wretched, vermin-infested conditions at the army’s hospital in Istanbul. She began collecting figures showing the devastating effects of the filth and the dramatic benefits of the sanitary improvements she implemented. Her presentation on the need for cleaner care facilities, published in 1858, led to reforms that ultimately saved millions of lives and increased life expectancy in the U.K. Florence Nightingale, it turns out, was a pioneering data scientist.

Data, when used to reveal the value of hospital hygiene or the harm of tobacco smoke, can be a vital force for good, as Tim Harford reminds us in “The Data Detective.”

. . .

Imprecise and inconsistent definitions are one source of confusion.  . . .  . . . “infant mortality,” a key data point for public health, varies depending on the specific time in fetal development when the line is drawn between a miscarriage and a tragically premature birth.

. . .

To learn from data, it’s essential to present it well. For her analysis after the Crimean War, Florence Nightingale created one of the first infographics, using shrewdly designed diagrams to tell a memorable story. From the outset, she regarded visually compelling data displays as indispensable to making her arguments.

. . .

An authentically open mind can make a difference, Mr. Harford says, noting that the top forecasters tend to be not experts but earnest learners who constantly take in new data while challenging and refining their hypotheses. Data, Mr. Harford concludes, can illuminate and inform as well as distract and deceive. It’s often maddeningly hard to know the difference, but it would be unforgivable not to try.

For the full review see:

David A. Shaywitz. “Bookshelf; Broadly Informed, Easily Misled.” The Wall Street Journal (Friday, Jan. 29, 2021 [sic]): A15.

(Note: ellipses added.)

(Note: the online version of the review has the date January 28, 2021 [sic], and has the title “Bookshelf; ‘The Data Detective’ Review: Broadly Informed, Easily Misled.”)

The book under review is:

Harford, Tim. The Data Detective: Ten Easy Rules to Make Sense of Statistics. New York: Riverhead Books, 2021.

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.

For the full commentary see:

David Brooks. “Death by a Thousand Paper Cuts.” The New York Times (Friday, January 18, 2024): A18.

(Note: ellipses added.)

(Note: the online version of the commentary has the date January 19, 2024, and has the title “Lessons of the Trump Assassination Attempt.”)

The article by Lowrey mentioned above is:

Lowrey, Annie. “The Time Tax; Why Is So Much American Bureaucracy Left to Average Citizens?” The Atlantic, July 27, 2021. Available at: https://www.theatlantic.com/politics/archive/2021/07/how-government-learned-waste-your-time-tax/619568/

The academic paper co-authored by Himmelstein that underlies the Reuters article cited by Brooks above is:

Himmelstein, David, Terry Campbell, and Steffie Woolhandler. “Health Care Administrative Costs in the United States and Canada, 2017.” Annals of Internal Medicine (2020) doi:10.7326/M19-2818.

The article by Howard mentioned above is:

Howard, Philip K. “Bureaucracy Vs. Democracy.” The American Interest (Jan. 31, 2019) Available at: https://www.nytimes.com/2024/01/18/opinion/american-life-bureaucracy.html?searchResultPosition=1.

The article by Edmundson mentioned above is:

Edmundson, Mark. “Good People: The New Discipline.” Liberties Journal 3, no. 4 (2023) Available at: https://libertiesjournal.com/articles/good-people-the-new-discipline/.

The two Tocqueville quotes are from Book 4, Chapter 6 of:

Tocqueville, Alexis de. Democracy in America. Chicago: University of Chicago Press, 2000 (1st ed. 1835).

Hayflick Said Lifespans Are Limited by Maximum Times Cells Can Divide (the “Hayflick Limit”)

Hayflick thought the “Hayflick limit” was a permanently binding constraint on the maximum lifespans that humans could achieve. But cancer cells provide a proof-of-concept that some cells are able to escape the limit. The challenge is to engineer cells that escape the limit without otherwise killing us. (Hayflick himself died of cancer.)

(p. A20) Leonard Hayflick, a biomedical researcher who discovered that normal cells can divide only a certain number of times — setting a limit on the human life span and frustrating would-be-immortalists everywhere — died on Aug. 1 [2024] at his home in Sea Ranch, Calif. He was 96.

His son, Joel Hayflick, said the cause was pancreatic cancer.

Like many great scientific findings, Dr. Hayflick’s came somewhat by accident. As a young scientist in the early 1960s at the Wistar Institute, a research organization at the University of Pennsylvania, he was trying to develop healthy embryonic cell lines in order to study whether viruses can cause certain types of cancer.

He and a colleague, Paul Moorhead, soon noticed that somatic — that is, nonreproductive — cells went through a phase of division, splitting between 40 and 60 times, before lapsing into what he called senescence.

. . .

This finding, which the Nobel-winning virologist Macfarlane Burnet later called the Hayflick limit, ran counter to everything scientists believed about cells and aging — especially the thesis that cells themselves are immortal, and that aging is a result of external causes, like disease, diet and solar radiation.

. . .

Dr. Hayflick made other important contributions to science. He developed a particularly vibrant cell line, WI-38, which has been used for decades to make vaccines.

. . .

The National Institutes of Health had funded the research on his WI-38 cell line but declined to fund its distribution, even as other researchers clamored for samples. Dr. Hayflick established a company to process orders, charged a minimal fee for shipping and set the proceeds aside until ownership was clarified.

But in a private report that was released to the news media, the N.I.H. accused Dr. Hayflick of theft. He sued the institute, charging invasion of privacy and reputational damage, including a forced resignation from his position at Stanford. The litigation took six years and ended in a settlement that allowed him to keep some of the money and cell samples.

During those six years, Congress passed the Bayh-Dole Act, which allows scientists to profit off government-funded research. The law, which would have made Dr. Hayflick’s earlier actions unquestionably legal, helped catalyze the biotech industry.

For the full obituary see:

Clay Risen. “Leonard Hayflick, 96, Explorer of Cells Who Showed Why No One Lives Forever.” The New York Times (Tuesday, August 20, 2024): A20.

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

(Note: the online version of the obituary was updated Aug. 19, 2024, and has the title “Leonard Hayflick, Who Discovered Why No One Lives Forever, Dies at 96.”)

Otherwise Innovative Retailers Exit Healthcare Due to “the Layers of Government”

(p. B3) Walmart, the world’s largest retailer, said Tuesday [April 30, 2024] that it was shutting down its health care centers, a network that only last year it said it planned to expand.

The retailer said in a blog post that its 51 health centers across five states would close.

. . .

Offering health care is more difficult than selling consumer goods like laundry detergent and car parts, said David Silverman, a retail analyst at Fitch Ratings, noting the layers of government and insurance providers involved.

“The attempts to enter these spaces and some of the failures of doing so really underscore the challenges and complexities of operating in the U.S. health care space,” Mr. Silverman said.

. . .

In 2021, Amazon, Berkshire Hathaway and JPMorgan Chase ended their high-profile joint health care venture, which sought to explore new ways to deliver health care to their employees. In March, Walgreens said it had closed 140 of its VillageMD clinics and planned to close 20 more.

For the full story see:

Jordyn Holman. “Walmart Is Shutting Down Health Centers in 5 States.” The New York Times (Wednesday, May 1, 2024): B3.

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

(Note: the online version of the story has the date April 30, 2024, and has the title “Walmart Is Shutting Health Centers After Plan to Expand.”)

Hygiene Hypothesis Says Parasites Help the Immune System to Develop

(p. D6) The kakapo, a large flightless parrot that can live 95 years and perhaps longer, is dangerously close to extinction. Once found throughout New Zealand, the population has dwindled to fewer than 150.

Conservation biologists are doing everything they can to keep the kakapo from vanishing. And so, when they discovered a few years ago that a pair of captive kakapos were infected with tapeworms, they did the obvious thing: They dewormed the birds.

Hamish G. Spencer, a geneticist at the University of Otago in New Zealand, thinks that was unwise. If endangered species are going to escape extinction, he argues, they may need parasites to survive.

“Some of these parasites may turn out to be quite good for their hosts,” Dr. Spencer said.

. . .

Evidence accumulated over the decades for what came to be known as the hygiene hypothesis. Supporters argued that over the past two centuries, modern civilization has radically changed our relationship with our inner residents.

For millions of years, our evolving bodies had to strike a tricky balance. We depended on a powerful immune system to fend off deadly infections. But if the immune system were to attack indiscriminately, it could destroy the body’s beneficial bacteria, for example, or damage its tissues with relentless inflammation.

According to the hygiene hypothesis, our ancestors came to tolerate low levels of infection. They even came to depend on parasites to help the immune system develop properly.

. . .

It’s possible, Dr. Spencer said, that the lack of parasites may help explain why some species restoration projects have been disappointing. “There are a number of cases where reintroduced populations haven’t done very well,” he said. “It might be that their immune systems are not very good.”

. . .

A first step, Dr. Spencer said, would be to stop medicating captive animals so freely. “We are arguing against the idea that you just dose the hell out of everything before you put animals back in the wild,” he said.

For the full story see:

Carl Zimmer. “Parasites as Welcome Guests.” The New York Times (Tuesday, April 5, 2016 [sic]): D6.

(Note: ellipses added.)

(Note: the online version of the story has the date March 31, 2016 [sic], and has the title “Tapeworms and Other Parasites Can Make Good Guests.” The paragraph that starts “For millions of years,” appears in the online version, but not in the print version.)

For more on the hygiene hypothesis see the following academic article:

Versini, Mathilde, Pierre-Yves Jeandel, Tomer Bashi, Giorgia Bizzaro, Miri Blank, and Yehuda Shoenfeld. “Unraveling the Hygiene Hypothesis of Helminthes and Autoimmunity: Origins, Pathophysiology, and Clinical Applications.” BMC Medicine 13, no. 1 (2015). DOI: https://doi.org/10.1186/s12916-015-0306-7.

Patients Lack Key Information About Our Heavily Regulated Healthcare System

Amazon is widely criticized for its size, but it is big because so many consumers choose to buy from it. Consumers value the wide selection and the quick delivery. But I hypothesize that what consumers value most is the information. Product ratings are informative. The ratings themselves are rated. Comparisons within categories are offered. Price changes can be tracked for a given product, and compared among different products. Features can be easily compared. In healthcare the government, as with HIPAA, often mandates the protection over the provision, of information. But even when healthcare information is provided, it is often provided too slowly and too obscurely to be actionable by patients. In the example discussed in the passages quoted below, quick and accurate information is literally a matter of life and death. Entrepreneurs like Jeff Bezos in a free enterprise system have the freedom and the incentive to please consumers by providing them with quick and accurate information. Bureaucrats in government or highly regulated systems, lack the freedom to violate rigid rules and are rewarded if they please their bosses by preserving the status quo.

(p. A3) After her water broke early, doctors told Fatima Goines to prepare for her newborn’s death.

Goines was 22 weeks into her pregnancy, just past the halfway mark. Doctors at Methodist Hospital in suburban Minneapolis said they couldn’t save such a premature baby and that no hospital could. They told her that once the baby girl was born, Goines could hold her until the infant died.

Goines didn’t want to give up. She checked herself out of Methodist Hospital and, on the recommendation of a fellow mom on Facebook, went to a birthing center connected to Children’s Minnesota hospital, 7 miles away from Methodist. After Goines gave birth, doctors there immediately intubated the baby to help her breathe and placed her in an incubator.

Me’Lonii is now a healthy 4-year-old, and has surpassed all the developmental milestones for her age. “She’s doing wonderfully well,” said Dr. Thomas George, who directs (p. A7) the Children’s Minnesota neonatal intensive care unit.

Medical advances over the past several decades have given hospitals the ability to save younger and younger premature newborns. Yet most hospitals don’t try—and parents often aren’t aware of what’s possible or that other hospitals, even just a few miles away, might offer their newborns a fighting chance.

Doctors are now capable of saving the lives of babies born at 22 weeks and, in rare cases, a week earlier, with improved techniques to help tiny lungs develop and protect fragile skin and organs. Hospitals with extensive experience resuscitating extremely premature babies report survival rates as high as 67% for babies born at 22 weeks.

Fragile infants

Some U.S. hospitals aren’t sufficiently equipped or capable of pulling off the new advances. Others have chosen not to offer the care, saying it is likely to fail, is expensive—typically more than $100,000 a child, and sometimes much more—and subjects tiny, fragile infants to needless pain and the risk of long-term disabilities.

Instead, they often provide comfort care: wrapping the newborn in a blanket, placing it on the mother’s chest and sometimes giving medicines to ease the child’s final moments.

The difference can be a matter of life or death for the roughly 8,000 infants born between 22 and 24 weeks gestation in the U.S. each year.

Doctors agree that babies born at 25 or 26 weeks can and should be treated as long as they don’t have other complications, while those born at 20 weeks or less are too small to save.

In between is a “gray zone,” as doctors call it, where newborns’ fate can depend on which hospital happens to be delivering.

. . .

No way to know

Rachel Sherman, a hairstylist who now lives in Florence, Ariz., wishes she had had more information.

When her water broke at 22 weeks pregnant in 2021, while she was living in Utah, the first Salt Lake City-area hospital she went to told her they couldn’t help until her baby was 24 weeks. She and her husband drove about 30 minutes to the University of Utah Hospital instead. It has a Level 3 NICU and shares a campus with a children’s hospital with a Level 4 NICU.

The staff there also told Sherman it wouldn’t save a 22-week baby and there wasn’t a neonatal unit in the U.S. that would treat an infant under 24 weeks, she recalled. But another hospital within half an hour’s drive was offering active treatment for babies at 22 weeks that year, The Wall Street Journal confirmed.

For the full story see:

Liz Essley Whyte. “A Life-or-Death Divide For Very Premature Babies.” The Wall Street Journal (Friday, Aug. 9, 2024): A1 & A7.

(Note: ellipsis added.)

(Note: the online version of the story has the date August 7, 2024, and has the title “Doctors Can Now Save Very Premature Babies. Most Hospitals Don’t Try.” The “Fragile infants” sub-heading quoted above appears in the print, but not in the online, version.)

The paper co-authored by Christensen and mentioned above, is:

Christensen, Kaare, Gabriele Doblhammer, Roland Rau, and James W. Vaupel. “Ageing Populations: The Challenges Ahead.” Lancet 374, no. 9696 (Oct. 3, 2009): 1196-208.

The 2021 paper co-authored by Vaupel and mentioned above, is:

Vaupel, James W., Francisco Villavicencio, and Marie-Pier Bergeron-Boucher. “Demographic Perspectives on the Rise of Longevity.” Proceedings of the National Academy of Sciences 118, no. 9 (2021): e2019536118.