Category: Regulations

Mainstream Approach to Alzheimer’s Is Built on Doctored Data

Widespread fraud among highly credentialled, and richly financed, medical researchers results in fewer and slower cures. Many millions of dollars are required to bring a major drug to market, much of it due to the hyper-costly and mandated Phase 3 randomized double-blind clinical trials. There are more good ideas than can received such financing. The intense competition creates a temptation to cut various corners, as the book review quoted below emphasizes.

Aaron Rothstein, the reviewer of Piller’s Doctored book, emphasizes the sad revelation of widespread fraud. But in an earlier entry on this blog, I quoted an essay of Piller’s that suggests that Piller also has something substantive to say about how to cure Alzheimer’s. The current system is broken, vastly reducing the diversity of approaches to curing important diseases like Alzheimer’s. Piller suggests that the ruling clique among Alzheimer’s researchers may in effect be silencing other approaches that could bring us a better faster cure.

Rothstein downplays this substantive aspect of Piller’s book. (It probably reflects too much cynicism on my part to wonder how close Rothstein himself is to the ruling clique?)

I look forward to reading Piller’s book, both for what it has to say about widespread fraud and for what it has to say about Alzheimer’s. Doctored is scheduled for release in a few days, on February 4, 2025.

(p. C9) In 2023 my colleagues and I were preparing to enroll patients in a clinical trial of a new drug that promised to mitigate brain damage in stroke victims. The National Institutes of Health, a governmental organization that funds billions of dollars of research every year, had committed $30 million to the trial. The drug was, in part, the brainchild of Berislav Zlokovic, a neuroscientist at the University of Southern California.

Then, suddenly, the NIH paused the trial. Charles Piller, an investigative journalist for Science magazine, had published an article alleging that multiple papers from Dr. Zlokovic, including many supporting the new drug, contained seemingly altered data. Though Dr. Zlokovic disputed some of the concerns, this news stunned us. We might have put patients at risk, while offering groundless hope. A fraud of the sort Mr. Piller described would violate the basic ethics of clinical trials and overturn the presumption of trust on which the practice of medicine relies.

I thought of this episode often as I read Mr. Piller’s “Doctored,” which brings together his long-form journalism about neuroscience-research malfeasance, including that alleged of Dr. Zlokovic. Though the book sometimes attempts to do too much—diving into scientific theories about the causes of Alzheimer’s, for example—its strength lies in Mr. Piller’s dramatic and damning investigation of scientific transgression. The author’s reporting is largely based on the research of Matthew Schrag, a Vanderbilt neurologist who uses technical expertise to identify episodes of misconduct.

. . .

Mr. Piller thoroughly double checks Dr. Schrag’s work. He asks researchers and image analysts to confirm Dr. Schrag’s findings, and they concur.

. . .

“Doctored” demonstrates how some of the most accomplished and elite scientific gatekeepers may have lied, cheated, squandered trust and endangered lives. How did this happen? The temptations of ego and fame perennially entice humans, but our system of peer review, grant funding and administrative oversight is meant to check these temptations.

The scientific publication process does not contain all the safeguards one might expect. Peer reviewers do not always see the original data from authors. Thus they trust that numbers or images in a manuscript accurately reflect the experiment. And determining whether an image is fraudulent requires skilled image analysis that peer reviewers may not possess. Furthermore, digging for such mistakes is costly: It takes time away from other research, from teaching, from seeing patients and from home life.

What can be done about this? Making raw data available to peer reviewers and giving them time to review articles could help. Mr. Piller suggests a less professionally incestuous relationship between researchers, the Food and Drug Administration, the NIH and pharmaceutical companies could reduce favoritism in funding. A major overhaul of the finances and administrative swell of our system would help, as well.

For the full review see:

Aaron Rothstein. “Medical Promise Betrayed.” The Wall Street Journal (Saturday, Jan. 25, 2025): C9.

(Note: the online version of the review has the date January 24, 2025, and has the title “‘Doctored’ Review: Medical Promise Betrayed.”)

The book under review is:

Piller, Charles. Doctored: Fraud, Arrogance, and Tragedy in the Quest to Cure Alzheimer’s. New York: Atria/One Signal Publishers, 2025.

Surgeons Respond More to Individual Incentives Than to Group Incentives

Medicare introduced a new billing code that reimburses surgeons more for repairing hernias that are at least 3 cm long. As a result the percent of repaired hernias that were less than 3 cm dropped from 60% to 49%. It is probably not too hard for surgeons to justify this change. Probably surgeries on hernias just under 3 cm, are just as hard to do as surgeries on hernias that are just above 3 cm. So probably it seems arbitrarily unfair to reimburse more for the slightly larger ones. So look at the close calls closer until you find an angle where one that on first glance was less than 3 cm, now appears to be more than 3 cm.

On the other hand, consider the response when Blue Cross Blue Shield in Michigan offered to pay more to urology group practices that had more patients on active surveillance for prostate cancer. (A growing consensus suggests that most low-risk prostate cancer patients would be better off with active surveillance, rather than quick prostate surgery by urologists.) The response by Michigan urologists–no change in the percent of prostate cancer patients on active surveillance.

Why the difference? I suggest that surgeons, like other people, respond more to individual incentives than to group incentives. A person who responds to group incentives bears the costs themselves, but shares the benefits with others who may be free-riders. If the incentive is individual, no one free rides.

I became aware of the recent academic articles on how incentives do or don’t influence surgeons by reading:

Millenson, Michael L. “It’s Money That Changes Everything (or Doesn’t) for Surgeons.” Forbes.com, Jan. 26, 2025 [cited Jan 27, 2025]. Available from https://www.forbes.com/sites/michaelmillenson/2025/01/26/its-money-that-changes-everything-or-doesnt-for-surgeons/ .

The academic article showing that individual incentives matter to some surgeons is:

Hallway, Alexander, Erin Isenberg, Ryan Howard, Sean O’Neill, Jenny Shao, Leah Schoel, Michael Rubyan, Anne Ehlers, and Dana Telem. “Medicare Coding Changes and Reported Hernia Size.” JAMA (published online on Jan. 16, 2025).

The academic article showing that group incentives don’t seem to matter to surgeons is:

Srivastava, Arnav, Samuel R. Kaufman, Addison Shay, Mary Oerline, Xiu Liu, Monica Van Til, Susan Linsell, Corinne Labardee, Christopher Dall, Kassem S. Faraj, Avinash Maganty, Tudor Borza, Kevin Ginsburg, Brent K. Hollenbeck, and Vahakn B. Shahinian. “Physician Payment Incentives and Active Surveillance in Low-Risk Prostate Cancer.” JAMA Network Open 8, no. 1 (Jan. 8, 2025): e2453658-e58.

At Age 84 Scolnick Has the Passion to Persevere at Curing His Son’s Illness

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. A1) Dr. Edward Scolnick figures he needs five, maybe 10 more years to solve one of the brain’s greatest mysteries.

Scolnick, 84 years old, has spent most of the past two decades working to understand and find better ways to treat schizophrenia and bipolar disorder, mental illnesses suffered by tens of millions of people, including his son.

“I know I can crack it,” said Scolnick, a noted drug developer who spent his career plumbing the building blocks of DNA for new treatments.

Long before his latest quest, Scolnick spent 22 years at Merck, mostly as head of the drug giant’s laboratory research. He led development of more than two dozen medicines, including the first approved statin to lower cholesterol, an osteoporosis treatment and an anti-HIV therapy.

. . .

(p. A9) In 2021, Scolnick learned that a group of scientists analyzing DNA from thousands of people with schizophrenia had found mutations in 10 genes that substantially increased the risk of developing the illness. They estimated that a mutation on a single gene, called Setd1a, raised the risk 20-fold.

“It got my blood boiling,” Scolnick said. He began pursuing an emerging class of treatments called LSD1 inhibitors, hoping to develop a new drug. Scolnick enlisted Dr. Hugh Young Rienhoff Jr., who recently developed an LSD1 inhibitor to treat blood disorders.

. . .

Rienhoff anticipates testing a new drug for safety as early as next year, first in animals. He said he saw Scolnick’s passion about fielding a breakthrough treatment but didn’t fully understand why until Scolnick shared about his son’s lifelong struggles with mental illness.

Jason Scolnick, 54, said his doctor has been regularly fine-tuning his medications for bipolar disorder over the years to minimize their debilitating side effects. Using the drugs currently prescribed for schizophrenia or bipolar disorder is like undergoing chemotherapy, he said. “There’s no guarantee it will work and it makes you feel terrible, but the cancer will feel worse or kill you.”

There remains a long road ahead for any new medicine. It takes more than a decade, on average, to get a drug from the research lab through government approvals to patients.

. . .

After leaving Merck, Scolnick was hired in 2004 by the Broad Institute of MIT and Harvard to lead research on psychiatric disorders. He fostered ties with Ted Stanley, a memorabilia entrepreneur whose son also suffered with mental illness. In 2007, Stanley gave $100 million to launch the Stanley Center for Psychiatric Research at the Broad, headed by Scolnick for five years.

. . .

Scolnick and Rienhoff had sat together at a Blackstone dinner years earlier. During the meal, Scolnick shared stories with his table companions about Merck’s development of Crixivan, the anti-HIV drug. “I was hearing a piece of history,” Rienhoff said, “not just HIV history.”

Scolnick became emotional describing how the drug developers, facing various obstacles, wrestled with whether or not to keep going. He pushed for the study to continue, given the urgency. At the time, AIDS was killing tens of thousands of people a year in the U.S.

“I said to Ed, ‘You are thinking like a doctor not a scientist,’” Rienhoff said. “That was the beginning of our relationship.”

. . .

Rienhoff has a team of chemists making and testing compounds at labs in the U.S. and abroad.

“I am optimistic something will come of this,” Rienhoff said. “I can do it, but I wouldn’t have done it if not for Ed. I am, really, doing this in a way for Ed.”

. . .

Biotech company Oryzon Genomics in Spain is developing LSD1 inhibitors for cancer and other conditions. Columbia University researchers tried Oryzon’s drug in mice and found it reversed cognitive impairments caused by the Setd1a genetic mutation connected to schizophrenia. Oryzon is running a small trial in Spain of the LSD1 inhibitor in patients with schizophrenia.

Dr. Joseph Gogos, who led the Columbia research, said it was possible such treatments would be approved for people.

Scolnick is more certain—of both a revolutionary new treatment and his living to witness it.

“Before I die, we will see new medicines, new diagnostics, better outcomes for patients burdened by schizophrenia or bipolar illness,” he said. “I will not be happy to die. But I will die happy that my life helped.”

For the full story see:

Amy Dockser Marcus. “Aging Scientist Races Against Time.” The Wall Street Journal (Friday, Nov. 29, 2024): A1 & A9.

(Note: ellipses added.)

(Note: the online version of the story has the date November 26, 2024, and has the title “A Scientist’s Final Quest Is to Find New Schizophrenia Drugs. Will He Live to See Them?”)

Patients Are Too Patient About the Time They Waste in Worthless Healthcare

Healthcare appointments are often too numerous, too time-consuming, too stressful, and too harmful. Journalist Paula Span, often citing the words and research of MD Ishani Ganguli, presents this as an outrageous revelation. Dr. Ganguli tells us “there are opportunity costs” and “you don’t have infinite time, energy and attention” (Ganguli as quoted in Span 2024, p. D3). Outrageous it is, but to few of us is it a revelation. Patients know because they experience. If they are smart (I am often stupid) they will stifle their complaints so they do not annoy their care-givers. But care-givers know also. Those implementing the time-wasting or onerous practices are not evil. But they often do not have the incentive, or sometimes even the power, to change.

Every time I go into a doctor’s office, I am weighed. I always ask, “Do you want me to take my shoes off?” The nurse or medical assistant always shrugs and says they do not care. If my weight mattered, shouldn’t it be taken consistently, either always with shoes on or shoes off? I have had my weight taken countless times but I cannot remember a single time when the doctor mentioned the weight measure from earlier in the appointment. Prescription lists are endlessly requested, even by those who do the prescribing. Many lab tests are done out of the inertia of routine. In many hospitals sleeping patients are interrupted by a “care-giver” who comes in and performs a routine task, like asking them how much pain they are feeling. The “care-giver” records the answer and departs, taking no other action, but in the meantime diminishing the healing sleep of the patient. Tasks of this sort must be damaging to the morale of the care-giver. They signed up to do good, not to do harm. But they must do harm to follow the mandated protocol, or they risk being punished.

Why do these practices continue? Because they have been done in the past. No one will be rewarded for dropping them, and the care-giver who fails to do them is at risk of being criticized or punished. In a non-entrepreneurial, litigious, and highly regulated system, much that is done is not done for the benefit of the patient. It is done for CYA (“Cover Your Ass”).

But hope abides. We could deregulate healthcare. Then doctors could tell their nurses to only take the patient’s weight when it is actually needed. Hospital entrepreneurs could tell staff to only ask patients of their pain when they are awake and complaining of pain. Options in healthcare would be more diverse. But some of the options would actually make sense. Care-givers providing options that make sense would expand their own practice and be imitated by others. We would have better care and less wasted time.

The commentary by Paula Span, mentioned above, is:

Paula Span. “Too Much Time Spent on Doctors.” The New York Times (Tuesday, November 26, 2024): D3.

(Note: the online version of Span’s commentary has the date Nov. 23, 2024, and has the title “So Many Days Lost at the Doctor’s Office.”)

An academic article co-authored by Ganguli presents empirical evidence on how much time patients spend in healthcare activities:

Ganguli, Ishani, Emma D. Chant, E. John Orav, Ateev Mehrotra, and Christine S. Ritchie. “Health Care Contact Days among Older Adults in Traditional Medicare: A Cross-Sectional Study.” Annals of Internal Medicine 177, no. 2 (Feb. 2024): 125-33.

In an academic op-ed piece, Ganguli justly laments how the healthcare system often wastes patients’ time, sometimes even resulting in worse health. She uses the example of the severe cardiac side-effects from the eight weeks of Monday through Friday radiation that her 81-year-old father was given for his recently discovered prostate cancer:

Ganguli, Ishani. “How Does Health Care Burden Patients? Let Me Count the Days.” New England Journal of Medicine 391, no. 10 (Sept. 7, 2024): 880-83.

Keep Raging at “the Dying of the Light”

I still remember as an undergraduate at Wabash College reading in our intro psychology textbook of an experiment in which a dog was put in a box. Every time the dog tried to leap out of the box, he received an electric shock. Eventually the electric current was turned off. But the dog never again tried to leap. Are we like the dog, too discouraged by past constraints, so that we are resigned to accept the Biblical limit of “three score and 10” (Psalm 90:10)?

But there is a paradox. Kloc cites an article claiming a very high market value for expanded lifespans. But then where are the voters urgently demanding that medical entrepreneurs be unbound? Where are the citizens demanding that regulators stop mandating Phase 3 clinical trials? Citizens with a sense of urgency can make a difference–see the Act-Up movement in the early years of AIDs. When will they?

(p. 1) The longevity industry is coming off perhaps its best run on record. The expected span of an American life has increased by about three decades since 1900 — to around 78 as of 2023. But for many people, even 78 years just won’t do.

The Methuselah Foundation, a biomedical charity, for example, wants to “make 90 the new 50,” and scientists at one biotechnology firm have argued that, unencumbered by disease, the body could potentially make it all the way to age 150. Even more optimistic estimates put the number closer to 1,000.

​​Whatever the maximum human life span may be, people appear increasingly determined to find it — in particular men, who are more inclined to favor radically extending life, maybe even indefinitely. Last year, nearly 6,000 studies of longevity made their way onto PubMed, a database of biomedical and life sciences papers; that’s almost five times as many as two decades ago.

Along with the creation of dozens of popular podcasts and a sizable supplement industry, that zeal has led to efforts to preserve organs, search out life-extending diets and even try to reverse aging itself.

. . .

(p. 24) Researchers at Harvard and Oxford recently tried to gauge that interest in the marketplace today. They estimated that the total value of any scientific breakthrough that added another decade to global life expectancy would be worth $367 trillion.

For the full story see:

Joe Kloc. “Gilgamesh, Ponce and the Quest to Live Forever.” The New York Times, First Section (Sunday, January 19, 2025): 1 & 24.

(Note: ellipsis added.)

(Note: the online version of the story has the date Jan. 18, 2025, and has the title “The Centuries-Old, Incredibly Male Quest to Live Forever.”)

When Kloc mentions estimates of possible human lifespan “closer to 1,000” he links to a Scientific American interview with João Pedro de Magalhães, professor of biogerontology at England’s University of Birmingham. João Pedro de Magalhães believes that in principle humans could live to 1,000:

Gifford, Bill. “How Old Can Humans Get?” Scientific American (July 31, 2023). Available from https://www.scientificamerican.com/article/how-old-can-humans-get/.

When Kloc says that some “even try to reverse aging itself” he links to:

Poganik, Jesse R., Bohan Zhang, Gurpreet S. Baht, Alexander Tyshkovskiy, Amy Deik, Csaba Kerepesi, Sun Hee Yim, Ake T. Lu, Amin Haghani, Tong Gong, Anna M. Hedman, Ellika Andolf, Göran Pershagen, Catarina Almqvist, Clary B. Clish, Steve Horvath, James P. White, and Vadim N. Gladyshev. “Biological Age Is Increased by Stress and Restored Upon Recovery.” Cell Metabolism 35, no. 5 (2023): 807-20.

Kloc also links to estimates of the economic value of extending lifespans by one year, and by a decade, as given in:

Scott, Andrew J., Martin Ellison, and David A. Sinclair. “The Economic Value of Targeting Aging.” Nature Aging 1, no. 7 (July 2021): 616-23.

“Rage, rage against the dying of the light” is a line from Dylan Thomas’s poem “Do Not Go Gentle Into That Good Night.”

Ozempic 25 Years Sooner Would Have Saved and Improved Many Lives

Apparently Ozempic had been discovered in the late 1980s and could have been on the market roughly 25 years ago. Pfizer decided that the likely potential revenues were not sufficient to justify the huge costs. But what if the costs had not been so huge? For instance what if we adopted the proposal suggested by Milton Friedman, and advocated by me, to stop mandating hyper-expensive Phase 3 clinical trials to prove efficacy? (The mandates to prove safety through Phase 1 and Phase 2 trials would be retained.) With lower costs, Pfizer might have moved forward. Or if Pfizer had not, some other firm probably would have entered the breach sooner. If Ozempic had been available sooner, by now it would be much cheaper. Many lives would have been saved that have been lost. Other lives would have been healthier and happier.

(p. A26) They called 2023 the year of Ozempic, but it now seems GLP-1 drugs might define an entire decade — or an even longer era. The game-changing drugs, which mimic the hormone GLP-1, offer large benefits for not just diabetes management and especially weight loss but also, apparently, heart and kidney and liver disease, Alzheimer’s and dementia, Parkinson’s and addiction of all kinds. And perhaps because of widespread use of the drugs, the obesity epidemic in America may finally and mercifully be reversing.

But of all the things we learned this year about GLP-1s, the most astonishing could be that the revolution might have started decades earlier. Researchers identified the key breakthrough for GLP-1 drugs nearly 40 years ago, it turns out, long before most Americans had even heard the phrase “obesity epidemic.”

This summer, a former dean of Harvard Medical School, Jeffrey Flier, published a long personal reflection that doubled as an alternate history of what may well be the most spectacular and impactful medical breakthrough of the century so far. In 1987, Flier co-founded a biotech start-up that pursued GLP-1 as a potential treatment for diabetes, not long after it had first been identified by researchers who’d also found that the hormone enhanced insulin secretion in the presence of glucose.

The startup obtained worldwide rights to develop GLP-1 as a metabolic therapy from a group of those researchers, based at Massachusetts General Hospital. They even generated clinical results that suggested it might have promise as a weight-loss drug as well — only to have Pfizer, which had agreed to fund the research, withdraw its support, without providing the researchers with an especially satisfying explanation. Instead, Pfizer told Flier and his partners that the company didn’t believe there would be a market for another injectable diabetes treatment after insulin. Well, Flier tells me, “they were wrong.”

. . .

. . . Flier’s memoir is not just a lament for what might have been. In the aftermath of the pandemic emergency, as citizens and officials alike have embraced a more libertarian attitude toward public health, there’s been a similar drift in the public conversation about drug discovery and development. Operation Warp Speed is often held up as a new model — calls for an Operation Warp Speed 2.0 have been followed by those for an Operation Warp Speed for everything — . . .

Many of the same reformers will complain about all the red tape at the F.D.A. and C.D.C., tallying up huge mortality costs imposed by slow-moving government, arguing for human challenge trials in which individuals volunteer to take untested drugs and be deliberately infected and even talking about the invisible graveyard of unnecessary regulation and delay.

This is all fine and good — there are surely lots of things those agencies can speed up. And in recent years, reformers of various stripes have lobbied some worthy additional proposals into the biomedical zeitgeist — for a system based not on patents but on huge and direct cash prizes for medical breakthroughs, for instance, or one helped along by advance market commitments or benevolent patent extensions. Just last week the researchers Willy Chertman and Ruxandra Tesloianu published “The Case for Clinical Trial Abundance,” an invigorating manifesto for drug development reform.

. . . in focusing on government bureaucracy as the major biomedical bottleneck, we are seeing just one piece of the picture and overlooking what is perhaps the central challenge of research and development — that it is, at present, so complicated that difficulties or bad decisions at any stage can stifle the whole decades-long process, distorting the actual medical and public-health functions of drug development in countless ways.

For the full commentary see:

David Wallace-Wells. “We Could Have Had Ozempic Years Ago.” The New York Times, SundayOpinion Section (Sunday, Jan. 5, 2025): 11.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Dec. 25, 2024, and has the title “Pfizer Stopped Us From Getting Ozempic Decades Ago.”)

Dr. Flier’s published “memoir” mentioned above is:

Flier, Jeffrey S. “Drug Development Failure: How GLP-1 Development Was Abandoned in 1990.” Perspectives in Biology and Medicine 67, no. 3 (Summer 2024): 325-36.

“The Clinical Trial Manifesto” mentioned above is the introductory essay in the compilation referenced below. Another essay that looks promising in the compilation is “Unblocking Human Challenge Trials for Faster Progress.”

Chertman, Willy, and Ruxandra Tesloianu, eds. The Case for Clinical Trial Abundance: A Series of Short Papers Outlining Reform Possibilities for Our Nation’s Clinical Trials. Washington, DC: The Institute for Progress (IFP), 2024.

To Kill a Dam, Environmentalist “Scientists” Lied About the Existence of the So-Called “Snail Darter”

In the 1970s the building of a dam in Tennessee was delayed because environmentalists claimed that its construction would threaten the extinction of a small fish they called the “snail darter.” Now fish biologists have established that there is no snail darter. The fish previously identified as a “snail darter” has the DNA of a small fish called a “stargazing darter” which was not, and is not, endangered.

A co-author of a new study says that this was no innocent mistake.

Dr. Near, . . . a professor who leads a fish biology lab at Yale, and his colleagues report in the journal Current Biology that the snail darter, Percina tanasi, is neither a distinct species nor a subspecies. Rather, it is an eastern population of Percina uranidea, known also as the stargazing darter, which is not considered endangered.

Dr. Near contends that early researchers “squinted their eyes a bit” when describing the fish, because it represented a way to fight the Tennessee Valley Authority’s plan to build the Tellico Dam on the Little Tennessee River, about 20 miles southwest of Knoxville.

“I feel it was the first and probably the most famous example of what I would call the ‘conservation species concept,’ where people are going to decide a species should be distinct because it will have a downstream conservation implication,” Dr. Near said.

In other words environmentalist “scientists” deliberately lied in order to promote their political agenda of cutting energy production.

The New York Times article quoted above is:

Jason Nark. “How a Mistaken Identity Halted a Dam’s Construction.” The New York Times (Sat., Jan. 4, 2025): A13.

(Note: ellipsis added.)

(Note: the online version of The New York Times article was updated Jan. 4, 2025, and has the title “This Tiny Fish’s Mistaken Identity Halted a Dam’s Construction.”)

The academic paper co-authored by Near, that Nark summarizes in The New York Times article mentioned and cited above is:

Ghezelayagh, Ava, Jeffrey W. Simmons, Julia E. Wood, Tsunemi Yamashita, Matthew R. Thomas, Rebecca E. Blanton, Oliver D. Orr, Daniel J. MacGuigan, Daemin Kim, Edgar Benavides, Benjamin P. Keck, Richard C. Harrington, and Thomas J. Near. “Comparative Species Delimitation of a Biological Conservation Icon.” Current Biology. Published online on Jan. 3, 2025.

In 2023, Costs of Medical Care Rose 40% Faster Than Overall Inflation

If rising healthcare costs were clearly due to improving health outcomes, few would be angry. The anger arises from rising fraud, inefficiency, and inertia. Many healthcare workers are paper pushers and the paper pushed is often inaccurate and opaque. Other healthcare workers enforce protocols that slow innovation. And of course mandated regulations, most notably Phase 3 clinical trials, enormously increase costs.

(p. A3) The killing of a health insurance executive in New York City prompted a furious outpouring of anger over the industry and healthcare prices. So just how much have healthcare costs and spending been going up?

The short answer: a lot. National healthcare spending increased 7.5% year over year in 2023 to $4.867 trillion, or $14,570 per person, according to data released Wednesday by the Centers for Medicare and Medicaid Services.

. . .

The 7.5% rise represented a much faster pace of growth than the 4.6% increase in 2022.

. . .

Over the past couple of decades, the price index for what the Labor Department classifies as medical care—which includes visits to doctors, hospital stays, prescription drugs and medical equipment—has risen roughly 40% faster than the overall pace of inflation. Healthcare tends to rise more quickly than overall inflation because of high labor costs in the sector, as well as advancements leading to new and more expensive drugs and treatments. Demand for healthcare is also increasing as the population ages.

. . .

Hospitals are . . . adding billions of dollars in “facility fees” to medical bills for routine care at outpatient centers, according to reporting by The Wall Street Journal. That means patients are often paying hundreds of additional dollars for standard care like colonoscopies, mammograms and heart screenings.

. . .

Employers are shouldering a lot of those costs. For example, the average worker spent $6,296 in premiums for family coverage in 2024, according to KFF [a healthcare nonprofit]. Employers spent $19,276.

But when a company is paying more for insurance premiums for its workers, that leaves it with less money for giving out raises or reinvesting and expansion.

“It’s ultimately all of us who pay for [healthcare] either in the form of lower wages for people who have employer insurance or in the form of higher taxes to cover Medicare and Medicaid,” said Katherine Baicker, professor of health economics at the University of Chicago.

For the full story see:

Harriet Torry. “Nation’s Healthcare Tab Is Surging Amid Rising Wages, Hospital Fees.” The Wall Street Journal (Friday, Dec. 20, 2024): A3.

(Note: ellipses added. The first bracketed words were added by me; the second bracketed word was in the original.)

(Note: the online version of the story was updated December 18, 2024, and has the title “Why Are Americans Paying So Much More for Healthcare Than They Used To?” Where there is a slight difference in wording between the print and online versions, the passages I quote above follow the online version.)

The source for some of the data discussed in The New York Times article appears to have been:

“National Health Expenditures 2023 Highlights.” Centers for Medicare & Medicaid Services (CMS), Last modified on Dec. 18, 2024.

Higher Fluoride in Water Correlated with Lower I.Q. in Children

When I was young, in the 1960s, I remember my family opposing the government fluoridation of the South Bend, Indiana water supply, even though our dentist, Dr. Stan Severyn, who we liked and respected, was in favor of fluoridating South Bend water. We thought that when consumed in water, fluoride was a cumulative poison, and we thought the dental benefits of fluoride could be obtained through applying fluoride directly to the teeth (as Dr. Severyn did to my teeth) or through the careful use of fluoridated toothpaste.

My memory is that the South Bend city council overwhelmingly approved adding fluoride to the city waster. My family was in a small minority and our views were widely dismissed. But small minorities are not always wrong. See The New York Times article quoted below. Or see the history of medicine more broadly, for instance when Ignaz Semmelweis was in a small minority suggesting that physicians returning from dissections in the morgue should wash their hands before delivering babies.

When our daughter Jenny was very young, I read that very young children often accidentally swallow toothpaste when they start brushing their own teeth. Then, as now, almost all toothpaste contained fluoride. So when Jenny reached the age of brushing I searched the shelves of several Omaha stores seeking non-fluoridated toothpaste. I finally found a couple of tubes, imported from Sweden I think, in a now defunct store called The Drug Emporium. Jenny used that toothpaste until she was old enough to reliably spit out the toothpaste after brushing.

[In the passages quoted below, “JAMA” stands for The Journal of the American Medical Association which, along with The New England Journal of Medicine and The Lancet, is widely considered to be one of the handful of top medical journals in the world. JAMA Pediatrics is one of several JAMA-associated field journals.]

(p. 19) Water fluoridation is widely seen as one of the great public health achievements of the 20th century, credited with substantially reducing tooth decay. But there has been growing controversy among scientists about whether fluoride may be linked to lower I.Q. scores in children.

A comprehensive federal analysis of scores of previous studies, published this week in JAMA Pediatrics, has added to those concerns. It found a significant inverse relationship between exposure levels and cognitive function in children.

Higher fluoride exposures were linked to lower I.Q. scores, concluded researchers working for the National Institute of Environmental Health Sciences.

. . .

The subject is so divisive that JAMA Pediatrics commissioned two editorials with opposing viewpoints to publish alongside the report.

In one, Dr. Steven M. Levy, a public health dentist at the University of Iowa, said that many of the studies included in the analysis were of very low quality.

. . .

In a second editorial published alongside the new study, a public health expert, Dr. Bruce P. Lanphear, noted that as far back as 1944, the editor of The Journal of the American Dental Association expressed concern about adding fluoride, which he termed “a highly toxic substance,” to drinking water. He wrote that “the potentialities for harm far outweigh those for good.”

Some studies have suggested that dental health has improved not because fluoride was added to water, but because of fluoridated toothpastes and better dental hygiene practices.

. . .

Some 74 studies from 10 countries, including China, Mexico, Canada, India and Denmark, were examined. Dr. Lanphear noted that the consistent links between fluoride and I.Q. were found in very different populations.

He urged the U.S. Public Health Service to set up a committee, perhaps one that does not include researchers who have studied the subject in the past and can take a fresh look at the topic, to examine two questions seriously: whether fluoride is neurotoxic, and whether it is as beneficial for oral health as it is believed to be.

“If that doesn’t happen urgently, my concern is there will be growing distrust of public health agencies amid the public, and they will have deserved it,” he said.

For the full story, see:

Roni Caryn Rabin. “High Fluoride Exposure Is Linked to Lower I.Q. In Children, Study Finds.” The New York Times, First Section (Sunday, January 12, 2025): 19.

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

(Note: the online version of the story has the date January 8, 2025, and has the title “Study Links High Fluoride Exposure to Lower I.Q. in Children.”)

The JAMA Pediatrics academic article mentioned above is:

Taylor, Kyla W., Sorina E. Eftim, Christopher A. Sibrizzi, Robyn B. Blain, Kristen Magnuson, Pamela A. Hartman, Andrew A. Rooney, and John R. Bucher. “Fluoride Exposure and Children’s IQ Scores: A Systematic Review and Meta-Analysis.” JAMA Pediatrics (published online on Jan. 6, 2025).

During the Covid Pandemic, “Public Health Officials Could Not Be Trusted to Tell the Whole Truth”

From the review quoted below, Rivers’s book is refreshingly open about the downsides of public health actions against epidemics. But in the end, I infer that Rivers still gives pride of place to public health actions in fighting epidemics. She wants public health actions to be reformed but believes that public health officials will be and should be the dominant actors during epidemics. I, to the contrary, believe that innovative medical entrepreneurs will be and should be the dominant actors. I believe that partly because medical entrepreneurship respects human liberty, while public health official commands do not respect human liberty, but also partly because medical entrepreneurship is more effective at ending epidemics.

(p. A15) As recently as 2019, confides Caitlin Rivers, an epidemiologist at Johns Hopkins, “I was confident that we knew how to navigate, if not control, a pandemic.” But within a year “that hubris was laid bare.” Covid-19 “overran us,” leaving in its wake a striking loss of confidence in public health.

“Crisis Averted” is Ms. Rivers’s ambitious and, given its charge, surprisingly successful attempt to reset our relationship with the field of public health. With a judicious blend of candor, hopefulness and pragmatism, she calls out its mistakes, reminds us of its historic accomplishments and emphasizes the need for the discipline to adjust its strategies if its full promise is to be realized.

. . .

. . . for every public-health triumph there are heartbreaking disappointments. In 2010, a lack of clean water and adequate sanitation allowed a cholera epidemic to rampage through Haiti after a catastrophic earthquake; worse, the disease, not endemic in the region, arrived through foreign aid workers. Human error was also responsible for the last recorded smallpox fatality, a medical photographer in the U.K. who died after the virus leaked from a sloppy lab on the floor below.

. . .

Animating much of Ms. Rivers’s narrative and analysis is the Covid-19 pandemic, a crisis that, as she laments, wasn’t averted.  . . .  She . . . describes early advice from public-health officials claiming that mask use was “not recommended” and “should be avoided” as “odd and brittle assertions that did not hold up to the slightest scrutiny” and left many with the impression that “public health officials could not be trusted to tell the whole truth.”

. . .

After years of relentless insistence that we “follow the science,” it’s refreshing to hear an expert illuminate all that remains unknown—from the vagaries of the common cold to the vexing challenge of coaxing healthy behavior change. Most epidemics of the past century, Ms. Rivers points out, “took forms that were slightly off-center from what epidemiologists expected”—the recent pandemic, for example, was caused not by an influenza virus, as anticipated, but rather by a coronavirus. Her advice: Expect a surprise.

For the full review see:

Shaywitz, David A. “Bookshelf; What the Doctors Ordered.” The Wall Street Journal (Wednesday, Oct. 2, 2024): A15.

(Note: ellipses added.)

(Note: the online version of the review has the date October 1, 2024, and has the title “Bookshelf; ‘Crisis Averted’ Review: What the Doctors Ordered.”)

The book under review is:

Rivers, Caitlin. Crisis Averted: The Hidden Science of Fighting Outbreaks. New York: Viking, 2024.

Medicare “Advantage” Health Insurers (Especially UnitedHealth) Pressure Doctors to Recode Patients as Having Bogus, but Lucrative, Health Problems

The “advantage” in Medicare “Advantage” health insurance plans accrues to health insurance companies, not to patients or taxpayers. In an earlier entry I discussed an earlier Wall Street Journal article documenting how health insurers (especially UnitedHealth) sent nurses to patients’ homes for the purpose of harvesting diagnoses that would add to the health insurers’ payments. In an even earlier entry I discussed a Wall Street Journal article documenting how UnitedHealth has used vertical integration to game the system of Medicare “Advantage.”

(p. A1) Like most doctors, Nicholas Jones prefers to diagnose patients after examining them. When he worked for UnitedHealth Group, though, the company frequently prepared him a checklist of potential diagnoses before he ever laid eyes on them.

UnitedHealth only did that with the Eugene, Ore., family physician’s Medicare Advantage recipients, he said, and its software wouldn’t let him move on to his next patient until he weighed in on each diagnosis.

The diagnoses were often irrelevant or wrong, Jones said. UnitedHealth sometimes suggested a hormonal condition, secondary hyperaldosteronism, that was so obscure Jones had to turn to Google for help. “I needed to look it up,” he said.

The government’s Medicare Advantage system, which uses private insurers to provide health benefits to seniors and disabled people, pays the companies based on how sick patients are, to cover the higher costs of sicker patients. Medicare calculates sickness scores from information supplied by doctors and submitted by the insurers. In the case of UnitedHealth, many of those doctors work directly for UnitedHealth.

More diagnoses make for higher scores—and larger payments. A Wall Street Journal analysis found sickness scores increased when patients moved from traditional Medicare to Medicare Advantage, leading to billions of dollars in extra government payments to insurers.

Patients examined by doctors working for UnitedHealth, an industry pioneer in directly employing large numbers of physicians, had some of the biggest increases in sickness scores after moving (p. A8) from traditional Medicare to the company’s plans, according to the Journal’s analysis of Medicare data between 2019 and 2022.

Sickness scores for those UnitedHealth patients increased 55%, on average, in their first year in the plans, the analysis showed. That increase was roughly equivalent to every patient getting newly diagnosed with HIV, the virus that causes AIDS, and breast cancer, the analysis showed.

That far outpaced the 7% year-over-year rise in the sickness scores of patients who stayed in traditional Medicare, according to the analysis. Across Medicare Advantage plans run by all insurers, including UnitedHealth, scores for all newly enrolled patients rose by 30% in the first year.

. . .

In a series of articles this year [2024], the Journal has examined the practices of Medicare Advantage companies, including UnitedHealth, the largest. Among other things, the articles showed how diagnoses added by insurers increased payments from the government.

. . .

Jones, the Oregon doctor, said UnitedHealth didn’t suggest diagnoses for patients he treated outside Medicare Advantage, where it doesn’t pay.

Traditional Medicare patients treated by UnitedHealth doctors had much lower sickness scores, the Journal’s analysis showed.

A case of hyperaldosteronism—the obscure hormonal condition that sometimes appeared on Jones’s checklists—could trigger about $2,000 a year in Medicare Advantage payments during the period the Journal studied. The Journal’s analysis showed that doctors who didn’t work for UnitedHealth seldom diagnosed that condition, which involves elevated levels of a hormone linked to high blood pressure.

. . .

“The system is not primarily about taking care of the patient,” said Dr. Emilie Scott, who worked for a UnitedHealth-owned practice in California before leaving in 2016. “It’s, how do you get the money to flow?”

The Journal analysis is based on billions of Medicare records obtained under a research agreement with the federal government. The Journal also examined internal documents from medical practices owned by or under contract with UnitedHealth.

. . .

When Dr. Naysha Isom started working at a UnitedHealth medical group in the Las Vegas area in 2019, she said, she got two days of training on how to record diagnoses. At the training, a UnitedHealth employee suggested that Isom, who had practiced for more than a decade, should consider diagnoses she had never made before.

Isom said she was told that signs of bruising could be recorded as senile purpura, a condition that generated payments in Medicare Advantage but generally didn’t require treatment. Isom saw no point, since the finding didn’t change patients’ care: “OK, wear some sunscreen. Maybe stop bumping the wall.”

After she decided not to diagnose peripheral artery disease, a narrowing of blood vessels, based on a screening test she distrusted, she said, a supervisor pressed her to reconsider. UnitedHealth didn’t require her to make diagnoses, she said.

“You’re just encouraged to, because obviously, if you don’t, they come bothering you,” said Isom, who left UnitedHealth to start her own practice in 2022.

UnitedHealth’s doctors in the Journal’s analysis diagnosed the bruising condition, which triggered extra payments of about $1,900 a year at the time, 28 times more often with patients in UnitedHealth Medicare Advantage plans than those in traditional Medicare.

. . .

Jones, the former UnitedHealth doctor in Oregon, said the suggestions included diagnoses based on scant evidence, such as long-term insulin use for patients who had received the drug only once during a long-ago hospital stay.

. . .

The design of the system, he said, could lead to good-faith errors as doctors clicked through all the boxes. “The system is made to have these happy little accidents that end up resulting in a lot of money from taxpayers,” he said.

. . .

Andy Pasternak, an independent family doctor in Reno, Nev., has lower-than-average sickness scores across his practice, records show. He said he gets a per-patient bonus of $2 a month, or $2,256 annually, for the 94 Medicare Advantage patients covered by his contract with UnitedHealth.

Pasternak said UnitedHealth offered to send nurses to visit those patients to diagnose them more fully. The company would pay him $250 for each patient their nurses examined, he said.

“That’s more than I get paid for treating my own patients,” he said. He said the focus on diagnosing has soured him on Medicare Advantage, and made him grateful when patients younger than 65 come to his office.

One UnitedHealth document reviewed by the Journal projected Pasternak could receive as much as $23,250 a year in such payments. A UnitedHealth executive in his area told him in an email his practice also would benefit from any additional diagnoses made by the nurse.

Valerie O’Meara, a former UnitedHealth nurse practitioner, said she never provided treatment for the patients she saw in doctors’ offices in Washington state. “Your job is finding diagnoses, that was clear as a bell,” she said. “I was like, am I finding all these things that the doctors who are taking care of these people didn’t find?”

She said a Minnesota-based UnitedHealth manager urged her to make new diagnoses beyond what doctors had treated. Patients were often confused, she said, about why she, not their own doctor, was examining them. “They don’t tell the patient, the nurse needs to see you to make sure your high-scoring medical problems are checked off this year.”

Chris Henretta, a UnitedHealth Medicare Advantage plan member who lives in The Villages, a retirement community in central Florida, was suspicious when his primary-care doctor diagnosed him as morbidly obese during his annual exam in October.

He is a lifelong weightlifter, plays water volleyball five times a week and has an athletic build.

“I told her I didn’t think I was obese,” Henretta said. When she recorded morbid obesity anyway, he said, he began to “suspect my doctor may have a financial incentive to portray people as higher risk.”

The diagnosis can trigger payments of about $2,400 a year to Medicare Advantage insurers.

For the full story see:

Christopher Weaver, Anna Wilde Mathews and Tom McGinty. “UnitedHealth’s Army of Doctors Helped It Boost Medicare Payments.” The Wall Street Journal (Tuesday, Dec. 31, 2024): A1 & A8.

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

(Note: the online version of the story has the date December 29, 2024, and has the title “UnitedHealth’s Army of Doctors Helped It Collect Billions More From Medicare.” In the passages I quote above, I do not include any of the subheadings that appeared in both the online and print versions of the article.)