Category: Regulations

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.)

“Trusting the Experts Is Not a Feature of Science. It’s the Opposite of Science.”

Over my desk, in the biggest font my printer will print, I have the Latin motto “Nullius in Verba.” That is the motto of the Royal Society of London, the first association for the advancement of science. In English the motto says “on no one’s word” and is usually interpreted to mean that if we are doing science we rely on evidence, and not on the authority of experts. C.S. Peirce said truth is what results from infinite inquiry. Science is a process of asking questions, not a body of unquestionable truths. During the Covid pandemic we were told to stop asking questions and blindly accept the orders of “experts” who the government identified as scientists. Citizens who valued free speech and understood Nullius in Verba rebelled.

Vaccines and antibiotics are two of the greatest achievements in medicine. But both have side-effects and risks. By denying the real side-effects and risks of Covid vaccines, the “experts” destroyed their credibility with the thinking (i.e., the scientific) public. The public’s anger at being lied to was so great that some went so far as to reject all vaccines, even in the frequent situation where on balance the benefits of the vaccine outweigh the side-effects and risks. This was the unnecessary, outrageous, and sad result of government regulators who did not value freedom and did not understand the meaning of “science.”

(p. A1) The rise of Robert F. Kennedy Jr. from fringe figure to the prospective head of U.S. health policy was fueled by skepticism and distrust of the medical establishment—views that went viral in the Covid-19 pandemic.

. . .

Lingering resentment over pandemic restrictions helped Kennedy and his “Make America Healthy Again” campaign draw people from the left and the right, voters who worried about the contamination of food, water and medicine. Many of them shared doubts about vaccines and felt their concerns were ignored by experts or regarded as ignorant.

. . .

(p. A8) Much of Kennedy’s popularity reflects residual pandemic anger—over being told to stay at home or to wear masks; the extended closure of schools and businesses; and vaccine requirements to attend classes, board a plane or eat at a restaurant.

“We weren’t really considering the consequences in communities that were not New York City,” the places where the virus wasn’t hitting as hard, former National Institutes of Health Director Francis Collins said at an event last year.

Authorities focused on ways to stop the disease and failed to consider “this actually, totally disrupts peoples’ lives, ruins the economy and has many kids kept out of school,” Collins said. The U.S. overall took the right approach, he said, but overlooking long-term consequences was “really unfortunate. That’s another mistake we made.”

. . .

. . ., Jessica Malaty Rivera, an epidemiologist with hundreds of thousands of Instagram followers, shared information on the importance of vaccines and face masks. She dismissed unsupported claims as misinformation and described some of their purveyors as grifters.

Looking back, Rivera said her sometimes scolding messages weren’t helpful. “Everybody has been tempted by the slam dunk,” she said. “It’s not an effective way to communicate science. It’s just not.” She and others say they are dialing back the use of the word misinformation, saying it makes people feel they are being called liars or dumb.

During the pandemic, Palmira Gerlach had questions about the Covid-19 vaccines, but doctors “were very dismissive,” the 44-year-old recalled.

Gerlach, a stay-at-home mother outside Pittsburgh, said she falsely told her child’s pediatrician that she got the shot, seeking to avoid judgment. The doctor told her, “Good girl.” Gerlach turned to podcasts featuring Kennedy, drawn to his willingness to question pandemic measures.

. . .

“We were all told in Covid: ‘Trust the experts.’ But that’s not a thing,” Kennedy said in an episode of the “What is Money?” podcast in April [2024]. “Trusting the experts is not a feature of science. It’s the opposite of science. It’s not a feature of democracy.”

For the full story see:

Liz Essley Whyte. “How Science Lost America’s Trust.” The Wall Street Journal (Thursday, Nov. 21, 2024): A1 & A8.

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

(Note: the online version of the story has the date November 19, 2024, and has the title “How Science Lost America’s Trust and Surrendered Health Policy to Skeptics.” In passages where the online version is more detailed, I quote from the online version.)

Drugs for Dog Longevity May Also Aid Human Longevity

Dogs have long contributed to advances in human medicine. For instance C. Walton Lillehei experimented on dogs to develop his path-breaking human open-heart operations (see the book King of Hearts). What pains me about those dog contributions is that the dogs themselves died in the experiments. In the more recent dog contributions to human medicine, as discussed in the passages quoted below, the dogs themselves have a good chance to benefit as they contribute to human health. I like that a lot better.

(p. A11) In the quest to help people live longer, scientists and companies are turning to dogs.

. . .

Behind the growing enthusiasm is a mix of scientists and entrepreneurs—building on the surging interest from people aiming to live longer. These groups say insights into dog longevity could provide lessons and perhaps eventually treatments that could help people, too.

. . .

On Tuesday [Nov. 28, 2023], a biotech startup that’s hoping to have the first FDA-approved treatment to extend healthy lifespan in dogs, took a step toward that goal. In a letter viewed by The Wall Street Journal, the Food and Drug Administration affirmed that its drug had demonstrated “reasonable expectation of effectiveness.”

The company, called Loyal, still has to complete several more steps before it can market the drug, and it’s only aimed at canines.

. . .

Celine Halioua, chief executive of Loyal, the biotech startup working toward conditional approval of its lifespan drug, says there is a larger aim in addition to helping dogs live healthier for longer. The company has set a possible precedent for other drugs to be approved for lifespan extension, potentially opening a door for other animal—or human—drug companies to follow.

“I think we can both take the opportunity to build better medicines for our dogs and also to better understand these really complex diseases,” says Halioua, whose own 85-pound Rottweiler mix, Della, is nearing the end of her projected lifespan.

The firm’s drug is an injectable that is designed to reduce levels of IGF-1, a hormone that drives cell growth, in large dogs. High blood levels of IGF-1 have been associated with shorter lifespans in some animal and human studies.

The company’s research has indicated that the drug can reduce those hormone levels, but it would still need a large clinical trial demonstrating it can extend dog lifespans in order to achieve full FDA approval. It also needs the agency’s signoff on the drug’s safety and proper manufacturing before getting conditional approval and beginning to sell it, which Loyal hopes to do in 2026.

Still, the FDA nod this week is a promising next step for the field, dog aging researchers say, and will likely drive more interest from biotech and pharmaceutical companies.

“If it is proven that the drug is effective in dogs then there is a higher chance that it will work in the case of humans, too,” says Eniko Kubinyi, a biologist studying dog behavior and cognition with the Budapest-based Family Dog Project.

For the full story see:

Alex Janin. “Secrets of Anti-Aging, Gleaned From Dogs.” The Wall Street Journal (Thursday, Nov. 30, 2023 [sic]): A11.

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

(Note: the online version of the story has the date November 29, 2023 [sic], and has the title “The Clues to Longer Life That Are Coming From Dogs.” The last four paragraphs quoted above appeared in the more detailed online version, but not the print version, of the article. Some of the earlier quoted sentences are quoted in the longer form that appeared in the online version.)

The biography of Lillehei mentioned in my opening comments above is:

Miller, G. Wayne. King of Hearts: The True Story of the Maverick Who Pioneered Open Heart Surgery. New York: Crown, 2000.

Innovative Medical Project Entrepreneur Alan Scott “Coaxed” the F.D.A. to Approve Botox

Even though Alan Scott may have been a “lousy businessman,” he appears nonetheless to still have been an important innovative medical project entrepreneur. (I have not yet read the book discussed in the passages quoted below, but I hope to read it soon. Besides my admiration for innovative project entrepreneurs, an added reason that I am interested in the book is that I have always suffered from esophoria, which is one form of the strabismus that Alan Scott was trying to treat.)

(p. C9) Today botulinum toxin—purified, diluted and known as Botox—nets annual sales in the billions. It is used to treat everything from wrinkles to migraines, yet the pioneer largely responsible for fulfilling Kerner’s prophecy and bringing botulinum into medicine is virtually unknown. He was, it turns out, a laconic Bay Area ophthalmologist named Alan Scott, a self-described “lousy businessman” who barely recouped his own expenses as he coaxed the product to FDA approval.

Eugene Helveston seeks to rescue Scott from oblivion in “Death to Beauty,” a pandemic passion project and labor of love. As an ophthalmologist “of the same era,” Dr. Helveston knew Scott professionally and participated as a researcher in the original clinical trial of botulinum in the mid-1980s. Recognizing that only a few people were still around who could “tell the story firsthand,” Dr. Helveston resolved to document this medical history and corresponded with Scott from June 2021 until Scott’s death six months later, at age 89. The result is an absorbing insider’s account of an exceptional journey.

. . .

Scott was especially interested in strabismus, a disorder characterized by misaligned eyes. The condition was usually treated with surgery, with often disappointing results. Scott began to wonder if strabismus could be treated without surgery by injecting a substance that would weaken a specific eye muscle and thus help restore alignment. It was this line of research that led him to contemplate botulinum, which he requested and received from Schantz in 1972, delivered by the Postal Service in a sealed metal container. Fatefully, he reported promising results in animal models the next year without first filing a patent, which meant that his valuable intellectual property went unprotected.

To enable human testing, Scott submitted an application to the FDA in 1974; the document “lay on some FDA desk for almost four years,” he told Dr. Halversten, before a nudge from a colleague re-engaged the agency. Scott received testing authorization in 1978 and injected the first human subject with a low test dose to evaluate safety. There were no complications, and the trial proceeded.

. . .

Though Botox never gained much traction for the treatment of strabismus, the drug’s other uses lifted it to blockbuster status. Scott received only modest compensation for his foundational work, yet by all accounts he had no regrets. Allergan may have “got all the money,” he said, but “we had all the fun.”

For the full review see:

David A. Shaywitz. “Toning Up With a Toxin.” The Wall Street Journal (Saturday, Dec. 17, 2024): C9.

(Note: ellipses added.)

(Note: the online version of the review has the date February 9, 2024, and has the title “‘Death to Beauty’ Review: The Birth of Botox.”)

The book under review is:

Helveston, Eugene M. Death to Beauty: The Transformative History of Botox. Bloomington, IN: Indiana University Press, 2024.

Price Controls on Drugs Reduce Drug Innovation

Price controls on drugs may reduce some short-term healthcare costs for consumers, but will also reduce the innovation that brings us more cures, less pain, and fewer side effects. If we want to both reduce costs for consumers and increase innovation, we should end government mandates for the Phase 3 clinical trials–the phase of clinical trials that make up most of the cost of gaining regulatory approval.

(p. A19) The Biden White House has proposed requiring Medicare to “negotiate” drug prices.

. . .

Unfortunately, the debate is being informed by erroneous Congressional Budget Office analysis. CBO says . . . the supply of new drugs will only be reduced by 5% from 2021 to 2039, a loss of only two drugs a year.

The CBO minimizes the harmful effects on innovation, but the entire supply chain that funds medical R&D relies on rate-of-return assessments driven by future earnings. An analysis I released this week finds 10 times the effect on R&D, a loss of up to some 340 drugs over the same period.

The White House also claims that price controls won’t hamstring innovation because they only govern top-selling drugs. But the occasional blockbuster funds the roughly 90% of pipeline drugs that never pass Food and Drug Administration review. CBO even acknowledges that only the top 7% of Medicare drugs drive U.S. profits. Targeting financially successful drugs could make large segments of the development portfolio unprofitable, even if such drugs aren’t affected by price controls.

For the full commentary see:

Tomas J. Philipson. “Biden’s Price Controls Will Make Good Health More Expensive.” The Wall Street Journal (Thursday, Sept. 16, 2021 [sic]): A19.

(Note: ellipses added.)

(Note: the online version of the commentary has the date September 15, 2021 [sic], and has the same title as the print version.)

The research brief co-authored by Philipson and mentioned above is:

Philipson, Tomas J., and Troy Durie. “The Evidence Base on the Impact of Price Controls on Medical Innovation.” Issue Brief. Becker Friedman Institute, University of Chicago, Sept. 14, 2021.

Supporting Philipson’s argument is a 2024 working paper showing that Medicare-mandated price cuts in medical equipment has resulted in less innovation in medical equipment:

Ji, Yunan, and Parker Rogers. “The Long-Run Impacts of Regulated Price Cuts: Evidence from Medicare.” NBER Working Paper #33083, Oct. 2024.

To End Drug Shortages Make Healthcare a Free Market

Drug shortages are sometimes blamed on the free market. A bum rap. In a free market when supply declines or demand increases, prices rise, and the increase in price incentivizes a greater quantity supplied, eventually ending a short-run period where quantity demanded at the going price exceeds quantity supplied at the going price (in other words, a shortage). But healthcare in America is far from a free market. Every aspect is highly regulated. Prices are negotiated, often by middlemen called (Pharmacy Benefit Managers, aka PBMs), entry is not free, and the demanders (patients) often do not know (or care) about the prices, since they are paid by a third party (insurers, employers, or the government). Perverse incentives abound.

(p. A26) There’s been a bombardment of bad news for drug supplies. The American Society of Health-System Pharmacists found this summer that nearly all of the members it surveyed were experiencing drug shortages, which generally affect half a million Americans. Cancer patients have scrambled as supplies of chemotherapy drugs dwindle. Other shortages include antibiotics for treatable diseases, such as the only drug recommended for use during pregnancy to prevent congenital syphilis (a disease that is 11 times more common today than a decade ago), and A.D.H.D. medications, without which people struggle to function in their day-to-day lives. The toll on Americans is heavy.

Over half of the shortages documented this summer by health consulting firm IQVIA had persisted for more than two years. But even though drug shortages affect millions of Americans, policymakers and industry leaders have provided little to no long-term relief for people in need.

Shortages have occurred regularly since at least the early 2000s, when national tracking began. Hundreds of drugs, in every major therapeutic category, have been unavailable for some period. The average drug shortage lasts about 1.5 years. Even when substitute medications are available, they may be suboptimal (for example, deaths by septic shock rose by 10 percent during a 2011 shortage of the first-line medication, norepinephrine) or have spillover effects (such as possibly increasing the risk of antimicrobial resistance). In addition to harming patients, shortages have cost health systems billions of dollars in increased labor and substitute medications.

. . .

Large hospital chains can readily monitor shortage risks and preemptively place large orders. This panic buying can wipe out inventory, and leave hospitals with fewer resources strapped since they may get notice of a drug shortage only when it’s too late. There is little penalty for over-ordering because unused drugs can often be returned.

. . .

Addressing the underlying fragility of our essential drug supply will take structural change and investments. While all industries must grapple with how to build resilient supply chains, the pharmaceutical industry is unique. The people who are most affected by supply chain vulnerabilities — patients — are also those with least say in the choice to buy from reliable manufacturers. When people buy cars, they may pay more based on company reputation, ratings by outside testers and reviews from other customers. In contrast, patients bear the harm of drug shortages, yet they cannot choose the manufacturers of their essential drugs nor evaluate their reliability.

For the full commentary see:

Emily Tucker. “We’re Stuck in a Constant Cycle of Drug Shortages.” The New York Times (Thursday, December 7, 2023 [sic]): A26.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Dec. 6, 2023 [sic], and has the title “America Is Having Yet Another Drug Shortage. Here’s Why It Keeps Happening.”)