Category: Health

Nonprofit Hospitals Get $60 Billion in Annual Tax Breaks in Order to Aid the Poor, but Often Use High-Pressure Opaque Tactics to Collect Full Payment

(p. A1) Nonprofit hospitals must have financial-assistance policies for needy patients, under federal requirements tied to an estimated $60 billion in annual tax breaks.

They often make that aid hard to get. Hospitals put up obstacles, delay checking eligibility and sometimes press for payments that aren’t refunded even if a patient eventually gets qualified for assistance.

That is according to a Wall Street Journal analysis of thousands of nonprofit hospital policies in filings to the Internal Revenue Service and posted by hospitals, as well as thousands of pages of internal documents from government hospitals obtained through public-record requests and the experiences of dozens of advocates and patients who have (p. A9) applied for aid.

. . .

An earlier Journal analysis of Medicare filings highlighted how little of nonprofit hospitals’ billions in revenue goes toward financial help for low-income patients. The new analysis uncovered the barriers many hospitals place in the way of patients who should qualify for assistance—even under the hospitals’ own criteria.

Under tax laws, nonprofit hospitals are set up to function as charities benefiting their communities. Government facilities, whose policies the Journal also looked at, are also intended to serve the public, though they aren’t subject to all the same IRS requirements as private nonprofits. The Journal found that many of these hospitals act like for-profit businesses in their efforts to get paid, even by those who can’t afford it.

. . .

Separate from the analysis of nonprofit hospitals’ IRS documents, the Journal also obtained internal documents on patient-billing procedures from large state and local government hospitals, including academic medical centers, through public-records requests. These hospitals share a similar mission with private nonprofits to serve communities.

The thousands of pages of procedures, scripts and other training material for hospital staff give an inside look at how some hospitals routinely push patients toward payment, including through installment plans that may come with interest. The guidelines often play down or don’t raise the option of financial assistance. Adding to the pressure, these tactics are often deployed before the patient gets care.

In a document titled “Collections Scripting for Non-Emergent Visits,” used by Georgia-based Augusta University Health System, staffers are supposed to start by requesting the entire amount due from the patient, saying, “How would you like to take care of that today?”

For the full story, see:

Anna Wilde Mathews, Andrea Fuller and Melanie Evans. “Some Hospitals Skimp on Aid.” The Wall Street Journal (Friday, Nov. 18, 2022): A1 & A9.

(Note: ellipses added.)

(Note: the online version of the story has the date November 17, 2022, and has the title “Hospitals Often Don’t Help Needy Patients, Even Those Who Qualify.”)

Cardiologist Braunwald Transformed Treatment of Heart Attacks

The book praised by Collison is about one of the founders of modern cardiology. David McCullough praised the book as “splendid.” Others did too.

(p. C6) We recently started Arc, a new biomedical research organization, and I’ve been digging into the early days of other institutions. Thomas Lee’s “Eugene Braunwald and the Rise of Modern Medi-(p. C7)cine” stood out.

For the full review, see:

Patrick Collison. “12 Months of Reading; Patrick Collison.” The Wall Street Journal (Saturday, Dec. 10, 2021): C6-C7.

(Note: the online version of the review has the date December 8, 2022, and has the title “Who Read What in 2022: Political and Business Leaders.”)

The book praised by Patrick Collison is:

Lee, Thomas H. Eugene Braunwald and the Rise of Modern Medicine. Cambridge, MA: Harvard University Press, 2013.

Regulations Block CRISPR Cures

(p. 6) Scientists like me can now visualize an ideal scenario for the future of CRISPR medicines: When a 3-month-old starts to develop antibiotic-resistant infections, her primary care doctor orders a DNA test, and 48 hours later, ‌‌the faulty gene that is preventing the development of a normal immune system is identified. “Not a problem. We will refer your child for corrective CRISPR therapy,” says the physician to the devastated parents.

. . .

(p. 7) ‌To make CRISPR cures a reality, the biomedical community needs to start with regulation. For treatments developed for genetic diseases that affect tens of thousands of people (or, say, if a company tries to take on heart disease, which affects millions), the Food and Drug Administration has a well-established, yearslong review process. But the F.D.A. needs to consider a new regulatory process that could create a more streamlined path for bringing much-needed CRISPR medicine tailored to patients with a one-of-a-kind genetic typo. There is precedent for this: Starting in the late 1990s, the F.D.A. facilitated regulatory pathways for innovation of a then-new class of genomic medicines for cancer — CAR-T therapy — which is now widely used clinically. The same can be done for CRISPR.

For the full commentary, see:

Fyodor Urnov. “We Can Edit A Person’s DNA. So Why Don’t We?” The New York Times, SundayOpinion Section (Sunday, December 11, 2022): 6-7.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date Dec. 9, 2022, and has the title “We Can Cure Disease by Editing a Person’s DNA. Why Aren’t We?”)

So-Called “Inflation Reduction Act” Reduces Incentive for Pharma Firms to Seek Approval for New Uses of Drugs


(p. A17) It may take years before we can fully appreciate the impact of the Inflation Reduction Act on the pharmaceutical industry, but we’re already getting signs of the damage. While Democrats boast that they’ve given Medicare the power to “negotiate” drug prices, the effect has been to saddle manufacturers with a complex and ill-conceived price-setting scheme. In response, many have canceled drug-development programs, resulting in an unfortunate but predictable loss for patients nationwide.

One poorly crafted provision is driving companies away from research into treating rare diseases. In its Oct. 27 earnings statement, Alnylam announced it is suspending development of a treatment for Stargardt disease, a rare eye disorder, because of the company’s need “to evaluate impact of the Inflation Reduction Act.” Alnylam’s decision turns on a provision in the Democrats’ bill that exempts from price-setting negotiations drugs that treat only one rare disease. The company’s drug is currently marketed as treating only amyloidosis, and thus is exempt from Medicare’s price setting. If Alnylam proceeded with research into treating Stargardt, it would lose its exemption.

That disincentive might be most pronounced in cancer treatments. On Tuesday [Nov. 1, 2022], Eli Lilly announced it is canceling work on a drug that had been undergoing studies for certain blood cancers. “In light of the Inflation Reduction Act,” the company wrote to Endpoints News, “this program no longer met our threshold for continued investment.”

. . .

Nearly 60% of oncology medications approved a decade ago received additional approvals in later years. The new law eliminates the incentive to conduct additional research, because its price-setting mechanisms kick in after nine years for small-molecule drugs and 13 years for biologics, regardless of how much research companies conduct after the drug’s initial approval.

For the full commentary, see:

Joe Grogan. “The Inflation Reduction Act Is Already Killing Potential Cures.” The Wall Street Journal (Saturday, Nov. 4, 2022): A17.

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

(Note: the online version of the commentary has the date November 3, 2022, and has the same title as the print version.)

Dogs Can Accurately Know by Smell When a Human Is Stressed


(p. C4) Dogs are champion sniffers, equipped with 100 to 300 million olfactory receptors in their noses—compared with a mere 6 million in our own—and an olfactory cortex 40 times as large as ours. They can be trained to detect disease in human beings, including cancer cells, a latent epileptic seizure, or a Covid infection, just by sniffing—no blood samples, biopsies, MRIs, antigen or PCR tests required.

. . .

In a study published in September in the journal PLoS One, Ms. Wilson and colleagues tested whether dogs can read and respond to our emotional states, without the benefit of facial expression, tone of voice, or social context. The researchers trained four dogs to detect and react to the smell of human stress, depending on their sense of smell alone to distinguish between a person’s baseline scent and the unique cocktail of volatile organic compounds (VOCs) in their sweat and breath when they’re feeling stressed out.

. . .

The results offered overwhelming confirmation that dogs can smell psychological states as well as physical ones. On average, the four dogs picked out the stress sample 94% of the time, with individual dogs ranging between 90% and 97% accuracy. “There’s a smell to stress,” Ms. Wilson concludes. “If we can add it to the dog’s repertoire, we can use it to identify anxiety and panic attacks before they occur.”

For the full commentary, see:

Susan Pinker. “MIND AND MATTER; Dogs Can Sniff Out When a Human Is Stressed.” The Wall Street Journal (Saturday, Oct. 22, 2022): C4.

(Note: ellipses added.)

(Note: the online version of the commentary has the date October 20, 2022, and has the title “MIND AND MATTER; Dogs Can Sniff Out Human Stress.”)

Pharmacy Benefit Managers (PBMs) Create Incentives to Reduce Hiring and Pay of Pharmacists

(p. A1) If any group of workers might have expected their pay to rise last year, it would arguably have been pharmacists. With many drugstores dispensing coronavirus tests and vaccines while filling hundreds of prescriptions each day, working as a pharmacist became a sleep-deprived, lunch-skipping frenzy — one in which ornery customers did not hesitate to vent their frustrations over the inevitable backups and bottlenecks.

“I was stressed all day long about giving immunizations,” said Amanda Poole, who left her job as a pharmacist at a CVS in Tuscaloosa, Ala., in June. “I’d look at patients and say to them, ‘I’d love to fill your prescriptions today, but there’s no way I can.’”

Yet pay for pharmacists, who typically spend six or seven years after high school working toward their professional degree, fell nearly 5 percent last year after adjusting for inflation. Dr. Poole said her pay, about $65 per hour, did not increase in more than four years — first at an independent pharmacy, then at CVS.

For many Americans, one of the pandemic’s few bright spots has been wage growth, with pay rising rapidly for those near the bottom and those at the top. But a broad swath of workers in between has lagged behind.

. . .

(p. A16) Pharmacies also faced external challenges. To hold down the cost of prescription drugs, insurance companies and employers rely on so-called pharmacy benefit managers to negotiate discounts with drugmakers and pharmacies. Consolidation among benefit managers gave them more leverage over pharmacies to drive prices lower. (CVS merged with a large benefits manager in 2007.)

Big drugstore chains often responded by trying to rein in labor costs, according to William Doucette, a professor of pharmacy practice at the University of Iowa. Several pharmacists who worked at Walgreens and CVS said the formulas their companies used to allocate labor resulted in low levels of staffing that were extremely difficult to increase.

According to documents provided by a former CVS pharmacist, managers are motivated by bonuses to stay within these aggressive targets.

. . .

In most cases, an industry without enough workers to meet customer demand would simply hire more, or at least raise wages to attract them.

Yet, according to the Bureau of Labor Statistics, neither of those things happened last year. The number of pharmacists employed in the United States dropped about 1 percent from 2020 to 2021. On balance, employers did not raise wages — in fact, median pay fell slightly, even without adjusting for inflation.

. . .

Several pharmacists said they were especially concerned that understaffing had put patients at risk, given the potentially deadly consequences of mix-ups. “It was so mentally taxing,” said Dr. Poole, the Tuscaloosa pharmacist. “Every day, I was like: I hope I don’t kill anyone.”

. . .

Asked about safety and staffing, CVS and Walgreens said they had made changes, like automating routine tasks, to help pharmacists focus on the most important aspects of their jobs.

Many pharmacists contacted for this article quit rather than face this persistent dread, often taking lower-paying positions.

Still, none had regrets about the decision to leave. “I was 4,000 pounds lighter the moment I sent my resignation email in,” said Dr. Wommack, who left the company in May 2021 and now works at a small community hospital.

As for the medication she had taken for depression and anxiety while at Walgreens, she said, “Shortly after I stopped working there, I stopped taking those pills.”

For the full story, see:

Noam Scheiber. “Why Working At Pharmacies Lost Its Luster.” The New York Times (Tuesday, September 13, 2022): A1 & A16.

(Note: ellipses added.)

(Note: the online version of the story has the same date as the print version, and has the title “How Pharmacy Work Stopped Being So Great.”)

Federal Government Botches Distribution of Monkeypox Vaccine

“A protest outside the San Francisco Federal Building . . .” Source of photo and caption: online version of the article quoted and cited below. (The wording of the caption is different in the online and print versions.)

(p. A1) Roughly 5,000 doses of monkeypox vaccine intended for Fort Lauderdale, Fla., left the national stockpile’s warehouse in Olive Branch, Miss., on July 19 [2022]. They somehow ended up in Oklahoma.

Then Tennessee. Then Mississippi again. Then, finally, Florida.

In Idaho, a shipment of 60 vaccine doses disappeared and showed up six days later, refrigerated rather than frozen, as needed. Another 800 doses sent to Minnesota — a significant portion of the state’s total allotment — were unusable because the shipment was lost in transit for longer than the 96-hour “viability window.”

The federal government’s distribution of monkeypox vaccine has been blemished by missteps and confusion, burdening local officials and slowing the pace of immunizations even as the virus spreads, according to interviews with state health officials and documents obtained by The New York Times.

Officials in at least 20 states and jurisdictions have complained about the delivery of the vaccine, called Jynneos. (More than half are led by Democrats, including California, Washington, Connecticut and Michigan, suggesting that their grievances are not politically motivated.)

“This is happening everywhere,” said Claire Hannan, exec-(p. A17)utive director of the Association of Immunization Managers, a nonprofit group that represents state, local and territorial officials.

“Our response is completely inefficient and breaking the back of state and local responders,” she added. Ms. Hannan said she had never “seen this level of frustration and stress.”

. . .

. . . Jynneos is being disbursed from the National Strategic Stockpile by a different government agency under the Department of Health and Human Services. That agency was never set up to take ongoing orders, arrange deliveries from the stockpile, track shipments or integrate with state systems.

Instead, the stockpile was designed to deliver massive amounts of vaccine to each state in response to a catastrophic event, according to a federal official with knowledge of the stockpile’s operations.

For the full story, see:

Apoorva Mandavilli. “States Blame Federal Mix-Ups As Monkeypox Shots Are Lost.” The New York Times (Tuesday, August 16, 2022): A1 & A17.

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

(Note: the online version of the story has the date Aug. 15, 2022, and has the title “‘Frustration and Stress’: State Officials Fault Rollout of Monkeypox Vaccine.”)

“Advances in Gene Sequencing” Have Not “Unlocked the Key to Cures for Cancer”

(p. 10) In his new book, “The Song of the Cell,” Siddhartha Mukherjee has taken on a subject that is enormous and minuscule at once. Even though cells are typically so tiny that you need a microscope to see them, they also happen to be implicated in almost anything to do with medicine — and therefore almost anything to do with life.

. . .

If Mukherjee were another kind of storyteller — tidier, if less honest — he could have showcased a more linear narrative, emphasizing how developments in cell research have yielded some truly amazing possibilities. He himself has been collaborating on a project to engineer certain cells in the immune system so that they eat tumors without stirring up an indiscriminate inflammatory response.

But as a practicing physician, he has seen too much suffering and death to succumb to an easy triumphalism. He recalls the “exuberance” of the mid-2000s, when spectacular advances in gene sequencing had made it appear as if “we had unlocked the key to cures for cancer.” Such exuberance turned out to be fleeting; the data from clinical trials were “sobering.”

Many medical mysteries remain unsolved. If the book’s protagonist — our understanding of cell biology — seemed to be riding high again on new advances in immunology, such “self-assuredness” was laid low by the Covid-19 pandemic. Mukherjee presents a string of questions that are still unsettled. “The monotony of answers is humbling, maddening,” he writes. “We don’t know. We don’t know. We don’t know.”

For the full review, see:

Jennifer Szalai. “Building Blocks.” The New York Times Book Review (Sunday, November 13, 2022): 10.

(Note: ellipsis added.)

(Note: the online version of the review was updated Nov. 2, 2022, and has the title “Siddhartha Mukherjee Finds Medical Mystery — and Metaphor — in the Tiny Cell.”)

The book under review is:

Mukherjee, Siddhartha. The Song of the Cell: An Exploration of Medicine and the New Human. New York: Scribner, 2022.

Through Evolution, Body Parts Are Inelegantly Repurposed into Workaround Kluges

If the body itself is an amalgam of workaround kluges, then maybe our regulators should be more tolerant of medical MacGyvers who attempt to keep the body working through medical workaround kluges.

(p. A15) Mr. Pievani is a professor of biology at the University of Padua. His brief and thoughtful book (translated from the Italian by Michael Gerard Kenyon) isn’t just a description of imperfection, but a paean to it. There’s plenty of description and discussion, too, as “Imperfection” takes the reader on a convincing whirlwind tour of the dangers as well as the impossibility of perfection, how imperfection is built into the nature of the universe, and into all living things—including ourselves.

. . .

Readers wanting to get up to speed on imperfection would do well to attend to two little-known words with large consequences. The first is “palimpsest,” which in archaeology refers to any object that has been written upon, then erased, then written over again (sometimes many times), but with traces of the earlier writings still faintly visible. Every living thing is an evolutionary palimpsest, with adaptations necessarily limited because they’re built upon previous structures.

Consider, for example, childbirth. As smart critters, we’ve been selected (naturally) to have big heads. But in becoming bipedal, we had to rotate our pelvises, which set limits on the size of the birth canal. As a result, an unborn baby’s head is perilously close to being too big to get out. Usually, they manage it, but not without much painful laboring and sometimes, if this cephalopelvic disproportion is too great, or if the baby is malpositioned, by means of a cesarean delivery. In such cases, obstetricians take the newborn out the obvious way: through that large, unobstructed abdominal space between pelvis and lower ribs. Things would have been much easier and safer for mother and baby if the birth canal were positioned there, too, but our palimpsest nature precludes such a straightforward arrangement.

Which brings us to our second unusual word: “kluge,” something—assembled from diverse components—that shouldn’t work, but does. A kluge is a workaround: often clumsy, inelegant, inefficient, but that does its job nonetheless. Because we and all other living things are living palimpsests, we are kluges as well.

For the full review, see:

David P. Barash. “BOOKSHELF; Unintelligent Design.” The Wall Street Journal (Wednesday, October 26, 2022): A15.

(Note: ellipsis added.)

(Note: the online version of the review has the date October 25, 2022, and has the title “BOOKSHELF; ‘Imperfection’ Review: Unintelligent Design.”)

The book under review is:

Pievani, Telmo. Imperfection: A Natural History. Translated by Michael Gerard Kenyon. Cambridge, MA: The MIT Press, 2022.

Medical Entrepreneurs “Muster the Courage and Determination to Forge Brazenly Ahead”

(p. C7) The accidental birth and stuttering development of cell biology is the focus of Siddhartha Mukherjee’s “The Song of the Cell.” It is an audacious, often mesmerizing, frequently dizzying, occasionally exhausting and reliably engaging tour of cell biology and scientific inquiry. Dr. Mukherjee, an oncologist at Columbia University and the author of “Emperor of All Maladies: A Biography of Cancer” (2010), enthusiastically instructs and, much of the time, delights—all the while hustling us across a preposterously vast and intricate landscape.

. . .

In the course of describing the evolution of cell biology, Dr. Mukherjee reminds us of the critical role of technological innovation, like the microscopes used by Leeuwenhoek and Hooke, which first revealed the existence of the cellular world. Similarly, it was the invention of the electron microscope, and its deliberate application to biology by pioneering Rockefeller University scientist George Palade, that afforded researchers the resolution needed to examine the components of an individual cell.

. . .

Dr. Mukherjee’s dual roles as clinical oncologist and cell biologist find a common voice as he grapples with the complexity of cancer, “cell biology visualized in a pathological mirror.” He notes the heterogeneity of tumors, observing that while “two ‘breast cancers’ may look identical under the pathologist’s microscope,” the cancers may differ genetically and require different treatments. Even a single breast tumor, he writes, “is actually a collage of mutant cells—an assembly of non-identical diseases.” Because of the maddening similarity between cancer cells and normal cells, targeting cancer can be challenging: A promising therapy may fail, as it did for one of his friends, because it also attacks healthy cells.

Ultimately, Dr. Mukherjee seems to decide, we must accept, rather than rationalize away, the baffling idiosyncrasies that we observe in cell biology and see reflected in the behavior of cancers. Why did his friend’s cancer spread to some organs but spare others? Why did the treatment his friend received eliminate tumors in the skin but not the lungs? “There are mysteries beyond mysteries,” he writes, and he cautions us against succumbing to reductionist explanations. Cells, by themselves, are “incomplete explanations for organismal complexities.” We must understand the context in which a cell exists, he emphasizes, its local environment. Even then, he admits, we often “don’t even know what we don’t know.”

Dr. Mukherjee’s hard-won lessons contain a message for us all: We should resist simple, universal explanations in life science—cell biology, in particular, is rarely that cooperative. The journey he relates also reminds us to appreciate the researchers who, despite the unforgiving and rarely predictable terrain before them, muster the courage and determination to forge brazenly ahead.

For the full review, see:

David A. Shaywitz. “Fantastic Voyage Within.” The Wall Street Journal (Saturday, October 29, 2022): C7.

(Note: ellipses added.)

(Note: the online version of the review has the date October 28, 2022, and has the title “‘The Song of the Cell’ Review: Fantastic Voyage Within.”)

The book under review is:

Mukherjee, Siddhartha. The Song of the Cell: An Exploration of Medicine and the New Human. New York: Scribner, 2022.

With Both Covid and Monkeypox, C.D.C. Wrongly “Tried to Maintain Control Over Testing”

(p. A14) Too often in a crisis, government officials look for easy solutions, with dramatic and immediate impact. But there are none for managing pandemics.

“A pandemic is by definition a problem from hell. You’re vanishingly unlikely to be able to remove all of its negative consequences,” said Bill Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health.

Instead, he added, officials should bet on combinations of imperfect strategies, with an emphasis on speed over accuracy.

In both the coronavirus pandemic and the monkeypox outbreak, for example, the C.D.C. at first tried to maintain control over testing, instead of disseminating the responsibility as widely as possible. The move led to limited testing, and left health officials blind to the spread of the viruses.

The Food and Drug Administration was slow to help academic labs develop alternatives for testing, and encouraged the highest quality of diagnosis. It may be reasonable for officials to ask which test is faster or which one produces the least errors, Dr. Hanage said, but “all of them are better than not doing anything.”

For the full commentary, see:

Apoorva Mandavilli. “Unprepared for Covid and Monkeypox. And the Next Outbreak, Too.” The New York Times (Saturday, October 1, 2022): A14.

(Note: the online version of the commentary was updated Sept. 30, 2022, and has the title “New Infectious Threats Are Coming. The U.S. Probably Won’t Contain Them.”)