Entrepreneurship – Page 5 – artdiamondblog.com

“Medicine Is Riddled With Flawed, Incomplete Evidence”

William Osler’s hospital residency system may have been an advance when he invented it. But it is far from perfect. We need lighter regulations so that medical entrepreneurs can create institutional innovations.

(p. D3) Medicine is full of young recruits writing veterans’ books, war stories full of hopes and fears for the next in line.

. . .

None in recent memory has wielded a set of intellectual and writerly tools to such dazzling and instructive effect as Dr. Nussbaum’s “The Finest Traditions of My Calling: One Physician’s Search for the Renewal of Medicine.”

. . .

. . . Dr. Nussbaum steers his narrative directly to the hard questions about 21st-century medicine, a profession just about as variously troubled as his patients.

. . . None of the usual medical heroes apply. Even the enduring William Osler, who started the hospital residency system at the turn of the 20th century and is routinely worshiped as a medical saint, comes up short. Osler was all about the physical evidence of illness, and Dr. Nussbaum faults him for seeing the body primarily as a collection of diseased parts, “a decidedly incomplete view.”

Few of Osler’s heirs strike Dr. Nussbaum as free of their own shortcomings.

He notes that partisans of today’s much promoted evidence-based medicine must determinedly finesse the fact that medicine is riddled with flawed, incomplete evidence. The leaders of genomic revolution trumpet a future that keeps being postponed. Quality-control gurus abound, but their work often fails to yield actual quality.

And those who would update and streamline medical routines offer up paradigms Dr. Nussbaum finds simply bizarre. He points to Atul Gawande, the Harvard surgeon and health policy writer who in a New Yorker article lauded the ability of large chain restaurants like the Cheesecake Factory to serve a uniform, reproducible product thousands of times over. Dr. Gawande charged medicine to do likewise, but that image of the physician as a line cook feeding faceless strangers does not inspire Dr. Nussbaum.

Still, if a doctor is to be neither parts mechanic nor line cook, then what? Dr. Nussbaum considers some alternatives.

. . .

Dr. Nussbaum considers the alternatives in a flowing, complex stream of anecdotes and reflections, all the stronger for its frequent uncertainty. He writes beautifully, in a lucid prose as notable for its process as its conclusions: The reader can actually watch him think.

For the full review see:

Abigail Zuger, M.D. “Unsparing Examination by a Young Doctor.” The New York Times (Tuesday, April 5, 2016 [sic]): D3.

(Note: ellipses added.)

(Note: the online version of the review has the date April 4, 2016 [sic], and has the title “Book Review: ‘The Finest Traditions of My Calling’.”)

The book under review is:

Nussbaum, Abraham M. The Finest Traditions of My Calling: One Physician’s Search for the Renewal of Medicine. New Haven, CT: Yale University Press, 2016.

Cloud Brightening Could Counter Global Warming

If the costs of global warming become large enough, we can brighten clouds to reverse global warming.

(p. A1) A little before 9 a.m. on Tuesday [April 2, 2024], an engineer named Matthew Gallelli crouched on the deck of a decommissioned aircraft carrier in San Francisco Bay, pulled on a pair of ear protectors, and flipped a switch.

A few seconds later, a device resembling a snow maker began to rumble, then produced a great and deafening hiss. A fine mist of tiny aerosol particles shot from its mouth, traveling hundreds of feet through the air.

It was the first outdoor test in the United States of technology designed to brighten clouds and bounce some of the sun’s rays back into space, a way of temporarily cooling a planet that is now dangerously overheating. The scientists wanted to see whether the machine that took years to create could consistently spray the right size salt aerosols through the open air, outside of a lab.

If it works, the next stage would be to aim at the heavens and try to change the composition of clouds above the Earth’s oceans.

. . .

(p. A14) Brightening clouds is one of several ideas to push solar energy back into space — sometimes called solar radiation modification, solar geoengineering, or climate intervention. Compared with other options, such as injecting aerosols into the stratosphere, marine cloud brightening would be localized and use relatively benign sea salt aerosols as opposed to other chemicals.

. . .

“I hope, and I think all my colleagues hope, that we never use these things, that we never have to,” said Sarah Doherty, an atmospheric scientist at the University of Washington and the manager of its marine cloud brightening program.

. . .

But it’s vital to find out whether and how such technologies could work, Dr. Doherty said, in case society needs them. And no one can say when the world might reach that point.

In 1990, a British physicist named John Latham published a letter in the journal Nature, under the heading “Control of Global Warming?,” in which he introduced the idea that injecting tiny particles into clouds could offset rising temperatures.

Dr. Latham later attributed his idea to a hike with his son in Wales, where they paused to look at clouds over the Irish Sea.

“He asked why clouds were shiny at the top but dark at the bottom,” Dr. Latham told the BBC in 2007. “I explained how they were mirrors for incoming sunlight.”

Dr. Latham had a proposal that may have seemed bizarre: create a fleet of 1,000 unmanned, sail-powered vessels to traverse the world’s oceans and continuously spray tiny droplets of seawater into the air to deflect solar heat away from Earth.

The idea is built on a scientific concept (p. A15) called the Twomey effect: Large numbers of small droplets reflect more sunlight than small numbers of large droplets. Injecting vast quantities of minuscule aerosols, in turn forming many small droplets, could change the composition of clouds.

“If we can increase the reflectivity by about 3 percent, the cooling will balance the global warming caused by increased C02 in the atmosphere,” Dr. Latham, who died in 2021, told the BBC. “Our scheme offers the possibility that we could buy time.”

A version of marine cloud brightening already happens every day, according to Dr. Doherty.

As ships travel the seas, particles from their exhaust can brighten clouds, creating “ship tracks,” behind them. In fact, until recently, the cloud brightening associated with ship tracks offset about 5 percent of climate warming from greenhouse gases, Dr. Doherty said.

Ironically, as better technology and environmental regulations have reduced the pollution emitted by ships, that inadvertent cloud brightening is fading, as well as the cooling that goes along with it.

A deliberate program of marine cloud brightening could be done with sea salts, rather than pollution, Dr. Doherty said.

For the full story see:

Christopher Flavelle. “Salting the Clouds to Cool an Overheating Earth.” The New York Times (Thursday, April 4, 2024): A1 & A14-A15.

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

(Note: the online version of the story has the date April 2, 2024, and has the title “Warming Is Getting Worse. So They Just Tested a Way to Deflect the Sun.”)

The article by the physicist John Latham, published in the one of the top two journals in science, and mentioned above, is:

Latham, John. “Control of Global Warming?” Nature 347, no. 6291 (Sept. 27, 1990): 339-40.

Low Government-Negotiated Drug Prices Will Slash Pharma Revenue Needed to Finance Government-Mandated Costly Phase 3 Trials

Mandated Phase 3 randomized double-blind clinical trials cost many millions of dollars each, and most of the trials fail. To fund all the trials that fail and the few that succeed, the few new drugs that succeed need to have high price tags. The only other way for new drug development to be economically sustainable, is to stop mandating Phase 3 clinical trials. If we stopped mandating Phase 3 clinical trials, we would, in other words, allow physicians and patients to try drugs after safety has been shown through Phase 1 and Phase 2 trials, but without the expensive proof of efficacy from Phase 3 trials. We would thereby allow physicians and patients greater freedom.

(p. B6) While many companies, from Pfizer to Bristol-Myers Squibb to Bayer and Novartis, have announced big layoffs, news from a key outsourcer on Wednesday [Aug. 7, 2024] showed that the industry’s cost-cutting ways are intensifying.

Charles River Laboratories International, which provides drug-development services, plunged 12.6% on Wednesday [Aug. 7, 2024], the most in four years, after sounding the alarm over pharma research spending plans. The Massachusetts-based company said it now expects to post a decline in sales for the full year, primarily owing to lower demand from pharma clients. The company previously expected to grow this year. “There are profound cuts at pharmaceutical companies,” James Foster, Charles River’s chief executive officer, told analysts. Foster called the reduction in pharma research spending “unusual” and “sudden.”

Foster said his clients are blaming the cuts on the Inflation Reduction Act, which allows Medicare to negotiate some drug prices directly with manufacturers, and a looming patent cliff, which will see more than $200 billion in annual drug sales come under threat from copycat generics.

For the past few years, pharma companies have been warning that they might need to cut back on innovation as the U.S. government forces some companies to negotiate prices of their top-selling drugs.

. . .

A reduction in preclinical testing, the kind of services that Charles River provides, is the sort of thing that will only be felt in the long term. By that time, current management teams, desperate to lift their stocks now, might be long gone. . . .

Big pharma wants to clean house. Expensive studies of drugs that won’t make it to market for many years to come are an easy target.

For the full commentary see:

David Wainer. “Big Pharma Scales Back R&D, Sending Shudders Through Industry.” The Wall Street Journal (Friday, Aug. 9, 2024): B6.

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

(Note: the online version of the commentary has the date August 8, 2024, and has the title “Big Pharma Cuts R&D, Sending Shudders Through Industry.” The quoted paragraph starting with “Foster said” appears in the online, but not the print, version of the commentary.)

The New York Times Is Open to the Possibility and Desirability of Geoengineering

In the past, The New York Times either ignored, or was dismissive of, geoengineering to reverse or mitigate the alleged future effects of global warming. A few months ago, I was pleasantly surprised to see the paper publish a page one article, quoted below, that was open to the policy of geoengineering. This is progress because the left’s standard response to the alleged effects of global warming is to advocate reduced economic growth. Geoengineering would allow economic growth, and the human flourishing it allows, to continue, even if global warming becomes as severe as the pessimists fear.

(p. 1) On a windswept Icelandic plateau, an international team of engineers and executives is powering up an innovative machine designed to alter the very composition of Earth’s atmosphere.

If all goes as planned, the enormous vacuum will soon be sucking up vast quantities of air, stripping out carbon dioxide and then locking away those greenhouse gases deep underground in ancient stone — greenhouse gases that would otherwise continue heating up the globe.

Just a few years ago, technologies like these, that attempt to re-engineer the natural environment, were on the scientific fringe. They were too expensive, too impractical, too sci-fi. But with the dangers from climate change worsening, and the world failing to meet its goals of slashing greenhouse gas emissions, they are quickly moving to the mainstream among both scientists and investors, despite questions about their effectiveness and safety.

. . . Once science fiction, today these ideas are becoming reality.

Researchers are studying ways to block some of the sun’s radiation. They are testing whether adding iron to the ocean could carry carbon dioxide to the sea floor. They are hatching plans to build giant parasols in space. And with massive facilities like the one in Iceland, they are seeking to reduce the concentration of carbon dioxide in the air.

. . .

(p. 12) A plant similar to the one in Iceland, but far larger, is being built in Texas by Occidental Petroleum, the giant oil company.

. . .

The Occidental plant, being built near Odessa, Texas, and known as Stratos, will be more than 10 times more powerful than Mammoth, powered by solar energy, and have the potential to capture and sequester 500,000 metric tons of carbon dioxide per year.

It uses a different process to extract carbon dioxide from the air, though the goal is the same: Most of it will be locked away deep underground. But at least some of the carbon dioxide, Occidental says, will also be used to extract more oil.

In that process, carbon dioxide is pumped into the ground to force out oil that might otherwise be too difficult to reach. Techniques like this have made Occidental a company worth more than $50 billion and helped send American crude production to a new high in recent years.

Of course, it is the world’s reliance on the burning of oil and other fossil fuels that has so dangerously sent carbon dioxide levels soaring. In the atmosphere, carbon dioxide acts as a blanket, trapping the sun’s heat and warming the world.

Today, Occidental says it is trying to become a “carbon management” company as well as an oil producer. Last year, it paid $1.1 billion for a start-up called Carbon Engineering that had developed a way to soak up carbon dioxide from the air, and began building the Stratos project. Today, what was a barren plot of dirt less than 12 months ago is a bustling construction site.

“It’s like the Apollo missions at NASA,” said Richard Jackson, who oversees carbon management and domestic oil operations at Occidental. “We’re trying to move as quickly as we can.”

For the full story see:

David Gelles. “Can We Engineer Our Way Out of a Climate Crisis?” The New York Times, First Section (Sunday, March 31, 2024): 1 & 12-13.

(Note: ellipses added.)

(Note: the online version of the story was updated April 4, 2024, and has the title “Can We Engineer Our Way Out of the Climate Crisis?” The sentence above that starts “Once science fiction” appeared in the print, but not the online, version.)

Prepare for Next Unexpected Disaster By Unbinding Nimble Entrepreneurs Who Can Pivot and Improvise

Governments have trouble preparing for uncertain and rare disasters, such as pandemics. So they “fight the last war,” expecting that the next disaster will look like the last disaster. Before WWII, France built the Maginot line, which they thought would have protected them against the kind of attack they had faced in WWI. The U.S. was more prepared for an Ebola pandemic than for a Covid pandemic. In an uncertain world, the best way to prepare for rare disasters is to allow and encourage nimble entrepreneurs who can resiliently pivot and improvise to counter whatever disaster arrives.

(p. A8) Britain’s government “failed” the country’s citizens in its handling of the coronavirus pandemic, a damning report from an official public inquiry said on Thursday [July 18, 2024], partly because officials had prepared for “the wrong pandemic.”

The arrival of Covid-19 in 2020 exposed flaws in Britain’s public health system and its pandemic preparedness that had been ignored for years, the report said. During the early waves of infections, Britain’s per capita death rate was among the highest in Europe, eventually leading to more than 225,000 deaths in total, according to official data.

“Had the U.K. been better prepared for and more resilient to the pandemic, some of that financial and human cost may have been avoided,” the report said.

. . .

Britain had a plan, but it was “outdated and lacked adaptability,” the report said.

It was also too focused on the possibility of a flu pandemic. “Although it was understandable for the U.K. to prioritize pandemic influenza, this should not have been to the effective exclusion of other potential pathogen outbreaks,” the report said.

. . .

Ministers, who are political appointees, did not have access to a broad enough range of scientific research and opinions that would have informed their policies, and advisers did not feel confident about expressing dissenting views.

“The advice offered to ministers and international bodies may well have been affected by a degree of ‘groupthink’,” the report said.

For the full story see:

Lynsey Chutel. “Before Covid, U.K. Prepared for ‘the Wrong Pandemic,’ Inquiry Finds.” The New York Times (Monday, July 22, 2024): A8.

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

(Note: the online version of the story has the date July 18, 2024, and has the title “U.K. Failed in Handling of Covid Pandemic, Inquiry Finds.”)

The “damning report” mentioned above, is:

Hallett, Baroness. “Uk Covid-19 Inquiry; Module 1: The Resilience and Preparedness of the United Kingdom.” July 18, 2024.

The “Innovative Approach” of the Dog Aging Project May Have Hurt Its Odds for Renewed Funding

Veterinary medicine is less regulated than human medicine, and so trial and error experiments may allow faster innovation that would benefit both dogs and humans.

(p. D3) In late 2019, scientists began searching for 10,000 Americans willing to enroll their pets in an ambitious new study of health and longevity in dogs. The researchers planned to track the dogs over the course of their lives, collecting detailed information about their bodies, lifestyles and home environments. Over time, the scientists hoped to identify the biological and environmental factors that kept some dogs healthy in their golden years — and uncover insights about aging that could help both dogs and humans lead longer, healthier lives.

Today, the Dog Aging Project has enrolled 47,000 canines and counting, and the data are starting to stream in. The scientists say that they are just getting started.

“We think of the Dog Aging Project as a forever project, so recruitment is ongoing,” said Daniel Promislow, a biogerontologist at the University of Washington and a co-director of the project. “There will always be new questions to ask. We want to always have dogs of all ages participating.”

But Dr. Promislow and his colleagues are now facing the prospect that the Dog Aging Project might have its own life cut short. About 90 percent of the study’s funding comes from the National Institute on Aging, a part of the National Institutes of Health, which has provided more than $28 million since 2018. But that money will run out in June, and the institute does not seem likely to approve the researchers’ recent application for a five-year grant renewal, the scientists say.

“We have been told informally that the grant is not going to be funded,” said Matt Kaeberlein, the other director of the Dog Aging Project and a former biogerontology researcher at the University of Washington. (Dr. Kaeberlein is now the chief executive of Optispan, a health technology company.)

. . .

Steven Austad, a biogerontologist at the University of Alabama at Birmingham who is not part of the research team, said he was surprised that the researchers’ grant might not be renewed. “The importance of the things they publish and the depth of detail will increase over time, but I thought they got off to a really good start,” he said. “A large study like this really deserves a chance to mature.”

Dr. Austad’s miniature dachshund, Emmylou, is enrolled in the Dog Aging Project. But at 2 years old, he noted, Emmylou is “not going to teach them a lot about aging for a long time yet.”

The project’s innovative approach might have worked against it, Dr. Austad added. Reviewers accustomed to evaluating short-term research on lab mice and long-term studies of humans may not have known what to make of an enormous epidemiological study of pet dogs.

Whatever the reason, the refusal to commit to more funding is “wrong,” Dr. Kaeberlein said. “It’s just really, really difficult to justify this decision, if you look at the productivity and the impact of the project.”

That impact extends beyond the findings themselves, he added. “This project has engaged almost 50,000 Americans in biomedical scientific research.”

Over the last few years, Shelley Carpenter, of Gulfport, Miss., has provided the researchers with regular updates on and medical records for her Pembroke Welsh corgi, Murfee. (She also collected a cheek swab for genomic sequencing.) Ms. Carpenter, whose previous corgi died from a neurodegenerative disease similar to A.L.S., hoped that the project might produce new medical knowledge that could help both dogs and people.

For the full story see:

Emily Anthes. “Scientists Scramble to Keep Dog Aging Project Alive.” The New York Times (Tuesday, January 16, 2024): D3.

(Note: ellipses added.)

(Note: the online version of the story has the date Jan. 11, 2024, and has the same title as the print version.)

When Medical Insurers Own Doctor Practices, Medicare Advantage Creates “Conflicts of Interest and Opportunities to Game the System”

Through its Optum division health insurer UnitedHealth has 90,000 affiliated doctors. Under the federal government’s Medicare Advantage program, UnitedHealth received higher payments from the federal government for its customers who have more dire diagnoses. This creates an incentive for UnitedHealth to pressure its affiliated doctors to code their patients with dire diagnoses.

(p. A3) UnitedHealth has built a sprawling health services company that shows no sign of slowing down. With annual revenue of $372 billion in 2023, it ranks among the five largest companies in the U.S. on that measure. Its stock, meanwhile, has returned more than 600% in the past decade.

UnitedHealth’s success has been fueled by its expansion beyond insurance as its care delivery and solutions unit Optum steadily acquires a vast array of health services companies, from a pharmacy-benefits manager to specialty pharmacies to doctor groups and surgical centers. Over the past two decades, Optum has spent about $82 billion on nearly 100 acquisitions, according to a tally by Raymond James analysts.

Much like the rest of the U.S. economy, America’s healthcare system has consolidated in recent decades, creating giant hospital systems, chain-owned medical practices and vertically integrated insurance conglomerates. Immense scale can drive efficiencies and reduce the cost of care. But in the highly complex and opaque world of U.S. healthcare, where giant companies always seem to be a step ahead of regulators, it also raises potential conflicts of interest and opportunities to game the system. The benefits of size often flow to those companies, not patients or the employers and taxpayers footing much of the bill.

. . .

A key growth driver for UnitedHealth is Optum’s steady acquisitions of doctor practices. Optum now has ties with 90,000 doctors—about 10% of the country’s physician workforce.

. . .

Much of the vertical integration in the industry has focused on the Medicare Advantage business, the sector’s golden goose. These are the private plans in which the government pays insurers a fixed rate to manage the care of seniors. The sicker the patient, the more the government pays.

In recent years, some insurers’ acquisitions seem targeted at controlling the Medicare coding apparatus. If you control the doctors who code patients, you control how much you get paid, explains Loren Adler, a fellow at the Center on Health Policy at the Brookings Institution, a nonprofit research organization. UnitedHealth and other insurers argue that they are simply coding patients according to their risk profile and that they comply with Centers for Medicare and Medicaid Services rules.

But they have been accused of abusing the system by coding patients too aggressively. An investigation by the Office of Inspector General of the Department of Health and Human Services found that Medicare insurers received $9 billion in questionable payments in a single year.

For the full commentary see:

David Wainer. “Insurers as Healthcare Providers Risk Conflict of Interest.” The Wall Street Journal (Friday, June 14, 2024): B10.

(Note: ellipses added.)

(Note: the online version of the commentary has the date June 13, 2024, and has the title “What Happens When Your Insurer Is Also Your Doctor and Your Pharmacist.”)

Ending the “License Raj” in India Allowed Economic Growth and the Creation of Earned Entrepreneurial Wealth

(p. A8) The younger son of Mukesh Ambani, India’s richest man, is set to wed his fiancée in Mumbai on Friday, the finale of a monthslong extravaganza that signaled the arrival of the unapologetic Indian billionaire on the global stage — and introduced the world to the country’s Gilded Age.

. . .

Kavil Ramachandran, a professor of entrepreneurship at the Indian School of Business, said there were more billionaires with fatter wallets because India has sustained a high growth rate for more than two decades. That’s created a deep domestic market for goods and services, and pushed Indian companies to pursue new businesses, pairing opportunity with ambition.

“It’s a consequence of rapid growth and entrepreneurialism,” Mr. Ramachandran said.

. . .

India has come a long way from its socialist origins. Until 1990, the country operated under strict government supervision and protectionist policies. Companies could only run after procuring multiple permits and licenses from the government, leading to the name “License Raj” — a play on the term British Raj, which referred to colonial rule.

Once India opened up its economy after a series of reforms, some domestic companies embraced the logic of free markets while remaining family-run and tightly controlled, diversifying into new businesses.

. . .

Many Indians see in Mr. Ambani’s staggering rise in stature and wealth a version of the India they want: a country that doesn’t make a play for attention but demands it. Some even feel pride that his son’s wedding has attracted such global attention. To them, India’s poverty is a predictable fact, such opulence is not.

“Based on the level of the Ambanis’ wealth, the wedding is perfect,” said Mani Mohan Parmar, a 64-year-old resident from Mumbai.

“Even the common man here in India spends more than his capacity on a wedding,” Ms. Parmar said. “So it’s nothing too much if we talk about Ambani. He has so much money due to God’s grace, so why shouldn’t he spend it by his choice?”

For the full story see:

Anupreeta Das. “India’s New Gilded Age on Display at a Wedding.” The New York Times (Monday, June 15, 2024): A8.

(Note: ellipses added.)

(Note: the online version of the story has the date July 12, 2023, and has the title “A Wedding Puts India’s Gilded Age on Lavish Display.”)

Copper Hospital Fixtures Would Reduce Bacterial Infections

If healthcare was unregulated, nimble entrepreneurs could make quick use of the findings summarized below. In our sclerotic hyper-regulated healthcare system, healthcare workers have neither the incentives nor the decision rights to make use of them.

(p. D6) Researchers equipped nine rooms in a small rural hospital with copper faucet handles, toilet flush levers, door handles, light switches and other commonly touched equipment. They left nine other rooms with traditional plastic, porcelain and metal surfaces.

. . .

. . . on average, fixtures in copper-equipped rooms had concentrations of bacteria about 98 percent lower than in rooms furnished with traditional equipment, whether the rooms were occupied or not. On half of the copper components, the researchers were unable to grow any bacteria at all.

“Copper in hospital rooms is not yet common,” said the lead author, Shannon M. Hinsa-Leasure, an associate professor of biology at Grinnell College in Iowa.

For the full story see:

Nicholas Bakalar. “Copper May Stem Infections.” The New York Times (Tuesday, Oct. 11, 2016 [sic]): D6.

(Note: ellipses added.)

(Note: the online version of the story has the date Oct. 4, 2016 [sic], and has the title “Copper Sinks and Faucets May Stem Hospital Infections.”)

The academic paper reporting the results summarized above is:

Hinsa-Leasure, Shannon M., Queenster Nartey, Justin Vaverka, and Michael G. Schmidt. “Copper Alloy Surfaces Sustain Terminal Cleaning Levels in a Rural Hospital.” American Journal of Infection Control 44, no. 11 (Nov. 2016): e195-e203.

Perfusion Eases the Scarcity of Organs for Transplantation

(p. A1) Surgeons are experimenting with organs from genetically modified animals, hinting at a future when they could be a source for transplants. But the field is already undergoing a paradigm shift, driven by technologies in widespread use that allow clinicians to temporarily store organs outside the body.

Perfusion, as its called, is changing every aspect of the organ transplant process, from the way surgeons operate, to the types of patients who can donate organs, to the outcomes for recipients.

. . .

(p. A12) Scientists have long experimented with techniques for keeping organs in more dynamic conditions, at a warmer temperature and perfused with blood or another oxygenated solution. After years of development, the first device for preserving lungs via perfusion won approval from the Food and Drug Administration in 2019. Devices for perfusing hearts and livers were approved in late 2021.

. . .

Now surgical teams can recover an organ, perfuse it overnight while they sleep and complete the transplant in the morning without fear that the delay will have damaged the organ.

Perhaps most important, perfusion has further opened the door to organ donation by comatose patients whose families have withdrawn life support, allowing their hearts to eventually stop. Each year, tens of thousands of people die this way, after the cessation of circulation, but they were rarely donor candidates because the dying process deprived their organs of oxygen.

. . .

By tapping this new cadre of donors, transplant centers said they could find organs more quickly for the excess of patients in urgent need. Dr. Shimul Shah said the organ transplant program he directs at the University of Cincinnati had essentially wiped out its waiting list for livers. “I never thought, in my career, I would ever say that,” he said.

. . .

Dr. Shaf Keshavjee, a surgeon at the University of Toronto whose lab was at the forefront of developing technologies to preserve lungs outside the body, said the devices could eventually allow doctors to remove, repair and return lungs to sick patients rather than replace them. “I think we can make organs that will outlive the recipient you put them in,” he said.

Dr. Ashish Shah, the chairman of cardiac surgery at Vanderbilt University, one of the busiest heart transplant programs in the country, agreed, calling that “the holy grail.”

“Your heart sucks,” he said. “I take it out. I put it on my apparatus. While you don’t have a heart, I can support you with an artificial heart for a little while. I then take your heart and fix it — cells, mitochondria, gene therapy, whatever — and then I sew it back in. Your own heart. That’s what we’re really working for.”

For the full story see:

Ted Alcorn. “Keeping Organs For Transplants Alive for Longer.” The New York Times (Wednesday, April 3, 2024): A1 & A12.

(Note: ellipses added.)

(Note: the online version of the story has the date April 2, 2024, and has the title “The Organ Is Still Working. But It’s Not in a Body Anymore.”)

The Absence of a Randomized Double-Blind Clinical Trial Is Used as an Excuse to Ignore an Emergency Procedure That Saves Lives

In an urgent emergency the son and wife of a man with a stopped heart, improvised the use of a toilet plunger to get his heart to start pumping again. In his wonderful account of the sources of insight, Gary Klein told a different example of urgent emergency improvisation: “Wag” Dodge saved himself from a massive wildfire racing toward him by lighting a match to the grass at his feet to pre-burn a patch he could lie down in. When the wildfire reached him, it passed on both sides, avoiding the patch that now had no fuel. Neither the son-and-mother, nor Wag Dodge, got their insight from collaboration or a randomized double-blind controlled trial.

(p. D5) In 1988, a 65-year-old man’s heart stopped at home. His wife and son didn’t know CPR, so in desperation they grabbed a toilet plunger to get his heart going until an ambulance showed up.

Later, after the man recovered at San Francisco General Hospital, his son gave the doctors there some advice: Put toilet plungers next to all of the beds in the coronary unit.

The hospital didn’t do that, but the idea got the doctors thinking about better ways to do CPR, or cardiopulmonary resuscitation, the conventional method for chest compressions after cardiac arrest. More than three decades later, at a meeting of emergency medical services directors this week in Hollywood, Fla., researchers presented data showing that using a plunger-like setup leads to remarkably better outcomes for reviving patients.

. . .

The new procedure, known as neuroprotective CPR, has three components. First, a silicone plunger forces the chest up and down, not only pushing blood out to the body, but drawing it back in to refill the heart. A plastic valve fits over a face mask or breathing tube to control pressure in the lungs.

The third piece is a body-positioning device sold by AdvancedCPR Solutions, a firm in Edina, Minn., that was founded by Dr. Lurie. A hinged support slowly elevates a supine patient into a partial sitting position. This allows oxygen-starved blood in the brain to drain more effectively and to be replenished more quickly with oxygenated blood.

. . .

. . ., a study carried out in four states found . . . [p]atients who received neuroprotective CPR within 11 minutes of a 911 call were about three times as likely to survive with good brain function as those who received conventional CPR.

. . .

Dr. Karen Hirsch, a neurologist at Stanford University and a member of the CPR standards committee for the American Heart Association, said that the new approach was interesting and made physiological sense, but that the committee needed to see more research on patients before it could formally recommend it as a treatment option.

“We’re limited to the available data,” she said, adding that the committee would like to see a clinical trial in which people undergoing cardiac arrests are randomly assigned to conventional CPR or neuroprotective CPR. No such trials are happening in the United States.

Dr. Joe Holley, the medical director for the emergency medical service that serves Memphis and several surrounding communities, isn’t waiting for a larger trial. Two of his teams, he said, were getting neurologically intact survival rates of about 7 percent with conventional CPR. With neuroprotective CPR, the rates rose to around 23 percent.

His crews are coming back from emergency calls much happier these days, too, and patients are even showing up at fire stations to thank them for their help.

“That was a rare occurrence,” Dr. Holley said. “Now it’s almost a regular thing.”