Category: Health

Deregulation of Hearing Aids Will Lower Cost and Increase Innovation

(p. B5) Hearing aids typically cost thousands of dollars, require multiple visits to specialists and often aren’t covered by health insurance. Untreated hearing loss is associated with cognitive decline, dementia and other harms. Overcoming barriers to hearing treatment may significantly improve Americans’ health.

The federal government is poised to help. Congress in 2017 passed legislation that would let anyone buy hearing aids approved by the Food and Drug Administration without a prescription from an audiologist. The F.D.A. has missed a deadline to release draft guidelines for this new category of over-the-counter hearing aids.

Experts told me that when the F.D.A. moves ahead, it’s likely to lead to new products and ideas to change hearing aids as we know them.

. . .

It is already possible to buy a hearing helper — they can’t legally be called hearing aids — without a prescription. These devices, called personal sound amplification products or PSAPs, vary wildly in quality from excellent to junk.

. . .

Nicholas Reed, director of audiology at the Johns Hopkins Cochlear Center for Hearing and Public Health, told me that the F.D.A. process should provide a path for the best PSAPs to be approved as official over-the-counter hearing aids. He expects new companies to hit the market, too.

You may doubt that a gadget you buy next to the toilet paper at CVS could be a serious medical device. Dr. Reed’s research, however, has found that some hearing helpers for $350 or less were almost as good as prescription hearing aids for people with mild-to-moderate hearing loss.

Dr. Reed described the best lower-cost devices as the Hyundai of hearing help. (This was a compliment.) They aren’t flashy, but they will get many people safely and effectively where they need to go. He also imagines that the F.D.A. rules will create the conditions for many more people to buy hearing aids — both over the counter and by prescription.

. . .

Health care in the United States can often feel as if it’s stuck, and technology is usually not the solution. But with hearing aids, technology and a change in government policy could bring helpful health innovation.

For the full commentary, see:

Shira Ovide. “ON TECH; Affordable and Accessible Hearing Aids.” The New York Times (Monday, April 19, 2021): B5.

(Note: ellipses added.)

(Note: the online version of the commentary has the date April 12, 2021, and has the title “ON TECH; Hearing Aids for the Masses.”)

Reed’s research mentioned above is documented in:

Reed, Nicholas S., Joshua Betz, Nicole Kendig, Margaret Korczak, and Frank R. Lin. “Personal Sound Amplification Products Vs a Conventional Hearing Aid for Speech Understanding in Noise.” JAMA 318, no. 1 (July 4, 2017): 89-90.

Automation Tools Assist, but Do Not Replace, Surgeons

(p. D4) Using many of the same technologies that underpin self-driving cars, autonomous drones and warehouse robots, researchers are working to automate surgical robots too. These methods are still a long way from everyday use, but progress is accelerating.

. . .

The aim is not to remove surgeons from the operating room but to ease their load and perhaps even raise success rates — where there is room for improvement — by automating particular phases of surgery.

Robots can already exceed human accuracy on some surgical tasks, like placing a pin into a bone (a particularly risky task during knee and hip replacements). The hope is that automated robots can bring greater accuracy to other tasks, like incisions or suturing, and reduce the risks that come with overworked surgeons.

During a recent phone call, Greg Hager, a computer scientist at Johns Hopkins, said that surgical automation would progress much like the Autopilot software that was guiding his Tesla down the New Jersey Turnpike as he spoke. The car was driving on its own, he said, but his wife still had her hands on the wheel, should anything go wrong. And she would take over when it was time to exit the highway.

“We can’t automate the whole process, at least not without human oversight,” he said. “But we can start to build automation tools that make the life of a surgeon a little bit easier.”

. . .

. . . the Berkeley researchers have been working to automate their robot, which is based on the da Vinci Surgical System, a two-armed machine that helps surgeons perform more than a million procedures a year. Dr. Fer and his colleagues collect images of the robot moving the plastic rings while under human control. Then their system learns from these images, pinpointing the best ways of grabbing the rings, passing them between claws and moving them to new pegs.

But this process came with its own asterisk. When the system told the robot where to move, the robot often missed the spot by millimeters. Over months and years of use, the many metal cables inside the robot’s twin arms have stretched and bent in small ways, so its movements were not as precise as they needed to be.

Human operators could compensate for this shift, unconsciously. But the automated system could not. This is often the problem with automated technology: It struggles to deal with change and uncertainty. Autonomous vehicles are still far from widespread use because they aren’t yet nimble enough to handle all the chaos of the everyday world.

. . .

Many obstacles lie ahead, scientists note. Moving plastic pegs is one thing; cutting, moving and suturing flesh is another. “What happens when the camera angle changes?” said Ann Majewicz Fey, an associate professor at the University of Texas, Austin. “What happens when smoke gets in the way?”

For the foreseeable future, automation will be something that works alongside surgeons rather than replaces them.

For the full story, see:

Cade Metz. “When the Robot Wields the Scalpel.” The New York Times (Tuesday, May 4, 2021): D4.

(Note: ellipses added.)

(Note: the online version of the story has the date April 30, 2020, and has the title “The Robot Surgeon Will See You Now.”)

Always-Curious Microbiologist Found Useful Robust New Bacterium in Yellowstone Hot Spring

An enzyme in the bacterium that Brock discovered was used by Kary Mullis to create the polymerase chain reaction (PCR) that is part of Covid-19 tests.

(p. B11) Thomas Brock, a microbiologist, was driving west to a laboratory in Washington State in 1964 when he stopped off at Yellowstone National Park.

. . .

What fascinated him, on what would be the first of many trips to Yellowstone, were the blue-green algae living in a hot spring — proof that some life could tolerate temperatures above the boiling point of water.

It was the beginning of research that led to a revolutionary find in 1966: a species of bacteria that he called Thermus aquaticus, which thrived at 70 degrees Celsius (158 degrees Fahrenheit) or more.

. . .

The yellow bacteria — discovered by Dr. Brock and Hudson Freeze, his undergraduate assistant at Indiana University — survive because all their enzymes are stable at very high temperatures, including one, Taq polymerase, that replicates its own DNA. It proved essential to the invention of the process behind the gold standard in coronavirus testing.

. . .

When he arrived at Yellowstone, he did not have grandiose ambitions.

“I was just looking for a nice, simple ecosystem where I could study microbial ecology,” he said in an interview for the website of the University of Wisconsin, Madison, where he was a professor of natural sciences in the department of bacteriology from 1971 to 1990. “At higher temperatures, you don’t have the complications of having animals that eat all the microbes.”

Stephen Zinder worked with Dr. Brock as a student from 1974 to 1977, a period that included Dr. Brock’s last summer of work at Yellowstone and his research into the ecology of Wisconsin’s lakes, including Lake Mendota in Madison.

“He had an encyclopedic knowledge of microbiology and science in general,” said Dr. Zinder, now a professor of microbiology at Cornell University. “He was always learning and picking up new things.” He added, “I think his real ability was to see things simply and to figure out simple techniques to find out what the organisms were doing in their environment.”

For the full obituary, see:

Richard Sandomir. “Thomas Brock, 94, Scientist Who Shared a Nobel Prize’.” The New York Times (Saturday, May 1, 2021): B11.

(Note: ellipses added.)

(Note: the online version of the obituary was updated April 26, 2020, and has the title “Thomas Brock, Whose Discovery Paved the Way for PCR Tests, Dies at 94.”)

Why “Efficacy” Is Greater Than “Effectiveness”

Some literature in medicine distinguishes between the “efficacy” of a medicine and the “effectiveness” of a medicine. The efficacy is measured by the medicine’s success in a randomized clinical trial; the “effectiveness” is measured by the medicine’s success in actual clinical practice. Since medicines are usually administered under better conditions, and often to cherry-picked patients, in randomized clinical trails, the “efficacy” of a medicine is almost always higher than the “effectiveness” of the same medicine.

In recent months a study has shown that airline air ventilation technology has very high efficacy in preventing the spread of Covid-19. Yet other studies have shown that in actual practice the “effectiveness” of airline technology has allowed cases of substantial transmission of Covid-19. The article quoted below, plausibly explains that ventilation systems are often turned off, or operate at low levels, when planes are on the ground. Puzzle solved.

(p. A9) The Federal Aviation Administration has few ventilation requirements in cabins, generally deferring to requirements from manufacturers. This has been an issue in the past, when cabins were left without ventilation for long periods with passengers on board. The FAA has issued guidance to airlines recommending passengers be taken off planes if cabin ventilation is shut down for more than 30 minutes, an FAA spokeswoman says.

Leonard Marcus, the director of Harvard’s Aviation Public Health Initiative, says that researchers have found that it’s important to have ventilation running full force on the ground.

“The risk of transmission is increased when people are walking up and down the aisle, when they are putting their luggage in the overhead, when they are breathing on top of one another,” Dr. Marcus says. “So to compensate for that, you have to keep the airflow moving, which is true for all communicable diseases of this nature.”

American says its procedures call for the use of ground air while at the gate and during boarding. Spokeswoman Sarah Jantz says captains have discretion to turn on the APU “if the flow of preconditioned air is not sufficient” or not cooling the aircraft enough. American didn’t change procedures during the pandemic, but did provide additional education to crews “to ensure optimal ventilation,” she says.

. . .

Airline claims about the safety of travel are predicated on functioning ventilation systems. An October [2020] study from Harvard University’s School of Public Health, funded by the airline industry, used mathematical models and found a low risk of coronavirus transmission on airplanes because of a layered approach, including aircraft ventilation and masks.

The study, directed by Dr. Marcus, did recommend extending “in-flight level of ventilation while on the ground.” It didn’t estimate the risk of being in an airplane with even brief periods of little or no ventilation.

For the full commentary, see:

Scott McCartney. “THE MIDDLE SEAT; The Importance of Airflow Before Takeoff.” The Wall Street Journal (Thursday, April 8, 2021): A9.

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

(Note: the online version of the commentary has the date April 7, 2021, and has the title “THE MIDDLE SEAT; The Key to Safe Airflow for Planes Before Takeoff.”)

Where Hospitals Charge Higher Prices for C-Sections, More C-Sections Are Performed

(p. B6) The more a hospital profits from a cesarean delivery, the more likely a woman is to get one, a new analysis suggests.

For the study, published in JAMA Network Open, researchers analyzed records of 13.2 million deliveries nationwide from 2010 to 2014, using a large database of generally healthy women.

. . .

During that period, profit from C-sections varied, from an average of $4,969 for the one-quarter of hospitals with the lowest charges to $26,129 for the quarter that charge the most.

The researchers found that compared with the one-quarter of hospitals that averaged the lowest profit per cesarean, those that made the most per formed 8 per cent more C-sections.

For the full story, see:

Nicholas Bakalar. “In Brief; Making Profits From C-Sections.” The New York Times (Tuesday, April 13, 2021): D6.

(Note: ellipsis added.)

(Note: after considerable search, I could not find this article in the online version of the NYT as of 4/24/21.)

The JAMA Network Open article discussed in the passages quoted above is:

Sakai-Bizmark, Rie, Michael G. Ross, Dennys Estevez, Lauren E. M. Bedel, Emily H. Marr, and Yusuke Tsugawa. “Evaluation of Hospital Cesarean Delivery–Related Profits and Rates in the United States.” JAMA Network Open 4, no. 3 (2021): e212235-e35.

Differences in Study Results Are Seldom Due to Whether Study Design Is Observational or a Randomized Clinical Trial

(p. A17) The health system would be less burdened if more patients were treated before they require hospitalization, and there are promising therapeutic options that patients can administer themselves at home. This was the subject of a Nov. 19 [2020] hearing before the Senate Homeland Security and Governmental Affairs Committee.

Testimony from the hearing underscored an important issue: Too many doctors have interpreted the term “evidence-based medicine” to mean that the evidence for a treatment must be certain and definitive before it can be given to patients. Because accusing a physician of not being “evidence based” can be a career-damaging allegation, fear of straying from the pack has prevailed, favoring inertia and inaction amid uncertainty about Covid-19 treatments.

For diseases with established treatment options, holding out for certainty may be prudent. But when options are limited and there are safe treatments with evidence for effectiveness, holding out for certainty can be catastrophic. Requiring a high degree of certainty during a crisis may elevate the augustness of medical organizations and appease the sensibilities of medical professionals, but it does nothing for patients who need help.

The penchant for certainty is visible in the frequently updated treatment guidelines for Covid-19 from the National Institutes of Health. These guidelines were developed by scientists around the country, but because of a mentality that is biased toward virtually irrefutable evidence, no distinction is made for treatments with evidence for effectiveness that falls below the mark of certainty. This framework almost certainly has contributed to many avoidable deaths during this pandemic.

. . .

While some health officials dismiss nonrandomized studies, the Cochrane organization, an international leader in evidence-based medicine, published a review of several hundred studies showing that randomized clinical trials and nonrandomized studies of treatments generally yield similar findings. Modern epidemiologic and statistical methods can usually overcome biases inherent in nonrandomized study designs.

For the full commentary, see:

Joseph A. Ladapo. “Too Much Caution Is Killing Covid Patients.” The Wall Street Journal (Wednesday, Nov. 25, 2020): A17.

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

(Note: the online version of the commentary has the date November 24, 2020, and has the same title as the print version.)

The Cochrane organization review mentioned above is:

Anglemyer, Andrew, Hacsi T. Horvath, and Lisa Bero. “Healthcare Outcomes Assessed with Observational Study Designs Compared with Those Assessed in Randomized Trials.” In Cochrane Database of Systematic Reviews, 2014.

“A Public Choice Analysis of Mandated Randomized Double-Blind Clinical Trials”

My “A Public Choice Analysis of Mandated Randomized Double-Blind Clinical Trials” was presented on April 13, 2021 in the Law & Economics session of the Association of Private Enterprise Education meetings. I am grateful to Ray DeGennaro and Matthew McClanahan for including me in McClanahan’s session and to Lauren Nicole Hughes for recording the session on her smartphone.

To some extent, the presentation was an outgrowth of my book:

Diamond, Arthur M., Jr. Openness to Creative Destruction: Sustaining Innovative Dynamism. New York: Oxford University Press, 2019.

Unintended Consequences of Centralized Lockdown in India Spread Covid-19

(p. A1) SURAT, India — The crowds surged through the gates, fought their way up the stairs of the 160-year-old station, poured across the platforms and engulfed the trains.

It was May 5 [2020], around 10 a.m. Surat was beastly hot, 106 degrees. Thousands of migrant laborers were frantic to leave — loom operators, diamond polishers, mechanics, truck drivers, cooks, cleaners, the backbone of Surat’s economy. Two of them were Rabindra and Prafulla Behera, brothers and textile workers, who had arrived in Surat a decade ago in search of opportunity and were now fleeing disease and death.

. . .

They were among tens of millions of migrant workers stranded without work or food after Prime Minister Narendra Modi imposed a national coronavirus lockdown in March. By spring and summer, these workers were so desperate that the government provided emergency trains to carry them back to their home villages. The trains were called Shramik Specials, because shramik means “laborer” in Hindi.

But they became the virus trains.

India has now reported more coronavirus cases than any country besides the United States. And it has become clear that the special trains operated by the government to ease suffering — and to counteract a disastrous lack of lockdown planning — instead played a significant role in spreading the coronavirus into almost every corner of the country.

The trains became contagion zones: Every passenger was supposed to be screened for Covid-19 before boarding but few if any were tested. Social distancing, if promised, was nonexistent, as men pressed into passenger cars for journeys that could last days. Then the trains disgorged passengers into distant villages, in regions that before had few if any coronavirus cases.

. . .

(p. A12) On March 24 [2020], at 8 p.m., Mr. Modi hit the lockdown switch. In a televised address, he ordered the entire nation to stay inside their homes for three weeks — starting in four hours.

The decision was pure Modi: sudden, dramatic and firm, like when he abruptly wiped out nearly 90 percent of India’s currency bills in 2016, a bolt-from-the-blue measure that he said was necessary to fight corruption but proved economically devastating.

Prafulla and Rabindra Behera had just finished a dinner of rice, lentils and potatoes, their usual fare. They lived in squalid, bare rooms in Surat’s industrial zone, sleeping wall to wall on the floor with a half dozen other laborers. Within minutes of Mr. Modi’s address, they started getting calls.

“Everyone was thinking the same: This will be over soon and somehow we’ll pass the days,” Rabindra said.

At the time, India had fewer than 600 known virus cases.

Many experts have criticized Mr. Modi’s government for overlooking the plight of migrant laborers, who suddenly had no work, no income and no support network in the cities. The government’s Covid-19 task force lacked migrant specialists and was hardly representative of India. Of its 21 members, only two were women and the rest were largely upper-caste men. Many of the migrant laborers came from lower castes and economically underprivileged backgrounds.

. . .

In Surat, the Behera brothers were down to their last bag of rice. They could not work — the factories were closed. But they weren’t allowed to leave the city, where virus cases were beginning to surge.

“We were trapped,” Rabindra said.

On May 1, India’s Labor Day, the railways ministry made a grand announcement: Shramik Specials. Routes were drawn up from Surat, Mumbai, Chennai, New Delhi, Ahmedabad and other cities deep into rural areas.

. . .

The Beheras were told they would quarantine for 21 days at a center and each was given a toothbrush, a slice of soap, a bucket to wash with and a thin sheet to sleep on.

But the next morning, Prafulla awoke with a splitting headache. A doctor didn’t think he had coronavirus but suggested, as a precaution, that he be moved into the courtyard, away from the other men.

The following morning, Prafulla could barely breathe and called his wife on his cellphone.

“Come and bring the girls,” he whispered. “I need to see you.”

An hour later, he was dead. A subsequent test revealed that Prafulla Behera was Ganjam’s first coronavirus death.

For the full story, see:

Jeffrey Gettleman, Suhasini Raj, Sameer Yasir, Karan Deep Singh and Atul Loke. “Rails Spread Virus as Workers Fled India’s Cities.” The New York Times (Wednesday, December 16, 2020): A1 & A12-A13.

(Note: ellipses added.)

(Note: the online version of the story was updated Feb. [sic] 2, 2021, and has the title “The Virus Trains: How Lockdown Chaos Spread Covid-19 Across India.”)

On Vaccines and Economics, Europe Suffers “the Same Bureaucratic and Intellectual Rigidity”

(p. A25) Europe’s vaccination debacle will almost surely end up causing thousands of unnecessary deaths. And the thing is, the continent’s policy bungles don’t look like isolated instances, a few bad decisions made by a few bad leaders. Instead, the failures seem to reflect fundamental flaws in the continent’s institutions and attitudes — including the same bureaucratic and intellectual rigidity that made the euro crisis a decade ago far worse than it should have been.

The details of the European failure are complex. But the common thread seems to be that European officials were not just risk averse, but averse to the wrong risks. They seemed deeply worried about the possibility that they might end up paying drug companies too much, or discover that they had laid out money for vaccines that either proved ineffective or turned out to have dangerous side effects.

So they minimized these risks by delaying the procurement process, haggling over prices and refusing to grant liability waivers. They seemed far less worried about the risk that many Europeans might get sick or die because the vaccine rollout was too slow.

For the full commentary, see:

Paul Krugman. “A Fiasco That’s Very European: Vaccines.” The New York Times (Friday, March 19, 2021): A25.

(Note: the online version of the commentary has the date March 18, 2021, and has the title “Vaccines: A Very European Disaster.”)

Are We Right to Experiment on Animals to Save Humans?

I believe that higher animals feel emotions and maybe even have souls, so we should try to treat them humanely. I am deeply conflicted on how far animal experiments are justified in the pursuit of curing human diseases. Whenever possible, animal experiments should have the potential to benefit the animals in the experiments, as well as the human experimenters.

(p. A15) The “title characters” of Brandy Schillace’s admirable biography “Mr. Humble and Dr. Butcher: A Monkey’s Head, the Pope’s Neuroscientist, and the Quest to Transplant the Soul” were one and the same person: Robert J. White, a distinguished neurosurgeon, an accomplished neuroscientist and a man dedicated to searching for the means to transplant souls by transplanting the human brain. If this makes White sound macabre, Ms. Schillace’s account of his life, work and temperament is anything but. She deftly persuades the reader to take White seriously (he wasn’t even eccentric) and to ponder profound medical-scientific-philosophical issues. Best of all, the book is fascinating.

. . .

White felt it was his religious and medical duty to devise techniques for rescuing healthy brains from otherwise diseased and dying bodies. His solution was to transplant heads (containing their brains) onto cadavers that were brain dead but otherwise physiologically viable.

Before he could attempt such surgery on people, White experimented, mostly on monkeys, dozens of times, to ascertain and refine the necessary procedures. In March 1970 he succeeded in transplanting a monkey’s head onto another monkey’s body.

. . .

During the era in which White conducted his experiments, politicians, doctors, journalists and celebrities were becoming deeply and increasingly dismayed by scientific experiments on animals. White ran afoul of the animal-rights advocacy organization People for the Ethical Treatment of Animals (PETA) and was threatened by animal-rights extremists (he remained imperturbable). White prided himself on scrupulously avoiding harm to his animal subjects. But he didn’t believe that animals had souls: For him, Ms. Schillace writes, “the human was more than animal, and equating the two was not only wrong, it was dangerous.” One of White’s rejoinders to those who would halt animal experimentation was, to paraphrase: If you were a surgeon, how would you like to tell parents that their young child is going to die because the operation that might save him or her was impossible to perform, mainly because the necessary animal-dissection research that would have permitted it was forbidden by law or the medical canon of ethics? His foes never had a good answer.

For the full review, see:

Howard Schneider. “A Heart in the Right Place.” The Wall Street Journal (Monday, February 22, 2021): A15.

(Note: ellipses added; italics in original.)

(Note: the online version of the review has the date February 21, 2021, and has the title “Mr. Humble and Dr. Butcher’ Review: A Heart in the Right Place.”)

The book under review is:

Schillace, Brandy. Mr. Humble and Dr. Butcher: A Monkey’s Head, the Pope’s Neuroscientist, and the Quest to Transplant the Soul. New York: Simon & Schuster, 2021.

Vaccine Immunity, Plus Natural Immunity from Getting Covid-19, Equals Herd Immunity Soon

The author of the passages I quote below is a surgeon and professor at the Johns Hopkins School of Medicine and has authored The Price We Pay, which I recently read. It is a disturbing, eye-opening, excellent account of why the costs of drugs are high and rising.

(p. A17) Anthony Fauci has been saying that the country needs to vaccinate 70% to 85% of the population to reach herd immunity from Covid-19. But he inexplicably ignores natural immunity. If you account for previous infections, herd immunity is likely close at hand.

. . .

Dr. Fauci’s vaccination-only path to herd immunity has significantly influenced the national conversation. KNBC-TV in Los Angeles has a county-by-county vaccine tracker showing a bar graph of the percentage of Californians vaccinated, with the zone 70% to 85% labeled “herd immunity.” Currently, it’s at 26%. The false construct does create a greater urgency for everyone to get vaccinated. But it also creates false justification for continued excessive restrictions on freedom. And it raises the possibility that authorities are misallocating the limited vaccine supply by failing to direct it toward people without natural antibodies.

. . .

Some experts claim they don’t talk about natural immunity because we shouldn’t trust it. But a recent Public Health England study found that less than 1% of 6,614 healthcare workers who had Covid-19 developed a reinfection within five months—even though many of them work with Covid patients. Other experts believe natural immunity is powerful. “Natural immunity after Covid-19 infection is likely lifelong, extrapolating from data on other coronaviruses that cause severe illness, SARS and MERS,” says Monica Gandhi, an infectious-disease physician and professor at the University of California.

For the full commentary, see:

Marty Makary. “Herd Immunity Is Near, Despite Fauci’s Denial.” The Wall Street Journal (Thursday, March 25, 2021): A17.

(Note: ellipses added.)

(Note: the online version of the commentary has the date March 24, 2021, and has the same title as the print version.)

The Makary book praised above is:

Makary, Marty. The Price We Pay: What Broke American Health Care–and How to Fix It. New York: Bloomsbury Publishing, 2019.