Category: Regulations

Socialized Medicine “Mummifies Its Doctors in Spools of Red Tape”

(p. A17) One of the reasons patients find condescension from doctors especially loathsome is that it diminishes them — if you’re gravely ill, the last thing you need is further diminishment. But the desires of patients, Marsh notes, are often paradoxical. They also pine for supreme confidence in their physicians, surgeons especially, because they’ve left their futures — the very possibility of one at all, in some cases — in their doctors’ custody. “So we quickly learn to deceive,” Marsh writes, “to pretend to a greater level of competence and knowledge than we know to be the case, and try to shield our patients a little from the frightening reality they often face.”
Over time, Marsh writes, many doctors start to internalize the stories they tell themselves about their superior judgment and skill. But the best, he adds, unlearn their self-deceptions, and come to accept their fallibility and learn from their mistakes. “We always learn more from failure than from success,” he writes. “Success teaches us nothing.”
This was a prominent theme in Marsh’s last book, and readers may have a sense of déjà vu while reading this one. Like “Do No Harm,” “Admissions” is wandering and ruminative, an overland trek through the doctor’s anxieties and private shames. Once again, he recounts his miscalculations and surgical catastrophes, citing the French doctor René Leriche’s observation that all surgeons carry cemeteries within themselves of the patients whose lives they’ve lost. Once again, he rails against the constraints of an increasingly depersonalized British health care system, which mummifies its doctors in spools of red tape. Once again, he describes his operating theater in all of its Grand Guignol splendor, with brains swelling beyond their skulls and suction devices “slurping obscenely” as tumors evade his reach.

For the full review, see:
JENNIFER SENIOR. “Books of The Times; Surgical Catastrophes, Private Shames.” The New York Times (Sat., Oct. 7, 2017): A17.
(Note: the online version of the review has the date Oct. 5, 2017, and has the title “Books of The Times; A Surgeon Not Afraid to Face His Mistakes, In and Out of the Operating Room.)

The book under review, is:
Marsh, Henry. Admissions: Life as a Brain Surgeon. New York: Thomas Dunne Books/St. Martin’s Press, 2017.

NIH and FDA Should Allow Gene Editors to Cure Diseases

(p. A15) Should Americans be allowed to edit their DNA to prevent genetic diseases in their children? That question, which once might have sounded like science fiction, is stirring debate as breakthroughs bring the idea closer to reality. Bioethicists and activists, worried about falling down the slippery slope to genetically modified Olympic athletes, are calling for more regulation.
The bigger concern is exactly the opposite–that this kind of excessive introspection will cause patients to suffer and even die needlessly. Anachronistic restrictions at the Food and Drug Administration and the National Institutes of Health effectively ban gene-editing research in human embryos that would lead to implantation and births. These prohibitions are inhibiting critical clinical research and should be lifted immediately.
. . .
What’s holding researchers back, at least in America, is outmoded regulations. The FDA is blocked by law from accepting applications for research involving gene editing of the human germ line–meaning eggs, sperm and embryos. The NIH, whose approval also would be needed, is similarly barred from even considering applications to conduct such experiments in humans. These rules date as far back as the 1970s, when the technology was in its infancy. It’s easy to invoke hypothetical fears when actual lifesaving interventions are decades away.
Today they aren’t–and desperate patients deserve access to whatever cures this technology may be able to provide. The public thinks so, too. A survey this summer found that nearly two-thirds of Americans support therapeutic gene editing–in somatic and germ-line cells alike. Popular opinion is in tune with scientific reality. Legislators and regulators need to catch up.

For the full commentary, see:
Henry I. Miller. “Gene Editing Is Here, and Desperate Patients Want It; Two-thirds of Americans support therapeutic use, but regulators are still stuck in the 1970s.” The Wall Street Journal (Fri., OCT. 13, 2017): A15.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date OCT. 12, 2017.)

After 30 Years, Medical Entrepreneur Rosenberg’s Slow Hunch Pays Off

(p. B3) In the another significant development, the cancer institute’s prominent cancer researcher and chief of surgery, Steven A. Rosenberg, detailed for the first time an immunotherapy success against metastatic breast cancer, in a talk earlier this month.
In the lecture at a Boston meeting of the American Association of Cancer Research, Dr. Rosenberg reported on the first patient with metastatic breast cancer who is disease-free nearly two years after her first immunotherapy treatment. In the therapy, a person’s own cells are multiplied billions of times and reinfused into the patient. Dr. Rosenberg’s lab has already reported successes in treatment of melanoma, lymphoma, colorectal cancer and bile-duct cancer.
That patient is Judy Perkins, a 51-year-old structural engineer from Port St. Lucie, Fla. She was diagnosed with metastatic cancer–cancer that spread beyond the original location–in 2013.
. . .
Ms. Perkins is only one case. But the fact that she had metastatic breast cancer that is no longer detectable makes it very consequential. It follows reports from the Rosenberg lab about other internal-organ cancers, specifically colorectal and bile-duct.
. . .
Dr. Rosenberg’s interest in immunotherapy was piqued three decades ago, when he was struck by a chance encounter with a stomach-cancer patient who improbably recovered despite no treatment. This became a lifelong quest to discover how that patient had in effect cured himself. Scores of recoveries at the cancer institute of melanoma and lymphoma patients followed after immunotherapy treatment from his lab.
Now, his lab is exploring the promise of treating and accomplishing tumor regressions in far-more-common solid-tumor cancers of internal organs, including the breast, colon and bile-duct.

For the full story, see:
Thomas M. Burton. “Immunotherapy Treatments for Cancer Gain Momentum.” The Wall Street Journal (Fri., Oct. 13, 2017): B3.
(Note: ellipses added.)
(Note: the online version of the story has the date Oct. 12, 2017.)

FCC Spectrum Regulations Drive Innovators to Bankruptcy

(p. A17) In 2004 the FCC moved to relax L-Band rules, permitting deployment of a terrestrial mobile network. Satellite calls would continue, but few were being made, and sharing frequencies with cellular devices made eminent sense. By 2010, L-Band licensee LightSquared was ready to build a state-of-the-art 4G network, and the FCC announced that the 40 MHz bandwidth would become available. LightSquared quickly spent about $4 billion of its planned $14 billion infrastructure rollout. Americans would soon enjoy a fifth nationwide wireless choice.
But in 2012 the FCC yanked LightSquared’s licenses. Various interests, from commercial airlines to the Pentagon, complained that freeing up the L Band could cause interference with Global Positioning System devices, since they are tuned to adjacent frequencies. Yet cheap remedies–such as a gradual roll-out of new services while existing networks improved reception with better radio chips–were available. In reality, the costliest spectrum conflicts emanate from overprotecting old services at the expense of the new. With its licenses snatched away, LightSquared instantly plunged into bankruptcy.
. . .
. . . regulatory impediments continue to block progress. Years after the L-Band spectrum was slated for productive use in 4G, it lies fallow–now delaying upgrades to 5G.

For the full commentary, see:
Thomas W. Hazlett. “How Politics Stalls Wireless Innovation; The FCC unveiled its National Broadband Plan in 2010–but couldn’t stick to it.” The Wall Street Journal (Mon., Oct. 2, 2017): A17.
(Note: ellipses added.)
(Note: the online version of the commentary has the date Oct. 1, 2017.)

The commentary, quoted above, is related to the author’s book:
Hazlett, Thomas W. The Political Spectrum: The Tumultuous Liberation of Wireless Technology, from Herbert Hoover to the Smartphone. New Haven, CT: Yale University Press, 2017.

Federal and State Mandates Constrain “Creativity in the Classroom”

(p. A11) Mrs. DeVos sees choice as a means to the end of promoting educational innovation–including within traditional public schools. “Instead of focusing on systems and buildings, we should be focused on individual students,” she says. That means encouraging young people “to pursue their curiosity and their interests, and being OK with wherever that takes them–not trying to conform them into a path that everybody has to take.”
What stands in the way? “I think a real robust defense of the status quo is the biggest impediment,” Mrs. DeVos says. She doesn’t mention teachers unions until I raise the subject, whereupon she observes: “I think that they have done a good job in continuing to advocate for their members, but I think it’s a focus more around the needs of adults” rather than students.
Many of the adults are frustrated, too. Recently I met a veteran middle-school teacher who said his creativity in the classroom has been increasingly constrained by federal and state mandates on curriculum and testing. Another teacher I know, who wants to start a charter, complains that “it is getting harder and harder to work for the idiots in traditional schools.”
That sounds familiar to Mrs. DeVos. “I do hear sentiments from many teachers like that,” she says, “and particularly from many teachers that are really effective and creative themselves. I’ve also heard from many teachers who have stopped teaching because they feel like they can’t really be free to do their best, because they’re either subtly or not subtly criticized by peers who might not be as effective as they are–or by administrators who don’t want to see them sort of excelling and upsetting the apple cart within whatever system they’re in.”
She continues: “I talked to a bunch of teachers that had left teaching that had been Teachers of the Year in their states or their counties or whatever. I recall one of the teachers said he just felt so beaten down after being told repeatedly to have his class keep it down–that they were having too much fun, and the kids were too engaged. Well, what kind of a message is that?”

For the full interview, see:
James Taranto, interviewer. “THE WEEKEND INTERVIEW with Betsey DeVos; The Teachers Union’s Public Enemy No. 1.” The Wall Street Journal (Sat., Sept. 2, 2017): A11.
(Note: the online version of the interview has the date Sept. 1, 2017, and has the title “THE WEEKEND INTERVIEW; The Teachers Union’s Public Enemy No. 1.”)

More Cures If Local Physicians Can Conduct Clinical Trials

(p. A17) The good news is that technology innovations are moving us toward modern clinical trial designs. Electronic health records, now common in U.S. medical practices, allow physicians to collect timely and detailed data that could be used for exploring ways of bringing clinical research directly to patients. Those records are becoming the technological building blocks of a new research model based on real-world evidence, which aims to provide insights regarding the usage and potential benefits or risks of a drug by analyzing patient data collected as part of routine delivery of care.
Real-world evidence captures the experience of real-world patients, who are generally more diverse than the selective cohorts enrolled in clinical trials. Additionally, real-world data from electronic health records may be used after a drug’s approval to answer important questions about its use. Researchers can, for example, search through anonymized data from patients taking a specific cancer drug to see whether those with a certain tumor mutation respond better or worse than other patients. Such information could help doctors personalize therapies based on the patient’s genomic makeup.
Moving clinical research to a doctor’s office, the point of routine care, may also address the difficulties patients and doctors face with off-label drugs. If local physicians can participate in conducting real-world randomized clinical trials in their own practices, new uses of approved drugs could be carefully studied, potentially generating evidence supporting approval of a new use. Real-world clinical trials could also limit disruptions to patients’ lives by reducing the need for long-distance travel.

For the full commentary, see:
Amy Abernethy and Sean Khozin. “Clinical Drug Trials May Be Coming to Your Doctor’s Office; Electronic medical records make possible a new research model based on real-world evidence.” The Wall Street Journal (Weds., Sept. 13, 2017): A17.
(Note: the online version of the commentary has the date Sept. 12, 2017.)

Nursing Unions “Keep Aides from Encroaching on Their Turf”

(p. B2) There are a few reasons long-term care is such a bad job. “Most people see it as glorified babysitting,” said Robert Espinoza, vice president for policy at PHI, an advocacy group for personal care workers that also develops advanced training curriculums to improve the quality of the work force.
The fact that most workers are immigrant women does not help the occupation’s status. Occupational rules that reserve even simple tasks for nurses, like delivering an insulin shot or even putting drops into a patient’s eye, also act as a barrier against providing care workers with better training.
. . .
. . . there are the powerful nursing unions, ready to fight tooth and nail to keep aides from encroaching on their turf. Carol Raphael, former chief executive of the Visiting Nurse Service of New York, the largest home health agency in the United States, told Professor Osterman that when the association tried to expand the role of home-care aides, the “nurses went bonkers.”

For the full commentary, see:
Porter, Eduardo. “ECONOMIC SCENE; Rethinking Home Health Care as a Path to the Middle Class.” The New York Times (Weds., AUG. 30, 2017): B1-B2.
(Note: ellipses added.)
(Note: the online version of the commentary has the date AUG. 29, 2017, and has the title “ECONOMIC SCENE; Home Health Care: Shouldn’t It Be Work Worth Doing?”)

“The Regulations Are Absurd”

(p. A6) CIUDAD del ESTE, Paraguay–This remote South American country, long known for contraband traffickers and a 35-year dictatorship, is now becoming something else: a manufacturing hub.
Paraguay has attracted scores of foreign factories since 2013, as predominantly Brazilian companies respond to new incentives by flocking to this gritty border city to make everything from toys to motor scooters for export.
Koumei SA, a family-run Brazilian light-fixtures company, is typical. Its owners moved the plant and about 150 jobs here last year, saying they were fed up with Brazil’s high taxes and complicated labor rules.
“It’s just easier here,” said Seijii Abe, who directs the company with his father.
. . .
Brazil ranked 123rd out of 190 in the World Bank’s 2017 survey on ease of doing business, right behind Uganda and Egypt. Companies there say they are bedeviled by rules that smother entrepreneurial impetus. They point to labor regulations that make hiring and firing difficult, high energy bills, a legal system that encourages employee lawsuits and taxes of up to 35% on imported goods.
“The regulations are absurd,” said João Carlos Komuchena, owner of Kompar SA, a company which makes small plastic bottles used for packing soy sauce and other products that moved to Paraguay from Brazil last year. “We need to wake up in Brazil; there is a lot of prejudice against business.”

For the full story, see:
Jeffrey T. Lewis. “Businesses Flee Brazil Rules for Paraguay.” The Wall Street Journal (Mon., Aug. 28, 2017): A6.
(Note: ellipsis added.)
(Note: the online version of the story has the date Aug. 26, 2017, and has the title “Brazil’s Woes Multiply as Manufacturers Move to Paraguay.”)

German Energy Consumers Pay Double Due to Ineffective Solar Subsidies

(p. B1) BETZIGAU, Germany — Katharina Zinnecker’s farm in the foothills of the German Alps has been in the family since 1699. But to squeeze a living from it today, she and her husband need to do more than sell the milk from their herd of cows.
So they carpeted the roofs of their farm buildings with solar panels. And thanks to hefty government guarantees, what they earn from selling electricity is “safe money, not like cows,” Ms. Zinnecker said. “Milk prices go up and down.”
The farm has been a beneficiary of “Energiewende,” the German word for energy transition. Over the past two decades, Germany has focused its political will and treasure on a world-leading effort to wean its powerful economy off the traditional energy sources blamed for climate change.
The benefits of the program have not been universally felt, however. A de facto class system has emerged, saddling a group of have-nots with higher electricity bills that help subsidize the installation of solar panels and wind turbines elsewhere.
. . .
(p. B2) . . . renewable energy subsidies are financed through electric bills, meaning that Energiewende is a big part of the reason prices for consumers have doubled since 2000.
These big increases “are absolutely not O.K.,” said Thomas Engelke, team leader for construction and energy at the Federation of German Consumer Organizations, an umbrella organization of consumer groups.
The higher prices have had political consequences.
The far-right party Alternative for Germany, which won enough support in the recent elections to enter Parliament, has called for an “immediate exit” from Energiewende. The party, known by its German initials AfD, sees the program as a “burden” on German households, and many supporters have come into its fold in part because of the program’s mounting costs.
Julian Hermneuwöhner is one such voter. Mr. Hermneuwöhner, a 27-year-old computer science student, said his family paid an additional €800 a year because of Energiewende.
“But it hasn’t brought lower CO2 emissions,” he said. “It’s frustrating that we’re paying so much more, because the country hasn’t gotten anything for it.”
As a clean energy pioneer, Germany has not always seen the results it desired from its heavy spending.
. . .
. . . progress has been undone somewhat by the government’s decision to accelerate its phase out of nuclear power after the 2011 disaster in Fukushima, Japan. That has made the country more reliant on its sizable fleet of coal-fired power stations, which account for the bulk of emissions from electricity generation.
The country has yet to address the transport industry, where emissions have increased as the economy boomed and more cars and trucks hit the road.

For the full story, see:
STANLEY REED. “$222 Billion Shift Hits a Snag.” The New York Times (Thurs., OCT. 7, 2017): B1-B2.
(Note: ellipses added.)
(Note: the online version of the story has the title “Germany’s Shift to Green Power Stalls, Despite Huge Investments.”)

On Private Property, Innovator “Can Try New Ideas Without as Much Red Tape”

(p. B1) SAN JOSE, Calif. — Molly Jackson, an 82-year-old retired nurse, was sitting in the back seat of a self-driving taxi when the vehicle jerked to a halt at a crossing as its computer vision spotted an approaching golf cart.
When the vehicle, a modified Ford Fusion developed by a start-up named Voyage, started to inch forward, it abruptly stopped again as the golfers pressed ahead and cut in front of the car.
Ms. Jackson seemed unfazed by the bumpy ride. As a longtime resident of the Villages Golf and Country Club, a retirement community in San Jose, Calif., she knew all about aggressive golf cart drivers.
“I like that; we made a good stop there,” Ms. Jackson said. “I stop for them. They say we don’t have to, but I do.”
. . .
The speed limit, just 25 miles an hour, helps reduce the risk if something goes wrong. And because it is private property, the company does not have to share ride information with regulators and it can try new ideas without as much red tape.
(p. B6) Cars that can drive themselves could be a great benefit to older people. Residents at the Villages say that once people stop driving, they often pull back from activities and interacting with friends.

For the full story, see:
DAISUKE WAKABAYASHI. “Where Cars Brake for Golf Carts.” The New York Times (Thurs., OCT. 5, 2017): B1 & B6.
(Note: ellipses added.)
(Note: the online version of the story has the date OCT. 4, 2017, and has the title “Where Driverless Cars Brake for Golf Carts.”)