Regulations – Page 52 – artdiamondblog.com

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.”)

Washington, D.C. Regulators Protect Citizens from Goat Yoga

“Goat yoga has spread nationwide since last year. Practitioners in Glendale, Calif., in May.” Source of caption and photo: online version of the WSJ article quoted and cited below.

(p. A1) WASHINGTON–Young goats have on occasion grazed in the Historic Congressional Cemetery, deployed to keep down brush. A yoga instructor has been holding weekly classes in the chapel.

Goats and yoga go together, as any modern yogi knows. So, cemetery staff proposed this spring, why not combine them and bring inner peace to all on the grounds?
“I asked the farmer if there’s any harm to the goats doing yoga,” says Kelly Carnes, who teaches the discipline on the cemetery grounds. “She said quite the opposite–the baby goats just love to interact with humans.”
Gruff was the response from District of Columbia officials. District policy, they decreed, prohibited the human-animal contact goat yoga presented: “At this time the request for the event with the inclusion of baby goats has been denied.”
. . .
(p. A12) This spring at the Congressional Cemetery, Ms. Carnes read about goat yoga and raised the idea with participants in her “yoga mortis” classes at the cemetery. They were “crazy to try it,” she says.
She spoke with Paul Williams, president of the nonprofit that manages the cemetery, about trying it with the goats they had twice hired over the past several years to eat down unwanted plants.
The cemetery planned to hold goat classes in a pen in a grassy area. In June, Mr. Williams sought permission from the health department.
The “no” came that month. The capital’s health code, says Dr. Vito DelVento, manager of the District of Columbia Department of Health’s animal-services program, bans animals beyond common household pets from within district limits.
. . .
Then there’s Washington’s “no touch” policy barring direct contact between humans and animals beyond household pets.
“Baby goats are probably one of the most fun animal species–they are a blast,” says Dr. DelVento, who has farm animals outside the District and has raised goats. “But the fact that we have baby goats jumping on people and interacting with people obviously violates our ‘no touch’ policy.”
Mr. Williams says he will try again next year when Mrs. Bowen has a fresh herd of kids. He will seek a no-touch-policy exemption.
“We’re really trying to offer a service,” says Mrs. Bowen, “that is good for people’s mental health and physical health.”

For the full story, see:
Daniel Nasaw. “The Kids Are Not Alright: Bureaucrats Buck Goat Yoga.” The Wall Street Jounal (Sat., OCT. 2, 2017): A1 & A12.
(Note: ellipses added.)
(Note: the online version of the story has the date OCT. 1, 2017, and has the title “Goat Yoga, Meet the Zoning Board.”)

Wisconsin Regulators Protect Consumers from Delicious Imported Kerrygold Butter

(p. A3) Attorneys with the Wisconsin Institute for Law and Liberty are taking the state to court over a 1953 law that mandates all butter sold in Wisconsin be graded and labeled on factors such as flavor, texture and color by state-licensed tasters.
Those convicted of selling unlabeled butter in the state more than once could pay up to $5,000 in fines and spend a year in county jail.
The statute has enraged devotees of the popular Kerrygold brand of butter, which is produced in Ireland and hasn’t been tested by the state. Local retailers say their inability to sell the grass-fed, gold-packaged spread has affected their bottom line. WILL is representing four consumers in counties across Southeast Wisconsin in the suit, as well as a health-food store in Grafton.
“I think the issue is important because it’s a specific instance of a larger problem,” Rick Esenberg, WILL President and lead counsel, said of the obscure, 64-year-old ordinance. “The government should not restrict our liberties–particularly our ability to engage in a legitimate business and make a living.”
. . .
Wisconsin laws have shielded the dairy industry from out-of-state competition for decades, but have often crumbled under judicial scrutiny.
The Wisconsin Supreme Court in 1927 ruled unconstitutional a law prohibiting the sale of oleomargarine and other butter substitutes in the state, and in 1952 turned back an attempt to ban the sale of Dairy Queen soft-serve.
In 1895, Wisconsin forbade the sale of artificially colored margarine, forcing neighbors to pool funds and make “oleo runs” to the Illinois border to buy yellow-hued margarine in bulk. That law wasn’t repealed until 1967.
A half-century later, Wisconsin residents are now embarking on similar Midwestern voyages to stock up on Kerrygold.
“It has a richness to it and a taste to it that’s uncomparable to the other butters,” said Jean Smith, an avid consumer of Kerrygold and one of the plaintiffs in the Wisconsin suit.
Ms. Smith especially enjoys adding the Irish butter to her tea on mornings when she doesn’t have time for a full breakfast, and is a member of a Facebook group where neighbors keep each other abreast of the few Wisconsin stores supplying Kerrygold.
She buys the product whenever she travels out of state, picking up roughly a dozen bricks of butter on two trips to Nebraska this summer and then again when visiting Montana in May for her nephew’s graduation.
“The fact that I have to do that is absolutely ridiculous,” Ms. Smith said. “If it’s not related to safety, it’s not the government’s decision whether they should offer a product or not.”

For the full story, see:
Quint Forgey. “Wisconsin Lawsuit Aims to Whip Butter Statute.” The Wall Street Journal (Sat., Aug. 31, 2017): A3.
(Note: ellipsis added.)
(Note: the online version of the story has the date Aug. 30, 2017, and has the title “Wisconsin Lawsuit Aims to Cut Through Butter Laws.” Of the last eight short paragraphs quoted above, the first and third appear in both the online and the print version of the article. The rest only appear in the online version.)