Category: Regulations

Manic Energy from Bipolar Disorder May Enable “Heights of Success”

(p. A17) Dr. Ronald R. Fieve, who was a pioneer in the prescription of lithium to treat mania and other mood disorders — while avowing that some gifted individuals, like Abraham Lincoln, Theodore Roosevelt and Winston Churchill, might have benefited from being bipolar — died on Jan. 2 [2018] at his home in Palm Beach, Fla.

. . .

He cited estimates that as many as one in 15 people experienced a manic episode during their lifetimes, and that bipolar disorder — characterized by swings from elation, hyperactivity and a decreased need for sleep to incapacitating depression — was often misclassified as schizophrenia or other illnesses, or undiagnosed altogether.

He cautioned, however, that some highly creative, exuberant and energetic people have derived benefits from the condition because they have what he called “a hypomanic edge.”

“I have found that some of the most gifted individuals in our society suffer from this condition — including many outstanding writers, politicians, business executives and scientists — where tremendous amounts of manic energy have enabled them to achieve their heights of success,” Dr. Fieve told a symposium in 1973.

But without proper treatment, he said, those individuals afflicted with manic depression “more often than not either go too ‘high’ or suddenly crash into a devastating depression that we only hear about after a successful suicide.”

In contrast to antidepressant drugs or electroshock treatments, he said, regular doses of lithium carbonate appeared to stabilize mood swings without cramping creativity, memory or personality.

. . .

Before it was approved to treat depression, lithium was found in the late 1940s to be potentially unsafe as a salt substitute. But Dr. Fieve pointed out that lithium had been found in natural mineral waters prescribed by Greek and Roman physicians 1,500 years earlier to treat what were then called manic insanity and melancholia.

For the full obituary, see:

Sam Roberts. “Dr. Ronald Fieve, Pioneer In Lithium, Is Dead at 87.” The New York Times (Wednesday, Jan. 17, 2018): A17.

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

(Note: the online version of the obituary has the date Jan. 12, 2018, and has the title “Dr. Ronald Fieve, 87, Dies; Pioneered Lithium to Treat Mood Swings.”)

Plastic Bags Have Lower Carbon Footprint Than Paper or Cotton Bags

(p. B5) The backlash against single-use plastic has engulfed straws, bags and takeout containers, but the plastics industry is fighting back, arguing alternatives can be worse for the environment and disruptive for businesses.

. . .

Critics of bans say single-use plastic bags are often used several times, and that they can be recycled at many supermarkets.

The American Progressive Bag Alliance, a trade body for plastic-bag manufacturers, is battling proposed bag bans in states including Maine and New Jersey.

. . .

The APBA highlights a U.K. government analysis that found paper bags must be used three times for their carbon footprint to drop below that of single-use plastic bags made from high-density polyethylene—or HDPE—and cotton bags 131 times. The study measured the impact of making paper bags by counting the use of energy and palm oil, and the disposal of ash from production. It said growing cotton and producing yarn depletes natural resources, emits damaging chemicals and depletes oxygen in water bodies.

The trade group, which says bans aren’t successful at reducing overall waste, said a study found thicker, reusable plastic bags wound up in Austin’s waste stream after the Texas city banned single-use plastic bags in 2013.

. . .

Some companies feel caught in the middle. McDonald’s Corp. scrapped plastic straws in the U.K. last year but now faces a backlash. Over 44,000 people recently signed a petition calling for the chain to bring back plastic straws, complaining that paper replacements go soggy and make it hard to drink milk shakes.

Others point to their use of plastics as a sustainability selling point.

Garçon Wines—a London-based firm that makes flat plastic wine bottles that fit through a mail slot—said its recycled bottles are 87% lighter than glass and shaped to allow more wine to be shipped in the same space, reducing emissions.

For the full story, see:

Saabira Chaudhuri. “In Plastics War, the Industry Fights Back.” The Wall Street Journal (Tuesday, May 21, 2019): B5.

(Note: ellipses added.)

(Note: the online version of the story has the date May 20, 2019, and the title “In Plastic-Bag Wars, the Industry Fights Back.” Where there are minor differences in wording, the passages quoted above follow the online version.)

Regulators Allowed New York City to Exploit Taxi Medallion Buyers

(p. A1) . . . The New York Times published a two-part investigation revealing that a handful of taxi industry leaders artificially inflated the price of a medallion — the coveted permit that allows a driver to own and operate a cab — and made hundreds of millions of dollars by issuing reckless loans to low-income buyers.

The investigation also found that regulators at every level of government ignored warning signs, and the city fed the frenzy by selling medallions and promoting them in ads as being “better than the stock market.”

The price of a medallion rose to more than $1 million before crashing in late 2014, which left borrowers with debt they had little hope of repaying. More than 950 medallion owners have filed for bankruptcy, (p. A20) and thousands more are struggling to stay afloat.

For the full story, see:

Niraj Chokshi. “New York’s Top Lawyer Begins Inquiry Into Reckless Taxi Loans.” The New York Times (Tuesday, MAY 21, 2019): A1 & A20.

(Note: ellipsis added.)

(Note: the online version of the story has the date MAY 20, 2019, and has the title “Inquiries Into Reckless Loans to Taxi Drivers Ordered by State Attorney General and Mayor.” Where the online version includes a few extra words, or slightly different wording, the quotes above follow the online version.)

Environmentalist Regulations Inspire Vigilantes to Destroy Fairy Houses

(p. A10) Monhegan and a growing number of other environmentally conscious locales are fighting the scourge of fairy gardens, miniature habitats built by children and young-at-heart adults to attract tiny mythical creatures.

Typically they include a pint-size house with a path leading to its entrance and surrounded with small plants. The houses can range from rustic lean-tos handmade from twigs, bark and pebbles to store-bought plastic castles accompanied by LED lights, artificial plants, colorful glass beads and a family of fairy figurines.

On Monhegan, it is easy to run afoul of the regulations, which forbid picking living plants or using anything brought from the shore. No items are to be used “from your pockets,” including coins, food and anything plastic.

It is also easy to run afoul of Ms. Durst, a retired computer consultant who, like several other like-minded vigilantes, calls herself a “stomper” and has crushed many a fairy house over the years.

. . .

Julie Cole, . . . , is something of a scofflaw. She oversees a 5,564-member fairy-garden discussion group on Facebook, sells fairy furniture online and teaches fairy-gardening classes near her home in Jefferson, Ohio. “It’s a true taste of serendipity to be along a trail and see a little fairy door on a tree,” says Ms. Cole. “I can’t imagine anyone not liking that, but there’s always someone.”

For the full story, see:

Ellen Byron. “‘Fairy Houses’ Are Violating Building Codes.” The Wall Street Journal (Thursday, July 18, 2018): A1 & A10.

(Note: ellipses added.)

(Note: the online version of the story has the date July 17, 2018, and the title “Hey Tinkerbell, Get Your Fairy House Up to Code or It’s Coming Down.”)

“If You Do No Harm, Then You Do No Harm to the Cancer, Either”

(p. B16) James F. Holland, a founding father of chemotherapy who helped pioneer a lifesaving drug treatment for pediatric leukemia patients, died on Thursday [March 22, 2018] at his home in Scarsdale, N.Y.

. . .

“Patients have to be subsidiaries of the trial,” he told The New York Times in 1986. “I’m not interested in holding patients’ hands. I’m interested in curing cancer.”

He acknowledged that some patients become guinea pigs, and that they sometimes suffer discomfort in the effort to eradicate tumors, but he said that even those who die provide lessons for others who will survive.

“If you do no harm,” Dr. Holland said, “then you do no harm to the cancer, either.”

. . .

Dr. Holland acknowledged that while experimenting with drug treatment sometimes amounts to trial and error, the primary killer is typically the disease itself.

“The thing to remember,” he said, “is that the deadliest thing about cancer chemotherapy is not the chemotherapy.” Continue reading ““If You Do No Harm, Then You Do No Harm to the Cancer, Either””

“If You Lower the Hurdles to Innovation . . . , You’ll Get More of It”

(p. A2) You’d think from the debate raging in Washington that taxes are the key to economic growth. They aren’t. In the long run, innovation matters way more, and that depends on inspiration, experimentation and luck, not tax-law changes.

Yet presidents matter for promoting innovation even if it’s less glamorous than taxes. Their support often takes the form of directing money toward basic research or favored industries such as defense or renewable energy.

Under President Donald Trump the place to look is the regulators. Two of his appointees in particular, Food and Drug Administration Commissioner Scott Gottlieb and Federal Communications Commission Chairman Ajit Pai, have prioritized reducing regulatory hurdles to private investment as a way of boosting innovation. It’s too early to gauge their success, but the efforts merit more attention at a time when the growth debate is focused on steep, deficit-financed tax cuts.

. . .

At the FCC, Mr. Pai has targeted the “digital divide,” the gap in broadband access between some communities, especially in rural areas, and others. The share of U.S. households with a fixed broadband connection has stalled at roughly a third in recent years. Mr. Pai thinks the solution is “setting rules that maximize private investment in high-speed networks.”

Controversially, that includes a proposed rollback of his predecessor’s imposition of utility-like regulation so that internet service providers (ISPs) adhere to “net neutrality”—charging all content providers the same to access their networks. Without those limitations, he reckons ISPs will have more incentive to expand capacity and thus access; critics worry this will favor rich, established content providers over innovative newcomers.

. . .

. . . , Mr. Gottlieb’s and Mr. Pai’s theory is that if you lower the hurdles to innovation in specific sectors, you’ll get more of it. It offers a potentially more tangible payoff than fiddling with the tax code.

For the full commentary, see:

Greg Ip. “CAPITAL ACCOUNT; Why Innovation Tops Tax Cuts.” The Wall Street Journal (Thursday, October 26, 2017): A2.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Oct. 25, 2017, and the title “CAPITAL ACCOUNT; Trump’s Regulators Aim to Boost Growth by Lowering Hurdles to Innovation.”)

To Be Dangerous with Crispr Takes a Lot of Genetics Knowledge

(p. A11) “I frankly have been flabbergasted at the pace of the field,” says Jennifer Doudna, a Crispr pioneer who runs a lab at the University of California, Berkeley. “We’re barely five years out, and it’s already in early clinical trials for cancer. It’s unbelievable.”

. . .

Scientists have fiddled with genes for decades, but in clumsy ways.

. . .

Crispr is much more precise, as Ms. Doudna explains in her new book, “A Crack in Creation.” It works like this: An enzyme called Cas9 can be programmed to latch onto any 20-letter sequence of DNA. Once there, the enzyme cuts the double helix, splitting the DNA strand in two. Scientists supply a snippet of genetic material they want to insert, making sure its ends match up with the cut strands. When the cell’s repair mechanism kicks in to fix the cut, it pastes in the new DNA.

. . .

A . . . Crispr worry is that it makes DNA editing so easy anybody can do it. Simple hobby kits sell online for $150, and a community biotech lab in Brooklyn offers a class for $400. Jennifer Lopez is reportedly working on a TV drama called “C.R.I.S.P.R.” that, according to the Hollywood Reporter, “explores the next generation of terror: DNA hacking.”

Ms. Doudna provides a bit of assurance. “Genetics is complicated. You have to have quite a bit of knowledge, I think, to be able to do anything that’s truly dangerous,” she says. “There’s been a little bit of hype, in my opinion, about DIY kits and are we going to have rogue scientists—or even nonscientists—randomly doing crazy stuff. I think that’s not too likely.”

For the full interview, see:

Peterson, Kyle, interviewer. “THE WEEKEND INTERVIEW; The Gene Editors Are Only Getting Started; Would you eradicate malaria-carrying insects? Change your baby’s DNA? Scientists soon may have the power to do both.” The Wall Street Journal (Saturday, July 8, 2017): A11.

(Note: ellipses added.)

(Note: the online version of the interview has the date July 7, 2017, and the same title as the print versio.)

Doudna’s book, mentioned above, is:

Doudna, Jennifer A., and Samuel H. Sternberg. A Crack in Creation: Gene Editing and the Unthinkable Power to Control Evolution. New York: Houghton Mifflin Harcourt, 2017.

“Freakin’ Ridiculous” Regulation

(p. A1) REHOBOTH BEACH, Del.—Capt. Kent Buckson’s radio crackled with word of a situation on the beach. A lifeguard had spotted a large canopy amid the sea of umbrellas. That meant one thing. Time for a takedown.

“We’ve got to get to that one,” said Mr. Buckson, the soft-spoken beach patrol boss. He and his deputy, Aaron Tartal, jumped into an all-terrain vehicle and headed over. Mr. Tartal, shirtless and in red swim trunks, strode over to the canopy owner.

“Good morning, sir. I’ve got bad news,” Mr. Tartal told the man. Then he laid out the new law on the two-mile beach. No tents or canopies allowed, except baby tents up to 3 feet high, wide or deep.

“Freakin’ ridiculous,” groused the man, who declined to give his name, as he dismantled the black 8-by-10-foot canopy he had just erected.

“New city ordinance, it’s a little bit of a learning curve,” Mr. Tartal gamely replied, pointing out the nearby shacks that rent umbrellas for $12 a day.

. . .

(p. A14) . . . , the 25-year-old Mr. Tartal, who is a lifeguard in addition to Capt. Buckson’s beach patrol deputy, told Marjorie Danko, a receptionist from Hershey, Pa., that the $40 three-sided tent she bought for her grandchildren didn’t pass muster, either.

“I don’t understand this,” she said. “I think umbrellas are much more dangerous. What kind of ordinance is that? I mean, really dumb.”

Mr. Tartal apologized but didn’t debate her. “We don’t write the ordinances,” he said, “we just enforce them.”

Clutching some cash, Ms. Danko marched off to go rent an umbrella.

For the full story, see:

Scott Calvert. “Beach Patrol Draws a Line In the Sand: No More Tents.” The Wall Street Journal (Wednesday, July 5, 2017): A1 & A10.

(Note: ellipses added.)

(Note: the online version of the story has the date July 4, 2017, and the title “Beach Patrol Confronts a New Menace: Oversize Tents.”)

Mandated Long Clinical Trials Favor Trivial Incremental Drugs and Impede Magic Bullet Cures

(p. B1) AstraZeneca PLC’s new cancer research chief, José Baselga, wants the company to prioritize early-stage cancers over advanced disease when developing new cancer drugs. If successful, his unorthodox strategy could reap rewards for both patients—the potential to cure cancer is much greater when it is treated early—and company coffers.

The approach turns the tried-and-tested model of cancer drug development on its head. Typically, drug companies aim their new cancer drugs at patients with advanced forms of the disease who have exhausted other treatment options. Of the more than 30 new drugs for solid tumors approved for sale in the U.S. since the start of 2014, just two targeted early cancer.

That is largely because there is a clear-cut case for testing new drugs on patients with advanced cancer, as they don’t have other options. What’s more, measuring a new medicine’s effect in advanced cancer is straightforward: a meaningful extension in survival can usually be measured in months. Such patients are also often more willing to try experimental drugs, and regulators have smoothed the path for treatments that show they can prolong lives by delaying tumor growth in advanced cancer.

. . .

(p. B5) “One thing with early stage disease, you have to be able to cure patients,” said Daniel Chen, who spent more than a decade running cancer drug development projects at Roche Holding AG. “The majority of cancer drugs delay cancer growth, they don’t cure patients.” Dr. Chen is now chief medical officer at biotech startup IGM Biosciences Inc.

Running clinical trials could also be difficult, as it would involve persuading patients to try experimental drugs when they might already be cured.

Another challenge is measuring the drug’s effectiveness. In patients whose cancer is diagnosed and treated early, it would take years to determine whether a new drug meaningfully extended survival, making for very long clinical trials.

For the full story, see:

Denise Roland. “Drug Giant Tests Bold Tactic to Battle Cancer.” The Wall Street Journal (Tuesday, May 28, 2019): B1 & B5.

(Note: ellipsis added.)

(Note: the online version of the story has the date May 27, 2019, and has the title “Drug Giant Tries New Tactic to Fight Cancer.”)

FAA to Slightly Ease Regulation of Supersonic Test Flights

(p. B3) . . . , the FAA is poised to propose first-of-their-kind noise standards targeting takeoffs and landings of supersonic aircraft during test flights. Such maneuvers can exceed current standards for comparably sized conventional aircraft operating around airports. Some of the proposed supersonic jetliners are projected to be about one-third longer than the roughly 120-foot length of an older Boeing Co. 737.

Based on size, the FAA wants to permit more takeoff noise for supersonic craft than would be allowed under existing standards, but in every case no more than is now permitted for the largest wide-body airliners.

The FAA’s primary goal, according to Mr. Elwell, is to make sure “we don’t become a hindrance to the movement of this technology” into commercial applications.

Bombardier has restructured its aviation division over the past two years, highlighted by its joint venture with Airbus that put the European plane maker in charge of the production and sales of the 110- to 130-seat planes that the Montreal company had originally conceived as the CSeries. Those jets are now rebranded as the Airbus A220.

. . .

The anticipated regulations won’t deal with noise constraints at higher altitudes and supersonic speeds, where controlling sonic boom remains a major design and operational challenge requiring a new generation of quieter, more fuel-efficient engines. But for some time, supersonic proponents have lobbied Congress and tried to persuade the FAA to take preliminary steps to remove hurdles to development flights.

For the full story, see:

Andy Pasztor. “Supersonic Flights Poised for Return.” The Wall Street Journal (Tuesday, June 18, 2019): B3.

(Note: ellipses added.)

(Note: the online version of the story has the date June 17, 2019, and has the title “FAA Seeks to Enable Return of Supersonic Passenger Aircraft.”)

New Opiod Regulations Make Life Harder for Those in Severe Pain

(p. C4) There’s a great deal in “Dopesick” that’s incredibly bleak, but the most chilling moment for me was a quote from one of Macy’s journalist friends. Synthetic opioids had allowed this woman, despite a severe curvature of her spine, to lead an active life without risky surgery. She resented new rules that made it more onerous for her to get the pills. “My life,” she told Macy, “is not less important than that of an addict.”

For the full review, see:

Jennifer Szalai. “BOOKS OF THE TIMES; A Ground-Level Look At the Opioid Epidemic.” The New York Times (Thursday, July 26, 2018): C1 & C4.
(Note: ellipsis added.)

(Note: the online version of the review has the date July 25, 2018, and has the title “BOOKS OF THE TIMES; ‘Dopesick’ Traces the Opioid Crisis, From Beginning to Blow Up.”)

The book under review, is:

Macy, Beth. Dopesick: Dealers, Doctors, and the Drug Company That Addicted America. New York: Little, Brown and Company, 2018.