(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””
Category: Regulations
“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:
(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:
(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:
(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:
(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:
(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.
Fire Marshall Regulations Reduce Use of Hospital Hand Sanitizers, Helping Spread Dangerous Bacteria
(p. A11) With the use of alcohol-based hand sanitizer — often more effective and convenient than soap and water — it’s far easier to keep hands clean than clothing.
But the placement of alcohol-based hand sanitizer for health workers isn’t as convenient as it could be, reducing its use. The reason? In the early 2000s, fire marshals began requiring hospitals to remove or relocate dispensers because hand sanitizers contain at least 60 percent alcohol, making them flammable.
Fire codes now limit where they can be placed — a minimum distance from electrical outlets, for example — or how much can be kept on site.
Hand sanitizers are most often used in hallways, though greater use closer to patients (like immediately before or after touching a patient) could be more effective.
. . .
Although there have been fires in hospitals traced to alcohol-based hand sanitizer, they are rare. Across nearly 800 American health care facilities that used alcohol-based hand sanitizer, one study found, no fires had occurred. The World Health Organization puts the fire risk of hand sanitizers as “very low.”
For the full commentary, see:
(Note: ellipsis added.)
(Note: the online version of the commentary has the date April 29, 2019, and has the title “Why Your Doctor’s White Coat Can Be a Threat to Your Health.” The last two sentences quoted above, occur in the online, but not the print, version of the article.)
The the rarity of hand sanitizer hospital fires was documented in:
Boyce, John M., and Michele L. Pearson. “Low Frequency of Fires from Alcohol-Based Hand Rub Dispensers in Healthcare Facilities.” Infection Control & Hospital Epidemiology 24, no. 8 (Aug. 2003): 618-19.
$15 Minimum Wage Equals Income About Twice Federal Poverty Level for Household of Two
(p. B1) The legal minimum wage in the United States is $7.25 per hour, . . .
The minimum wage roughly meshes with federal poverty guidelines. According to the guidelines, a two-person household with a total annual income below $16,910 is considered to be living in poverty. To clear the poverty line, one of those two people would have to make $8.13 an hour or more. At least 17 states have minimum wages higher than that. The $15-per-hour minimum wage in New York City, for example, translates to an annual income of $31,200, which is almost twice the federal poverty level for a household of two.
For the full story, see:
(Note: ellipsis added.)
(Note: the online version of the story has the date June 5, 2019, and has the title “What a ‘Living Wage’ Actually Means.”)
Cost of Housing Is Main Driver of Migration from Superstar Cities
(p. B1) Last month the Census Bureau confirmed a confounding dynamic taking hold across the American landscape: Superstar cities, the nation’s economic powerhouses, hotbeds of opportunity at the cutting edge of technological progress, are losing people to other parts of the country.
For the first time in at least a decade, 4,868 more people left King County, Wash. — Amazon’s home — than arrived from elsewhere in the country.
Santa Clara County, Calif., home to most of Silicon Valley, lost 24,645 people to domestic migration, its ninth consecutive annual loss.
The trend is becoming widespread. Eight of the 10 largest metropolitan areas in the country, including those around New York, San Francisco, Los Angeles and Miami, lost people to other places in 2018. That was up from seven in 2016, five in 2013 and four in 2010. Migration out of the New York area has gotten so intense that its total population shrank in 2018 for the second year in a row.
. . .
(p. B5) Research by Peter Ganong from the University of Chicago and Daniel Shoag of Harvard suggests that housing costs are a principal driver of the change in migration decisions: As the highly educated have flocked to superstar cities, they have pushed housing prices way beyond the reach of people earning less. Continue reading “Cost of Housing Is Main Driver of Migration from Superstar Cities”
Modi Cut India’s Taxes, Corruption, and Regulations
(p. B1) MUMBAI, India — A jeans maker saw his delivery costs cut by half when the highway police stopped asking for bribes. An aluminum wire factory faced only three inspectors rather than 12 to keep its licenses. Big companies like Corning, the American fiber-optic cable business, found they could wield a new bankruptcy law to demand that customers pay overdue bills.
Prime Minister Narendra Modi promised nearly five years ago to open India for business. Fitfully and sometimes painfully, his government has streamlined regulations, winnowed a famously antiquated bureaucracy and tackled corruption and tax evasion.
. . .
(p. B5) Mehta Creation, a jeans maker in a dilapidated concrete building in the northern outskirts, paid a welter of taxes until two years ago. That included the dreaded octroi, a British import from medieval times that allowed states and some cities to collect taxes whenever goods crossed a boundary.
Mehta Creation’s budget was contorted by corruption. To avoid the octroi, which could triple the cost of a delivery and add delays, Mehta paid drivers about $5 for each parcel of jeans and then reimbursed them up to $6 per parcel to bribe the local police at every border, said Dhiren Sharma, the company’s chief operating officer.
Mehta’s costs dropped after the government abolished 17 taxes, including the octroi, two years ago and established instead a national value-added tax on most business activity. Continue reading “Modi Cut India’s Taxes, Corruption, and Regulations”