Category: Government

Expense of Clinical Trials Reduce the Incentive to Re-Purpose Old, Cheap, Off-Patent Vaccines

(p. A5) “Retrospective studies are great and they provide some hints, but there are caveats,” said Dr. Shyam Kottilil, a professor of medicine with the Institute of Human Virology at the University of Maryland School of Medicine. “It’s very difficult to establish causality.”

Interest in the cross-protective effects of vaccines has led to efforts to repurpose old vaccines that may have potential to provide at least transient protection against the coronavirus until a specific vaccine against SARS-CoV-2 is developed and proven safe and effective, he said.

“But nobody knows whether this approach will work unless we test them,” Dr. Kottilil said. “To endorse this, you need to do really good randomized clinical trials.” There is little incentive for private companies to invest in expensive trials because the old vaccines are cheap and off-patent, he added.

For the full story, see:

Roni Caryn Rabin. “Are Past Vaccinations a Shield? It’s Doubtful.” The New York Times (Thursday, July 30, 2020): A5.

(Note: the online version of the story has the date July 29, 2020, and has the title “Old Vaccines May Stop the Coronavirus, Study Hints. Scientists Are Skeptical.”)

The Son of Jonas Salk Calls Operation Warp Speed “Absolutely Extraordinary”

A screen capture from the Replica Edition of the NYT, p. A4 for Thurs., Nov. 18, 2020.

(p. A4) A 76-year-old man in La Jolla, Calif., says he will get a coronavirus but not the way he got a polio vaccine when he was 9 — lined up in the kitchen next to his two siblings. Their father had sterilized the needles and syringes by boiling them on the stove.

The father was Dr. Jonas Salk, who had developed the vaccine.

. . .

At the time, the vaccine had gone through trials with small numbers of children. A trial with 1.8 million children did not begin until the next year, and the vaccine did not receive approval as safe and effective until a year after that — a timetable that he said made the development of coronavirus vaccine candidates in just months “absolutely extraordinary.” He said he had been concerned about pressure from the Trump administration to have a vaccine ready by Election Day. But he also said the decision to back the development of vaccines through Operation Warp Speed, the federal effort to accelerate vaccine development, “was quite positive.”

For the full story, see:

Barron, James. “Coronavirus Update; ‘l Just Didn’t Feel the Shot’.” The New York Times (Wednesday, November 18, 2020): A4.

(Note: ellipsis added.)

(Note: after considerable time spent searching, I was unable to find this article on the nytimes.com web site. I searched on 11/21/20 for the article that had appeared in-print on 11/18/20. In my experience, it is extremely rare for so recent a print article to be missing from the online web site. So, for documentary purposes, I have reproduced a screen capture of the article from the Replica Edition. (For subscribers to the NYT, The Replica Edition provides an online replica of the print edition for the previous 30 days of issues of the NYT.)

California Energy Shortage Partly Due to Government Mandated Price Ceiling on Energy Imported from Out-of-State

(p. B9) As California keeps facing electricity shortages, the discussion around its grid often veers to extremes.

. . .

Should California . . . have shut down less natural gas and nuclear power? That is definitely part of the issue, and future shutdowns might need to slow.

. . .

. . . at least some of the shortage is addressable through market rules.

For example, California has a hard import bid cap of $1,000 per megawatt hour. Christopher DaCosta, regional director of western power markets at Wood Mackenzie, says that surrounding areas have a softer cap and are able to pay more. During this summer, that meant power plants often rerouted electricity to higher bidders than California.

For the full commentary, see:

Jinjoo Lee. “To Keep Lights On, California Needs Power Play.” The Wall Street Journal (Thursday, September 17, 2020): B9.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Sep. 16, 2020, and has the title “How to Keep the Lights On in California.”)

California Government Allowed “Buildup” of “Fuel for Future Blazes”

(p. A1) California is one of America’s marvels. By moving vast quantities of water and suppressing wildfires for decades, the state has transformed its arid and mountainous landscape into the richest, most populous and bounteous place in the nation.

. . .

(p. A16) The intensity of the fires . . . reflects decades of policy decisions that altered those forests, according to Robert Bonnie, who oversaw the United States Forest Service under President Barack Obama. And the cost of those decisions is now coming due.

In an effort to protect homes and encourage new building, governments for decades focused on suppressing fires that occurred naturally, allowing the buildup of vegetation that would provide fuel for future blazes. Even after the drawbacks of that approach became clear, officials remained reluctant to reduce that vegetation through prescribed burns, wary of upsetting residents with smoke or starting a fire that might burn out of control.

That approach made California’s forests more comfortable for the estimated 11 million people who now live in and around them. But it has also made them more susceptible to catastrophic fires. “We’ve sort of built up this fire debt,” Mr. Bonnie said. “People are going to have to tolerate smoke and risk.”

For the full story, see:

Christopher Flavelle. “Mankind’s Feats Place California At Climate Risk.” The New York Times (Monday, September 21, 2020): A1 & A15.

(Note: ellipses added.)

(Note: the online version of the story has the date September 20, 2020, and has the title “How California Became Ground Zero for Climate Disasters.”)

Boeotia Was “an Early Model of Democratic Federalism”

(p. C12) Mr. Cartledge, a professor emeritus at Cambridge and author of popular history books such as “The Spartans,” “Thermopylae,” “Alexander the Great” and “Democracy: A Life,” has picked an opportune time to look afresh at Thebes and Boeotia. The modern city of Thebes, an uninspiring market town, would not normally attract tourists, but is home to a glittering new museum, among the most up-to-date in Greece, featuring exhibits of archaeological finds (many unique in type) and historical objects from prehistory to the present. (One exhibit is titled, provocatively, “The Intellectual Radiance of Boeotia.”) There is a book forthcoming, from scholar James Romm, about Thebes’s “Sacred Band,” its elite unit of soldiers, made up of pairs of devoted homosexual lovers. Thebes is in the spotlight.

. . .

The biography of the Theban leader Epaminondas (418 B.C.-362 B.C.) written by Plutarch is, unfortunately, lost. Even so, his reputation shines. Admired by figures from Cicero and Montaigne to Sir Walter Raleigh (who called him “the worthiest man that ever was bred by the nation of Greece”), Epaminondas seems to have had a philosophical bent as well as a brilliant military mind.

. . .

Perhaps his greatest act, . . ., even if it might have been intended more to inconvenience the Spartans than as a benevolent deed, was freeing the helots of Messenia, a people that had been enslaved by the Spartans for 300 years. He helped found a new capital city for the Arcadian federation (Megalopolis), and also for the ex-helots (Messene). Maybe Epaminondas was not only the Nelson of his age, but the Lincoln as well. He died in battle and was buried alongside his male beloved, Caphisodorus, with an epitaph that listed his children (daughters, being female) as the cities Messene and Megalopolis; it ended “Greece is free.”

Mr. Cartledge’s command of the historical material is effortless and exhaustive, and his appreciation of Thebes is persuasive. Between the radical but self-destructive democracy of Athens and Sparta’s totalitarian oligarchy (both imperialist), Thebes and Boeotia stand in the middle as an early model of democratic federalism—the “united states” of Boeotia, for instance, shared a currency. It was Thebes that dealt a critical blow to Spartan domination, and a Theban leader who freed a long-enslaved people. Alexander the Great himself adopted military tactics from Epaminondas. If Thebes’s period of hegemony was brief—barely a decade—it also changed the course of the ancient world.

For the full review, see:

A.E. Stallings. “Greece’s Mythic Heartland.” The Wall Street Journal (Saturday, September 12, 2020): C12.

(Note: ellipses added.)

(Note: the online version of the review has the date Sep. 11, 2020, and has the title “‘Thebes: The Forgotten City of Ancient Greece’ Review: Mythic Roots.”)

The book under review is:

Cartledge, Paul. Thebes: The Forgotten City of Ancient Greece. New York: Abrams Press, 2020.

“Operation Warp Speed, . . . , Is More Imaginative Than the Bureaucratic Norm”

(p. 11) . . . the blundering of the Trump administration, while real and deadly, may not be responsible for the bulk of America’s coronavirus fatalities.

. . .

. . . : the absence of challenge trials for vaccines (in which young, healthy participants agree to be vaccinated and then infected with the virus), the predictable expert resistance to at-home testing. But the most important one was the straightforward bureaucratic calamity at the C.D.C. that delayed effective testing for a fateful month.

An effective president might have addressed some of these problems. (Although Operation Warp Speed, the White House’s vaccine initiative, is more imaginative than the bureaucratic norm.) But overall they are problems with structures and habits rather than personalities — an institutional decadence that predated Trump and will persist when he is gone.

. . .

. . . the third thing you see when you look beyond Trump [is] the fact that so many countries in Western Europe, to say nothing of our neighbors in the Americas, have had death rates similar to ours.

This reality speaks not of exceptionalism but of convergence — and the possibility that the trends of the early 21st century have left us sharing more in common not only with France and Spain but also with Mexico and Brazil than most Americans might expect.

This, too, may matter long after Trump is gone. Where there are crises, in this dispensation, they are likely to be general rather than just American. Where there is decadence, it is the shared experience of late modernity. And if renewal comes to an exhausted West, it will not necessarily come through America alone.

For the full commentary, see:

Ross Douthat. “What Isn’t Trump’s Fault.” The New York Times, SundayReview Section (Sunday, September 13, 2020): 11.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Sept. 12, 2020, and has the same title as the print version.)

“Before the White People Left”

(p. A1) CHICAGO — The old guard of this city’s Roseland neighborhood, a community on the South Side famous for molding a young Barack Obama and infamous for its current blight, has never forgotten the fruit trees.

Back in the 1970s, before the full exodus of white residents, the erosion of local businesses, the crack epidemic of the 1980s and the disinvestment that followed, it was the trees that signaled the societal elevation of Black families — separating those who moved here from the urban high rises they fled. An apple tree greeted Antoine Dobine’s family in 1973, he said. The tree meant a yard. A yard meant a home. And a home meant a slice of the American dream, long deferred for Black Americans.

“Pear trees, peaches, apples, it was beautiful,” Mr. Dobine recalled. “Before the white people left.”

. . .

The fruit trees have been replaced with overgrown lots. Residents say gangs use the abandoned areas to stockpile weapons, which children sometimes find.

For the full story, see:

Astead W. Herndon. “Black Area Embraces Protests But Still Has No Grocery Store.” The New York Times (Wednesday, August 12, 2020): A1 & A21.

(Note: ellipsis added. The online version say that the New York print version had the title “In a Black Chicago Community, Doubt Defies Hope for Change.” My National print version had the title “Black Area Embraces Protests But Still Has No Grocery Store.”)

(Note: the online version of the story was updated Aug. 28 [sic], 2020, and has the title “‘A Smoking Gun’: Infectious Coronavirus Retrieved From Hospital Air.”)

“Pessimism of the Intellect and Optimism of the Will”

(p. C4) Advertisers may have been peddling baubles or junk food, but their cash funded serious journalism — the kind that could afford to send a reporter to, say, every municipal board meeting. “People knew that,” the former editor of the once mighty Youngstown Vindicator told Sullivan, “and they behaved.” This watchdog function had tangible benefits for subscribers and nonsubscribers alike. “When local reporting waned,” Sullivan writes, “municipal borrowing costs went up.” Local news outlets provide the due diligence that bondholders often count on. Without the specter of a public shaming, corruption is freer to flourish.

. . .

“Ghosting the News” concludes with a soaring quote from the Italian theorist Antonio Gramsci about “pessimism of the intellect and optimism of the will,” but the local reporter in Sullivan follows it up with a more immediate analogy: Even if no one seems to be coming to the rescue while your house is on fire, you still have to “get out your garden hose and bucket, and keep acting as if the fire trucks are on the way.”

For the full review, see:

Jennifer Szalai. “Books of the Times; Another Endangered Species.” The New York Times (Thursday, July 30, 2020): C1 & C4.

(Note: ellipsis added.)

(Note: the online version of the review has the date July 26, 2020, and has the title “Books of the Times; Yes, Fake News Is a Problem. But There’s a Real News Problem, Too.”)

The book under review is:

Sullivan, Margaret. Ghosting the News: Local Journalism and the Crisis of American Democracy. New York: Columbia Global Reports, 2020.

Neighborhood Center Delivered the Air-Conditioning that NYC Had Promised

(p. A7) It seemed like a noble idea to offer quick help during the pandemic: New York City would give away free air-conditioners this summer to low-income older people who are stuck indoors.

It turned out to be a far more complicated mission for the city.

. . .

The difficulty in getting a free air-conditioner left many seniors frustrated and confused by what they described as a bureaucratic, inefficient process.

Concepcion Reyes, who is 67 and has asthma, said she made numerous phone calls to a handful of city agencies from her stuffy apartment last week, after seeing her neighbor snag a free air-conditioner from the city.

“I’ve been in the shower two times already today,” Ms. Reyes, who lives at Holmes Towers, a public housing building on the Upper East Side of Manhattan, said last week. “I’m sweating bullets.”

. . .

Frustrated by delays, officials at the Stanley M. Isaacs Neighborhood Center in Manhattan spent nearly $30,000 on 56 air-conditioners for older people.

Rosalina Acevedo, who is 73 and diabetic, had one of the units installed in her bedroom at Holmes Towers in July [2020]. When she turned it on for the first time, she instantly felt relief.

“It was delicious,” she said.

Gregory J. Morris, the center’s executive director, said the city should have worked with community groups that could easily have provided a list of older residents with serious health conditions who urgently needed the units. The city had its own lists, and names were missing.

“They were desperate,” he said of the older people his center works with. “There was no timeline from the city. If you’re in the middle of a heat wave, do I wait longer for the city? Or do I step in and solve the problem?”

For the full story, see:

Emma G. Fitzsimmons. “The Wait for Promised Air-Conditioners Leaves Some Older Residents Sweating.” The New York Times (Saturday, August 22, 2020): A7.

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

(Note: the online version of the story has the date Aug. 21, 2020, and has the title “Older New Yorkers Sweat It Out, Waiting for Promised Air-Conditioners.”)

Our Government Sends 19-Year-Olds to War but Does Not Allow Them to Try High-Risk, High-Reward Covid-19 Drugs and Vaccines

(p. A11) “Many drug programs are suspended or not pursued at all—not because of flaws in the science but because of commercial and strategic reasons,” Mr. Milken says. Researchers screen those programs, and he calls in his partners either to fund the ideas or promote their development at other companies if the inventors make them available.

It’s a niche in the pharmaceutical world that public funding can’t fill. Mr. Milken sustains a model “where a person could just give me a five-page summary and get a meeting. Government isn’t going to fund that, but philanthropy does.” “These little companies,” he adds—“they’re not Johnson & Johnson, they’re not Novartis, they’re not Amgen. They need financial capital.”

. . .

Mr. Milken’s deals not tinged by controversy, such as his 1983 issuance of bonds to finance telecom company MCI’s long-distance network, show the same preference that shapes his philanthropy: high risk for a high reward.

. . .

A perennial struggle for Mr. Milken has been to convince regulators to share that urgency. He says drug trials generally are too rigid: “We send 19-year-olds into war zones knowing that no matter what we do, some number—greater than zero—will lose their lives or their limbs. But we tell a patient who is going to die not to try something because it could be dangerous.”

Nonetheless, the partners he’s made in his search for cures prove that imagination and activity are still scattered through the country. Discussing the coronavirus with biotech founders and Nobel Prize winners, Mr. Milken says he’s been “thrust back into the 1970s and early ’80s, where any time someone had a new idea—a new company, a passion for something—I had set aside time every day to listen.” On the day a vaccine or effective cure for Covid-19 is finally announced, Americans will owe thanks to such risk takers, who Mr. Milken says “invest in where the world is going, not where it is.”

For the full interview, see:

Mene Ukueberuwa, interviewer. “THE WEEKEND INTERVIEW; What Would You Risk for a Faster Cure?” The Wall Street Journal (Saturday, May 2, 2020): A11.

(Note: ellipses added.)

(Note: the online version of the interview has the date May 1, 2020, and has the same title as the print version.)

Patients Die Due to Doctors Who Are “Busy Entering Health Care Data” Required by “Mandated Protocols”

(p. 18) Doctors today often complain of working in an occupational black hole in which patient encounters are compressed into smaller and smaller space and time. You can do a passable job in a 10-minute visit, they say, but it is impossible to appreciate the subtleties of patient care when you are rushing.

Enter “Slow Medicine: The Way to Healing,” a wonderful new memoir by Dr. Victoria Sweet.

. . .

One of the most compelling stories in the book is about Joey, a 3-year-old who is diagnosed with terminal lung disease after a near-drowning but against the odds makes it off the ventilator and out of the hospital. Sweet interprets Joey’s recovery in part as a victory for prayer. “Prayer worked,” she writes, “at least that once and maybe sometimes and maybe always.” I would see it differently: Joey was saved because a lung specialist slowly decreased airway pressure and tidal volume over several weeks in a patient with acute respiratory distress syndrome. And, as Sweet points out, it was slow medicine that allowed that doctor to make the proper adjustments.

Perhaps Sweet’s most depressing conclusion is that Joey would have died today. His doctors “would have been too busy entering health care data” that was required “according to all the mandated protocols.”

For the full review, see:

Sandeep Jauhar. “Heals Over Time.” The New York Times Book Review (Sunday, January 28, 2018): 18.

(Note: ellipsis added.)

(Note: the online version of the review has the date Jan. 26, 2018, and has the title “A Doctor Argues That Her Profession Needs to Slow Down, Stat.”)

The book under review is:

Sweet, Victoria. Slow Medicine: The Way to Healing. New York: Riverhead Books, 2017.