Former FDA Commissioners Urge Early “Emergency Use Authorization” for Covid-19 Vaccine

(p. A17) As former FDA commissioners, we are confident in the FDA’s career scientists to oversee vaccine development rigorously.

If a Covid vaccine clears this process, it could be made available initially to specific groups of people through an Emergency Use Authorization. This emergency authority enables the FDA to make products available before a full application is approved by the agency. Congress created the emergency-use pathway as part of the Project BioShield Act of 2004, which provided for the development of medical countermeasures against chemical, biological, radiological and nuclear threats. Following 9/11 and anthrax, lawmakers expected an urgent need for such defenses.

After the 2009 swine flu, Congress expanded this pathway in the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, a bipartisan measure aimed at preparing the country to weather a pandemic. The law streamlined the application process for emergency use, expanded the classes of drugs eligible, and broadened the testing the FDA could require.

. . .

This authority enables the staged entry of a vaccine. It’s unlikely that a Covid-19 vaccine will receive full approval and broad distribution right away. Instead, the FDA will probably authorize vaccines for use in targeted groups of people at high risk from Covid and most likely to benefit from the vaccine. For them, it may make sense to provide access to the vaccine before long-term follow-up studies that address very remote risks.

This might include health-care providers or first responders, who face greater exposure, or older people, who are more prone to severe complications if infected.

. . .

This process exists precisely to deal with public-health emergencies like Covid-19. It isn’t a lower standard for FDA approval. It’s a more tailored, flexible standard that helps protect those who need it most while developing the evidence needed to make the public confident about getting a Covid-19 vaccine.

For the full commentary, see:

Mark McClellan, and Scott Gottlieb. “How ‘Emergency Use’ Can Help Roll Out a Covid Vaccine.” The Wall Street Journal (Monday, September 15, 2020): A17.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Sep. 13, 2020, and has the same title as the print version.)

“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.

Many Men “in the West” View Mask-Wearing to Be “a Sign of Weakness”

(p. A4) As countries begin to reopen their economies, face masks, an essential tool for slowing the spread of coronavirus, are struggling to gain acceptance in the West. One culprit: Governments and their scientific advisers.

Researchers and politicians who advocate simple cloth or paper masks as cheap and effective protection against the spread of Covid-19, say the early cacophony in official advice over their use—as well as deeper cultural factors—has hampered masks’ general adoption.

There is widespread scientific and medical consensus that face masks are a key part of the public policy response for tackling the pandemic. While only medical-grade N95 masks can filter tiny viral particles and prevent catching the virus, medical experts say even handmade or cheap surgical masks can block the droplets emitted by speaking, coughing and sneezing, making it harder for an infected wearer to spread the virus.

. . .

Male vanity . . . appears to be a powerful factor in rejecting masks. A study by Middlesex University London, U.K., and the Mathematical Sciences Research Institute in Berkeley, Calif., found that more men than women agreed that wearing a mask is “shameful, not cool, a sign of weakness, and a stigma.”

For the full story, see:

Bojan Pancevski, Jason Douglas. “Mask-Wearing Still Meets Resistance.” The Wall Street Journal (Monday, June 29, 2020): A4.

(Note: ellipses added.)

(Note: the online version of the story was updated June 29, 2020, and has the title “Masks Could Help Stop Coronavirus. So Why Are They Still Controversial?”)

“Can You Imagine Turning on Someone Who Saves Your Life?”

(p. A20) WASHINGTON — Alice Marie Johnson was watching the Super Bowl with two of her sisters on Sunday night [Feb. 2, 2020] when she saw her own face in an advertisement amid the commercials for Doritos and Audis.

Ms. Johnson was serving a life sentence in an Alabama prison for a nonviolent drug conviction when the president commuted her sentence in 2018. The reality television star Kim Kardashian West had discovered Ms. Johnson’s story on social media and personally appealed to him on her behalf.

And now the 64-year-old African-American woman was the star of the Trump campaign’s multimillion-dollar Super Bowl ad, . . .

. . .

“I’ve been such a source of pride for him,” she said. “Who doesn’t want to show something they’re proud of during an election year? That’s what all the candidates do. For him to highlight me, it makes me know he’s not only proud, he’s super proud.”

She described herself as “not an expert in politics” but someone fighting for “anything that advances my cause, anything that advances my cause of bringing people home.”

Ms. Johnson would not say whether she would vote for Mr. Trump if she could. “I can’t vote, and that’s part of what I’m fighting for,” she said. But as for criticizing Mr. Trump, she said that was simply out of the question for her.

“Can you imagine turning on someone who saves your life?” she said. “Just on a personal level, can you imagine?”

For the full story, see:

Annie Karni. “Life as the Face of Trump’s Super Bowl Ad.” The New York Times (Friday, Feb. 7, 2020): A20.

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

(Note: the online version of the story has the date Feb. 6, 2020, and the title “What It’s Like to Be the Face of Trump’s Super Bowl Ad.”)

An Informed Public Can Protect Themselves Better than Central Planners Can Protect Them

(p. A15) China teaches one thing: When a novel respiratory virus emerges, a free press is on balance an indispensable medical asset. The steps an informed public can take to protect itself are far more potent than any top-down action. Unknown is whether the new disease really originated in a meat market in Wuhan, as was first reported. But suppressing news of its outbreak once it was discovered was China’s most fatal mistake.

For the full commentary, see:

Holman W. Jenkins, Jr. “BUSINESS WORLD; Coronavirus Needs a Free Press.” The Wall Street Journal (Wednesday, February 12, 2020): A15.

(Note: the online version of the commentary has the date Feb. 11, 2020, and has the same title as the print version.)

Low Quality Parts from Corrupt Contractors Endanger Russian Sailors in Deep-Diving Subs

(p. A22) OFF THE COAST OF NORWAY — There could hardly have been a more terrifying place to fight a fire than in the belly of the Losharik, a mysterious deep-diving Russian submarine.

. . .

A fire on any submarine may be a mariner’s worst nightmare, but a fire on the Losharik was a threat of another order altogether. The vessel is able to dive far deeper than almost any other sub, but the feats of engineering that allow it do so may have helped seal the fate of the 14 sailors killed in the disaster.

. . .

(p. A23) As for the accident itself, few expressed surprise that a jewel of the Russian submarine fleet might catch fire not very far from its home base — probably in water no more than 1,000 feet deep — leaving most of its crew dead. The Russians, some experts said, seem to have a greater tolerance for risk than the West.

. . .

Mr. Lobner, the former American submarine officer, said “we have nothing except unmanned vehicles” operating at such depths.

Still, while some see an engineering marvel, others see evidence that Russia may be unable to build the kind of sophisticated, autonomous underwater drones the United States appears to rely on.

“They would rather adapt existing systems, modernize them, and try to muddle through,” Mr. Boulègue said. “So, no wonder these things keep exploding,” he said. Mr. Boulègue believes accidents have been far more common than publicly known.

John Pike, director of the think tank GlobalSecurity.org, said the Losharik fire suggested that the Russian military was still contending with some longstanding issues: corrupt contractors, and problems with quality control in manufacturing, spare parts supply chains and maintenance.

“I assume that every other sub in the Russian fleet has similar problems,” Mr. Pike said. “I just think the whole thing is held together with a lot of baling wire and spit.”

For the full story, see:

James Glanz and Thomas Nilsen. “A Deep-Diving Sub, a Deadly Fire And Russia’s Secret Undersea Agenda.” The New York Times (Tuesday, April 21, 2020): A22-A23.

(Note: ellipses added.)

(Note: the online version of the story was updated April 21, 2020, and has the title “A Deep-Diving Sub. A Deadly Fire. And Russia’s Secret Undersea Agenda.”)

“Bludgeoned by Years of Subservience to Their Masters in Beijing”

(p. C2) The salient fact that we have learned about Chinese administrative and managerial practices from this latest outbreak is not that China is capable of impressive infrastructure projects but that its vaunted system of top-down decision-making, state control and central planning is directly responsible in large part for the virulence, intensity and rapid spread of the disease that has already claimed more than 1,300 Chinese lives.

According to reports from Wuhan in this and other news outlets, one of the principal reasons that the virus spread so quickly and infected so many was because officials in Wuhan, bludgeoned by years of subservience to their masters in Beijing, were simply terrified of taking any initiative. Zhou Xianwang, Wuhan’s mayor, told reporters that he didn’t take measures to deal with the epidemic earlier because he needed authorization from his political bosses.

For the full commentary, see:

Gerard Baker. “China’s Crisis Exposes a Badly Flawed Model.” The Wall Street Journal (Saturday, February 15, 2020): C2.

(Note: the online version of the commentary was updated Feb. 14, 2020, and has the title “THE NEW NEW WORLD; A Loyal Chinese Critic Vanishes, in a Blow to the Nation’s Future.”)

Outspoken Admirer of Friedman and Hayek Disappears in Communist China

(p. A19) The disappearance of Mr. Ren, a longtime critic of the Chinese government, adds to fears that China is sliding backward and abandoning the reforms that saved it from extreme poverty and international isolation. Mr. Ren was no radical — he was a decades-long loyal Communist Party member, the former leader of a state-run company and a friend to some of China’s most powerful politicians. He emerged in what now seems a distant time, from the 1980s to the period before Mr. Xi became top leader, when the party brooked no challenge to its rule but allowed some individuals to question some of its choices.

Mr. Ren’s fate remains unclear. But if he was punished for his writing, it suggests China’s leadership won’t tolerate criticism no matter how justified it might be.

. . .

He was influenced by free-market economists like Milton Friedman and Friedrich Hayek. He believed government control needed to be checked.

“State power in any country is greedy, so it needs to be subject to public supervision,” he wrote in his autobiography. “Otherwise, the power will be abused and everybody will suffer from it.”

. . .

In 2011, near the peak of China’s openness to new ideas, Mr. Ren, an avid reader, started a book club. It drew China’s top entrepreneurs, intellectuals and government officials. Books included Alexis de Tocqueville’s “Democracy in America” and Hannah Arendt’s “The Origins of Totalitarianism.” The events became so popular that people had to apply through a lottery system to join. Some people flew to Beijing from all over the country to attend.

Mr. Ren said his goal was to help China’s young generation develop independent thinking so it would not follow the orders of authority slavishly. The government said no to some topics and speakers, but left it largely alone.

By early 2016, he had nearly 38 million followers on Weibo. But party attitudes toward expression were changing.

That same year, Mr. Xi declared that all Chinese news media had to serve the party. No Chinese leader since Mao Zedong had made that obligation so explicit. Mr. Ren shot back on Weibo, writing that the news media should serve the people, not the party, or the people would suffer.

Retribution was swift. His Weibo account was deleted. His party membership was suspended for a year. His passport was taken away. Members of his family weren’t allowed to leave the country. He faced constant investigations and interrogations.

. . .

Then came the coronavirus outbreak. When doctors working with the disease tried to publicly warn China about the outbreak, they were threatened by government officials. For Mr. Ren, friends said, this confirmed his argument that a media that serves the party couldn’t serve the people.

“Without a media representing the interests of the people by publishing the actual facts,” he wrote in the essay that circulated this year, “people’s lives are being ravaged by both the virus and the major illness of the system.”

He shared the essay with a few friends. Three days after his 69th birthday, he disappeared. His assistant and his son have disappeared, too.

For the full commentary, see:

Li Yuan. “THE NEW NEW WORLD; A Longtime Party Insider Vanishes, in a Blow to China’s Future.” The New York Times (Wednesday, April 1, 2020): A19.

(Note: ellipses added.)

(Note: the online version of the commentary was updated April 2, 2020, and has the title “THE NEW NEW WORLD; A Loyal Chinese Critic Vanishes, in a Blow to the Nation’s Future.”)

Scientists Are “a Political Interest Group Like Any Other”

(p. B15) Mr. Greenberg, who spent most of his professional life in Washington, became a science journalist at a time when many practitioners seemed to view their job as advancing the cause of research — a consideration that many researchers expected.

As an author, newspaper reporter and magazine editor, and as the founding editor and publisher of Science & Government Report, a newsletter he ran for almost 30 years, Mr. Greenberg took a different view.

From his vantage point in the capital, he tracked scientific rivalries and battles over the government’s science priorities, describing research not as a uniquely worthy activity but rather as one of many enterprises competing for federal largess.

“He recognized that science, and the scientific endeavor broadly, was a political interest group like any other, and they behaved like any other, and he covered them like any other,” said Daniel Sarewitz, a congressional staffer in the science policy arena in the early 1990s and now director of the Washington-based Consortium for Science, Policy and Outcomes at Arizona State University.

“He was not a toady or an advocate for the science community,” Dr. Sarewitz said. “He was a journalist covering science.”

Writing in The New York Times Book Review in 1968, Robert K. Merton, the eminent 20th-century sociologist of science, said Mr. Greenberg’s “perceptive” first book, “The Politics of Pure Science,” was one that “should be read by the President, legislators, scientists and the rest of us ordinary folk.”

For the full obituary, see:

Cornelia Dean. “Daniel S. Greenberg, 88, Science Journalist.” The New York Times (Thursday, March 26, 2020): B15.

(Note: the online version of the obituary was last updated March 26, 2020, and has the title “Daniel S. Greenberg, Science Journalist and Iconoclast, Dies at 88.” Williams’s question is in bold; Achorn’s answer is not in bold.)

The second edition of the book by Greenberg, mentioned in the passage quoted above, is:

Greenberg, Daniel S. The Politics of Pure Science. Second ed. Chicago: University of Chicago Press, 1999.

French Jobs Rise as Labor Regulations Fall

(p. A1) PARIS — One after another, the speakers in Parliament have denounced President Emmanuel Macron and his revolutionary plans, calling them “cynicism” and a “flagrant crime.” Outside, hundreds of protesters shout their fury. Other demonstrators, invoking a long French tradition, have called for his head.

. . .

(p. A6) Mr. Macron has upset the French, and he is deeply unpopular for it. So it has become the defining paradox of his rule that he remains much despised, even as his changes begin to bear fruit.

The intractable unemployment rate, slayer of his predecessors, appears finally to be bending to a French president’s touch, recently reaching its lowest rate in 12 years at 8.1 percent.

Working-age employment rates are up, worker-training programs are showing big gains, quality long-term job contracts are outpacing precarious, short-term ones.

All of those are advances plausibly attributed to Mr. Macron’s landmark loosening of the rigid French labor market.

For the full story, see:

Adam Nossiter. “As the French Call for His Head, Macron Is Reshaping the Nation.” The New York Times (Wednesday, February 26, 2020): A1 & A6.

(Note: ellipsis added.)

(Note: the online version of the story has the date Feb. 25, 2020, and has the same title “As Emmanuel Macron’s Impact Grows, So Does French Disdain.”)

At Nonprofit Hospitals Revenue Rises and Charity Care Falls

(p. 7) On paper, the average value of community benefits for all nonprofits about equals the value of the tax exemption, but there is tremendous variation among individual hospitals, with many falling short. There is also intense disagreement about how those community benefits are calculated and whether they actually serve the community in question.

Charity medical care is what most people think of when it comes to a community benefit, and before 1969 that was the legal requirement for hospitals to qualify for tax-exempt status. In that year, the tax code was changed to allow for a wide range of expenses to qualify as community benefits. Charitable care became optional and it was left up to the hospitals to decide how to pay back that debt. Hospitals could even declare that accepting Medicaid insurance was a community benefit and write off the difference between the Medicaid payment and their own calculations of cost.

An analysis by Politico found that since the full Affordable Care Act coverage expansion, which brought millions more paying customers into the field, revenue in the top seven nonprofit hospitals (as ranked by U.S. News & World Report) increased by 15 percent, while charity care — the most tangible aspect of community benefit — decreased by 35 percent.

. . .

The average chief executive’s package at nonprofit hospitals is worth $3.5 million annually. (According to I.R.S. regulations, “No part of their net earnings is allowed to inure to the benefit of any private shareholder or individual.”) From 2005 to 2015, average chief executive compensation in nonprofit hospitals increased by 93 percent. Over that same period, pediatricians saw a 15 percent salary increase. Nurses got 3 percent.

For the full commentary, see:

Ofri, Danielle. “Nonprofit Hospitals Are Too Profitable.” The New York Times, SundayReview Section (Sunday, February 23, 2020): 7.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date Feb. 20, 2020, and has the title “Why Are Nonprofit Hospitals So Highly Profitable.”)

The Politico article mentioned in the passages quoted above, is:

Diamond, Dan. “Health Care; How Hospitals Got Richer Off Obamacare.” Politico (Posted July 17, 2017). Available from https://www.politico.com/interactives/2017/obamacare-non-profit-hospital-taxes/.