Category: Regulations

Andrew Cuomo Explains Slow New York Rollout of Vaccines: “It’s Bureaucracy”

(p. A1) ALBANY, N.Y. — New York, the onetime center of the pandemic, faced a growing crisis on Monday [Jan. 4, 2021] over the lagging pace of coronavirus vaccinations, as deaths continue to rise in the second wave and Gov. Andrew M. Cuomo came under mounting pressure to overhaul the process.

. . .

(p. A5) The state has had a deliberate approach in distributing the vaccine; until Monday, the vaccinations were almost exclusively given to health care workers, group home residents, and those living and working at nursing homes.

That cautious approach was also evident in the state’s initial guidance to determine which health care employees should be prioritized for vaccines; the state had advised clinics and other facilities to rank employees through a matrix that takes into account age, comorbidities, occupation and the section of the facility where the person works.

. . .

Mr. Cuomo rejected any notion that his administration was at fault for not distributing more vaccines, asserting that the problem was a local issue, and urging Mr. de Blasio and other leaders who oversee public hospital systems to take “personal responsibility” for their performance.

“They have to move the vaccine,” the governor said in Albany. “And they have to move the vaccine faster.”

. . .

“There is no one cause,” he said, noting that he had spoken to dozens of hospitals about the issue.

He did suggest, however, that management was at fault in some cases, saying that there was a lack of “urgency” in certain hospital systems.

“It’s bureaucracy,” he said.

For the full story, see:

Jesse McKinley, Luis Ferré-Sadurní and Emma G. Fitzsimmons. “New York Lags In Vaccinations While Toll Rises.” The New York Times (Tuesday, January 5, 2021): A1 & A5.

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

(Note: the online version of the story has the date Jan. 4, 2021, and has the title “New Variant Detected in New York Amid Growing Crisis Over Vaccine Rollout.”)

Optimal Size Changes With Changing Demand and Technology

(p. B1) Twirling above a strip of land at the mouth of Rotterdam’s harbor is a wind turbine so large it is difficult to photograph. The turning diameter of its rotor is longer than two American football fields end to end. Later models will be taller than any building on the mainland of Western Europe.

Packed with sensors gathering data on wind speeds, electricity output and stresses on its components, the giant whirling machine in the Netherlands is a test model for a new series of giant offshore wind turbines planned by General Electric.

. . .

(p. B5) In coming years, customers are likely to demand even bigger machines, industry executives say. On the other hand, they predict that, just as commercial airliners peaked with the Airbus A380, turbines will reach a point where greater size no longer makes economic sense.

“We will also reach a plateau; we just don’t know where it is yet,” said Morten Pilgaard Rasmussen, chief technology officer of the offshore wind unit of Siemens Gamesa Renewable Energy, the leading maker of offshore turbines.

For the full story, see:

Stanley Reed. “A Monster Wind Turbine Is Upending an Industry.” The New York Times (Saturday, January 2, 2021): B1 & B5.

(Note: ellipsis added.)

(Note: the online version of the story has the date Jan. 1, 2021, and has the same title as the print version.)

“Celebrities Have Access to Better Care Than Ordinary People”

As the passages quoted below suggest, Trump’s friends may have had access to drugs that not everyone had access to. But it also should be acknowledged that Trump was pushing for Covid-19 drugs to be available sooner and with fewer restrictions.

(p. A25) Both the Regeneron and Eli Lilly therapies are meant for people who are at risk of getting sick enough with Covid to be hospitalized, not those who are hospitalized already. The emergency use authorization for the Regeneron treatment specifically says that it is “not authorized” for “adults or pediatric patients who are hospitalized due to Covid-19.”

A physician with experience administering the new monoclonal antibodies, who didn’t want to use his name because he’s not authorized by his hospital to speak publicly, said giving them to Giuliani “appears to be an inappropriate use outside the guidelines of the E.U.A. for a very scarce resource.” Very scarce indeed: According to the Department of Health and Human Services, as of Wednesday the entire country had about 77,000 total doses of the Regeneron cocktail and almost 260,000 doses of Eli Lilly’s monoclonal antibody treatment. That’s less than you’d need to treat everyone who’d tested positive in just the previous two days.

Right now, the criteria for distributing these drugs can be murky. Robert Klitzman, co-founder of the Center for Bioethics at Columbia, said that the federal government allocates doses to states, states allocate them to hospitals and hospitals then decide which patients among those most at risk will get treated. Some states have developed guidelines for monoclonal antibody treatment, “but my understanding is that most states have not yet done that,” Klitzman said.

Hospitals try to come up with ethical triage frameworks, but Klitzman told me there are often workarounds for V.I.P.s. He said it helps to know someone on the hospital’s board. Such bodies typically include wealthy philanthropists. Often, he said, when these millionaires and billionaires ask hospital administrators for special treatment for a friend, “hospitals do it.”

Why? “Hospitals have huge financial problems, especially at the moment with Covid,” he said. They’ve had to shut down profitable elective surgeries and treat many people without insurance. More than ever, he said, they “need money that is given philanthropically from potential donors.”

In other words, Giuliani was right: Celebrities have access to better care than ordinary people. “When someone is in the public eye, or if someone is a potential donor, or has already been a donor to a hospital, then there’s folks in the hospital hierarchy, in the administration, who are keenly aware if they’re coming in, if they’re present, if they need something,” said Shoa Clarke, a cardiologist and professor at Stanford University School of Medicine. Covid, which is leading to rationing of medical resources, only magnifies this longstanding inequality.

For the full commentary, see:

Michelle Goldberg. “Why Trump Cronies Get Covid Meds.” The New York Times (Saturday, December 12, 2020): A25.

(Note: the online version of the commentary has the date Dec. 10, 2020, and has the title “Covid Meds Are Scarce, but Not for Trump Cronies.” The passage quoted above includes several sentences, and a couple of words, that appear in the online, but not in the print, version of the commentary.)

Why Canadian Regulators Approved Vaccine Quicker: “We’re Just Better”

(p. A8) OTTAWA — Canada on Wednesday become only the second Western country to approve a coronavirus vaccine, a week after Britain did so and a day before U.S. regulators will meet to consider taking that step, opening the possibility that Canadians will start being inoculated next week.

. . .

“It’s a testament to the work of regulators internationally,” said Dr. Supriya Sharma, the chief medical adviser at Health Canada, the regulator. “It’s an exceptional day for Canada.”

The go-ahead means that Canadians could receive the vaccine — which requires two doses, weeks apart — before Americans do, though Pfizer is based in the United States. That is likely to aggravate President Trump, who has demanded faster action by the F.D.A. and was angry that Britain, which began inoculating people on Tuesday, [Dec. 28, 2020] had acted before the United States.

. . .

When asked why her group was able to approve the vaccine ahead of the F.D.A. in the United States, Dr. Sharma said, apparently jokingly, “we’re just better.”

For the full story, see:

Ian Austen. “Canada Approves Covid Vaccine, Becoming 2nd in West to Reach Milestone.” The New York Times (Thursday, December 10, 2020): A8.

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

(Note: the online version of the story was updated Jan. 7, 2021, and has the title “Canada Approves Vaccine and Could Start Shots Next Week.”)

Even Alibaba Entrepreneur Jack Ma Cannot Speak His Mind in Communist China

(p. A1) Chinese President Xi Jinping personally made the decision to halt the initial public offering of Ant Group, which would have been the world’s biggest, after controlling shareholder Jack Ma infuriated government leaders, according to Chinese officials with knowledge of the matter.

. . .

In a speech on Oct. 24 [2020], days before the financial-technology giant was set to go public, Mr. Ma cited Mr. Xi’s words in what top government officials saw as an effort to burnish his own image and tarnish that of regulators, these people said.

At the event in Shanghai, Mr. Ma, the country’s richest man, quoted Mr. Xi saying, “Success does not have to come from me.” As a result, the tech executive said, he wanted to help solve China’s financial problems through innovation. Mr. Ma bluntly criticized the government’s increasingly tight financial regulation for holding back technology development, part of a long-running battle between Ant and its overseers.

. . .

During his 21-minute speech, he criticized Beijing’s campaign to control financial risks. “There is no systemic risk in China’s financial system,” he said. “Chinese finance has no system.”

He also took aim at the regulators, saying they “have only focused on risks and overlooked development.” He accused big Chinese banks of harboring a “pawnshop mentality.” That, Mr. Ma said, has “hurt a lot of entrepreneurs.”

His remarks went viral on Chinese social media, where some users applauded Mr. Ma for daring to speak out. In Beijing, though, senior officials were angry, and officials long calling for tighter financial regulation spoke up.

After Mr. Xi decided that Ant’s IPO needed to be halted, financial regulators led by Mr. Liu, the leader’s economic czar, convened on Oct. 31 and mapped out an action plan to take Mr. Ma to task, according to the government officials familiar with the decision-making.

For the full story, see:

Jing Yang and Lingling Wei. “China’s President Personally Scuttled Record Ant IPO.” The Wall Street Journal (Friday, Nov 13, 2020): A1 & A9.

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

(Note: the online version of the story has the date November 12, 2020, and has the title “China’s President Xi Jinping Personally Scuttled Jack Ma’s Ant IPO.”)

Members of the Elite Exempt Themselves from Rules They Impose on the Hoi Polloi

(p. 12) SAN FRANCISCO — It was an intimate meal in a wood-paneled, private dining room in one of California’s most exclusive restaurants. No one around the table wore masks, not the lobbyists, not even the governor.

Photos that surfaced this week of a dinner at the French Laundry, a temple of haute cuisine in Napa Valley where some prix fixe meals go for $450 per person, have sparked outrage in a state where Democratic leaders have repeatedly admonished residents to be extra vigilant amid the biggest spike in infections since the pandemic began.

. . .

The photos of the gathering, taken by a diner at a nearby table and shared with a local television station, also showed the chief executive for the California Medical Association and the organization’s top lobbyist.

. . .

In a 2019 review of the French Laundry and two other Napa restaurants, the New York Times critic Tejal Rao described being “overwhelmed by the opulence” and feeling as if transported onto a “spaceship for the 1 percent, now orbiting a burning planet.” Mr. Newsom said in October that his children, who attend private school, returned to in-person classes even as most of the state struggles with remote learning.

“Newsom and the first partner eschewed state public health guidelines to dine with friends at a time when the governor has asked families to scale back Thanksgiving plans,” wrote the Sacramento Bee editorial board on Friday. It added, “If the governor can eat out with friends — and if his children can attend their expensive school — why must everyone else sacrifice?”

For the full story, see:

Thomas Fuller. “Officials’ Lavish Meal Out Spurs Outrage Among Californians.” The New York Times, First Section (Sunday, November 22, 2020): 12.

(Note: ellipses added.)

(Note: the online version of the story has the date Nov. 18, 2020, and has the title “For California Governor the Coronavirus Message Is Do as I Say, Not as I Dine.” The online version says that the title of the New York print version was “California Governor Calls” and appeared on Thursday, Nov. 19, 2020. The title of my National print version was “Officials’ Lavish Meal Out Spurs Outrage Among Californians” and appeared on Sunday, November 22, 2020.)

Tariffs Create Incentive to Drink Higher Alcohol Wine

(p. A1) Washington put 25% tariffs on wine from France, Spain, Germany and the U.K. in October 2019 in retaliation for subsidies they made to European aircraft man-(p. A9)ufacturer Airbus SE, arguing they hurt Boeing Co. But it applied only to wine with alcohol content of 14% or less.

What followed was a textbook lesson in tariff economics. Before, America imported about $150 million a year in European wine that exceeded 14% alcohol, Commerce Department data show. In the 12 months since the tariff took effect, that rose to $434 million.

For the full story, see:

Josh Zumbrun. “America Taxed Your Favorite Bordeaux? Try One With More Alcohol.” The Wall Street Journal (Friday, Nov 20, 2020): A1 & A9.

(Note: the online version of the story has the date November 19, 2020, and has the title “The Tale Behind StubHub’s Sale: How Eric Baker Bought Back the Ticket Seller.”)

Epidemic Showed Limits of China’s “Government-Driven, Top-Down Solutions”

(p. B1) WULONGQIAO, China — A devastating disease spreading from China has wiped out roughly one-quarter of the world’s pigs, reshaping farming and hitting the diets and pocketbooks of consumers around the globe.

China’s unsuccessful efforts to stop the disease may have hastened the spread — creating problems that could bedevil Beijing and global agriculture for years to come.

. . .

The epidemic shows the limits of China’s emphasis on government-driven, top-down solutions to major problems, sometimes at the expense of the practical. It has also laid bare the struggle of a (p. B6) country of 1.4 billion people to feed itself.

. . .

When the swine fever began to spread 16 months ago, the Ministry of Agriculture told the country’s local governments to cull all pigs in herds if there was even one sick animal, and to compensate the farmers. The ministry authorized local governments to pay up to $115 for the largest pigs, a cap later raised to $170. Before the epidemic, however, many pigs sold for $250 or more apiece, particularly breeding sows, according to government data. With the epidemic, the price has soared to $600 or more.

To get that partial reimbursement, many farmers had to deal with tightfisted local officials. The ministry said it would reimburse local governments only for between 40 percent and 80 percent of their costs. Local governments also had to provide proof, often including laboratory tests, that pigs died of African swine fever and not some other ailment.

As a result, culling has been slow. Official data show only 1.2 million pigs, or less than 0.3 percent of the country’s herds, have been culled. It is not clear where the rest of the country’s vanished herds went, but food experts say many were likely butchered and turned into food. That would worsen the spread, because the disease can lurk in meat for months.

For the full story, see:

Keith Bradsher and Ailin Tang. “China Flubs Effort to Halt Lethal Turn of Pig Illness.” The New York Times (Thursday, December 26, 2019): B1 & B6.

(Note: ellipses added.)

(Note: the online version of the story has the date Dec. 17, 2019, and has the title “China Responds Slowly, and a Pig Disease Becomes a Lethal Epidemic.”)

For California Electricity Regulator: “Safety Is Not a Glamorous Thing”

(p. A1) PG&E’s collapse has exposed the California Public Utilities Commission’s failure to hold the utility accountable on safety. The CPUC (p. A12) for years focused attention elsewhere, on setting rates and pushing for cleaner power.

Now, the agency tasked with regulating utility safety is struggling to refocus on the issue while also grappling with its failure to prevent the state’s second electricity crisis in two decades.

. . .

From the early 2000s, the commission’s focus was on setting rates and implementing Sacramento’s renewable-energy goals. Starting in 2002, three consecutive governors, two Democrats and a Republican, signed bills ratcheting up the percentage of wind and solar power utilities had to buy.

These mandates required investor-owned utilities such as PG&E to change their mix of generation, effectively phasing out burning coal and lowering reliance on natural gas while signing contracts to buy electricity from new solar and wind farms. The CPUC oversaw these deals, as well as figuring out how to integrate thousands of new rooftop solar installations.

“Was there a considerable amount of resources placed on policy? Yeah, there was,” says Timothy Alan Simon, a commissioner between 2007 and 2012 and now a utilities consultant. “It’s a challenge to balance between the safety aspects and the need for policy deliberation.”

Michael Peevey, a former Southern California Edison president, and CPUC president between 2002 and 2014, was a vocal champion of renewable-energy policies. Now retired, he says the regulator was large enough to focus on safety and renewables simultaneously but that it was tough to get Sacramento lawmakers excited about funding safety.

When compared with eliminating coal and adding solar energy, he says, “Safety is not a glamorous thing.”

For the full story, see:

Ruth Simon. “PG&E Regulators Failed to Stop Crisis.” The Wall Street Journal (Saturday, December 9, 2019): A1 & A12.

(Note: ellipsis added.)

(Note: the online version of the story has the date December 8, 2019, and has the title “‘Safety Is Not a Glamorous Thing’: How PG&E Regulators Failed to Stop Wildfire Crisis.”)

Chris Rock on Covid-19, Blackface, and Cancel Culture

(p. 7) [Rock:] Part of the reason we’re in the predicament we’re in is, the president’s a landlord. No one has less compassion for humans than a landlord. [Laughs.] And we’re shocked he’s not engaged.

Did you ever see that movie “The Last Emperor,” where like a 5-year-old is the emperor of China? There’s a kid and he’s the king. So I’m like, it’s all the Democrats’ fault. Because you knew that the emperor was 5 years old. And when the emperor’s 5 years old, they only lead in theory. There’s usually an adult who’s like, “OK, this is what we’re really going to do.” And it was totally up to Pelosi and the Democrats. Their thing was, “We’re going to get him impeached,” which was never going to happen. You let the pandemic come in. Yes, we can blame Trump, but he’s really the 5-year-old.

Put it this way: Republicans tell outright lies. Democrats leave out key pieces of the truth that would lead to a more nuanced argument. In a sense, it’s all fake news.

. . .

[Itzkoff:] Jimmy Fallon drew significant criticism this past spring for a 20-year-old clip of himself playing you in blackface on “Saturday Night Live.” How did you feel about that segment?

[Rock:] Hey, man, I’m friends with Jimmy. Jimmy’s a great guy. And he didn’t mean anything. A lot of people want to say intention doesn’t matter, but it does. And I don’t think Jimmy Fallon intended to hurt me. And he didn’t.

. . .

[Itzkoff:] There’s been a wider push to expunge blackface from any movies or TV shows where it previously appeared. Have people taken it too far?

[Rock:] If I say they are, then I’m the worst guy in the world. There’s literally one answer that ends my whole career. Blackface ain’t cool, OK? That’s my quote. Blackface is bad.

For the full interview, see:

Dave Itzkoff, interviewer. “Chris Rock’s New Universe.” The New York Times, Arts&Leisure Section (Sunday, September 20, 2020): 6-7.

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

(Note: the online version of the interview was updated Sept. 24, 2020, and has the title “Chris Rock Tried to Warn Us.”)

2016 Law Requires FDA to Move to Mining Real-World Data and Away from Costly and Slow Clinical Trials

(p. A1) Drugmakers are trying to win drug approvals by parsing vast data sets of electronic medical records, shifting away from lengthy, and costly, clinical trials in patients.

. . .

For the companies, the use of real-world data can cut costs and shorten drug-development times. Instead of finding trial subjects, companies simply mine hospital and doctor files for cases where patients already took a drug in routine medical care, looking for changes in blood pressure, tumor size and other readings to see if the medicine is helping or causing a side effect.

. . .

(p. A2) . . . for rare diseases especially, it can take a while to even enroll enough patients in studies. And their cost can limit the number of trials that companies can fund, drugmakers say.

A 2016 law required the FDA to explore greater use of real-world data, and the agency is developing standards to assess the reliability of different data sources and which kinds of decisions the data support.

“Real-world evidence should not be a means toward dropping standards, but rather a mechanism to have more efficiency in evidence generation while maintaining standards,” said FDA Principal Deputy Commissioner Amy Abernethy, a former executive at health-data firm Flatiron Health.

A market has emerged in recent years for digital drug-use information. Iqvia Inc., which tracks prescription and health data, has about a dozen projects under way, said Nancy Dreyer, the company’s chief scientific officer of real-world evidence.

For the full story, see:

Peter Loftus. “Drugmakers Mine Data to Avoid Clinical Trials.” The Wall Street Journal (Tuesday, Dec. 24, 2019): A1-A2.

(Note: ellipses added.)

(Note: the online version of the story was updated Dec. 23, 2019, and has the title “Drugmakers Turn to Data Mining to Avoid Expensive, Lengthy Drug Trials.”)