Regulations – Page 18 – artdiamondblog.com

With Both Covid and Monkeypox, C.D.C. Wrongly “Tried to Maintain Control Over Testing”

(p. A14) Too often in a crisis, government officials look for easy solutions, with dramatic and immediate impact. But there are none for managing pandemics.

“A pandemic is by definition a problem from hell. You’re vanishingly unlikely to be able to remove all of its negative consequences,” said Bill Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health.

Instead, he added, officials should bet on combinations of imperfect strategies, with an emphasis on speed over accuracy.

In both the coronavirus pandemic and the monkeypox outbreak, for example, the C.D.C. at first tried to maintain control over testing, instead of disseminating the responsibility as widely as possible. The move led to limited testing, and left health officials blind to the spread of the viruses.

The Food and Drug Administration was slow to help academic labs develop alternatives for testing, and encouraged the highest quality of diagnosis. It may be reasonable for officials to ask which test is faster or which one produces the least errors, Dr. Hanage said, but “all of them are better than not doing anything.”

For the full commentary, see:

Apoorva Mandavilli. “Unprepared for Covid and Monkeypox. And the Next Outbreak, Too.” The New York Times (Saturday, October 1, 2022): A14.

(Note: the online version of the commentary was updated Sept. 30, 2022, and has the title “New Infectious Threats Are Coming. The U.S. Probably Won’t Contain Them.”)

Deregulation of Hearing Aids Will Lower Costs and Increase Innovation

(p. A1) The Food and Drug Administration decided on Tuesday to allow hearing aids to be sold over the counter without a prescription to adults, a long-sought wish of consumers frustrated by expensive exams and devices.

The high cost of hearing aids, which are not covered by basic Medicare, has discouraged millions of Americans from buying the devices. Health experts say that untreated hearing loss can contribute to cognitive decline and depression in older people.

Under the F.D.A.’s new rule, people with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores as soon as October, without being required to see a doctor for an exam to get a prescription.

. . .

“This could fundamentally change technology,” said Nicholas Reed, an audiologist at the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health. “We don’t know what these companies might come up with. We may literally see new ways hearing aids work, how they look.”

. . .

The change has been percolating for years. In 2016, a proposal for the F.D.A. to approve over-the-counter hearing aids for adults with mild to moderate hearing was released in a report by the National Academies of Science, Engineering and Medicine. The following year, Senators Chuck Grassley, a Republican of Iowa, and Elizabeth Warren, a Democrat of Massachusetts, introduced a bill enabling the agency to make the change. Congress approved the legislation and President Trump signed it into law.

Finalizing regulations has moved slowly since then, with some conflict over details, like how the federal rule would interact with state laws on hearing aid returns or warranty policies and how much the devices should amplify sound.

Mr. Biden issued an executive order last July calling for greater competition in the economy, which urged the F.D.A. to take action “to promote the wide availability of low-cost hearing aids.”

For the full story, see:

Christina Jewett. “F.D.A. Decides to Allow Over-the-Counter Sales of Hearing Aids.” The New York Times (Wednesday, August 17, 2022): A1 & A23.

(Note: ellipses added.)

(Note: the online version of the story was updated Aug. 23, 2022, and has the title “F.D.A. Clears Path for Hearing Aids to Be Sold Over the Counter.”)

Senate Cedes Sovereignty on Air Conditioning HFC Regulation

(p. A17) WASHINGTON — The Senate voted on Wednesday to approve an international climate treaty for the first time in 30 years, agreeing in a rare bipartisan deal to phase out of the use of planet-warming industrial chemicals commonly found in refrigerators and air-conditioners.

. . .

Many American manufacturers had a business incentive to support the amendment. Under the pact, nations that do not ratify the amendment will have restricted access to expanding international markets starting in 2033.

Some Republicans from states with many chemical manufacturers supported the Kigali deal.

. . .

Americans for Prosperity, a political action committee founded by the billionaire Koch brothers, sent a letter to lawmakers last week saying that ratifying the Kigali Amendment would be an “abdication of U.S. sovereignty over environmental regulation” to the United Nations. The group also argued it would raise the price of air-conditioning, refrigeration and industrial cooling for American consumers.

For the full story, see:

Lisa Friedman and Coral Davenport. “Senate Ratifies Global Pact to Curb HFCs, Used in Cooling.” The New York Times (Thursday, September 22, 2022): A17.

(Note: ellipses added.)

(Note: the online version of the story has the date Sept. 21, 2022, and has the title “Senate Ratifies Pact to Curb a Broad Category of Potent Greenhouse Gases.” Where there is a minor difference between the online and print versions, the passages quoted above follow the online version.)

Netherlands Dairy Farmers “No Longer Allowed To Exist” Due to “Climate Tyranny”

(p. 6) WOUDENBERG, Netherlands — The dairy farmers of the Netherlands have had enough.

They have set fire to hay and manure along highways, dumped trash on roads to create traffic jams, and blockaded food distribution centers with their tractors, leading to empty shelves in supermarkets. Across the country, upside down flags wave from farmhouses in protest.

The anger of the farmers is directed at the government, which has announced plans for a national 50 percent reduction of nitrogen emissions by 2030, in line with European Union requirements to preserve protected nature reserves, that they believe unfairly targets them. Factories and cars also emit large amounts of nitrogen and have not been targeted, they say, although the government said that cuts associated with both polluters would be addressed in the future.

Agriculture is responsible for the largest share of nitrogen emissions in the Netherlands, much of it from the waste produced by the estimated 1.6 million cows that provide the milk used to make the country’s famed cheeses, like Gouda and Edam.

To realize those planned cuts, thousands of farmers will be required to significantly reduce livestock numbers and the size of their farming operations. If they cannot meet the cuts the government demands of them, they may be forced to close their operations altogether.

The Dutch government has set aside about 25 billion euros, about $26 billion, to carry out its plan, and some of that money will be used to help farmers build more sustainable operations — or buy them out, if possible.

“My livelihood and my network is being threatened,” said Ben Apeldoorn, whose farm in the province of Utrecht has about 120 cows producing milk for making cheese. “You’re just no longer allowed to exist,” said Mr. Apeldoorn, 52, who has been a farmer for 30 years.

. . .

Prime Minister Mark Rutte, who this month became the country’s longest-serving prime minister and has grappled with what is known in the Netherlands as “the nitrogen crisis,” has condemned the protests, calling them “unacceptable.”

. . .

Helma Breunissen, 47, a dairy farmer who with her husband also runs a veterinarian’s office, attended one of the meetings with Mr. Rutte to make her anger known.

“If half of the cattle needs to disappear, then my veterinary’s office will also end,” Ms. Breunissen said by telephone. “I don’t want a bag of money from the government, I just want to do my job.”

. . .

While many Dutch support the aims of a greener Netherlands, some right-wing groups have expressed support for the Dutch farmers as a way of opposing climate activism. The right-wing Forum for Democracy has declared that “there is no climate crisis” and opposes the government’s plans.

And the Dutch farmers have also received some support from abroad.

“Farmers in the Netherlands — of all places — are courageously opposing the climate tyranny of the Dutch government, can you believe it?” former President Donald J. Trump said at a rally last month.

For the full story, see:

Claire Moses. “Emission Cuts in the Netherlands Have Dairy Farmers Up in Arms.” The New York Times, First Section (Sunday, August 21, 2022): 6.

(Note: ellipses added.)

(Note: the online version of the story has the date Aug. 20, 2022, and has the title “Dairy Farmers in the Netherlands Are Up in Arms Over Emission Cuts.” Where there is a minor difference between the online and print versions, the passages quoted above follow the online version.)

Since Adderall Is “Highly Regulated” Pharmacies and Patients Can’t “Quickly Pivot” in Response to Scarcity

(p. A13) The Food and Drug Administration has declared a nationwide shortage of Adderall, a medication used to treat A.D.H.D. that has had surging demand in recent years.

. . .

Adderall, which contains the stimulant amphetamine, is a controlled substance and highly regulated, so it is difficult for pharmacies to quickly pivot and carry new brands, analysts said.

. . .

While a number of companies make Adderall and generic versions, pharmacies may find it difficult to pivot to other suppliers because of amphetamine’s status as a controlled substance that typically includes restrictions on its use and monitoring of prescription orders. Any given pharmacy might risk raising red flags with the Drug Enforcement Administration by doubling its supply, said Erin Fox, an expert on drug shortages at the University of Utah.

“With a controlled substance, it’s harder for patients to call around and find a pharmacy that has product for them,” Ms. Fox said.

For the full story, see:

Christina Jewett. “F.D.A. Confirms Widespread Shortages of Adderall.” The New York Times (Friday, October 14, 2022): A13.

(Note: ellipses added.)

(Note: the online version of the story has the date Oct. 13, 2022, and has the title “F.D.A. Confirms Wide Shortage of Adderall.”)

Environmentalists Ignore “The Unintended Impacts of Policies”

(p. A1) Nicole Kramaritsch of Roxbury, N.J., has 46 bags just sitting in her garage. Brian Otto has 101 of them, so many that he’s considering sewing them into blackout curtains for his baby’s bedroom. (So far, that idea has gone nowhere.) Lili Mannuzza in Whippany has 74.

“I don’t know what to do with all these bags,” she said.

The mountains of bags are an unintended consequence of New Jersey’s strict new bag ban in supermarkets. It went into effect in May and prohibits not only plastic bags but paper bags as well. The well-intentioned law seeks to cut down on waste and single-use plastics, but for many people who rely on grocery delivery and curbside pickup services their orders now come in heavy-duty reusable shopping bags — lots and lots of them, week after week.

While nearly a dozen states nationwide have implemented restrictions on single-use plastic bags, New Jersey is the only one to ban paper bags because of their environmental impact. The law also bans polystyrene foam food containers and cups, and restricts restaurants from handing out plastic straws unless they’re requested.

Emily Gonyou, 22, a gig worker in Roselle Park who provides shopping services for people (p. A11) through Instacart, said she was surprised when she learned the delivery company had no special plans for accommodating the ban. “They pretty much said, ‘OK, do exactly what you’re doing, but with reusable bags,’” she said.

Ms. Gonyou said she goes through up to 50 reusable bags a day, many of which, she suspects, could end up in the garbage.

Compared to single-use plastics, the more durable reusable bags are better for the environment only if they are actually reused. According to Shelie Miller, a professor at the University of Michigan School for Environment and Sustainability, a typical reusable bag, manufactured from polypropylene, must be used at least 10 times to account for the additional energy and material required to make it. For cotton totes, that number is much higher.

. . .

Dr. Miller said the bag situation in New Jersey was emblematic of a lot of environmental policies. “If we don’t pay attention to the unintended impacts of policies such as the plastic waste ban, we run into the potential of playing environmental Whac-a-Mole,” she said. “We solve one environmental problem only to create or exacerbate another problem.”

For the full story, see:

Clare Toeniskoetter. “New Jersey Bag Ban’s Unforeseen Consequence: Too Many Bags.” The New York Times (Friday, September 2, 2022): A1 & A11.

(Note: ellipsis added.)

(Note: the online version of the story has the date Sept. 1, 2022, and has the title “Why Do Some People in New Jersey Suddenly Have Bags and Bags of Bags?”)

Regulators Slowed Development of Moderna Vaccine

How much credit for the Covid vaccines goes to government and how much to entrepreneurs? Loftus’s book focuses on Moderna, and makes the case that government deserves considerable credit, mostly for early funding. A case can be made that at least as much focus should be given to BioNTech. If BioNTech had been the focus, that case might have been harder to make.

(p. C5) In late 2019, just weeks before the world heard of Covid-19, scientists from the National Institute of Allergy and Infectious Diseases visited the new manufacturing plant of a small, 9-year-old biotechnology company called Moderna. The company’s leaders boasted that the new plant in Norwood, Mass., could make a batch of a newly designed vaccine in 60 days—rapid by standard timelines that usually take 12 months or more.

. . .

One Friday afternoon in August [2020], the company was expecting delivery of large air-handling units to help expand production at its factory. Moderna had hired construction cranes to lift the tractor-trailer-sized units onto the roof of its plant. But delivery was delayed because the supplier lacked all the state permits needed to transport oversize cargo from the Midwest to Massachusetts. If the units didn’t get there by Sunday, Moderna would lose the cranes and a week of production.

Frantic, Moderna executives called Warp Speed officials. They gave the job to an Army colonel, who leaned on state officials, who in turn sent state police with sirens blaring to escort the delivery to their state line and then hand off the convoy to a new escort. The precious cargo rolled into Moderna’s plant on Sunday morning, in time for the cranes.

The much larger and older Pfizer, meanwhile, mostly opted out of Operation Warp Speed for fear it would slow the company down. As for Moderna’s collaboration, it generated enough friction to make the company’s chief medical officer during 2020, Tal Zaks, question at times whether it was worth it to accept the federal assistance.

Dr. Zaks had wanted to use a private contract research organization to run the whole trial, but NIAID officials wanted their clinical-trial network involved. Eventually, Dr. Zaks backed off, and both entities participated. “I realized we were at an impasse, and I was the embodiment of the impasse,” Dr. Zaks said.

Next, when Moderna’s 30,000-person study began enrolling volunteers in July 2020, the subjects weren’t racially diverse enough. Moncef Slaoui, who led Warp Speed’s vaccine efforts, and Dr. Fauci began holding Saturday Zoom calls with Mr. Bancel and other Moderna leaders to “help coax and advise Moderna how to get the percentage of minorities up to a reasonable level,” Dr. Fauci recalled.

Drs. Fauci and Slaoui wanted Moderna to slow down overall enrollment, to give time to find more people of color. Moderna executives resisted at first. “That was very tense,” Dr. Slaoui said. “Voices went up, and emotions were very high.” Moderna ultimately agreed, and the effort worked, but it cost the trial about an extra three weeks. Later, Mr. Bancel called the decision to slow enrollment “one of the hardest decisions I made this year.”

For the full essay, see:

Peter Loftus. “The Partnership That Made the First U.S. Covid Vaccine.” The Wall Street Journal (Saturday, July 30, 2022): C5.

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

(Note: the online version of the essay has the date July 29, 2022, and has the same title as the print version.)

The essay quoted above is an adaptation from Loftus’s book:

Loftus, Peter. The Messenger: Moderna, the Vaccine, and the Business Gamble That Changed the World. Boston: Harvard Business Review Press, 2022.

Government’s “Controlled Burn” Created an Environmental “Catastrophe”

(p. A1) Heavy monsoon rains would normally be cause for celebration in the drought-parched mountains of northeastern New Mexico, where the Rockies meet the Great Plains, especially after the largest wildfire in state history came within a mile of torching the region’s largest community this spring.

. . .

Instead of replenishing reservoirs, the downpours are flooding a burn scar left by the blaze known as the Calf Canyon/Hermits Peak fire, releasing contaminants into private wells and overwhelming Las Vegas’s main water (p. A16) supply with ashy sludge.

It is the latest chapter in a catastrophe created by the federal government when Forest Service employees lost control of not just one but two prescribed burns set this spring to clear out undergrowth. That sparked a vast blaze that destroyed hundreds of homes and displaced thousands of people across a fire zone larger than the city of Los Angeles.

. . .

Mr. Trujillo, the mayor of Las Vegas, emphasized that the federal government, which was responsible for starting the fire, should cover the costs of securing the town’s water supply over both the short and long term. “We intend to bill them for every cent,” he said. “I’m having to hold their feet to the fire, no pun intended.”

For the full story, see:

Simon Romero. “A Controlled Burn Left Scars and a Water Crisis.” The New York Times (Tuesday, September 27, 2022): A1 & A16.

(Note: ellipses added.)

(Note: the online version of the story was updated Sept. 28, 2022, and has the title ‘How New Mexico’s Largest Wildfire Set Off a Drinking Water Crisis.” Where there are minor differences in wording between versions, the passages quoted above follow the online version.)

Weary and Angry with Lockdowns in China, “Everyone Is Scared”

(p. A12) In the hours before the southern Chinese city of Chengdu entered a coronavirus lockdown, Matthew Chen visited four vegetable markets in an attempt to stock up on fresh food. But seemingly the entire city had the same idea, and by the time he got to each place, most of the shelves had been stripped bare, except for hot peppers and fruit, he said.

Mr. Chen, a white-collar worker in his 30s, managed to scavenge enough cherry tomatoes, meat and greens for about one day, and since then has been ordering grocery deliveries to tide him through the lockdown, which began on Friday. But he worries about whether that supply will remain stable, and how much longer he will have to rely on it.

“The longer a lockdown goes, the more problems emerge, and the harder it is to tolerate it,” he said, noting that the Chengdu government had not given a timeline for reopening.

. . .

The challenges in enforcing such extensive controls are daunting, perhaps more so now than at any other point in the pandemic. Nearly three years of on-and-off lockdowns have lashed the economy, sending unemployment soaring, especially among young people. The country is increasingly isolated, as the rest of the world largely abandons Covid restrictions. New subvariants are ever more transmissible. And the seemingly endless restrictions leave more ordinary Chinese people wearier by the day.

. . .

Chengdu officials themselves have already tested residents’ trust, after the authorities last week ordered a man detained for 15 days, accusing him of spreading false rumors on social media about a looming lockdown. Two days later, when the city did actually lock down, social media erupted with support for the man and anger at the government.

“Everyone is scared, scared that the situation will become like Shanghai,” said Mr. Chen, the office worker, who had traveled to Chengdu on business before becoming trapped there by the restrictions.

Still, he saw little alternative but to bear with the situation. “Personally, I’m extremely fed up with and not supportive of these policies. But there’s nothing I can do,” he said. “I can only wait.”

For the full story, see:

Vivian Wang. “As Beijing Imposes More Covid Lockdowns Across China, ‘Everyone Is Scared’.” The New York Times (Tuesday, September 6, 2022): A12.

(Note: ellipses added.)

(Note: the online version has the date Sept. 5, 2022, and has the title “As China Imposes More Covid Lockdowns, ‘Everyone Is Scared’.”)

Young Men in Russia Vote with Their Feet Against Putin’s Tyranny

(p. A12) A little more than 12 hours after he heard that Russian civilians could be pressed into military service in the Ukraine war, the tour guide said he bought a plane ticket and a laptop, changed money, wrapped up his business, kissed his crying mother goodbye and boarded a plane out of his country, with no idea when he might return.

. . .

“I was sitting and thinking about what I could die for, and I didn’t see any reason to die for the country,” said the tour guide, 23, who, like others interviewed for this article, declined to give his name for fear of reprisals.

Since President Vladimir V. Putin’s announcement on Wednesday of a new troop call-up, some Russian men who had once thought they were safe from the front lines have fled the country. And they have done so in a rush, lining up at the borders and paying rising prices to catch flights to countries that allow them to enter without visas, such as Armenia, Georgia, Montenegro and Turkey.

. . .

In principle, European Union officials say they stand in solidarity with the men who don’t want to fight. “Russians are voting with their feet, basically, ” said Peter Stano, a spokesman for the European Commission.

. . .

A 26-year-old merchant mariner who gave his name only as Dmitriy said he would wait in Turkey until his next ship job began in December [2022], to ensure that he would not be drafted in the meantime.

. . .

The mariner said that most of his friends had stayed in Russia after the invasion of Ukraine, believing the war would not affect them much. He said most were rushing to get out.

“Lots of people want to leave Russia now because they don’t want to fight for the opinion of one person,” he said, dismissing the invasion as a personal project of Mr. Putin.

“It is not about defending your family,” he said.

For the full story, see:

Ben Hubbard. “Fearing a Military Call-Up, Men Rush to Leave Russia.” The New York Times (Friday, September 23, 2022): A12.

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

(Note: the online version has the date Sept. 22, 2022, and has the title “‘A Lot of Panic’: Russian Men, Fearing Ukraine Draft, Seek Refuge Abroad.”)

An Electric Prayer

(p. A4) BEIRUT, Lebanon — The second the light above Hasmik Tutunjian’s bed came on at midnight, she said a prayer of thanks and got up quickly. She did not know how much time she had before she would be plunged back into darkness.

First, Ms. Tutunjian, 66, stripped the sheets off the bed — soaked with sweat from Beirut’s stifling and humid heat. She grabbed a phone charger hanging on a hook next to a tote bag that reads, “Keep Calm and Carry On,” and plugged it in. Then she moved into the living room to plug in three chargeable lights. Finally, she put in the first of as many loads of laundry as the electricity would allow.

. . .

Power cuts have long been a part of life in this country because of a dysfunctional electricity sector. But over the past year, they have worsened with acute fuel shortages leading to severe blackouts across Lebanon and state-supplied power coming on for only an hour or two a day — at most — and on no set schedule.

. . .

. . . with Lebanese inflation rising to 168 percent in the year that ended in July [2022], and unemployment skyrocketing, a dwindling number of people can afford the extra generator power. And some of the generators provide only a few amps — enough to power a refrigerator, a fan and the television.

Ms. Tutunjian cannot afford any amps.

She has a chargeable fan, but the power does not come on long enough to fully charge it. She tries to cool herself with a folding fan, which does little to fight the suffocating heat of a Beirut summer.

“Sometimes I tell myself I’m not going to get sad, but I can’t help it,” she said, sitting in her living room. “At night, I get into bed angry, I cry.”

. . .

Last month, an armed 42-year-old man held a Beirut bank hostage for hours, demanding that he be allowed to withdraw his entire life’s savings — more than $200,000. But the amount far exceeded the paltry caps on cash withdrawals.

He said he needed the money to pay for an operation for his father, and threatened to kill everyone inside the bank and to set himself on fire.

“That man, good what he did,” Ms. Tutunjian said.

Eventually, he was allowed to take out a small portion of his savings in exchange for his surrender and arrest. He became an instant hero, capturing a nation’s frustrations, and was released days later amid an outpouring of public support.

“He said he’ll do it again,” Ms. Tutunjian said.