Regulations – Page 19 – artdiamondblog.com

Proposed 20 Years Ago, Heart Polypill Is Safe, Effective, and Easier to Take, but Is Not Allowed by FDA

(p. A7) Heart disease kills more people than any other condition, but despite advances in treatment and prevention, patients often do not stick to their medication regimens. Now researchers may have found a solution: a so-called polypill that combines three drugs needed to prevent cardiovascular trouble.

In what is apparently the largest and longest randomized controlled trial of this approach, patients who were prescribed a polypill within six months of a heart attack were more likely to keep taking their drugs and had significantly fewer cardiovascular events, compared with those receiving the usual assortment of pills.

The participants also experienced one-third fewer cardiovascular deaths, although their overall risk of death from all causes was not significantly changed.

The study of more than two thousand heart patients, who were followed for three years, was published Friday morning in The New England Journal of Medicine, as the findings were presented at the European Society of Cardiology Congress in Barcelona.

. . .

The polypill combines a blood-pressure medication, a cholesterol-lowering drug and aspirin, which helps prevent blood clots. The idea was first floated two decades ago in a more radical form: Advocates proposed giving a daily polypill to everyone once they turned 55, saying it would slash cardiovascular events globally by 80 percent.

. . .

The polypill used in the study has not been approved by the Food and Drug Administration and is not available to patients in the United States right now. Dr. Fuster said the results of the new trial would be submitted to the agency shortly in an effort to obtain approval.

He called the results of the new study “striking,” and said the benefit of the polypill for prevention rivaled that of low-dose aspirin, which is now routinely prescribed to people who have already had a heart attack or other cardiovascular event.

And since participants became even more likely to keep taking the polypill over time, he said, “The potential results could be even better with more follow-up.” Several studies have shown that only about half of patients, or even less, take all their medications as instructed.

The new study, a randomized controlled clinical trial, enrolled just under 2,500 patients at 113 sites in Spain, Italy, France, Germany, Poland, the Czech Republic and Hungary.

. . .

Over three years, 12.7 percent of the patients taking an assortment of pills experienced another heart attack or stroke, or died of a cardiac event or needed urgent treatment to open a blocked artery, compared with 9.5 percent of patients taking a polypill, for a relative reduction in risk of 24 percent.

There was no difference between the two groups in overall mortality, however, as the reduction in cardiovascular deaths in the polypill group was offset by deaths from other causes.

For the full story, see:

Roni Caryn Rabin. “Heart Disease Patients Are More Likely to Stick to a One-Pill Daily Regimen, Researchers Say.” The New York Times (Saturday, August 27, 2022): A7.

(Note: ellipses added.)

(Note: the online version of the story has the date Aug. 26, 2022, and has the title “How to Get Heart Patients to Take Their Pills? Give Them Just One”)

Minorities, Disabled, Less-Educated, and Felons Are First Laid Off in a Recession

(p. A1) Black Americans have been hired much more rapidly in the wake of the pandemic shutdowns than after previous recessions. But as the Federal Reserve tries to soften the labor market in a bid to tame inflation, economists worry that Black workers will bear the brunt of a slowdown — and that without federal aid to cushion the blow, the impact could be severe.

Some 3.5 million Black workers lost or left their jobs in March and April 2020. In weeks, the unemployment rate for Black workers soared to 16.8 percent, the same as the peak after the 2008 financial crisis, while the rate for white workers topped out at 14.1 percent.

Since then, the U.S. economy has experienced one of its fastest rebounds ever, one that has extended to workers of all races. The Black unemployment rate was 6 percent last month, just above the record low of late 2019. And in government data collected since the 1990s, wages for Black workers are rising at their fastest pace ever.

Now policymakers at the Fed and in the White House face the challenge of fighting inflation without inducing a recession that would erode or reverse those workplace gains.

Decades of research has found that workers from racial and ethnic minorities — along with those with other barriers to employment, such as disabilities, criminal records or low levels of education — are among the first laid off during a downturn and the last hired during a recovery.

For the full story, see:

Talmon Joseph Smith and Ben Casselman. “Job Gains for Black Workers Could Reverse in a Downturn.” The New York Times (Wednesday, August 24, 2022): A1 & A14.

(Note: the online version of the story has the same date as the print version and has the title “What Will Happen to Black Workers’ Gains if There’s a Recession?”)

Europe Subsidizes Burning Old Trees That Release More Carbon Dioxide Than Released by Burning Coal

(p. A24) Across Central Europe, companies are clear-cutting forests and at times grinding up centuries-old trees in the name of renewable energy. All of this is legal.
In fact, it is encouraged by government subsidies meant to help the European Union reach its renewable energy goals.

In reality, though, burning wood can be even dirtier than burning coal.

New York Times journalists followed six truckloads to the factory on a recent day and watched as logs from one of the continent’s most important conservation areas were churned into sawdust.

Wood was never supposed to be the cornerstone of the European Union’s green energy strategy.

When the bloc began subsidizing wood burning over a decade ago, it was seen as a quick boost for renewable fuel and an incentive to move homes and power plants away from coal and gas. Chips and pellets were marketed as a way to turn sawdust waste (p. A10) into green power.

Those subsidies gave rise to a booming market, to the point that wood is now Europe’s largest renewable energy source, far ahead of wind and solar.

But today, as demand surges amid a Russian energy crunch, whole trees are being harvested for power. And evidence is mounting that Europe’s bet on wood to address climate change has not paid off.

. . .

And while European nations can count wood power toward their clean-energy targets, the E.U. scientific research agency said last year that burning wood released more carbon dioxide than would have been emitted had that energy come from fossil fuels.

“People buy wood pellets thinking they’re the sustainable choice, but in reality, they’re driving the destruction of Europe’s last wild forests,” said David Gehl of the Environmental Investigation Agency, a Washington-based advocacy group that has studied wood use in Central Europe.

. . .

Scientists have calculated that, per unit of energy, burning wood actually releases more greenhouse gas emissions than burning gas, oil, or even coal.

. . .

(p. A11) The association opposes cutting subsidies or changing the way clean energy is defined. If the European Union no longer considers energy from burnt wood to be carbon-neutral, it would immediately throw many countries off track to hit renewable-energy targets.

That would have major consequences for countries like Italy, the continent’s largest consumer of wood pellets. More than a third of its renewable energy comes from burning plant material. For years, the Italian government has offered tax deductions to encourage buying pellet stoves.

For the full story see:

Sarah Hurtes and Weiyi Cai. “Sacrificing Centuries-Old Trees In Name of Renewable Energy.” The New York Times (Saturday, September 10, 2022): A1 & A10-A11.

(Note: ellipses added.)

(Note: the online version of the story has the date Sept. 7, 2022, and has the title “Europe Is Sacrificing Its Ancient Forests for Energy.” Where the wording and content of the versions differs, the passages quoted above follow the print version.)

Deep-Sea Nodules Are a New Source of Scarce Metals

(p. B11) Companies could start mining the ocean floor for metals used to make electric-vehicle batteries within the next year, a development that could occur despite broad concerns about the environmental impact of deep-sea mining.

The International Seabed Authority, a United Nations observer organization that regulates deep-sea mining in international waters, is drawing up a final regulatory framework for deep-sea mining that all 168 members would need to agree to within the next 12 months. The U.S. isn’t a member of the ISA. With or without the finalized rules, the ISA will permit seabed mining by July 2023, according to people familiar with the matter.

The intent of deep-sea mining is to scrape the ocean floor for polymetallic nodules—tennis-ball-size pieces of rock that contain iron and manganese oxide layers. A seabed in the Pacific Ocean called the Clarion Clipperton Zone, which cover 1.7 million square miles between Mexico and Hawaii, contains a high volume of nodules made of battery metals, such as cobalt, manganese and lithium. The International Seabed Authority in 2010 estimated the zone had roughly 30 billion metric tons of nodules. Cobalt and other metals used in making rechargeable batteries that power products from phones to electric vehicles are in high demand, setting off a race to find and procure them. Prices of these metals are soaring as mining for them comes under scrutiny, curtailing supply.

For the full story see:

Yusuf Khan. “Deep-Sea Mining Nears Reality.” The Wall Street Journal (Tuesday, Aug. 23, 2022): B11.

(Note: as of Sept. 9, 2022, the article was not available online.)

Stimulating Brain with Electrical Currents Can Improve Long-Term Memory for Older Adults

(p. A5) Zapping the brain with weak electrical currents that mimic normal neural activity can boost memory in healthy older adults, at least over the short term, researchers said in a study published Monday [Aug. 22, 2022] in the journal Nature Neuroscience.

. . .

The researchers found that repeated delivery of low-frequency currents to a brain region known as the parietal cortex—located in the upper back portion of the organ—improved recall of words toward the end of the 20-word lists. When the researchers targeted the prefrontal cortex at the front of the brain with high-frequency currents, the study participants saw improvements in their ability to remember words from the beginning of the lists.

. . .

The electrical stimulation improved both short- and longer-term memory lasting minutes by about 50 to 65 percent over four days of treatment, Dr. Reinhart said. The improvements persisted one month after the treatment sessions. Short-term, or working, memory involves storing information over a period of seconds like remembering a phone number someone just gave you. Long-term memory involves storing and then retrieving information over minutes, days, months or years.

. . .

Though the apparatus used in the experiments is lightweight and easy to use, Dr. Reinhart said, it hasn’t been cleared for clinical use by the U.S. Food and Drug Administration and for now is available only in research settings.

For the full story see:

Aylin Woodward and Daniela Hernandez. “Electrical Brain Stimulation Is Shown to Boost Memory.” The Wall Street Journal (Tuesday, Aug. 23, 2022): A5.

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

(Note: the online version of the story has the date August 22, 2022, and has the title “Improve Memory by Zapping Your Brain? Study Says It’s Possible.”)

The academic article summarized in the passages quoted above is:

Grover, Shrey, Wen Wen, Vighnesh Viswanathan, Christopher T. Gill, and Robert M. G. Reinhart. “Long-Lasting, Dissociable Improvements in Working Memory and Long-Term Memory in Older Adults with Repetitive Neuromodulation.” Nature Neuroscience 25, no. 9 (Sept. 2022): 1237-46.

Costs of Covid Lockdowns and Mask Mandates Exceeded Benefits

(p. A15) The Centers for Disease Control and Prevention belatedly admitted failure this week. “For 75 years, CDC and public health have been preparing for Covid-19, and in our big moment, our performance did not reliably meet expectations,” Director Rochelle Walensky said. She vowed to establish an “action-oriented culture.”

. . .

U.S. states with more-restrictive policies fared no better, on average, than states with less-restrictive policies. There’s still no convincing evidence that masks provided any significant benefits. When case rates throughout the pandemic are plotted on a graph, the trajectory in states with mask mandates is virtually identical to the trajectory in states without mandates. (The states without mandates actually had slightly fewer Covid deaths per capita.) International comparisons yield similar results. A Johns Hopkins University meta-analysis of studies around the world concluded that lockdown and mask restrictions have had “little to no effect on COVID-19 mortality.”

. . .

In 2006 he and colleagues at the University of Pittsburgh considered an array of proposed measures to deal with a virus as deadly as the 1918 Spanish flu.

Should schools be closed? Should everyone wear face masks in public places? Should those exposed to an infection be required to quarantine at home? Should public-health officials rely on computer models of viral spread to impose strict limitations on people’s movements? In each case, the answer was no, because there was no evidence these measures would make a significant difference.

“Experience has shown,” Henderson’s team concluded, “that communities faced with epidemics or other adverse events respond best and with the least anxiety when the normal social functioning of the community is least disrupted.” The researchers specifically advised leaders not to be guided by computer models, because no model could reliably predict the effects of the measures or take into account the “devastating” collateral damage. If leaders overreacted and panicked the public, “a manageable epidemic could move toward catastrophe.”

This advice was subsequently heeded in the pre-Covid pandemic plans prepared by the CDC and other public-health agencies. The WHO’s review of the scientific literature concluded that there was “no evidence” that universal masking “is effective in reducing transmission.” The CDC’s pre-2020 planning scenarios didn’t recommend universal masking or extended school and business closures even during a pandemic as severe as the 1918 Spanish flu.

For the full commentary see:

John Tierney. “Fauci and Walensky Double Down on Failure.” The Wall Street Journal (Friday, Aug. 19, 2022): A15.

(Note: ellipses added.)

(Note: the online version of the commentary has the date August 18, 2022, and has the title “Fauci and Walensky Double Down on Failed Covid Response.”)

Human Challenge Trial Sped Phase 3 of Typhoid Vaccine Clinical Trial

Observers Give Thumbs-Up to Matthew Speight as He Prepared to Drink Typhoid Bacteria as Part of a Human Challenge Trial.
Source of Image: NYT commentary cited below.

(p. D3) “I was curious.” That’s how James M. Duggan, an Oxford University medical student, explains why he agreed to swallow a big dose of live typhoid bacteria.

. . .

Mr. Duggan, 33, was not on a self-destructive sympathy bender. Like more than 100 other residents of Oxford, England, he was taking part in a trial of a new typhoid vaccine.

Typhoid fever, caused by the bacteria Salmonella typhi and spread in food and water, kills almost 200,000 victims a year — many of them young children — in Africa, Asia and Latin America. Survivors may suffer perforated intestines, heart problems and other complications.

The experimental vaccine was a big success. The trial’s results were published in The Lancet on Thursday [Sept. 28, 2017]: the vaccine turned out to be 87 percent effective.

. . .

“These are great results,” said Dr. Anita Zaidi, the foundation’s director of diarrheal diseases. “And challenge tests are a great way to short-circuit the process of proving it works.

“If we’d done this in the field, we would have had to follow children for three or four years.”

So-called challenge tests involve giving subjects an experimental vaccine and then deliberately infecting them with the disease to see if it protects them.

These tests can only be done with illnesses — like cholera or malaria — that can be rapidly and completely cured, or with diseases — like seasonal flu — that normally do not damage healthy adults.

. . .

So what would motivate dozens of well-educated Britons to swallow a vial full of the germs that made Typhoid Mary famous? In interviews, they gave various reasons.

Some, like Mr. Duggan, were curious. Some wanted to help poor people. And some mostly wanted the cash.

Participants who followed all the steps, which included recording their temperatures online, making daily clinic visits and providing regular blood and stool samples, received about $4,000.

They all said they understood the risks.

For the full commentary see:

Donald G. McNeil Jr. “Curiosity, and Cash, Fight a Fever.” The New York Times (Tuesday, October 3, 2017): D3.

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

(Note: the online version of the commentary has the date Sept. 28, 2017, and has the title “They Swallowed Live Typhoid Bacteria — On Purpose.”)

The print version of The Lancet article mentioned above is:

Jin, Celina, Malick M. Gibani, Maria Moore, Helene B. Juel, Elizabeth Jones, James Meiring, Victoria Harris, Jonathan Gardner, Anna Nebykova, Simon A. Kerridge, Jennifer Hill, Helena Thomaides-Brears, Christoph J. Blohmke, Ly-Mee Yu, Brian Angus, and Andrew J. Pollard. “Efficacy and Immunogenicity of a Vi-Tetanus Toxoid Conjugate Vaccine in the Prevention of Typhoid Fever Using a Controlled Human Infection Model of Salmonella Typhi: A Randomised Controlled, Phase 2b Trial.” The Lancet 390, no. 10111 (Dec. 2, 2017): 2472-80.

Miami Mayor Welcomes Private Enterprise with Public Safety, Low Taxes, and Few Regulations

(p. A15) On one side, we have the socialist model: high taxes, high regulation, less competition and declining public services with government imposing itself as the solver and arbiter of all social problems. On the other side, we have the Miami model: low taxes, low regulation and a commitment to public safety and private enterprise. The models present a stark choice on issues ranging from personal freedom, economic opportunity, public safety and the role of government.

. . .

In Miami, many residents have personally experienced the socialist model along with its symptoms of hyperinflation, class resentment and stagnant growth. Four years ago Miami residents elected me to pursue a different path. We reduced taxes dramatically, and our revenue base doubled. We invested in our police, and our crime rate dropped. And last week we reduced taxes to their lowest level in history—cutting costs for residents and promoting economic growth.

Miami is a place where you can keep what you earn, invest what you save, and own what you build. We are meeting the high demand of rent costs by encouraging public-private partnerships, activating underutilized land through zoning reforms, and harnessing free-market forces to build more. It works, and our new residents from New York and California can confirm it.

For the full commentary see:

Francis X. Suarez. “Miami Takes On the Socialist Model.” The Wall Street Journal (Monday, Aug. 22, 2022): A15.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date August 21, 2022, and has the same title as the print version.)

Leftist Anti-Covid-Vaccine Roman Catholic Nun Defends Free Speech

(p. A12) MONTSERRAT, Spain — Sister Teresa Forcades came to public notice years ago for her unflinching liberal views: an outspoken Roman Catholic nun whose pronouncements ran counter to the church’s positions on same-sex marriage and abortion.

She became a fixture on Spanish television, appearing in her nun’s habit to advocate independence for her native region of Catalonia, and to debate other hot-button topics, including vaccines. She had trained as a doctor, partly in the United States, and argued that vaccinations might one day pose a danger to a free society.

. . .

“It’s always important that criticism is possible, to have dissenting voices,” she said of her views, which center as much on her doubts about the vaccines as her right to question them in public. “The answer cannot be that in the time of a crisis, society cannot allow the criticism — it’s precisely then that we need it.”

. . .

In the world of vaccine skeptics, Sister Teresa, who was born in 1966 to a nurse and a commercial agent, is hard to categorize. She acknowledges that some vaccines are beneficial, but opposes making them mandatory. Her misgivings about coronavirus vaccines largely stem from her view that pharmaceutical companies are not to be trusted, and the clinical trials were rushed.

. . .

Sister Teresa, though staunchly leftist, doesn’t distance herself from right-wing followers, calling her distrust of some vaccines a “transversal question able to reach a wide spectrum of people.”

For the full story see:

Nicholas Casey. “Spanish Nun With Medical Training Champions Vaccine Distrust.” The New York Times (Saturday, April 24, 2021): A12.

(Note: ellipses added.)

(Note: the online version of the article has the date April 23, 2021, and has the title “A Nun and a Doctor, She’s One of Europe’s Longstanding Vaccine Skeptics.”

“Paradox”: “Masks Work and Mask Mandates Do Not Work”

(p. A19) The Evidence

From the beginning of the pandemic, there has been a paradox involving masks. As Dr. Shira Doron, an epidemiologist at Tufts Medical Center, puts it, “It is simultaneously true that masks work and mask mandates do not work.”

To start with the first half of the paradox: Masks reduce the spread of the Covid virus by preventing virus particles from traveling from one person’s nose or mouth into the air and infecting another person. Laboratory studies have repeatedly demonstrated the effect.

Given this, you would think that communities where mask-wearing has been more common would have had many fewer Covid infections. But that hasn’t been the case.

In U.S. cities where mask use has been more common, Covid has spread at a similar rate as in mask-resistant cities. Mask mandates in schools also seem to have done little to reduce the spread. Hong Kong, despite almost universal mask-wearing, recently endured one of the world’s worst Covid outbreaks.

Advocates of mandates sometimes argue that they do have a big effect even if it is not evident in populationwide data, because of how many other factors are at play. But this argument seems unpersuasive.

After all, the effect of vaccines on severe illness is blazingly obvious in the geographic data: Places with higher vaccination rates have suffered many fewer Covid deaths. The patterns are clear even though the world is a messy place, with many factors other than vaccines influencing Covid death rates.

Yet when you look at the data on mask-wearing — both before vaccines were available and after, as well as both in the U.S. and abroad — you struggle to see any patterns.

Almost 30 Percent

The idea that masks work better than mask mandates seems to defy logic. It inverts a notion connected to Aristotle’s writings: that the whole should be greater than the sum of the parts, not less.

The main explanation seems to be that the exceptions often end up mattering more than the rule. The Covid virus is so contagious that it can spread during brief times when people take off their masks, even when a mandate is in place.

For the full commentary see:

David Leonhardt. “Masks Work, So Why Haven’t Mandates Made Much Difference?” The New York Times (Wednesday, June 1, 2022): A19.

(Note: the headings appeared in bold in the original.)

(Note: the online version of the commentary has the date May 31, 2021, and has the title “Why Masks Work, but Mandates Haven’t.”

Illegal Entrepreneur “Vagabond” Works Hard to Please Customers

(p. 16) . . . nutcrackers, homemade brews that are not technically classified as to-go cocktails in New York, are still illegal, as is drinking in local parks and beaches.

. . .

Vagabond, who is in his early 30s, has kept his face and name out of articles for fear of getting into legal trouble. He said that he started selling cocktails for $10 to $15 in the park during the summer of 2020 — after his restaurant temporarily shut down — to support his family.

“None of the restaurants were open; the beaches were closed,” he said. “The only places to be were people’s backyards or the park.”

He said that nutcrackers were traditionally “really sweet, really harsh alcohol, and it’s just going to give you a buzz,” but that many sellers found ways to rebrand and shake up the colorful drinks during the pandemic.

Vagabond said that he puts a lot of thought into his cocktails, using specific liqueurs and infusing them with herbs like mint and basil, which requires extra time and effort.

Some people balk at the idea of spending $15 on a nutcracker. But as Mr. Lewis jokes about his drink, “I prefer the gentrified term — ‘craft cocktail.’”

He also said that in the nearly two years since he’s been selling the drinks, he’s never been stopped by the police.

. . .

Vagabond said that an article that featured him in 2020 gave him an uncomfortable amount of exposure.

“Within days of this New York Post article coming out, N.Y.P.D. was looking for my Instagram,” he said. “My worst fear came true. I got caught.”

After being let off with a warning, he decided selling in the park wasn’t worth the heightened risk and effort. Now, he said, he mostly just delivers drinks — occasionally catering events like birthdays and weddings.

“Some people think I just magically appear in the park and I’m just strolling along,” he said. “I think people miss how hard and demanding it is.”

Mr. Lewis also said that he’s hoping Gov. Kathy Hochul and Mayor Eric Adams will consider legalizing the work that nutcracker vendors do around the city.

“Don’t criminalize this, incorporate this,” he said. “I would rather pay a $200 license fee than a $200 fine.”

He said that he’s on cordial terms with the other people who sell drinks in Prospect Park — “there’s enough pie in New York City for everybody.”

The biggest obstacle he usually faces, he said, is the sheer labor involved in dragging the heavy bags of drinks through the park.