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The place the Grass is Greener, Besides When It’s ‘Nonfunctional Turf’

If you’re looking for a sign of the End Times, here’s one: Las Vegas, the city where seemingly anything and everything is condoned, has made grass — the ornamental kind — illegal.

Much of the West is experiencing the worst drought in decades, a “megadrought” that has kindled early wildfires and severe water shortages — and the seasonal heat has hardly begun. “There’s a 100 percent chance that it gets worse before it gets better,” Daniel Swain, a climate scientist at the University of California, Los Angeles, tells the graphics editor Nadja Popovich in The Times today. “We have the whole long, dry summer to get through.”

Lake Mead, which sits on the Colorado River (behind the Hoover Dam) and provides 90 percent of the water supply for Las Vegas and southern Nevada, this week reached its lowest capacity since its creation in the 1930s. And several states that draw their water, in strict allotments, from the Colorado River must absorb stark restrictions on its use in cities and for farming.

“We’re kind of at an existential point right now in the West,” said Kyle Roerink, executive director of the nonprofit Great Basin Water Network, in a phone conversation. “Even basic terminology that once was a given — now we’re seeing a shift in the nomenclature toward saying, well, we’re not in a period of drought, we’re in a period of aridification.”

Enter aridification, exit grass. Gov. Steve Sisolak of Nevada just signed into law bill AB356, which requires the removal of all “nonfunctional turf” from the Las Vegas Valley by the year 2027. The effort will conserve about 10 percent of the region’s annual allotment of water from the Colorado River. “It’s a really good time to have put forth something like this,” said Mr. Roerink, whose organization was part of a bipartisan coalition, including the Southern Nevada Home Builders Association, that supported the bill.

The Southern Nevada Water Authority has not yet formed the committee that will actually define “nonfunctional turf.” For now, the category loosely describes the few thousand acres of grass carpeting the region’s street meridians, office parks and housing developments, and amounts to roughly one-third of all the grass in the region.

“The best way to describe it is, it’s the type of grass that’s only used when someone is pushing a lawn mower over it,” Mr. Roerink said. “Other shorthand that became commonspeak during this legislative session was ‘useless grass.’” (That other ostensibly useful grass — at parks, schools, golf courses and single-family lawns — is still allowed, at least for now.)

“Nonfunctional turf” — the very phrase is an existential knot. Is it redundant, or an oxymoron? Either way, it perfectly encapsulates our contorted relationship to nature: Some grass is good, some grass is bad, and all of it (except the kind that grows wild in meadows) is engineered and curated by us.

The challenge isn’t excess grass so much as excess people. Southern Nevada has had explosive growth in recent years, and water usage has increased by more than 9 percent since 2018. Eliminating “useless” grass was a good first step, Mr. Roerink said, but he worried that the water savings would simply be translated into an argument for new development (doubtless with more useful grass).

“What are the Mojave Desert’s limits?” he said. “You know, in some of the areas where Vegas wants to develop is desert tortoise habitat, and there’s not a lot of good desert tortoise habitat left. What’s the future of that going to be?”

The fundamental question is: What counts as a “functional” or non-useless species? Humanity seems dead-set on finding out. We have a knack for seeking out the harshest environments and trying to plant ourselves there, from the Amazon to Antarctica. Lately it’s outer space, with Mars as the ultimate destination. On Monday the billionaire entrepreneur Jeff Bezos announced that he would soon be venturing into orbit, beating the billionaire entrepreneur Elon Musk to the punch (unless the billionaire entrepreneur Richard Branson gets there even sooner).

It bears noting that Mars has no grass, functional or otherwise, nor discernible life of any kind. (Earth’s deserts, including the Mojave, are where Mars rovers go for practice.) If Martian colonists are fortunate, they might dig up something akin to the microscopic, multicellular rotifers that scientists recently retrieved from Siberian permafrost. The tiny animals — resistant to radiation, extreme acidity, starvation, low oxygen and dehydration — had been effectively frozen for 24,000 years, yet they bounced right back to life and began to multiply.

“They’re the world’s most resistant animal to just about any form of torture,” Matthew Meselson, a molecular biologist at Harvard, told The Times. “They’re probably the only animals we know that could do pretty well in outer space.”

The last time the rotifers were up and about, woolly mammoths roamed the planet, including in what is now the Las Vegas Valley. To the extent that mammoths thought anything, they probably held very strong opinions about who was and was not a “functional” species. Alas, we’ll never know.

MALINTA, Ohio — A terrific shock jarred six Ohio counties today, rocked houses in dozens of towns in this state and Indiana and roused thousands of sleeping persons. Tonight the crowds of people who came to Malinta as the center of the shock were mystified as to whether it was caused by an explosion or by the fall of a giant meteor.

Sensing that something far out of the ordinary had happened, hordes of motorists drove from many places to find out the cause. A strange hole, half a mile from Malinta on State Route 109 was the focus of the crowd. …

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The FDA reportedly forces J&J to scrap about 60 million doses of its Covid vaccine

A detail of the Janssen Johnson & Johnson COVID-19 vaccine that is not currently being issued because it has been put on hold.

Allen J. Cockroaches | Los Angeles Times | Getty Images

Federal regulators are forcing Johnson & Johnson to scrap approximately 60 million doses of the Covid-19 vaccine made at a troubled Baltimore facility operated by Emergent BioSolutions due to possible contamination, the New York Times reported on Friday, citing with people familiar with the matter.

The facility closed in April after an inspection revealed several violations, including possible contamination of J & J’s vaccines with a key ingredient from AstraZeneca’s Covid vaccine. About 170 million doses of both vaccines were eligible after the inspection, the Times reported.

The FDA confirmed to CNBC that several lots were not “suitable for use” without confirming the exact number of doses discarded. According to an email statement, the agency announced that it is releasing two batches of vaccine materials made at the facility for use. The Associated Press reported that the two batches would make 10 million cans.

“The FDA has determined that several other lots are unsuitable for use, but additional lots are still being tested and the agency will inform the public of the completion of these tests,” said a statement sent via email.

The US currently has more than enough doses of two other vaccines approved by Pfizer and Moderna to complete vaccination of the American population.

Approximately 10 million doses of the Johnson & Johnson vaccine continue to be distributed in the United States and donated to other countries. The rescued cans will come with a warning stating that federal regulators cannot guarantee that the manufacturing facility operator, Emergent BioSolutions, is following good manufacturing practices, the Times reported.

“Before making this decision, the FDA conducted a thorough review of the facility records and the results of the manufacturer’s quality checks,” the agency said. “Although the FDA is not yet ready to include the Emergent BioSolutions facility in the Janssen EUA as an authorized manufacturing facility, the agency continues to address issues with Janssen and the management of Emergent BioSolutions.”

The Biden government planned to donate more cans of the shots, but those plans were stifled by the investigation of the emergent facility.

The World Health Organization said it would take 11 billion doses worldwide to stop the pandemic from getting worse. The US is buying 500 million doses of Pfizer’s two-shot vaccine to be distributed to countries in need, President Joe Biden is expected to announce at G-7 meetings this weekend.

– CNBC’s Berkeley Lovelace Jr. contributed to this article.

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The right way to Reopen Places of work Safely

Many American offices have been virtually empty for the past 15 months. Conference rooms and cubicles remained unused, elevators not called, files untouched. Whiteboards became time capsules. Succulents had to take care of themselves.

But many of these jobs will slowly come back to life in the coming weeks. According to a recent poll by the Partnership for New York City, around half of the million office workers in Manhattan are expected to return to their desks at least part-time by September.

Although the risk of contracting Covid-19 in the United States has decreased significantly – especially for those who are fully vaccinated – it has not completely gone and many workers remain nervous about going back to their desks. (Many others, of course, never had the luxury of working remotely.)

“If you’re still feeling uncomfortable or anxious, that’s totally understandable,” said Joseph Allen, a healthy building expert who teaches at Harvard TH Chan School of Public Health. “This pandemic has had a profound impact on all of us, and people will be ready to go back to life or interact with people at other times.”

But scientists have learned a lot about the virus over the past year, and there are some clear, evidence-based steps employers can take to protect their workers – and workers can take to protect themselves. Some of these strategies are likely to pay dividends that will last out of the current crisis.

“I think it’s important for us as a community, but also for individual employers, to think about these questions for more than just this week and this month,” said Alex Huffman, an aerosol scientist at the University of Denver. “How do we make decisions now that will continue to benefit the safety and health of our workplaces in the future?”

Although Covid-19 is the number one health problem, long-term building closures can pose their own risks. For example, unused sanitary systems can be colonized by Legionella pneumophila, bacteria that can cause a type of pneumonia known as Legionnaires’ disease.

“Long periods of standing, lukewarm water in pipes – the exact conditions in many understaffed buildings currently – create ideal conditions for the growth of Legionella,” said Dr. All.

Some schools have already reported that they found the bacteria in their water. In buildings with lead pipes or fittings, high amounts of the toxic metal can also accumulate in standing water. Employers can reduce both risks by flushing their faucets thoroughly or turning the water on and running before opening it again.

“We know that flushing water during periods of inactivity usually reduces lead levels and also reduces potential bacteria that can build up,” said Jennifer Hoponick Redmon, senior environmental health scientist at RTI International, a North Carolina-based nonprofit research organization. She added, “A general rule of thumb is 15 minutes to an hour of flushing for long-term closings, such as for Covid-19.”

The Centers for Disease Control and Prevention also recommend companies test for mold and pest infestation before reopening.

Since the coronavirus is believed to spread primarily through tiny airborne droplets, employers should upgrade their ventilation and filtration systems before bringing workers back, experts said.

“One thing you can do before going back to work is just ask them what they did,” said Dr. All. “And when you hear things like, ‘Yes, we hit code,’ it is an indication that something is wrong. They should exceed the minimum ventilation and filtration rates. “

In general, while the ideal rate of ventilation varies, employers should maximize the amount of fresh air that gets in from the outside, he said. In a relatively small room – about the size of a typical school classroom – employers should aim for four to six air changes per hour, which means that the air in the room is completely renewed every 10 to 15 minutes. Opening windows can also improve airflow.

Good quality air filters, such as those rated MERV 13 or higher, can trap a majority of the virus particles in the air. Some commercial buildings are not equipped for these high-performance filters; In these offices, portable air purifiers equipped with HEPA filters can be effective, experts said.

Updated

June 11, 2021, 10:35 a.m. ET

“These types of portable units are great at removing particles from space,” said Dr. Huffman. “And the next level is even a desktop-level HEPA filter where you have a really small unit that delivers clean air into your direct breathing zone.”

These personal units can be particularly useful in poorly ventilated offices, although experts stressed that it is employers, not employees, that should be responsible for improving indoor air quality.

While ventilation and filtration are critical, employers and property managers should stay away from fog machines, fumigators, ionizers, ozone generators, or any other “air cleaning device” that promises to neutralize the coronavirus by adding chemical disinfectants to the air. “These are all really terrible ideas about what to do with indoor air,” said Delphine Farmer, an atmospheric chemist at Colorado State University.

The compounds these products emit – which can include hydrogen peroxide, bleach-like solutions, or ozone – can be toxic, inflame the lungs, cause asthma attacks, and lead to other types of respiratory or cardiovascular problems. And there’s no rigorous, real-world evidence that these devices actually reduce disease transmission, said Dr. Farmer.

“A lot of employers now think – and school districts and property managers – think that using these devices they solved the problem,” said Dr. Farmer. “So then they don’t increase the ventilation rates or add other filters. And that means that people think they are safer than they actually are. “

Surfaces pose a minimal risk of coronavirus transmission, and unnecessarily applied disinfectants can also get into the air and be toxic if inhaled. In most normal workplaces, wiping the desk with bleach is likely to do more harm than good, said Dr. Farmer. (According to experts, some specific workplaces – such as hospitals, laboratories, or commercial kitchens – may still require disinfection.)

There is also no particular need for special antimicrobial wipes or detergents that can encourage the emergence of antibiotic-resistant bacteria and wipe out communities of benign or beneficial microbes. “As tempting as it is to sterilize everything, it will never happen and the consequences can be serious,” said Erica Hartmann, an environmental microbiologist at Northwestern University.

In the first few months of the pandemic, plastic barriers emerged in schools, shops, restaurants, offices, and other common areas. “They can be great for stopping the bigger droplets – they’re really big sneezers,” said Dr. Huffman.

But the smallest and lightest particles can simply float above and around them. These barriers “may not offer enough advantages to justify their costs,” said Martin Bazant, a chemical engineer at the Massachusetts Institute of Technology. They can even increase the risk of disease transmission by encouraging riskier behavior or obstructing airflow.

There are some environments where these types of barriers can still be useful. “It can be a really good idea for people who otherwise have very close personal contact, such as grocery store clerks at the cash register,” said Dr. Farmer. “But beyond that, in offices where you sit for a long time, there is no advantage in being in a plexiglass cage.”

Social distancing can still have some benefits; When an employee exhales infectious viruses, people sitting directly in that person’s breathing zone are likely to be exposed to the highest doses. “If you are sitting at a common table half a meter away from someone, there could be potential value in moving a little further away,” said Dr. Huffman.

But aerosols can stay in the air for hours and travel well over six feet, so moving desks further apart is likely to have diminishing returns. “Strict distancing orders like the six-foot rule protect little against long-distance aerial transmissions,” said Dr. Bazant, “and can convey a false sense of security in poorly ventilated rooms.”

In offices where most people are vaccinated and local case numbers are low, the benefits of distancing are likely to be minimal, scientists said. In higher-risk workplaces, de-compression should be considered or the number of people present at the same time – any of whom could be infectious – should be reduced. “For me, that was the biggest benefit of this indoor social distancing,” said Dr. Farmer. “There are just fewer potential sources of SARS-CoV-2 in a room.”

Organizations could allow a subset of employees to work from home indefinitely or on alternate days or weeks. You could also consider “cohorting” or creating separate teams of employees who do not have face-to-face interactions with those who are not on their team.

The formation of such cohorts could also facilitate the response if someone becomes infected with the virus, so that the affected team can be quarantined without having to close an entire workplace. “When thinking about reopening, do we have to think about what to do when we inevitably see a case?” said Justin Lessler, an infectious disease epidemiologist at Johns Hopkins University. “There are creative ways to reduce the impact.”

Regular hand washing, which can reduce the spread of all types of pathogens, is always a good idea. “The message at the beginning of the pandemic to wash your hands and wash your hands for at least 20 seconds – that is absolutely valid and still very important,” said Dr. Hartmann.

And if the office needs to be cleaned yourself, a mild detergent is usually enough, she adds, “Soap and water are great.”

Masks also remain effective. “If you are someone who has been vaccinated and is still afraid of going back to work, it is best to keep wearing a mask for the first few weeks until you feel more comfortable,” said Dr. All.

Scientists recommended that unvaccinated workers continue to wear masks in the office. But for those eligible, the most effective risk reduction strategy is obvious, said Dr. Allen: “Number one is to get vaccinated.”

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5 issues to know earlier than the inventory market opens Friday, June 11

Here are the most important news, trends and analysis that investors need to start their trading day:

1. S&P 500 looks to add to Thursday’s record close

A Wall Street sign is pictured outside the New York Stock Exchange amid the coronavirus disease (COVID-19) pandemic in the Manhattan borough of New York, April 16, 2021.

Carlo Allegri | Reuters

U.S. stock futures rose Friday, one day after the S&P 500 logged its 27th record close of 2021 but its first since May 7. Shaking off a red-hot inflation report, the Dow also rose Thursday, breaking a three-session losing streak and finishing less than 1% from last month’s record close. The Nasdaq’s gain Thursday brought the tech-heavy index within 1% of its last record close in late April.

Ahead of Friday’s open on Wall Street, the Nasdaq was up 1.5% for the week, on pace for a fourth straight weekly gain for the first time since January. The S&P 500 was looking to clinch a three-week winning streak. The Dow was off 0.8% for the week, on track to break two positive weeks in a row.

The 10-year Treasury yield ticked lower Friday, trading just above 1.4%, around its early March lows before it spiked above 1.7% to 14-month highs later that month.

2. Meme stocks get some relief after hitting a wall

SELINSGROVE, PENNSYLVANIA, UNITED STATES – 2021/01/27: A woman walks past the GameStop store inside the Susquehanna Valley Mall. An online group sent share prices of GameStop (GME) and AMC Entertainment Holdings Inc. (AMC) soaring in an attempt to squeeze short sellers.

Photo by Paul Weaver/SOPA Images/LightRocket via Getty Images

Meme stocks were getting some relief early Friday after hitting a wall Thursday. Shares of GameStop, which tanked 27% on Thursday, rose 6% in the premarket. GameStop investors seemed to be running for the exits Thursday, one day after the video game retailer announced the appointments of two former Amazon executives as CEO and CFO and said it may sell as many as 5 million additional shares to raise money. GameStop — off about 50% from its $483 per share all-time high in January — remained up nearly 1,100% in 2021. Last week’s big winner, AMC Entertainment, rose 4% in Friday’s premarket after closing down 13% on Thursday. The stock — down more than 40% from last week’s all-time high of $72.62 — was still up 1,900% this year.

3. Biden, G-7 leaders to endorse a global minimum corporate tax

U.S. President Joe Biden poses for a picture during a meeting with Britain’s Prime Minister Boris Johnson (not pictured) ahead of the G7 summit, at Carbis Bay, Cornwall, Britain June 10, 2021.

Toby Melville | Reuters

President Joe Biden and G-7 leaders will publicly endorse a global minimum corporate tax of at least 15% on Friday, one piece of a broader agreement to update international tax laws for a globalized, digital economy. Meeting at a resort in the U.K., the world leaders will also announce a plan to replace Digital Services Taxes, which targeted the biggest American tech companies, with a new tax plan linked to the places where multinationals are actually doing business, rather than where they are headquartered. The White House also said G-7 leaders will agree to “continue providing policy support to the global economy for as long as necessary to create a strong, balanced, and inclusive economic recovery.”

4. Two Royal Caribbean passengers test positive for Covid

A file photo shows the Celebrity Millennium cruise ship at Kai Tak cruise terminal in Kowloon Bay.

Felix Wong | South China Morning Post | Getty Images

Royal Caribbean said late Thursday that two guests onboard its Celebrity Millennium ship tested positive for Covid. According to the cruise operator, which didn’t reveal their ages, the passengers were asymptomatic and in isolation. Celebrity Millennium was one of the first cruises in North America to restart sailing last week. In lifting the more than one year pandemic halt, the CDC required a fully vaccinated crew and everyone over 16 to present proof of vaccination. In the early days of Covid last year, cruise ships became hotbeds for the coronavirus.

5. Tesla begins deliveries of its new Model S Plaid

Tesla Model S Plaid

Source: Tesla

Tesla kicked off deliveries of its new Model S Plaid, with a livestream event Thursday night at the electric auto maker’s test track near its Fremont, California factory. CEO Elon Musk made his entrance by driving a Model S Plaid around the track and onto the stage. Musk, in weeks before the even, hyped the months-delayed vehicle as the “quickest production car ever made.” The Model S Plaid, a high-performance version of Tesla’s flagship sedan, starts at $129,990 compared with $79,990 for a long-range 2021 Model S. On Sunday, Musk tweeted that Tesla canceled the $150,000 Model S Plaid Plus, saying there was “no need, as the Plaid is just so good.”

— Reuters contributed to this report. Follow all the market action like a pro on CNBC Pro. Get the latest on the pandemic with CNBC’s coronavirus coverage.

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Vaccinated Adults Helps Defend Unvaccinated Kids, Research Finds

New data from Israel, which had the fastest Covid-19 vaccine rollout in the world, provides real evidence that widespread vaccination against the coronavirus can protect unvaccinated people as well.

The Israeli study, published Thursday in the journal Nature Medicine, capitalized on the fact that until recently Israel only vaccinated people 16 and older. For every 20 percentage points increase in the proportion of 16 to 50 year olds vaccinated in a community, the proportion of unvaccinated under 16 year olds who tested positive for the virus fell by half.

“Vaccination not only offers benefits to the individual vaccine, but also to the people around them,” said Roy Kishony, a biologist, physicist and data scientist who studies microbial evolution and disease at the Technion-Israel Institute of Technology. Dr. Kishony led the research with Dr. Tal Patalon, who heads KSM, the Maccabi Research and Innovation Center, in Israel. The first authors of the paper are Oren Milman and Idan Yelin, researchers in Dr. Kishony’s laboratory.

Israel began vaccinating adults in December last year. Within nine weeks, it had vaccinated nearly half of its population.

The researchers examined the anonymized electronic health records of members of Maccabi Healthcare Services, an Israeli HMO. They analyzed vaccination reports and virus test results between December 6, 2020 and March 9, 2021. The records were from 177 different geographic areas with different vaccination rates and vaccination rates.

For each community, they calculated the proportion of adults between the ages of 16 and 50 who were vaccinated at different times. They also calculated the percentage of children under the age of 16 who tested positive for PCR.

They found a clear connection: As more and more adults were vaccinated in a community, the proportion of children who tested positive for the virus fell as a result.

People who are vaccinated are significantly less likely to contract the virus. Research also suggests that even if people who have been vaccinated become infected with the virus, they may have lower viral loads, which reduces their ability to be contagious. As more and more people are vaccinated, the likelihood that unvaccinated people will encounter infected, contagious people is decreasing.

“The results are consistent with the fact that vaccinated people not only do not get sick themselves, but also do not transmit the virus to others,” said Dr. Kishony. “Such effects can be intensified over several infection cycles.”

In another recent article that has not yet been published in a scientific journal, Finnish researchers reported that after vaccinating health workers, even unvaccinated family members were less likely to be infected with the virus.

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High FDA advisor says children should be vaccinated towards Covid

U.S. Senator Bob Casey, right, watches as Dr. Paul Offit speaks during a press conference in Philadelphia on Friday, Feb. 13, 2015.

Matt Rourke | AP

Children need to be vaccinated against Covid-19, a top advisor to the Food and Drug Administration’s childhood vaccines told the agency on Thursday.

“It just seems silly to think that we don’t need to involve children,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and advisor to the FDA. “They can suffer and be hospitalized and occasionally die.”

He said 300 children had died of Covid so far.

Offit, a voting member of the Agency’s Vaccines and Related Biological Products Advisory Committee, spoke about the use of Covid-19 vaccines in children 6 months of age during the panel’s meeting.

“We have variants that are becoming more contagious, which means you need higher population immunity … for years, if not decades,” Offit said. He also said that we vaccinate children against polio every year, although we haven’t had a polio case since the 1970s.

Data from the American Academy of Pediatrics shows that nearly 4 million children have tested positive for Covid since the pandemic began. In the past week, the data said more than 16,000 new cases in children were reported, the lowest since June 2020. In states reported, less than 1% of all Covid cases in children resulted in death, the AAP wrote their website.

“I think in winter we will really see how well we do on population immunity,” Offit said. “I think the idea that we will no longer have to vaccinate children in the future is wrong.”

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Three F.D.A. Advisers Resign Over Approval of Alzheimer’s Drug

In a strong rejection of the Food and Drug Administration’s approval of Biogen’s controversial Alzheimer’s drug, three scientists have stepped down from the independent committee that advised the agency on the treatment.

“This could be the worst regulatory decision the FDA has made that I can remember,” said Dr. Aaron Kesselheim, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, who resigned Thursday after six years on the committee.

He said the agency’s approval of the drug aducanumab, marketed as Aduhelm, a monthly intravenous infusion that Biogen has set at $ 56,000 a year, was incorrect “because of so many different factors, including the fact that there is no good evidence ”. that the drug works. “

Two other members of the committee resigned earlier this week and expressed dismay at the drug’s approval, although the committee overwhelmingly opposed it after reviewing clinical trial data in November.

The committee found that the evidence was inconclusive that Aduhelm could slow cognitive decline in people with the early stages of the disease – and that the drug could potentially cause serious side effects of brain swelling and hemorrhage. None of the eleven committee members thought the drug was ready for approval: ten voted against, one was unsure.

“The approval of an ineffective drug has serious potential to interfere with future research into new treatments that may be effective,” said Dr. Joel Perlmutter, a neurologist at Washington University School of Medicine in St. Louis, who first stepped down from the committee.

“In addition, aducanumab therapy will potentially cost billions of dollars to introduce, and those dollars could be better spent developing better evidence for aducanumab or other therapeutic interventions,” added Dr. Mother-of-pearl added.

Shannon P. Hatch, an FDA spokeswoman, said the agency does not comment on matters that affect individual advisory committee members.

Biogen plans to ship the drug in about two weeks. It expects more than 900 locations across the country, usually memory clinics that treat patients with dementia, to be ready to administer the drug soon.

The FDA’s green light decision, announced Monday, marked the first approval of an Alzheimer’s treatment in 18 years. Patient advocacy groups had pushed for approval because there are only five other drugs for the debilitating disease and they only treat dementia symptoms for a few months.

But since last fall, several respected experts, including some Alzheimer’s doctors who worked on the clinical trials of aducanumab, have said that the evidence available casts significant doubts on the drug’s effectiveness. They also said that even if it could slow cognitive decline in some patients, the proposed benefit – slowing symptoms down for about four months over 18 months – might be barely noticeable to patients and outweigh the risks of side effects on the brain would.

In addition to the high price of the drug, the additional cost of screening patients before treatment and having regular MRIs needed to monitor their brain for problems could add tens of thousands of dollars to the bill. Medicare is expected to cover much of that.

“Giving patients a drug that is not working and of course has great risks that require multiple MRIs costing $ 56,000 a year puts patients in a really challenging position and puts doctors in a difficult position.” said Kesselheim.

Aside from believing that the existing evidence of Aduhelm’s benefits is weak, the resigning advisory committee members – as well as several prominent Alzheimer’s experts – rejected two important aspects of the FDA’s approval decision.

One problem is that the FDA has approved the drug for a much broader group of patients – anyone with Alzheimer’s – than many experts expected. In the clinical trials, the drug was only tested in patients with early-stage Alzheimer’s disease or mild cognitive impairment from the disease.

The other problem is that a key part of the FDA’s rationale for granting the approval was that the drug’s ability to attack the amyloid protein in patients’ brains would help slow their cognitive symptoms.

“This is a big problem,” said Dr. Mother-of-pearl.

While amyloid is considered a biomarker of Alzheimer’s disease because its buildup in the brain is an important aspect of the disease, there is very little scientific evidence that reducing amyloid can actually help patients by relieving their memory and thinking problems.

Clinical studies of other amyloid-lowering drugs for more than two decades have shown no evidence that the drugs slow cognitive decline. As a result, many experts had said it was especially important to have solid evidence of Aduhelm’s ability to treat symptoms.

In November, FDA officials told advisory committee members that the agency would not count the drug’s ability to reduce amyloid as an indication of its effectiveness. But in Monday’s decision, the FDA announced that it did just that.

“The FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that reducing these plaques is likely to predict important benefits for patients,” said the director of the Center for Drug Evaluation and Research of the FDA, Dr. Patrizia Cavazzoni wrote on the agency’s website about the decision to make the drug available under a program called accelerated approval.

The advisory committee members said, however, that the committee was never advised that the agency would be considering approval based on amyloid reduction and that their opinion on this significant change was never sought. Dr. Perlmutter said the committee was “unaware of any additional information or statistical analysis to support approval.”

Dr. David Knopman, a clinical neurologist at Mayo Clinic, wrote in an email to FDA officials informing them of his resignation from the advisory committee on Wednesday: “Biomarker justification for approval in the absence of consistent clinical benefit 18 months of treatment is “unreasonable.”

Dr. Knopman, who stepped out of the November meeting for serving as the lead investigator for one of the aducanumab trials, added that “the whole aducanumab approval saga, which culminated in accelerated approval on Monday, is a mockery “The role of the advisory board.

Dr. Peter Stein, who heads the Office of New Drugs at the FDA Center for Drug Evaluation and Research, said in a briefing with reporters following the decision that the agency’s reviewers were convinced of what he saw as a strong relationship between plaque reduction and potential clinical benefit described by Aduhelm, which he said had not been seen in previous studies of amyloid-eradicating drugs.

Dr. Stein also defended the agency’s decision to approve the drug in such a broad patient population, saying it could be relevant beyond the early stages of Alzheimer’s.

“Since amyloid is a hallmark of the disease throughout its course, this drug is expected to provide benefits across this spectrum,” said Dr. Stone.

As a condition of approval, the FDA said Biogen would conduct another clinical trial and give the company approximately nine years to complete. These terms apply to some experts as well. They say the drug will be available without restriction during these years, and if the new study doesn’t prove the drug beneficial, the agency may, but is not required to, withdraw its approval and has not always done so for other drugs.

“The timeframe they gave for the so-called confirmatory study of nine years is problematic,” said Dr. Kesselheim, who also directs Harvard Medical School’s regulation, therapy, and law program. “During this time, the product will be used a lot.”

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Bitcoin 2021 attendees report Covid instances after coming back from Miami

Some of the 12,000 attendees who flew to Miami for the largest Bitcoin event in history last weekend have started testing positive for Covid.

Bitcoin 2021 attracted crypto enthusiasts from around the world to the Mana Wynwood Convention Center in the arts and entertainment district of Miami. For three days, conference attendees huddled in overcrowded lecture halls, happy and hugging. It was the first major conference since the pandemic began, and many attendees said they were relieved to be among colleagues sharing messages and updates.

There was no mask requirement and no proof of compulsory vaccination for participation. Covid was just a topic of conversation in connection with everyone’s excitement about being on the other side of the pandemic.

This is of course until some conference participants said on Twitter that they had tested positive for the corona virus.

For full disclosure, I attended the show after receiving two doses of the Moderna vaccine this spring. Vaccination isn’t a 100% guarantee of immunity, but at the moment I have no symptoms. A lot of my conversations with Uber and Lyft drivers started with a discussion about vaccination together.

It remains to be seen whether the conference will ultimately be billed as a super spreader event.

It is unclear how many people are affected and whether the city of Miami had a contingency plan for such an outcome. The mayor’s office and conference organizers did not immediately respond to CNBC’s request for comment.

On Tuesday, Florida said it would no longer report daily Covid cases and deaths as vaccinations increase and move into the “next phase” of the pandemic. Florida reported an average of eight new cases per 100,000 residents last week, well below its pandemic high of 84 per 100,000, according to Johns Hopkins University.

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OSHA Points Covid Office Security Rule, However Just for Well being Care

During the Trump administration, OSHA passed a policy to largely limit Covid-related inspections to a small number of high-risk industries such as healthcare and emergency aid. Meat wrap was not included in this high-risk group – studies showed it was a major source of virus transmission.

Some labor groups praised OSHA under President Donald J. Trump for enforcing health care safety regulations, including proposed fines of over $ 1 million for violations in dozens of health and nursing homes. However, critics accused the agency of largely failing to punish meat processors for lax safety standards, such as a lack of adequate distancing from workers.

Mr Walsh said the risks for most non-healthcare workers had decreased as cases decreased and vaccination rates increased. He also noted that the Centers for Disease Control and Prevention guidelines last month, telling vaccinated individuals that they generally do not need to wear a mask indoors, played a role in OSHA’s decision on one dispense with the broader Covid-19 standard.

“OSHA has adjusted the rule to reflect the reality on the ground, the success of the vaccine effort, as well as the latest guidance from the CDC and the changing nature of the pandemic,” Walsh said on the call.

David Michaels, an OSHA chief during the Obama administration, said the CDC guidelines made it difficult to implement a broader OSHA rule. “In order to justify an emergency standard, OSHA needs to demonstrate that there is great danger,” said Dr. Michaels. “To do this, the CDC should have clarified its recommendation and said that there is a great danger for many workers.”

Without such clarification, said Dr. Michaels, now a professor at the George Washington University School of Public Health, would have employer groups likely challenged any new OSHA rule in court, arguing that the CDC guidelines indicated that a rule was unnecessary.

Dr. Michaels said the new standard was an overdue move, but it was disappointing that no Covid-specific standard had been issued for industries such as meat packaging, corrections and retail. “If exposure is not controlled in these workplaces, they will continue to be major drivers of infection,” he said.

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CDC says coronary heart irritation in 16- to 24-year-olds increased than anticipated after second shot

A young man in West Virginia receives the vaccine while overlooking the West Virginia Capitol Building at Riggleman Hall.

Stephen Zenner | LightRakete | Getty Images

There have been a higher than expected number of cases of heart inflammation in 16- to 24-year-olds after receiving their second dose of Covid-19 vaccine from Pfizer or Moderna, the Centers for Disease Control and Prevention shared on Thursday Relying on preliminary data from its vaccine safety monitoring system.

The CDC has received reports of 275 cases in this age group as of May 31, the agency said in a presentation prepared for a meeting of the Food and Drug Administration advisory panel on Thursday. Scientists expected between 10 and 102 cases of myocarditis, or pericarditis – in which the heart muscle or the lining of the heart becomes inflamed, according to the CDC.

“We clearly have an imbalance,” said Dr. Tom Shimabukuro of the CDC’s Immunization Safety Office on Thursday on the FDA Advisory Committee on Vaccines and Related Biological Products to discuss safety issues related to the use of Covid-19 vaccines in children 6 months and older.

Although rare, a total of 475 cases of myocarditis or pericarditis have been reported in people aged 30 years and younger, according to the CDC. Most of the patients hospitalized, or 81% of them, had fully recovered from their symptoms, the agency said. May there are still 15 people in the hospital, three of them in the intensive care unit.

The majority of cases appear to occur in men, and the median time to onset of symptoms is two to three days, according to the CDC.

Some of the reported cases could be something other than myocarditis or pericarditis upon further investigation, Shimabukuro said.

The CDC’s Vaccine Safety Group announced last month that it is examining heart infections in “relatively few” people who have received Covid vaccinations.

The cases mostly affected adolescents and young adults and usually occurred within four days of the vaccination, the CDC said at the time. The condition has been seen more often in men and most cases appear to be mild, the agency said, although officials are following up on patients.

The CDC is coordinating its investigation with the FDA, which last month approved the Pfizer BioNTech vaccine for adolescents ages 12-15.

“We still don’t know if this is really related to the vaccine,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, during a virtual question-and-answer event on May 27th. He added that the “handful” of reported cases were “very mild, lasting a day or two,” and usually occurred after a second dose.

Health experts say finding rare side effects once a vaccine or drug is administered to the general population, and if myocarditis is found to be related to the Covid vaccine, the risk is negligible compared to the risks of infection with Covid-19.