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concerns Coronavirus

Coronavirus concerns mean U.S. parents and school leaders face dilemmas – Los Angeles Times

Back to school. In pre-pandemic days, it was the most mundane of catchphrases, a bit corny and comical, freighted with a bittersweet wish that the chlorine-scented days of summer could last a little longer.

Now, across the coronavirus-haunted United States, those words are a signifier of existential dread, a political lightning rod, a confounding multiple-choice question that has no real right answer, but plenty of wrong ones.

Parents, especially working ones, are desperate to get their kids back into the classroom. President Trump, eager to revive a devastated U.S. economy, is demanding that schools open for in-person instruction.

But a pandemic is raging, particularly in the country’s South and West, and with days ticking down to a new school year, no one is sure how to keep students, teachers and school workers — and, like the radiating spokes of a wheel, all those who come into contact with them — safe from contagion.

School administrators are scrambling, trying to figure out rules on everything from facial coverings to plexiglass separators if students do physically return, and how to manage months of online learning if they do not. And any guidelines agreed upon now could change before the school bells ring.

In tens of millions of American households, the overarching dilemmas are personified in small, wriggling, restless bodies — schoolchildren like Keily Mitchell’s 8-year-old son, Eli.

When schools in Vidalia, Ga., shut down along with those in the rest of the country at the outbreak’s onset in March, Eli rapidly discovered that he hated distance learning. And Mitchell, a 41-year-old registered nurse who works in a local hospital, equally hated standing over him and nagging him to do his worksheets.

Georgia Gov. Brian Kemp, a Republican, is leaving the decision of reopening up to local school districts, setting the stage for a patchwork approach as COVID-19 spreads rapidly across the state. The state has seen more than 115,000 cases, and nearly 3,000 deaths.

Big public school systems in Atlanta and Savannah have announced virtual-only school openings, but in many suburban and rural areas, classrooms will throw open their doors in late July and early August.

Some, like Vidalia, a small city about 170 miles southeast of Atlanta, will offer a virtual-learning option as well. But Mitchell and her husband, although worried, think they will most likely take their chances and send Eli and his 13-year-old sister Annika back to the classroom.

“I really, truly don’t know what the best answer is,” Mitchell said. “Bottom line, as a working parent, I don’t have another option but to send my kids to school.”

In the nationwide back-to-school debate, critics of the Trump administration see a macabre replay of the misguided push for early reopening of businesses and public spaces in the very states — many in the South — that are now inundated by the virus. The U.S. has experienced more than 136,800 deaths related to the coronavirus and at least 3.4 million people have been infected.

School openings will be a crucial component of any economic recovery, with classroom time, or the lack of it, woven tightly into the working life of every parent.

But Trump and his allies have sought to frame the argument in terms that essentially ignore urgent public health concerns, asserting that the social and developmental perils of missed learning outweigh the risks.

Frustrated critics say the question isn’t whether being kept out of school harms kids — it does, of course, they say — but that it is deeply irresponsible to try to strong-arm school districts into in-person openings without taking the scale and severity of area outbreaks into account.

Florida, which has more than 300,000 confirmed coronavirus cases and more than 4,510 deaths, has issued a directive requiring all school districts to offer in-person instruction. With the state a coronavirus epicenter, Republican Gov. Ron DeSantis has come under criticism from many municipal leaders over the state telling school districts they must hold classes in person.

In theme-park-heavy Orlando, Adelise Berrios has taught kindergarten at Oakshire Elementary School for 20 years. She’s extremely worried about safety protocols — especially with a roomful of irrepressible little charges prone to “playing with boogers or whatever.”

“You get children that will sneeze all over the table and another child comes in and just leans on the table,” Berrios said. “You don’t know because you cannot have your eyes on every single student.”

Her district could seek state permission for virtual options, but only weeks before the start of school, “not knowing, it’s just killing us,” she said. Like many other teachers, Berrios said she’ll work with whatever instructions she’s handed, but the details — or even the broad outlines — remain unclear.

“If they say, ‘OK, next month or next week, you have to be in school,’ I will be in school, taking all the precautions,” she said. “But then it’s like driving blind. You don’t know who has it. If we open the school and one person gets COVID, do we have to close the school because there is one case?”

Trump has at times appeared dismissive of the wrenching dilemmas faced by parents and teachers. Asked in an interview that aired Tuesday on CBS what he would say to those opting for online learning because of safety fears, he replied: “I would tell parents and teachers that you should find yourself a new person, whoever is in charge of that decision, because it’s a terrible decision.”

Trump allies like Sen. John Kennedy, a Louisiana Republican, have suggested that keeping children out of school is a ploy by Democrats to harm the president’s reelection prospects.

“They’re using our kids as political pawns, and to them I say unashamedly, they can kiss my ass,” he told Fox News’ Sean Hannity on Monday. “That’s wrong to do that to the kids of America.”

Schooling, like wearing a mask, has become increasingly politically fraught. In Texas, where new cases have spiked above 10,000 a day, Republican Gov. Greg Abbott and the state education agency have insisted schools reopen next month, although they face growing opposition from local officials and teachers.

Texas’ death toll stands at nearly 4,000, with almost 300,000 cases. Last week, officials in the border cities of El Paso and Laredo, where infections have jumped, issued orders barring schools from reopening. And officials in Texas’ Rio Grande Valley have also asked the governor to postpone reopening schools due to a soaring infection rate.

According to the state, reopening means districts can teach remotely for three weeks, but must offer in-person options. If districts refuse, Abbott and other officials have said they will lose state funding, a large portion of their budgets.

“That’s a form of blackmail,” said Clay Robison, a spokesman for the Austin-based Texas State Teachers Assn., which represents about 65,000 school staff. Citing health vulnerabilities on the part of many teachers, he called Texas’ coronavirus numbers “just out of control.”

Teachers’ unions and school officials have argued that major expenditures are needed — for physically reconfiguring classrooms, setting staggered hours, setting up medical-grade cleaning regimens, but no new funding has been forthcoming.

Without proper precautions, they say, not only will pupils and teachers will be imperiled, but the risk spills over to everyone in a given child’s circle — parents, grandparents, siblings, any of whom could have particular health vulnerabilities.

“It’s a scary time — no matter what we do,” said Tom Lee, 39, an eighth-grade teacher at Dalton Middle School in northern Georgia who is still waiting for his school district to finalize its plans for a school year that is supposed to start the first week of August.

His school district, he said, had been fairly proactive about sending out surveys and inviting teachers to focus group meetings, and is still weighing three options: start school fully face-to-face, usher in a hybrid plan that would combine digital and face-to-face learning, or have everyone move to digital learning.

“It’s just a slate of bad options,” he said. “I don’t feel comfortable with the students sitting at home. I also don’t feel comfortable taking them to into a building.”

Lost opportunities are hard to quantify, but some parents — and pupils — are already feeling the sting of chances that might slip away.

In Seattle, public schools plan to offer at least two days a week of in-person instruction for kindergarten through 12th grade, with the option for families to choose online-only learning. But administrators say plans could change, depending on public health guidelines. Washington state, hit hard and early, has seen more than 44,000 confirmed infections and at least 1,400 deaths.

Mercedes Diggs, 47, said her son, August, an athletic 13-year-old who is about to enter eighth grade, is beside himself with eagerness to get back to Denny International Middle School, a public school in Seattle.

“My son is African American, and we’re so pleased with all the rich programs they have,” Diggs said, citing in particular an elective class for Black male students, teaching Black history, cultural knowledge, positive self-identity and literacy.

August — a sociable youngster who was on two tournament basketball teams as well as the school basketball team, with track practice about to start when the lockdown began — coped with the school closure, but was “miserable,” his mother said. He’s happy for two days a week of school attendance, but would love to go every day, she said.

Diggs is torn, but ultimately sees it differently. For safety reasons, she would prefer online learning only.

“It would be excruciating for my son not to go to school,” she said. “But as a parent, if they end up going only online, I’m OK with that.”

Times staff writers King reported from Washington, Jarvie from Atlanta and Baxter from Orlando, Fla. Staff writers Molly Hennessy-Fiske in Houston and Richard Read in Seattle contributed to this report.

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concerns journals

Top journals raise concerns about data in two studies related to Covid-19 – STAT

Two of the world’s leading medical journals on Tuesday expressed concern about potential flaws in the data produced by a small company to draw major conclusions about Covid-19 — that certain heart drugs are safe, and that the malaria drug hydroxychloroquine is not. The latter finding led to the pause of an important study of hydroxychloroquine by the World Health Organization.

“Serious questions have been raised about the reliability of the findings reported in this paper,” Richard Horton, the editor of the Lancet, where the hydroxychloroquine study was published, wrote on Twitter.

Eric Rubin, the editor of the New England Journal of Medicine, which published the study of heart drug safety, struck a similar tone.

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“Substantive concerns have been raised about the quality of the information in that database,” Rubin wrote in the so-called expression of concern published by the journal. “We have asked the authors to provide evidence that the data are reliable.”

The concerns, which have built over the past several days on social media, highlight larger issues with using big databases to draw conclusions about medicines, an approach that has been gaining rigor in the era of big data. Experts warn that conducting such studies properly is far more difficult than it appears.

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“This is not for the faint of heart,” said Harlan Krumholz, director of the Center for Outcomes Research and Evaluation at Yale New Haven Hospital. “This is not just a matter of dial-a-study when you get access to data. Well-done studies are based on understanding the provenance of the data and making sure what you are doing is reasonable. There is good science to be done with big databases, but there are also major mistakes to be made. The question is: What happened here?”

Both studies in question used data from Surgisphere, a little-known company based in Chicago that claimed in the Lancet study to have data from 671 hospitals on six continents. The Lancet paper found that the malaria drugs chloroquine and hydroxychloroquine, which had been explored as potential therapies for Covid-19, did not correspond with improved outcomes for patients, and were also associated with higher mortality. The paper in the New England Journal of Medicine reported that blood pressure medications were not associated with worse outcomes in patients with Covid-19. The studies share some of the same authors, including Sapan Desai, who runs Surgisphere.

After suspending the clinical trial arm focused on hydroxychloroquine, the WHO said it would review the data generated so far. That portion of the WHO’s multidrug Solidarity Trial remains paused, delaying answers on a drug that has become a political flashpoint even as the evidence on its potential benefits and risks is murky.

But news reports and experts have raised questions about the integrity of the Surgisphere data. The Guardian, for example, reported on discrepancies in data said to come from Australia in the Lancet study. The Lancet study’s authors have corrected errors about the number of participants, but have stood behind their conclusions.

Outside experts, however, have raised broader concerns. In a May 28 letter to the editor of the Lancet and the study’s authors, more than 180 scientists outlined questions about the statistical analysis and a lack of transparency. The study’s authors did not release the full data underlying the study and did not say which countries or hospitals contributed data, the letter says. The outside scientists called on Surgisphere to at least provide details about how it sourced its data and called for an independent validation of the analysis.

On Tuesday, the group of concerned researchers also wrote to the editor of the New England Journal, raising “similar issues” as they had seen in the Lancet paper. One issue, according to the letter: In some countries, “a relatively small number of hospitals are reported to have provided electronic patient record data to Surgisphere, yet these reports describe a remarkably high proportion of all PCR-confirmed cases in the respective countries.” They flagged specific concerns with data purported to come from the United Kingdom and Turkey.

In a statement, the lead author of the two studies, cardiologist Mandeep Mehra of Brigham and Women’s Hospital, said that the research team “initiated independent reviews of the data used in both papers after learning of the concerns that have been raised about the reliability of the database.” Mehra said the decision for the outside reviews came the remaining co-authors of the papers, “independent of Surgisphere.”

“The goal of the independent third-party auditor is to verify the source data and assess the accuracy of the database and the authors’ findings,” Mehra said.

The Lancet and New England Journal on Tuesday separately issued their expressions of concerns.

In their notice, the Lancet’s editors said the independent audit of the data was “expected very shortly” and noted the “serious scientific questions” that had been raised.

Surgisphere did not immediately respond to a request for comment. In a statement on its website after criticisms were raised about the Lancet study, it highlighted “the validity of our database.” It said its registry was based on electronic health records from customers of its machine learning program and data analytics platform, which allow the company to in turn use data from the records to study “real-world, real-time patient encounters.”

“Together, we stand behind the integrity of our studies and our scientific researchers, clinical partners, and data analysts,” the statement said.

The results of the hydroxychloroquine and chloroquine study in particular grabbed attention, as the drugs’ potential as Covid-19 treatments has become politicized. President Trump and his allies have touted their purported benefits, even as no gold-standard clinical trials have yet produced results and observational studies cast doubt on their efficacy. Trump said he was taking hydroxychloroquine to try to protect himself from the coronavirus.

But there have been concerns raised about the potential side effects of the drugs in people with Covid-19; the Food and Drug Administration, for example, has said it should not be used outside of clinical trials or for patients who are not hospitalized, because of the risk it poses to heart health. Trump’s critics used the Lancet study to argue that by promoting the drug, the president had been endangering the public.

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concerns Sovereignty

Sovereignty concerns may be why China is taking a strong stance on Hong Kong, expert says – CNBC

China’s desire to display its sovereign might could be part of why it has approved a draft national security law for Hong Kong, one analyst told CNBC.

“There’s probably sort of a multi-layered cake of Chinese motivations,” Christopher Johnson, Freeman Chair in China Studies at think tank Center for Strategic and International Studies, said Thursday before China’s parliament voted to approve the bill that some say infringes on the city’s freedoms and autonomy.

The proposed bill is highly contentious as it bypasses Hong Kong’s legislature and could undermine the city’s semi-autonomous status that went into effect when Britain handed Hong Kong over to China in 1997.

One of the reasons China is ready to take a strong stance toward Hong Kong could be because Beijing is troubled by recent U.S. support for Taiwan, said Johnson, a former China analyst with the Central Intelligence Agency.

Beijing views Taiwan as a breakaway province with no rights to state-to-state relations. The Chinese Communist Party has never governed Taiwan.

U.S.-Taiwan relations

“China has a lot of concerns about what’s happening on Taiwan … rather how the U.S. is approaching Taiwan,” Johnson told CNBC.

Taiwan has emerged as comparatively successful in managing to control the coronavirus outbreak, and posted just 442 cases and seven deaths in a population of nearly 24 million. That’s despite its proximity to mainland China and their close business ties.

Earlier this year, U.S. Secretary of State Mike Pompeo — alongside a clutch of world leaders — openly backed Taiwan’s participation in a World Health Organization meeting. The move provoked Beijing which views Taiwan as a territory that cannot have its own diplomatic representation.

China has reportedly told the U.S. that Taiwan is the most sensitive issue in their relationship.

U.S. support of Taiwan “stimulates the desire on China’s part to demonstrate the inviolability of Chinese territory integrity. They can’t reach out and touch Taiwan, but they certainly can (for) Hong Kong,” said Johnson.

‘Sense of anxiety’

Another reason is that with China being scrutinized — both abroad and even at home — over its handling of the coronavirus, the Chinese Communist Party is looking to shore up support and nationalism, even as it seeks to get its economy back on track.

“It is reflective of a sense of anxiety … on the part of the Chinese leadership coming out of the Covid situation, whether there are serious concerns about the state of economy, the employment situation and so on,” said Johnson. He added that there is also “the desire to show that this is not the time to suggest that perhaps the leadership in Beijing is not in control of Chinese sovereignty.”

In addition to that, Hong Kong is no longer as economically important to China as it was more than 20 years ago.

According to Reuters, Hong Kong contributed only about 2.7% to China’s GDP last year, compared to more than 18% in 1997 — when it was handed over to China.

“So therefore, China probably sees this as worth the risk in terms of the ability to demonstrate to its population that it’s standing up to foreign pressure,” said Johnson.

China’s National People’s Congress, the country’s parliament, on Thursday voted to approve the proposal to impose a new national security law for Hong Kong. The move paves the way for the law to be finalized and implemented in the city.

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concerns Studies

Some studies raise concerns about sunscreen chemicals. But if you dig deeper, evidence is still lacking, experts say. – The Washington Post

It is part of a daily routine for some, and for others, a routine source of doubt and uncertainty: to wear sunscreen or not?

Recent research has deepened the confusion. In a clinical trial published this year, researchers from the Food and Drug Administration reported that six common chemical ingredients in sunscreens permeate the skin and enter the bloodstream in amounts high enough to require extra safety testing by the FDA. Levels of the chemicals, which included oxybenzone and avobenzone, increased with each subsequent day of use.

It can feel like a lose-lose scenario: If you put sunscreen on, you risk damage from chemical ingredients. If you don’t, you risk UV damage from the sun.

Experts say there is still no evidence that chemical sunscreens cause harm, especially if used on limited areas that are most exposed to the sun. There are other ways of protecting yourself from UV rays in addition to sunscreen. And other sunscreen options exist: Studies show that mineral alternatives, including zinc dioxide and titanium dioxide, are both safe and effective.

“There’s really no reason to forgo sunscreen when we have known tested safe alternatives,” says Kanade Shinkai, a dermatologist at the University of California at San Francisco. Despite what can seem like alarming research, she adds, chemical versions are not necessarily dangerous. “The systemic absorption of chemical sunscreen does not necessarily mean that it’s unsafe or unhealthy. And avoiding the risks of UV exposure is still a very important health aim.”

Sunscreen has a decades-long history that gave it a pass onto pharmacy shelves, Shinkai says. Invented before the FDA developed standards for testing over-the-counter products for safety and effectiveness, sunscreen was grandfathered in for sale before its ingredients had been thoroughly studied.

Over time, plenty of evidence has accumulated to show that UV radiation from the sun triggers skin cancers, including melanoma, and that sunscreen helps mitigate those risks.

In one long-running study of more than 1,600 people that began in 1992, Australian researchers randomized people to either wear sunscreen or do what they normally do. After more than a decade of follow-up, results showed that, compared with the group that didn’t get instructions to slather it on, the sunscreen group developed far fewer cases of skin cancer, says Henry Lim, a dermatologist at the Henry Ford Medical Center in Detroit.

In another study published in 2012, one of the same researchers and colleagues estimated that increasing sunscreen use could lead to between 231,000 and 797,000 fewer melanomas for people with white skin in the United States by 2031.

But for decades, evidence has also been accumulating to suggest that the ingredients in sunscreen can get through our skin and into our bodies.

In a 1997 study, researchers instructed nine healthy people to apply sunscreen with a sun protection factor of at least 15 on their forearms, using the amount they would normally use. Twelve hours later, they washed the sunscreen off with soap and water. Urine samples taken before and after application showed that between 1 and 2 percent of the applied amount of oxybenzone seeped through the skin.

Then in 2008, researchers from the Centers for Disease Control and Prevention analyzed more than 2,500 urine samples collected as part of the long-running National Health and Nutrition Examination Survey. They found the sunscreen ingredient benzophenone-3 in nearly 97 percent of samples. The study couldn’t show that sunscreen was the source of the chemical in people’s bodies, Shinkai says: The same chemicals are also used on commercial products, such as outdoor lawn furniture. Still, the results were suggestive.

Testing data from the FDA finally started to come out in 2019, two decades after the agency announced its plans to systematically investigate the safety of sunscreen. The study included 24 people who applied sunscreen four times a day for four days, covering 75 percent of their bodies with each application. Participants were randomized into four groups, who received different combinations of four active ingredients (avobenzone, oxybenzone, octocrylene, and ecamsule) in creams, lotions or sprays.

Results drew plenty of attention: analyses of blood plasma showed, for the first time, concentrations of all four ingredients that exceeded levels at which FDA guidelines require more safety testing.

“It was the first study to really demonstrate that four really common ingredients that are found in the top-selling sunscreens are all absorbed into the bloodstream, and they do so at levels exceeding that safety threshold set by the FDA,” Shinkai says.

The FDA’s follow-up study in 2020 duplicated the results for three of the same ingredients and three others in 48 people. It also found levels exceeding the threshold after a single application.

Shinkai emphasized that the studies don’t show that sunscreen causes harm, and that more research is needed. “We have no idea whether there is actually any negative health impact,” she says. “We need the data.”

One reason not to freak out yet about the new findings is that the amount of sunscreen that participants were instructed to use does not mimic real-world conditions, Lim says.

Multiple studies suggest that, when left to their own whims, people use 80 percent less sunscreen than the 2 milligrams per centimeter of skin enforced in the study. Study participants also covered most of their bodies with sunscreen multiple times a day, whereas typical use is far less extensive.

“Most of us only do that for the three days a year we go to Florida,” Shinkai says.

Even if sunscreen chemicals do get into the bloodstream, it is not clear that they cause harm there, either.

Animal studies have raised concerns about endocrine disruption and reproductive issues. But animals are not people, Lim says. And despite decades of sunscreen use, there has been no population-wide signal that rates of infertility, birth defects or other health problems are higher in people who use more sunscreen or in places where people apply more of it.

So far, safety research has included only healthy adults, leaving a dearth of information about potential risks to pregnant women and children. Because children’s bodies have a relatively larger surface area compared with adults, absorption is theoretically higher, Kanade says. Lim advises his pregnant patients to use mineral sunscreens, which have been studied extensively.

To stay safe from the sun, researchers also recommend looking beyond sunscreen to other strategies. Wear hats, sunglasses and clothing. Concentrate time outdoors during the hours of the day when the sun is not as intense — early in the morning or later in the afternoon. Sit in the shade. And take a vitamin D supplement to avoid inconsistent evidence about how much of the vitamin people manage to get from sun exposure.

“What I tell all my patients is that we do know that excessive sun exposure is not good for your skin, from wrinkling to skin cancer,” Lim says.

Protecting yourself requires a multipronged approach, he adds.

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