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Dozens of Clinical Trials Have Been Frozen in Response to Trump’s USAID Order

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Dozens of Clinical Trials Have Been Frozen in Response to Trump’s USAID Order

Asanda Zondi received a startling phone call last Thursday, with orders to make her way to a health clinic in Vulindlela, South Africa, where she was participating in a research study that was testing a new device to prevent pregnancy and H.IV. infection.

The trial was shutting down, a nurse told her. The device, a silicone ring inserted into her vagina, needed to be removed right away.

When Ms. Zondi, 22, arrived at the clinic, she learned why: The U.S. Agency for International Development, which funded the study, had withdrawn financial support and had issued a stop-work order to all organizations around the globe that receive its money. The abrupt move followed an executive order by President Trump freezing all foreign aid for at least 90 days. Since then, the Trump administration has taken steps to dismantle the agency entirely.

Ms. Zondi’s trial is one of dozens that have been abruptly frozen, leaving people around the world with experimental drugs and medical products in their bodies, cut off from the researchers who were monitoring them, and generating waves of suspicion and fear.

The State Department, which now oversees U.S.A.I.D., replied to a request for comment by directing a reporter to USAID.gov, which no longer contains any information except that all permanent employees have been placed on administrative leave. Secretary of State Marco Rubio has said that the agency is wasteful and advances a liberal agenda that is counter to President Trump’s foreign policy.

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In interviews, scientists — who are forbidden by the terms of the stop-work order to speak with the news media — described agonizing choices: violate the stop-work orders and continue to care for trial volunteers, or leave them alone to face potential side effects and harm.

The United States is signatory to the Declaration of Helsinki that lays out ethical principles under which medical research must be conducted, requiring that researchers care for participants throughout a trial, and report the results of their findings to the communities where trials were conducted.

Ms. Zondi said she was baffled and frightened. She talked with other women who had volunteered for the study. “Some people are afraid because we don’t know exactly what was the reason,” she said. “We don’t really know the real reason of pausing the study.”

The stop-work order was so immediate and sweeping that the research staff would be violating it if they helped the women remove the rings. But Dr. Leila Mansoor, a scientist with the Centre for the AIDS Programme of Research in South Africa (known as CAPRISA) and an investigator on the trial, decided she and her team would do so anyway.

“My first thought when I saw this order was, There are rings in people’s bodies and you cannot leave them,” Dr. Mansoor said. “For me ethics and participants come first. There is a line.”

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In the communities where her organization works, people have volunteered for more than 25 years to test H.I.V. treatments, prevention products and vaccines, contributing to many of the key breakthroughs in the field and benefiting people worldwide.

That work relied on a carefully constructed web of trust that has now been destroyed, Dr. Mansoor said. Building that trust took years in South Africa, where the apartheid regime conducted medical experiments on Black people during the years of white rule. Those fears are echoed in a long history of experimentation by researchers and drug companies in developing countries and in marginalized populations in the United States.

The Times identified more than 30 frozen studies that had volunteers already in the care of researchers, including trials of:

  • malaria treatment in children under age 5 in Mozambique

  • treatment for cholera in Bangladesh

  • a screen-and-treat method for cervical cancer in Malawi

  • tuberculosis treatment for children and teenagers in Peru and South Africa

  • nutritional support for children in Ethiopia

  • early-childhood-development interventions in Cambodia

  • ways to support pregnant and breastfeeding women to reduce malnutrition in Jordan

  • an mRNA vaccine technology for H.I.V. in South Africa

It is difficult to know the total number of trials shut down, or how many people are affected, because the swift demolition of U.S.A.I.D. in recent days has erased the public record. In addition to the disabled website, the agency no longer has a communications department. And the stop-work order prohibits any implementing agency from speaking publicly about what has happened.

In England, about 100 people have been inoculated with an experimental malaria vaccine in two clinical trials. Now, they no longer have access to the clinical trial staff if that vaccine were to cause an adverse reaction in their bodies. The trial is an effort to find a next-generation vaccine better than the one now used in Africa; that shot protects children against about a third of malaria cases, but researchers hoped to find a vaccine that offered much more protection. Malaria remains a top global killer of children; 600,000 people died of the disease in 2023, the latest figure available.

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Had the trial not been frozen, the participants would be coming to a clinic routinely to be monitored for adverse physical effects, and to have blood and cell samples taken to see whether the vaccine was working. The participants are meant to be followed for two years to assess the vaccine’s safety.

A scientist who worked on the trial said she hoped that partners at the University of Oxford, where it was being conducted, were shuffling staff to respond if any participant fell ill. But she was fired last week and no longer has access to any information about the trial. She spoke on condition of anonymity because she feared jeopardizing her ability to work on malaria research the U.S. might conduct in the future.

“It’s unethical to test anything in humans without taking it to the full completion of studies,” she said. “You put them at risk for no good reason.”

Had the stop-work order come later this year, the newly-vaccinated volunteers might have been in an even more precarious position. They were scheduled to be deliberately infected with malaria to see if the experimental vaccine protected them from the disease.

Dr. Sharon Hillier, a professor of reproductive infectious diseases at the University of Pittsburgh, was until this week director of a five-year, $125 million trial funded by U.S.A.I.D. to test the safety and efficacy of six new H.I.V. prevention products. They included bimonthly injections, fast-dissolving vaginal inserts and vaginal rings.

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With the study suspended, she and her colleagues cannot process biological samples, analyze the data they have already collected, or communicate findings to either participants or the partnering government agencies in countries where the trials were conducted. These are requirements under the Helsinki agreement.

“We have betrayed the trust of ministries of health and the regulatory agencies in the countries where we were working and of the women who agreed to be in our studies, who were told that they would be taken care of,” Dr. Hillier said. “I’ve never seen anything like it in my 40 years of doing international research. It’s unethical, it’s dangerous and it’s reckless.”

Even trials that were not funded in whole or part by U.S.A.I.D. have been thrown into turmoil because they were using medical or development infrastructure that was supported by the agency and is no longer operational. Millions of dollars of U.S. taxpayer funds already spent to start those trials will not be recouped.

The shutdowns have business consequences as well. Many of those trials were partnerships with U.S. drug companies, testing products they hoped to sell overseas.

“This has made it impossible for pharmaceutical companies to do research in these countries,” Dr. Hillier said.

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Another H.I.V. trial, called CATALYST, has thousands of volunteers in five countries testing an injectable drug called long-acting cabotegravir. Participants were receiving bimonthly injections to maintain a sufficient level of the drug in their bodies to prevent H.I.V. infection. Without regular injections, or a carefully-managed end to use of the drug, the participants will not have enough cabotegravir to stop a new infection, but there will be enough in their systems that, if they were to contract the virus, it could easily mutate to become drug-resistant, said Dr. Kenneth Ngure, president-elect of the International AIDS Society.

This is a significant threat to the trial volunteers and also to the millions of people living with H.I.V. because cabotegravir is closely related to a drug that is already used worldwide in standard treatment of the virus. Development of resistance could be catastrophic, Dr. Ngure said: “It’s wrong on so many levels — you can’t just stop.”

A clinical trial run by the development organization FHI 360, which implemented many U.S.A.I.D.-funded health programs and studies, was testing a biodegradable hormonal implant to prevent pregnancy. Women in the Dominican Republic had the devices in their bodies when U.S.A.I.D. funding was cut off. A spokeswoman for the organization, which furloughed more than a third of its staff this week, said that it had pulled together other resources to ensure that participants continue to receive care.

Another trial, in Uganda, was testing a new regimen of tuberculosis treatment for children. The stop-work order cuts those children off from potentially lifesaving medication.

“You can’t walk away from them, you just can’t,” a researcher in that trial said.

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How Much Should Weight Loss Drugs Like Wegovy and Zepbound Cost?

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How Much Should Weight Loss Drugs Like Wegovy and Zepbound Cost?

It’s easy to make a medical case for blockbuster weight loss drugs like Wegovy and Zepbound, which have been shown to prevent heart attacks and strokes and save lives.

But for the employers and government programs being asked to pay for the medications, the financial case for them is less clear. Are the drugs’ benefits worth their enormous cost?

The answer right now is no, according to a new study published on Friday in the journal JAMA Health Forum, by researchers at the University of Chicago.

To be considered cost effective by a common measure used by health economists, the price of Novo Nordisk’s Wegovy would need to be cut by over 80 percent, to $127 per month, the researchers concluded. And Eli Lilly’s Zepbound would be cost effective only if its price fell by nearly a third, to $361 per month. (Zepbound warranted a higher price, the researchers said, because it produced greater benefits in clinical trials.)

“There’s no doubt that the drugs are demonstrating tremendous health benefits,” said David Kim, a health economist at the University of Chicago and the senior author of the study, which was funded by government grants. “The problem is the price is too high.”

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There’s widespread hope that the drugs will effectively pay for themselves in the long run, by making patients healthier and preventing expensive medical bills. It’s not clear yet whether that will turn out to be true.

Eli Lilly rejected the new study’s findings, arguing that it ignored the results of several clinical trials in which the company’s drug had shown benefit. It instead used “a limited data set to draw sweeping conclusions,” said Courtney Kasinger, a spokeswoman for the company. And Liz Skrbkova, a spokeswoman for Novo Nordisk, said there are “no universally accepted thresholds for what determines a drug to be cost-effective.”

Employers and government programs pay different prices for the drugs, and those numbers are almost always kept a secret. The University of Chicago researchers estimated the price for Wegovy to be $700 per month, on average, compared with $520 for Zepbound.

Huge demand for the drugs has caused employers’ drug costs to balloon, prompting some companies to impose restrictions on who can get them, or stop covering the medications altogether. Con Edison, the energy utility that serves New York City and Westchester County, recently said it needed to raise rates to offset increased expenses that included a surge in spending on weight loss drugs.

Medicare covers the drugs for patients with diabetes, and a much smaller subset of people who contend with both obesity and another health condition, like a heart problem, or sleep apnea. Congress has resisted expanding coverage for millions more older people who are overweight or obese, because it would be so expensive.

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Patients who pay for the drugs using their own money instead of going through insurance face varying prices; some pay more than $1,300 per month. But for a low dose of Zepbound, patients can pay $350 out of pocket, a price the University of Chicago researchers considered cost-effective.

To come up with their estimates, researchers ran computer simulations of what might happen if people who were overweight or obese took one of the weight loss drugs for the remainder of their lives. Based on the results from clinical trials, the model projected benefits that might accrue over the long run. Many overweight patients would never become obese, for example. Other patients would avert diabetes or heart disease. They would stay productive, and out of the hospital.

These benefits added up to many years of good health — so-called quality-adjusted life years. Many health economists think it’s reasonable for society to pay $100,000 for each such healthy year. But in the model, the years of good health provided by Wegovy and Zepbound cost much more.

Drug companies often push back fiercely against such cost-effectiveness analyses, saying they fail to capture the true value medications can bring to patients and societies. Still, they sometimes fund such studies. An analysis financed by Novo Nordisk, similar to that by the University of Chicago researchers, found the company’s weight loss drug to be cost-effective.

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Sunlight exposure can pose life-changing health benefits, expert says

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Sunlight exposure can pose life-changing health benefits, expert says

As spring arrives and the weather warms, exposure to sunlight could have an immense impact on overall health.

Dr. Roger Seheult, a critical care physician, pulmonologist and associate clinical professor at the University of California and Loma Linda University schools of medicine, shared the benefits of sunlight exposure in an interview with Fox News Digital.

Seheult, who recently appeared on Dr. Andrew Huberman’s podcast Huberman Lab to discuss enhancing the immune system, noted that the light from the sun boosts our ability to regulate sleep, circadian rhythm and mood.

BOOST YOUR IMMUNE SYSTEM WITH THESE 8 SIMPLE STEPS 

“So many people have seasonal affective disorder, and that’s a manifestation of the lack of sunlight during winter,” he said.

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Children with tuberculosis were put into an outdoor solarium for periods of rest in 1946. This sanitarium accommodated 200 patients ranging from infants to 20-year-olds. (Alamy)

Sunlight’s healing properties

As far back as the 1920s, medical professionals leveraged light exposure to promote healing.

Hospitals made use of sundecks, where patients could be transported for periods of time to take in the sunlight and fresh air, according to Seheult.

JUST ONE NIGHT OF POOR SLEEP COULD HAVE THESE SURPRISING HEALTH EFFECTS

But then with the development of pencillin and other advancements in modern medicine, doctors relied less on holistic methods, he said.

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The sun’s ultraviolet B (UV-B) light produces vitamin D in the body by causing a chemical reaction in the skin, Seheult noted.

Couple in sunlight

Sunlight can boost the body’s ability to regulate sleep, circadian rhythm and mood. (iStock)

Vitamin D is a known anti-inflammatory and antioxidant that supports immune health, muscle and brain function, according to Mayo Clinic.

The sun also produces infrared light, which has been shown to relieve pain and inflammation.

Just 15 to 20 minutes of sunlight exposure can help boost the immune system and potentially even ward off chronic disease, according to Seheult.

Balancing risks and benefits

Warnings of sunlight leading to skin cancer may have caused decreased exposure, the doctor suggested.

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“Certainly, if we go outside in the sun for too long for a period of time without protection, we can get those types of skin damage,” he said. 

“There are some benefits to getting out into the sun, if it’s done in moderation and if it’s done smartly.”

But the doctor revealed that some recent studies have found that the more time spent outside in sunlight, the less likely people are to die of all causes, including cancer.

Dr. Richard Weller, a professor of dermatology at the University of Edinburgh, published a piece in the Journal of Investigative Dermatology in August 2024, discussing this data and the need to rethink the influence of the sun.

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“UVR is a skin carcinogen, yet no studies link sun exposure to increased all-cause mortality,” Weller wrote in the study abstract.

Rearview shot of a senior couple going for a walk in the park

Walking in green spaces can offer even more light exposure, as trees, leaves and plants are “highly reflective of infrared light.” (iStock)

“Growing evidence shows that sunlight has health benefits through vitamin D-independent pathways, such as photomobilization of nitric oxide from cutaneous stores with reduction in cardiovascular morbidity. Sunlight has important systemic health benefits as well as risks.”

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Seheult agreed, encouraging people to “rethink the idea that the sun is a deadly laser and that actually there are some benefits to getting out into the sun, if it’s done in moderation and if it’s done smartly.”

WHY THE END OF DAYLIGHT SAVING TIME CAN NEGATIVELY AFFECT YOUR HEALTH

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People who are fair-skinned or sensitive to sunlight can wear clothing, hats and other protective gear while still getting the benefits.

“Infrared light, because it is a long-wavelength, low-energy light, is able to penetrate not only through your skin and deep down into your body, but it’s also able to penetrate very easily through clothes,” Seheult pointed out.

Man in sunglasses bonding with dog on a wooden bench.

Vitamin D from sunlight acts as an anti-inflammatory and antioxidant, helping to support immune health, muscle and brain function. (iStock)

“If they’re still getting outside, they’re going to get quite a bit of infrared light, even in that setting, and not be susceptible to getting [burned]. So, you don’t need to have bare skin for sunlight exposure.”

Sunlight is also still present on cloudy and rainy days and in urban areas, Seheult noted.

WHY HIGHER UV INDEX NUMBERS ARE MORE DANGEROUS DURING SUN EXPOSURE

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“The amount of light inside a building [is] usually no more than 100 lux,” he said. “When you go outside on a bright, sunny day, that’s 100,000 lux. That’s 1,000 times brighter.”

Although that exposure will be reduced on cloudy days or in the winter, it won’t be “nearly as low” as indoor lighting, Sehuelt added.

Mother and daughter in a park touching leaves

“Kids are spending so much more time inside,” Seheult said. “Any sort of movement that we make toward going outside will be very beneficial.” (iStock)

To reap the benefits of infrared light without the risk, Seheult recommends going outside and covering up for about 30 minutes, even in the morning or evening while the sun is setting.

“These are times when there is an abundance of infrared light, far more than you would get inside your home,” he said.

“All it takes is about 15 to 20 minutes of infrared light exposure … and we’re seeing effects that last for days.”

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For those who work in an office and spend their daylight hours inside, Seheult suggested taking short breaks and stepping outside into the light or a green space.

“All it takes is about 15 to 20 minutes of infrared light exposure at the level of the mitochondria, and we’re seeing effects that last for days,” he said.

Blend of holistic and modern methods

Seheult shared his hope for a balance between modern medicine — including advancements like medical-grade oxygen and antibiotics — and holistic health trends.

“There are definitely modern inventions and things that are very beneficial to the human body,” he said. “What I would like to do is incorporate both together.”

For more Health articles, visit www.foxnews.com/health

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“There is a disadvantage to wholly depending on things that need and require supply chains, especially in pandemics,” he said. 

“The sunlight and fresh air … are not things that depend on supply chains. We have sunlight accessible most times of the year.”

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Science Amid Chaos: What Worked During the Pandemic? What Failed?

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Science Amid Chaos: What Worked During the Pandemic? What Failed?

Until 2020, few Americans needed to think about how viruses spread or how the human immune system works. The pandemic offered a painful crash course. Sometimes, it seemed that the science was evolving as quickly as the virus itself.

So The New York Times asked experts to revisit the nightmare. Of the most significant public health measures introduced during Covid, which have held up scientifically, and which turned out to be wrongheaded?

The question is particularly important now, because pandemics that could upend American lives are inevitable. One candidate has already surfaced: bird flu.

Perhaps the biggest lesson learned, several experts said, is that recommendations during any pandemic are necessarily based on emerging and incomplete information. But during Covid, federal agencies often projected more confidence in their assessments than was warranted.

Next time, the scientists said, officials should be more forthright about the uncertainties and prepare the public for guidance that may shift as the threat comes into clearer focus.

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Rather than promote preventive measures as infallible solutions, they should also acknowledge that no single intervention is perfect — though many imperfect measures can build a bulwark.

If you venture out in a “huge, heavy rainstorm, your umbrella alone is not going to keep you from getting wet,” said Linsey Marr, an expert in airborne viruses at Virginia Tech.

“You need your umbrella; you need your boots; you need your waterproof pants and jacket; and you would probably try to avoid the puddles,” she said.

A victory, but officials oversold the benefits at first.

The mRNA vaccines were, in a sense, victims of their own unexpected success in clinical trials in 2020. Those results were spectacular: The shots warded off symptomatic illness caused by the original version of the coronavirus at miraculous rates.

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But government officials had to walk back their enthusiasm as breakthrough infections with the Delta variant surged in the summer of 2021. Americans were told to get boosters. Then again, and again.

Federal health officials should have acknowledged at the start that the long-term effectiveness was unknown, said Natalie Dean, a biostatistician at Emory University.

Mistrust over the safety and effectiveness of the Covid vaccines is now taking a toll on other immunizations, including those targeting childhood diseases like measles.

“Making claims early on that this was going to prevent all infections was, I think, a little bit of an overpromise” that eventually undermined public trust, said Saskia Popescu, an infection prevention expert at the University of Maryland.

Still, the vaccines saved an estimated 14 million lives just in the first year after their introduction.

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Surfaces were not the problem. Indoor air was.

Disagreements among scientists about how the coronavirus traveled had profound ramifications for how Americans were told to protect themselves.

Early on, health officials insisted that the virus was spread through large droplets that were coughed or sneezed out by an infected person onto other people or objects. The “fomite” theory led to protocols that made little sense in retrospect.

Remember the plexiglass barriers during the Presidential debates? The face shields? Schools closed for cleaning days midway through the week. People were scrubbing down groceries and mail.

“The whole hygiene theater was terribly unfortunate,” said Michael Osterholm, an infectious disease expert at the University of Minnesota. It wasted millions of dollars and gave people a false sense of security.

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Health agencies took months to admit that the virus was carried aloft by tiny droplets, called aerosols, that could be exhaled, traveling long distances indoors. Sadly, that insight initially led to another overreaction.

Some states closed down beaches and parks, and forbade interactions outdoors, even though “there’s good scientific evidence that outdoor events are lower risk,” Dr. Dean said.

Eventually, understanding that the virus was primarily floating indoors prompted the Biden administration to earmark funds for improved ventilation in schools.

It worked if you used the right masks, correctly.

As the pandemic spread in the United States, masking morphed from a public health intervention into a cultural flashpoint.

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Assuming that the coronavirus traveled like the flu and worried that hospitals might not have enough resources, federal heath officials at first told the public that masks were not needed.

That advice was suddenly reversed once scientists learned that the coronavirus was airborne. Even so, officials initially recommended cloth masks — which are not very effective at keeping out airborne viruses — and did not endorse more protective N95 respirators until January 2022, well after much of the public had stopped using cloth masks.

Dozens of studies have shown that when used correctly and consistently, N95 masks or their equivalents can prevent infected people from spreading the virus and protect wearers from contracting it.

Unfortunately, several flawed studies and the politics of personal freedom created a culture war surrounding the use of masks, especially by children, said Bill Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health.

In the event of another respiratory outbreak, “I feel quite anxious that a whole constituency has already discarded masks,” he said.

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Children in Asia routinely wear masks, especially during respiratory virus and allergy seasons, some experts noted.

“I wish we could infuse more infection prevention into especially elementary schools during respiratory virus season,” Dr. Popescu said. “It seemed like a really great way to get children back in schools.”

A chimera. We never got there.

For nearly two years after the pandemic began, experts talked of reaching herd immunity once enough of the population had acquired protection either by being ill or getting vaccinated.

That was a mistake, experts said. Herd immunity is only possible if immunity is sterilizing — meaning it prevents reinfections — and lifelong. Immunity to most viruses is neither.

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Seasonal coronaviruses change rapidly enough that people undergo repeated infections throughout their lives, said Jeffrey Shaman, an epidemiologist at Columbia University who insisted early on that the new coronavirus might also cause reinfections.

Once vaccines arrived, officials at first presented the shots as a way to stay safe from the virus forever, rather than as a means to lessen the severity of infections.

“There was a lot of confusion and misconceptions about herd immunity — that the toothpaste was going back in the tube somehow,” Dr. Dean said.

Necessary at first. Questionable as time went on.

Few aspects of the pandemic provoke as much rancor as school closures. In many parts of the country, test scores never recovered and absenteeism has become an intractable problem.

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But experts said it was the right decision to close schools in the spring of 2020, when a poorly understood pathogen was sweeping across the country. Ideally, schools would have reopened that fall, but with measures — improved ventilation, testing, masks — to mitigate the risks.

“And of course, we didn’t really have any of those things,” Dr. Hanage said.

By early fall in 2020, it was clear that schoolchildren were not driving community transmission significantly. Still, many schools stayed closed for months longer than they needed to, forcing children to muddle through remote learning and causing some to fall irrevocably behind.

“It’s a really difficult one to Monday-morning quarterback,” Dr. Shaman said.

“We don’t have the counterfactual, that alternative scenario to see how it really would have played out.”

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If bird flu turns into a pandemic, it would be foolish to base school policies on how the coronavirus behaved, he and others warned. Other respiratory viruses, like the flu, tend to be deadlier among young children and older adults.

“We have every reason to think that a future flu pandemic would be far more dangerous to young people than Covid was,” Dr. Hanage said. “I think we should talk about what we could do to mitigate transmission in schools.”

They slowed the virus, but the price was high.

The pandemic destroyed local businesses, sent unemployment rates soaring and increased household debt. Many people now feel that lockdowns were to blame for much of the damage — and that their harms outweighed any benefits.

Many scientists see it differently. “The economy got shut down by just the pure force of the pandemic,” said Dr. Osterholm.

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No American state’s policies neared the strictness of those in China, India, Italy or Jordan — where people were not allowed to leave home at all — and much of the work force and societal activities continued because they were deemed essential, he noted.

By the end of May 2020, indoor dining and religious services had resumed in much of the country, if they had been paused at all, although many cities continued to institute temporary bans as virus levels rose and fell.

The shutdowns may have been unpopular in part because they were introduced with no clear explanation or end in sight.

Instead, Dr. Osterholm said, health officials could have instituted a “snow day” concept. People stayed home when hospitals were overwhelmed, as they do when roads are snowed under, but their behavior returned to normal when the situation eased.

The shutdowns eased the burden on hospitals and slowed the transmission of the virus, buying time to develop a vaccine. Studies from multiple other countries have also shown that stay-at-home orders and restrictions on mass gatherings were the most effective measures for curbing transmission of the virus within communities.

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“Whatever people did in 2020, before folks were vaccinated, saved millions of lives,” Dr. Hanage said. “If we had done nothing, truly done nothing at all, things would have been much, much worse.”

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