Cancer is striking more people in their 30s and 40s. Here’s what you need to know | CNN



CNN
 — 

It’s World Cancer Day, and the outlook for winning the war against this deadly disease is both good and bad.

In the United States, deaths from cancer have dropped 33% since 1991, with an estimated 3.8 million lives saved, mostly due to advances in early detection and treatment. Still, 10 million people worldwide lost their lives to cancer in 2020.

“During the last three years, the No. 1 leading leading cause of death in the world was actually cancer, not Covid-19,” said Dr. Arif Kamal, chief patient officer for the American Cancer Society.

Symptoms of cancer can mimic those of many other illnesses, so it can be difficult to tell them apart, experts say. Signs include unexplained weight loss or gain, swelling or lumps in the groin, neck, stomach or underarms and fever and night sweats, according to the National Cancer Institute.

Bladder, bowel, skin and neurological issues may be signs of cancer, such as changes in hearing and vision, seizures, headaches and bleeding or bruising for no reason, the institute said. But most cancers do not cause pain at first, so you can’t rely on that as a sign.

“We tell patients that if they have symptoms that do not get better after a few weeks, they should visit a doctor,” Kamal said. “It doesn’t mean the diagnosis will be cancer, however.”

Rather than wait for symptoms, the key to keeping cancer at bay is prevention, along with screenings to detect the disease in its early stages. That’s critical, experts say, as new cases of cancer are on the rise globally.

A surprising number of new diagnoses are in people under 50, according to a 2022 review of available research by Harvard University scientists.

Cases of breast, colon, esophagus, gallbladder, kidney, liver, pancreas, prostate, stomach and thyroid cancers have been increasing in 50-, 40- and even 30-year-olds since the 1990s.

That’s unusual for a disease that typically strikes people over 60, Kamal said. “Cancer is generally considered an age-related condition, because you’re giving yourself enough time to have sort of a genetic whoopsie.”

Older cells experience decades of wear and tear from environmental toxins and less than favorable lifestyle choices, making them prime candidates for a cancerous mutation.

“We believed it takes time for that to occur, but if someone is 35 when they develop cancer, the question is ‘What could possibly have happened?’” Kamal asked.

No one knows exactly, but smoking, alcohol consumption, air pollution, obesity, a lack of physical activity and a diet with few fruits and vegetables are key risk factors for cancer, according to the World Health Organization.

Add those up, and you’ve got a potential culprit for the advent of early cancers, the Harvard researchers said.

“The increased consumption of highly processed or westernized foods together with changes in lifestyles, the environment … and other factors might all have contributed to such changes in exposures,” the researchers wrote in their 2022 review.

“You don’t need 65 years of eating crispy, charred or processed meat as a main diet, for example,” Kamal added. “What you need is about 20 years, and then you start to see stomach and colorectal cancers, even at young ages.”

So how do you fight back against the big C? Start in your 20s, Kamal said.

Many of the most common cancers, including breast, bowel, stomach and prostate, are genetically based — meaning that if a close relative has been diagnosed, you may have inherited a predisposition to develop that cancer too.

That’s why it’s critical to know your family’s health history. Kamal suggests young people sit down with their grandparents and other close relatives and ask them about their illnesses — and then write it down.

“The average person doesn’t actually know the level of granularity that is helpful in accessing risk,” he said.

“When I talk to patients, what they’ll say is, ‘Oh, yeah, Grandma had cancer.’ There’s two questions I want to know: At what age was the cancer diagnosed, and what specific type of cancer was it? I need to know if she had cancer in her 30s or 60s, because it determines your level of risk. But they often don’t know.”

The same applies to the type of cancer, Kamal said.

“People often say ‘Grandma had bone cancer.’ Well, multiple myeloma and osteosarcoma are bone cancers, but both of them are relatively rare,” he said. “So I don’t think Grandma had bone cancer. I think Grandma had another cancer that went to the bone, and I need to know that.”

Next, doctors need to know what happened to that relative. Was the cancer aggressive? What was the response to treatment?

“If I hear Mom or Grandma was diagnosed with breast cancer at 40 and passed away at 41, then I know that cancer is very aggressive, and that changes my sense of your risk. I may add additional tests that aren’t in the guidelines for your age.”

Cancer screening guidelines are based on population-level assessments, not individual risk, Kamal said. So, if cancer (or other conditions such as heart disease, diabetes, Alzheimer’s, or even migraines) runs in the family, you become a special case and need a personalized plan.

“And I will tell you the entire scientific community is observing this younger age shift for different cancers and is asking itself: ‘Should guidelines be more deliberate and intentional for younger populations to give them some of this advice?”

closeup of a young caucasian doctor man with a pink ribbon for the breast cancer awareness pinned in the flap of his white coat; Shutterstock ID 724387357; Job: CNN Digital

Report: Black women more likely to die from breast cancer

If your family history is clear of cancer, that lowers your risk — but doesn’t remove it. You can decrease the likelihood of cancer by eating a healthy, plant-based diet, getting the recommended amount of exercise and sleep, limiting alcohol consumption and not smoking or vaping, experts say.

Protecting yourself from the sun and tanning beds is key, too, as harmful ultraviolet rays damage DNA in skin cells and are the prime risk factor for melanoma. However, skin cancer can show up even where the sun doesn’t shine, Kamal said.

“There’s been an increase of melanoma that’s showing up in non-sun-exposed areas such as the underarm, the genital area and between the toes,” he said. “So it’s important to check — or have a partner or dermatologist check — your entire body once a year.”

Skin check: Take off all your clothes and look carefully at all of your skin, including the palms, soles of feet, between toes and buttocks and in the genital area. Use the A, B, C, D, E method to analyze any worrisome spots and then see a specialist if you have concerns, the American Academy of Dermatology advised.

Also see a dermatologist if you have any itching, bleeding or see a mole that looks like an “ugly duckling” and stands out from the rest of the spots on your body.

Get vaccinated if you haven’t: Two vaccinations protect against cervical and liver cancers, and others for cancers such as melanoma are in development.

Hepatitis B is transmitted via blood and sexual fluids and can cause liver cancer and cirrhosis, which is a scarred and damaged liver. A series of three shots, starting at birth, is part of the US recommended childhood vaccines schedule. Unvaccinated adults should check with their doctor to see if they are eligible.

The HPV vaccine protects against several strains of human papillomavirus, the most common sexually transmitted infection, according to the US Centers for Disease Control and Prevention.

Human papillomavirus can cause deadly cervical cancer as well as vaginal, anal and penile cancer. It can also cause cancer in the back of the throat, including the tongue and tonsils.

“These HPV-related head and neck cancers are more aggressive than the non-HPV-related cancers,” Kamal said, “so boys as well as girls should be vaccinated.”

Since the vaccine’s approval in 2006 in the US for adolescents ages 11 to 13, cervical cancer rates have declined by 87%. Today, the vaccine can be given through age 45, the CDC said.

Breast self-exams: Breast cancer is the most common type of cancer diagnosed worldwide, according to the WHO, followed by lung, colorectal, prostate, skin and stomach cancers.

Both men and women can get breast cancer, so men with a family history should be aware of the symptoms as well, experts say. These include pain, redness or irritation, dimpling, thickening or swelling of any part of the breast. New lumps, either in the breast or armpit, any pulling in of the nipple and nipple discharge other than breast milk are also worrisome symptoms, the CDC said.

Women should do a self-exam once a month and see a doctor if there are any warning signs, the National Breast Cancer Association advised. Choose a time when the breasts will be less tender and lumpy, which is about seven to 10 days after the beginning of the menstrual flow.

Screenings and tests: At-home exams and vaccinations can save lives, but many cancers can only be detected through laboratory tests, scans or biopsies. The American Cancer Society has a list of recommended screening by ages.

Getting those done in a timely manner increases the chance for early detection and treatment, but it’s still each person’s responsibility to know their risk factors, Kamal said.

“Remember, guidelines are only for people at average risk,” he said. “The only way someone can know whether the guidelines apply to them is to really understand their family history.”

vital signs WFIRM 01

Could lab-grown organs and cancer vaccines be the future of medicine?

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Proposed changes to school lunches aim to reduce sugar and sodium, but flavored milk stays | CNN



CNN
 — 

If new US Department of Agriculture school food guidelines stand as proposed, chocolate milk is in, but for the first time ever, at least some added sugars will be out – and sodium levels will be reduced gradually.

Agriculture Secretary Tom Vilsack publicly announced the changes on Friday.

“The purpose of this is to improve the health and welfare of our children. And I think everybody who comes to this issue shares that goal and hopefully, collectively, we can make sure it happens,” Vilsack told CNN in an interview Thursday ahead of the announcement.

The federally assisted school meal program provides nutritionally balanced meals at school at low or no-cost.

More than 15.3 million kids every day get breakfast at school in the US and 29.6 million get a school lunch, Vilsack said. The numbers were higher earlier in the pandemic, when meals were offered free to all children regardless of their family’s income, but in June, Congress did not extend the Covid-19 pandemic waivers that had expanded the program.

While school meals are paid for by local and federal funding, the standards for what goes on a kids’ cafeteria tray are set by the USDA. The agency’s job is to make sure any meal served at school is nutritious and falls in line with the US Dietary Guidelines.

Flavored milk with “reasonable limits on added sugars” would be allowed under the proposal. Vilsack said school meal administrators tell the USDA that kids just won’t drink much no-fat skim milk or unflavored milk. “That’s not what they get at home,” Vilsack said. “We want to encourage kids to drink milk because there are there’s tremendous nutritional value in milk.”

However, the proposed standards would limit added sugar in certain high-sugar products like prepackaged muffins, yogurt, and cereal. Eventually, the guidelines would then limit added sugars across the weekly menu.

The standards would reduce sodium limits, but that would happen gradually over several school years.

“The [US Food and Drug Administration] provided some insight and direction by suggesting that it is easier for people to accept and adopt to reduced sodium if you do it over a period of time in small increments,” Vilsack said.

A gradual reduction would also give industry time to reformulate their products, said Dr. Lauren Au, an assistant professor at UC Davis’ Department of Nutrition who studies the effectiveness of school nutrition programs.

The guidelines would also place a bigger emphasis on whole grains, but still leave options open for an occasional non-whole grain product.

“Maybe a biscuit can be instituted for a little variety, or grits can be provided where that may make sense from a geographic standpoint. You are sensitive to cultural demands and needs,” Vilsack said.

The proposed rule would also strengthen the Buy American requirements encouraging schools to use more locally grown food.

The USDA will invest $100 million in the Healthy Meals Incentives initiative which offers farm-to-school grants and grants to buy equipment. In the 1980s, schools around the country tore out kitchens and bought prepackaged processed food. To make more nutritious meals, schools have had to rebuild or update kitchens.

“A lot of schools have outdated ovens, freezers, fridges, and that puts limitations on how they can prepare food, so grants that have helped with equipment have been really successful,” Au said.

The money would also reward schools that do a good job providing nutritious meals. Grants would also be aimed at small and rural districts and training.

Vilsack said the USDA created these proposed standards after the USDA received thousands of comments and held 50 listening sessions with parents, school food administrators, the food industry, public health and nutrition experts.

“Establishing these standards are difficult because you have to follow the science you have to follow the dietary guidelines, but you also have to understand that they need to be implemented in the real world which is which is which is tough,” Vilsack said in an interview with CNN.

Real world circumstances are tough already with the higher cost of food, staff shortages and supply chain problems.

Au hasn’t seen all of the proposed policies, but she said what she has seen look good.

“It’s a step forward in terms of promoting healthy nutrition in schools,” Au said. The reduction of added sugar, she added is a big deal.

“Reducing added sugars for this age range is so important,” AU said.

Megan Lott, deputy director for the Robert Wood Johnson Foundation program Healthy Eating Research, said that the policies seem to be heading in the right direction.

“There are a couple of things we would probably like to see strengthened, but it also seems like there are plans to do that over time,” Lott said.

The sugar standard is a good start, she said, but she’d prefer the proposal instead say that no more than 10% of calories should come from added sugars across the meal plan.

“But we recognize that schools might need a little bit of time for implementation,” Lott said.

Lott had also hoped they would take flavored milk off the menu. Research shows that schools that have gotten rid of flavored milk show a drop in milk consumption for a year or two, but milk sales eventually rebound.

School food has become a proverbial hot potato.

After decades of bipartisan support for school meals, the program has been politicized in about the last 10 years Lott says, meaning there is bound to be some pushback.

Friday’s proposed changes would be the first large scale reform of school meal standards since President Barack Obama signed the 2010 Healthy, Hunger-Free Kids Act into law.

The law that went into effect in 2012, championed by first lady Michelle Obama, really did improve US kids’ diet, studies show. The law raised the minimum standards and required schools to serve more whole grains, fruit, vegetables, and fat-free and/or low-fat milk more frequently and serve fewer starchy vegetables and foods high in trans fat and sodium.

Meals that were eaten by students – not just served to students and then tossed into garbage cans – were much healthier and had better overall nutritional quality, the study showed. Students who didn’t participate in the national program did not see an improvement in their diets.

Despite the program’s success, in 2018, the Trump administration announced a proposal to roll back many of the policies in the name of “flexibility,” including ones that involved sodium and whole grains. Trump’s policy would essentially create a loophole letting schools sell more burgers, pizza and french fries and reduce the fruit and vegetables sold. A federal court struck down the rule in April 2020.

During the pandemic, some of the polices were relaxed, like for whole grains, because it was difficult to find products, Lott said.

Studies show kids who eat meals at school ate more fruits, vegetables, whole grains and dairy, compared with those who ate at school less frequently.

Better nutrition can help prevent obesity. About 20% of the US population ages 2 to 19 live with obesity, which can cause kids to have high blood pressure, breathing problems and type 2 diabetes, and lead to lifelong health problems, according to the US Centers for Disease Control and Prevention.

Hungry kids have a hard time paying attention in class. Students who ate healthy meals at school scored better on end-of-year academic tests, studies have shown.

The new standards are just a proposal. The USDA will ask for additional feedback.

Vilsack is hopeful the standards will incentivize more schools to offer more healthy options.

“In terms of future of this program,” Vilsack said, “we want to see more and more school districts push themselves not only to meet the standards, but in some cases to exceed them.”

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Tracking the opioid crisis: Inside the DEA’s secret lab | CNN

Watch CNN Films’ “American Pain” at 9 p.m. ET Sunday, February 5.



CNN
 — 

Sitting among the warehouses of Dulles, Virginia, is one of the US Drug Enforcement Administration’s forensic labs. It’s one of eight across the country where scientists analyze illegal drugs and try to stay ahead of what’s driving deadly overdoses.

Starting in the late 1990s with overprescribing of prescription narcotics, the opioid epidemic has continued to plague the United States for decades. What has changed is the type of drugs that have killed more than half a million people during the past 20 years.

CNN was granted rare access to the secret lab where the DEA tests seized illicit drugs to understand what’s coming next.

“The market is constantly changing, so we are trying to do everything we can from a science base to keep up with that,” Scott Oulton, deputy assistant administrator of the DEA’s Office of Forensic Sciences, told CNN Chief Medical Correspondent Dr. Sanjay Gupta.

Holding a white bag of fentanyl precursor powder – one of the chemicals used to make the opioid – Oulton explained that the illicitly made painkiller continues to be a dominant presence in the drugs officials are finding.

“This kilogram can be converted into fentanyl to make approximately 800 grams,” he said. “So it doesn’t take that much material, it’s fairly cheap, it’s inexpensive to obtain.”

Fentanyl is the deadliest drug in the United States, and it’s often found in combination with other illicit drugs, including cocaine and heroin. But increasingly, fentanyl is showing up in illicit pills disguised as common prescription drugs like oxycodone, hydrocodone, even Adderall.

Users buying drugs on the street that look like prescription pills may end up with a highly potent, potentially deadly drug they never intended to take.

“Over 99% of what we see are fake. They contain fentanyl,” Oulton says of the pills that the agency is seizing.

The 800 grams of fentanyl that Oulton held could be turned into 400,000 to 500,000 potentially lethal pills.

As more and more of these lethal pills circulate, the opioid epidemic is reaching more of the population.

Deena Loudon of Olney, Maryland, is among those living with its effects.

“I truly love sharing Matthew with the world,” Loudon says as she flips through pictures of her son.

One of her favorite memories is Matthew playing hockey – what Loudon calls his happy place.

Matthew Loudon's mom says he turned to drugs after struggling with anxiety.

But she also recalls his struggles with anxiety, which led him to turn to drugs. He started dabbling in them in the 10th grade. By the following year, his grades began to fall, and he couldn’t keep them high enough to stay in hockey.

“He was using Xanax to help self-medicate himself and I think to help get rid of some of that angst so he could live somewhat of a normal life,” Loudon said.

Matthew was always honest, almost to a fault, Loudon says. “He told me he tried everything. Like everything. Heroin, meth, crack, you name it, cocaine, whatever – until I guess he found what made him feel the best, and it was Xanax.”

And as much as a mother can worry, Loudon says, Matthew always tried to reassure her. “I know what I’m doing,” he would tell her.

She had heard about fentanyl showing up in pills in their area.

“But you don’t ever think it’s going to happen to you,” Loudon said.

She said they even had a conversation about fentanyl the day before he died. “I was sort of naive, wanting to stick my head in the sand and thinking ‘I bet he does know what he’s doing.’ ”

On November 3, 2020, she found 21-year-old Matthew on the floor of their basement.

Matthew’s autopsy report lists his cause of death as fentanyl and despropionyl fentanyl intoxication.

“I don’t say he overdosed. I say he died from fentanyl poisoning. … Truthfully, like, at the end of the day, to me, he was murdered, right? Because he asked for one thing. They gave him something different. And it took his life.”

For a parent, she said, the hardest thing is burying their child. It’s a pain she speaks out about in hopes of keeping other families safe.

“It’s Russian roulette,” she warns them. “You never know what you’re gonna get.”

The number of pills the DEA has seized skyrocketed in just three years, from 2.2 million in 2019 to 50.6 million in 2022.

The sheer volume of pills has been one of the biggest challenges for the DEA’s lab, Oulton says. As the fentanyl threat continues to grow, the Virginia facility is expanding to accommodate the analysis needed.

The lab can test for something as simple as the presence of fentanyl, but something called the purity of the pill also offers important insight. This means how much fentanyl is actually in one of these illicit pills.

“Lately, we’ve been seeing a purity increase over the last year, where we used to say roughly four out of the 10 seizures that we were receiving would contain a lethal dose of greater than 2 milligrams. As of October last year, we started reporting that we’ve seen an uptick. Now we’re saying that six out of 10 of the seizures that we’re receiving contain over 2 milligrams,” Oulton said.

He says they’re finding an average of 2.3 milligrams of fentanyl in each pill.

Two milligrams may be the cutoff for what is considered lethal, but Oulton says that doesn’t necessarily mean a pill with 1.99 milligrams of fentanyl can’t be deadly.

“One pill can kill” is his warning.

“The message I would like to send out is, don’t take it,” he said. “Don’t take the chance. It’s not worth your life.”

Oulton says he and his team are constantly finding new and different drugs and substances in pills – things they’ve never seen before.

One machine in the lab is almost the equivalent of an MRI in a medical office, showing the structure and detail of a pill.

“We will do what we call structural elucidation to determine that this is a different version of a fentanyl that’s got a new compound and molecule that’s been added to it,” Oulton said.

They’ve seen “hundreds and hundreds of unique combinations,” he said.

“We’ll see one that contains fentanyl, one with fentanyl and xylazine, one with fentanyl and caffeine, one with fentanyl and acetaminophen, and you don’t know what you’re getting.”

Xylazine, a veterinary tranquilizer, poses a unique problem. It’s not an opioid, so even when it’s mixed with fentanyl, drugs designed to reverse an opioid overdose may not work.

Narcan or naloxone, one of the more common overdose-reversing drugs, has become increasingly necessary as the prevalence and potency of illicit drugs increases. About 1.2 million doses of naloxone were dispensed by retail pharmacies in 2021, according to data published by the American Medical Association – nearly nine times more than were dispensed five years earlier.

Oulton wants to be clear: The problem Isn’t with pills prescribed by your doctor and dispensed by a pharmacy – it’s the pills on the illicit market.

Those, Matthew’s mother warns, are easy to get.

“The first pills [Matthew] got was in high school. And it was just flipping out, floating around, and it was easy for him to get his hands on,” she said.

Loudon’s message for parents now: Keep your eyes open.

“Just be mindful of what your children are doing. You just just have to keep your eyes open. And even sometimes, when you keep your eyes open, you can miss some of the warning signs, but I think a parent knows their child best, so just keep talking.”

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Mpox is almost gone in the US, leaving lessons and mysteries in its wake | CNN



CNN
 — 

The US public health emergency declaration for mpox, formerly known as monkeypox, ends Tuesday.

The outbreak, which once seemed to be spiraling out of control, has quietly wound down. The virus isn’t completely gone, but for more than a month, the average number of daily new cases reported to the US Centers for Disease Control and Prevention has hovered in the single digits, plummeting from an August peak of about 450 cases a day.

Still, the US led the world in cases during the 2022-23 outbreak. More than 30,000 people in the US have been diagnosed with mpox, including 23 who died.

Cases are also down across Europe, the Western Pacific and Asia but still rising in some South American countries, according to the latest data from the World Health Organization.

It wasn’t always a given that we’d get here. When mpox went global in 2022, doctors had too few doses of a new and unproven vaccine, an untested treatment, a dearth of diagnostic testing and a difficult line to walk in their messaging, which needed to be geared to an at-risk population that has been stigmatized and ignored in public health crises before.

Experts say the outbreak has taught the world a lot about this infection, which had only occasionally been seen outside Africa.

But even with so much learned, there are lingering mysteries too – like where this virus comes from and why it suddenly began to spread from the Central and West African countries where it’s usually found to more than 100 other nations.

Before May 2022, when clusters of people with unusual rashes began appearing in clinics in the UK and Europe, the country reporting the most cases of mpox was the Democratic Republic of Congo, or DRC.

There, cases have been steadily building since the 1970s, according to a study in the CDC’s Morbidity and Mortality Weekly Report.

In the DRC, people in rural villages depend on wild animals for meat. Many mpox infections there are thought to be the result of contact with an animal to which the virus has adapted; this animal host is not known but is assumed to be a rodent.

For years, experts who studied African outbreaks observed a phenomenon known as stuttering chains of transmission: “infections that managed to transmit themselves or be transmitted from person to person to a limited degree, a certain number of links in that chain of transmission, and then suddenly just aren’t able to sustain themselves in humans,” said Stephen Morse, an epidemiologist at Columbia University’s Mailman School of Public Health.

Informally, scientists kept track, and Morse says that for years, the record for links in a mpox chain was about four.

“Traditionally, it always burned itself out,” he said.

Then the chains started getting longer.

In 2017, Nigeria – which hadn’t had a confirmed case of mpox in more than four decades – suddenly saw a resurgence of the virus, with more than 200 cases reported that year.

“People have speculated maybe it was a change in the virus that allowed it to be made better-adapted to humans,” Morse said.

From 2018 through 2021, eight cases of mpox were reported outside Africa. All were in men ages 30 to 50, and all had traveled from Nigeria. Three reported that the rashes had started in their groin area. One went on to infect a health care provider. Another infected two family members.

This Nigerian outbreak helped experts realize that mpox could efficiently spread between people.

It also hinted that the infection could be sexually transmitted, but investigators couldn’t confirm this route of spread, possibly because of the stigma involved in sharing information about sexual contact.

In early May 2022, health officials in the UK began reporting confirmed cases of mpox. One of the people had recently traveled to Nigeria, but others had not, indicating that it was spreading in the community.

Later, other countries would report cases that had started even earlier, in April.

Investigators concluded that mpox had been silently spreading before they caught up to it.

In early summer, as US case numbers began to grow, the public health response bore some uncomfortable similarities to the early days of Covid-19. People with suspicious rashes complained that it was too hard to get tested because a limited supply was being rationed. Because the virus had so rarely appeared outside certain countries in Africa, most doctors weren’t sure how to recognize mpox or how to test for it and didn’t understand all its routes of spread.

A new vaccine was available, and the government had placed orders for it, but most of those doses weren’t in the United States. Beyond that, its efficacy against mpox had been studied only in animals, so no one knew whether it would actually work in humans.

There was an experimental treatment, Tpoxx, but it too was unproven, and doctors could get it only after filling out reams of paperwork required by the government for compassionate use.

Some just gave up.

“Tpoxx was hard to get,” said Dr. Jeffrey Klausner, a clinical professor of public health at the University of Southern California’s Keck School of Medicine.

“I was scrambling to find places that could prescribe it because my own institution just became a bureaucratic nightmare. So I basically would be referring people for treatment outside my own institution to be able to get monkeypox treatment,” he said.

Finally, in August, the federal government declared a public health emergency. This allowed federal agencies to access pots of money set aside for emergencies. It also allows the government to shift funds from one purpose to another to help cover costs of the response – and it helped raise awareness among doctors that mpox was something to watch for.

The government also set up a task force led by Robert Fenton, a logistics expert from the Federal Emergency Management Agency, and Dr. Demetre Daskalakis, director of the CDC’s Division of HIV and AIDS Research.

Daskalakis is openly gay and sex-positive, right down to his Instagram account, which mixes suit-and-tie shots from White House briefings with photos revealing his many tattoos.

“Dr. Daskalakis … really walks on water in most of the gay community, and then [Fenton is] a logistics expert, and I think that combination of leadership was the right answer,” Klausner said.

Early on, after the CDC identified men who have sex with men as being at highest risk of infection, officials warned of close physical contact, the kind that often happens with sexual activity. They also noted that people could be infected through contact with contaminated surfaces like sheets or towels.

But they stopped short of calling it a sexually transmitted infection, a move that some saw as calculated.

“In this outbreak, in this time and context to Europe, United States and Australia, was definitely sexually transmitted,” said Klausner, who points out that many men got rashes on their genitals and that infectious virus was cultured in semen.

Klausner believes vague descriptions about how the virus spread were intentional, in order to garner resources needed for the response.

“People felt that if they called it an STD from the get-go, it was going to create stigma, and because of the stigma of the type of sex that was occurring – oral sex, anal sex, anal sex between same-sex male partners – there may not have been the same kind of federal response,” Klausner said. “So it was actually a political calculation to garner the resources necessary to have a substantial response to be vague about how it spread.”

This ambiguity created room for misinformation and confusion, said Tony Hoang, executive director of Equality California, a nonprofit advocacy group for LGBTQ civil rights.

“I think there was a balancing dance of not wanting to create stigma, in terms of who is actually the highest rates of transmission without being forthright,” Hoang said.

Hoang’s group launched its own public information campaign, combining information from the CDC on HIV and mpox. The messaging stressed that sex was the risky behavior and made sure to explain that light brushes or touches weren’t likely to pass the infection, he said.

Klausner thinks the CDC could have done better on messaging.

“By giving vague, nonspecific information and making comments like ‘everyone’s potentially at risk’ or ‘there’s possible spread through sharing a bed, clothing or close dancing’ … that kind of dilutes the message, and people who engage in risk behavior that does put them at risk get confused, and they say ‘well, maybe this isn’t really a route of spread,’ ” he said.

In July and August, when the US was reporting hundreds of new mpox cases each day, health officials were worried that the virus might be here to stay.

“There were concerns that there would be ongoing transmission and that ongoing transmission would become endemic in the United States like other STIs: gonorrhea, chlamydia, syphilis. We have not seen that occur,” said Dr. Jonathan Mermin, director of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention.

“We are now seeing three to four cases a day in the United States, and it continues to decline. And we see the possibility of getting to zero as real,” he said.

At the peak of the outbreak, officials scrambled to vaccinate the population at highest risk – men who have sex with men – in the hopes of limiting both severity of infections and transmission. But no one was sure whether this strategy would work.

The Jynneos vaccine was approved by the US Food and Drug Administration in 2019 to prevent monkeypox and smallpox in people at high risk of those infections.

At that time, the plan was to bank it in the Strategic National Stockpile as a countermeasure in case smallpox was weaponized. The approval for mpox, a virus closely related to smallpox, was tacked on because the US had seen a limited outbreak of these infections in 2003, tied to the importation of exotic rodents as pets.

Jynneos had passed safety tests in humans. In lab studies, it protected primates and mice from mpox infections. But researchers only learn how effective vaccines are during infectious disease outbreaks, and Jynneos has never been put through its paces during an outbreak.

“We were left, when this started, with that great unknown: Does this vaccine work? And is it safe in large numbers?” Mermin said.

Beyond those uncertainties, there wasn’t enough to go around, and infectious disease experts feared that a shortage of the vaccine might thwart any effort to stop the outbreak.

So public health officials announced a change in strategy: Instead of injecting a full dose under the skin, or subcutaneously, they would inject just one-fifth of that dose between the skin’s upper layers, or intradermally.

An early study in the trials of the vaccine had suggested that intradermal dosing could be effective, but it was a risk. Again, no one was sure this dose-sparing strategy would work.

Ultimately, all of these gambles appear to have paid off.

Early studies of vaccine effectiveness show that the Jynneos vaccine protected men from mpox infections. According to CDC data, people who were unvaccinated were almost 10 times as likely to be diagnosed with the infection as those who got the recommended two doses.

Men who had two doses were about 69% less likely, and men with a single dose were about 37% less likely, to have an mpox infection that needed medical attention compared with those who were unvaccinated, according to the CDC.

Mermin says studies have since showed that the vaccine worked well no matter if was given into the skin or under the skin – another win.

Still, the vaccine is almost certainly not the entire reason cases have plunged, simply because not enough people have gotten it. The CDC estimates that 2 million people in the United States are eligible for mpox vaccination. Mermin says that about 700,000 have had a first dose – about 36% of the eligible population.

So it’s unlikely that vaccination was the only reason for the steep decline in cases. CDC modeling suggests that behavior change may have played a substantial role, too.

In an online survey of men who have sex with men conducted in August, half of participants indicated that they had reduced their number of partners and one-time sexual encounters, behaviors that could cut the growth of new infections by 20% to 30%.

If that’s the case, some experts worry that the US could see monkeypox flare up again as the weather warms.

“The party season was during the summer, during the height of the outbreak, and we’re in the dead of winter. So there’s a possibility that behavior change may not able to be sustained,” said Gregg Gonsalves, an epidemiologist at the Yale School of Public Health.

Although we’re clearly in a much better position than we were last summer, he says, public health officials shouldn’t make this a “mission accomplished” moment.

“Now, put your foot on the accelerator. Let’s get the rest of these cases,” Gonsalves said.

Mermin says that’s exactly what the CDC intends to do. It isn’t finished with the response but intends to switch to “a ground game.”

“So much of our work in the next few months will be setting up structures so that getting vaccinated is easy,” he said.

Nearly 40% of mpox cases in the United States were diagnosed in people who also had HIV, Mermin said. So the CDC is going to make sure Jynneos vaccines are available as a routine part of care at HIV clinics and STI clinics that offer pre-exposure prophylaxis, or PrEP, for HIV.

Mermin said officials are also going to continue to go to LGBTQ festivals and events to offer on-site vaccinations.

Additionally, they’re going to study people who’ve been vaccinated and infected to see whether they remain immune – something else that’s still a big unknown.

Experts say that’s just one of many questions that need a closer look. Another is just how long the virus had been spreading outside Africa before the world noticed.

“We’re starting to see some data that suggests that asymptomatic infection and transmission is possible, and that certainly will change how we how we think about this virus and and risk,” said Anne Rimoin, an epidemiologist at the Fielding School of Public Health at UCLA.

When researchers at a sexual health clinic in Belgium rescreened more than 200 nasal and oral swabs they had taken in May 2022 to test for the STIs chlamydia and gonorrhea, they found positive mpox cases that had gone undiagnosed. Three of the people reported no symptoms, while another reported a painful rash, which was misdiagnosed as herpes. Their study was published in the journal Nature Medicine.

“Mild and asymptomatic infections may have indeed delayed the detection of the outbreak,” study author Christophe Van Dijck of the Laboratory of Medical Microbiology at the University of Antwerp in Belgium said in an email to CNN.

While researchers tackle those pursuits, advocacy groups say they aren’t ready to relax.

Hoang says Equality California is pushing the CDC to address continuing racial disparities in mpox vaccination and treatment, particularly in rural areas.

He’s not worried that gay men will drop their guard now that the emergency has expired..

“We’ve learned that we have to take health into our own hands, and I do think that we will remain vigilant as a community for this outbreak and future outbreaks,” Hoang said.



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Children’s mental health tops list of parent worries, survey finds | CNN



CNN
 — 

Forty percent of US parents are “extremely” or “very” worried that their children will struggle with anxiety or depression at some point, a new survey finds.

The Pew Research Center report said mental health was the greatest concern among parents, followed by bullying, which worries 35% of parents. These concerns trumped fears of kidnapping, dangers of drugs and alcohol, teen pregnancy and getting into trouble with the police.

Concerns varied by race, ethnicity and income level, with roughly 4 in 10 Latino and low-income parents and 3 in 10 Black parents saying they are extremely or very worried that their children could be shot, compared with about 1 in 10 high-income or White parents.

Nearly two-thirds of the respondents said that being a parent has been at least somewhat harder than they expected, about 41% say that being a parent is tiring, and 29% say it is stressful all or most of the time.

The report captured the perceptions of a nationally representative sample of 3,757 US parents whose children were younger than 18 in 2022.

Experts say mental health issues among children and adolescents have skyrocketed in recent years.

“I would say over the last 10 years, since I’ve been practicing as a general pediatrician, I have seen a shift both in the amount of patients and of all ages dealing with anxiety and depression. And their parents being concerned about this is a key issue,” said Dr. Katherine Williamson, a pediatrician and spokesperson for the American Academy of Pediatrics. “Even before the pandemic, we were seeing skyrocketing numbers of kids and adolescents dealing with mental health issues, and that has increased exponentially since the pandemic.”

Suicide became the second leading cause of death among children 10 to 14 during the Covid-19 pandemic, according to the US Centers for Disease Control and Prevention. Mental health-related emergency room visits among adolescents 5 to 11 and 12 to 17 also jumped 24% and 31%, respectively.

Many parents feel helpless when their children have mental health issues because they don’t feel equipped to offer support in this area.

“They are unable to relieve [mental health issues] and address that as they could if they were struggling with their grades or other things that seem more traditional to for kids to struggle with,” said Allen Sabey, a family therapist at the Family Institute at Northwestern University.

Parents trying to “work out and look at and connect with their own feelings will give them important information about what feels off or OK for their kid,” he said.

When it comes to anxiety and depression in children, pediatricians say, parents can watch for signs like decreased interest or pleasure in things they previously enjoyed, poor self-esteem and changes in mood, appetite or sleep.

Experts also say parents should consider the amount and content of social media their child consumes, as research has found that it can have negative effects on their mental health.

But, they say, having more parents recognize the importance of mental health in children is a step in the right direction.

“I have always felt there’s been so much resistance to seeking care for mental health among the population that I serve. And I am actually happy that since the Covid pandemic, at least people now are recognizing this as a very key and important health need,” said Dr. Maggi Smeal, a pediatrician at Stanford Medicine Children’s Health.

Smeal hopes that “all people that are interacting with children can be aware of these issues and feel empowered to identify and advocate for these children, to tell them to go to their primary care provider and have an assessment just like you do if your kid has a cough or a fever or ear infection.”

The number of parents concerned about gun violence reflects the fact that guns are the leading cause of death among children in the US, research has showed. From 2019 to 2020, the rate of firearm-related deaths increased 29.5% – more than twice the increase as in the general population.

“Gun violence is a real risk to our kids today. And that is both being killed by somebody else as well as suicide in the face of the mental health issues that we’re seeing today,” Williamson said.

The survey found that Black, Hispanic and lower-income parents were most likely to be concerned about gun violence, a finding that’s consistent with the communities most affected. Research has shown that from 2018 to 2021, the rate of firearm-related deaths doubled among Black youth and increased 50% among Hispanic youth. Another study found that children living in low-income areas are at higher risk of firearm-related death.

Direct and indirect exposure to gun violence can contribute to mental health problems.

“Even if they hear gunshots in their community, they hear adults talking, there’s all different ways that children are traumatized and victimized by gun violence. And what we see is all the symptoms of anxiety in even the youngest of children. We see children with somatic complaints – stomachaches, headaches. They have post-traumatic stress disorder,” Smeal said.

Most of the parents in the survey said parenting is harder than they expected, and that they feel judgment from various sources.

“The findings of this of this report were, as a pediatrician and a parent, just exactly what you would expect. Parenting is the hardest thing you’ll ever do, and there are very high levels of stress and fatigue, especially in the parents of young children,” Smeal said.

One of the best things parents can do is lean on fellow parents, experts say.

“The main challenge for parents is our siloed independent nature sometimes, and so we want to find people who we trust and kind of work towards being more vulnerable and open with,” Sabey said. “To where it’s like not just you and your kid, but it’s a kind of a group of people caring and working together.”

Pediatricians emphasize that no parent is perfect and that the most important thing you can do is to just be there for your child.

“We know that the best chance for a child to be successful and happy is for them to have at least one person in their life who believes in them and advocates for them. So I think it’s important for parents to know that there’s no such thing as a perfect parent, because we are all human, and humans are imperfect by nature, but that is OK,” Williamson said.

A parent’s job is to “really make sure that they know how important they are and they have a voice in this world,” she said. “Every child will have their own unique struggles, whether it is academically, emotionally, physically. Our job is to help them with the areas [where] they struggle, but even more, help them recognize their strengths.”

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Weight loss surgery extends lives, study finds | CNN



CNN
 — 

Weight loss surgery reduces the risk of premature death, especially from such obesity-related conditions as cancer, diabetes and heart disease, according to a new 40-year study of nearly 22,000 people who had bariatric surgery in Utah.

Compared with those of similar weight, people who underwent one of four types of weight loss surgery were 16% less likely to die from any cause, the study found. The drop in deaths from diseases triggered by obesity, such as heart disease, cancer and diabetes, was even more dramatic.

“Deaths from cardiovascular disease decreased by 29%, while deaths from various cancers decreased by 43%, which is pretty impressive,” said lead author Ted Adams, an adjunct associate professor in nutrition and integrative physiology at the University of Utah’s School of Medicine.

“There was also a huge percentage drop — a 72% decline — in deaths related to diabetes in people who had surgery compared to those who did not,” he said. One significant downside: The study also found younger people who had the surgery were at higher risk for suicide.

The study, published Wednesday in the journal Obesity, reinforces similar findings from earlier research, including a 10-year study in Sweden that found significant reductions in premature deaths, said Dr. Eduardo Grunvald, a professor of medicine and medical director of the weight management program at the University of California San Diego Health.

The Swedish study also found a significant number of people were in remission from diabetes at both two years and 10 years after surgery.

“This new research from Utah is more evidence that people who undergo these procedures have positive, beneficial long-term outcomes,” said Grunvald, who coauthored the American Gastroenterological Association’s new guidelines on obesity treatment.

The association strongly recommends patients with obesity use recently approved weight loss medications or surgery paired with lifestyle changes.

“And the key for patients is to know that changing your diet becomes more natural, more easy to do after you have bariatric surgery or take the new weight loss medications,” said Grunvald, who was not involved in the Utah study.

“While we don’t yet fully understand why, these interventions actually change the chemistry in your brain, making it much easier to change your diet afterwards.”

Despite the benefits though, only 2% of patients who are eligible for bariatric surgery ever get it, often due to the stigma about obesity, said Dr. Caroline Apovian, a professor of medicine at Harvard Medical School and codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital in Boston. Apovian was the lead author for the Endocrine Society’s clinical practice guidelines for the pharmacological management of obesity.

Insurance carriers typically cover the cost of surgery for people over 18 with a body mass index of 40 or higher, or a BMI of 35 if the patient also has a related condition such as diabetes or high blood pressure, she said.

“I see patients with a BMI of 50, and invariably I will say, ‘You’re a candidate for everything — medication, diet, exercise and surgery.’ And many tell me, ‘Don’t talk to me about surgery. I don’t want it.’ They don’t want a surgical solution to what society has told them is a failure of willpower,” she said.

“We don’t torture people who have heart disease: ‘Oh, it’s because you ate all that fast food.’ We don’t torture people with diabetes: ‘Oh, it’s because you ate all that cake.’ We tell them they have a disease, and we treat it. Obesity is a disease, too, yet we torture people with obesity by telling them it’s their fault.”

Most of the people who choose bariatric surgery — around 80% — are women, Adams said. One of the strengths of the new study, he said, was the inclusion of men who had undergone the procedure.

“For all-causes of death, the mortality was reduced by 14% for females and by 21% for males,” Adams said. In addition, deaths from related causes, such as heart attack, cancer and diabetes, was 24% lower for females and 22% lower for males who underwent surgery compared with those who did not, he said.

Four types of surgery performed between 1982 and 2018 were examined in the study: gastric bypass, gastric banding, gastric sleeve and duodenal switch.

Gastric bypass, developed in the late 1960s, creates a small pouch near the top of the stomach. A part of the small intestine is brought up and attached to that point, bypassing most of the stomach and the duodenum, the first part of the small intestine.

In gastric banding, an elastic band that can be tightened or loosened is placed around the top portion of the stomach, thus restricting the volume of food entering the stomach cavity. Because gastric banding is not as successful in creating long-term weight loss, the procedure “is not as popular today,” Adams said.

“The gastric sleeve is a procedure where essentially about two-thirds of the stomach is removed laparoscopically,” he said. “It takes less time to perform, and food still passes through the much-smaller stomach. It’s become a very popular option.”

The duodenal switch is typically reserved for patients who have a high BMI, Adams added. It’s a complicated procedure that combines a sleeve gastrectomy with an intestinal bypass, and is effective for type 2 diabetes, according to the Cleveland Clinic.

One alarming finding of the new study was a 2.4% increase in deaths by suicide, primarily among people who had bariatric surgery between the ages of 18 and 34.

“That’s because they are told that life is going to be great after surgery or medication,” said Joann Hendelman, clinical director of the National Alliance for Eating Disorders, a nonprofit advocacy group.

“All you have to do is lose weight, and people are going to want to hang out with you, people will want to be your friend, and your anxiety and depression are going to be gone,” she said. “But that’s not reality.”

In addition, there are postoperative risks and side effects associated with bariatric surgery, such as nausea, vomiting, alcoholism, a potential failure to lose weight or even weight gain, said Susan Vibbert, an advocate at Project HEAL, which provides help for people struggling with eating disorders.

“How are we defining health in these scenarios? And is there another intervention — a weight neutral intervention?” Vibbert asked.

Past research has also shown an association between suicide risk and bariatric surgery, Grunvald said, but studies on the topic are not always able to determine a patient’s mental history.

“Did the person opt for surgery because they had some unrealistic expectations or underlying psychological disorders that were not resolved after the surgery? Or is this a direct effect somehow of bariatric surgery? We can’t answer that for sure,” he said.

Intensive presurgery counseling is typically required for all who undergo the procedure, but it may not be enough, Apovian said. She lost her first bariatric surgery patient to suicide.

“She was older, in her 40s. She had surgery and lost 150 pounds. And then she put herself in front of a bus and died because she had underlying bipolar disorder she had been self-medicating with food,” Apovian said. “We as a society use a lot of food to hide trauma. What we need in this country is more psychological counseling for everybody, not just for people who undergo bariatric surgery.”

Managing weight is a unique process for each person, a mixture of genetics, culture, environment, social stigma and personal health, experts say. There is no one solution for all.

“First, we as a society must consider obesity as a disease, as a biological problem, not as a moral failing,” Grunvald said. “That’s my first piece of advice.

“And if you believe your life is going to benefit from treatment, then consider evidence-based treatment, which studies show are surgery or medications, if you haven’t been able to successfully do it with lifestyle changes alone.”

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FDA vaccine advisers vote to harmonize Covid-19 vaccines in the United States | CNN



CNN
 — 

A panel of independent experts that advises the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to update all Covid-19 vaccines so they contain the same ingredients as the two-strain shots that are now used as booster doses.

The vote means young children and others who haven’t been vaccinated may soon be eligible to receive two-strain vaccines that more closely match the circulating viruses as their primary series.

The FDA must sign off on the committee’s recommendation, which it is likely to do, before it goes into effect.

Currently, the US offers two types of Covid-19 vaccines. The first shots people get – also called the primary series – contain a single set of instructions that teach the immune system to fight off the original version of the virus, which emerged in 2019.

This index strain is no longer circulating. It was overrun months ago by an ever-evolving parade of new variants.

Last year, in consultation with its advisers, the FDA decided that it was time to update the vaccines. These two-strain, or bivalent, shots contain two sets of instructions; one set reminds the immune system about the original version of the coronavirus, and the second set teaches the immune system to recognize and fight off Omicron’s BA.4 and BA.5 subvariants, which emerged in the US last year.

People who have had their primary series – nearly 70% of all Americans – were advised to get the new two-strain booster late last year in an effort to upgrade their protection against the latest variants.

The advisory committee heard testimony and data suggesting that the complexity of having two types of Covid-19 vaccines and schedules for different age groups may be one of the reasons for low vaccine uptake in the US.

Currently, only about two-thirds of Americans have had the full primary series of shots. Only 15% of the population has gotten an updated bivalent booster.

Data presented to the committee shows that Covid-19 hospitalizations have been rising for children under the age of 2 over the past year, as Omicron and its many subvariants have circulated. Only 5% of this age group, which is eligible for Covid-19 vaccination at 6 months of age, has been fully vaccinated. Ninety percent of children under the age of 4 are still unvaccinated.

“The most concerning data point that I saw this whole day was that extremely low vaccination coverage in 6 months to 2 years of age and also 2 years to 4 years of age,” said Dr. Amanda Cohn, director of the US Centers for Disease Control and Prevention’s Division of Birth Defects and Infant Disorders. “We have to do much, much better.”

Cohn says that having a single vaccine against Covid-19 in the US for both primary and booster doses would go a long way toward making the process less complicated and would help get more children vaccinated.

Others feel that convenience is important but also stressed that data supported the switch.

“This isn’t only a convenience thing, to increase the number of people who are vaccinated, which I agree with my colleagues is extremely important for all the evidence that was related, but I also think moving towards the strains that are circulating is very important, so I would also say the science supports this move,” said Dr. Hayley Gans, a pediatric infectious disease specialist at Stanford University.

Many others on the committee were similarly satisfied after seeing new data on the vaccine effectiveness of the bivalent boosters, which are cutting the risk of getting sick, being hospitalized or dying from a Covid-19 infection.

“I’m totally convinced that the bivalent vaccine is beneficial as a primary series and as a booster series. Furthermore, the updated vaccine safety data are really encouraging so far,” said Dr. David Kim, director of the the US Department of Health and Human Services’ National Vaccine Program, in public discussion after the vote.

Thursday’s vote is part of a larger plan by the FDA to simplify and improve the way Covid-19 vaccines are given in the US.

The agency has proposed a plan to convene its vaccine advisers – called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC – each year in May or June to assess whether the instructions in the Covid-19 vaccines should be changed to more closely match circulating strains of the virus.

The time frame was chosen to give manufacturers about three months to redesign their shots and get new doses to pharmacies in time for fall.

“The object, of course – before anyone says anything – is not to chase variants. None of us think that’s realistic,” said Jerry Weir, director of the Division of Viral Products in the FDA’s Office of Vaccines Research and Review.

“But I think our experience so far, with the bivalent vaccines that we have, does indicate that we can continue to make improvements to the vaccine, and that would be the goal of these meetings,” Weir said.

In discussions after the vote, committee members were supportive of this plan but pointed out many of the things we still don’t understand about Covid-19 and vaccination that are likely to complicate the task of updating the vaccines.

For example, we now seem to have Covid-19 surges in the summer as well as the winter, noted Dr. Michael Nelson, an allergist and immunologist at the University of Virginia. Are the surges related? And if so, is fall the best time to being a vaccination campaign?

The CDC’s Dr. Jefferson Jones said that with only three years of experience with the virus, it’s really too early to understand its seasonality.

Other important questions related to the durability of the mRNA vaccines and whether other platforms might offer longer protection.

“We can’t keep doing what we’re doing,” said Dr. Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation. “It’s been articulated in every one of these meetings despite how good these vaccines are. We need better vaccines.”

The committee also encouraged both government and industry scientists to provide a fuller picture of how vaccination and infection affect immunity.

One of the main ways researchers measure the effectiveness of the vaccines is by looking at how much they increase front-line defenders called neutralizing antibodies.

Neutralizing antibodies are like firefighters that rush to the scene of an infection to contain it and put it out. They’re great in a crisis, but they tend to diminish in numbers over time if they’re not needed. Other components of the immune system like B-cells and T-cells hang on to the memory of a virus and stand ready to respond if the body encounters it again.

Scientists don’t understand much about how well Covid-19 vaccination boosts these responses and how long that protection lasts.

Another puzzle will be how to pick the strains that are in the vaccines.

The process of selecting strains for influenza vaccines is a global effort that relies on surveillance data from other countries. This works because influenza strains tend to become dominant and sweep around the world. But Covid-19 strains haven’t worked in quite the same way. Some that have driven large waves in other countries have barely made it into the US variant mix.

“Going forward, it is still challenging. Variants don’t sweep across the world quite as uniform, like they seem to with influenza,” the FDA’s Weir said. “But our primary responsibility is what’s best for the US market, and that’s where our focus will be.”

Eventually, the FDA hopes that Americans would be able to get an updated Covid-19 shot once a year, the same way they do for the flu. People who are unlikely to have an adequate response to a single dose of the vaccine – such as the elderly or those with a weakened immune system – may need more doses, as would people who are getting Covid-19 vaccines for the first time.

At Thursday’s meeting, the advisory committee also heard more about a safety signal flagged by a government surveillance system called the Vaccine Safety Datalink.

The CDC and the FDA reported January 13 that this system, which relies on health records from a network of large hospital systems in the US, had detected a potential safety issue with Pfizer’s bivalent boosters.

In this database, people 65 and older who got a Pfizer bivalent booster were slightly more likely to have a stroke caused by a blood clot within three weeks of their vaccination than people who had gotten a bivalent booster but were 22 to 42 days after their shot.

After a thorough review of other vaccine safety data in the US and in other countries that use Pfizer bivalent boosters, the agencies concluded that the stroke risk was probably a statistical fluke and said no changes to vaccination schedules were recommended.

At Thursday’s meeting, Dr. Nicola Klein, a senior research scientist with Kaiser Permanente of Northern California, explained how they found the signal.

The researchers compared people who’d gotten a vaccine within the past three weeks against people who were 22 to 42 days away from their shots because this helps eliminate bias in the data.

When they looked to see how many people had strokes around the time of their vaccination, they found an imbalance in the data.

Of 550,000 people over 65 who’d received a Pfizer bivalent booster, 130 had a stroke caused by a blood clot within three weeks of vaccination, compared with 92 people in the group farther out from their shots.

The researchers spotted the signal the week of November 27, and it continued for about seven weeks. The signal has diminished over time, falling from an almost two-fold risk in November to a 47% risk in early January, Klein said. In the past few days, it hasn’t been showing up at all.

Klein said they didn’t see the signal in any of the other age groups or with the group that got Moderna boosters. They also didn’t see a difference when they compared Pfizer-boosted seniors with those who were eligible for a bivalent booster but hadn’t gotten one.

Further analyses have suggested that the signal might be happening not because people who are within three weeks of a Pfizer booster are having more strokes, but because people who are within 22 to 42 days of their Pfizer boosters are actually having fewer strokes.

Overall, Klein said, they were seeing fewer strokes than expected in this population over that period of time, suggesting a statistical fluke.

Another interesting thing that popped out of this data, however, was a possible association between strokes and high-dose flu vaccination. Seniors who got both shots on the same day and were within three weeks of those shots had twice the rate of stroke compared with those who were 22 to 42 days away from their shots.

What’s more, Klein said, the researchers didn’t see the same association between stroke and time since vaccination in people who didn’t get their flu vaccine on the same day.

The total number of strokes in the population of people who got flu shots and Covid-19 boosters on the same day is small, however, which makes the association a shaky one.

“I don’t think that the evidence are sufficient to conclude that there’s an association there,” said Dr. Tom Shimabukuro, director of the CDC’s Immunization Safety Office.

Nonetheless, Richard Forshee, deputy director of the FDA’s Office of Biostatistics and Pharmacovigilance, said the FDA is planning to look at these safety questions further using data collected by Medicare.

The FDA confirmed that the agency is taking a closer look.

“The purpose of the study is 1) to evaluate the preliminary ischemic stroke signal reported by CDC using an independent data set and more robust epidemiological methods; and 2) to evaluate whether there is an elevated risk of ischemic stroke with the COVID-19 bivalent vaccine if it is given on the same day as a high-dose or adjuvanted seasonal influenza vaccine,” a spokesperson said in a statement.

The FDA did not give a time frame for when these studies might have results.

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It’s been three years since the first Covid-19 case in the United States. What have we learned and what more do we need to understand? | CNN



CNN
 — 

It’s been three years since the first Covid-19 case was diagnosed in the United States, on January 20, 2020. In the time since, nearly 1.1 million Americans have died from the coronavirus; the US has reported 102 million Covid cases, more than any other country, according to Johns Hopkins University. Both figures, many health officials believe, are likely to have been undercounted.

There have also been remarkable scientific achievements in our response to the pandemic, not least of which is the development of Covid-19 vaccines. But there are still many unanswered questions. To help with reflections on what we’ve learned and what more we need to understand, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician, public health expert and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She is also author of “Lifelines: A Doctor’s Journey in the Fight for Public Health.”

CNN: You’re a physician caring for patients, a public health researcher and professor. What are the key lessons you’ve learned from the last three years of Covid-19?

Dr. Leana Wen: There are three main lessons that come to mind. First, we have seen how much the global scientific community has come together and delivered some truly incredible achievements. Less than a year after Covid-19 was declared a pandemic, we had a vaccine developed, authorized and being distributed. The scientific community has rallied on many other aspects of the response to Covid-19, including to identify treatments and improve surveillance testing.

Many of the scientific developments will last beyond this pandemic and help with other aspects of our infectious disease response. For instance, the technology behind mRNA vaccines could be used to make vaccines for other diseases. The wastewater surveillance being used to identify and track Covid-19 may be helpful for detecting other viruses.

Second, Covid-19 has unmasked many existing crises and amplified them for the world to see. The coronavirus didn’t create health disparities — these long-predated the virus — but exacerbated existing ones.

There were also many faults with the public health infrastructure that, while long known to those of us in the field, have been exposed for all to see. Data systems are not integrated between public health agencies, for example, and city and county health departments are woefully underfunded given their many responsibilities. These stem from the fragmented health care system we have in the US, as well as the ongoing lack of investment in local public health agencies.

At the same time, Covid has also demonstrated how crucial public health is. There is a saying that “public health saved your life today, you just don’t know it.” I think there is much more recognition among many that public health is essential to preventing problems that can have a major impact on people’s health and well-being.

With that said, Covid-19 occurred during a time of deep division. Virtually every aspect of the pandemic has become politicized and polarized. So thirdly, there has been rampant misinformation and disinformation that’s made the response much more challenging. We are seeing the lasting effects, such as reduced uptake of routine childhood immunizations. I’m very concerned that public health itself has become politicized in a way that could harm our response to future pandemics.

CNN: You mentioned that we’ve learned a lot scientifically. What more do we need to understand about Covid-19?

Wen: At this point in the pandemic, a lot of people have moved on from Covid-19 and no longer think about it as a major factor in their everyday lives. However, there are millions of Americans vulnerable to severe illness who remain very concerned about the coronavirus. These are people who are immunocompromised, elderly or with multiple underlying illnesses. To me, the most important research questions pertain to these individuals.

There are some antiviral medications that are effective for Covid-19 treatment, such as Paxlovid. Some patients are not eligible for Paxlovid, though, and other options are becoming more limited. The US Food and Drug Administration has revoked their authorization for monoclonal antibodies that could treat Covid-19 infection, as they no longer appear to be effective against new circulating variants. Recently, the FDA has also said that the preventive antibody Evusheld may be ineffective against some variants, including the XBB.1.5 variant that’s currently dominant in the US.

It should be an urgent priority to focus on developing better treatments for those most vulnerable to severe disease from Covid-19. I also hope that there will be much more investment into finding better vaccines. The vaccines that we have are excellent at protecting against severe disease, which is most important. However, they are not very effective at preventing infection.

The ideal vaccine would be more effective at reducing infection, and target the virus broadly so that we are not always trying to anticipate what variant will develop next — and then scrambling to find a vaccine that works against that variant. There is research being undertaken into nasal vaccines and pan-coronavirus vaccines, for example. I hope these efforts will be expedited.

CNN: We are learning more about long Covid, but is this an area that needs more research?

Wen: Absolutely. We know that many people have lingering symptoms after a Covid-19 infection. According to a large study from Israel, most symptoms resolve within the first year after infection for people with mild illness. However, there are some who have lasting symptoms, like fatigue, headache, palpitations and shortness of breath, that are so debilitating they can no longer work.

There is a lot that we don’t yet know about long Covid. The most important is how to treat patients who have it. The physiological mechanisms behind what’s causing their lingering symptoms are also unclear, along with exactly how common they are.

There are long waits to get into specialized clinics that treat this condition at present, so a lot more education needs to be done for primary care physicians and other clinicians who will probably end up being the main health care providers for many people suffering from long Covid.

CNN: What do you anticipate will happen in this coming year around Covid-19?

Wen: Right now, China is undergoing a massive surge of cases. It’s the last major country to have enforced a strict zero-Covid policy, and now that policy has been reversed. Once China’s infection numbers stabilize, Covid-19 will probably become endemic there, as it has become in most other parts of the world.

There will, no doubt, be new variants that arise. We need to keep on top of them and monitor accordingly to see if they are more deadly and/or evade the effectiveness of existing vaccines. The key, as I said earlier, is to develop vaccines that can more broadly cover variants.

And we must again remember that, while many people have resumed pre-pandemic lives, others have not. In the next year of Covid-19, I believe that the focus needs to be much more specific to these individuals who need our help the most. We should target boosters and treatments to those most vulnerable, for example.

Finally, there should be a much greater effort to rebuild our public health infrastructure. This is long overdue. Doing so is critical not just for preparing for the next pandemic, but also for improving health and well-being for all Americans.

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How to be prepared in case of a shooting without living in fear | CNN



CNN
 — 

At first, Brandon Tsay froze when a gunman aimed a firearm at him, he said. He was sure those would be his last moments.

But then something came over Tsay, who was working the ticket counter in the lobby of his family’s Lai Lai Ballroom & Studio, a dance hall in Alhambra, California.

He lunged toward the armed man and struggled through being hit several times in order to wrestle the gun away, he told CNN’s Anderson Cooper Monday evening.

The gunman had already killed 11 people and injured 10 others before arriving at Tsay’s workplace.

Tsay’s courage saved his life that day, but probably also saved countless more, said Ronald Tunkel, a former special agent with the US Bureau of Alcohol, Tobacco, Firearms and Explosives, who was trained as a criminal profiler.

While Tsay’s actions show heroism and bravery, what he did is more possible than people think, said Dr. Ragy Girgis, associate professor of clinical psychiatry at Columbia University in New York City.

“People have a great capacity for responding to tragedies like these. People wouldn’t realize how heroically they could respond,” he said.

Fortunately, most people will not find themselves in a situation in which they will have to respond to a mass shooter, Girgis said. But incidents like these are all too common and on the rise in the US, according to the Gun Violence Archive.

There is not much research on intervention in mass shootings by civilians, Girgis said.

Still, as the US sees mass shootings on a regular basis, companies, nonprofits and schools are training people about how to respond. Tunkel and Jon Pascal, an instructor for both Krav Maga Worldwide and the Force Training Institute, say they are seeing more training and protocols around active shooting situations for everyday people.

A word of warning: If your awareness around safety starts to contribute to anxiety or interfere with life in a meaningful way, it may be time to consult a mental health expert, said psychiatrist Dr. Keith Stowell, chief medical officer of behavioral health and addictions for Rutgers Health and RWJBarnabas Health.

Tunkel said being able to respond effectively to emergency situations takes two things: awareness and preparation.

Create “a habit of safety,” Pascal recommended. That means that people should routinely make note of the mood of crowds they are in, the exits and entrances, and what tools are available around them in case they need to respond to a scary event.

“We don’t want to walk around paranoid and not live our lives, but I think if we make personal safety a habit, it becomes something normal,” he said.

Your worst-case scenario is probably never going to happen, but being prepared means you have ways to take care of yourself and those around you if it does, Pascal added.

In addition to implementing awareness of your surroundings, Pascal recommends making a plan for how you will respond in case of medical, fire or violent emergencies.

It is always important to look for two ways of exiting a building in case danger or an obstacle is blocking one, he said. And at home or in workplaces, he recommended taking note of doors that can be locked and things that can be used to barricade.

Once you have the plan, practice it, he added. That bookcase might look like the perfect barricade in your head, but then be impossible to move in an emergency, Pascal said. And you want to be sure your escape routes don’t have locked doors you can’t open.

But preparation can also take the form of training — and it doesn’t have to be long-term, intensive and specific to the situation, Tunkel said.

Self-defense or active shooter training can help give you knowledge and strategies to use quickly if ever they are needed, Pascal said. But even more general training can help give you the mental and physical responses needed in case of emergency, Tunkel said.

Weight lifting and team sports can show you that you are physically capable of responding, he said. Yoga and meditation can train your breath and brain to stay calm and make good decisions in crisis, he said.

And in a dangerous situation, acting quickly and decisively is often safest, Pascal said.

It’s hard to be decisive when bullets are flying. Many victims of mass shootings have reported that the events were confusing and that it was hard to tell what was happening, Girgis said.

And if people don’t know what is happening, they often rely on their instincts to make decisions on what to do next, which can be scary, Pascal said.

The human brain likes categories to make things simpler, so it will often default to relating new things to those we have been exposed to before, Stowell said. When a person hears a popping noise, they might be likely to assume the sound is something familiar like a firecracker, he added.

Instead, Pascal advised people — whether they think they hear balloons popping or gunshots — to stop, look around to gather as much information as they can about what is going on around them, listen to see if they can learn anything from the sound, and smell the air.

Because where there are gunshots, there is often gunpowder, Pascal said.

Once someone has gathered what information they can, it is important to trust your perception of danger, Tunkel said.

Knowing there is danger activates a fight-or-flight response, which humans have honed over thousands of years to respond to predators, Stowell said.

But when a person is in a dangerous situation that is so far from anything they’ve experienced before, it is not uncommon for them to freeze, he added.

That is where training of any kind comes in. Even if it doesn’t teach you every detail of how to respond, it gives your brain a set of knowledge to fall back on in a terrifying situation, Stowell said.

Wrestling a gun away isn’t the only way to act when there is a mass shooter, Pascal said.

The US Department of Homeland Security developed a protocol called “Run, hide, fight.”

“Run” refers to the first line of defense — to get yourself away from a dangerous situation as quickly as possible, Pascal said. You can encourage others to run away too, but don’t stay back if they won’t leave with you.

If it isn’t possible to run, the next best option is to hide, making it more difficult in some way for the perpetrator to get to you, he said.

If none of those are an option, you can fight.

“You don’t have to be the biggest, strongest person in the room,” Pascal said. “You just have to have that mindset that no one is going to do this to me and I’m going home safe.”

Even though most people are capable of responding to danger in some way, it is important not to judge how much or how little a bystander or victim acts, Tunkel said.

“What may be reasonable for one person in one situation is not for someone else in another situation,” Pascal said.

No matter how well a person has been trained, mass shootings are “beyond the scope of anything we’ve had to experience in our everyday lives,” Stowell said. “There’s no real expectation of a right response, despite training.”

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FDA proposes new levels for lead in baby food, but critics say more action is needed | CNN



CNN
 — 

The allowable levels of lead in certain baby and toddler foods should be set at 20 parts per billion or less, according to new draft guidance issued Tuesday by the US Food and Drug Administration.

“For babies and young children who eat the foods covered in today’s draft guidance, the FDA estimates that these action levels could result in as much as a 24-27% reduction in exposure to lead from these foods,” said FDA Commissioner Dr. Robert Califf in a statement.

The

Baby foods covered by the new proposal – which is seeking public comment – include processed baby foods sold in boxes, jars, pouches and tubs for babies and young children younger than 2 years old, the agency said.

While any action on the part of the FDA is welcome, the suggested levels of lead are not low enough to move the needle, said Jane Houlihan, the national director of science and health for Healthy Babies Bright Futures, a coalition of advocates committed to reducing babies’ exposures to neurotoxic chemicals.

“Nearly all baby foods on the market already comply with what they have proposed,” said Houlihan, who authored a 2019 report that found dangerous levels of lead and other heavy metals in 95% of manufactured baby food.

That report triggered a 2021 congressional investigation, which found leading baby food manufacturers knowingly sold products with high levels of toxic metals.

“The FDA hasn’t done enough with these proposed lead limits to protect babies and young children from lead’s harmful effects. There is no known safe level of lead exposure, and children are particularly vulnerable,” Houlihan said.

The director of food policy for Consumers Reports, Brian Ronholm, also expressed concerns. In 2018, Consumer Reports analyzed 50 baby foods and found “concerning” levels of lead and other heavy metals. In fact, “15 of them would pose a risk to a child who ate one serving or less per day,” according to Consumer Reports.

“The FDA should be encouraging industry to work harder to reduce hazardous lead and other heavy metals in baby food given how vulnerable young children are to toxic exposure,” Ronholm said in a statement.

Exposure to toxic heavy metals can be harmful to the developing brain of infants and children. “It’s been linked with problems with learning, cognition, and behavior,” according to the American Academy of Pediatrics.

Lead, arsenic, cadmium and mercury are in the World Health Organization’s top 10 chemicals of concern for infants and children.

As natural elements, they are in the soil in which crops are grown and thus can’t be avoided. Some crop fields and regions, however, contain more toxic levels than others, partly due to the overuse of metal-containing pesticides and ongoing industrial pollution.

The new FDA guidance suggests manufactured baby food custards, fruits, food mixtures — including grain and meat-based blends — puddings, vegetables, yogurts, and single-ingredient meats and vegetables contain no more than 10 parts per billion of lead.

The exception to that limit is for single-ingredient root vegetables, such as carrots and sweet potatoes, which should contain no more than 20 parts per billion, according to the new guidance.

Dry cereals marketed to babies and toddlers should also not contain more than 20 parts per billion of lead, the new FDA guidance said.

However, the FDA didn’t propose any lead limit for cereal puffs and teething biscuits, Houlihan said, even though the products account for “7 of the 10 highest lead levels we’ve found in over 1,000 baby food tests we have assessed.”

The limit set for root vegetables will be helpful, Houlihan added. Because they grow underground, root vegetables can easily absorb heavy metals. For example, sweet potatoes often exceed the 20 parts per billion limit the FDA has proposed, she said.

Prior to this announcement, the FDA had only set limits for heavy metals in one baby food — infant rice cereal, Houlihan said. In 2021, the agency set a limit of 100 parts per billion for arsenic, which has been linked to adverse pregnancy outcomes and neurodevelopmental toxicity.

There is much more that can be done, according to Scott Faber, senior vice president of government affairs for the Environmental Working Group, a nonprofit environmental health organization.

“We can change where we farm and how we farm to reduce toxic metals absorbed by plants,” Faber said. “We also urge baby food manufacturers to conduct continuous testing of heavy metals in all their products and make all testing results publicly available.”

Companies can require suppliers and growers to test the soil and the foods they produce, and choose to purchase from those with the lowest levels of heavy metals, Houlihan added.

“Growers can use soil additives, different growing methods and crop varieties known to reduce lead in their products,” she said.

What can parents do to lessen their child’s exposure to toxic metals? Unfortunately, buying organic or making baby food at home isn’t going to solve the problem, as the produce purchased at the grocery store can also contain high levels of contaminants, experts say.

A 2022 report by Healthy Babies, Bright Futures found lead in 80% of homemade purees or store-bought family foods. Arsenic was found in 72% of family food either purchased or prepared at home.

The best way to lessen your child’s exposure to heavy metals, experts say, is to vary the foods eaten on a daily basis and choose mostly from foods which are likely to have the least contamination. Healthy Babies, Bright Futures created a chart of less to most contaminated foods based on their testing.

Fresh bananas, with heavy metal levels of 1.8 parts per billion, were the least contaminated of foods tested for the report. After bananas, the least contaminated foods were grits, manufactured baby food meats, butternut squash, lamb, apples, pork, eggs, oranges and watermelon, in that order.

Other foods with lower levels of contamination included green beans, peas, cucumbers and soft or pureed home-cooked meats, the report found.

The most heavily contaminated foods eaten by babies were all rice-based, the report said. Rice cakes, rice puffs, crisped rice cereals and brown rice with no cooking water removed were heavily contaminated with inorganic arsenic, the more toxic form of arsenic.

After rice-based foods, the analysis found the highest levels of heavy metals in raisins, non-rice teething crackers, granola bars with raisins and oat-ring cereals. But those were not the only foods of concern: Dried fruit, grape juice, arrowroot teething crackers and sunflower seed butter all contained high amounts of at least one toxic metal, according to the report.

While buying organic cannot reduce the levels of heavy metals in infant food, it can help avoid other toxins such as herbicides and pesticides, Dr. Leonardo Trasande, director of environmental pediatrics at NYU Langone Health told CNN previously.

“There are other benefits to eating organic food, including a reduction in synthetic pesticides that are known to be as bad for babies, if not even more problematic,” Trasande said.

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