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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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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Recently identified inflammatory disease VEXAS syndrome may be more common than thought, study suggests | CNN



CNN
— 

David Adams spent half a decade fighting an illness he couldn’t name. He was in and out of the hospital several times per year. His inflamed joints made his hands feel like they had been squeezed into gloves – and he could no longer play his beloved classical and jazz guitars.

He had constant fevers and fatigue. He even developed pain and swelling in his genitalia, which was his first sign that something was really wrong.

“At the turn of the year 2016, I started with some really painful effects in the male anatomy,” said Adams, now 70. “After that, again, a lot of fatigue – my primary care physician at that point had blood tests done, and my white blood cell count was very, very low.”

Next, Adams, who lives in Alexandria, Virginia, saw a hematologist, a pulmonologist, a urologist, a rheumatologist and then a dermatologist. Some of them thought he might have cancer.

Adams’ symptoms continued, with even more fatigue, pneumonia and a large rash below his waist. He tried at least a dozen medications, saw about two dozen doctors, and nothing helped.

In 2019, worsening symptoms forced him to retire early from his decades-long career in clinical data systems. But he remained in the dark about what was causing the problems.

Finally, in 2020, scientists at the National Institutes of Health discovered and named a rare genetic disorder: VEXAS syndrome, which wreaks havoc on the body through inflammation and blood problems.

Adams had an appointment with his rheumatologist at the time, and when he walked into the office, he saw that his physician “was giddy like a little kid.”

In his doctor’s hands was a copy of a paper in the New England Journal of Medicine detailing the discovery of VEXAS syndrome.

Adams had his answer.

“For the first time, there was a one-to-one correlation of symptoms,” he said. “It was quite a shock.”

An estimated 1 in about 13,500 people in the United States may have VEXAS syndrome, a new study suggests, which means the mysterious and sometimes deadly inflammatory disorder may be more common than previously thought.

In comparison, the genetic disorder spinal muscular atrophy affects about 1 in 10,000 people and Huntington’s disease occurs in about 1 in every 10,000 to 20,000 people.

Since its discovery, occasional VEXAS cases have been reported in medical research, but the study reveals new estimates of its prevalence.

The research, published Tuesday in the journal JAMA, suggests that about 1 in 13,591 people in the US have mutations in the UBA1 gene, which develop later in life and cause VEXAS syndrome.

“This study is demonstrating that there’s likely tens of thousands of patients in the US that have this disease, and the vast majority of them are probably not being recognized because physicians aren’t really considering this as a diagnosis more broadly,” said Dr. David Beck, an assistant professor in the Department of Medicine at NYU Langone Health and a lead author of the study.

VEXAS syndrome is not inherited, so people who have it don’t pass the disease to their children. But the UBA1 gene is on the X chromosome, so the syndrome is an X-linked disease. It predominantly affects men, who carry only one X chromosome. Women have two X chromosomes, so if they have a mutation in a gene on one X chromosome but not the other, they are generally unaffected.

“It’s present in 1 in 4,000 men over the age of 50. So we think it’s a disease that should be thought about in terms of testing for individuals that have the symptoms,” said Beck, who also led the federal research team that identified the shared UBA1 mutation among VEXAS patients in 2020.

“The benefit of VEXAS syndrome is that we have a test. We have a genetic test that can help directly provide the diagnosis,” he said. “It’s just a question of patients who meet the criteria – who are older individuals with systemic inflammation, low blood counts, who really aren’t responding to anything but steroids – then advocating to their doctors to get genetic testing to get a diagnosis.”

Adams, who became a patient of Beck’s, said that finally getting a diagnosis – and understanding the cause of his symptoms – was life-changing.

“It really was incredibly freeing to have the diagnosis,” he said.

“You can’t fight your enemy unless your enemy has a name,” he added. “We finally had something where we could point to and say, ‘OK, we understand what’s going on. This is VEXAS.’ “

For the new study, Beck and his colleagues at the NIH, New York University, Geisinger Research and other institutions analyzed data on 163,096 patients in a health system in central and northeastern Pennsylvania, from January 1996 to January 2022, including electronic health records and blood samples.

Eleven of the patients had a disease-causing UBA1 variant, and a 12th person had a “highly suspicious” variant.

Only three of the 12 are still alive. A five-year survival rate of 63% has been previously reported with VEXAS.

Among the 11 patients in the new study who had pathogenic variants in UBA1, only two were women. Seven had arthritis as a symptom, and four had been diagnosed with rheumatologic diseases, such as psoriasis of the skin or sarcoidosis, which causes swollen lumps in the body. All had anemia or low blood cell counts.

“None had been previously clinically diagnosed with VEXAS syndrome,” Beck said.

The finding “is emphasizing how it’s important to be able to pick these patients out, give them the diagnosis and start the aggressive therapies or aggressive treatments to keep their inflammation in check,” he said.

VEXAS – an acronym for five clinical characteristics of the disease – has no standardized treatment or cure, but Beck said symptoms can be managed with medications like the steroid prednisone or other immunosuppressants.

“But the toxicities of prednisone over years is challenging. There are other anti-inflammatory medications that we use, but they’re only partially effective at the moment,” he said. “One treatment for individuals that we’ve seen that’s very effective is bone marrow transplantation. That comes with its own risks, but that’s just underscoring the severe nature of the disease.”

Although the new study helps provide estimates of the prevalence and symptoms of VEXAS syndrome, the data is not representative of the entire United States, and Beck said that more research needs to be done on a larger, more diverse group of people.

Some men might be hesitant to seek medical care for VEXAS symptoms, but Adams said that doing so could save their life.

“Eventually, it’s going to get so bad that you’ll end up like my first hospitalization, where you’re on death’s door,” Adams said. “You don’t want to be in that situation.”

Adams has been taking prednisone to ease his symptoms, and it’s helped. But because steroid use can have side effects such as cataracts and weight gain, he has been working with his doctors to find other therapies so he can reduce his intake of the medication.

Beck and his colleagues are studying targeted therapies for VEXAS syndrome, as well as conducting stem cell bone marrow transplant trials at the NIH.

“There are many different facets of the disease,” Dr. Bhavisha Patel, a hematologist and researcher in the National Heart, Lung and Blood Institute’s Hematopoiesis and Bone Marrow Failure Laboratory, said in an NIH news release last month.

“I believe that is what is challenging when we think about treatment, because it’s so heterogeneous,” said Patel, who was not involved in the new study.

“Both at NIH and worldwide, the groups that have dedicated themselves to VEXAS are looking for medical therapies to offer to other patients who don’t qualify for a bone marrow transplant,” she said. “We continue to collaborate on many projects in order to categorize this disease further and ultimately come up with the best treatment options.”

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Many women underestimate breast density as a risk factor for breast cancer, study shows | CNN



CNN
— 

Dense breast tissue has been associated with up to a four times higher risk of breast cancer. However, a new study suggests few women view breast density as a significant risk factor.

The study, published in JAMA Network Open, surveyed 1,858 women ages 40 to 76 years from 2019 to 2020 who reported having recently undergone mammography, had no history of breast cancer and had heard of breast density.

Women were asked to compare the risk of breast density to five other breast cancer risk factors: having a first-degree relative with breast cancer, being overweight or obese, drinking more than one alcoholic beverage per day, never having children and having a prior breast biopsy.

“When compared to other known and perhaps more well-known breast cancer risks, women did not perceive breast density as significant of a risk,” said Laura Beidler, an author of the study and researcher at the Dartmouth Institute for Health Policy and Clinical Practice.

For example, the authors report that dense breast tissue is associated with a 1.2 to four times higher risk of breast cancer compared with a two times higher risk associated with having a first-degree relative with breast cancer – but 93% of women said breast density was a lesser risk.

Dense breasts tissue refers to breasts that are composed of more glandular and fibrous tissue than fatty tissue. It is a normal and common finding present in about half of women undergoing mammograms.

The researchers also interviewed 61 participants who reported being notified of their breast density and asked what they thought contributes to breast cancer and how they could reduce their risk. While most women correctly noted that breast density could mask tumors on mammograms, few women felt that breast density could be a risk factor for breast cancer.

Roughly one-third of women thought there was nothing they could do to reduce their breast cancer risk, although there are several ways to reduce risk, including maintaining a healthy, active lifestyle and minimizing alcohol consumption.

Breast density changes over a woman’s lifetime, and is generally higher in women who are younger, have a lower body weight, are pregnant or breastfeeding, or are taking hormone replacement therapy.

The level of breast cancer risk increases with the degree of breast density; however, experts aren’t certain why this is true.

“One hypothesis has been that women who have more dense breast tissue also have higher, greater levels of estrogen, circulating estrogen, which contributes to both the breast density and to the risk of developing breast cancer,” said Dr. Harold Burstein, a breast oncologist at the Dana-Farber Cancer Institute who was not involved in the study. “Another hypothesis is that there’s something about the tissue itself, making it more dense, that somehow predisposes to the development of breast cancer. We don’t really know which one explains the observation.”

Thirty-eight states currently mandate that women receive written notification about their breast density and its potential breast cancer risk following mammography; however, studies have shown that many women find this information confusing.

“Even though women are notified usually in writing when they get a report after a mammogram that says, ‘You have increased breast density,’ it’s kind of just tucked in there at the bottom of the report. I’m not sure that anyone is explaining to them, certainly in person or verbally, what that means,” said Dr. Ruth Oratz, a breast oncologist at NYU Langone’s Perlmutter Cancer Center who was not involved in the study.

“I think what we’ve learned from this study is that we have to do a better job of educating not only the general public of women, but the general public of health care providers who are doing the primary care, who are ordering those screening mammograms,” she added.

Current screening guidelines recommend women of average risk of breast cancer undergo breast cancer screening every one to two years between ages 50 to 74 with the option of beginning at age 40.

Because women with dense breast tissue are considered to have higher than average cancer risks, the authors of the study suggest women with high breast density may benefit from supplemental screening like breast MRI or breast ultrasound, which may detect cancers that are missed on mammograms. Currently, coverage of supplemental screening after the initial mammogram varies, depending on the state and insurance policy.

The authors warn that “supplemental screening not only can lead to increased rates of cancer detection but also may result in more false-positive results and recall appointments.” They say clinicians should use risk assessment tools when discussing tradeoffs associated with supplemental screening.

“Usually, it’s a discussion between the patient, the clinical team, and the radiologist. And it’ll be affected by prior history, by whether there’s anything else of concern on the mammogram, by the patient’s family history. So those are the kinds of things we discuss frequently with patients who are in such situations,” Burstein said.

Breast cancer screening recommendations differ between medical organizations, and experts say women at higher risk due to breast density should discuss with their doctor what screening method and frequency are most appropriate.

“I think it’s really, really important that everyone understands – and this is the doctors, the nurses, the women themselves – that screening is not a one size fits all recommendation. We cannot just make one general recommendation to the entire population because individual women have different levels of risks of developing breast cancer,” Oratz said.

For the nearly one-third of women with dense breast tissue that reported there was nothing they could do to prevent breast cancer, experts say there are some steps you can take to reduce your risk.

“Maintaining an active, healthy lifestyle and minimizing alcohol consumption address several modifiable factors. Breastfeeding can decrease the risk. On the other hand, use of hormone replacement therapy increases breast cancer risk,” said Dr. Puneet Singh, a breast surgical oncologist at the MD Anderson Cancer Center who was not involved in the study.

The researchers add that there are approved medications, such as tamoxifen, that can be given for those at significantly increased risk that may reduce the chances of breast cancer by about half.

Finally, breast cancer doctors say that in addition to appropriate screening, knowing your risk factors and advocating for yourself can be powerful tools in preventing and detecting breast cancer.

“At any age, if any woman feels uncomfortable about something that’s going on in her breast, if she has discomfort, notices a change in the breast, bring that to the attention of your doctor and make sure it gets evaluated and don’t let somebody just brush you off,” Oratz said.

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Pediatricians are giving out free gun locks to approach the gun violence epidemic as a public health crisis | CNN



CNN
— 

In a triage waiting room of St. Louis Children’s Hospital in Missouri, a clear basket filled with gun locks sits near the walkway, just noticeable enough to those passing by.

The hospital staff calls it the “No Questions Asked” basket, to encourage gun safety without having to confront gun owners about what can be a sensitive and divisive topic. It holds an assortment of cable gun locks free of charge, available to those who need them, alongside pamphlets explaining how to properly and safely store firearms.

The initiative, aimed at reducing the stigma of addressing gun safety, is part of a growing effort by medical professionals who are treating the country’s gun violence epidemic as a public health crisis.

“It takes standing at the bedside of one child who has been shot to realize that we all have to do more and as the leading cause of death for children in this country, pediatricians need to be front and center of the solution, of all the solutions,” said Dr. Annie Andrews, a professor of pediatrics at the Medical University of South Carolina and an expert on gun violence prevention.

Over the course of two years, thousands of gun locks have been taken from the basket, according to Dr. Lindsay Clukies, a pediatric emergency medicine physician at the hospital.

In the coming weeks, baskets filled with free gun locks will be available at more than 17 locations operated by BJC HealthCare, an organization serving metro St. Louis, mid-Missouri and Southern Illinois, Clukies said. It’s a low-cost and effective way to easily distribute firearm safety devices.

“We’ve had employees as well as patients take our locks, also their families and even a grandmother who took one for her grandson. It’s for anyone who needs them,” Clukies told CNN. In recent years, a rising number of pediatricians across the country have been engaging with the topic of gun safety in medical settings by focusing on safety and prevention, already a natural aspect of their work.

During patient visits, it’s increasingly common for pediatricians to ask the patient’s parents if there are guns at home, and if so, how they are stored. Some hospitals then offer free gun locks, often sourced from donations or police departments and paired with safe storage education.

Some pediatricians, who bear witness to the effects of gun violence on children in their workplace every day, told CNN they see it as their obligation as medical professionals to be part of the solution to the epidemic.

In 2022, 1,672 children and teenagers under 17 were killed by gun violence and 4,476 were injured, according to the Gun Violence Archive, a nonprofit organization tracking injuries and deaths by gunfire since 2014.

“We have just as an important voice in this conversation as anyone else because we’re the ones who have invested our entire careers to protecting children and ensuring that children can grow up to be the safest healthiest version of themselves,” said Andrews.

“It is only natural that we see these things that we understand that they’re preventable, and we want to get involved in finding the solutions,” she added.

So far in 2023, high-profile incidents of children accessing firearms have heeded calls for stronger, more consistent laws nationwide, requiring adults to safely secure their guns out of the reach of children and others unauthorized to use them. They have also highlighted a lack of public education on the responsibility of gun owners to store their guns unloaded, locked and away from ammunition, CNN previously reported.

In early January, a 6-year-old boy was taken into police custody after he took a gun purchased by his mother from his home, brought it to school and shot his teacher at Richneck Elementary School in Newport News, Virginia, police said. Just over a week later, a man was arrested in Beech Grove, Indiana, after video was shown on live TV of a toddler, reportedly the man’s son, waving and pulling the trigger of a handgun, CNN previously reported.

Hundreds of children in the US every year gain access to firearms and unintentionally shoot themselves or someone else, according to research by Everytown for Gun Safety, a leading non-profit organization focusing on gun violence prevention. In 2022, there were 301 unintentional shootings by children, resulting in 133 deaths and 180 injuries nationally, Everytown data showed.

Firearm injuries are now the leading cause of death among people younger than 24 in the United States, according to the Centers for Disease Control and Prevention. The American Academy of Pediatrics released an updated policy statement in October 2022, stating firearms are now the leading cause of death in children under the age of 24 in the US.

The Academy’s statement urged a “multipronged approach with layers of protection focused on harm reduction, which has been successful in decreasing motor vehicle-related injuries, is essential to decrease firearm injuries and deaths in children and youth.”

The Academy has free educational modules for pediatricians to guide them on how to have what can be challenging or uncomfortable conversations about firearms with families, according to Dr. Lois Kaye Lee, a pediatrician and the chair of the Academy’s Council on Injury, Violence and Poison Prevention.

“This shouldn’t be considered as something extra; it should be considered as part of the work that we do every day around injury prevention, be it around firearms, child passenger safety and suicide prevention,” Lee said.

Dr. Georges Benjamin, executive director of the American Public Health Association, told CNN the public health approach to addressing gun violence removes the politics from the issue and “puts it into a scientific evidence-based framework.”

“Physicians have a unique opportunity to engage their patients, the parents of kids or the parents themselves as individuals to make their homes safer,” Benjamin said. “We already do this for toxins under our kitchen cabinets, razor blades and outlets in the wall.”

In the emergency department at St. Louis Children’s Hospital, all patients are screened for access to firearms and offered free gun locks, as well as safe storage education, Clukies said. Gun locks can also be mailed to families, free of cost, through the hospital’s website.

“Every patient that comes into our emergency department, whether it’s for a fever or a cold or a broken arm, is asked about access to firearms,” said Clukies, adding 5,000 locks have been given out since the initiatives were started in 2021.

In a collaborative effort between trauma nurses, physicians, social workers, violence intervention experts and family partners, the hospital created a “nonjudgmental” script for doctors to follow as they ask patients about access to firearms, Clukies said.

During the screening process, pediatricians will ask parents or caretakers questions such as: Do you have access to a firearm where your child lives or plays? How is it stored? Is it stored unloaded or loaded?

“When I first started doing this, I would say, ‘Are there any guns in the home? Yes, or no?’ But I have found and learned from other experts that if you just say, ‘If there are any guns in the home, do you mind telling me how they’re secured?’ it takes away the judgment,” said Andrews, a pediatrician whose hospital, the Medical University of South Carolina, also offers free gun locks to patients.

An assortment of cable gun locks offered free of charge by the Medical University of South Carolina.

Families are asked about firearms in the “social history” phase of a patient visit, during which pediatricians will ask who lives in the home, what grade the child is in, what activities they engage in and where the child goes to school, according to Andrews. When parents indicate their firearms are not safely stored, like on the top of a shelf or in a nightstand drawer, Andrews said those are important opportunities for intervention and education about storage devices such as keypad lockboxes, fingerprint biometric safes and other types of lock systems.

It’s also important for pediatricians to understand the parents’ or caretakers’ motivation for owning a firearm to “inform the conversation about where they’re willing to meet you as far as storage goes,” she added.

Andrews and Clukies said they were pleasantly surprised by the willingness of families to discuss firearm safety, most of whom recognize it is an effort to protect their children.

“I expected more pushback than we received, which is attributed to us really focusing on how we properly word these questions,” Clukies said. “I think it’s because we turn it into a neutral conversation, and we focus on safety and prevention.”

Andrews added it is uncommon for medical schools or residencies to discuss gun violence prevention, which she says is due to the “politics around the issue.”

“Thankfully, that has evolved, and more and more pediatricians are realizing that we have to be an integral part of the solution to this problem,” Andrews said.

At the St. Louis Children’s Hospital, pediatricians followed up with patients who received a free gun lock in a research study roughly two months after they launched the initiative in the fall of 2021 to see if their storage practices changed.

The study found two-thirds of families reported using the gun lock provided to them by the hospital and there was a “statistically significant decrease” in those who didn’t store their firearms safely, as well as an increase in those who stored their firearms unloaded, according to Clukies.

But there is still much more work to be done in the medical community to fight the gun violence epidemic and scientific research on the issue is “woefully underfunded,” Andrews contended.

According to the American Public Health Association’s Benjamin, a multidisciplinary approach by policymakers, law enforcement and the medical community is essential to fostering a safer environment for children.

“Injury prevention is a core part of every physician’s job,” Benjamin said. “It’s clearly in our lane.”

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Flu, Covid-19 and RSV are all trending down for the first time in months | CNN



CNN
— 

A rough respiratory virus season in the US appears to be easing, as three major respiratory viruses that have battered the country for the past few months are finally all trending down at the same time.

A new dataset from the US Centers for Disease Control and Prevention shows that the number of emergency department visits for the three viruses combined – flu, Covid-19 and RSV – have dropped to the lowest they’ve been in three months. The decline is apparent across all age groups.

Measuring virus transmission levels can be challenging; health officials agree that Covid-19 cases are vastly undercounted, and surveillance systems used for flu and RSV capture a substantial, but incomplete picture.

But experts say that tracking emergency department visits can be a good indicator of how widespread – and severe – the respiratory virus season is.

“There’s the chief complaint. When you show up to the emergency room, you complain about something,” said Janet Hamilton, executive director at Council of State and Territorial Epidemiologists. “Being able to look at the proportion of individuals that seek care at an emergency department for these respiratory illness concerns is a really good measure of the respiratory disease season.”

In the week following Thanksgiving, emergency department visits for respiratory viruses topped 235,000 – matching rates from last January, according to the CDC data.

While the surge in emergency department visits early in the year was due almost entirely to Omicron, the most recent spike was much more varied. In the week ending December 3, about two-thirds of visits were for flu, about a quarter were for Covid-19 and about 10% were for RSV.

Grouping the impact of all respiratory viruses together in this way offers an important perspective.

“There’s a strong interest in thinking about respiratory diseases in a more holistic way,” Hamilton said. “Transmission is the same. And there are certain types of measures that are good protection against all respiratory diseases. So that could really help people understand that when we are in high circulation for respiratory diseases, there are steps that you can take – just in general.”

Now, Covid-19 again accounts for most emergency department visits but flu and RSV are still the reason behind about a third of visits – and they’re all trending down for the first time since the respiratory virus season started picking up in September.

More new data from the CDC shows that overall respiratory virus activity continues to decline across the country. Only four states, along with New York City and Washington, DC, had “high” levels of influenza-like illness. Nearly all states were in this category less than a month ago.

Whether that pattern will hold is still up in the air, as vaccination rates for flu and Covid-19 are lagging and respiratory viruses can be quite fickle. Also, while the level of respiratory virus activity is lower than it’s been, it’s still above baseline in most places and hospitals nationwide are still about 80% full.

RSV activity started to pick up in September, reaching a peak in mid-November when 5 out of every 100,000 people – and 13 times as many children younger than five – were hospitalized in a single week.

RSV particularly affects children, and sales for over-the-counter children’s pain- and fever-reducing medication were 65% higher in November than they were a year before, according to the Consumer Healthcare Products Association. While “the worst may be over,” demand is still elevated, CHPA spokesperson Logan Ramsey Tucker told CNN in an email – sales were up 30% year-over-year in December.

But this RSV season has been significantly more severe than recent years, according to CDC data. The weekly RSV hospitalization rate has dropped to about a fifth of what it was two months ago, but it is still higher than it’s been in previous seasons.

Flu activity ramped up earlier than typical, but seems to have already reached a peak. Flu hospitalizations – about 6,000 new admissions last week – have dropped to a quarter of what they were at their peak a month and a half ago, and CDC estimates for total illnesses, hospitalizations and deaths from flu so far this season have stayed within the bounds of what can be expected. It appears the US has avoided the post-holiday spike that some experts cautioned against, but the flu is notoriously unpredictable and it’s not uncommon to see a second bump later in season.

The Covid-19 spike has not been as pronounced as flu, but hospitalizations did surpass levels from the summer. However, the rise in hospitalizations that started in November has started to tick down in recent weeks and CDC data shows that the share of the population living in a county with a “high” Covid-19 community level has dropped from 22% to about 6% over the past two weeks.

Still, the XBB.1.5 variant – which has key mutations that experts believe may be helping it to be more infectious – continues to gain ground in the US, causing about half of all infections last week. Vaccination rates continue to lag, with just 15% of the eligible population getting their updated booster and nearly one in five people remain completely unvaccinated.

Ensemble forecasts published by the CDC are hazy, predicting a “stable or uncertain trend” in Covid-19 hospitalizations and deaths over the next month.

And three years after the first Covid-19 case was confirmed in the US, the virus has not settled into a predictable pattern, according to Dr. Maria Van Kerkhove, the World Health Organization’s technical lead for the Covid-19 response.

“We didn’t need to have this level of death and devastation, but we’re dealing with it, and we are doing our best to minimize the impact going forward,” Van Kerkhove told the Conversations on Healthcare podcast this week.

Van Kerkhove says she does believe 2023 could be the year in which Covid-19 would no longer be deemed a public health emergency in the US and across the world, but more work needs to be done in order to make that happen and transitioning to longer-term respiratory disease management of the outbreak will take more time.

“We’re just not utilizing [vaccines] most effectively around the world. I mean 30% of the world still has not received a single vaccine,” she said. “In every country in the world, including in the US, we’re missing key demographics.”

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