They Were Shot at the Super Bowl Parade — And Might Have Bullets in Their Bodies Forever

James Lemons, 39, wants the bullet removed from his thigh so he can go back to work.

Sarai Holguin, a 71-year-old woman originally from Mexico, has accepted the bullet lodged near her knee as her “compa” — a close friend.

Mireya Nelson, 15, was hit by a bullet that went through her jaw and broke her shoulder, where fragments remain. She’ll live with them for now, while doctors monitor lead levels in her blood for at least two years.

Nearly three months after the Kansas City Chiefs Super Bowl parade shooting left at least 24 people injured, recovery from those wounds is intensely personal and includes a surprising gray area in medicine: whether the bullets should be removed.

Medical protocol offers no clear answer. A 2016 survey of surgeons found that only about 15% of respondents worked at medical facilities that had policies on bullet removal. Doctors in the U.S. often leave bullets buried deep in a person’s body, at least at first, so as not to cause further trauma.

But as gun violence has emerged as a public health epidemic, some researchers wonder if that practice is best. Some of the wounded, like James Lemons, are left in a precarious place.

“If there’s a way to get it out, and it’s safely taken out, get it out of the person,” Lemons said. “Make that person feel more secure about themselves. And you’re not walking around with that memory in you.”

Lemons, Holguin, and Nelson are coping in very different ways.

Pain Became a Problem

Three days after the Chiefs won the Super Bowl, Lemons drove the 37 miles from Harrisonville, Missouri, to downtown Kansas City to celebrate the victory. The warehouse worker was carrying his 5-year-old daughter, Kensley, on his shoulders when he felt a bullet enter the back of his right thigh.

A photo of a man at the Kansas City Chiefs Super Bowl parade carrying his daughter on his shoulders.
James Lemons was carrying daughter Kensley on his shoulders at the Kansas City Chiefs Super Bowl parade when he felt a bullet enter the back of his right thigh. He says his first thought amid the chaos was getting his family to safety.(Brandie Lemons)

Gunfire erupted in the area packed with revelers, prosecutors later said, after a “verbal confrontation” between two groups. Detectives found “multiple 9mm and .40 caliber spent shell casings” at the scene. Lemons said he understood immediately what was happening.

“I know my city. We’re not shooting off fireworks,” he said.

Lemons shielded Kensley’s face as they fell to the ground so she wouldn’t hit the concrete. His first thought was getting his family — also including his wife, Brandie; 17-year-old daughter, Kallie; and 10-year-old son, Jaxson — to safety.

“I’m hit. But don’t worry about it,” Lemons recalled telling Brandie. “We gotta go.”

He carried Kensley on his shoulders as the family walked a mile to their car. His leg bled through his pants at first then stopped, he said. It burned with pain. Brandie insisted on driving him to the hospital but traffic was at a standstill so she put on her hazard lights and drove on the wrong side of the road.

“She’s like: ‘I’m getting you to a hospital. I’m tired of people being in my way,’” Lemons recalled. “I’ve never seen my wife like that. I’m looking at her like, ‘That’s kinda sexy.’”

Lemons clapped and smiled at his wife, he said, to which she replied, “What are you smiling for? You just got shot.” He stayed in quiet admiration until they were stopped by a sheriff, who summoned an ambulance, Lemons said.

He was taken to the emergency room at University Health, which admitted 12 patients from the rally, including eight with gunshot wounds. Imaging showed the bullet barely missed an artery, Lemons said. Doctors cleansed the wound, put his leg in a brace, and told him to come back in a week. The bullet was still in his leg.

“I was a little baffled by it, but I was like, ‘OK, whatever, I’ll get out of here,’” Lemons recalled.

When he returned, doctors removed the brace but explained they often leave bullets and fragments in the body — unless they grow too painful.

“I get it, but I don’t like that,” Lemons said. “Why wouldn’t you take it out if you could?”

University Health spokesperson Leslie Carto said the hospital can’t comment on individual patient care because of federal privacy laws.

Surgeons typically do remove bullets when they encounter them during surgery or they are in dangerous locations, like in the spinal canal or risking damage to an organ, said Brendan Campbell, a pediatric surgeon at Connecticut Children’s.

Campbell also chairs the Injury Prevention and Control Committee of the American College of Surgeons’ Committee on Trauma, which works on firearm injury prevention.

LJ Punch, a trauma surgeon by training and the founder of the Bullet Related Injury Clinic in St. Louis, said the origins of trauma care also help explain why bullets are so often left.

“Trauma care is war medicine,” Punch said. “It is set to be ready at any moment and any time, every day, to save a life. It is not equipped to take care of the healing that needs to come after.”

In the survey of surgeons, the most common reasons given for removing a bullet were pain, a palpable bullet lodged near the skin, or an infection. Far less common were lead poisoning and mental health concerns such as post-traumatic stress disorder and anxiety.

What patients wanted also affected their decisions, the surgeons said.

A man in glasses and a sports jersey stands next to a tree and poses for a photo.
After being shot in the leg at the Kansas City Chiefs Super Bowl parade, Lemons was initially told the bullet would stay there, unless it became a problem. “I get it, but I don’t like that,” Lemons says. “Why wouldn’t you take it out if you could?”(Bram Sable-Smith/KFF Health News)

Lemons wanted the bullet out. The pain it caused in his leg radiated up from his thigh, making it difficult to move for more than an hour or two. Working his warehouse job was impossible.

“I gotta lift 100 pounds every night,” Lemons recalled telling his doctors. “I gotta lift my child. I can’t work like this.”

He has lost his income and his health insurance. Another stroke of bad luck: The family’s landlord sold their rental home soon after the parade, and they had to find a new place to live. This house is smaller, but it was important to keep the kids in the same school district with their friends, Lemons said in an interview in Kensley’s pink bedroom, the quietest spot to talk.

They’ve borrowed money and raised $6,500 on GoFundMe to help with the deposit and car repairs, but the parade shooting has left the family in a deep financial hole.

Without insurance, Lemons worried he couldn’t afford to have the bullet removed. Then he learned his surgery would be paid for by donations. He set up an appointment at a hospital north of the city, where a surgeon took measurements on his X-ray and explained the procedure.

“I need you to be involved as much as I’m going to be involved,” he remembered being told, “because — guess what — this ain’t my leg.”

The surgery is scheduled for this month.

‘We Became Friends’

Sarai Holguin isn’t much of a Chiefs fan, but she agreed to go to the rally at Union Station to show her friend the best spot to see the players on stage. It was an unseasonably warm day, and they were standing near an entrance where lots of police were stationed. Parents had babies in strollers, kids were playing football, and she felt safe.

A little before 2 p.m., Holguin heard what she thought were fireworks. People started running away from the stage. She turned to leave, trying to find her friend, but felt dizzy. She didn’t know she’d been shot. Three people quickly came to her aid and helped her to the ground, and a stranger took off his shirt and made a tourniquet to put on her left leg.

Holguin, a native of Puebla, Mexico, who became a U.S. citizen in 2018, had never seen so much chaos, so many paramedics working under such pressure. They were “anonymous heroes,” she said.

She saw them working on Lisa Lopez-Galvan, a well-known DJ and 43-year-old mother of two. Lopez-Galvan died at the scene, and was the sole fatality at the parade. Holguin was rushed to University Health, about five minutes from Union Station.

A woman sits next to a man on a couch. The woman holds a walker.
In the chaos of being shot at the Kansas City Chiefs Super Bowl parade, then hospitalized, Sarai Holguin lost her purse and cellphone. Her husband, Cesar, and daughter searched for her for about eight hours.(Christopher Smith for KFF Health News)

There doctors performed surgery, leaving the bullet in her leg. Holguin awoke to more chaos. She had lost her purse, along with her cellphone, so she couldn’t call her husband, Cesar. She had been admitted to the hospital under an alias — a common practice at medical centers to begin immediate care.

Her husband and daughter didn’t find her until about 10 p.m. — roughly eight hours after she’d been shot.

“It has been a huge trauma for me,” Holguin said through an interpreter. “I was injured and at the hospital without doing anything wrong. [The rally] was a moment to play, to relax, to be together.”

Holguin was hospitalized for a week, and two more outpatient surgeries quickly followed, mostly to remove dead tissue around the wound. She wore a wound VAC, or vacuum-assisted closure device, for several weeks and had medical appointments every other day.

Campbell, the trauma surgeon, said wound VACs are common when bullets damage tissue that isn’t easily reconstructed in surgery.

“It’s not just the physical injuries,” Campbell said. “Many times it’s the emotional, psychological injuries, which many of these patients take away as well.”

The bullet remains near Holguin’s knee.

A woman sits on a couch, holding a walker, with a bandage wrapped around her left knee.
Holguin, a native of Puebla, Mexico, who became a U.S. citizen in 2018, was shot in the leg at the Kansas City Chiefs Super Bowl parade. Now using a walker, she says the most frustrating consequence is not being able to travel to see her father, still in Mexico.(Christopher Smith for KFF Health News)

“I’m going to have it for the rest of my life,” she said, saying she and the bullet became “compas,” close friends.

“We became friends so that she doesn’t do any bad to me anymore,” Holguin said with a smile.

Punch, of the Bullet Related Injury Clinic in St. Louis, said some people like Holguin are able to find a way to psychically live with bullets that remain.

“If you’re able to make a story around what that means for that bullet to be in your body, that gives you power; that gives you agency and choice,” Punch said.

Holguin’s life changed in an instant: She’s using a walker to get around. Her foot, she said, acts “like it had a stroke” — it dangles, and it’s difficult to move her toes.

The most frustrating consequence is that she cannot travel to see her 102-year-old father, still in Mexico. She has a live camera feed on her phone to see him, but that doesn’t offer much comfort, she said, and thinking about him brings tears.

She was told at the hospital that her medical bills would be taken care of, but then lots of them came in the mail. She tried to get victim assistance from the state of Missouri, but all the forms she had were in English, which made them difficult to comprehend. Renting the wound VAC alone cost $800 a month.

Finally she heard that the Mexican Consulate in Kansas City could help, and the consul pointed her to the Jackson County Prosecutor’s Office, with which she registered as an official victim. Now all of her bills are being paid, she said.

Holguin isn’t going to seek mental health treatment, as she believes one must learn to live with a given situation or it will become a burden.

“I have processed this new chapter in my life,” Holguin said. “I have never given up and I will move on with God’s help.”

A woman wearing a black dress walks in her dining room using a walker.
At the Kansas City Chiefs Super Bowl parade, Holguin heard what she thought were fireworks, unaware she had been shot. She underwent surgery and doctors opted to leave the bullet in her leg. She’s now using a walker to get around.(Christopher Smith for KFF Health News)

‘I Saw Blood on My Hands’

Mireya Nelson was late to the parade. Her mother, Erika, told her she should leave early, given traffic and the million people expected to crowd into downtown Kansas City, but she and her teenage friends ignored that advice. The Nelsons live in Belton, Missouri, about a half hour south of the city.

Mireya wanted to hold the Super Bowl trophy. When she and her three friends arrived, the parade that had moved through downtown was over and the rally at Union Station had begun. They were stuck in the large crowd and quickly grew bored, Mireya said.

Getting ready to leave, Mireya and one of her friends were trying to call the driver of their group, but they couldn’t get cell service in the large crowd.

Amid the chaos of people and noise, Mireya suddenly fell.

An adolescent girl lies in a hospital bed with wounds on her face.
A bullet went through the jaw of Mireya Nelson during the Kansas City Chiefs Super Bowl parade on Feb. 14. She also has bullet fragments in her shoulder and will need to have her blood tested for lead for at least the next two years.(Erika Nelson)

“I saw blood on my hands. So then I knew I got shot. Yeah, and I just crawled to a tree,” Mireya said. “I actually didn’t know where I got shot at, at first. I just saw blood on my hands.”

The bullet grazed Mireya’s chin, shot through her jaw, broke her shoulder, and left through her arm. Bullet fragments remain in her shoulder. Doctors decided to leave them because Mireya had already suffered so much damage.

Mireya’s mother supports that decision, for now, noting they were just “fragments.”

“I think if it’s not going to harm her the rest of her life,” Erika said, “I don’t want her to keep going back in the hospital and getting surgery. That’s more trauma to her and more recovery time, more physical therapy and stuff like that.”

Bullet fragments, particularly ones only skin-deep, often push their way out like splinters, according to Punch, although patients aren’t always told about that. Moreover, Punch said, injuries caused by bullets extend beyond those with damaged tissue to the people around them, like Erika. He called for a holistic approach to recover from all the trauma.

“When people stay in their trauma, that trauma can change them for a lifetime,” Punch said.

Mireya will be tested for lead levels in her blood for at least the next two years. Her levels are fine now, doctors told the family, but if they get worse she will need surgery to remove the fragments, her mother said.

Campbell, the pediatric surgeon, said lead is particularly concerning for young children, whose developing brains make them especially vulnerable to its harmful effects. Even a tiny amount of lead — 3.5 micrograms per deciliter — is enough to report to state health officials, according to the Centers for Disease Control and Prevention.

A photo of a woman in a hospital bed. A man and a woman stand next to her, smiling.
Nelson was one of at least 24 people injured by gunfire during the parade. Here, Chiefs quarterback Patrick Mahomes and his wife, Brittany, visit her at Children’s Mercy hospital.(Erika Nelson)

Mireya talks about cute teenage boys’ being “fine” but also still wears Cookie Monster pajamas. She appears confused by the shootings, by all the attention at home, at school, from reporters. Asked how she feels about the fragments in her arm, she said, “I don’t really care for them.”

Mireya was on antibiotics for 10 days after her hospital stay because doctors feared there was bacteria in the wound. She has had physical therapy, but it’s painful to do the exercises. She has a scar on her chin. “A dent,” she said, that’s “bumpy.”

“They said she was lucky because if she wouldn’t have turned her head in a certain way, she could be gone,” Erika said.

Mireya faces a psychiatric evaluation and therapy appointments, though she doesn’t like to talk about her feelings.

So far, Erika’s insurance is paying the medical bills, though she hopes to get some help from the United Way’s #KCStrong fund, which raised nearly $1.9 million, or a faith-based organization called Unite KC.

Erika doesn’t want a handout. She has a job in health care and just got a promotion.

The bullet has changed the family’s life in big ways. It is part of their conversation now. They talk about how they wish they knew what kind of ammunition it was, or what it looked like.

“Like, I wanted to keep the bullet that went through my arm,” Mireya said. “I want to know what kind of bullet it was.” That brought a sigh from her mom, who said her daughter had watched too many episodes of “Forensic Files.”

Erika beats herself up about the wound, because she couldn’t protect her daughter at the parade.

“It hits me hard because I feel bad because she begged me to get off work and I didn’t go there because when you have a new position, you can’t just take off work,” Erika said. “Because I would have took the bullet. Because I would do anything. It’s mom mode.”

This article was produced by KFF Health News, a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

Forget Ringing the Button for the Nurse. Patients Now Stay Connected by Wearing One.

HOUSTON — Patients admitted to Houston Methodist Hospital get a monitoring device about the size of a half-dollar affixed to their chest — and an unwitting role in the expanding use of artificial intelligence in health care.

The slender, battery-powered gadget, called a BioButton, records vital signs including heart and breathing rates, then wirelessly sends the readings to nurses sitting in a 24-hour control room elsewhere in the hospital or in their homes. The device’s software uses AI to analyze the voluminous data and detect signs a patient’s condition is deteriorating.

Hospital officials say the BioButton has improved care and reduced the workload of bedside nurses since its rollout last year.

“Because we catch things earlier, patients are doing better, as we don’t have to wait for the bedside team to notice if something is going wrong,” said Sarah Pletcher, system vice president at Houston Methodist.

But some nurses fear the technology could wind up replacing them rather than supporting them — and harming patients. Houston Methodist, one of dozens of U.S. hospitals to employ the device, is the first to use the BioButton to monitor all patients except those in intensive care, Pletcher said.

“The hype around a lot of these devices is they provide care at scale for less labor costs,” said Michelle Mahon, a registered nurse and an assistant director of National Nurses United, the profession’s largest U.S. union. “This is a trend that we find disturbing,” she said.

The rollout of BioButton is among the latest examples of hospitals deploying technology to improve efficiency and address a decades-old nursing shortage. But that transition has raised its own concerns, including about the device’s use of AI; polls show the public is wary of health providers relying on it for patient care.

The BioButton, a monitoring device, is being used in dozens of hospitals employing artificial intelligence to analyze patients’ vital signs. (Phil Galewitz/KFF Health News)

Houston Methodist Hospital, just a few miles south of downtown Houston, is located amid a giant medical complex that includes several hospitals. (Phil Galewitz/KFF Health News)

In December 2022 the FDA cleared the BioButton for use in adult patients who are not in critical care. It is one of many AI tools now used by hospitals for tasks like reading diagnostic imaging results.

In 2023, President Joe Biden directed the Department of Health and Human Services to develop a plan to regulate AI in hospitals, including by collecting reports of patients harmed by its use.

The leader of BioIntelliSense, which developed the BioButton, said its device is a huge advance compared with nurses walking into a room every few hours to measure vital signs. “With AI, you now move from ‘I wonder why this patient crashed’ to ‘I can see this crash coming before it happens and intervene appropriately,’” said James Mault, CEO of the Golden, Colorado-based company.

The BioButton stays on the skin with an adhesive, is waterproof, and has up to a 30-day battery life. The company says the device — which allows providers to quickly notice deteriorating health by recording more than 1,000 measurements a day per patient — has been used on more than 80,000 hospital patients nationwide in the past year.

Hospitals pay BioIntelliSense an annual subscription fee for the devices and software.

Houston Methodist officials would not reveal how much the hospital pays for the technology, though Pletcher said it equates to less than a cup of coffee a day per patient.

For a hospital system that treats thousands of patients at a time — Houston Methodist has 2,653 non-ICU beds at its eight Houston-area hospitals — such an investment could still translate to millions of dollars a year.

Hospital officials say they have not made any changes in nurse staffing and have no plans to because of implementing the BioButton.

Inside the hospital’s control center for virtual monitoring on a recent morning, about 15 nurses and technicians dressed in scrubs sat in front of large monitors showing the health status of hundreds of patients they were assigned to monitor.

A red checkmark next to a patient’s name signaled the AI software had found readings trending outside normal. Staff members could click into a patient’s medical record, showing patients’ vital signs over time and other medical history. These virtual nurses, if you will, could contact nurses on the floor by phone or email, or even dial directly into the patient’s room via video call.

Nutanben Gandhi, a technician who was watching 446 patients on her monitor that morning, said that when she gets an alert, she looks at the patient’s health record to see if the anomaly can be easily explained by something in the patient’s condition or if she needs to contact nurses on the patient’s floor.

Oftentimes an alert can be easily dismissed. But identifying signs of deteriorating health can be tough, said Steve Klahn, Houston Methodist’s clinical director of virtual medicine.

“We are looking for a needle in a haystack,” he said.

Donald Eustes, 65, was admitted to Houston Methodist in March for prostate cancer treatment and has since been treated for a stroke. He is happy to wear the BioButton.

“You never know what can happen here, and having an extra set of eyes looking at you is a good thing,” he said from his hospital bed. After being told the device uses AI, the Montgomery, Texas, man said he has no problem with its helping his clinical team. “This sounds like a good use of artificial intelligence.”

Patients and nurses alike benefit from remote monitoring like the BioButton, said Pletcher of Houston Methodist.

A nurse inside Houston Methodist Hospital’s virtual intensive care unit monitors patients from afar. Nurses can track dozens of patients using technology that helps them supplement bedside care. (Phil Galewitz/KFF Health News)

Sarah Pletcher, system vice president at Houston Methodist, stands inside the hospital’s 24-hour virtual intensive care unit where patients are monitored by nurses and technicians. (Phil Galewitz/KFF Health News)

The hospital has placed small cameras and microphones inside all patient rooms enabling nurses outside to communicate with patients and perform tasks such as helping with patient admissions and discharge instructions. Patients can include family members on the remote calls with nurses or a doctor, she said.

Virtual technology frees up on-duty nurses to provide more hands-on help, such as starting an intravenous line, Pletcher said. With the BioButton, nurses can wait to take routine vital signs every eight hours instead of every four, she said.

Pletcher said the device reduces nurses’ stress in monitoring patients and allows some to work more flexible hours because virtual care can be done from home rather than coming to the hospital. Ultimately it helps retain nurses, not drive them away, she said.

Sheeba Roy, a nurse manager at Houston Methodist, said some members of the nursing staff were nervous about relying on the device and not checking patients’ vital signs as often themselves. But testing has shown the device provides accurate information.

“After we implemented it, the staff loves it,” Roy said.

A photo of a BioButton being held up by a finger.
Houston Methodist this year plans to send the BioButton home with patients so the hospital can better track their progress in the weeks after discharge, measuring the quality of their sleep and checking their gait.(Phil Galewitz/KFF Health News)

Serena Bumpus, chief executive officer of the Texas Nurses Association, said her concern with any technology is that it can be more burdensome on nurses and take away time with patients.

“We have to be hypervigilant in ensuring that we are not leaning on this to replace the ability of nurses to critically think and assess patients and validate what this device is telling us is true,” Bumpus said.

Houston Methodist this year plans to send the BioButton home with patients so the hospital can better track their progress in the weeks after discharge, measuring the quality of their sleep and checking their gait.

“We are not going to need less nurses in health care, but we have limited resources and we have to use those as thoughtfully as we can,” Pletcher said. “Looking at projected demand and seeing the supply we have coming, we will not have enough to meet demand, so anything we can do to give time back to nurses is a good thing.”

This article was produced by KFF Health News, a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

What’s Keeping the US From Allowing Better Sunscreens?

When dermatologist Adewole “Ade” Adamson sees people spritzing sunscreen as if it’s cologne at the pool where he lives in Austin, Texas, he wants to intervene. “My wife says I shouldn’t,” he said, “even though most people rarely use enough sunscreen.”

At issue is not just whether people are using enough sunscreen, but what ingredients are in it.

The Food and Drug Administration’s ability to approve the chemical filters in sunscreens that are sold in countries such as Japan, South Korea, and France is hamstrung by a 1938 U.S. law that requires sunscreens to be tested on animals and classified as drugs, rather than as cosmetics as they are in much of the world. So Americans are not likely to get those better sunscreens — which block the ultraviolet rays that can cause skin cancer and lead to wrinkles — in time for this summer, or even the next.

Sunscreen makers say that requirement is unfair because companies including BASF Corp. and L’Oréal, which make the newer sunscreen chemicals, submitted safety data on sunscreen chemicals to the European Union authorities some 20 years ago.

Steven Goldberg, a retired vice president of BASF, said companies are wary of the FDA process because of the cost and their fear that additional animal testing could ignite a consumer backlash in the European Union, which bans animal testing of cosmetics, including sunscreen. The companies are asking Congress to change the testing requirements before they take steps to enter the U.S. marketplace.

In a rare example of bipartisanship last summer, Sen. Mike Lee (R-Utah) thanked Rep. Alexandria Ocasio-Cortez (D-N.Y.) for urging the FDA to speed up approvals of new, more effective sunscreen ingredients. Now a bipartisan bill is pending in the House that would require the FDA to allow non-animal testing.

“It goes back to sunscreens being classified as over-the-counter drugs,” said Carl D’Ruiz, a senior manager at DSM-Firmenich, a Switzerland-based maker of sunscreen chemicals. “It’s really about giving the U.S. consumer something that the rest of the world has. People aren’t dying from using sunscreen. They’re dying from melanoma.”

Every hour, at least two people die of skin cancer in the United States. Skin cancer is the most common cancer in America, and 6.1 million adults are treated each year for basal cell and squamous cell carcinomas, according to the Centers for Disease Control and Prevention. The nation’s second-most-common cancer, breast cancer, is diagnosed about 300,000 times annually, though it is far more deadly.

Though skin cancer treatment success rates are excellent, 1 in 5 Americans will develop skin cancer by age 70. The disease costs the health care system $8.9 billion a year, according to CDC researchers. One study found that the annual cost of treating skin cancer in the United States more than doubled from 2002 to 2011, while the average annual cost for all other cancers increased by just 25%. And unlike many other cancers, most forms of skin cancer can largely be prevented — by using sunscreens and taking other precautions.

But a heavy dose of misinformation has permeated the sunscreen debate, and some people question the safety of sunscreens sold in the United States, which they deride as “chemical” sunscreens. These sunscreen opponents prefer “physical” or “mineral” sunscreens, such as zinc oxide, even though all sunscreen ingredients are chemicals.

“It’s an artificial categorization,” said E. Dennis Bashaw, a retired FDA official who ran the agency’s clinical pharmacology division that studies sunscreens.

Still, such concerns were partly fed by the FDA itself after it published a study that said some sunscreen ingredients had been found in trace amounts in human bloodstreams. When the FDA said in 2019, and then again two years later, that older sunscreen ingredients needed to be studied more to see if they were safe, sunscreen opponents saw an opening, said Nadim Shaath, president of Alpha Research & Development, which imports chemicals used in cosmetics.

“That’s why we have extreme groups and people who aren’t well informed thinking that something penetrating the skin is the end of the world,” Shaath said. “Anything you put on your skin or eat is absorbed.”

Adamson, the Austin dermatologist, said some sunscreen ingredients have been used for 30 years without any population-level evidence that they have harmed anyone. “The issue for me isn’t the safety of the sunscreens we have,” he said. “It’s that some of the chemical sunscreens aren’t as broad spectrum as they could be, meaning they do not block UVA as well. This could be alleviated by the FDA allowing new ingredients.”

Ultraviolet radiation falls between X-rays and visible light on the electromagnetic spectrum. Most of the UV rays that people come in contact with are UVA rays that can penetrate the middle layer of the skin and that cause up to 90% of skin aging, along with a smaller amount of UVB rays that are responsible for sunburns.

The sun protection factor, or SPF, rating on American sunscreen bottles denotes only a sunscreen’s ability to block UVB rays. Although American sunscreens labeled “broad spectrum” should, in theory, block UVA light, some studies have shown they fail to meet the European Union’s higher UVA-blocking standards.

“It looks like a number of these newer chemicals have a better safety profile in addition to better UVA protection,” said David Andrews, deputy director of Environmental Working Group, a nonprofit that researches the ingredients in consumer products. “We have asked the FDA to consider allowing market access.”

The FDA defends its review process and its call for tests of the sunscreens sold in American stores as a way to ensure the safety of products that many people use daily, rather than just a few times a year at the beach.

“Many Americans today rely on sunscreens as a key part of their skin cancer prevention strategy, which makes satisfactory evidence of both safety and effectiveness of these products critical for public health,” Cherie Duvall-Jones, an FDA spokesperson, wrote in an email.

D’Ruiz’s company, DSM-Firmenich, is the only one currently seeking to have a new over-the-counter sunscreen ingredient approved in the United States. The company has spent the past 20 years trying to gain approval for bemotrizinol, a process D’Ruiz said has cost $18 million and has advanced fitfully, despite attempts by Congress in 2014 and 2020 to speed along applications for new UV filters.

Bemotrizinol is the bedrock ingredient in nearly all European and Asian sunscreens, including those by the South Korean brand Beauty of Joseon and Bioré, a Japanese brand.

D’Ruiz said bemotrizinol could secure FDA approval by the end of 2025. If it does, he said, bemotrizinol would be the most vetted and safest sunscreen ingredient on the market, outperforming even the safety profiles of zinc oxide and titanium dioxide.

As Congress and the FDA debate, many Americans have taken to importing their own sunscreens from Asia or Europe, despite the risk of fake products.

“The sunscreen issue has gotten people to see that you can be unsafe if you’re too slow,” said Alex Tabarrok, a professor of economics at George Mason University. “The FDA is just incredibly slow. They’ve been looking at this now literally for 40 years. Congress has ordered them to do it, and they still haven’t done it.”

This article was produced by KFF Health News, a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

Amgen Plows Ahead With Costly, Highly Toxic Cancer Dosing Despite FDA Challenge

When doctors began using the drug sotorasib in 2021 with high expectations for its innovative approach to attacking lung cancer, retired medical technician Don Crosslin was an early beneficiary. Crosslin started the drug that July. His tumors shrank, then stabilized.

But while the drug has helped keep him alive, its side effects have gradually narrowed the confines of his life, said Crosslin, 76, who lives in Ocala, Florida: “My appetite has been minimal. I’m very weak. I walk my dogs and get around a bit, but I haven’t been able to golf since last July.”

He wonders whether he’d do better on a lower dose, “but I do what my oncologist tells me to do,” Crosslin said. Every day, he takes eight of the 120-milligram pills, sold under Amgen’s brand name Lumakras.

Crosslin’s concern lies at the heart of an FDA effort to make cancer drugs less toxic and more effective. Cancer drug trials are structured to promote high doses, which then become routine patient care. In the face of evidence that thousands of patients become so ill that they skip doses or stop taking the drugs — thereby risking resurgence of their cancers — the FDA has begun requiring companies to pinpoint the right dosage before they reach patients.

The initiative, Project Optimus, launched in 2021 just as Amgen was seeking to market sotorasib. At the time, the FDA’s leading cancer drug regulator, Richard Pazdur, co-authored an editorial in the New England Journal of Medicine that said Amgen’s trials of the $20,000-a-month drug were “hampered by a lack of robust dose exploration.”

The FDA conditionally approved sotorasib but required Amgen to conduct a study comparing the labeled dosage of 960 mg with a dosage of 240 mg. The trial, published in November, showed that the 960-mg dose may have given patients a month more of life, on average, but caused more severe side effects than the lower dose.

Amgen is keeping the 960-mg dosage as it conducts further tests to get final approval for the drug, spokesperson Elissa Snook said, adding that the dose showed superiority in one study. Whether medically justified or not, the heavier dosage allows the company to protect 75% of its revenue from the drug, which brought in nearly $200 million in the United States last year.

And there appears to be nothing the FDA can do about it.

“There’s a gap in FDA’s authority that results in patients getting excess doses of a drug at excess costs,” said Mark Ratain, a University of Chicago oncologist who has pushed for more accurate cancer drug dosing. “We should do something about this.”

Deciding on Dosage

It may be too late for the FDA to change the sotorasib dosage, although in principle it could demand a new regimen before granting final approval, perhaps in 2028. Under Project Optimus, however, the agency is doing something about dosage guidelines for future drugs. It is stressing dose optimization in its meetings with companies, particularly as they prepare to test drugs on patients for the first time, spokesperson Lauren-Jei McCarthy said.

“When you go in front of FDA with a plan to approve your drug now, they are going to address dosing studies,” said Julie Gralow, chief medical officer of the American Society of Clinical Oncology. “A lot of companies are struggling with this.”

That’s largely because the new requirements add six months to a year and millions in drug development costs, said Julie Bullock, a former FDA drug reviewer who advocated for more extensive dosing studies and is now senior vice president at Certara, a drug development consultancy.

In part, Project Optimus represents an effort to manage the faults of the FDA’s accelerated approval process, begun in 1992. While the process gets innovative drugs to patients more quickly, some medicines have proved lackluster or had unacceptable side effects.

That’s especially true of the newer pills to treat cancer, said Donald Harvey, an Emory University pharmacology professor, who has led or contributed to more than 100 early-phase cancer trials.

A study released last month in the Journal of the American Medical Association showed that 41% of the cancer drugs granted accelerated approval from 2013 to 2017 did not improve overall survival or quality of life after five years.

Many of these drugs flop because they must be given at toxic dosages to have any effect, Harvey said, adding that sotorasib might work better if the company had found an appropriate dosage earlier on.

“Sotorasib is a poster child for incredibly bad development,” Harvey said. The drug was the first to target the KRAS G12C mutation, which drives about 15% of lung cancers and was considered “undruggable” until University of California-San Francisco chemist Kevan Shokat figured out how to attack it in 2012.

Given the specificity of sotorasib’s target, Harvey said, Amgen could have found a lower dosage. “Instead, they followed the old model and said, ‘We’re going to push the dose up until we see a major side effect.’ They didn’t need to do that. They just needed more experience with a lower dose.”

The 960-mg dose “is really tough on patients,” said Yale University oncologist and assistant professor Michael Grant. “They get a lot of nausea and other GI side effects that are not pleasant. It hurts their quality of life.”

The FDA noted in its review of sotorasib that in phase 1 studies tumors shrank when exposed to as little as a fifth of the 960-mg daily dose Amgen selected. At all doses tested in that early trial, the drug reached roughly the same concentrations in the blood, which suggested that at higher doses the drug was mostly just intensifying side effects like diarrhea, vomiting, and mouth sores.

For most classes of drugs, companies spend considerable time in phases 1 and 2 of development, homing in on the right dosage. “No one would think of dosing a statin or antibiotic at the highest tolerable dose,” Ratain said.

Things are different in cancer drug creation, whose approach originated with chemotherapy, which damages as many cancer cells as possible, wrecking plenty of healthy tissue in the bargain. Typically, a company’s first series of cancer drug trials involve escalating doses in small groups of patients until something like a quarter of them get seriously ill. That “maximum tolerated dose” is then employed in more advanced clinical trials, and goes on the drug’s label. Once a drug is approved, a doctor can “go off-label” and alter the dosage, but most are leery of doing so.

Patients can find the experience rougher than advertised. During clinical trials, the side effects of the cancer drug osimertinib (Tagrisso) were listed as tolerable and manageable, said Jill Feldman, a lung cancer patient and advocate. “That killed me. After two months on that drug, I had lost 15 pounds, had sores in my mouth and down my throat, stomach stuff. It was horrible.”

Some practitioners, at least, have responded to the FDA’s cues on sotorasib. In the Kaiser Permanente health system, lung cancer specialists start with a lower dose of the drug, spokesperson Stephen Shivinsky said.

Smaller Doses — And Revenue

Amgen was clearly aware of the advantages of the 240-mg dosage before it sought FDA approval: It filed a provisional patent application on that dosage before the agency gave breakthrough approval for the drug at 960 mg. The company doesn’t appear to have disclosed the patent filing to investors or the FDA. McCarthy said the FDA was prohibited by law from discussing the particulars of its sotorasib regulation plans.

A photo of a man standing outside by the beach.
Don Crosslin visits Flagler Beach, Florida, in 2018. The retired medical technician has been taking the drug sotorasib (Lumakras) to treat his advanced lung cancer disease since 2021. Crosslin says he’s grateful for the drug’s role in keeping him alive but wonders whether he could be on a lower dose.(Don Crosslin)

Switching to a 240-mg dosage could register a huge hit to Amgen’s revenue. The company markets the drug at more than $20,000 for a month of 960-mg daily doses. Each patient who could get by with a quarter of that would trim the company’s revenue by roughly $180,000 a year.

Amgen declined to comment on the patent issue or to make an official available to discuss the dosage and pricing issues.

Crosslin, who depends on Social Security for his income, couldn’t afford the $3,000 a month that Medicare required him to pay for sotorasib, but he has received assistance from Amgen and a charity that covers costs for patients below a certain income.

While the drug has worked well for Crosslin and other patients, its overall modest impact on lung cancer suggests that $5,000, rather than $20,000, might be a more appropriate price, Ratain said.

In the company’s phase 3 clinical trial for advanced lung cancer patients, sotorasib kept patients alive for about a month longer than docetaxel, the current, highly toxic standard of care. Docetaxel is a generic drug for which Medicare pays about $1 per injection. The trial was so unconvincing that the FDA sent Amgen back to do another.

Ratain, a staunch critic of Amgen’s handling of sotorasib, told Centers for Medicare & Medicaid Services officials at a recent meeting that they should pay for sotorasib on a basis of 240 mg per day. But CMS would do that only “if there is a change in the drug’s FDA-approved dosage,” spokesperson Aaron Smith said.

Drug companies generally don’t want to spend money on trials like the one the FDA ordered on sotorasib. In 2018, Ratain and other researchers used their institutions’ funding to conduct a dosing trial on the prostate cancer drug abiraterone, marketed under the brand name Zytiga by Johnson & Johnson. They found that taking one 250-mg pill with food was just as effective as taking four on an empty stomach, as the label called for.

Although J&J hasn’t changed the Zytiga label, the evidence generated in that trial was strong enough for the standards-setting National Comprehensive Cancer Network to change its recommendations.

Post-marketing studies like that one are hard to conduct, Emory’s Harvey said. Patients are reluctant to join a trial in which they may have to take a lower dosage, since most people tend to believe “the more the better,” he said.

“It’s better for everyone to find the right dose before a drug is out on the market,” Harvey said. “Better for the patient, and better for the company, which can sell more of a good drug if the patients aren’t getting sick and no longer taking it.”

This article was produced by KFF Health News, a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

Biden Team’s Tightrope: Reining In Rogue Obamacare Agents Without Slowing Enrollment

President Joe Biden counts among his accomplishments the record-high number of people, more than 21 million, who enrolled in Obamacare plans this year. Behind the scenes, however, federal regulators are contending with a problem that affects people’s coverage: rogue brokers who have signed people up for Affordable Care Act plans, or switched them into new ones, without their permission.

Fighting the problem presents tension for the administration: how to thwart the bad actors without affecting ACA sign-ups.

Complaints about these unauthorized changes — which can cause affected policyholders to lose access to medical care, pay higher deductibles, or even incur surprise tax bills — rose sharply in recent months, according to brokers who contacted KFF Health News and federal workers who asked not to be identified.

Ronnell Nolan, president and CEO of the trade association Health Agents for America, said her group has suggested to the Centers for Medicare & Medicaid Services that it add two-factor authentication to healthcare.gov or send text alerts to consumers if an agent tries to access their accounts. But the agency told her it doesn’t always have up-to-date contact information.

“We’ve given them a whole host of ideas,” she said. “They say, ‘Be careful what you wish for.’ But we don’t mind going an extra step if you can stop this fraud and abuse, because clients are being hurt.”

Some consumers are pursued when they respond to misleading social media marketing ads promising government subsidies, but most have no idea how they fell victim to plan-switching. Problems seem concentrated in the 32 states using the federal exchange.

Federal regulators have declined to say how many complaints about unauthorized sign-ups or plan switches they’ve received, or how many insurance agents they’ve sanctioned as a result. But the problem is big enough that CMS says it’s working on technological and regulatory solutions. Affected consumers and agents have filed a civil lawsuit in federal district court in Florida against private-sector firms allegedly involved in unauthorized switching schemes.

Biden has pushed hard to make permanent the enhanced subsidies first put in place during the covid pandemic that, along with other steps including increased federal funding for outreach, helped fuel the strong enrollment growth. Biden contrasts his support for the ACA with the stance of former President Donald Trump, who supported attempts to repeal most of the law and presided over funding cuts and declining enrollment.

Most proposed solutions to the rogue-agent problem involve making it more difficult for agents to access policyholder information or requiring wider use of identity questions tied to enrollees’ credit history. The latter could be stumbling blocks for low-income people or those with limited financial records, said Sabrina Corlette, co-director of the Center on Health Insurance Reforms at Georgetown University.

“That is the knife edge the administration has to walk,” said Corlette, “protecting consumers from fraudulent behavior while at the same time making sure there aren’t too many barriers.”

Jeff Wu, acting director of the Center for Consumer Information & Insurance Oversight, said in a statement that the agency is evaluating options on such factors as how effective they would be, their impact on consumers’ ability to enroll, and how fast they could be implemented.

The agency is also working closely, he wrote, with insurance companies, state insurance departments, and law enforcement “so that agents violating CMS rules or committing fraud face consequences.” And it is reaching out to states that run their own ACA markets for ideas.

That’s because Washington, D.C., and the 18 states that run their own ACA marketplaces have reported far fewer complaints about unauthorized enrollment and plan-switching. Most include layers of security in addition to those the federal marketplace has in place — some use two-factor authentication — before agents can access policyholder information.

California, for example, allows consumers to designate an agent and to “log in and add or remove an agent at will,” said Robert Kingston, interim director of outreach and sales for Covered California, the state’s ACA marketplace. The state can also send consumers a one-time passcode to share with an agent of their choice. Consumers in Colorado and Pennsylvania can similarly designate specific agents to access their accounts.

By contrast, agents can more easily access policyholder information when using private-sector websites that link them to the federal ACA market — all they need is a person’s name, date of birth, and state of residence — to enroll them or switch their coverage.

CMS has approved dozens of such “enhanced direct enrollment” websites run by private companies, which are designed to make it easier and faster for agents certified to offer insurance through healthcare.gov.

Rules went into effect last June requiring agents to get written or recorded consent from clients before enrolling them or changing their coverage, but brokers say they’re rarely asked to produce the documentation. If CMS makes changes to healthcare.gov — such as adding passcodes, as California has — it would need to require all alternative-enrollment partners to do the same.

The largest is San Francisco-based HealthSherpa, which assisted 52% of active enrollments nationally for this year, said CEO George Kalogeropoulos.

The company has a 10-person fraud investigation team, he said, which has seen “a significant spike in concerns about unauthorized switching.” They report problems to state insurance departments, insurance carriers, and federal regulators “and refer consumers to advocates on our team to make sure their plans are corrected.”

Solutions must be “targeted,” he said. “The issue with some of the solutions proposed is it negatively impacts the ability of all consumers to get enrolled.”

Most people who sign up for ACA plans are aided by agents or platforms like HealthSherpa, rather than doing it themselves or seeking help from nonprofit organizations. Brokers don’t charge consumers; instead, they receive commissions from insurers participating in state and federal marketplaces for each person they enroll in a plan.

While California officials say their additional layers of authentication have not noticeably affected enrollment numbers, the state’s recent enrollment growth has been slower than in states served by healthcare.gov.

Still, Covered California’s Kingston pointed to a decreased number of uninsured people in the state. In 2014, when much of the ACA was implemented, 12.5% of Californians were uninsured, falling to 6.5% in 2022, according to data compiled by KFF. That year, the share of people uninsured nationwide was 8%.

Corlette said insurers have a role to play, as do states and CMS.

“Are there algorithms that can say, ‘This is a broker with outlier behavior’?” Insurance companies could then withhold commissions “until they can figure it out,” she said.

Kelley Schultz, vice president of commercial policy at AHIP, the trade association for large insurance companies, said sharing more information from the government marketplace about which policies are being switched could help insurers spot patterns.

CMS could also set limits on plan switches, as there is generally no legitimate need for multiple changes in a given month, Schultz said.

Could Better Inhalers Help Patients, and the Planet?

Miguel Divo, a lung specialist at Brigham and Women’s Hospital in Boston, sits in an exam room across from Joel Rubinstein, who has asthma. Rubinstein, a retired psychiatrist, is about to get a checkup and hear a surprising pitch — for the planet, as well as his health.

Divo explains that boot-shaped inhalers, which represent nearly 90% of the U.S. market for asthma medication, save lives but also contribute to climate change. Each puff from an inhaler releases a hydrofluorocarbon gas that is 1,430 to 3,000 times as powerful as the most commonly known greenhouse gas, carbon dioxide.

“That absolutely never occurred to me,” said Rubinstein. “Especially, I mean, these are little, teeny things.”

So Divo has begun offering a more eco-friendly option to some patients with asthma and other lung diseases: a plastic, gray cylinder about the size and shape of a hockey puck that contains powdered medicine. Patients suck the powder into their lungs — no puff of gas required and no greenhouse gas emissions.

“You have the same medications, two different delivery systems,” Divo said.

Patients in the United States are prescribed roughly 144 million of what doctors call metered-dose inhalers each year, according to the most recently available data published in 2020. The cumulative amount of gas released is the equivalent of driving half a million gas-powered cars for a year. So, the benefits of moving to dry powder inhalers from gas inhalers could add up.

Hydrofluorocarbon gas contributes to climate change, which is creating more wildfire smoke, other types of air pollution, and longer allergy seasons. These conditions can make breathing more difficult — especially for people with asthma and chronic obstructive pulmonary disease, or COPD — and increase the use of inhalers.

Divo is one of a small but growing number of U.S. physicians determined to reverse what they see as an unhealthy cycle.

“There is only one planet and one human race,” Divo said. “We are creating our own problems and we need to do something.”

So Divo is working with patients like Rubinstein who may be willing to switch to dry powder inhalers. Rubinstein said no to the idea at first because the powder inhaler would have been more expensive. Then his insurer increased the copay on the metered-dose inhaler so Rubinstein decided to try the dry powder.

“For me, price is a big thing,” said Rubinstein, who has tracked health care and pharmaceutical spending in his professional roles for years. Inhaling the medicine using more of his own lung power was an adjustment. “The powder is a very strange thing, to blow powder into your mouth and lungs.”

But for Rubinstein, the new inhaler works and his asthma is under control. A recent study found that some patients in the United Kingdom who use dry powder inhalers have better asthma control while reducing greenhouse gas emissions. In Sweden, where the vast majority of patients use dry powder inhalers, rates of severe asthma are lower than in the United States.

Rubinstein is one of a small number of U.S. patients who have made the transition. Divo said that, for a variety of reasons, only about a quarter of his patients even consider switching. Dry powder inhalers are often more expensive than gas propellant inhalers. For some, dry powder isn’t a good option because not all asthma or COPD sufferers can get their medications in this form. And dry powder inhalers aren’t recommended for young children or elderly patients with diminished lung strength.

Also, some patients using dry powder inhalers worry that without the noise from the spray, they may not be receiving the proper dose. Other patients don’t like the taste powder inhalers can leave in their mouths.

Divo said his priority is making sure patients have an inhaler they are comfortable using and that they can afford. But, when appropriate, he’ll keep offering the dry powder option.

Advocacy groups for asthma and COPD patients support more conversations about the connection between inhalers and climate change.

“The climate crisis makes these individuals have a higher risk of exacerbation and worsening disease,” said Albert Rizzo, chief medical officer of the American Lung Association. “We don’t want medications to contribute to that.”

A photo of a doctor's hand holding up a metered-dose inhaler. His patient is seen looking at it in the background.
Divo holds a metered-dose inhaler. Current versions release a greenhouse gas that’s up to 3,000 times as potent as carbon dioxide.(Jesse Costa/WBUR)

Rizzo said there is work being done to make metered-dose inhalers more climate-friendly. The United States and many other countries are phasing down the use of hydrofluorocarbons, which are also used in refrigerators and air conditioners. It’s part of the global attempt to avoid the worst possible impacts of climate change. But inhaler manufacturers are largely exempt from those requirements and can continue to use the gases while they explore new options.

Some leading inhaler manufacturers have pledged to produce canisters with less potent greenhouse gases and to submit them for regulatory review by next year. It’s not clear when these inhalers might be available in pharmacies. Separately, the FDA is spending about $6 million on a study about the challenges of developing inhalers with a smaller carbon footprint.

Rizzo and other lung specialists worry these changes will translate into higher prices. That’s what happened in the early to mid-2000s when ozone-depleting chlorofluorocarbons (CFCs) were phased out of inhalers. Manufacturers changed the gas in metered-dose inhalers and the cost to patients nearly doubled. Today, many of those re-engineered inhalers remain expensive.

William Feldman, a pulmonologist and health policy researcher at Brigham and Women’s Hospital, said these dramatic price increases occur because manufacturers register updated inhalers as new products, even though they deliver medications already on the market. The manufacturers are then awarded patents, which prevent the production of competing generic medications for decades. The Federal Trade Commission says it is cracking down on this practice.

After the CFC ban, “manufacturers earned billions of dollars from the inhalers,” Feldman said of the re-engineered inhalers.

When inhaler costs went up, physicians say, patients cut back on puffs and suffered more asthma attacks. Gregg Furie, medical director for climate and sustainability at Brigham and Women’s Hospital, is worried that’s about to happen again.

“While these new propellants are potentially a real positive development, there’s also a significant risk that we’re going to see patients and payers face significant cost hikes,” Furie said.

Some of the largest inhaler manufacturers, including GSK, are already under scrutiny for allegedly inflating prices in the United States. Sydney Dodson-Nease told NPR and KFF Health News that the company has a strong record for keeping medicines accessible to patients but that it’s too early to comment on the price of the more environmentally sensitive inhalers the company is developing.

Developing affordable, effective, and climate-friendly inhalers will be important for hospitals as well as patients. The Agency for Healthcare Research and Quality recommends that hospitals looking to shrink their carbon footprint reduce inhaler emissions. Some hospital administrators see switching inhalers as low-hanging fruit on the list of climate-change improvements a hospital might make.

But Brian Chesebro, medical director of environmental stewardship at Providence, a hospital network in Oregon, said, “It’s not as easy as swapping inhalers.”

Chesebro said that even among metered-dose inhalers, the climate impact varies. So pharmacists should suggest the inhalers with the fewest greenhouse gas emissions. Insurers should also adjust reimbursements to favor climate-friendly alternatives, he said, and regulators could consider emissions when reviewing hospital performance.

Samantha Green, a family physician in Toronto, said clinicians can make a big difference with inhaler emissions by starting with the question: Does the patient in front of me really need one?

Green, who works on a project to make inhalers more environmentally sustainable, said that research shows a third of adults diagnosed with asthma may not have the disease.

“So that’s an easy place to start,” Green said. “Make sure the patient prescribed an inhaler is actually benefiting from it.”

Green said educating patients has a measurable effect. In her experience, patients are moved to learn that emissions from the approximately 200 puffs in one inhaler are equivalent to driving about 100 miles in a gas-powered car. Some researchers say switching to dry powder inhalers may be as beneficial for the climate as a patient adopting a vegetarian diet.

One of the hospitals in Green’s health care network, St. Joseph’s Health Centre, found that talking to patients about inhalers led to a significant decrease in the use of metered-dose devices. Over six months, the hospital went from 70% of patients using the puffers, to 30%.

Green said patients who switched to dry powder inhalers have largely stuck with them and appreciate using a device that is less likely to exacerbate environmental conditions that inflame asthma.

This article is from a partnership that includes WBUR,NPR, and KFF Health News.

This article was produced by KFF Health News, a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

Stranded in the ER, Seniors Await Hospital Care and Suffer Avoidable Harm

Every day, the scene plays out in hospitals across America: Older men and women lie on gurneys in emergency room corridors moaning or suffering silently as harried medical staff attend to crises.

Even when physicians determine these patients need to be admitted to the hospital, they often wait for hours — sometimes more than a day — in the ER in pain and discomfort, not getting enough food or water, not moving around, not being helped to the bathroom, and not getting the kind of care doctors deem necessary.

“You walk through ER hallways, and they’re lined from end to end with patients on stretchers in various states of distress calling out for help, including a number of older patients,” said Hashem Zikry, an emergency medicine physician at UCLA Health.

Physicians who staff emergency rooms say this problem, known as ER boarding, is as bad as it’s ever been — even worse than during the first years of the covid-19 pandemic, when hospitals filled with desperately ill patients.

While boarding can happen to all ER patients, adults 65 and older, who account for nearly 20% of ER visits, are especially vulnerable during long waits for care. Also, seniors may encounter boarding more often than other patients. The best estimates I could find, published in 2019, before the covid-19 pandemic, suggest that 10% of patients were boarded in ERs before receiving hospital care. About 30% to 50% of these patients were older adults.

“It’s a public health crisis,” said Aisha Terry, an associate professor of emergency medicine at George Washington University School of Medicine and Health Sciences and the president of the board of the American College of Emergency Physicians, which sponsored a summit on boarding in September.

What’s going on? I spoke to almost a dozen doctors and researchers who described the chaotic situation in ERs. They told me staff shortages in hospitals, which affect the number of beds available, are contributing to the crisis. Also, they explained, hospital administrators are setting aside more beds for patients undergoing lucrative surgeries and other procedures, contributing to bottlenecks in ERs and leaving more patients in limbo.

Then, there’s high demand for hospital services, fueled in part by the aging of the U.S. population, and backlogs in discharging patients because of growing problems securing home health care and nursing home care, according to Arjun Venkatesh, chair of emergency medicine at the Yale School of Medicine.

The impact of long ER waits on seniors who are frail, with multiple medical issues, is especially serious. Confined to stretchers, gurneys, or even hard chairs, often without dependable aid from nurses, they’re at risk of losing strength, forgoing essential medications, and experiencing complications such as delirium, according to Saket Saxena, a co-director of the geriatric emergency department at the Cleveland Clinic.

When these patients finally secure a hospital bed, their stays are longer and medical complications more common. And new research finds that the risk of dying in the hospital is significantly higher for older adults when they stay in ERs overnight, as is the risk of adverse events such as falls, infections, bleeding, heart attacks, strokes, and bedsores.

Ellen Danto-Nocton, a geriatrician in Milwaukee, was deeply concerned when an 88-year-old relative with “strokelike symptoms” spent two days in the ER a few years ago. Delirious, immobile, and unable to sleep as alarms outside his bed rang nonstop, the older man spiraled downward before he was moved to a hospital room. “He really needed to be in a less chaotic environment,” Danto-Nocton said.

Several weeks ago, Zikry of UCLA Health helped care for a 70-year-old woman who’d fallen and broken her hip while attending a basketball game. “She was in a corner of our ER for about 16 hours in an immense amount of pain that was very difficult to treat adequately,” he said. ERs are designed to handle crises and stabilize patients, not to “take care of patients who we’ve already decided need to be admitted to the hospital,” he said.

How common is ER boarding and where is it most acute? No one knows, because hospitals aren’t required to report data about boarding publicly. The Centers for Medicare & Medicaid Services retired a measure of boarding in 2021. New national measures of emergency care capacity have been proposed but not yet approved.

“It’s not just the extent of ED boarding that we need to understand. It’s the extent of acute hospital capacity in our communities,” said Venkatesh of Yale, who helped draft the new measures.

In the meantime, some hospital systems are publicizing their plight by highlighting capacity constraints and the need for more hospital beds. Among them is Massachusetts General Hospital in Boston, which announced in January that ER boarding had risen 32% from October 2022 to September 2023. At the end of that period, patients admitted to the hospital spent a median of 14 hours in the ER and 26% spent more than 24 hours.

Maura Kennedy, Mass General’s chief of geriatric emergency medicine, described an 80-something woman with a respiratory infection who languished in the ER for more than 24 hours after physicians decided she needed inpatient hospital care.

“She wasn’t mobilized, she had nothing to cognitively engage her, she hadn’t eaten, and she became increasingly agitated, trying to get off the stretcher and arguing with staff,” Kennedy told me. “After a prolonged hospital stay, she left the hospital more disabled than she was when she came in.”

When I asked ER doctors what older adults could do about these problems, they said boarding is a health system issue that needs health system and policy changes. Still, they had several suggestions.

“Have another person there with you to advocate on your behalf,” said Jesse Pines, chief of clinical innovation at US Acute Care Solutions, the nation’s largest physician-owned emergency medicine practice. And have that person speak up if they feel you’re getting worse or if staffers are missing problems.

Alexander Janke, a clinical instructor of emergency medicine at the University of Michigan, advises people, “Be prepared to wait when you come to an ER” and “bring a medication list and your medications, if you can.”

To stay oriented and reduce the possibility of delirium, “make sure you have your hearing aids and eyeglasses with you,” said Michael Malone, medical director of senior services for Advocate Aurora Health, a 20-hospital system in Wisconsin and northern Illinois. “Whenever possible, try to get up and move around.”

Friends or family caregivers who accompany older adults to the ER should ask to be at their bedside, when possible, and “try to make sure they eat, drink, get to the bathroom, and take routine medications for underlying medical conditions,” Malone said.

Older adults or caregivers who are helping them should try to bring “things that would engage you cognitively: magazines, books … music, anything that you might focus on in a hallway where there isn’t a TV to entertain you,” Kennedy said.

“Experienced patients often show up with eye masks and ear plugs” to help them rest in ERs with nonstop stimulation, said Zikry of UCLA. “Also, bring something to eat and drink in case you can’t get to the cafeteria or it’s a while before staffers bring these to you.”

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care, and advice you need in dealing with the health care system. Visit kffhealthnews.org/columnists to submit your requests or tips.

This article was produced by KFF Health News, a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

Journalists Delve Into Climate Change, Medicaid ‘Unwinding,’ and the Gap in Mortality Rates

KFF Health News senior correspondent Samantha Young discussed Medicaid and climate change on KCBS Radio’s “On-Demand” podcast on April 29.


KFF Health News contributor Andy Miller discussed Medicaid unwinding on WUGA’s “The Georgia Health Report” on April 26.


KFF Health News Nevada correspondent Jazmin Orozco Rodriguez discussed mortality rates in rural America on The Daily Yonder’s “The Yonder Report” on April 24.


Oh, Dear! Baby Gear! Why Are the Manuals So Unclear?

Since becoming a father a few months ago, I’ve been nursing a grudge against something tiny, seemingly inconsequential, and often discarded: instructional manuals. Parenthood requires a lot of gadgetry to maintain a kid’s health and welfare. Those gadgets require puzzling over booklets, decoding inscrutable pictographs, and wondering whether warnings can be safely ignored or are actually disclosing a hazard.

To give an example, my daughter, typically a cooing little marsupial, quickly discovered babyhood’s superpower: Infants emerge from the womb with talon-strength fingernails. She wasn’t afraid to use them, against either her parents or herself. So we purchased a pistachio-green, hand-held mani-pedi device.

That was the easy part. The difficulty came when we consulted the manual, a palm-sized, two-page document.

A photo of a father holding his infant daughter while reading an instruction manual in his other hand.
KFF Health News correspondent Darius Tahir holds his nearly 5-month-old daughter while reviewing an instruction manual. Tahir writes that the manuals for baby health and wellness gadgetry can be hard to understand, even for tech-savvy parents.(The Tahir family)

The wandlike tool is topped with a whirring disc. One can apparently adjust the speed of its rotation using a sliding toggle on the wand. But the product manual offered confusing advice: “Please do not use round center position grinding,” it said. Instead, “Please use the outer circle position to grinding.” It also proclaimed, “Stay away from children.” In finer print, the manual revealed the potential combination of kids and the device’s smaller parts was the reason for concern.

One would hope for more clarity about a doodad that could inadvertently cause pain.

Later, I noticed another warning: “If you do not use this product for a long time, please remove the battery.” Was it dangerous? Or simply an unclear and unhelpful yet innocuous heads-up? We didn’t know what to do with this information.

We now notice shoddy instructions everywhere.

One baby carrier insert told us to use the product for infants with “adequate” head, neck, and torso control — a vague phrase. (The manufacturer declined to comment.)

Another manual, this one online and for a car seat — a device that’s supposed to protect your kid — informed readers with words and images that a model baby was “properly positioned” relative to the top of the headrest “structure” when more than one inch from the top. Just pixels away, the same model, slumped further down, was deemed improperly positioned: “The headrest should not be more than 1” from the top of her head,” it said, in tension with its earlier instructions. Which was it, more than one inch or not? So we fiddle and hope for the best.

I acknowledge this sounds like new-parent paranoia. But we’re not entirely crazy: Manuals are important, and ones for baby products “are notoriously difficult to write,” Paul Ballard, the managing director of 3di Information Solutions, a technical writing firm, told me.

Deborah Girasek, a professor of social and behavior sciences at the Uniformed Services University of the Health Sciences, told me that for decades, for the young and middle-aged alike, unintentional injury has been the leading cause of death. That’s drownings, fires, suffocation, car crashes. The USU is a federal service academy training medical students destined for the armed services or other parts of the government.

Some of these deaths are caused by lack of effective communication — that is, the failure of instruction about how to avoid injury.

And these problems stretch from cheap devices to the most sophisticated products of research and development.

It’s a shortcoming that’s prompted several regulatory agencies charged with keeping Americans healthy, including the Consumer Product Safety Commission, the Food and Drug Administration, and the National Highway Traffic Safety Administration, to prod companies into providing more helpful instructions.

By some lights, they’ve had success. NHTSA, for example, has employees who actually read manuals. The agency says about three-quarters of car seats’ manuals rate four or five stars out of five, up from 38% in 2008. Then again, our car seat’s has a five-star rating. But it turns out the agency doesn’t evaluate online material.

Medical product manuals sometimes don’t fare too well either. Raj Ratwani, director of MedStar Health’s Human Factors program, told me that, for a class he teaches to nurses and doctors, he prompted students to evaluate the instructions for covid-19 tests. The results were poor. One time, instructions detailed two swabs. The kit had only one.

Technical writers I spoke with identified this kind of mistake as a symptom of cost cutting. Maybe a company creates one manual meant to cover a range of products. Maybe it puts together the manual at the last moment. Maybe it farms out the task to marketers, who don’t necessarily think about how manuals need to evolve as the products do.

For some of these cost-cutting tactics, “the motivation for doing it can be cynical,” Ballard said.

Who knows.

Some corners of the technical writing world are gloomy. People worry their jobs aren’t secure, that they’re going to be replaced by someone overseas or artificial intelligence. Indeed, multiple people I spoke with said they’d heard about generative AI experiments in this area.

Even before AI has had its effect, the job market has weighed in. According to the federal government, the number of technical writers fell by a third from 2001, its recent peak, to 2023.

One solution for people like us — frustrated by inscrutable instructions — is to turn to another uncharted world: social media. YouTube, for instance, has helped us figure out a lot of the baby gadgets we have acquired. But those videos also are part of a wild West, where creators offer helpful tips on baby products then refer us to their other productions (read: ads) touting things like weight loss services. Everyone’s got to make a living, of course; but I’d rather they not make a buck off viewers’ postpartum anxiety.

It reminds me of an old insight that became a digital-age cliché: Information wants to be free. Everyone forgets the second half: Information also wants to be expensive. It’s cheap to share information once produced, but producing that information is costly — and a process that can’t easily or cheaply be replaced. Someone must pay. Instruction manuals are just another example.

This article was produced by KFF Health News, a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

Bird Flu Is Bad for Poultry and Dairy Cows. It’s Not a Dire Threat for Most of Us — Yet.

Headlines are flying after the Department of Agriculture confirmed that the H5N1 bird flu virus has infected dairy cows around the country. Tests have detected the virus among cattle in nine states, mainly in Texas and New Mexico, and most recently in Colorado, said Nirav Shah, principal deputy director at the Centers for Disease Control and Prevention, at a May 1 event held by the Council on Foreign Relations.

A menagerie of other animals have been infected by H5N1, and at least one person in Texas. But what scientists fear most is if the virus were to spread efficiently from person to person. That hasn’t happened and might not. Shah said the CDC considers the H5N1 outbreak “a low risk to the general public at this time.”

Viruses evolve and outbreaks can shift quickly. “As with any major outbreak, this is moving at the speed of a bullet train,” Shah said. “What we’ll be talking about is a snapshot of that fast-moving train.” What he means is that what’s known about the H5N1 bird flu today will undoubtedly change.

With that in mind, KFF Health News explains what you need to know now.

Q: Who gets the bird flu?

Mainly birds. Over the past few years, however, the H5N1 bird flu virus has increasingly jumped from birds into mammals around the world. The growing list of more than 50 species includes seals, goats, skunks, cats, and wild bush dogs at a zoo in the United Kingdom. At least 24,000 sea lions died in outbreaks of H5N1 bird flu in South America last year.

What makes the current outbreak in cattle unusual is that it’s spreading rapidly from cow to cow, whereas the other cases — except for the sea lion infections — appear limited. Researchers know this because genetic sequences of the H5N1 viruses drawn from cattle this year were nearly identical to one another.

The cattle outbreak is also concerning because the country has been caught off guard. Researchers examining the virus’s genomes suggest it originally spilled over from birds into cows late last year in Texas, and has since spread among many more cows than have been tested. “Our analyses show this has been circulating in cows for four months or so, under our noses,” said Michael Worobey, an evolutionary biologist at the University of Arizona in Tucson.

Q: Is this the start of the next pandemic?

Not yet. But it’s a thought worth considering because a bird flu pandemic would be a nightmare. More than half of people infected by older strains of H5N1 bird flu viruses from 2003 to 2016 died. Even if death rates turn out to be less severe for the H5N1 strain currently circulating in cattle, repercussions could involve loads of sick people and hospitals too overwhelmed to handle other medical emergencies.

Although at least one person has been infected with H5N1 this year, the virus can’t lead to a pandemic in its current state. To achieve that horrible status, a pathogen needs to sicken many people on multiple continents. And to do that, the H5N1 virus would need to infect a ton of people. That won’t happen through occasional spillovers of the virus from farm animals into people. Rather, the virus must acquire mutations for it to spread from person to person, like the seasonal flu, as a respiratory infection transmitted largely through the air as people cough, sneeze, and breathe. As we learned in the depths of covid-19, airborne viruses are hard to stop.

That hasn’t happened yet. However, H5N1 viruses now have plenty of chances to evolve as they replicate within thousands of cows. Like all viruses, they mutate as they replicate, and mutations that improve the virus’s survival are passed to the next generation. And because cows are mammals, the viruses could be getting better at thriving within cells that are closer to ours than birds’.

The evolution of a pandemic-ready bird flu virus could be aided by a sort of superpower possessed by many viruses. Namely, they sometimes swap their genes with other strains in a process called reassortment. In a study published in 2009, Worobey and other researchers traced the origin of the H1N1 “swine flu” pandemic to events in which different viruses causing the swine flu, bird flu, and human flu mixed and matched their genes within pigs that they were simultaneously infecting. Pigs need not be involved this time around, Worobey warned.

Q: Will a pandemic start if a person drinks virus-contaminated milk?

Not yet. Cow’s milk, as well as powdered milk and infant formula, sold in stores is considered safe because the law requires all milk sold commercially to be pasteurized. That process of heating milk at high temperatures kills bacteria, viruses, and other teeny organisms. Tests have identified fragments of H5N1 viruses in milk from grocery stores but confirm that the virus bits are dead and, therefore, harmless.

Unpasteurized “raw” milk, however, has been shown to contain living H5N1 viruses, which is why the FDA and other health authorities strongly advise people not to drink it. Doing so could cause a person to become seriously ill or worse. But even then, a pandemic is unlikely to be sparked because the virus — in its current form — does not spread efficiently from person to person, as the seasonal flu does.

Q: What should be done?

A lot! Because of a lack of surveillance, the U.S. Department of Agriculture and other agencies have allowed the H5N1 bird flu to spread under the radar in cattle. To get a handle on the situation, the USDA recently ordered all lactating dairy cattle to be tested before farmers move them to other states, and the outcomes of the tests to be reported.

But just as restricting covid tests to international travelers in early 2020 allowed the coronavirus to spread undetected, testing only cows that move across state lines would miss plenty of cases.

Such limited testing won’t reveal how the virus is spreading among cattle — information desperately needed so farmers can stop it. A leading hypothesis is that viruses are being transferred from one cow to the next through the machines used to milk them.

To boost testing, Fred Gingrich, executive director of a nonprofit organization for farm veterinarians, the American Association of Bovine Practitioners, said the government should offer funds to cattle farmers who report cases so that they have an incentive to test. Barring that, he said, reporting just adds reputational damage atop financial loss.

“These outbreaks have a significant economic impact,” Gingrich said. “Farmers lose about 20% of their milk production in an outbreak because animals quit eating, produce less milk, and some of that milk is abnormal and then can’t be sold.”

The government has made the H5N1 tests free for farmers, Gingrich added, but they haven’t budgeted money for veterinarians who must sample the cows, transport samples, and file paperwork. “Tests are the least expensive part,” he said.

If testing on farms remains elusive, evolutionary virologists can still learn a lot by analyzing genomic sequences from H5N1 viruses sampled from cattle. The differences between sequences tell a story about where and when the current outbreak began, the path it travels, and whether the viruses are acquiring mutations that pose a threat to people. Yet this vital research has been hampered by the USDA’s slow and incomplete posting of genetic data, Worobey said.

The government should also help poultry farmers prevent H5N1 outbreaks since those kill many birds and pose a constant threat of spillover, said Maurice Pitesky, an avian disease specialist at the University of California-Davis.

Waterfowl like ducks and geese are the usual sources of outbreaks on poultry farms, and researchers can detect their proximity using remote sensing and other technologies. By zeroing in on zones of potential spillover, farmers can target their attention. That can mean routine surveillance to detect early signs of infections in poultry, using water cannons to shoo away migrating flocks, relocating farm animals, or temporarily ushering them into barns. “We should be spending on prevention,” Pitesky said.

Q: OK it’s not a pandemic, but what could happen to people who get this year’s H5N1 bird flu?

No one really knows. Only one person in Texas has been diagnosed with the disease this year, in April. This person worked closely with dairy cows, and had a mild case with an eye infection. The CDC found out about them because of its surveillance process. Clinics are supposed to alert state health departments when they diagnose farmworkers with the flu, using tests that detect influenza viruses, broadly. State health departments then confirm the test, and if it’s positive, they send a person’s sample to a CDC laboratory, where it is checked for the H5N1 virus, specifically. “Thus far we have received 23,” Shah said. “All but one of those was negative.”

State health department officials are also monitoring around 150 people, he said, who have spent time around cattle. They’re checking in with these farmworkers via phone calls, text messages, or in-person visits to see if they develop symptoms. And if that happens, they’ll be tested.

Another way to assess farmworkers would be to check their blood for antibodies against the H5N1 bird flu virus; a positive result would indicate they might have been unknowingly infected. But Shah said health officials are not yet doing this work.

“The fact that we’re four months in and haven’t done this isn’t a good sign,” Worobey said. “I’m not super worried about a pandemic at the moment, but we should start acting like we don’t want it to happen.”

This article was produced by KFF Health News, a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.