Christina Kashiwada was traveling for work during the summer of 2018 when she noticed a small, itchy lump in her left breast.

She thought little of it at first. She did routine self-checks and kept up with medical appointments. But a relative urged her to get a mammogram. She took the advice and learned she had stage 3 breast cancer, a revelation that stunned her.

“I’m 36 years old, right?” said Kashiwada, a civil engineer in Sacramento, California. “No one’s thinking about cancer.”

About 11,000 Asian American and Pacific Islander women were diagnosed with breast cancer in 2021 and about 1,500 died. The latest federal data shows the rate of new breast cancer diagnoses in Asian American and Pacific Islander women — a group that once had relatively low rates of diagnosis — is rising much faster than that of many other racial and ethnic groups. The trend is especially sharp among young women such as Kashiwada.

About 55 of every 100,000 Asian American and Pacific Islander women under 50 were diagnosed with breast cancer in 2021, surpassing the rate for Black and Hispanic women and on par with the rate for white women, according to age-adjusted data from the National Institutes of Health. (Hispanic people can be of any race or combination of races but are grouped separately in this data.)

The rate of new breast cancer cases among Asian American and Pacific Islander women under 50 grew by about 52% from 2000 through 2021. Rates for AAPI women 50 to 64 grew 33% and rates for AAPI women 65 and older grew by 43% during that period. By comparison, the rate for women of all ages, races, and ethnicities grew by 3%.

Researchers have picked up on this trend and are racing to find out why it is occuring within this ethnically diverse group. They suspect the answer is complex, ranging from cultural shifts to pressure-filled lifestyles — yet they concede it remains a mystery and difficult for patients and their families to discuss because of cultural differences.

Helen Chew, director of the Clinical Breast Cancer Program at UC Davis Health, said the Asian American diaspora is so broad and diverse that simple explanations for the increase in breast cancer aren’t obvious.

“It’s a real trend,” Chew said, adding that “it is just difficult to tease out exactly why it is. Is it because we’re seeing an influx of people who have less access to care? Is it because of many things culturally where they may not want to come in if they see something on their breast?”

There’s urgency to solve this mystery because it’s costing lives. While women in most ethnic and racial groups are experiencing sharp declines in breast cancer death rates, about 12 of every 100,000 Asian American and Pacific Islander women of any age died from breast cancer in 2023, essentially the same death rate as in 2000, according to age-adjusted, provisional data from the Centers for Disease Control and Prevention. The breast cancer death rate among all women during that period dropped 30%.

The CDC does not break out breast cancer death rates for many different groups of Asian American women, such as those of Chinese or Korean descent. It has, though, begun distinguishing between Asian American women and Pacific Islander women.

Nearly 9,000 Asian American women died from breast cancer from 2018 through 2023, compared with about 500 Native Hawaiian and Pacific Islander women. However, breast cancer death rates were 116% higher among Native Hawaiian and Pacific Islander women than among Asian American women during that period.

Rates of pancreatic, thyroid, colon, and endometrial cancer, along with non-Hodgkin lymphoma rates, have also recently risen significantly among Asian American and Pacific Islander women under 50, NIH data show. Yet breast cancer is much more common among young AAPI women than any of those other types of cancer — especially concerning because young women are more likely to face more aggressive forms of the disease, with high mortality rates.

“We’re seeing somewhere almost around a 4% per-year increase,” said Scarlett Gomez, a professor and epidemiologist at the University of California-San Francisco’s Helen Diller Family Comprehensive Cancer Center. “We’re seeing even more than the 4% per-year increase in Asian/Pacific Islander women less than age 50.”

Gomez is a lead investigator on a large study exploring the causes of cancer in Asian Americans. She said there is not yet enough research to know what is causing the recent spike in breast cancer. The answer may involve multiple risk factors over a long period of time.

“One of the hypotheses that we’re exploring there is the role of stress,” she said. “We’re asking all sorts of questions about different sources of stress, different coping styles throughout the lifetime.”

It’s likely not just that there’s more screening. “We looked at trends by stage at diagnosis and we are seeing similar rates of increase across all stages of disease,” Gomez said.

Veronica Setiawan, a professor and epidemiologist at the Keck School of Medicine of the University of Southern California, said the trend may be related to Asian immigrants adopting some lifestyles that put them at higher risk. Setiawan is a breast cancer survivor who was diagnosed a few years ago at the age of 49.

“Asian women, American women, they become more westernized so they have their puberty younger now — having earlier age at [the first menstrual cycle] is associated with increased risk,” said Setiawan, who is working with Gomez on the cancer study. “Maybe giving birth later, we delay childbearing, we don’t breastfeed — those are all associated with breast cancer risks.”

Moon Chen, a professor at the University of California-Davis and an expert on cancer health disparities, added that only a tiny fraction of NIH funding is devoted to researching cancer among Asian Americans.

Whatever its cause, the trend has created years of anguish for many patients.

Kashiwada underwent a mastectomy following her breast cancer diagnosis. During surgery, doctors at UC Davis Health discovered the cancer had spread to lymph nodes in her underarm. She underwent eight rounds of chemotherapy and 20 sessions of radiation treatment.

Throughout her treatments, Kashiwada kept her ordeal a secret from her grandmother, who had helped raise her. Her grandmother never knew about the diagnosis. “I didn’t want her to worry about me or add stress to her,” Kashiwada said. “She just would probably never sleep if she knew that was happening. It was very important to me to protect her.”

Kashiwada moved in with her parents. Her mom took a leave from work to help take care of her.

Kashiwada’s two young children, who were 3 and 6 at the time, stayed with their dad so she could focus on her recovery.

“The kids would come over after school,” she said. “My dad would pick them up and bring them over to see me almost every day while their dad was at work.”

Kashiwada spent months regaining strength after the radiation treatments. She returned to work but with a doctor’s instruction to avoid lifting heavy objects.

Kashiwada had her final reconstructive surgery a few weeks before COVID lockdowns began in 2020. But her treatment was not finished.

Her doctors had told her that estrogen fed her cancer, so they gave her medicine to put her through early menopause. The treatment was not as effective as they had hoped. Her doctor performed surgery in 2021 to remove her ovaries.

More recently, she was diagnosed with osteopenia and will start injections to stop bone loss.

Kashiwada said she has moved past many of the negative emotions she felt about her illness and wants other young women, including Asian American women like her, to be aware of their elevated risk.

“No matter how healthy you think you are, or you’re exercising, or whatever you’re doing, eating well, which is all the things I was doing — I would say it does not make you invincible or immune,” she said. “Not to say that you should be afraid of everything, but just be very in tune with your body and what your body’s telling you.”

Phillip Reese is a data reporting specialist and an associate professor of journalism at California State University-Sacramento.

This article was produced by KFF Health News , which publishes California Healthline , an editorially independent service of the California Health Care Foundation . Supplemental support comes from the Asian American Journalists Association-Los Angeles through The California Endowment.

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

When pediatrician Eric Ball opened a refrigerator full of childhood vaccines, all the expected shots were there — DTaP, polio, pneumococcal vaccine — except one.

“This is where we usually store our COVID vaccines, but we don’t have any right now because they all expired at the end of last year and we had to dispose of them,” said Ball, who is part of a pediatric practice in Orange County, California.

“We thought demand would be way higher than it was.”

Pediatricians across the country are pre-ordering the updated and reformulated COVID-19 vaccine for the fall and winter respiratory virus season, but some doctors said they’re struggling to predict whether parents will be interested. Providers like Ball don’t want to waste money ordering doses that won’t be used, but they need enough on hand to vaccinate vulnerable children.

The Centers for Disease Control and Prevention recommends that anyone 6 months or older get the updated COVID vaccination, but in the 2023-24 vaccination season only about 15% of eligible children in the U.S. got a shot.

Ball said it was difficult to let vaccines go to waste last year. It was the first time the federal government was no longer picking up the tab for the shots, and providers had to pay upfront for the vaccines. Parents would often skip the COVID shot, which can have a very short shelf life compared with other vaccines.

“Watching it sitting on our shelves expiring every 30 days, that’s like throwing away $150 repeatedly every day, multiple times a month,” Ball said.

This year, Ball slashed his fall vaccine order to the bare minimum to avoid another costly mistake.

“We took the number of flu vaccines that we order, and then we ordered 5% of that in COVID vaccines,” Ball said. “It’s a guess.”

That small vaccine order cost more than $63,000, he said.

Pharmacists, pharmacy interns, and techs are allowed to give COVID vaccines only to children age 3 and up, meaning babies and toddlers would need to visit a doctor’s office for inoculation.

It’s difficult to predict how parents will feel about the shots this fall, said Chicago pediatrician Scott Goldstein. Unlike other vaccinations, COVID shots aren’t required for kids to attend school, and parental interest seems to wane with each new formulation, he said. For a physician-owned practice such as Goldstein’s, the upfront cost of the vaccine can be a gamble.

“The cost of vaccines, that’s far and away our biggest expense. But it’s also the most important thing we do, you could argue, is vaccinating kids,” Goldstein said.

Insurance doesn’t necessarily cover vaccine storage accidents, which can put the practice at risk of financial ruin.

“We’ve had things happen like a refrigerator gets unplugged. And then we’re all of a sudden out $80,000 overnight,” Goldstein said.

South Carolina pediatrician Deborah Greenhouse said she would order more COVID vaccines for older children if the pharmaceutical companies that she buys from had a more forgiving return policy.

“Pfizer is creating that situation. If you’re only going to let us return 30%, we’re not going to buy much,” she said. “We can’t.”

Greenhouse owns her practice, so the remaining 70% of leftover shots would come out of her pocket.

Vaccine maker Pfizer will take back all unused COVID shots for young children, but only 30% of doses for people 12 and older.

Pfizer said in an Aug. 20 emailed statement, “The return policy was instituted as we recognize both the importance and the complexity of pediatric vaccination and wanted to ensure that pediatric offices did not have hurdles to providing vaccine to their young patients.”

Pfizer’s return policy is similar to policies from other drugmakers for pediatric flu vaccines, also recommended during the fall season. Physicians who are worried about unwanted COVID vaccines expiring on the shelves said flu shots cost them about $20 per dose, while COVID shots cost around $150 per dose.

“We run on a very thin margin. If we get stuck holding a ton of vaccine that we cannot return, we can’t absorb that kind of cost,” Greenhouse said.

Vaccine maker Moderna will accept COVID vaccine returns, but the amount depends on the individual contract with a provider. Novavax will accept the return of only unopened vaccines and doesn’t specify the amount they’ll accept.

Greenhouse wants to vaccinate as many children as possible but said she can’t afford to stock shots with a short shelf life. Once she runs out of the doses she’s ordered, Greenhouse said, she plans to tell families to go to a pharmacy to get older children vaccinated. If pediatricians around the country are making the same calculations, doses for very small children could be harder to find at doctors’ offices.

“Frankly, it’s not an ideal situation, but it’s what we have to do to stay in business,” she said.

Ball, the California pediatrician, worries that parents’ limited interest has caused pediatricians to minimize their vaccine orders, in turn making the newest COVID shots difficult to find once they become available.

“I think there’s just a misperception that it’s less of a big deal to get COVID, but I’m still sending babies to the hospital with COVID,” Ball said. “We’re still seeing kids with long COVID. This is with us forever.”

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

SAVANNAH, Ga. — Blocks from where tourists stroll along the cobblestoned riverfront in this racially divided city, Detraya Gilliard made her way down the dark, ruptured sidewalks of Yamacraw Village, looking for her missing 15-year-old daughter.

Like most other people living in one of the nation’s oldest public housing projects, Gilliard endured the boarded-up buildings and mold-filled apartments because it was the only place she could afford.

Without working streetlights in parts of Yamacraw, Gilliard relied on the crescent moon’s glow to search for her daughter Desaray in May 2022. She passed yards dotted with clotheslines and power lines, and a broken-down playground littered with juice boxes and red Solo cups.

“I happened to look down, and I knew it was her by her feet, by the shoes she had on,” Gilliard said. She was “barely hanging on and she was covered in blood.”

The year before Desaray died, President Joe Biden called for the federal government to spend tens of billions of dollars to fix dilapidated public housing that he said posed “critical life-safety concerns.” The repairs, Biden said, would mostly help people of color, single mothers like Gilliard who work in low-income jobs, and people with disabilities.

The federal Department of Housing and Urban Development estimates that $115 billion is needed to fund a backlog of public housing repairs. But, two years ago, money to fund those repairs became a casualty of negotiations between the Biden administration and congressional lawmakers over the Inflation Reduction Act. Republicans also have blocked efforts to lift 25-year-old legislation that effectively prohibits the construction of additional public housing, despite the catastrophic public health consequences.

Tenants living in derelict housing face conditions that contribute to higher rates of heart disease, diabetes, asthma, violence, and other life-threatening risks.

The federal government has a long history of discriminatory practices in public housing. In cities across the country after World War II, Black families were barred from many public housing complexes even as the government induced white people to leave them by offering single-family homes in the suburbs subsidized by the Federal Housing Administration. Starting with the Nixon administration, lawmakers slowed investing in new public housing as more Black families and other people of color became tenants.

Today “residents are facing really terrible choices, or terrible options about their future,” said Sarah Saadian, senior vice president of policy for the National Low Income Housing Coalition. “We got here from Congress really failing to live up to its responsibilities of ensuring that people have access to an affordable, stable home.”

In 2022, an art deco luxury apartment building opened down the street. But little has changed in Yamacraw, which is filled with Black families.

Current and former tenants say the Housing Authority of Savannah, the agency that oversees Yamacraw, has ignored the mold, rats, and roaches that infest the units and sicken residents, and the bullet holes in windows and gunshots that ring through the night. Now they fear the city is using the poor state of Yamacraw as justification to push residents out.

In April, an inspection of Yamacraw apartments conducted by HUD, which oversees taxpayer-supported public housing nationwide, found 29 “life-threatening” deficiencies that pose a high risk of death to residents, according to a preliminary report.

The inspection cited 28 deficiencies it called “severe,” meaning they present a high risk of permanent disability, serious injury, or illness. An additional 195 deficiencies were cited as “moderate” because they could cause temporary harm or prompt a visit to a doctor.

Research links structural racism and disinvestment to chronic gun violence, which has taken a heavy toll on Black neighborhoods and kids such as Desaray. A study of gun injuries in four large cities at the height of the covid-19 pandemic found that Black children were 100 times as likely as white youths to suffer a firearm assault.

Study co-author Jonathan Jay, an assistant professor of community health sciences at Boston University, said most of the country’s gun violence stems from disputes in neighborhoods that lack investment in housing and other public services

“This is about white privilege,” Jay said. “The result is driven by racist policymaking.”

Desaray Gilliard was a high school freshman when she was killed. She loved clothes, music, dancing, and the color pink, her mother said. She planned to go to Italy with her art class. She was excited about learning to drive and getting a job. Desaray had her sights set on attending Ohio State University.

They’d lived in Yamacraw for seven years. The teen’s shooting death remains unsolved.

Gilliard has struggled with thoughts of self-harm, she said. She maintains a memorial with pictures, stuffed animals, and flowers near the spot where she found Desaray’s body.

“I have to remember this is for her,” she said of her middle child’s death, “because nobody else is doing these things for her to keep her memory alive.”

A Broken Promise?

Federally funded public housing must be kept in “decent, safe and sanitary” condition, according to HUD. In 2013, the agency’s then secretary, Shaun Donovan, visited Savannah to announce a program that could give the local housing authority millions of dollars to rehab four public housing complexes, including Yamacraw, which has been among the lowest-rated public housing complexes in Georgia.

The Rental Assistance Demonstration program touted by Donovan did not provide new public money. Instead, it loosened rules to allow local officials to work with private lenders and developers to pay for repairs, transforming public housing complexes into mixed-income developments with Section 8 project-based rental assistance.

Last year, a consultants’ report found a host of problems in Yamacraw, including water leaks and faulty wiring. “The Remaining Useful Life of the Property is estimated to be 0 years,” the consultants wrote. The housing authority wants to demolish Yamacraw and replace it with homes that are “healthier, more energy efficient and accessible,” the report said.

Yamacraw never saw the windfall Donovan promised, current and former tenants said. Even with a housing assistance waitlist of more than 3,000 families in Savannah, records show most of the 315 apartments in Yamacraw sit empty, many with boarded-up doors and windows. Some other public housing developments in the area have been repaired or rebuilt, but except for new roofing added in 2019, Yamacraw has not had a significant renovation in years, according to the consultants’ report.

Rather than repair the units, local officials started a process to tear down the complex, threatening to displace residents who have nowhere else to go in a city where the average two-bedroom apartment rents for more than $1,600 monthly.

Congress has provided less money than was needed over the past 20 years to fix Yamacraw and other public housing complexes nationwide, leaving local agencies in a tough spot, said Earline Davis, executive director of the Housing Authority of Savannah.

The housing authority still plans to demolish Yamacraw and redevelop the property with new affordable housing, she said. Residents fear that they will be pushed out, and that because of its prime location, the redevelopment plans would prioritize apartments that attract people who can afford higher rents.

“Anytime you want to do something to make money — go destroy the historic Black community,” said Georgia Benton, who grew up in Yamacraw. “But ain’t nobody hollerin’ ‘Stop.’”

She and her son LaRay Benton have been fighting the housing authority’s redevelopment plans, which they say could also disrupt the two-century-old First Bryan Baptist Church. Rev. Andrew Bryan, a former enslaved person and ordained minister, founded the church in 1788. He later bought his freedom.

The Bentons and three City Council members went door to door observing the condition of residents’ units. They said plumbing issues caused sewage overflows and leaky faucets, mold tracked across the ceilings, and there were insect and rodent infestations.

Many families said they developed respiratory problems, such as bronchitis and asthma, after they moved in. “It is an unhealthy situation,” LaRay Benton said.

About seven years ago, after his previous Savannah landlord raised the rent, Paris Snead, his wife, and two children found themselves homeless. A nonprofit helped them get into Yamacraw, where rent was $750 a month.

It’s been years since they left. Snead said he still takes a daily allergy pill because he believes he was exposed to mold in his unit, which caused allergy-like symptoms.

“The walls sweat like working men,” Snead said of his former apartment. “The walls will, literally, from the top to the bottom, leak water.”

“When you’re homeless, and you want to be able to have a place for your kids, I mean, you’ll make a home wherever you can,” he said.

Snead said he showed Yamacraw’s management the leaking walls, but they didn’t act.

“The management team there did more to evict people and cause problems than they did to help families and ensure they had a place to stay,” Snead said.

HUD, which conducts periodic inspections at public housing complexes, declined an interview request. The agency referred questions to the Housing Authority of Savannah.

The housing authority’s redevelopment plans have been delayed by HUD’s lengthy approval process, said Savannah Mayor Van R. Johnson II, who appoints people to a five-member board of commissioners that helps oversee the city’s public housing.

He said he met with HUD acting Secretary Adrianne Todman and other HUD officials about housing issues in Savannah.

“People don’t deserve to live like that,” Johnson said.

If Yamacraw is demolished and rebuilt, he said, current tenants will have a chance to return because the homes will be affordable to people with low incomes.

Nobody else is doing these things for her to keep her memory alive.

‘The Worst Experience of My Life’

Yamacraw’s struggles are rooted in century-old policies that have made it difficult for many Black neighborhoods to thrive.

In the 1930s, the federal government’s Home Owners’ Loan Corp. made color-coded maps for Savannah and 238 other cities and labeled redlined areas — usually places where Black people, Jews, immigrants, and Catholics lived — as undesirable for investment.

“The houses are occupied by the lowest class negro tenants,” a government surveyor wrote.

Yamacraw was opened in 1941 as segregated public housing for Black people. Today a health clinic occupies the original administrative building, designed to look like a plantation house.

Despite its problems, Johnson said, some of the city’s most prominent doctors, lawyers, and ministers grew up in Yamacraw.

Former and current tenants said the apartments slowly descended into disrepair.

Each year more than 10,000 public housing apartments across the U.S. become uninhabitable.

Some lawmakers have used the poor state of public housing as justification to refuse lifting a moratorium passed during the Clinton administration that prohibits the construction of additional units, even as the nation’s rental prices — and evictions — soar.

The argument that public housing “doesn’t work” is disingenuous, said Saadian, with the National Low Income Housing Coalition.

“The federal government really failed to invest in public housing, to keep it in good condition, and to keep those communities thriving,” Saadian said, “and in many cases, actively contributed to those communities declining.”

Instead of repairing public housing and building more high-quality units, federal lawmakers promised to provide housing vouchers, commonly known as Section 8, which helps people with low incomes rent privately owned homes. But most people who qualify for vouchers never receive them. Those who do often struggle to find landlords who will accept them, rendering them sometimes worthless.

Three years ago, LaTonya Atterbury was living in hotels north of Atlanta when she was offered a unit in Yamacraw for $511 a month. In August 2021, she moved in with her niece, now 29, and her niece’s son, now 8, relieved to have more stable housing.

But within the first week, she said, a neighbor’s son broke her window and the housing authority charged her $60 to fix it. She said her bathroom is covered in mold and mildew. One day, months after she moved in, Atterbury noticed a hole in her second-story window and saw a bullet on the floor, and realized there had been a shooting overnight. No one was injured, she said, but the bullet hole was only recently fixed — about 2½ years after the incident.

“It’s been the worst experience of my life,” Atterbury said. “Sitting here will make you very depressed.”

Atterbury said she and other residents remain in Yamacraw at least in part because the housing authority has promised vouchers to move elsewhere. Three years later, she is still waiting.

Demolishing and rebuilding Yamacraw could take years.

Davis, the housing authority’s executive director, said her agency has repeatedly told tenants they would be relocated to other public housing complexes or given a Section 8 voucher during construction if they have no lease violations. But residents say they routinely receive lease violations for harmless acts such as broken blinds. LaRay Benton said one resident was cited and fined $75 for leaving a stroller on her front porch while she took her baby inside.

A Mother’s Search

Researchers said that the presence of abandoned buildings can contribute to violent crime by making people feel unsafe and creating a sense of disorder. Studies suggest that razing abandoned buildings and improving green space can reduce it.

“No gun policy is going to work if we don’t fix social infrastructure,” said Jonathan Metzl, director of the Department of Medicine, Health, and Society at Vanderbilt University. “We need investments to make sure communities feel safe. This is not just a public health problem. This is a race problem. This is a democracy problem.”

In recent years, shooting victims or their relatives, including Desaray’s mother, have filed at least three lawsuits against the Housing Authority of Savannah. Those ongoing lawsuits allege the agency failed to take added security measures in its public housing complexes — some of which had fallen into disrepair — despite gun violence and other crimes.

“I don’t know how we can prevent shootings,” Davis said.

Davis declined to comment on the lawsuits. She would say only that her agency has installed cameras in Yamacraw, worked with police, and asked residents to report crime. The actions came after Desaray’s death.

Johnson, Savannah’s mayor, said police have investigated the Desaray Gilliard case, but there are people “who know what happened” and will not talk to officers.

Around 9 p.m. on a Friday night two years ago, Gilliard went looking for her daughter for the second time that night. Desaray missed an 8 p.m. curfew and wasn’t answering her phone.

Gilliard waited for about 30 minutes at a bench near a park in the middle of the complex, hoping Desaray would find her. Then she started to retrace her steps.

Gilliard called 911 after she saw her daughter’s body.

When the police arrived, they made their way through the darkened complex with flashlights, Gilliard said. An officer pulled up Desaray’s shirt and saw a bullet hole in her chest. Gilliard said she later learned from a funeral director that her daughter had been shot three times. She has yet to receive an autopsy report from the police.

Gilliard said “nothing has changed before, since, or after” her daughter’s death.

“It’s been very difficult,” she said. “Sometimes I wanted to give up. I even thought about committing suicide.”

About a month after Desaray died, Gilliard said someone tried to break into her apartment. A couple of weeks later, her request to move to a new complex was finally granted and Gilliard left Yamacraw.

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

Ashley and Kyle were newlyweds in early 2022 and thrilled to be expecting their first child. But bleeding had plagued Ashley from the beginning of her pregnancy, and in July, at seven weeks, she began miscarrying.

The couple’s heartbreak came a few weeks after the U.S. Supreme Court overturned the federal right to abortion. In Wisconsin, their home state, an 1849 law had sprung back into effect, halting abortion care except when a pregnant woman faced death.

Insurance coverage for abortion care in the U.S. is a hodgepodge. Patients often don’t know when or if a procedure or abortion pills are covered, and the proliferation of abortion bans has exacerbated the confusion. Ashley said she got caught in that tangle of uncertainties.

Ashley’s life wasn’t in danger during the miscarriage, but the state’s abortion ban meant doctors in Wisconsin could not perform a D&E — dilation and evacuation — even during a miscarriage until the embryo died. She drove back and forth to the hospital, bleeding and taking sick time from work, until doctors could confirm that the pregnancy had ended. Only then did doctors remove the pregnancy tissue.

“The first pregnancy was the first time I had realized that something like that could affect me,” said Ashley, who asked to be identified by her middle name and her husband by his first name only. She works in a government agency alongside conservative co-workers and fears retribution for discussing her abortion care.

A year later, the 1849 abortion ban still in place in Wisconsin, Ashley was pregnant again.

“Everything was perfect. I was starting to feel kicking and movement,” she said. “It was the day I turned 20 weeks, which was a Monday. I went to work, and then I picked Kyle up from work, and I got up off the driver’s seat and there was fluid on the seat.”

The amniotic sac had broken, a condition called previable PPROM. The couple drove straight to the obstetrics triage at UnityPoint Health-Meriter Hospital, billed as the largest birthing hospital in Wisconsin. The fetus was deemed too underdeveloped to survive, and the ruptured membranes posed a serious threat of infection.

Obstetrician-gynecologists from across Wisconsin had decided that “in cases of previable PPROM, every patient should be offered termination of pregnancy due to the significant risk of ascending infection and potential sepsis and death,” said Eliza Bennett, the OB-GYN who treated Ashley.

Ashley needed an abortion to save her life.

The couple called their parents; Ashley’s mom arrived at the hospital to console them. Under the 1849 Wisconsin abortion ban, Bennett, an associate clinical professor at the University of Wisconsin School of Medicine, needed two other physicians to attest that Ashley was facing death.

But even with an arsenal of medical documentation, Ashley’s health insurer, the Federal Employees Health Benefits Program, did not cover the abortion procedure. Months later, Ashley logged in to her medical billing portal and was surprised to see that the insurer had paid for her three-night hospital stay but not the abortion.

“Every time I called insurance about my bill, I was sobbing on the phone because it was so frustrating to have to explain the situation and why I think it should be covered,” she said. “It’s making me feel like it was my fault, and I should be ashamed of it,” Ashley said.

Eventually, Ashley talked to a woman in the hospital billing department who relayed what the insurance company had said.

“She told me,” Ashley said, “quote, ‘FEP Blue does not cover any abortions whatsoever. Period. Doesn’t matter what it is. We don’t cover abortions.’”

University of Wisconsin Health, which administers billing for UnityPoint Health-Meriter hospital, confirmed this exchange.

The Federal Employees Health Benefits Program contracts with FEP Blue, or the BlueCross BlueShield Federal Employee Program, to provide health plans to federal employees. In response to an interview request, FEP Blue emailed a statement saying it “is required to comply with federal legislation which prohibits Federal Employees Health Benefits Plans from covering procedures, services, drugs, and supplies related to abortions except when the life of the mother would be endangered if the fetus were carried to term or when the pregnancy is the result of an act of rape or incest.”

Those restrictions, known as the Hyde Amendment, have been passed each year since 1976 by Congress and prohibit federal funds from covering abortion services.

In Ashley’s case, physicians had said her life was in danger, and her bill should have immediately been paid, said Alina Salganicoff, director of Women’s Health Policy at KFF, a health information nonprofit that includes KFF Health News.

What tripped up Ashley’s bill was the word “abortion” and a billing code that is insurance kryptonite, said Salganicoff.

“Right now, we’re in a situation where there is really heightened sensitivity about what is a life-threatening emergency, and when is it a life-threatening emergency,” Salganicoff said. The same chilling effect that has spooked doctors and hospitals from providing legal abortion care, she said, may also be affecting insurance coverage.

In Wisconsin, Bennett said, lack of coverage for abortion care is widespread.

“Many patients I take care of who have a pregnancy complication or, more commonly, a severe fetal anomaly, they don’t have any coverage,” Bennett said.

Recently, the bill for $1,700 disappeared from Ashley’s online bill portal. The hospital confirmed that eight months later, after multiple appeals, the insurer paid the claim. When contacted again on Aug. 7, FEP Blue responded that it would “not comment on the specifics of the health care received by individual members.”

Ashley said tangling with her insurance company and experiencing the impact of abortion restrictions on her health care, similar to other women around the country, has emboldened her.

“I’m in this now with all these people,” she said. “I feel a lot more connected to them, in a way that I didn’t as much before.”

Ashley is pregnant again, and she and her husband hope that this time their insurance will cover whatever medical care her doctor says she needs.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

When Bristeria Clark went into labor with her son in 2015, her contractions were steady at first. Then, they stalled. Her cervix stopped dilating. After a few hours, doctors at Phoebe Putney Memorial Hospital in Albany, Georgia, prepped Clark for an emergency cesarean section.

It wasn’t the vaginal birth Clark had hoped for during her pregnancy.

“I was freaking out. That was my first child. Like, of course you don’t plan that,” she said. “I just remember the gas pulling up to my face and I ended up going to sleep.”

She remembered feeling a rush of relief when she woke to see that her baby boy was healthy.

Clark, a 33-year-old nursing student who also works full-time in county government, had another C-section when her second child was born in 2020. This time, the cesarean was planned.

Clark said she’s grateful the physicians and nurses who delivered both her babies were kind and caring during her labor and delivery. But looking back, she said, she wishes she had had a doula for one-on-one support through pregnancy, childbirth, and the postpartum period. Now she wants to give other women the option she didn’t have.

Clark is a member of Morehouse School of Medicine’s first class of rural doulas, called Perinatal Patient Navigators.

The program recently graduated a dozen participants, all Black women from southwestern Georgia. They have completed more than five months of training and are scheduled to begin working with pregnant and postpartum patients this year.

“We’re developing a workforce that’s going to be providing the support that Black women and birthing people need,” Natalie Hernandez-Green, an associate professor of obstetrics and gynecology at Morehouse School of Medicine, said at the doula commencement ceremony in Albany, Georgia.

Albany is Morehouse School of Medicine’s second Perinatal Patient Navigator program site. The first has been up and running in Atlanta since training began in the fall of 2022.

Georgia has one of the highest rates of maternal mortality in the country, according to an analysis by KFF, a health information nonprofit that includes KFF Health News. And Black Georgians are more than twice as likely as white Georgians to die of causes related to pregnancy.

“It doesn’t matter whether you’re rich or poor. Black women are dying at [an] alarming rate from pregnancy-related complications,” said Hernandez-Green, who is also executive director of the Center for Maternal Health Equity at Morehouse School of Medicine. “And we’re about to change that one person at a time.”

The presence of a doula, along with regular nursing care, is associated with improved labor and delivery outcomes, reduced stress, and higher rates of patient satisfaction, according to the American College of Obstetricians and Gynecologists.

Multiple studies also link doulas to fewer expensive childbirth interventions, including cesarean births.

Doulas are not medical professionals. They are trained to offer education about the pregnancy and postpartum periods, to guide patients through the health care system, and to provide emotional and physical support before, during, and after childbirth.

Morehouse School of Medicine’s program is among a growing number of similar efforts being introduced across the country as more communities look to doulas to help address maternal mortality and poor maternal health outcomes, particularly for Black women and other women of color.

Now that she has graduated, Clark said she’s looking forward to helping other women in her community as a doula. “To be that person that would be there for my clients, treat them like a sister or like a mother, in a sense of just treating them with utmost respect,” she said. “The ultimate goal is to make them feel comfortable and let them know ‘I’m here to support you.’” Her training has inspired her to become an advocate for maternal health issues in southwestern Georgia.

Grants fund Morehouse School of Medicine’s doula program, which costs $350,000 a year to operate. Graduates are given a $2,000 training stipend and the program places five graduates with health care providers in southwestern Georgia. Grant money also pays the doulas’ salaries for one year.

“It’s not sustainable if you’re chasing the next grant to fund it,” said Rachel Hardeman, a professor of health and racial equity at the University of Minnesota School of Public Health.

Thirteen states cover doulas through Medicaid, according to the Georgetown University Center for Children and Families.

Hardeman and others have found that when Medicaid programs cover doula care, states save millions of dollars in health care costs. “We were able to calculate the return on investment if Medicaid decided to reimburse doulas for pregnant people who are Medicaid beneficiaries,” she said.

That’s because doulas can help reduce the number of expensive medical interventions during and after birth, and improving delivery outcomes, including reduced cesarean sections.

Doulas can even reduce the likelihood of preterm birth.

“An infant that is born at a very, very early gestational age is going to require a great deal of resources and interventions to ensure that they survive and then continue to thrive,” Hardeman said.

There is growing demand for doula services in Georgia, said Fowzio Jama, director of research for Healthy Mothers, Healthy Babies Coalition of Georgia. Her group recently completed a pilot study that offered doula services to about 170 Georgians covered under Medicaid. “We had a waitlist of over 200 clients and we wanted to give them the support that they needed, but we just couldn’t with the given resources that we had,” Jama said.

Doula services can cost hundreds or thousands of dollars out-of-pocket, making it too expensive for many low-income people, rural communities, and communities of color, many of which suffer from shortages in maternity care, according to the March of Dimes.

The Healthy Mothers, Healthy Babies study found that matching high-risk patients with doulas — particularly doulas from similar racial and ethnic backgrounds — had a positive effect on patients.

“There was a reduced use of pitocin to induce labor. We saw fewer requests for pain medication. And with our infants, only 6% were low birth weight,” Jama said.

Still, she and others acknowledge that doulas alone can’t fix the problem of high maternal mortality and morbidity rates.

States, including Georgia, need to do more to bring comprehensive maternity care to communities that need more options, Hardeman said.

“I think it’s important to understand that doulas are not going to save us, and we should not put that expectation on them. Doulas are a tool,” she said. “They are a piece of the puzzle that is helping to impact a really, really complex issue.”

In the meantime, Joan Anderson, 55, said she’s excited to get to work supporting patients, especially from rural areas around Albany.

“I feel like I’m equipped to go out and be that voice, be that person that our community needs so bad,” said Anderson, a graduate of the Morehouse School of Medicine doula program. “I am encouraged to know that I will be joining in that mission, that fight for us, as far as maternal health is concerned.”

Anderson said that someday she wants to open a birthing center to provide maternity care. “We do not have one here in southwest Georgia at all,” Anderson said.

In addition to providing support during and after childbirth, Anderson and her fellow graduates are trained to assess their patients’ needs and connect them to services such as food assistance, mental health care, transportation to prenatal appointments, and breastfeeding assistance.

Their work is likely to have ripple effects across a largely rural corner of Georgia, said Sherrell Byrd, who co-founded and directs SOWEGA Rising, a nonprofit organization in southwestern Georgia.

“So many of the graduates are part of church networks, they are part of community organizations, some of them are our government workers. They’re very connected,” Byrd said. “And I think that connectedness is what’s going to help them be successful moving forward.”

This reporting is part of a fellowship with the Association of Health Care Journalists supported by The Commonwealth Fund. It comes from a partnership that includes WABE , NPR , and KFF Health News.

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

OSKALOOSA, Iowa — Rural regions like the one surrounding this southern Iowa town used to have a lot more babies, and many more places to give birth to them.

At least 41 Iowa hospitals have shuttered their labor and delivery units since 2000. Those facilities, representing about a third of all Iowa hospitals, are located mostly in rural areas where birth numbers have plummeted. In some Iowa counties, annual numbers of births have fallen by three-quarters since the height of the baby boom in the 1950s and ’60s, when many rural hospitals were built or expanded, state and federal records show.

Similar trends are playing out nationwide, as hospitals struggle to maintain staff and facilities to safely handle dwindling numbers of births. More than half of rural U.S. hospitals now lack the service.

“People just aren’t having as many kids,” said Addie Comegys, who lives in southern Iowa and has regularly traveled 45 minutes each way for prenatal checkups at Oskaloosa’s hospital this summer. Her mother had six children, starting in the 1980s, when big families didn’t seem so rare.

“Now, if you have three kids, people are like, ‘Oh my gosh, are you ever going to stop?’” said Comegys, 29, who is expecting her second child in late August.

These days, many Americans choose to have small families or no children at all. Modern birth control methods help make such decisions stick. The trend is amplified in small towns when young adults move away, taking any childbearing potential with them.

Hospital leaders who close obstetrics units often cite declining birth numbers, along with staffing challenges and financial losses. The closures can be a particular challenge for pregnant women who lack the reliable transportation and flexible schedules needed to travel long distances for prenatal care and birthing services.

The baby boom peaked in 1957, when about 4.3 million children were born in the United States. The annual number of births dropped below 3.7 million by 2022, even though the overall U.S. population nearly doubled over that same period.

West Virginia has seen the steepest decline in births, a 62% drop in those 65 years, according to federal data. Iowa’s births dropped 43% over that period. Of the state’s 99 counties, just four — all urban or suburban — recorded more births.

Births have increased in only 13 states since 1957. Most of them, such as Arizona, California, Florida, and Nevada, are places that have attracted waves of newcomers from other states and countries. But even those states have had obstetrics units close in rural areas.

In Iowa, Oskaloosa’s hospital has bucked the trend and kept its labor and delivery unit open, partly by pulling in patients from 14 other counties. Last year, the hospital even managed the rare feat of recruiting two obstetrician-gynecologists to expand its services.

The publicly owned hospital, called Mahaska Health, expects to deliver 250 babies this year, up from about 160 in previous years, CEO Kevin DeRonde said.

“It’s an essential service, and we needed to keep it going and grow it,” DeRonde said.

Many of the U.S. hospitals that are now dropping obstetrics units were built or expanded in the mid-1900s, when America went on a rural-hospital building spree, thanks to federal funding from the Hill-Burton Act.

“It was an amazing program,” said Brock Slabach, chief operations officer for the National Rural Health Association. “Basically, if you were a county that wanted a hospital, they gave you the money.”

Slabach said that in addition to declining birth numbers, obstetrics units are experiencing a drop in occupancy because most patients go home after a night or two. In the past, patients typically spent several days in the hospital after giving birth.

Dwindling caseloads can raise safety concerns for obstetrics units.

A study published in JAMA in 2023 found that women were more likely to suffer serious complications if they gave birth in rural hospitals that handled 110 or fewer births a year. The authors said they didn’t support closing low-volume units, because that could lead more women to have complications related to traveling for care. Instead, they recommended improving training and coordination among rural health providers.

Stephanie Radke, a University of Iowa obstetrics and gynecology professor who studies access to birthing services, said it is almost inevitable that when rural birth numbers plunge, some obstetrics units will close. “We talk about that as a bad event, but we don’t really talk about why it happens,” she said.

Radke said maintaining a set number of obstetrics units is less important than ensuring good care for pregnant women and their babies. It’s difficult to maintain quality of care when the staff doesn’t consistently practice deliveries, she said, but it is hard to define that line. “What is realistic?” she said. “I don’t think a unit should be open that only delivers 50 babies a year.”

In some cases, she said, hospitals near each other have consolidated obstetrics units, pooling their resources into one program that has enough staffers and handles sufficient cases. “You’re not always really creating a care desert when that happens,” she said.

The decline in births has accelerated in many areas in recent years. Kenneth Johnson, a sociology professor and demographer at the University of New Hampshire, said it is understandable that many rural hospitals have closed obstetrics units. “I’m actually surprised some of them have lasted as long as they have,” he said.

Johnson said rural areas that have seen the steepest population declines tend to be far from cities and lack recreational attractions, such as mountains or large bodies of water. Some have avoided population losses by attracting immigrant workers, who tend to have larger families in the first generation or two after they move to the U.S., he said.

Katy Kozhimannil, a University of Minnesota health policy professor who studies rural issues, said declining birth numbers and obstetric unit closures can create a vicious cycle. Fewer babies being born in a region can lead a birthing unit to shutter. Then the loss of such a unit can discourage young people from moving to the area, driving birth numbers even lower.

In many regions, people with private insurance, flexible schedules, and reliable transportation choose to travel to larger hospitals for their prenatal care and to give birth, Kozhimannil said. That leaves rural hospitals with a larger proportion of patients on Medicaid, a public program that pays about half what private insurance pays for the same services, she said.

Iowa ranks near the bottom of all states for obstetrician-gynecologists per capita. But Oskaloosa’s hospital hit the jackpot last year, when it recruited Taylar Swartz and Garth Summers, a married couple who both recently finished their obstetrics training. Swartz grew up in the area, and she wanted to return to serve women there.

She hopes the number of obstetrics units will level off after the wave of closures. “It’s not even just for delivery, but we need access just to women’s health care in general,” she said. “I would love to see women’s health care be at the forefront of our government’s mind.”

Swartz noted that the state has only one obstetrics training program, which is at the University of Iowa. She said she and her husband plan to help spark interest in rural obstetrics by hosting University of Iowa residency rotations at the Oskaloosa hospital.

Comegys, a patient of Swartz’s, could have chosen a hospital birthing center closer to her home, but she wasn’t confident in its quality. Other hospitals in her region had shuttered their obstetrics units. She is grateful to have a flexible job, a reliable car, and a supportive family, so she can travel to Oskaloosa for checkups and to give birth there. She knows many other women are not so lucky, and she worries other obstetrics units are at risk.

“It’s sad, but I could see more closing,” she said.

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

David Engler had been pretty sure he didn’t want children. Then a frustrating school day two years ago helped seal the deal for the now 43-year-old substitute teacher.

“It was wild. I had to call the office seven times to get kids pulled out,” he said. “The next day, I called Kaiser and said, ‘I’d like to know how much a vasectomy is.’”

A representative with Engler’s insurer, Kaiser Permanente, told him the procedure would be free because it was a form of birth control, he said. But after undergoing the vasectomy last winter, he received a bill for $1,080.

“I felt defeated, tricked, and frustrated,” said Engler, who lives in Portland, Oregon.

Engler’s experience highlights how a labyrinthine patchwork of insurance coverage rules on reproductive health care creates confusion for patients. Oregon requires that vasectomies be covered for most people who work in the public sector. But the federal Affordable Care Act — which mandates that most health plans cover preventive health services, such as contraception, at no cost to the consumer — does not require vasectomies to be covered.

And that perplexity surrounding coverage may get more complicated.

An ongoing federal lawsuit aims to strike down the ACA’s preventive care coverage requirements for private insurers. If the case knocks out the mandates, state-level laws — which vary widely across the country — would carry more weight, a change that would resume the “wild West” dynamic from before Obamacare, said Zachary Baron, a health policy researcher at Georgetown Law.

It would create an environment “in which insurers and employers pick and choose which services they want to cover or which services they want to charge for,” Baron said. “It would certainly threaten access to care for millions of Americans.”

Studies have shown the requirements to cover preventive care have reduced consumers’ out-of-pocket costs and increased their use of short- and long-term birth control methods.

The job of defining which contraceptive services should be covered falls to the Health Resources and Services Administration, or HRSA. Two other groups — the U.S. Preventive Services Task Force, or USPSTF, and the Advisory Committee on Immunization Practices, or ACIP — make recommendations on other kinds of care that the ACA requires insurers to cover.

The plaintiffs in the lawsuit, a group of individuals and Christian-owned businesses, argue the members of these three panels haven’t been properly appointed by Congress. They also say the recommendations for insurance plans to cover medication for HIV prevention violate their religious rights.

On June 21, the U.S. Court of Appeals for the 5th Circuit issued what it called a “mixed bag” opinion in the case. It said one group — the USPSTF — had not been properly appointed, and therefore its recommendations made after the ACA was signed into law were unconstitutional. The plaintiffs had asked for a nationwide ruling, but the court said only the plaintiffs’ organizations could be exempted from its recommendations.

The court then sent the plaintiffs’ challenges to the recommendations made by HRSA and ACIP — including those on contraception — back to a lower court to consider.

The case is likely headed to Reed O’Connor, a federal judge in Texas who has issued decisions undermining the ACA — including a ruling striking down the entire law that the U.S. Supreme Court later overturned.

“O’Connor is a judge notoriously hostile to the Affordable Care Act,” said Gretchen Borchelt, vice president of reproductive rights and health at the National Women’s Law Center. “He is someone who is willing to impose remedies where he takes access to care away from everybody in the country based on what’s happening in one situation.”

A win for the plaintiffs, she worried, could create confusion about what kind of contraception is covered and how much it costs, which would ultimately lead to more unintended pregnancies — all at a time when women have less access to abortions.

Nearly two dozen organizations — including the American Medical Association, the American Public Health Association, and the Blue Cross Blue Shield Association — have joined Borchelt’s group in filing briefs warning about the potential disruptions a ruling for the plaintiffs could cause.

Jay Carson, an attorney with the Buckeye Institute, a conservative think tank, said he’s happy with the court’s ruling. His group, along with the state of Texas, filed briefs in support of the plaintiffs.

“Unelected bureaucrats” shouldn’t have the power to decide what insurance plans should be required to cover, said Carson. “We’ve gotten so far afield of Congress actually making the laws and, instead, relying on Congress to just empower some agency to do the heavy lifting.”

What power agencies do have is likely to be curtailed in the wake of a June 28 U.S. Supreme Court decision that overturned a decades-old precedent dictating that courts should defer to federal agencies when it comes to regulatory or scientific decisions.

“Courts are going to be more able to scrutinize experts,” said Richard Hughes, a health care regulatory attorney with the firm Epstein, Becker, and Green. “It’s a vibe shift — we’re moving in the direction of the administrative state being curtailed.”

Eliminating federal coverage requirements for contraception would leave it up to states to determine what services health insurance plans would be required to provide.

“It would leave significant gaps in coverage,” Baron said.

A group of Democratic-led states made such an argument in a court brief last year, arguing for the mandates to be upheld to discourage self-funded plans from declining to offer preventive services, as they often did before the ACA.

Even when states can regulate what health plans cover, people still fall through the cracks. “I see denials all the time in instances where the treatment clearly is covered,” said Megan Glor, a health insurance attorney in Oregon.

Patients can appeal their insurers’ decisions, but that’s not easy. And if a patient’s appeals fail, litigation is generally the only option — but that’s a long, complicated, costly process, Glor said. Likely, the best outcome for a patient is an insurer covering what should have been covered in the first place.

When Engler called Kaiser Permanente about his vasectomy charge, he said a representative told him the bill was sent by mistake. Still, he said, the insurer kept asking for money. Engler filed and lost multiple appeals and eventually settled the charge for $540.

Engler’s vasectomy likely should have been free, Glor said. As a teacher, Engler is a public sector employee, which means his insurance would be subject to an Oregon law that mandates no-cost coverage for vasectomies.

Kaiser Permanente told KFF Health News that state law does not apply because of a federal rule for high-deductible health plans paired with health savings accounts. That rule requires patients to cover out-of-pocket costs until their deductible is met.

However, after KFF Health News contacted Kaiser Permanente about Engler’s situation, he said the company promised to issue a full refund for the $540 he had paid to settle his case.

“Although we administered the benefit correctly, an employee who spoke with Mr. Engler told him incorrectly that he would not have” to share the cost, said Debbie Karman, a Kaiser Permanente spokesperson.

Engler said he’s happy with the outcome, though he’s still unsure how Kaiser Permanente’s staff was confused about his insurance coverage.

He worries that others don’t have the means he had to advocate for himself.

“It’s scary,” he said. “So many people are limited in their resources or their understanding of how to fight — or even who to fight.”

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

In 2013, the FDA approved an implantable device to treat leaky heart valves. Among its inventors was Mehmet Oz, the former television personality and former U.S. Senate candidate widely known as “Dr. Oz.”

In online videos, Oz has called the process that brought the MitraClip device to market an example of American medicine firing “on all cylinders,” and he has compared it to “landing a man on the moon.”

MitraClip was designed to spare patients from open-heart surgery by snaking hardware into the heart through a major vein. Its manufacturer, Abbott, said it offered new hope for people severely ill with a condition called mitral regurgitation and too frail to undergo surgery.

“It changed the face of cardiac medicine,” Oz said in a video.

But since MitraClip won FDA approval, versions of the device have been the subject of thousands of reports to the agency about malfunctions or patient injuries, as well as more than 1,100 reports of patient deaths, FDA records show. Products in the MitraClip line have been the subject of three recalls. A former employee has alleged in a federal lawsuit that Abbott promoted the device through illegal inducements to doctors and hospitals. The case is pending, and Abbott has denied illegally marketing the device.

The MitraClip story is, in many ways, a cautionary tale about the science, business, and regulation of medical devices.

Manufacturer-sponsored research on the device has long been questioned. In 2013, an outside adviser to the FDA compared some of the data marshaled in support of its approval to “poop.”

The FDA expanded its approval of MitraClip to a wider set of patients in 2019, based on a clinical trial in which Abbott was deeply involved and despite conflicting findings from another study.

In the three recalls, the first of which warned of potentially deadly consequences, neither the manufacturer nor the FDA withdrew inventory from the market. The company told doctors it was OK for them to continue using the recalled products.

In response to questions for this article, both Abbott and the FDA described MitraClip as safe and effective.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” Abbott spokesperson Brent Tippen said. “Patients suffering from mitral regurgitation have severely limited quality of life. MitraClip can significantly improve survival, freedom for hospitalization and quality of life via a minimally invasive, now common procedure.”

An FDA spokesperson, Audra Harrison, said patient safety “is the FDA’s highest priority and at the forefront of our work in medical device regulation.”

She said reports to the FDA about malfunctions, injuries, and deaths that the device may have caused or contributed to are “consistent” with study results the FDA reviewed for its 2013 and 2019 approvals.

In other words: They were expected.

Inspiration in Italy

When a person has mitral regurgitation, blood flows backward through the mitral valve. Severe cases can lead to heart failure.

With MitraClip, flaps of the valve — known as “leaflets” — are clipped together at one or more points to achieve a tighter seal when they close. The clips are deployed via a catheter threaded through a major vein, typically from an incision in the groin. The procedure offers an alternative to connecting the patient to a heart-lung machine and repairing or replacing the mitral valve in open-heart surgery.

Oz has said in online videos that he got the idea after hearing a doctor describe a surgical technique for the mitral valve at a conference in Italy. “And on the way home that night, on a plane heading back to Columbia University, where I was on the faculty, I wrote the patent,” he told KFF Health News.

A patent obtained by Columbia in 2001, one of several associated with MitraClip, lists Oz first among the inventors.

But a Silicon Valley-based startup, Evalve, would develop the device. Evalve was later acquired by Abbott for about $400 million.

“I think the engineers and people at Evalve always cringe a little bit when they see Mehmet taking a lot of, you know, basically claiming responsibility for what was a really extraordinary team effort, and he was a small to almost no player in that team,” one of the company’s founders, cardiologist Fred St. Goar, told KFF Health News.

Oz did not respond to a request for comment on that statement.

As of 2019, the MitraClip device cost $30,000 per procedure, according to an article in a medical journal. According to the Abbott website, more than 200,000 people around the world have been treated with MitraClip.

Oz filed a financial disclosure during his unsuccessful run for the U.S. Senate in 2022 that showed him receiving hundreds of thousands of dollars in annual MitraClip royalties.

Abbott recently received FDA approval for TriClip, a variation of the MitraClip system for the heart’s tricuspid valve.

Endorsed ‘With Trepidation’

Before the FDA said yes to MitraClip in 2013, agency staffers pushed back.

Abbott had originally wanted the device approved for “patients with significant mitral regurgitation,” a relatively broad term. After the FDA objected, the company narrowed its proposal to patients at too-high risk for open-heart surgery.

Even then, in an analysis, the FDA identified “fundamental” flaws in Abbott’s data.

FDA “approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered,” the FDA said in a review prepared for a March 2013 meeting of a committee of outside advisers to the agency.

Some committee members expressed misgivings. “If your right shoe goes into horse poop and your left shoe goes into dog poop, it’s still poop,” cardiothoracic surgeon Craig Selzman said, according to a transcript.

The committee voted 5-4 against MitraClip on the question of whether it proved effective. But members voted 8-0 that they considered the device safe and 5-3 that the benefits of the device outweighed its risks.

Selzman voted yes on the last question “with trepidation,” he said at the time.

In October 2013, the FDA approved the MitraClip Clip Delivery System for a narrower group of patients: those with a particular type of mitral regurgitation who were considered a surgery risk.

“The reality is, there is no perfect procedure,” said Jason Rogers, an interventional cardiologist and University of California-Davis professor who is an Abbott consultant. The company referred KFF Health News to Rogers as an authority on MitraClip. He called MitraClip “extremely safe” and said some patients treated with it are “on death’s door to begin with.”

“At least you’re trying to do something for them,” he said.

Conflicting Studies

In 2019, the FDA expanded its approval of MitraClip to a wider set of patients.

The agency based that decision on a clinical trial in the United States and Canada that Abbott not only sponsored but also helped design and manage. It participated in site selection and data analysis, according to a September 2018 New England Journal of Medicine paper reporting the trial results. Some of the authors received consulting fees from Abbott, the paper disclosed.

A separate study in France reached a different conclusion. It found that, for some patients who fit the expanded profile, the device did not significantly reduce deaths or hospitalizations for heart failure over a year.

The French study, which appeared in the New England Journal of Medicine in August 2018, was funded by the government of France and Abbott. As with the North American study, some of the researchers disclosed they had received money from Abbott. However, the write-up in the journal said Abbott played no role in the design of the French trial, the selection of sites, or in data analysis.

Gregg Stone, one of the leaders of the North American study, said there were differences between patients enrolled in the two studies and how they were medicated. In addition, outcomes were better in the North American study in part because doctors in the U.S. and Canada had more MitraClip experience than their counterparts in France, Stone said.

Stone, a clinical trial specialist with a background in interventional cardiology, acknowledged skepticism toward studies sponsored by manufacturers.

“There are some people who say, ‘Oh, well, you know, these results may have been manipulated,’” he said. “But I can guarantee you that’s not the truth.”

‘Nationwide Scheme’

A former Abbott employee alleges in a lawsuit that after MitraClip won approval, the company promoted the device to doctors and hospitals using inducements such as free marketing support, the chance to participate in Abbott clinical trials, and payments for participating in “sham speaker programs.”

The former employee alleges that she was instructed to tell referring physicians that if they observed mitral regurgitation in their patients to “just send it” for a MitraClip procedure because “everything can be clipped.” She also alleges that, using a script, she was told to promote the device to hospital administrators based on financial advantages such as “growth opportunities through profitable procedures, ancillary tests, and referral streams.”

The inducements were part of a “nationwide scheme” of illegal kickbacks that defrauded government health insurance programs including Medicare and Medicaid, the lawsuit claims.

The company denied doing anything illegal and said in a court filing that “to help its groundbreaking therapy reach patients, Abbott needed to educate cardiologists and other healthcare providers.”

Those efforts are “not only routine, they are laudable — as physicians cannot use, or refer a patient to another doctor who can use, a device that they do not understand or in some cases even know about,” the company said in the filing.

Under federal law, the person who filed the suit can receive a share of any money the government recoups from Abbott. The suit was filed by a company associated with a former employee in Abbott’s Structural Heart Division, Lisa Knott. An attorney for the company declined to comment and said Knott had no comment.

Reports to the FDA

As doctors started using MitraClip, the FDA began receiving reports about malfunctions and cases in which the product might have caused or contributed to a death or an injury.

According to some reports, clips detached from valve flaps. Flaps became damaged. Procedures were aborted. Mitral leakage worsened. Doctors struggled to control the device. Clips became “entangled in chordae” — cord-like structures also known as heartstrings that connect the valve flaps to the heart muscle. Patients treated with MitraClip underwent corrective operations.

As of March 2024, the FDA had received more than 17,000 reports documenting more than 22,000 “events” involving mitral valve repair devices, FDA data shows. All but about 200 of those reports mention one iteration of MitraClip or another, a KFF Health News review of FDA data found.

Almost all the reports came from Abbott. The FDA requires manufacturers to submit reports when they learn of mishaps potentially related to their devices.

The reports are not proof that devices caused problems, and the same event might be reported multiple times. Other events may go unreported.

Despite the reports’ limitations, the FDA provides an analysis of them for the public on its website.

MitraClip’s risks weren’t a surprise.

Like the rapid-fire fine print in television ads for prescription drugs, the original product label for the device listed more than 60 types of potential complications.

Indeed, during clinical research on the device, about 6% of patients implanted with MitraClip died within 30 days, according to the label. Almost 1 in 4 — 23.6% – were dead within a year.

The FDA spokesperson, Harrison, pointed to a study originally published in 2021 in The Annals of Thoracic Surgery, based on a central registry of mitral valve procedures, that found lower rates of death after MitraClip went on the market.

“These data confirmed that the MitraClip device remains safe and effective in the real-world setting,” Harrison said.

But the study’s authors, several of whom disclosed financial or other connections to Abbott, said data was missing for more than a quarter of patients one year after the procedure.

A major measure of success would be the proportion of MitraClip patients who are alive “with an acceptable quality of life” a year after undergoing the procedure, the study said. Because such information was available for fewer than half of the living patients, “we have omitted those outcomes from this report,” the authors wrote.

KFF Health News audience engagement producer Tarena Lofton contributed to this report.

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

Over the past two years, a simple but baffling request has preceded most of my encounters with medical professionals: “Rate your pain on a scale of zero to 10.”

I trained as a physician and have asked patients the very same question thousands of times, so I think hard about how to quantify the sum of the sore hips, the prickly thighs, and the numbing, itchy pain near my left shoulder blade. I pause and then, mostly arbitrarily, choose a number. “Three or four?” I venture, knowing the real answer is long, complicated, and not measurable in this one-dimensional way.

Pain is a squirrely thing. It’s sometimes burning, sometimes drilling, sometimes a deep-in-the-muscles clenching ache. Mine can depend on my mood or how much attention I afford it and can recede nearly entirely if I’m engrossed in a film or a task. Pain can also be disabling enough to cancel vacations, or so overwhelming that it leads people to opioid addiction. Even 10+ pain can be bearable when it’s endured for good reason, like giving birth to a child. But what’s the purpose of the pains I have now, the lingering effects of a head injury?

The concept of reducing these shades of pain to a single number dates to the 1970s. But the zero-to-10 scale is ubiquitous today because of what was called a “pain revolution” in the ’90s, when intense new attention to addressing pain — primarily with opioids — was framed as progress. Doctors today have a fuller understanding of treating pain, as well as the terrible consequences of prescribing opioids so readily. What they are learning only now is how to better measure pain and treat its many forms.

About 30 years ago, physicians who championed the use of opioids gave robust new life to what had been a niche specialty: pain management. They started pushing the idea that pain should be measured at every appointment as a “fifth vital sign.” The American Pain Society went as far as copyrighting the phrase. But unlike the other vital signs — blood pressure, temperature, heart rate, and breathing rate — pain had no objective scale. How to measure the unmeasurable? The society encouraged doctors and nurses to use the zero-to-10 rating system. Around that time, the FDA approved OxyContin, a slow-release opioid painkiller made by Purdue Pharma. The drugmaker itself encouraged doctors to routinely record and treat pain, and aggressively marketed opioids as an obvious solution.

To be fair, in an era when pain was too often ignored or undertreated, the zero-to-10 rating system could be regarded as an advance. Morphine pumps were not available for those cancer patients I saw in the ’80s, even those in agonizing pain from cancer in their bones; doctors regarded pain as an inevitable part of disease. In the emergency room where I practiced in the early ’90s, prescribing even a few opioid pills was a hassle: It required asking the head nurse to unlock a special prescription pad and making a copy for the state agency that tracked prescribing patterns. Regulators (rightly) worried that handing out narcotics would lead to addiction. As a result, some patients in need of relief likely went without.

But this approach to pain management had clear drawbacks. Studies accumulated showing that measuring patients’ pain didn’t result in better pain control. Doctors showed little interest in or didn’t know how to respond to the recorded answer. And patients’ satisfaction with their doctors’ discussion of pain didn’t necessarily mean they got adequate treatment. At the same time, the drugs were fueling the growing opioid epidemic. Research showed that an estimated 3% to 19% of people who received a prescription for pain medication from a doctor developed an addiction.

Doctors who wanted to treat pain had few other options, though. “We had a good sense that these drugs weren’t the only way to manage pain,” Linda Porter, director of the National Institutes of Health’s Office of Pain Policy and Planning, told me. “But we didn’t have a good understanding of the complexity or alternatives.” The enthusiasm for narcotics left many varietals of pain underexplored and undertreated for years. Only in 2018, a year when nearly 50,000 Americans died of an overdose, did Congress start funding a program — the Early Phase Pain Investigation Clinical Network, or EPPIC-Net — designed to explore types of pain and find better solutions. The network connects specialists at 12 academic specialized clinical centers and is meant to jump-start new research in the field and find bespoke solutions for different kinds of pain.

A zero-to-10 scale may make sense in certain situations, such as when a nurse uses it to adjust a medication dose for a patient hospitalized after surgery or an accident. And researchers and pain specialists have tried to create better rating tools — dozens, in fact, none of which was adequate to capture pain’s complexity, a European panel of experts concluded. The Veterans Health Administration, for instance, created one that had supplemental questions and visual prompts: A rating of 5 correlated with a frown and a pain level that “interrupts some activities.” The survey took much longer to administer and produced results that were no better than the zero-to-10 system. By the 2010s, many medical organizations, including the American Medical Association and the American Academy of Family Physicians, were rejecting not just the zero-to-10 scale but the entire notion that pain could be meaningfully self-reported numerically by a patient.

In the years that opioids had dominated pain remedies, a few drugs — such as gabapentin and pregabalin for neuropathy, and lidocaine patches and creams for musculoskeletal aches — had become available. “There was a growing awareness of the incredible complexity of pain — that you would have to find the right drugs for the right patients,” Rebecca Hommer, EPPIC-Net’s interim director, told me. Researchers are now looking for biomarkers associated with different kinds of pain so that drug studies can use more objective measures to assess the medications’ effect. A better understanding of the neural pathways and neurotransmitters that create different types of pain could also help researchers design drugs to interrupt and tame them.

Any treatments that come out of this research are unlikely to be blockbusters like opioids; by design, they will be useful to fewer people. That also makes them less appealing prospects to drug companies. So EPPIC-Net is helping small drug companies, academics, and even individual doctors design and conduct early-stage trials to test the safety and efficacy of promising pain-taming molecules. That information will be handed over to drug manufacturers for late-stage trials, all with the aim of getting new drugs approved by the FDA more quickly.

The first EPPIC-Net trials are just getting underway. Finding better treatments will be no easy task, because the nervous system is a largely unexplored universe of molecules, cells, and electronic connections that interact in countless ways. The 2021 Nobel Prize in Physiology or Medicine went to scientists who discovered the mechanisms that allow us to feel the most basic sensations: cold and hot. In comparison, pain is a hydra. A simple number might feel definitive. But it’s not helping anyone make the pain go away.

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

If you or someone you know may be experiencing a mental health crisis, contact the 988 Suicide & Crisis Lifeline by dialing or texting “988.”

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For the most part, Cori Lint was happy.

She worked days as a software engineer and nights as a part-time cellist, filling her free hours with inline skating and gardening and long talks with friends. But a few days a month, Lint’s mood would tank. Panic attacks came on suddenly. Suicidal thoughts did, too.

She had been diagnosed with anxiety and depression, but Lint, 34, who splits her time between St. Petersburg, Florida, and Tulsa, Oklahoma, struggled to understand her experience, a rift so extreme she felt like two different people.

“When I felt better, it was like I was looking back at the experience of someone else, and that was incredibly confusing,” Lint said.

Then, in 2022, clarity pierced through. Her symptoms, she realized, were cyclical. Lint recognized a pattern in something her doctors hadn’t considered: her period.

For decades, a lack of investment in women’s health has created gaps in medicine. The problem is so prevalent that, this year, President Joe Biden signed an executive order to advance women’s health research and innovation.

Women are less likely than men to get early diagnoses for conditions from heart disease to cancer, studies have found, and they are more likely to have their medical concerns dismissed or misdiagnosed. Because disorders specifically affecting women have long been understudied, much remains unknown about causes and treatments.

That’s especially true when it comes to the effects of menstruation on mental health.

When Lint turned to the internet for answers, she learned about a debilitating condition at the intersection of mental and reproductive health.

Sounds like me, she thought.

What Is PMDD?

Premenstrual dysphoric disorder, or PMDD, is a negative reaction in the brain to natural hormonal changes in the week or two before a menstrual period. Symptoms are severe and can include irritability, anxiety, depression, and sudden mood swings. Others include fatigue, joint and muscle pain, and changes to appetite and sleep patterns, with symptoms improving once bleeding begins.

Unlike the mild discomfort of premenstrual syndrome, or PMS, the effects of premenstrual dysphoric disorder are life-altering. Those afflicted, according to one estimate, can endure almost four years of disability, cumulatively, over their lives.

Though researchers estimate that the dysphoric disorder affects around 5% of people who menstruate — about the same percentage of women with diabetes — the condition remains relatively unknown, even among health care providers.

In a 2022 survey of PMDD patients published in the Journal of Women’s Health, more than a third of participants said their family doctors had little knowledge of the premenstrual disorder or how to treat it. About 40% said the same was true of their mental health therapists.

Reproductive mental health has been sidelined as a specialty, said Jaclyn Ross, a clinical psychologist who researches premenstrual disorders as associate director of the CLEAR Lab at the University of Illinois-Chicago. Only some health care providers get training or even become aware of such disorders, Ross said.

“If you’re not considering the menstrual cycle, you’re at risk of misdiagnosing and missing what’s actually going on,” Ross said.

That was the case for Tampa, Florida, resident Jenna Tingum, 25, who had panic attacks and suicidal thoughts as a premed student at the University of Florida. It wasn’t until her college girlfriend read about PMDD online and noticed Tingum’s symptoms flared in the days leading up to her period that Tingum talked with her gynecologist.

“I don’t think I would have ever put the pieces together,” Tingum said.

Suicide Risk and Treatment

Because few researchers study the condition, the cause of PMDD is something of an enigma, and treatments remain limited.

It wasn’t until 2013 that the disorder was added to the Diagnostic and Statistical Manual, the handbook used by medical professionals in the U.S. to diagnose psychiatric conditions. PMDD was officially recognized by the World Health Organization in 2019, though references in medical literature date to the 1960s.

In one study, 72% of respondents with the disorder said they’d had suicidal thoughts in their lifetime. And 34% said they had attempted suicide, compared with 3% of the general population.

Marybeth Bohn lost her daughter, Christina Bohn, to suicide in 2021. It was only in the months before her death at age 33 that Christina connected her extreme distress to her cycle — no doctors had asked, Bohn said. Now Bohn, who lives in Columbia, Missouri, works with medical and nursing schools around the country to change curricula and encourage doctors to ask people in mental health emergencies about their premenstrual symptoms and cycles.

“We need more research to understand how and why these reactions to hormones occur,” Ross said. “There’s so much work to be done.”

While doctors haven’t settled on a universal approach to address the symptoms, three main treatments have emerged, said Rachel Carpenter, medical director of reproductive psychiatry at the University of Florida–Jacksonville College of Medicine.

Selective serotonin reuptake inhibitors, the most common form of antidepressants, are a first line of attack, Carpenter said. Some patients take the medication regularly; others in just the week or two that symptoms occur.

For some patients, hormonal birth control can alleviate symptoms by controlling or preventing the release of certain hormones.

Finally, talk therapy and cycle awareness can help patients build mental resilience for difficult weeks.

Sandi MacDonald, who co-founded the International Association for Premenstrual Disorders, a leading resource for patients and clinicians, said peer support is available through the nonprofit, but funding for research and education remains elusive.

She hopes the new White House initiative on advancing women’s health research will open doors.

Let’s Talk About Periods

Both Lint and Tingum, who were diagnosed by medical professionals after learning about the disorder on their own, said a lack of conversation around periods contributed to their care being delayed.

Lint doesn’t remember talking much about periods in grade school; they were often the butt of a joke, used to dismiss women.

“For the longest time, I thought, ‘Well, this happens to everyone, right?’” Lint said of her symptoms. “Has a doctor ever asked me what my symptoms are like? No, absolutely not. But we’re talking about a quarter or more of my life.”

Brett Buchert, a former University of Florida athlete who took time away from campus because her symptoms were so severe, said that when doctors do ask questions, it can feel like boxes being checked: “The conversation ends there.”

Buchert, who graduated with a degree in psychology and now lives in Boulder, Colorado, said understanding what’s happening to her and being aware of her cycle has helped her manage her condition.

Lint and Tingum agreed.

Even as Lint struggles to find a medicine that brings relief, tracking her cycle has allowed her to plan around her symptoms, she said. She makes fewer commitments in the week before her period. She carves out more time for self-care.

She’s also found solace in reading stories of others living with the condition, she said.

“It’s helped me process the extremes,” Lint said. “There’s not something wrong with me as an individual. I’m not crazy; this is something that’s legitimately happening to me. It helps to know I’m not alone.”

This article was produced through a partnership between KFF Health News and the Tampa Bay Times.

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.