Abortion access is important to McCoomb. She wants her daughter to grow up in a state where the option is available if needed, and the sign was a keepsake from the day Missourians voted to reverse the state’s near-total ban. McCoomb also couldn’t shake the feeling that she’d need to display the sign in her yard again soon.

“I have little faith in our Missouri government,” McCoomb said, sitting on her front porch.

Sure enough, just two years later, the state’s Republican-dominated legislature is asking Missouri voters to overturn the abortion protections they recently supported. The conflicting measures even have the same title: Amendment 3. But while a “yes” vote in 2024 supported adding protections to the state constitution, a “no” vote in 2026 would keep them. McCoomb covered the “YES” on her yard sign with a “NO” made from black duct tape before placing the sign back in her yard.

Voters will weigh in on abortion in Missouri, and three other states, in the November general election. Missouri is also one of two states voting on it for the second time since 2024. Nevada will vote again, too.

The spate of referendums comes after the U.S. Supreme Court overturned federal abortion protections with its 2022 decision in Dobbs v. Jackson Women’s Health Organization, leaving each state to make its own abortion policy. The result has been a patchwork of state rules of bans or limitations, and even a series of “shield laws” in states where abortion remains legal that aim to protect providers from prosecution in states where it’s not.

“I just think there’s a constitutional crisis that’s coming,” said , vice president of media and policy for the anti-abortion organization Students for Life Action.

“Can you have 50 state standards on whether or not a human being is a human being? Can you have 50 state standards on whether human beings have legal protection?” Hamrick said.

Advocacy Groups Work To Clarify Ballot Measures

That patchwork of abortion protections is the reason Nevadans for Reproductive Freedom introduced the 2024 ballot measure to enshrine the state’s law allowing abortions up to 24 weeks after conception into the state constitution, said , president of the coalition.

The measure received strong support two years ago, with 64% of voters in favor. Nevada law requires two majority votes to enshrine constitutional amendments, so voters will need to support the expanded protection again in November for it to be enacted.

The Nevada ballot measure wouldn’t change the state’s existing law allowing abortions up to 24 weeks after conception. But the proposal would make it more difficult to overturn abortion access, requiring voter approval of any new ban in two elections.

Lopez said Nevadans for Reproductive Freedom has been campaigning to ensure voters are still mobilized.

“Folks care about it,” she said. “They’re seeing what’s happening at the national level, and they want to make sure that whatever’s happening in our neighboring states, like Idaho and Utah, doesn’t happen here in Nevada.”

Idaho, where a ballot measure establishing abortion rights to go before voters in November, has one of the strictest abortion bans in the country. Voters will decide whether state statute should allow abortion through fetal viability, the point when a fetus can survive after birth, which is generally considered to be around 24 weeks.

In Utah, abortion is allowed up to 18 weeks while legal challenges to the state’s ban continue.

In Virginia, where abortion is already allowed through two trimesters of pregnancy, until 28 weeks, voters will decide whether to amend their state constitution to codify those rights.

Missouri is the only state voting this year on removing abortion protections already on the books. The the 2024 amendment that guaranteed abortion access through fetal viability in the state and replace it with a ban on abortions with exceptions for medical emergencies, fetal anomalies, and pregnancies resulting from rape or incest. Abortions for rape and incest would have to occur before 12 weeks of pregnancy.

Missouri was the first state to ban abortion after the Dobbs decision in 2022. At that time, abortions had already mostly ceased in the state after three decades of state regulations targeting the practice, including a , minimum dimensions for procedure rooms and hallways in clinics that provide abortions, and a mandate that the clinicians have at nearby hospitals, among others. Only were performed in Missouri in 2021, down from , state records show.

Even though Missouri voters backed the abortion amendment in 2024, it took nearly two years for medication abortions to resume in the state.

A Second Vote Causes Confusion

, CEO of St. Louis-based Planned Parenthood Great Rivers, said the whiplash of a second statewide vote on abortion mirrors the confusion that patients have experienced about whether abortion is available in the state.

“Chaos is kind of the point here,” Riphagen-Dunn said, “and it is absolutely a tactic that gets in the way of being able to provide.”

The confusion has presented problems for abortion opponents in the state as well.

“I think it’s unfortunate,” said Reagan Barklage, who is a vice president of Students for Life of America and the treasurer of the Missouri Students for Life Ballot Committee. “People need to be very clear on what they’re voting for.”

Barklage said she has had to correct anti-abortion voters while out canvassing to remind them that they are voting “yes” on Amendment 3 this year even though they voted “no” on Amendment 3 last time.

“It is crazy that it ended up being even the same number. I do not think that was intentional, but we’ve got to deal with what we’ve got,” Barklage said, adding, “I hope the pro-choicers kept their yard signs from last time.”

In Maplewood, Missouri, McCoomb said she was happy that her repurposed sign supporting abortion access had been noticed.

“I hope lots of people see and remember to revote,” McCoomb said.

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

Emery is director of New River’s Breathing Center and chair of the .

The disaster she’s reminded of started in 1930, when on a 3-mile tunnel through Gauley Mountain in West Virginia. Over the course of 18 months, some 3,000 miners, most of them Black, spent long hours drilling through sandstone, engulfed in a cloud of its toxic byproduct, silica dust. More than 750 men died from that exposure.

The risk still exists, and advocates for workers say the government should do more to rein it in.

In April of last year, the Trump administration paused the enforcement of a rule designed to help protect coal miners from an aggressive form of coal workers’ pneumoconiosis, commonly known as black lung disease, the primary cause of which is exposure to silica dust.

(Other occupations at high risk of include construction, countertop fabrication, and oil and gas work. The new rule would reduce the permissible limit of exposure in coal mining to the existing level in other industries.)

This April, the Labor Department’s Mine Safety and Health Administration announced an indefinite delay in enforcement of the rule.

Gary Hairston sits on New River Health’s board. For decades, Hairston, a retired coal miner and president of the national , has been an advocate for miners struggling with the debilitating effects of black lung, including extreme fatigue, an incessant cough, and a sensation of drowning. He regularly lobbies legislators for improved working conditions and black lung benefits. His entreaties, he said, seem to fall on deaf ears. He rarely gets an audience with the legislators themselves.

“I’d just like them to look me in the face,” Hairston said.

Evidence from just-released research underscores the urgency of his appeals for a safer work environment.

In August, the National Institute for Occupational Safety and Health, an agency within the federal Centers for Disease Control and Prevention, on the results of testing conducted over the past five years on miners in central Appalachia — eastern Kentucky, southwestern Virginia, and West Virginia — with 25 or more years underground. Almost 1 in 3 tested positive for black lung disease, the highest rate in nearly 50 years.

The rate in 2018, the last time the agency reported results, was 1 in 5. The lowest reported rate, in 1999, was less than 1 in 10.

“We knew this would happen,” said Sam Petsonk, a West Virginia attorney who has represented thousands of miners in the region. “It’s surprising to me that they only found one in three.”

Silica Dangers

Exposure to silica has increased as more-accessible coal seams are depleted, requiring mining operations to probe deeper, often through sandstone. The stone breaks into sharp particles that are than a grain of sand and, according to National Institute for Occupational Safety and Health research, are than coal dust. Trapped in lung tissue, those particles can cause a debilitating, sometimes fatal condition.

Kenny Thompson, a retired West Virginia miner who now lives in Richmond, Kentucky, was employed in the mines for 22 years. He would sometimes cut into four feet of sandstone to reach a coal seam.

“You ate a lot of dust,” Thompson recalled. It induced nausea. It took a toll.

In October 2025, he had his left lung removed. Post-surgery, he was in a coma for three months; he flatlined three times, he said. “They were about to really give up on me.”

He had to relearn to walk and to talk. Trekking to the mailbox still leaves him winded, lightheaded, and blurry-eyed.

The new silica rule would cut the allowable level of silica dust in half, thereby meeting the standard of other industries. Miner advocates laud the fact that it would require operators to deploy engineering controls, such as improved ventilation systems and water sprays.

But the National Mining Association and other industry trade groups argue that reaching and maintaining compliance would also require supplementing those controls with workforce measures, such as requiring personal protection equipment and rotating miners from particularly dusty areas. Many miners, and their advocates, say such measures are impractical — because respirators can impede breathing, can limit vision, and often malfunction, and because smaller mines don’t have enough workers to support rotating schedules.

In April 2025, the 8th U.S. Circuit Court of Appeals granted an emergency stay of the rule to give operators more time to comply.

In May of this year, the Labor Department sent the White House Office of Management and Budget a on the proposed rule. And in July, the department’s regulatory agenda included a new , indicating its intent to amend the rule.

The department’s Mine Safety and Health Administration “recognizes it has a clear duty under the law to impose stricter silica standards,” said Petsonk, the attorney representing coal miners. “They’re failing to provide that measure of protection to American coal miners, so they’re going through bureaucratic motions to make it seem like they’re doing something, when, in fact, they’re just perpetuating an illegal and lethal status quo.”

The Labor Department declined to comment on ongoing rulemaking or litigation.

‘It’s On the Books’

The rule is, in fact, in effect, said Chris Williamson, head of the Mine Safety and Health Administration in the Biden administration — it’s just not being enforced. He and his team filed a legal brief in the closing days of the administration defending the rule.

“It’s on the books,” Williamson said, adding that the prohibits weakening existing protections for miners. “I’m just genuinely curious,” he said. “I want to know how they can address the issues that the industry’s raised without weakening protections for miners.”

Meanwhile, younger miners, with a decade or less in the mines, are being diagnosed with advanced stages of black lung. New River Health’s Emery said the youngest person her clinic had diagnosed with was 30. He’d worked underground for 10 years.

This is no longer just your “papaw’s disease,” she said. “It’s your husband’s disease. It’s your son’s disease.” (More than 90% of coal miners are men.)

With families to support, Emery said, “what do these guys do when they’re disabled in their 30s?”

She told of a man who sat in her office with his wife, describing his symptoms. As he spoke, he began to cry. His wife was taken aback. “‘I didn’t know it was that bad,’” Emery recalled her saying. “And he said: ‘That’s why I haven’t fixed the deck. I haven’t fixed the deck because I can’t breathe, and I’m just so tired.’”

Thompson can relate. “For 22 years, you’re used to getting up, putting your boots on every day, and going to work,” he said. “I’d been in great health shape and 160 pounds. And here I am now, I don’t work at all and I’m 115 pounds.”

Still, he recognizes what the job afforded.

“You know, it put my girls through college,” he said. “And to me, as a dad, that was the best reward that I can give them, to move forward in life, to be successful at what they chose to be and not work like a dog like I had to.”

President Donald Trump said in an : “Our Nation’s beautiful clean coal resources will be critical to meeting the rise in electricity demand due to the resurgence of domestic manufacturing and the construction of artificial intelligence data processing centers.”

Six months later, the Energy Department announced a to “expand and reinvigorate America’s coal industry.”

Should the administration announce a weaker rule, it would be “an unconscionable crime against American coal miners,” Petsonk said. “But I fear that’s going to happen.”

In June, Hairston spoke at a reception for a photo exhibit titled “.”

“It seems like coal miners, we’re just a number,” he said. “Just a number.”

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

Another ArchCare nursing home, on Staten Island, has shut down a full floor. North of the city, in Dutchess County, its Ferncliff Nursing Home has contracted from 309 available beds to 196.

The eight nursing homes owned by ArchCare, a nonprofit that provides eldercare through the Archdiocese of New York, have 269 fewer usable beds than they did 18 months ago, a nearly 12% decline, creating waiting lists for patients seeking long-term care.

Across New York state, 24 nursing homes have closed since 2020, resulting in a loss of more than 3,000 licensed beds, according to LeadingAge New York, which represents nonprofit senior living organizations.

That mirrors . In 2015, the Centers for Medicare & Medicaid Services certified 15,648 nursing facilities. A decade later, that number had fallen by more than 900.

With the oldest baby boomers turning 80 this year, an age when the need for long-term care climbs sharply, researchers are sounding alarms. Will there be enough nursing home beds for a rapidly graying nation?

“We’re seeing a serious problem and it’s heading in the wrong direction,” said David Grabowski, a health policy researcher at Harvard Medical School. He is an author of a study in JAMA Internal Medicine that in national nursing home capacity from 2019 to 2024. “As you look at the demographics, this is only going to get worse, maybe a lot worse,” he said, especially given looming Trump administration policies on immigration and Medicaid financing.

The reasons for the shrinkage?

ArchCare blames inadequate state reimbursement for Medicaid, a perennial industry complaint. The primary payer for nursing home care, Medicaid provides less than the daily cost of care, said Clif Porter, chief executive of the American Health Care Association, an industry trade group.

“Before the pandemic and inflation, the losses were sustainable,” said Jason Hutchens, ArchCare’s chief operating officer. More recently, he said, “we were running at an unsustainable loss — we had no choice.”

Nursing homes, , try to compensate by attracting short-stay patients covered by Medicare, which pays higher rates than Medicaid. When they can’t, “unless you’re extremely rapacious or extremely efficient, you’re not going to make it,” said Vincent Mor, a health services researcher at the Brown University School of Public Health who is an author of an article, published in the New England Journal of Medicine, about reduced capacity. “The numbers don’t add up.”

Staff shortages, which have plagued nursing homes for decades, have also caused contractions and closures. Nursing home aides work stressful, low-paying jobs with historically high turnover rates. Their median hourly wage last year was $20.67, according to , a research and advocacy group for direct care workers. Although pay has risen over the past decade, about 40% of nursing home aides rely on some form of public assistance, such as Medicaid or the Supplemental Nutrition Assistance Program, PHI reported.

The number of nursing home aides has rebounded from the covid pandemic, according to PHI, but fewer are working than in 2015. And while hiring and retention have improved, Porter said, “there’s still a significant gap between demand, especially future demand, and where the workforce currently is.”

National occupancy rates, which fell sharply during the pandemic, have returned to a more typical 80%.

That figure can be misleading; it doesn’t mean 1 bed in 5 sit empty, awaiting a patient. Occupancy counts state-licensed beds, but the more meaningful number is operating beds — how many are actually available depending on a facility’s staffing and other factors.

That number is usually lower and, in many cases, sinking. The American Health Care Association reported in 2024 that almost half of nursing homes were and 57% had waiting lists for new residents.

It’s possible, of course, that they also face financial losses because of lower demand. “Nursing homes close because people don’t want to go to nursing homes,” said Sam Brooks, director of public policy for the National Consumer Voice for Quality Long-Term Care, an advocacy group. “The quality is so low that people avoid them like the plague.”

Last year, Medicare inspectors found at least one quality violation serious enough to harm or jeopardize residents in 27% of nursing homes, according to an analysis by KFF, a health information nonprofit.

In recent decades alternatives emerged that diverted patients from nursing homes. About a million older adults currently live in assisted living facilities. And among Medicaid recipients, the ongoing policy shift called “rebalancing” has enabled more people to receive services at home () rather than in nursing homes.

In 1988, only 10% of Medicaid expenditures for long-term services went to home- or community-based services; the rest paid for institutional care. By 2020, more than 60% of expenditures funded home and community care, said Priya Chidambaram, a KFF senior policy manager specializing in Medicaid, citing a staff analysis.

How big a problem these trends pose depends partly on geography. The decline in the number of nursing homes in rural locations — about 10% from 2015 to 2025 — than the national drop of about 6%.

“It’s more difficult to staff a rural nursing home,” Chidambaram said. “Labor pools are smaller, and it’s hard to get people to take lower-paid or part-time jobs if they have to travel long distances.”

Bed shortages are also creating bottlenecks at hospitals. Where nursing home capacity declined, Grabowski’s team found, patients stayed in hospitals longer because they couldn’t locate posthospital care. They often had to travel farther to find facilities. “It gums up the entire system,” Grabowski said.

On two fronts, Trump administration policies could make matters worse, experts said. Revoking legal status for certain immigrant groups .

So far, “we’re not seeing significant impact across the country,” Porter said. But the effects are being felt in specific locations, including Florida, New York, and Massachusetts, he confirmed. With further revocations and deportations, “a lot fewer older adults are going to have caregivers,” Grabowski said.

The administration’s more than $900 billion in cuts to Medicaid over a decade are also expected to exact a toll. As states grapple with reduced funding, analysts expect home and community services to take a greater initial hit than institutional care. But that could increase pressure on nursing homes if patients who lose home care turn to institutions instead.

Less of these services “means more nursing home entry,” Grabowski said.

As policy ideas circulate — with calls for better data tracking, special visas for immigrant health workers, and targeted grants for nursing homes serving high-cost populations — researchers, advocates, and families are waiting to see what unfolds.

“So much of this is speculative,” Chidambaram said. “We don’t know what states will decide. We don’t know how the market will react. We’re in new territory here.”

The New Old Age is produced through a partnership with .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

Eighteen months after his initial diagnosis, chemotherapy hadn’t slowed 21-year-old Mason Henderson’s rare brain tumor, which had spread to his spinal fluid. So he left his home in southeastern Texas to spend three weeks in a clinical trial in New York City.

But that failed, too, leaving a murky path for Henderson, whose cancer was so rare the World Health Organization had only in 2021. So early this year, Henderson’s doctors, evaluating his tumor’s deep genetic language, turned to a drug made by Merck and AstraZeneca called Lynparza.

It was not the standard of care for Henderson’s condition — there wasn’t really any standard, which is not unusual for rare cancers. And Henderson’s insurance would not pay for it, despite the careful justification given by the two specialists treating him.

“They have no guidelines for his cancer,” Henderson’s mother, Tabitha Lowe, said in a March interview with Ñî¹óåú´«Ã½Ò•îl Health News. “They’re discriminating against him because his cancer is so rare.”

Every year, tens of thousands of people — representing about a — are diagnosed with tumors that differ enough from frequently identified ones to be called rare. In determining whether to reimburse treatment for such ailments, insurers turn to Food and Drug Administration labels and expert guidelines.

But these rare afflictions often lack targeted, FDA-approved treatment options, even though in many cases, molecular tests offered by diagnostic companies and university labs can provide a strong suggestion of what will work.

“Insurance coverage routinely trails behind what genomic testing reveals about a patient’s cancer and what the science supports,” said Olivier Elemento, director of Weill Cornell Medicine’s Englander Institute for Precision Medicine.

Henderson’s neuro-oncologists, Jacob Mandel of the Baylor College of Medicine and Jessica Schulte of NYU Langone Health, decided to try Lynparza, also known by the generic name olaparib, in combination with chemotherapy. There wasn’t a wealth of evidence behind the drug but there was a “biologically reasonable” assumption it would help, Schulte said, because cells in tumors like Henderson’s have a flaw that drugs like Lynparza can target. Providers in several previous cases had seen brain cancers like Henderson’s respond well to the drug.

“In general, we try to base our treatment decisions on large patient studies” involving hundreds of patients, Schulte said. But large clinical trials will probably never be conducted for a cancer as rare as Henderson’s.

Schulte, who specializes in brain cancers in young adults, sees only a few of Henderson’s type each year, she said.

Mandel prescribed the drug on Jan. 16. Liviniti, Henderson’s pharmacy benefit manager, responded with a quick refusal on Jan. 30. Two weeks later, the company sent an explanation: “Lynparza is not approved for the diagnosis provided.” Out-of-pocket, the drug would cost about $8,700 per month, Lowe said. Liviniti did not respond to phone calls seeking comment.

Before his diagnosis, Henderson was a healthy, athletic young man with a big heart, faith in Jesus, and a tight group of friends, his mother said. At Evadale High School, north of Beaumont, Texas, Henderson played baseball and football and was homecoming king in 2022. After graduating, he worked at the local paper mill, spending his free time hunting, fishing, and exploring the woods on an all-terrain vehicle. He wanted to be a police officer, Lowe said.

Henderson was 20 on March 15, 2024, when his brother Gunner found him at the top of the stairs in the family home with his head in his hands. “He was in the post-seizure state,” Lowe said. “He couldn’t talk. Was crying. Trying to hug me. Could not communicate.”

At an emergency room in Beaumont, an MRI revealed a large tumor. He was transferred to Baylor St. Luke’s Medical Center in Houston and diagnosed with a form of brain cancer called diffuse hemispheric glioma (H3-G34 mutant).

Surgery a few days later cut out 90% of the tumor, but brain cancers are almost impossible to remove entirely, because of the delicacy of the tissue they’re embedded in, Schulte said.

After 16 months of radiation and chemotherapy, a September 2025 scan showed the cancer had spread to his spinal cord, a condition called leptomeningeal disease that usually proves fatal within a few months. Mandel contacted Schulte about a clinical trial she was leading. It consisted of 11 days of brutal craniospinal irradiation, which left Henderson exhausted. When it was over, the cancer was still there.

“The family was wonderful,” Schulte recalled. “They were trusting in their team, but they asked appropriate questions to make sure that we were thinking about Mason as a person.”

Coverage Refused

Lynparza, approved by the FDA in 2014 for ovarian cancer, works by interfering with tumor cells’ ability to multiply. After Liviniti, the pharmacy benefit manager, refused coverage for Henderson, his family turned to Jefferson County. Henderson’s stepfather, Jerry Lowe, flies helicopters for the county sheriff’s office.

The county, which had the final say on reimbursement because it pays claims directly for its employees’ family health coverage, also refused. When Henderson’s family appealed, the county review board authorized an independent medical reviewer to look at the case. The nonspecialist supported the board’s finding and recommended another drug, but Henderson’s doctors disagreed. The board didn’t respond to a request for comment.

AstraZeneca had also turned down the family’s request for a donation of the drug. By then it was March, six weeks after Lynparza was prescribed.

Cancers that start in the brain are unusual — only about 25,000 cases are diagnosed in the U.S. each year, compared with 320,000 breast cancers and 229,000 lung cancers. Only a few hundred people each year, mostly young adults, are diagnosed with Henderson’s type, according to Schulte.

Treatment options for diffuse hemispheric glioma are few; brain cancers in general are often excluded from clinical trials. They represent a relatively small market for a pharmaceutical company. Testing drugs against them is risky, because of the brain’s sensitivity, and difficult because the drug must pass through the tightly packed cell walls lining the blood vessels, known as the blood-brain barrier.

Still, drugmakers are increasingly homing in on narrower and potentially more accurate drug targets as science reveals more of cancer’s remarkable molecular diversity.

Under , the FDA has approved to be used for patients whose tumors have specific mutations, regardless of the organ where the cancer first appeared. These “tissue agnostic” drugs are still a tiny minority, but as genome sequencing becomes more common — order it for patients — insurers will have to keep up, Weill Cornell’s Elemento said.

Several U.S. research groups are hosting clinical experiments known as “basket trials,” in which mostly late-stage cancer patients are put on drug combinations based on tumor genetics, rather than the organ of origin.

The American Society of Clinical Oncology has recruited more than 3,000 patients into one of the biggest efforts, the Targeting Agent and Profiling Utilization Registry, , which began in 2016. It provides off-label treatments at no cost to advanced-staged cancer patients at more than 270 U.S. oncology practices.

About half the participants have benefited, and in rare cases the treatment kept patients alive for a year or more or seemingly cured them, said Richard Schilsky, the program’s founder and its principal investigator until recently. The results have led to changes in several treatment guidelines, he said, and a change in guidelines “usually is sufficient to create a pathway to reimbursement by insurance.”

Research has uncovered “quite a few” cases in which Lynparza was effective against a variety of tumor types, Schilsky said. But like many clinical trials, TAPUR excludes patients with primary brain tumors — like Henderson’s.

Oncologists disagree on how broadly genetics discoveries will transform cancer diagnosis. Cancers are currently identified as breast, colon, lung, etc., because those are the cells that pathologists see when diagnosing a tumor, said Razelle Kurzrock, the associate director of clinical research at the Medical College of Wisconsin Cancer Center.

But that’s a “mistake of history,” she said. “You’re making the diagnosis based on the pathologist’s view of the surface of the cell rather than what’s actually driving the cancer.”

A Dutch father and son invented the first light microscope to peer at cells around 1590. The Human Genome Project finished in 2003. If genome-enabled next-generation sequencing, now used for molecular tumor scans, had come before the light microscope, “no one would look at organ of origin,” she said.

Kurzrock leads a clinical trial in which every patient gets individualized cancer therapy based on DNA, RNA, and protein patterns in their tumor. Instead of getting drug combination A or B, “in our trial everyone gets a different set of drugs,” she said. Physicians can instead use standard therapies, she said, and their patients are the study controls.

Other oncologists see limitations to purely genetic diagnosis. Certain cancer centers advertise by saying, “‘We’ll sequence your tumor better than anyone else, and therefore you’ll live longer and do better if you come here,’” said Kathy Miller, a professor of oncology at Indiana University. “But the evidence doesn’t support those claims right now.”

‘I Wouldn’t Give Up’

In Henderson’s case, the problem was never diagnosis; Baylor clinicians identified his cancer type quickly. But its rarity and location made the tumor hard to fight, and the lack of financial help made it even harder.

On March 8, Tabitha Lowe went on Facebook, LinkedIn, and Instagram with photos of her son and descriptions of his plight. She tagged AstraZeneca, Liviniti, and the county board that had denied his reimbursement. “Rare cancer patients are denied treatment simply because their cancers are rare,” she wrote in one of the posts, which were shared hundreds of times.

“I hated to take this route, but when it comes to my kids there’s nothing I won’t do,” she told Ñî¹óåú´«Ã½Ò•îl Health News. “I’ve cried, I’ve stressed out, but I wouldn’t give up.”

The next day, AstraZeneca’s patient assistance program, which had turned down her request for the drug two weeks earlier, emailed her with good news: A bottle of 60 Lynparza pills had been shipped to her pharmacy. Company spokesperson Tara Parsell said patient confidentiality prevented her from commenting on its actions.

Lowe’s six-week battle had paid off. Now, “it’s in God’s hands,” she said in an April interview. By mid-April, however, Henderson could no longer walk. Then came issues with his speech. “It all happened so fast.”

On May 4, in the family’s living room, where his bed had been moved, Henderson died, after taking the drug for nearly two months. Hundreds attended his memorial service; their cars made a procession seven minutes long.

The family has created a college scholarship in Henderson’s name for graduates of the local high school. An online campaign and bass fishing tournament had raised nearly $24,000 by September. Willie Robertson of Duck Dynasty, professional pickleballer Tyson McGuffin, and pro fisherman Hank Parker donated items for a raffle. Country singer Mark Chestnutt sent two signed guitars, Lowe said.

“Faster treatment would have been better,” although it’s hard to know whether it would have extended Henderson’s life, NYU’s Schulte said.

“I will always wonder,” Lowe said in a phone interview this summer. “Cancer don’t pause while the paperwork’s in progress.”

“There’s something especially painful thinking about how much time I spent fighting healthcare instead of being with Mason,” she added. “I was forced to become a PBM, insurer, research expert, all while trying to be his mother.”

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

When the Durhams began their practice at the end of 2023 — he as a primary care physician and she as a pharmacist who handles the billing — the couple bought coverage for themselves and their two kids on the Affordable Care Act marketplace. But they said their monthly premiums for a similar health plan for this year rose several hundred dollars to nearly $1,600.

They decided to pay out-of-pocket for their medical expenses instead, leaning on $50,000 they had set aside in a health savings account over several years.

“It’s nerve-racking,” said Joshua Durham, 47. “It just takes, you know, one little accident, and then you got a big fat bill.”

The healthcare industry traditionally has more of its workforce on medical insurance than many other fields. Nationwide, 7% of all healthcare workers were uninsured in 2024, compared with 11% of all adults under 65, according to a KFF analysis of the most recent American Community Survey data. And doctors were especially unlikely to forgo health insurance, with just 2% uninsured.

But even healthcare workers are feeling the pinch as each year, with employers expecting that costs will jump an for 2027.

The Republican-led Congress also opted last year Affordable Care Act marketplace credits enacted during the covid pandemic. While subsidies remain in place for people with low incomes, the pandemic-era credits helped , especially those working in small businesses such as independent medical practices. Nearly half of marketplace enrollees worked for small businesses or were self-employed in 2024; some of the most common occupations included chiropractic care and dentistry.

Jack Dillon, executive director of the , which represents 4,000 physician-led practices, said premium increases have become untenable for small businesses, whether employers seek coverage through the marketplace or directly from insurers.

“The cost has become so astronomical,” Dillon said. “You’re looking at it and saying, ‘What’s the value?’”

As health insurance continues to become less affordable, Dillon said, more healthcare employers may seek alternatives to their standard coverage, such as providing higher hourly wages or providing only minimal plans.

The number of people without insurance in the U.S. is expected to increase by roughly over 10 years because of the expiration of the expanded ACA subsidies and resulting from President Donald Trump’s signature One Big Beautiful Bill Act, according to the Congressional Budget Office.

Healthier people are the most likely to opt out of insurance. That leaves insurance covering a smaller pool of people who tend to be sicker and need more expensive care. So insurers raise prices to cover the remaining enrollees, which fuels even higher premium costs.

‘Healthcare Is a Business’

Samantha LeGault, a nurse practitioner at a health clinic in Boise, said her employer-offered plan’s premium payment rose from $700 to $1,500 a month this year to insure herself, her husband, and four of their kids. LeGault has Crohn’s disease and two of their daughters also have medical conditions, so she said her family has no choice but to continue to pay for that health coverage.

But she decided to skip dental insurance to save money, and she prioritizes dental visits for her children over herself.

She had already struggled to set aside retirement savings and had switched her children from a private school they liked to public school to cut down on costs. Then the new health insurance costs tightened her budget even more. She estimated that about one-fifth of her income now goes toward her monthly premium payments.

“I know how the clinics work, that I am an expensive patient,” LeGault said. “At the end of the day, healthcare is a business in the United States.”

The Durhams have three other employees in their practice. Two of them receive health insurance through their spouses, Ashley Durham said. The Durhams said they pay $420 monthly toward their physician assistant’s premiums.

As a primary care physician, Joshua Durham said he doesn’t need regular doctor visits, because he can diagnose and treat himself — and, if needed, the rest of his family, though he acknowledged that’s frowned upon. The American Medical Association’s generally discourages doctors from treating themselves or relatives but makes exceptions for emergency situations or short-term, minor problems. Ashley Durham said she’s filled prescriptions for her family.

, a bioethicist and professor emeritus at New York University’s Grossman School of Medicine, said that as more people are “turning toward relatives because they can’t access or easily see a regular doctor,” it may make sense to revisit that aspect of the code of ethics.

Out-of-Pocket Expenses

Healthcare workers with less advanced medical certifications than the Durhams often don’t have the option of treating themselves or family members — or don’t have savings to fall back on for healthcare expenses. And many healthcare professionals, such as Jill Kordick, a 64-year-old retired healthcare executive in Norwalk, Iowa, aren’t willing to go without the safety net of insurance.

In her work, Kordick saw hospitalizations become financially devastating for patients, so she said she would never opt out of health insurance — even for just the 16 months before she’d become eligible for Medicare at age 65.

Last year, she qualified for the enhanced Affordable Care Act tax credits, allowing her to pay $75 a month for health coverage. Her premiums rose to $800 a month this year when those subsidies expired.

Because she has a $10,000 deductible, she put off going to the doctor for weeks when she had a sinus infection this year, until it ultimately evolved into an ear infection. She said she regularly rethinks, and sometimes returns, nonessential groceries in her shopping cart. And she keeps her house’s thermostat at 80 degrees in the summer to cut down on air conditioning costs.

Kordick said healthcare is a universal struggle in this country, regardless of how familiar patients are with the industry. “It’s disheartening that it’s as broken and fragmented as it is,” she said.

The Durhams have seen the impact of unaffordable healthcare on their patients. They said they try to lend some leeway to patients when they can — a luxury they have, operating their own practice. In one case, Ashley Durham said, she wrote off $1,160 in bills for a single father whose son didn’t have health insurance rather than send their bills to a collection agency.

“It’s hard, because as a human I want to help them out,” she said. “At the same time, we need revenue for our office.”

Joshua Durham is more nervous about going uninsured than his wife. As a child, he witnessed his parents struggling to pay medical bills for their family of nine in south-central Idaho. Durham recalled that his dad, who was a carpenter, helped build a surgeon’s house to pay for an operation.

Today, Durham also sometimes exchanges work for care. He said he gets free eye exams from an uninsured optometrist and offers him free primary care.

He worries about a worst-case scenario: a car crash, a sports injury, a serious diagnosis.

“Do I have pancreatic cancer today?” Durham said wryly.

So far, the couple has paid around $9,000 total for expenses out of their health savings account this year, including physical therapy to help with the thoracic outlet syndrome that affects Durham’s neck and shoulder, mental health appointments, and contact lenses. The expenses were higher than the Durhams anticipated. But it was still less than what their monthly premiums would have cost them.

Their decision has paid off, Joshua Durham said. At least for now.

Are you struggling to afford your health insurance? Have you decided to forgo coverage? Click here to contact Ñî¹óåú´«Ã½Ò•îl Health News and share your story.

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

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

Paul Nestadt is about as steeped in suicide prevention as a person can be.

He treats suicidal patients as a psychiatrist, has co-authored scores of research papers on how and why people kill themselves, and teaches graduate courses on the subject.

But he’ll be the first to admit: “I can’t tell you which of my patients is likely to die by suicide in the next six months.”

Almost nobody can.

predictions of who will be suicidal are only slightly better than a coin toss. And they haven’t improved over 50 years.

But that doesn’t make Nestadt hopeless. Instead, it pushes him to pursue interventions that don’t require pinpointing people at risk.

Chief among them: making it harder for people to carry out the act of killing themselves.

“Instead of asking every doctor to figure out which patient will die by suicide and locking that patient up, it might be that we need to make sure there aren’t loaded guns available,” Nestadt said.

In an ongoing series, Ñî¹óåú´«Ã½Ò•îl Health News is examining approaches to suicide prevention that expand beyond providing people at risk with medication and therapy. Although those are lifesaving measures, many clinicians, researchers, and people who have lost loved ones to suicide agree that more is needed. The challenge is that when it comes to firearms, broad policy approaches quickly become constitutionally complicated and politically polarizing.

Research shows that limiting access to lethal means is one of to save lives. It can involve on buildings to prevent people from jumping, as well as someone can buy or be prescribed at once.

And .

“That’s the one that will save the most lives,” said Nestadt, medical director at the Johns Hopkins Center for Suicide Prevention.

It may also be the most difficult to achieve.

killed themselves with a gun last year, representing more than half of all suicide deaths in the U.S., according to preliminary federal data. Even as overall suicide rates have dipped recently, gun suicides have hit record highs for five years in a row.

Most Gun Deaths in the U.S. Are Suicides

From 2021 to 2025, suicide deaths by gun hit record highs each year, even as homicides by gun decreased.

Source: <a href="; target="_blank" style="color:#0071ce">CDC WONDER</a> <br> Note: 2025 data is provisional. The following ICD-10 codes identify firearm death types: X93-95 (homicide), X72-X74 (suicide), W32-34, Y22-24, and Y35.0 (other, which includes accident, legal intervention, and undetermined). <br> Credit: Aneri Pattani/Ñî¹óåú´«Ã½Ò•îl Health News

Many of the deaths are among , two groups that have had high suicide rates for years. But more recently, gun suicides have risen among and among some and men. Researchers say a during the covid pandemic underscores the need for prevention efforts that can be applied widely.

Some people assume it’s futile to restrict access to bridges, pills, or guns. The thinking goes: Those who want to kill themselves will simply find another way.

But . Creating barriers for one method doesn’t typically push people to another.

Suicide risk can surge quickly, with people spending or even five minutes between deciding to die and acting on it. Anything that delays such action — for example, having to unlock a safe to access a gun — gives them time to reconsider or for someone to intervene.

A Sharp Rise in Gun Suicides Among Black Women

White women had the highest rates of gun suicides by women in 2015 and 2024, but among women of other races and ethnicities, the increase was faster and steeper over that time.

Source: <a href="; style="color:#0071ce">The Firearm Mortality Epidemic: Examining the U.S. Data From 2024, Johns Hopkins Center for Gun Violence Solutions</a> <br> Note: Rates represent gun suicide deaths per 100,000 people. <br> Credit: Aneri Pattani/Ñî¹óåú´«Ã½Ò•îl Health News

However, in the U.S., discussion around guns — even in the context of a traditionally bipartisan topic such as suicide prevention — is a political lightning rod. Mentions of background checks, waiting periods, or red flag laws often send people running to their respective corners. Gun owners and the firearm industry say many of the policies suicide prevention advocates seek threaten their Second Amendment rights, and many policymakers see the topic as a nonstarter.

President Donald Trump has been a of gun owners. His administration has dozens of firearms regulations and rescinded a previous that called gun violence a public health crisis. It has also revoked grants focused on and working on the issue.

The White House did not respond to specific questions about how these actions may affect the nation’s high rate of gun suicides or what it’s doing to prevent such deaths. But spokesperson Lauren Bis said in a statement that “President Trump is committed to Making America Healthy Again and that includes mental health.” She pointed to the administration’s for mental illness and an announcement of for veteran suicide prevention.

The Limits of Red Flag Laws

One gun policy that has gained some traction, , is the , more commonly known as a red flag law.

Adopted in some form in , these laws allow judges to temporarily remove a person’s guns when evidence suggests they pose a danger to themself or others.

Although such laws are often passed in the wake of , they’re more effective at preventing suicide.

Still, they require identifying someone at risk.

Someone like Dorothy Paugh’s dad.

In 1965, when Paugh was a young girl, her dad lost his job. He was distressed, not knowing how he’d support his wife and five children, Paugh said. He reviewed his life insurance policy, told his wife where he kept important documents, and bought a handgun.

“If my mom had been able to get an extreme risk protection order or if Dad’s best friend had asked to hold his gun for a while, maybe my dad would not have shot himself. He might have lived,” Paugh said.

Decades later, Paugh in Maryland and sat in the legislative gallery when the measure was passed.

She believes the law is saving lives.

across show that for every 10 to 20 guns removed under red flag laws, one suicide is averted, .

But Paugh also recognizes the law’s limitations.

“It wouldn’t have saved my son,” she said.

Her 25-year-old son, Peter, . He’d recently bought a house with his girlfriend and hosted a birthday celebration for his brother. He’d purchased a gift ahead of Mother’s Day — five novels by Charles Dickens, Paugh’s favorite author — that Paugh received after .

Unlike in her father’s case, Paugh said, no one saw warning signs for Peter. “I did not know that my son was suicidal. I didn’t have a clue,” she said. Even if a red flag law existed then, she wouldn’t have thought to use it.

The people most vulnerable to firearm suicide usually aren’t identified as such by family members or clinicians, said , a clinical psychologist and the executive director of the New Jersey Gun Violence Research Center.

Studies have shown that among people who die by suicide, those who used guns were less likely to have in the past. And most veterans and service members who die by gun suicide about their suicidal thoughts in the months leading to their death.

That’s why red flag laws are just a first step in suicide prevention, Anestis said. They target specific individuals at high risk — the aspect that makes such laws more politically palatable — but they do not apply to the many other people who are quietly suicidal.

Lessons From Road Safety

Nestadt, the Johns Hopkins psychiatrist, said the nation needs to approach suicide prevention the way it approaches car accidents.

“You’re not trying to figure out who’s at risk of an accident” by testing people’s reaction time or cataloging who gets into fender benders, Nestadt said.

Instead, speed limits, passed seat belt laws, and required auto manufacturers to install air bags and shatter-resistant windshields. The significantly.

Applying a similar strategy to suicide might involve requiring permits and background checks to buy a gun, as well as instituting before completing the purchase.

found that enacting a permit-to-purchase law in Connecticut was associated with a roughly 15% decrease in gun suicide rates, while repealing such a law in Missouri was linked to a 16% increase in firearm suicide rates.

Most Suicides in America Involve a Gun

Suicide deaths by gun have been increasing for several years, even as suicides by suffocation — the second most common method — have been decreasing.

Source: <a href="; target="_blank" style="color:#0071ce">CDC WONDER</a> <br> Note: 2025 data is provisional. "All other methods combined" includes cut/pierce, drowning, fall, fire/flame, other land transport, other, and unspecified. <br> Credit: Aneri Pattani/Ñî¹óåú´«Ã½Ò•îl Health News

About have enacted laws requiring owners to lock up their guns in homes where children live, a practice shown to . That’s an issue of particular importance, with 245% among Black youths and 98% among Latino youths since 2014.

Anestis said laws requiring permits and safe storage can also reduce homicides and other gun injuries.

Those types of violence not only hurt people directly but also increase their risk of suicide. people who are exposed to gun violence in their community experience trauma and become habituated to the idea of injury or death. That “double whammy” makes them more likely to kill themselves, Anestis said.

Responsibility, Rights, and Saving Lives

Gun owners and firearm trade associations generally oppose universal measures, such as requiring permits and waiting periods. They prefer education campaigns that teach people how to recognize warning signs, talk about mental health, and safely store guns — initiatives that place .

The National Shooting Sports Foundation, which represents the firearms industry, has partnered with the American Foundation for Suicide Prevention to create to be posted in gun shops.

“Our purpose is to provide educational materials to the firearm-owning community on how to help prevent suicide and save lives,” Bill Brassard, the NSSF’s senior director of suicide prevention initiatives, said in a statement.

The National Rifle Association said policies focused on guns miss deeper concerns that make someone suicidal, such as mental illness.

“Suicide is a serious issue that deserves serious solutions focused on the underlying causes, not on political efforts to restrict the rights of law-abiding Americans,” NRA spokesperson Justin Davis said in a statement. “A truly dangerous individual needs to be incapacitated, not just deprived of one particular means of harm.”

Some initiatives have managed to bring together unlikely bedfellows — gun store owners, public health experts, and even libraries — to to secure firearms at home, identify locations that will while they’re in crisis, and educate people on how to .

Those efforts give Paugh hope and fuel her passion to continue advocating for better mental health care, open conversations about suicide, and policies that decrease access to guns.

“It’s not a cure-all,” Paugh said of those policies. But “it does save lives.”

Having lost a parent and a child, she knows how valuable that can be.

“If you’re that one person or that person’s family, it’s all the difference in the world,” she said.

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

One problem cited: The manufacturer had provided only

As it often does, the FDA in 2021 approved the drug with a proviso: It required the manufacturer to conduct an additional years-long safety study once the drug was on the market.

Today, like many similar “postmarket” studies mandated by the FDA, that additional study is delayed, according to a . As of last fall, only 21 of the planned 300 patients had been enrolled, the FDA said in an and .

Meanwhile, the FDA has dozens of cases of “possibly” or “probably causally associated” with the drug. That was one of the potential side effects the postmarket study was meant to evaluate.

Tavneos illustrates the perils of the FDA’s approach to many drugs and medical devices — and the frequent lapses in follow-through.

A Ñî¹óåú´«Ã½Ò•îl Health News analysis of Food and Drug Administration data found hundreds of postmarket studies listed as delayed. In some cases, the work was delayed by more than a decade or the manufacturer was still developing a plan for the study.

As a result of delays, patients, doctors, and others could be left in a fog about the risks and benefits of the drugs or devices, even as they stake their money, their health, or their lives on the products.

Postmarket study requirements “have often proven toothless,” said cardiologist , an associate professor of medicine at the University of California-San Francisco who has published .

The FDA’s reliance on postmarket studies reflects a balancing act.

Making new treatments available faster can save or improve lives, especially when patients with grim prognoses and no good options have little to lose. The full risks and benefits may be revealed only over the long term, and when therapies are used by far more people than even large clinical trials enroll.

But relying on post-approval studies to resolve questions risks exposing patients to products that do more harm than good. Whoever is paying the bills — patients, insurance companies, employers, or government health programs such as Medicare and Medicaid — can end up wasting money and rewarding manufacturers for useless or risky products.

“Doctors rely on this evidence, patients rely on this evidence, and if that evidence is not there, it’s going to lead to a lot of uncertainty,” Dhruva said.

Trump administration policy changes designed to hasten drugs through FDA review could leave more riding on postmarket studies, medical researchers say.

For example, in February, that “the default requirement” for agency approvals will be one clinical trial instead of two.

Reducing pre-approval testing “will inevitably put a lot of pressure on the post-approval system,” said , a professor at Harvard Medical School who postmarket studies.

FDA officials said the new policy would “substantially reduce costs” for manufacturers and “speed drugs to market.” Writing in The New England Journal of Medicine, they denied the change would compromise safety or efficacy, saying that “erroneous conclusions may be reached even with two, three, or four studies.”

In response to questions for this article, a spokesperson for the Department of Health and Human Services, which includes the FDA, said postmarket studies can experience delays for legitimate reasons. “Assessing the significance of any delay requires a case-specific review,” said the spokesperson, Emily Hilliard.

The fact that a study is delayed “should not be treated as evidence that a product has an unresolved safety or effectiveness issue,” Hilliard said.

Amgen, the company that makes Tavneos, is still working on the postmarket research the FDA mandated, company spokesperson Alison Chartan said, adding, “We remain committed to completing this important study.”

Behind Schedule

An FDA database downloaded by Ñî¹óåú´«Ã½Ò•îl Health News in August tracks the progress of postmarket studies that makers of — such as vaccines and gene therapies — were required to perform or promised to perform.

The database showed almost 600 were running behind schedule.

Of those, more than 250 originally had final reports due before July 31, 2026 — the date that, according to an FDA webpage, the database last had been updated.

About a third of ongoing studies were listed as delayed.

In some cases, the FDA has granted extensions. In others, it has denied them. And in rare instances, the products were discontinued before the studies ran their course.

Postmarket studies can involve clinical trials or other analyses of patient data. They can look at safety or efficacy. A product can be the subject of more than one postmarket study.

The nearly 600 delayed studies involved almost 350 products, Ñî¹óåú´«Ã½Ò•îl Health News found.

The FDA has defined delayed as . That can mean off track or overdue.

As of August, other FDA databases tracking listed dozens of postmarket studies as behind schedule.

Products included:

The CustomFlex Artificial Iris, a prosthesis implanted in the eye in place of damaged, defective, or congenitally missing irises. The protocol for a study in children was accepted in 2019, the database said. The study was meant to follow patients for five years. According to an FDA page downloaded in August, zero patients were enrolled.

Barbara Fant of Clinical Research Consultants, to whom the FDA’s 2018 letter approving the product was addressed, said the rarity of an eye disease called aniridia poses challenges for post-approval studies. The German manufacturer, the U.S. distributor, and Clinical Research Consultants are working with the FDA to identify alternative ways to fulfill the postmarket requirements, Fant said.

“Confirming the long-term safety of the device remains a top priority for both the study team and FDA,” Fant said.

Paxlovid, a treatment for covid. A study to assess its safety in pregnant women was originally to be completed by the end of 2024, the FDA database said. “The trial completion and final report milestones were missed,” the database said.

Pfizer, the manufacturer, is working with the FDA and remains committed to “submitting results as soon as practicable,” Pfizer spokesperson Jerica Pitts said.

The Scandinavian Total Ankle Replacement system. The device and the original protocol for the clinical trial were approved in 2009. The study was meant to include a minimum of 500 subjects, the database said, but the actual number enrolled was 142. Almost half those patients had one or more adverse events, with dozens of “reoperations,” “revisions,” or “removals,” the database said.

Rachel Colloff and Cristina Pasquino — spokespeople for Enovis, which markets STAR Ankle — did not respond to multiple inquiries. Jenny Braga, a spokesperson for Stryker, which previously sold the product, did not answer questions about the postmarket study.

Oxaydo (originally named Oxecta), a form of the potentially addictive opioid painkiller oxycodone . When the FDA approved it in 2011, it required the manufacturer, , to conduct a postmarket study to assess whether it reduces “misuse and abuse, and their consequences: overdose, death and addiction.” The final report was originally scheduled to be submitted in 2016.

The FDA database listing the study as delayed said the agency “issued a failure to respond letter” in 2022.

Today the issue may be all but moot.  

Control of the product passed from company to company over the years until 2023, when Acura Pharmaceuticals said in a that patents on Oxaydo would begin expiring that year and it didn’t intend to continue marketing the drug.

According to another FDA database, Oxaydo .

The FDA has enforcement powers and uses them “where appropriate,” HHS’ Hilliard said. She did not provide requested details, and she did not answer questions about the studies listed above.

Delay Can Pay

For manufacturers, delay can pay, Harvard’s Kesselheim said. While postmarket studies are ongoing, companies can continue to sell the products.

“Medicare and Medicaid spent more than $18 billion from 2018 to 2021 for accelerated approval drugs with incomplete confirmatory trials past their original planned completion dates,” the HHS Office of Inspector General .

The FDA can demand postmarket studies for a variety of reasons, including to address concerns that arise after a product has been approved. Some look at uses not covered by the original approval, and some are meant to shed light on that are already known.

In April, when it approved Foundayo, a weight loss drug made by Eli Lilly, the FDA required the company to conduct additional research to assess a variety of concerns, including “retained gastric contents,” “major adverse cardiovascular events,” and “drug-induced liver injury,” as well as effects of exposure during pregnancy, such as “major congenital malformations,” “spontaneous abortions,” and “stillbirths.”

The FDA said it approved the drug under the new Commissioner’s National Priority Voucher program, intended for products that “.” The program strives for an “” review, the FDA has said — one to two months, instead of six months or more with other expedited pathways.

“Postmarketing requirements and enhanced safety monitoring are a routine part of the FDA’s approach to evaluating newly approved medicines,” Eli Lilly spokesperson Kristiane Silva Bello said, “including ongoing monitoring in areas identified during clinical development.”

‘False Hope’

The FDA waded into a world of uncertainty in 2016 when it granted accelerated approval to a drug for Duchenne muscular dystrophy, a degenerative disease that primarily affects boys, disabling them at a young age and ultimately killing them.

Agency scientists had found that the drug, Exondys 51, was unproven and argued against greenlighting it.

Ellis Unger, then a senior drug evaluation official at the FDA, that “thousands of patients and their families would be given false hope in exchange for hardship and risk.”

The manufacturer, Sarepta Therapeutics, . “A clinical benefit of EXONDYS 51 has not been established,” it said when the drug, also known by the generic name eteplirsen, was approved.

The drug, the first FDA-approved treatment for Duchenne muscular dystrophy, targeted a subset of patients with the disease.

The FDA required Sarepta to conduct further studies and it could withdraw approval if postmarket trials failed to verify a clinical benefit or were “not conducted with due diligence.”

Unger issued a warning of his own: “FDA has not succeeded in withdrawing the marketing of a single drug for lack of verification of clinical benefit following accelerated approval. The reality is that if eteplirsen is given accelerated approval, it is highly likely to remain on the market indefinitely, irrespective of whether or not efficacy is verified.”

Sarepta was originally required to submit a final report on a postmarket study by a May 2021 deadline, according to an FDA database and a 2016 FDA letter to the company.

Almost a decade after the drug was approved, and more than five years after that deadline, the study was listed in an FDA database as delayed.

“The final report milestone was missed, because the sponsor requested milestone extensions due to study delays,”  the database said.

Meanwhile, in 2022 the website ranked Exondys 51 as the second-most expensive drug in the U.S., at an annual cost of $750,000 to $1.5 million.

Last year, the drug generated for Sarepta, according to a company presentation to investors.

Sarepta found it difficult to recruit patients for the postmarket clinical trial, company spokesperson Tracy Sorrentino said. The target population is small, patients were hesitant to enroll, and Sarepta was competing with other clinical trials for participants, Sorrentino said.

The study has been fully enrolled since 2023, Sorrentino said, and the company plans to provide an initial look at the data late this year.

‘M²¹²Ô¾±±è³Ü±ô²¹³Ù±ð»å’

Amgen has cited similar challenges, even as Tavneos generated $459 million in global sales last year.

When an approved treatment is available, patients may be reluctant to enroll in a study in which they could be given a placebo, Amgen’s Chartan said.

The clinical trial supposed to be done . As of July 24, just 49 patients had been enrolled, Chartan said.

The FDA has said the study was to include , and each patient enrolled must be followed for five years, said Hilliard, the HHS spokesperson.

Tavneos was approved to treat severe cases of a group of diseases — known by the shorthand ANCA-associated vasculitis — in which, as the explains, the immune system inflicts potentially fatal damage on blood vessels and organs. 

“As of January 2026, estimated real-world exposure” to Tavneos “exceeds 25,000 patient-years globally, consisting of over 6,500 in the United States and 19,000 abroad,” Amgen has said. (For context, one patient taking a drug for five years would amount to five “patient-years.”)

A clinical trial sponsored by ChemoCentryx to secure approval of Tavneos failed to prove it was effective, the FDA now alleges. Instead of disclosing that outcome to the FDA, company personnel “” the , the FDA alleged in an to Amgen.

Amgen, the parent company of ChemoCentryx, has denied the results were manipulated and has said the data “.”

Nonetheless, the recently of Tavneos.

The FDA is trying to , and Amgen is fighting that effort.

The company has a lot riding on the outcome. Tavneos can cost more than $220,000 per year, according to the , and when Amgen in 2022 for $3.7 billion, Tavneos was the only drug ChemoCentryx had brought to market.

In a June , Amgen said the benefits of Tavneos outweigh the risks.

The FDA disagrees.

The FDA “can no longer conclude that there is, or has ever been, a valid demonstration of substantial evidence of effectiveness for TAVNEOS,” .

Citing 76 cases of DILI — — the agency said it was “increasingly concerned about the safety profile of TAVNEOS.” Without proof of effectiveness, at least for its approved use, “the drug’s benefits its known risks,” the FDA wrote.

Data reporter Maia Rosenfeld contributed to this report.

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

Julie Rovner Ñî¹óåú´«Ã½Ò•îl Health News Read Julie's stories. Julie Rovner is chief Washington correspondent and host of Ñî¹óåú´«Ã½Ò•îl Health News’ weekly health policy news podcast, "What the Health?" A noted expert on health policy issues, Julie is the author of the critically praised reference book "Health Care Politics and Policy A to Z," now in its third edition.

Reports from a top artificial intelligence company that it stopped several attempted uses of its product that could assist in manufacturing a bioweapon caught the attention of lawmakers in Washington this week. But it is still unclear whether or when Congress will act to regulate the fast-moving industry — and the House has left town until after Election Day.

Meanwhile, with many voters expressing anger over the rising cost of healthcare, President Donald Trump is proposing to send $500 checks to some people enrolled in Affordable Care Act insurance plans before the election. But even if those checks materialize, in most cases they will be smaller than the increases many policyholders have already seen.

This week’s panelists are Julie Rovner of Ñî¹óåú´«Ã½Ò•îl Health News, Anna Edney of Bloomberg News, Tami Luhby of CNN, and Alice Miranda Ollstein of Politico.

Panelists

Anna Edney Bloomberg News

Tami Luhby CNN

Alice Miranda Ollstein Politico

Among the takeaways from this week’s episode:

• Anxieties about AI reached a fever pitch this week, with a few leading developers calling to slow the pace of innovation amid troubling reports about AI’s progress and use, including reported attempts to misuse AI for biological warfare. Meanwhile, the Trump administration is pressing to incorporate AI into healthcare.
• Federal lawmakers are exploring changes to the independent arbitration system created by the No Surprises Act, which took effect in 2022. While the law has cut down on patient exposure to surprise out-of-network medical bills in emergencies, the system has resulted in far larger paydays than anticipated for many doctors — which, in turn, has prompted a sizable increase in coverage costs, including for employers.
• Some cities and states are suing to block implementation of the latest public charge rules from the Trump administration, arguing they could have a chilling effect for some who are entitled to public benefits, such as the eligible children of immigrants. They allege that could leave cities and states on the hook and harm local economies.
• Abortion opponents are claiming victory as the Environmental Protection Agency moves to test water for remnants of abortion pills, among other chemicals and drugs. California’s attorney general is wrapping up a lawsuit against two nonprofits offering what they describe as abortion pill reversals, despite a lack of evidence the method works or is safe. And the family of a Texas woman who died after being denied an abortion is suing her doctors and the state’s attorney general, Ken Paxton.

Also this week, Rovner interviews Sabrina Corlette of the Georgetown University Center for Health Insurance Reforms, discussing some potential short-term fixes to the nation’s health system.

Plus, for “extra credit” the panelists suggest health policy stories they read this week that they think you should read, too: 

Julie Rovner: KJZZ Phoenix’s “,” by Camryn Sanchez.

Tami Luhby: The Washington Post’s “,” by Erica Sloan.  

Anna Edney: Bloomberg News’ “,” by John Tozzi, Tanaz Meghjani, and Ike Swetlitz.

Alice Miranda Ollstein: Ñî¹óåú´«Ã½Ò•îl Health News’ “Indigenous Groups Are Exempt From Medicaid Work Rules, but Native Hawaiians Aren’t,” by Ashley Mizuo.

Also mentioned in this week’s podcast:

• Science’s “,” by Jocelyn Kaiser.
• The New York Times’ “,” by Christina Jewett.
• Roll Call’s “,” by Ariel Cohen.
• Ñî¹óåú´«Ã½Ò•îl Health News’ “A Generation of Kids Suffer as Trump Destabilizes Immigrant Families,” by Claudia Boyd-Barrett.
• Politico’s “,” by Miranda Willson, Alice Miranda Ollstein, Ariel Wittenberg.
• Politico’s “,” by Rachel Bluth and Alice Miranda Ollstein.

Credits

Click here to find all our podcasts.

And subscribe to “What the Health? From Ñî¹óåú´«Ã½Ò•îl Health News” on , , , , , or wherever you listen to podcasts.

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

After a few years, medical associations revise their guidelines, warning that the drug in question should be avoided or at least prescribed more selectively. It might be added to the Beers Criteria, an influential list of potentially inappropriate medications for older patients, published by the American Geriatrics Society.

If the drug’s role is preventive, the U.S. Preventive Services Task Force, an independent expert panel, may weigh in with cautions. The FDA may issue “black box” warnings about concerning side effects.

After a few more years, researchers look at broad national data to see whether use of this drug declined. Often, the answer is: Yes, but not enough. Sometimes, though, use didn’t decline much at all or actually increased.

“Medications are like barnacles,” said Michael Steinman, a geriatrician at the University of California-San Francisco and co-director of the . “They’re easy to start, but they can be hard to stop.”

This medical inertia partly reflects the time lag involved in disseminating findings. “Clinicians have a million things they need to know and attend to, and information may take a while to get to them,” Steinman said.

But it also reflects the way “clinicians and patients get used to treating conditions in certain ways,” he said. “They become ingrained habits.” Finding alternative approaches is challenging, so “it’s easy to go with what you know.”

Recent studies of three medications or classes of drugs widely used among older Americans illustrate the problem.

The Drawbacks of Benzodiazepines

Scientists began about benzodiazepines more than 20 years ago. Prescribed for insomnia and anxiety, “they offer prompt relief,” said Mark Olfson, a psychiatrist and epidemiologist at Columbia University.

? Benzodiazepines (including Valium, Xanax, and Ativan) and the related “Z” drugs (Ambien, Lunesta) “may impair balance, coordination, and cognition that can translate into falls and fractures and motor vehicle accidents,” Olfson said. In patients also taking opioids for pain, benzodiazepines can cause overdoses.

Moreover, “once you’ve taken them for a period of time, you develop a dependence,” Olfson added. “When you come off them, you may develop withdrawal symptoms.”

So what’s happened to , who are more sensitive to these effects? In a , published in the Annals of Internal Medicine, Olfson and his team reported progress. Among people 65 and older, the rate of patients filling prescriptions for benzos dropped to 11.5% in 2024, from about 14% in 2015.

But that decline has stalled since 2020, perhaps related to the covid-19 pandemic. Moreover, prescribed use actually rose among those over 75, from 12% in 2020 to about 13% four years later. Dispensing through pharmacies in long-term care facilities more than doubled. And about a third of users were taking the drug for longer than six months, increasing the likelihood of dependence. “It’s worrisome,” Olfson said.

But he cautioned that patients shouldn’t stop benzodiazepines suddenly or on their own, which can provoke withdrawal. “It requires supervised tapering” with a medical professional, he said. “It takes many weeks.”

Overprescribing Antibiotics

For years, the standard treatment for diverticulitis, the inflammation or infection of small pouches that form in the colon, was antibiotics, primarily fluoroquinolones (like Cipro and Levaquin) or amoxicillin-clavulanate (Augmentin).

“It was unquestioned,” said Jesse Sutton, a pharmacist and researcher at the Minneapolis Veterans Affairs healthcare system. “Antibiotics are safe and effective, great, lifesaving drugs, so the mindset was: When in doubt, use them.”

But in 2015, the against routinely prescribing antibiotics for “uncomplicated” diverticulitis, which represents a great majority of cases. Other .

Clinical trials had shown that, for this condition, antibiotics on mortality, the need for surgery, complications, or recurrences. “They hadn’t improved anything,” Sutton said.

And as with any drug, “, unintended consequences,” he said. “Side effects from antibiotics account for a ” for symptoms like nausea, vomiting, and diarrhea. Antibiotics heighten the risk of the virulent C. difficile infection, too.

Plus, “the more you use antibiotics, the less they work in the future,” Sutton said. The World Health Organization has “a major global health threat.”

So Sutton and his colleagues, studying treatment in 70,000 visits to 120 VA facilities, expected to see antibiotic use for uncomplicated diverticulitis decline over 10 years.

Instead, they in the Annals of Internal Medicine that antibiotic prescriptions remained nearly universal at 97% of visits, guidelines or no guidelines. The patients would most likely have done as well with a few days of Tylenol and a clear liquid diet.

for other conditions of later life, too, including the kind of that cause no troublesome symptoms and upper respiratory infections that are typically viral, not bacterial.

In such cases, when a doctor prescribes an antibiotic, “I’d encourage patients to say, ‘Please explain the rationale for doing this,’” Sutton said. “If they don’t, it’s OK to press pause.”

When Aspirin Isn’t the Answer

Aspirin is different. Because it’s cheap and sold over the counter, anybody can start taking it on their own — and , thinking it will help prevent cardiac problems.

For people who’ve already had a heart attack, stroke, or cardiac intervention like a stent or bypass surgery, daily low-dose aspirin for “secondary prevention” does lower the odds of another event, studies have demonstrated.

But for “primary prevention” in people who haven’t had one, the guidelines changed in 2019, when the American College of Cardiology and the American Heart Association for this purpose in those 70 or older. The , warning against aspirin for primary prevention starting at age 60.

Large clinical trials had shown scant benefit for aspirin as a primary prevention measure, but there were harms, notably gastrointestinal bleeding. “As we age, the risks of bleeding go up,” said Timothy Anderson, an internist at the University of Pittsburgh who co-directs its Prescribing Wisely Lab. More rarely, but more seriously, aspirin can cause bleeding in the brain.

In a published last year, Anderson and his co-author found the message was getting through: Aspirin use for primary prevention, as reported in the National Health and Nutrition Examination Survey, had dropped substantially from 2011 to 2023. But more than a third of those 70 or older were still taking it.

Some caveats: A subgroup of older adults with high risk factors for cardiovascular disease may benefit from aspirin for primary prevention. And, confusingly, some evidence suggests that older patients already taking aspirin face a higher risk of cardiovascular disease .

“Step 1 is a conversation with your primary care physician” about aspirin, Anderson said. “‘Is this still right for me as I get older?’”

Older patients taking aspirin, , “are interested in reducing their risk of heart attack and stroke,” he said. “They’re trying to be proactive and healthy.” But with blood pressure medications and statins for cholesterol, “we have better strategies than aspirin for that.”

The New Old Age is produced through a partnership with .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

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When Josh Fleig, Louisiana’s chief innovation officer, learned his state had set aside $20 million a year, for five years, to invest in startup rural health companies, his reaction was not surprising: “Wow!”

In rural America, where people are often reported to be sicker with poor access to healthcare, the cash influx is a relief. In the economic development space where Fleig operates, it’s an opportunity.

“Look, that’s a lot of money for what we do,” said Fleig, whose state-funded economic development office invests in corporate launches, ranging from software startups to shipbuilders.

Louisiana and a handful of other states set aside money from their share of the $50 billion federal Rural Health Transformation Program to quickly invest in new technologies, mirroring private industry moves. Lawmakers added the rural health program to offset more than $900 billion in reduced Medicaid spending expected over 10 years from Republicans’ sweeping 2025 tax and spending law.

But rather than filling the budget hole, the rural program’s assignment is to find new approaches for revitalizing rural communities where doctors are in short supply and hospitals have been downsizing and closing for decades. The federal government doled out the first-year rural health program awards to states this year, with pots ranging from $147 million in New Jersey to $281 million in Texas.

Modernizing technology infrastructure is a key pillar of the federal rural health program, and the catalyst money epitomizes the administration’s strategy to move fast and experiment with untested technology — much like the “move fast and break things” mantra during the heyday of Silicon Valley.

Instead of breaking things, though, the goal is to “move fast, fast-fail, innovate quickly, and move to sustainability,” said Aaron Bujnowski, a managing director with the healthcare industry group at the consultancy Alvarez & Marsal. “This is a transformation that is still meant to serve the people.”

Rigorous Rules and Tight Deadlines

Beyond Louisiana, Timothy Foster, a spokesperson for the Centers for Medicare & Medicaid Services, confirmed that Delaware, Georgia, Massachusetts, Nebraska, South Carolina, Virginia, and West Virginia are also creating rural health tech catalyst funds.

Every year, states must compete for rural funding in the five-year federal program. Federal regulators will take money away from states that do not meet the goals promised in their applications, including whether they designated money to companies for tech innovations.

CMS, which is overseeing the program, released a seven-step for states to follow when creating the tech catalyst operations. No more than 10% of each state’s award can be spent on a rural tech catalyst fund.

States’ initial annual progress reports for the rural fund were due at the end of August. CMS has declined to publicly post those reports; it plans to publish an annual report on state progress. States must show that first-year funds will be obligated — but not necessarily spent — by Oct. 30, according to the CMS guidance document.

Daniel X. O’Neil, a technology consultant who advocates for open data and open government, created a and parsed the original state applications to find dozens that mention catalyst awards and technology funds.

O’Neil said he is “looking forward to the clawbacks and the craziness of October because, you know, that’s serious stuff.”

For the rural health catalyst funds, CMS requires states to submit the list of finalists “at least 15 business days” before announcing winners, along with “sufficient information” for the agency to “assess each proposed project,” according to the guidance document.

The document outlines intellectual property and federal rights but does not provide guidance or standards for patient rights or protections. CMS spokesperson Foster stated in an email that the technology investments must comply with federal “privacy, security, interoperability, and patient safety” requirements.

Protecting Patients

Maya Sandalow, director of the health program at the Bipartisan Policy Center and one of the leading analysts watching the rural fund, said the catalyst funds are “public dollars” and has called for more transparency in the overall rural health program. The center is a nonprofit think tank in Washington, D.C.

Accurate and timely reporting must be done to ensure “the necessary guardrails are in place” to protect patients, she said, adding that the innovation needs to be “tested in a way that’s safe for the patients that they are going to be used on.”

To apply, startups must be less than 10 years old and have raised less than $50 million in early funding. Companies that win a portion of state catalyst funds must meet predetermined milestones before being paid — and federal officials will make “targeted reviews as needed,” according to the guidance document.

Louisiana officials announced the state’s tech catalyst fund with an event in rural Natchitoches, known as the filming location of the 1989 film Steel Magnolias. The fund quickly drew more than 200 companies competing for between $250,000 and $3 million in seed money.

Tiny startup Greens Health was invited to the event. The 2-year-old company analyzes Medicare claims to identify patients with chronic diseases, such as diabetes, and works with local home health nurses and senior facilities to improve care.

“We’ve been looking for a way to launch in Louisiana,” said Kehlin Swain, co-founder and chief executive of Greens Health. The company serves about 100 patients across Texas, Alabama, and Florida and hopes to get a $250,000 investment from Louisiana.

Louisiana’s Fleig said his state is “at a really interesting turning point.” The state secured $208.4 million for the first year of the rural health program and quickly created its catalyst fund using the state’s already established innovation department.

At the same time, nearly 1.1 million people live in Louisiana’s rural parishes and the state ranks as the “least healthy” in the nation, according to its own application. State rates of diabetes, obesity, and cardiovascular disease are among the highest in the nation.

Fleig believes Louisiana is an ideal place to test technology solutions. So, while Silicon Valley has “not needed much of what Louisiana has had to offer” for much of its existence, it does now, he said.

Caret Health is one of those companies. Co-founders Riya Pulicharam, who is a physician-researcher, and Kevin Zhao, an engineer, met in Silicon Valley. Together, they created a technology platform that identifies patients who need help getting to their appointments, having scans done, or picking up prescriptions. That technology flags a human, who then contacts the patient with a call or text.

Zhao said Caret had successful pilots at large health systems, but those places also had other vendors and “it was a pretty big uphill battle” to get in and scale. Then, in 2024, the company began paying attention to rural places.

“There wasn’t a lot of existing infrastructure. And that was really good for us because we were able to come in very quickly,” Zhao said. “A lot of the hospitals really needed this kind of service.”

Fast-forward to 2026: Caret Health is about 4 years old and has contracted with about 60 hospitals in 16 states. Pulicharam and Zhao hope to win $3 million to expand into Louisiana.

Louisiana’s Fleig said the state will take an equity stake in each company it invests in. “The dream” is that selected startup companies will also help the state make money to reinvest. If some companies fail — or fail fast — that’s to be expected, but the state should still make money because of “the law of averages,” he said.

“If we are good, we’ll make more money than we spent,” Fleig said. “Either way, it’s going to go back into improving healthcare outcomes.”

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .