Cancer Archives - 51视频 Health News /tag/cancer/ 51视频 Health News produces in-depth journalism on health issues and is a core operating program of 51视频. Wed, 30 Sep 2026 13:36:34 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.10 /wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=32 Cancer Archives - 51视频 Health News /tag/cancer/ 32 32 257378068 Rural MAHA Followers Say Trump Health Policies Haven鈥檛 Reached Their Communities /rural-health/kff-ap-poll-rural-voters-maha-make-america-healthy-again-local-impact-midterms/ Wed, 30 Sep 2026 10:01:00 +0000 /?p=2290225 About half of rural voters identify with , a sprawling political movement championed by the Trump administration, but most said President Donald Trump’s healthcare policies have not benefited their communities, according to a from The Associated Press in partnership with 51视频.

About 8 in 10 rural voters 鈥� an important voting bloc for Trump and fellow Republicans in recent elections 鈥� said the Trump administration’s policies have had a negative effect or no impact on the health of people where they live. Most MAHA supporters, 68%, also feel this way, according to the national survey of more than 2,000 rural registered voters.

The findings signal an apparent disconnect between the Trump administration’s MAHA-branded policy priorities and rural America’s perception of their reach and effectiveness.

Iowa pastor Mike Jager, 58, is a registered Republican and considers himself part of the MAHA movement. The Trump administration’s health policies have had “minimal” impact on the health of his community, Jager said, but he added that Trump’s health secretary, , is moving the needle “in the right direction.”

“It’s a beginning,” Jager said. “It’s a big ship to try and turn around and course-correct.”

Kennedy has used the MAHA label to support various agendas, including , , and investing in regenerative agriculture.

Jager lives in Sumner, Iowa, “less than a quarter mile from where the corn ends and the city begins.” He’s seen family members and neighbors develop diseases that he believes resulted in part from exposure to agricultural chemicals and consumption of unhealthy, processed foods.

In the June Republican primary for governor, Jager voted for Zach Lahn, a businessman and farmer, who ran on a MAHA platform and beat out Trump-backed U.S. Rep. Randy Feenstra. He plans to vote for him again in November.

A photo of Mike Jager standing in front of an altar inside of a church.
Jager said that President Donald Trump’s health secretary, Robert F. Kennedy Jr., is moving the needle “in the right direction.” (Miriam Alarcón Avila for 51视频 Health News)

Many Rural Voters Are Prioritizing Health Issues

About two-thirds of rural voters who support MAHA said it’s “extremely” or “very” important to them to vote for a candidate who does, too, while only 4 in 10 rural voters overall said the same.

Trump sought to seize on MAHA support during his campaign for another term two years ago. Now, amid tight midterm races, Kennedy has campaigned to galvanize the movement’s support. In May, he attended a MAHA bill signing with Iowa Republican Gov. Kim Reynolds, and in August, he went fishing with Lahn, posting about it on social media.

Yet the survey indicates voters are noticing “this weird split in the Trump administration” between what Kennedy messages and what Trump says and does, said David Peterson, a political science professor at Iowa State University.

“It’s this mix of things coming out of D.C., out of different pieces of the administration, that’s confusing people,” Peterson said.

In Iowa, concerns about what’s causing are “a big deal,” he said. For many people who identify with MAHA, being healthy includes taking on corporate agriculture and pharmaceutical companies that they think cause cancer, he added.

“The sort of populist messaging around that is appealing right now,” Peterson said.

In the poll, views on healthcare access and costs largely diverged along party lines. Most Democratic and independent voters said the Trump administration’s healthcare policies have had a negative impact on their healthcare costs and the health and well-being of people in their communities. Republicans were likelier to say there hasn’t been an impact.

Talking on the phone from her 200-acre farm in Carroll County, Iowa, 71-year-old Donna Klocke said that her husband had died from cancer and that she has neighbors who also have cancer.

“It’s just very prevalent,” Klocke said. “We’re in a farming community. We use chemicals and pesticides and all kinds of things that aren’t necessarily good for us.”

Klocke, a Democrat, said the MAHA movement is a good idea because she cares about being healthy, but she does not consider herself part of it and will not be voting for a candidate who represents the movement.

Kennedy, who was an anti-vaccine activist before entering politics and has sent to Americans about , scares her.

“Measles are coming back and polio,” Klocke said. “It’s the measles that really gets me. It’s like, do you not understand how dangerous it is?”

A photo of Donna Klocke standing in front of a cornfield in Iowa.
Donna Klocke cares about being healthy but does not consider herself part of the Make America Healthy Again movement. Her husband died from cancer after a life spent farming the family’s 200 acres in Carroll County, Iowa. (Kathyrn Gamble for 51视频 Health News)

Survey Reflects Angst Over Healthcare

About half of rural voters said their communities don’t have enough doctors or other healthcare providers, and even more said there aren’t enough mental health workers specifically. The share of rural voters who said their community does not have enough hospitals increased to 35% from 21% in a similar question asked in a 51视频-Washington Post survey in 2017.

And as with the general population, healthcare, gas, and grocery costs are top pain points. More than 6 in 10 rural voters said they were worried about healthcare costs.

The level of worry varied based on coverage, with rural voters enrolled in employer plans or Medicare less likely to be worried. The survey found that 80% of working-age rural voters on Medicaid were very or somewhat worried about healthcare costs. Last year, Republicans passed that cut over $900 billion in projected Medicaid spending over a decade and mandated new eligibility requirements.

Among rural voters who purchase their own insurance, such as the individual coverage plans available on Affordable Care Act marketplaces, 77% said they were worried.

In the tiny community of Lipan, Texas, west of Dallas, Kim Solis and her husband have a handyman-and-home-remodel business and get their insurance on the marketplace. Since Trump was elected again, their premium payment jumped from zero to $166 a month. Their copays went up, and their deductibles each increased by $2,000.

Solis, 62, said she worries what will happen if they get a big medical bill.

“Certainly, we’d be in a world of hurt trying to take money out of savings or getting it out of our 401(k) just to be able to do something about it,” she said.

Most MAHA Voters Are Also MAGA 鈥� But Not All

Like the general population, rural voters said they trust their own doctors and healthcare providers for health information over government agencies or officials, according to the poll.

Trust in Kennedy and Trump fell largely along partisan lines. About 10% of rural Democratic voters reported having a “great deal” or “fair amount” of trust in Kennedy, compared with 74% of rural Republican voters. About 5% of rural Democrats and 69% of rural Republicans said they trust Trump a “great deal” or “fair amount” for reliable health information.

While Make America Great Again and MAHA identities are “linked in a lot of ways,” the rising costs of healthcare and groceries pose a challenge for those committed to the MAHA principles that Kennedy promotes, said Peterson, the Iowa State professor.

Buying healthy food “becomes, 鈥業 can’t afford to do that because of Trump’s policies,’” he said.

In Stamping Ground, Kentucky, Alma Johnson, 65, works as night security at a horse farm. Johnson said gas had gone up but her overall cost of living had decreased since Trump took office.

Johnson voted for Trump in 2016, 2020, and 2024 and said she “pretty much” likes how Trump is running the country. But she said she is not a MAGA devotee, preferring to “think for myself.”

MAHA, however, is an easy sell for Johnson because, she said, she doesn’t think people should be able to buy junk food through the Supplemental Nutrition Assistance Program, or SNAP.

Still, she said she hasn’t seen much impact from the Trump administration’s healthcare policies, including the .

“It takes a long time to change people, their habits, their thoughts, or the things they do,” Johnson said.

About the Poll

The 51视频-AP Rural Voters Survey was conducted online and by telephone Aug. 12-24, 2026, among 2,241 registered voters living in rural areas, defined as census tracts that fall within codes 5-10 of the U.S. Department of Agriculture’s 2020 Rural-Urban Commuting Area codes. Voters were reached through a combination of the probability-based SSRS Opinion Panel and a registration-based sample from the L2 voter file. Overall results have a margin of sampling error of plus or minus 3 percentage points, including design effects due to weighting. Error margins are larger for subgroups. In collaboration with the AP, 51视频 researchers worked to design the survey sample and questionnaire and analyze and report findings.

This report is from a collaboration between 51视频 Health News and The Associated Press.

51视频 Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at 51视频鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 51视频 Health News and is republished here under a .

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Insurance Coverage Lags as Cancer Science, Treatment Move Forward /health-industry/rare-brain-cancer-tumors-genetics-drug-coverage-astrazeneca-lynparza-texas/ Tue, 22 Sep 2026 09:00:00 +0000 /?p=2285126 A photo of Mason Henderson and his mother, Tabitha Lowe, outside a shop in New York.
Mason Henderson with his mother, Tabitha Lowe, in November during a visit to New York, where Henderson was participating in a clinical trial to treat his brain cancer. Henderson died in May after a two-year battle with the disease. (Jerry Lowe)

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 鈥� 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 51视频 Health News. “They’re discriminating against him because his cancer is so rare.”

A photo of Tabitha Lowe and her son Mason Henderson smiling by a lake.
Tabitha Lowe and her son Mason Henderson. Lowe spent six weeks trying to get an $8,700-a-month drug for her son that the family’s pharmacy benefit manager wouldn’t cover. (Tabitha Lowe)

Every year, tens of thousands of people 鈥� representing about a 鈥� 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 鈥� 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.

A photo of Tabitha Lowe smiling with her son Mason Henderson.
Patients like Henderson often struggle to get medications that are prescribed off-label based on recent scientific findings. (Tabitha Lowe)

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 鈥� order it for patients 鈥� 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 鈥� 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, “鈥榃e’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.”

鈥業 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 51视频 Health News. “I’ve cried, I’ve stressed out, but I wouldn’t give up.”

A screenshot of a Facebook post by Tabitha Low tags AstraZeneca, @cancerresearch, @rarediseases, and the National Comprehensive Cancer Network. The text of the post reads, "PLEASE SHARE!" followed by images of Mason Henderson describing his condition.
Tabitha Lowe took to Facebook to try to get her son Mason Henderson access to the brain cancer treatment his doctors sought for him. (Tabitha Lowe)

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.”

51视频 Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at 51视频鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 51视频 Health News and is republished here under a .

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Health Journalists Visit Conservative Georgia District and Weigh AI Bioweapon Threat /on-air/on-air-september-19-2026-cancer-ai-biological-weapons-georgia-14th/ Sat, 19 Sep 2026 09:00:00 +0000 /?p=2286318&preview=true&preview_id=2286318

Céline Gounder, 51视频 Health News’ editor-at-large for public health, discussed the findings of a recent cancer report on CBS News 24/7’s Mornings on Sept. 16. Gounder also discussed the potential of artificial intelligence to be used in developing biological weapons on CBS News’ CBS Mornings on Sept. 11.

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51视频 Health News Georgia correspondent Briah Lumpkins discussed a conservative Georgia congressional district that has remained supportive of President Donald Trump despite rising healthcare costs on WUGA’s The Georgia Health Report on Sept. 11.


51视频 Health News Florida correspondent Daniel Chang discussed in Spanish how gun violence affects children in Florida on Radio Bilingüe’s Línea Abierta on Sept. 10.


51视频 Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at 51视频鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 51视频 Health News and is republished here under a .

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A Cancer Survivor Hoped To Work 鈥� Then She Lost Her Medicaid Disability Coverage /medicaid/disability-medicaid-work-requirements-cancer-state-reviews-montana/ Tue, 15 Sep 2026 09:00:00 +0000 /?p=2281022 Taya Hailstone has been in remission from childhood Hodgkin lymphoma for five years. But the cancer’s lasting damage to her organs and nerves can make basic tasks, like loading a dishwasher, hard.

Still, Montana’s health department decided last year that Hailstone is no longer eligible for low-cost disability health coverage through Medicaid. The department switched her coverage to the state’s Children’s Health Insurance Program, another Medicaid program 鈥� three months before she aged out.

Before making the decision, the state didn’t seek records from the medical team treating Hailstone, according to letters from those doctors reviewed by 51视频 Health News. Rather, the administrative ruling came after state officials learned the now-19-year-old had stopped receiving Social Security disability payments. She said she did that because she hoped to get healthy enough to work and save some money 鈥� beyond what’s allowed under the tethered to those payments. But her health changes day to day, and she said for now she’s still too sick to consistently work.

Hailstone, who lives with her mom, has been able to keep Medicaid coverage while they appeal the case. She said that without Medicaid she can’t afford the treatment to manage the aftermath of her cancer.

“It feels like this process was made to make you give up,” Hailstone said.

Patients with disabilities have long struggled with administrative hoops, blunders, and confusion when trying to qualify for federally subsidized health coverage because of their illness. Now, new federal Medicaid work requirements mean states face the additional task of deciding who qualifies for a medical exemption. That means reviewing medical cases for an even larger swath of Medicaid enrollees.

Attorneys, researchers, and advocates who specialize in public aid said disability cases like Hailstone’s 鈥� though separate from the incoming work requirements 鈥� are an indication that states aren’t ready. As a result, they said, more people will be denied coverage in an opaque process.

“This will be the story of millions of people,” said Anthony Wright, who heads Families USA, a national nonprofit that advocates for ways to make healthcare more accessible.

Jon Ebelt, a spokesperson with the Montana Department of Public Health and Human Services, said the state doesn’t comment on individual Medicaid cases.

An will have to meet the new rules requiring them to prove they’re working, going to school, or volunteering to keep their Medicaid coverage, according to the Congressional Budget Office. of those enrollees live with a chronic health condition, according to 51视频. Some will be excused from those rules if they can prove they’re too sick to work.

More than 5 million people are expected to lose Medicaid coverage by 2034 because of the work requirements, according to the CBO.

Work Requirements Become Law

Many Republican policymakers and the Trump administration have touted Medicaid work requirements to preserve coverage for the neediest. Congress made that national policy through last year’s One Big Beautiful Bill Act and gave states until January 2027 to implement work-for-coverage rules.

Some states are starting those checks early. Montana began in July. Nebraska initiated work requirements in May.

In the federal law creating the work requirements, Congress allowed states to exempt people who have an illness that qualifies them as “medically frail.” Many states created plans for those judgment calls, only to be surprised when federal officials released rules for the requirements that went beyond what Congress outlined, by also requiring enrollees to prove their illness makes it too hard to work.

Families USA and other organizations have argued the new rules force states to set up a patchwork of systems that, together, would be larger and more complicated than the Social Security Administration’s own disability review system. Last year, that federal program cost to administer to roughly 7 million people nationally. For comparison, Wright said, the federal law provided $200 million for states to share as they implement the work requirements. States are paying contractors millions of dollars to prepare often already flawed public aid systems to meet the new standards.

In June, 25 states over the medical frailty rules, arguing they’re too hard for patients to meet and for states to assess. That case is ongoing.

Hailstone was diagnosed with blood cancer at age 10. Her intestines tore, which led to their partial removal. As a result, her body struggles to process food and she can face severe dehydration. She said lingering side effects from her cancer treatment can leave her mind foggy and cause her hands and feet to swell enough that it’s hard to grip a fork or walk across a room.

Cancer dominated nearly half her life. It left mental scars, too.

“Some days you feel fine and then you suddenly crash,” Hailstone said.

Hailstone is seen without hair in a hospital room.
Hailstone during her treatment for Hodgkin lymphoma. Though she has been in remission for five years, she deals with lasting effects from the disease. Now she is trying to convince the state of Montana that she should still qualify for Medicaid’s disability coverage. (Kyla Hailstone)

Hailstone and her mom live in Roundup, a central Montana town of roughly 2,000 people. They regularly make the nearly two-hour round-trip drive to Billings for specialized care. She typically has three medical appointments a week to see her physical and occupational therapists and a mental health counselor.

Hailstone said she’s lucky she has her mother’s help navigating Medicaid. Her mom, Kyla Hailstone, said that the state hasn’t clearly defined how it determined her daughter’s disability status and that its appeal process has been slow and dysfunctional.

Taya Hailstone would qualify for Medicaid based on her income if she can’t prove her eligibility for disability coverage. But that would mean proving she’s too sick to meet the work requirement 鈥� putting her in the same position of having to rely on a state review of her illness.

“If I lose this, this is life-changing,” Hailstone said.

鈥楾hings Fall Through the Cracks’

Hailstone qualified as disabled through the federal government as recently as 2024, about a year before the state said it was dropping her coverage. State officials can do their own medical review to determine whether someone meets the federal definition of a disability to access Medicaid.

“Whether that happens is always a bit of a crapshoot just based on state capacity,” said Megan Dishong, deputy director of the Montana Legal Services Association, which helps low-income people navigate public programs. “Things fall through the cracks.”

Ebelt said the state health department accepts disability decisions from the Social Security Administration. The state agency can conduct an internal disability determination if a person doesn’t have one from the SSA, but Ebelt said it doesn’t have to if a person qualifies for coverage another way.

“We are committed to treating every client with respect and helping those who are eligible receive appropriate Medicaid coverage,” Ebelt said.

Montana instituted a three-month grace period for the work requirements. State officials won’t begin disenrolling people for noncompliance until October.

a University of Michigan social policy professor who has studied bureaucratic obstacles to public benefits, said convoluted disability cases are common enough for attorneys to specialize in accessing aid.

“When we’ve designed public programs in ways that people can’t figure out whether they’re eligible without consulting lawyers, we’ve done something wrong,” Herd said. “That has huge, huge implications for what’s to come.”

Montana officials have said they’ll automatically review medical records that could help patients qualify for an exemption. Even so, the federal guidelines released in June mean patients will probably still face additional steps to guarantee an exemption.

Meanwhile, already overstretched doctors worry they’ll face the burden of judging whether someone’s illness qualifies them for a work exemption.

Dishong said that between now and October, Montana officials could offer more clarity on how the process will work. She said she’s worried the state will end up “with a slow-roll mess” instead.

“This is a problem that’s just starting,” Dishong said.

As for Hailstone, she’s now reapplying for Social Security disability payments. That aid would limit how much she can work. But it would also guarantee access to Medicaid.

Have you tried to prove your eligibility for Medicaid under new rules that require people to show they are working, going to school, or participating in another qualifying activity? Click here鈥痶o contact 51视频 Health News.

51视频 Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at 51视频鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 51视频 Health News and is republished here under a .

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Her Breast MRI Was Approved, But That Didn鈥檛 Mean Her Insurance Would Pay /health-care-costs/breast-cancer-mri-preventive-care-bill-of-the-month-august-2026/ Wed, 26 Aug 2026 09:00:00 +0000 /?p=2278207 Last year, Stephanie Halver’s primary care doctor consulted a risk assessment tool to calculate her chances of one day developing breast cancer. Halver, now 43, remembered the likelihood “popped up really high.”

That’s partly because Halver’s mother and aunt have had breast cancer. Her age and dense breast tissue also put her at higher risk.

Halver, who lives in Vancouver, Washington, said her doctor recommended she get an annual breast MRI, six months after her yearly mammogram. The scan would serve as an additional safeguard, since breast MRIs can detect abnormalities that mammograms miss.

Case in point, actress Olivia Munn had a breast MRI in 2023 that detected an aggressive form of cancer in both breasts, even though a recent mammogram had been clear, . Like Halver, Munn said her doctor recommended the MRI after a risk assessment score showed she faced a greater-than-normal chance of developing breast cancer.

Catching breast cancer early, before it spreads, improves survival rates, according to the . After Halver’s insurer preapproved the scan, she scheduled the MRI for September.

“Luckily, they find nothing,” Halver recalled.

Then the bill came.

The Medical Service

A breast MRI 鈥� short for magnetic resonance imaging 鈥� is a preventive and diagnostic tool that captures pictures of breast tissue in higher detail than a mammogram. MRIs may be recommended for patients at an increased risk for breast cancer, including those with dense tissue, a family history of breast cancer, or certain genetic markers.

But the scans are generally not recommended for women considered at average risk, according to the , because they can also yield false positives, subjecting patients to unnecessary follow-up tests and procedures.

Breast MRIs are also used to diagnose cancer when an abnormality is detected during a mammogram, and they can determine the cancer’s stage after diagnosis.

The Bill

$1,205: After an insurance payment of $13.90, the patient was responsible for $1,191.10. The clinic also charged $65.60 for “Injectable/Oral Med,” often used to keep patients still or less anxious during the scan. Halver’s insurance covered about half of that charge.

The Billing Problem: Not Always Preventive

When Halver received the bill from Vancouver Clinic, where the MRI was conducted on Sept. 26, she was confused.

She knew that the Affordable Care Act requires health plans to cover preventive care, such as Pap smears and mammograms, at no cost to patients.

What’s more, Halver’s breast MRI had been recommended by her doctor and preapproved by Blue Cross Blue Shield of Texas, of which she is a beneficiary through her employer-sponsored plan. The whole point of it was preventive. That’s why she assumed it would cost her nothing.

To make things more confusing, requires many health insurers to cover breast MRIs.

“I’ve had many phone calls trying to understand” the bill, Halver said.

A photo of Stephanie Halver standing in her living room. Four colorful prints are seen hanging on the wall behind her.
Halver thought her health insurance plan would pay for a breast MRI recommended by her doctor in 2025. Even though the scan had been preapproved, she ended up with a $1,200 bill. (Kristina Barker for 51视频 Health News)

It came down to this: The U.S. Preventive Services Task Force, a panel of outside experts that advises the federal government, is charged with recommending which screenings health insurers are required to cover at no cost to patients, and preventive breast MRIs don’t fall into that category.

The task force “the current evidence is insufficient to assess the balance of benefits and harms” of breast MRIs for women with dense breast tissue “on an otherwise negative screening mammogram.”

The federal guidelines are different for patients whose mammograms detect an abnormality, said Cathy Peters, senior director of state and local campaigns at the American Cancer Society Cancer Action Network.

In these cases, Peters said, by the federal Health Resources and Services Administration specify that additional imaging, such as ultrasounds and MRIs, are preventive.

After an abnormal mammogram, these services are recommended “to address findings on the initial screening mammography” and to “complete the screening process for malignancies,” according to HRSA.

Those guidelines are a step in the right direction, but women who have not had an abnormal mammogram may end up “running into a big bill,” Peters said. This can be a deterrent when it comes to future screenings, she said, because when “you get hit with that once, you’re going to be very careful the next time you go.”

Some states have enacted laws that require insurers to cover breast MRIs, Peters said, but they generally don’t benefit patients like Halver who are enrolled in large, employer-sponsored insurance plans. These “self-insured” plans are regulated by the federal government, not by state lawmakers.

“Sadly, these state-by-state laws,” Peters said, don’t “fix the federal problem.”

The Resolution

Blue Cross Blue Shield of Texas declined to answer questions about Halver’s benefits or bill.

Halver appealed the insurer’s coverage determination, and in July she received a letter indicating that her appeal was denied.

Halver said she contacted her employer’s human resources department earlier this year and learned that mammograms are covered as a preventive screening under her health plan but breast MRIs are not. That means her annual breast MRI will be subject to deductibles, coinsurance, and other cost-sharing requirements.

In this case, the cost of Halver’s breast MRI was applied to her $3,300 annual deductible, an explanation of benefits from her insurer showed.

“I think I’m on the hook for this bill,” she said.

And because her risk of breast cancer is high, she said, “that’s a guaranteed bill every year.”

Stephanie Halver sits at a table in her home.
Halver learned that mammograms are covered as a preventive screening under her health plan but breast MRIs are not. (Kristina Barker for 51视频 Health News)

The Takeaway

If your doctor or medical provider recommends an annual breast MRI in addition to an annual mammogram, consider researching your state’s coverage rules on the . The nonprofit organization maintains a map with up-to-date information on state laws about breast cancer screenings. Depending on where you live and what type of health plan you have, preventive breast MRIs might be covered at no cost.

If it turns out you could be on the hook for a future bill, there are a few things you can do beforehand to potentially lower your out-of-pocket costs.

Ricki Fairley, co-founder of Touch, the Black Breast Cancer Alliance, recommended first finding a patient navigator at the hospital or cancer center to assist you.

She urged women to seek out resources in their communities or through national advocacy groups, including Touch, to find ways to lower screening costs. Programs funded by some states can help offset the cost of breast cancer screenings for low-income patients, Fairley said.

Beyond that, shop around for the best price. Freestanding imaging centers may charge less for a preventive breast MRI than a hospital. If possible, also consider scheduling the MRI at the end of your health plan’s deductible year. If you’ve already met your deductible, you could end up owing less out-of-pocket.

Bill of the Month is a crowdsourced investigation by 51视频 Health News and that dissects and explains medical bills. Since 2018, this series has helped many patients and readers get their medical bills reduced, and it has been cited in statehouses, at the U.S. Capitol, and at the White House. Do you have a confusing or outrageous medical bill you want to share? Tell us about it!

51视频 Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at 51视频鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 51视频 Health News and is republished here under a .

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How Much of a Cancer Drug Is Too Much? Patients, Researchers Challenge FDA-Approved Dosages /health-industry/cancer-drug-immunotherapy-fda-approved-dosages-challenged-keytruda-opdivo/ Thu, 20 Aug 2026 09:00:00 +0000 /?p=2273114 Northwestern University economist Chuck Manski studies decision-making amid uncertainty. That prepared him better than many other cancer patients to decide whether to stay on an immunotherapy treatment that was making him very ill.

For six months in 2022, Manski received monthly infusions of nivolumab to fight advanced melanoma. The drug ruined his thyroid gland, he said, requiring him to go on a special medication for the rest of his life, and caused severe dryness in his eyes, lips, and mouth. The FDA’s protocol for the drug called for an entire year of treatment, but Manski said his oncologist couldn’t explain why. It’s FDA-approved, “so that’s what we use,” she said.

By that point, Manski showed no cancer signs or symptoms, and after reading a lot of medical journal articles, he concluded that the intense side effects probably meant the treatment had done about all it could do.

“She couldn’t tell me a year was the optimal dose. Nobody could,” he said in a June interview from Spain, where he received an award for his economics work. “So I made my own diagnosis. I took myself off.”

Manski’s decision was in line with what doctors in , , were already doing: giving lower doses of nivolumab, sold under the brand name Opdivo, and of a similar drug, pembrolizumab (Keytruda), or giving them for shorter periods or over longer intervals than the FDA recommended. In India, oncologists found that of nivolumab had a powerful impact on several cancers.

“There is incredible uncertainty in drug dosing,” Manski said.

His experience impelled him to join an informal yet determined community of researchers, doctors, and patients pushing for extra studies to help patients and doctors find the right dosage for an array of cancer drugs. They point to evidence suggesting that taking smaller doses of some cancer drugs, or remaining on them for shorter periods, could save billions of dollars and prevent some of the worst side effects.

In a , 43% of U.S. adults said they had skipped their medication in the past year because of cost. A Vanderbilt University study of Medicare enrollees released in 2022 found that went unfilled at the pharmacy.

But dose-optimization studies rarely occur after the early stages of a drug’s development, or once it’s on the market. By then, few parties in the U.S. healthcare system 鈥� beyond patients 鈥� have a stake in learning that a lower dosage could work as well while causing less harm.

Pharmaceutical companies have shown little interest in dialing back recommended dosages. Once they set the price for a drug, the more sales, the more profit. One study that examined 29 expensive cancer drugs estimated that if minimum necessary dosages had been used in 2024, the U.S. healthcare system could have saved roughly $31 billion.

“Decisions aren’t always made with the best needs of the patients in mind. The bottom line is another reason,” said Matthew Goetz, a breast cancer researcher at the Mayo Clinic Comprehensive Cancer Center.

A photo of two IV bags as someone receives immunotherapy medication for melanoma treatment. The leftmost IV bag has "nivolumab" written on it.
Doctors in other countries have been giving patients lower doses of nivolumab or giving them for shorter periods or over longer intervals than the FDA recommends. (George Frey/Bloomberg via Getty Images)

Merck last year sold nearly $32 billion worth of pembrolizumab, a drug that’s FDA-approved for more than 40 cancer conditions. It accounted for almost half of Merck’s drug sales. Bristol Myers Squibb, meanwhile, brought in $10 billion from nivolumab, which works similarly to pembrolizumab in tweaking the immune system. Three important but often toxic breast cancer drugs 鈥� Ibrance, Verzenio, and Kisqali 鈥� at Pfizer, Eli Lilly, and Novartis by $4.1 billion, $5.7 billion, and $4.8 billion, respectively.

Pembrolizumab is usually prescribed at a fixed dosage; nivolumab is sometimes prescribed at a fixed dosage, sometimes based on the patient’s weight. If the patient is dosed less than what’s on the label, drugmakers generally get less money. And they aren’t the only ones who lose out.

Through a federal program known as 340B, created in 1992 to subsidize the treatment of low-income patients, hospitals that treat a certain percentage of low-income patients can buy drugs at a steep discount, while charging insurers or patients more. For Medicare patients, doctors are paid an additional for each infusion.

From 2010 to 2024, cancer drug revenue to doctors and hospitals increased from about $9 billion to nearly $36 billion, according to research by . About half those profits came from immunotherapy drugs like pembrolizumab and nivolumab.

“Pembrolizumab is ,” said Mark Ratain, a professor of medicine and chief hospital pharmacologist at University of Chicago Medicine. “That’s why you don’t see hospitals in this country running to do trials that test lower doses.”

A man stands in a garden area outside of his home. Foliage is seen blurred in the foreground.
Mark Ratain, a University of Chicago oncologist and clinical pharmacologist, battles what he sees as unnecessarily high dosages of high-cost cancer drugs such as Keytruda and Opdivo. (Taylor Glascock for 51视频 Health News)

Merck spokesperson Julie Cunningham said the drug’s dosage recommendations were based on extensive testing. “In a life-threatening and challenging disease such as cancer, it is critical that the dosing for a cancer therapy is established through well-designed clinical trials,” she said. “Changes in dose or duration that have not been similarly studied may potentially compromise the therapeutic effect.”

Still, some oncologists start their patients off slowly on any of a variety of cancer drugs, although there may be concerns about lawsuits by a patient or their survivors over a prescription of lower-than-labeled dosages.

Kathy Miller, a professor of oncology at the Indiana University School of Medicine, routinely starts metastatic breast cancer patients with 400 milligrams of Kisqali daily for three weeks (with one week off), rather than the 600 milligrams recommended on the label. Sometimes patients ask for the standard dosage.

“I have to tell them, 鈥業 don’t want to kill you,’” she said.

Insurers routinely challenge her lower-dosage prescriptions, Miller said, presumably because price rebates from the drug company are set to the standard dosage. To avoid endless phone battles with insurers, she prescribes 600 milligrams but tells her patients to take only two of the 200-mg pills and save the third for the next cycle.

Follow the Cures 鈥� And the Money

On May 31, at the annual meeting of the American Society of Clinical Oncology, or ASCO, at Chicago’s McCormick Place convention center, most of the audience of 8,000 rose in a prolonged standing ovation for the experimental drug daraxonrasib. Patients with pancreatic cancer who took the drug, presented that day, lived nearly twice as long 鈥� a median of 13 months 鈥� as those receiving chemotherapy.

The next day, in a slightly smaller hall, Amol Patel, a medical oncologist from New Delhi, discussed studies in various cancers in which 20- or 40-mg doses of nivolumab biweekly 鈥� one-sixth or one-twelfth the recommended dosage 鈥� gave Indian patients several months to a year longer survival than patients who underwent chemotherapy, and with fewer side effects.

Fewer than 100 people attended Patel’s talk.

The ingenious development of daraxonrasib was big news, since pancreatic cancer has been a death sentence until now. But from a global perspective, the news out of India might be just as important.

At the ASCO meeting, “the focus is always on the shiny new drug,” said Daniel Goldstein, an oncologist and drug policy researcher at the Rabin Medical Center in Israel who has fought for a decade, with some success, to lower pembrolizumab dosages in hospitals there and in other countries. “It can be quite lonely to be us,” he said, adding that he’s seen increasing appreciation of his work.

The data from India offered a glimpse of what could be. However, the studies Patel referred to compared ultralow-dosage immunotherapy to older chemo drugs; none compared ultralow doses against standard nivolumab or pembrolizumab treatments. In India, this would be a sterile exercise, because full-dose treatments are beyond the reach of any but the very wealthy, said Vanita Noronha, an oncologist at Tata Memorial Hospital in Mumbai.

Bristol Myers Squibb, or BMS, to make its drugs available in lower-income countries. But the company hasn’t been involved in the lower-dose nivolumab trials and, in a statement to 51视频 Health News, said the evidence suggested that or shorter duration harmed patients.

While not all U.S. oncologists agree with BMS’ assertion, the Indian data is, to most, a mere curiosity. “Can we really give 20 milligrams as opposed to 240?” asked Jessica Bauman of the Fox Chase Cancer Center in Philadelphia. “The only way we know for sure is a randomized study between the low dose and the highest.”

And such trials are unlikely to occur. That means only poorer countries are going to host “this groundbreaking research,” said Ratain, who is also a cancer doctor at the University of Chicago Medical Center. “The Indians may have better immunotherapy than we do.”

Clinicians in Europe, where maximizing healthcare dollars has long been a priority, have taken a middle course, studying lower, but not ultralow, doses of immunotherapy.

Pulmonologist Michel van den Heuvel at Utrecht University is comparing the standard nivolumab dosage for lung cancer patients with one that is as much as 50% lower. He also considered giving the low doses half as frequently, but that would have raised ethical concerns and led to a more cumbersome research protocol, van den Heuvel said.

In the United States, researchers led by a group at the Dana-Farber Cancer Institute are taking another tack: who’ve done well on 27 weeks of pembrolizumab can stop taking it, rather than doing the additional six months per FDA protocol.

At the Veterans Health Administration, which has more leeway in testing money-saving medical procedures, doctors saved $1.5 million, about 10% of the previous pembrolizumab cost, over two years at three Veterans Affairs hospitals where they implemented a pilot program to dose patients less frequently, said Garth Strohbehn, a University of Michigan oncologist who also works at the VA.

It saves money and requires fewer visits for veterans who often live hours from the hospital, he said. “It also helps other patients because it opens more slots for infusion.”

Julie Gralow, ASCO’s executive vice president and chief medical officer, has made testing dosage a priority. She’s working with scientists in India on an ambitious clinical trial to compare standard nivolumab with four lower dosage levels.

She’s also leading an , supported by the federally funded Patient-Centered Outcomes Research Institute, to see whether breast cancer patients can be effectively started on lower doses of the drugs Kisqali and Ibrance, which, along with Verzenio, are in a class of key breast cancer drugs known as CDK4/6 inhibitors.

“We want to maintain efficacy. But we also want patients to have excellent quality of life,” she said. Especially for patients with advanced cancers, where absolute cure is unlikely, “it’s our job to make sure we’re not compromising quality of life with higher doses that are unnecessary.”

In 2021, at Ratain’s urging, Richard Pazdur, who led the FDA’s cancer drug division for many years, launched , intended to get companies to conduct dosing studies that are more precise before launching the large clinical trials they use to obtain FDA approval for new drugs.

An exterior shot of the Food and Drug Administration headquarters.
The FDA usually can’t compel a drugmaker to conduct dose-ranging studies after a drug is approved, and by law the agency does not influence drug pricing, says Emily Hilliard, a Department of Health and Human Services spokesperson. (Valerie Plesch/Bloomberg via Getty Images)

The agency issued for dosing studies in 2024 and has incorporated Project Optimus principles into the approval process for new cancer drugs, said Health and Human Services spokesperson Emily Hilliard. For example, two dosing regimens were evaluated for each of four lung cancer drugs (fam-trastuzumab deruxtecan, tarlatamab, zongertinib, sunvozertinib), and the lower dose with fewer toxicities was approved in each case, she said.

The FDA usually can’t compel a drugmaker to conduct dose-ranging studies after a drug’s approval, Hilliard noted. And by law the agency does not influence drug pricing, she said.

Future drugs should have better dosage information, Bauman said, but “newer drugs will probably be just as expensive at lower doses.”

Financial Toxicity

Verzenio’s side effects made Allegra Warfield feel so sick, tired, and bewildered, she said, that she considered suicide. She switched to Kisqali, which was tolerable until last September, when coverage of the drug stopped despite her monthly premium payment of $6,000. The cash price for Kisqali was at least $16,000 a month.

After fighting her insurer for three months, Warfield, 42, sold her house and belongings in Palm Desert, California, and moved with her fiancé to Durham, North Carolina, where they’d found what they considered a reasonable insurance plan.

The cancer, the side effects, and the unpayable bills were bad enough. The lack of good answers for her treatment made everything worse, she said.

“I was left to research these medications on Facebook and Reddit. The only people talking about the daily reality of these drugs were other patients,” she said. “But I wanted the studies. I wanted practical guidance.”

Stories like these launched a new life mission for Kelly Shanahan, who was an OB-GYN in South Lake Tahoe, California, until side effects from a breast cancer drug caused her to lose sensation in her hands. Unable to practice medicine, Shanahan became a patient advocate who works with a group called the Patient-Centered Dosing Initiative. In 2021, Shanahan developed profound fatigue (“worse than caring for a newborn baby while being on call in my solo practice”) within a few weeks of going on Ibrance. Lowering the dosage caused her worst symptoms to lift, she said.

After gathering countless anecdotes, her group has approached drug companies seeking data 鈥� so far with little success 鈥� that might indicate what percentage of patients have needed dosage reductions, and how they fare on lower doses.

“If going down two dose levels cuts effectiveness by 50%, patients need to know that while making decisions. If it doesn’t, they need to know that,” Shanahan said 鈥� even if it means “the companies won’t make as much money.”

Shanahan suggested the data could be found in clinical trials and postmarket studies. But if drug companies won’t provide the necessary studies, Manski said, governments should.

“The knowledge to be gained is a common good,” he said.

A photo of Chuck Mansku standing in his home.
Manski’s research, focused on how people deal with conditions of uncertainty, helped him decide whether to stay on a melanoma treatment after it caused severe side effects. (Taylor Glascock for 51视频 Health News)

Has an insurance company or pharmacy benefit manager refused to cover a drug an oncologist recommended or prescribed for you or a loved one because the cancer is unusual or rare and lacks clear guidelines? Click here to contact 51视频 Health News’ reporting team.

51视频 Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at 51视频鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 51视频 Health News and is republished here under a .

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You Want To Join a Clinical Trial. Here鈥檚 What To Know About the Hurdles. /health-industry/clinical-trials-patients-hhs-easier-advice-on-how-to-enroll-seriously-ill-cancer/ Wed, 19 Aug 2026 09:00:00 +0000 /?p=2271463 Connecting people with clinical trials is complicated 鈥� even if people identify a promising match, there’s a slew of potentially thorny factors, including geographic incompatibility, and financial and time considerations.

Simply finding an appropriate trial can present an enormous hurdle. In a recent of more than 2,000 adults, 71% of patients with chronic conditions said they would be likely to participate in a clinical trial if given the chance. But two-thirds said that their healthcare provider had never discussed clinical trials with them. According to using data from 2020, just 9% of adults reported ever being invited to participate in a clinical trial.

Clinical trials are essential to the development of new and effective medical treatments. But gathering the real-world human data necessary to win Food and Drug Administration approval for drugs, devices, and other interventions can be an arduous task. By , up to 86% of clinical trials don’t meet their recruitment targets during the trial time frame.

Getting people signed up isn’t the only challenge.

“Recruitment is one thing 鈥� retention is another,” said Alan Balch, executive board chair at the Patient Advocate Foundation, which has a and maintains extensive educational materials online. “Every touchpoint is an opportunity for access and affordability to be a problem.”

The need to improve patient participation in clinical trials is not a new concern, but it’s attracting new interest.

In June, the Department of Health and Human Services to streamline and enhance clinical research in the United States. It included a public about whether to modify federal rules that currently deter some trial sponsors from paying clinical trial participants for expenses such as travel and lodging.

In July, a group of nearly 200 patient advocacy and public health groups to the Senate sponsors of the Clinical Trial Modernization Act, urging its passage. The bill would allow trial sponsors to cover trial participants’ medical costs, such as insurance deductibles and copays, and nonmedical expenses like travel and childcare. It would also exclude up to $2,000 in financial support for clinical trial participation from federal taxes, so people wouldn’t risk losing their eligibility for Medicaid or other income-based programs if they signed on.

While these efforts to improve clinical trials and patient participation are ongoing, here are answers to some questions about how the system works now and what patients can do if they want to take part.

Why Be a Guinea Pig? Understand the Facts

In some trials, some participants are given a new drug or therapy that’s being investigated while others receive a placebo with no physical effect.

But there are many . Some test different drug combinations, for example. They can test medical devices, preventive measures such as vaccines, or lifestyle changes. Others test ways to screen for or diagnose medical conditions.

For people with very serious illnesses, a clinical trial may offer the best hope for extending their life or improving their quality of life.

“Cancer is often a fatal disease, and clinical trials offer an opportunity to try something that may or may not be better,” said Mark Fleury, the policy principal for emerging science at the American Cancer Society Cancer Action Network. “If you know the existing standard of care has an average survival of eight months, you want something with a better opportunity.”

In addition, even if patients don’t receive the therapy being tested in the clinical trial, they are monitored closely throughout and receive the gold standard of care, which they might not receive elsewhere, patient advocates said.

Some people decide to participate in trials to aid in advancing science.

Jim Taylor’s wife, Geri, died of Alzheimer’s disease two years ago, more than a decade after her diagnosis in 2012. The couple for people with the disease, and Taylor is continuing that effort. He’s currently participating in three observational Alzheimer’s trials that are employing cognitive tests and scans to track how his brain is changing compared with the brains of people who’ve been diagnosed with the disease.

“The reason I’ve done it is so I can explain to people, with some authenticness and experience, what a trial is like,” he said.

Finding a Clinical Trial

Despite widespread interest in clinical trial participation, most patients don’t know how to find one.

They can’t necessarily count on their doctors for help. According to an of just over 500 primary care physicians in March, sponsored by the Patient Advocate Foundation, even though 86% of respondents said they were somewhat or very likely to refer their patients to a trial, only 37% had ever done so. When doctors did discuss clinical trials with their patients, it was usually because they had asked about them (67%), they weren’t responding to standard treatment (65%), or their disease was progressing (55%).

But for time-strapped doctors, identifying clinical trials for which patients might be eligible isn’t a simple task. A community oncologist, for example, would typically have to conduct a search using one of the available clinical trial search engines ( is the most comprehensive), type in all the patient’s characteristics, look at the trials that might be appropriate, and call the site to ask whether the trial is still open, Fleury said.

“And if they’re successful, what happens? They lose their patient,” he said.

Patients may have an even tougher time searching for trials on their own. Some patient advocacy groups have in-person or online navigators that can help people identify trials they might be eligible for.

The American Cancer Society has a , for example. Organizations such as the and the have information about disease-specific trials on their websites.

If a hospital or health facility is part of a clinical trial, patients there are often best positioned to enroll. Patients can ask their doctor or the facility for more information.

“Most recruitment for a trial happens at the site where the trial is happening,” Balch said.

There’s a Trial, but You Can’t Enroll

Much of the clinical research in the U.S. is conducted at large, often urban, academic medical centers. It can be tough for patients to enroll in a trial at a site unless they live nearby or are already being treated there, according to clinical trial experts.

To participate in a trial, people generally have to meet periodically with the researchers conducting it. They may also need to get regular blood draws or imaging, or to answer questionnaires to monitor their progress.

“The number one barrier keeping patients out of trials is a lack of onsite clinical trials,” Fleury said.

A that examined 8,893 cancer patients’ participation in clinical trials found that more than half (55.6%) didn’t have an available trial for their type and stage of cancer at the medical facility where they were being treated. An additional 21.5% didn’t meet the eligibility criteria for an available trial.

If a patient identifies a clinical trial at a viable location and wants to be considered, the patient should contact the trial recruiters directly and ask them, Balch said.

“That’s just the beginning,” he said. Patients also need to find out whether they meet a trial’s eligibility requirements and whether it’s covered by insurance, and to consider how they’re going to pay for any medical or nonmedical costs.

Recently there’s been a lot of interest in decentralized access to clinical trials, so patients could do at least some of the trial tasks at home or at their local cancer center, for example.

“It’s not common yet,” Balch said. But if decentralization grows, he said, it will open up the opportunity to more patients 鈥� and more representative groups of patients.

There’s a Trial, but You Can’t Afford It

If someone participates in a clinical trial, the trial sponsor picks up the tab for costs stemming directly from the trial, including the drug or device being investigated.

In addition, under the Affordable Care Act, most commercial health plans are required to cover associated with participating in a clinical trial.

But that doesn’t mean members won’t owe anything. They are generally still responsible for any deductibles, copays, or coinsurance amounts for the routine care that they receive during a clinical trial. And the ACA doesn’t require plans to have out-of-network benefits. That means if a clinical trial is sponsored by a provider that is out of someone’s provider network, the plan might not cover those costs.

and have similar requirements for coverage of routine clinical trial costs.

For some patients, incidental expenses can put participation in a clinical trial out of financial reach. Participants may face costs for travel to the trial site, parking, lodging, childcare, or taking time off work.

“There shouldn’t be an added set of concerns and disincentives around costs and financial toxicity,” said , the founder and CEO of WSCollaborative, a healthcare consultancy. Selig is also the project lead for , which aims to eliminate incidental costs for patients in trials.

Some trial sponsors pay for incidental expenses but might not make that clear up front to patients who are considering participating.

Patients should take the initiative and ask, Selig said. “There may in fact be help, and you should take advantage of it if it’s available.”

51视频 Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at 51视频鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 51视频 Health News and is republished here under a .

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Years After He Quit Smoking, a Lung Cancer Scan Saved His Life /aging/new-old-age-lung-cancer-screening-rates-smoking-survival/ Wed, 12 Aug 2026 09:00:00 +0000 /?p=2260817 Dennis Schmidt started smoking as a teenager, when that was so unexceptional that his Catholic high school designated outdoor “senior smoking quarters,” where students in their final year could take cigarette breaks. He smoked a pack of menthols daily for nearly 40 years.

As a registered nurse at the University of Cincinnati Medical Center and a former Air Force medic, he knew this was a bad idea. “I made a couple of attempts to quit and they failed miserably,” said Schmidt, now 75.

Not until 2007 was he able to stop, using a newly approved prescription drug that reduced cigarette cravings. “I put them down and never went back,” he said.

Despite his years as a healthcare professional, Schmidt was unaware that lung cancer screening had become available for current and past smokers. The influential U.S. Preventive Services Task Force, an independent expert panel, recommended it in 2013.

Besides, he said, “I thought I was in the clear after all these years of not smoking.”

But in 2021, his primary care doctor, running down a list of questions at his annual Medicare wellness visit, asked whether he’d be willing to undergo a CT scan to detect lung cancer, and he agreed. A few days later, the results popped up on his patient portal: adenocarcinoma.

“It was stunning to read those words,” Schmidt recalled. “I knew what that was: cancer.”

Even with sharp declines in smoking, lung cancer remains the leading cause of cancer deaths in the United States, with聽聽for this year, far exceeding fatal cases of colon, breast, or prostate cancer.

Yet in 2024, of the patients eligible for lung cancer screening,聽聽鈥� or聽, depending on which data researchers analyzed 鈥� were up to date on the recommended annual scans.

“Abysmally low, especially because of how deadly lung cancer is,” said Chi-Fu Jeffrey Yang, a thoracic surgeon at Mass General Brigham and the senior author of聽聽about the screening rates.

Patients over 65 were more likely than younger people to be up to date. Still, only about a third were screened regularly, a  than received other cancer screenings. Schmidt, for instance, had dutifully undergone colonoscopies and prostate cancer tests for years.

Data from national registries shows that older adults face聽. “Age is a risk factor for cancer generally,” said Priti Bandi, an epidemiologist at the American Cancer Society. But seniors may also accumulate more years as smokers. About a fifth of lung cancer cases arise in people who never smoked, but smoking remains the most common cause, “even if the exposure happened much earlier in your life,” Bandi said.

Screening has been shown to save lives. In 2011,聽聽demonstrated that annual screening with low-dose CT scans reduced lung cancer deaths by 20% compared with the chest X-rays used previously. That prompted the initial task force recommendation.

More recent European trials have found far greater reductions. In 2019, Italian researchers reported that after 10 years, patients with six years of screening had a 39% decrease in lung cancer deaths compared with those who weren’t screened.

Why, then, does screening remain so underused? “Lung cancer screening is so easy, a two-minute scan,” Yang said. “You don’t even have to put on a gown.”

One explanation: Determining eligibility gets complicated. The task force, in聽, recommended screening for those a) 50 to 80 years old with b) a “20 pack-year” smoking history who c) currently smoke or stopped within the past 15 years.

Both patients and doctors struggle with these criteria. Pack-year? It refers to how heavily someone smoked over time. Smoking a pack a day for 20 years creates a 20 pack-year history; so does smoking half a pack daily for 40 years.

Calculating that number is time-consuming and “challenging,” said Teva Brender, a hospitalist at the San Francisco VA Medical Center and a co-author of聽an 聽about lung cancer screening. “You might smoke a pack a day, then cut back to half a pack for two years, then stop. Then start again.”

The  probably also plays a role, sometimes making patients reluctant to disclose tobacco use. “Some people blame patients with lung cancer: 鈥榊ou did this to yourself because you smoked,’” Yang said. Screening rates also vary by state and insurance status.

Yet advances in treating lung cancer, including minimally invasive and robotic surgical procedures and increasingly effective drug therapies, mean that a diagnosis is “no longer a death sentence,” Bandi said. “The survival rate has improved dramatically.”

More than 80% of patients diagnosed in the earliest stages of the disease or more, although survival drops sharply for more advanced cancers. And screening increases the odds of finding cancer early.

Frustrated that a potentially lifesaving tool remains so underused, some doctors and organizations are calling for changes in the Preventive Services Task Force recommendations, which lead to coverage by Medicare (Medicaid coverage varies by state) and many private insurers. “The screening guidelines are too restrictive,” Yang said.

The American Cancer Society and the National Comprehensive Cancer Network have both聽聽from their guidelines, which would make patients eligible for screening no matter how long ago they stopped smoking.

“We were disqualifying people from screening at a time when their risk was still rising,” said Robert Smith, a screening expert at the society. He and his colleagues have urged the task force to also drop the 15-year stipulation,聽聽to back their claim.

罢丑别听, dropping both the 15-year and pack-year stipulations and advocating screening for anyone who smoked for 20 years.

The task force,  from Health and Human Services Secretary Robert F. Kennedy Jr., hasn’t responded to the American Cancer Society’s analysis. Nor did it respond to a reporter’s emails asking whether it planned to revise its lung cancer screening recommendations.

Expanding eligibility so that more people can undergo screening聽, too. Some scans will reveal abnormalities that don’t turn out to be lung cancer, but require additional scans (or, rarely, biopsies) and cause considerable anxiety. Even with low-dose scans, repeated screenings also involve some radiation exposure.

Moreover, a recent study showed that among older adults diagnosed with metastatic lung cancer, . “If the public health goal is to reduce deaths from lung cancer through screening, it only works if you treat the people it identifies,” said Steven Woloshin, a researcher at the Dartmouth Institute for Health Policy and Clinical Practice.

For Schmidt, though, screening and treatment worked as intended. The mass found by his 2021 screening, diagnosed as stage 1 lung cancer, led to robotic surgery at the University of Cincinnati Cancer Center to remove the upper lobe of his right lung.

Surveillance scans followed every six months, then annually 鈥� until a 2025 scan revealed a small nodule in his lower lobe, another stage 1 cancer. Surgery removed that nodule, too. Schmidt now takes a targeted anticancer drug daily, a three-year regimen, while continuing regular scans.

“It did what it was supposed to do,” Schmidt said of his screening. “I feel blessed.” He tends his extensive gardens in Bright, Indiana, flies kites, and goes camping with his grandchildren. He still works several shifts a month as a fire department paramedic.

Experts cautioned, however, that lung cancer screening and treatment cannot substitute for the benefits of stopping smoking 鈥� or never having started. “The risk is lower the longer you are away from cigarettes,” Woloshin said. “But it doesn’t go to zero.”

The New Old Age is produced through a partnership with .

51视频 Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at 51视频鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

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FDA鈥檚 Greenlight of Old Chemical Offers Chance To Restore Faith in Sunscreen /public-health/fda-approval-sunscreen-chemical-bemotrizinol-consumer-trust-maha/ Wed, 10 Jun 2026 17:02:49 +0000 /?p=2249263 Officials, environmental health advocates, and skin care industry groups are expressing hope that the Food and Drug Administration’s approval of a sunscreen ingredient on June 9 鈥� after consideration for two decades, and global use for nearly as long 鈥� will help in sunscreen.

“Bemotrizinol has been used safely in Europe for decades,” Health and Human Services Secretary Robert F. Kennedy Jr. about the approval. “FDA’s action will increase competition and consumer confidence in sunscreen products.”

Nonprofits that advocate for health, such as the Environmental Working Group, and the skin care industry alike had lobbied for approval of the ingredient, which makes sunscreens sheerer and lighter on the skin than many available American options while blocking a wider spectrum of ultraviolet rays that can cause premature aging and skin cancer.

The newly approved sunscreen filter will allow companies to re51视频te sunscreens to address consumers’ concerns, said Carl D’Ruiz, a senior manager at , a Swiss maker of sunscreen chemicals that applied for the FDA approval. In addition to allowing companies to offer what the FDA calls safe and effective 51视频tions, he said, the approval will allow sunscreens that are more like sought-after South Korean brands to be sold in the U.S. by autumn.

Confidence in U.S. sunscreen has faltered on two fronts: among those concerned about what’s in the sunscreens they use and those who believe sun exposure is healthy. But will the new ingredient win the trust of Make America Healthy Again skeptics and Gen Zers intentionally tanning? RFK Jr., strikingly bronzed, has helped stoke this confusion by pledging in 2024 to fight what he called the FDA’s “war on public health” and . Under his leadership, the FDA from a plan in March to ban people under 18 from using tanning beds.

All this matters because by age 70 in the United States. It is the in the nation, where about 3.3 million people are diagnosed each year with basal and squamous cell carcinomas.

D’Ruiz said he thinks bemotrizinol, also known as BEMT, will change the dynamic. “People will talk more positively about sunscreens,” he said.

In the U.S., new sunscreen chemicals are regulated as over-the-counter drugs like aspirin or cough syrup rather than as cosmetics, as in Japan and the European Union. That means they face more elaborate testing and safety protocols, such as animal testing that runs afoul of EU laws, which is why the for bemotrizinol took nearly two decades, D’Ruiz said.

What’s “generally recognized as safe and effective,” otherwise known as “GRASE” in FDA-speak, is at the center of the American sunscreen debate. Bemotrizinol joins zinc oxide and titanium dioxide on the FDA’s .

That could help rebuild trust, said , an environmental epidemiologist at the , a nonprofit that researches the ingredients in consumer products.

“It has strong safety data,” Friedman said. “The documents submitted to the FDA to achieve 鈥榞enerally recognized as safe and effective’ include tests of irritation, sensitization to allergies, two-year animal studies for carcinogenicity, and reproductive health.”

The approval will also give consumers access to sunscreens that don’t leave as much of a white cast, she said, which makes some people hesitant to use mineral sunscreens such as zinc oxide and titanium dioxide.

Bemotrizinol’s approval won’t change the possibility of several chemicals with unclear safety profiles being added to sunscreens.

In 2019, the there was insufficient data to support a positive “generally recognized as safe and effective” determination for 12 commonly used sunscreen chemicals.

The concerns emerged after the that said some sunscreen ingredients had been found in humans’ bloodstreams. Though the industry has since phased out several of those chemicals lacking GRASE status, four are still widely used: avobenzone, homosalate, octisalate, and octinoxate.

“The European Union had that homosalate was not safe at concentrations that they were using and recommended a very low percentage 鈥� which was effectively a ban,” Friedman said. “The U.K. also issued a safety evaluation.”

Octisalate and octinoxate have been associated with disruption of the endocrine system, and octinoxate was due to concerns that it harms marine life and bleaches coral reefs.

Avobenzone breaks down when exposed to light, making it less effective, Friedman said, and has been associated with allergic reactions.

Mark Mitchnick, a pediatrician who , which is known under the brand Z-Cote, said bemotrizinol will give chemists a new tool to make sunscreens that people will want to wear.

“It’s a good UVA block,” he said. “It gives us good flexibility. In my mind, it allows you to make really good products without using avobenzone, which I think has a lot of baggage.”

Most of the UV rays people are exposed to are UVA rays that can penetrate the middle layer of the skin and cause up to 90% of skin aging, along with a smaller amount of UVB rays, which are . falls on the electromagnetic spectrum between X-rays and visible light.

Mitchnick said major companies have used chemical filters because they work better on a per-pound basis compared with mineral sunscreens made with zinc oxide and titanium dioxide. “That’s why hybrids are great 鈥� you get the best of both worlds.” He said he expects companies, including , to release hybrid products containing bemotrizinol and zinc oxide later this year.

J. Frank Nash, a senior director and research fellow at Procter & Gamble, said skepticism about sunscreen is unfortunate because properly 51视频ted sunscreens do an excellent job blocking solar UV, “which we know is responsible for skin cancers and aging.”

He worries the industry has contributed to the trust gap by , called boosters, to mineral sunscreens, to raise sun protection factor ratings, or SPF. This leads consumers to wonder what’s in the products they’re buying.

Still, in Australia, where bemotrizinol has been used in sunscreens for years, a shows that even when regulators allow lauded UV filters, bad actors can taint a whole industry.

“People are not shunning sunscreen because they have stopped believing UV is dangerous,” said Joseph Mizikovsky, a director of the . “They are shunning it because they have lost trust in what is in the bottle.”

He applauds the FDA’s transparency with American consumers about the lack of safety data for filters without GRASE status, and FDA’s insistence on mandatory microbial testing of products.

But he said the FDA could do more to rebuild trust in sunscreens.

“My view is the FDA should move faster to ban filters that are missing safety data, and the public should focus on physical protection 鈥� shade, clothing, hats, sunglasses 鈥� with sunscreen as the last layer, not the first.”

51视频 Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at 51视频鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 51视频 Health News and is republished here under a .

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FDA Blocked Melanoma Drug as Confusion Reigned Under Makary /health-industry/fda-blocked-melanoma-drug-marty-makary-confusion-reigned/ Fri, 15 May 2026 09:00:00 +0000 /?p=2238195 The FDA’s to withhold approval of a new skin cancer treatment fell like a hammer on doctors who treat melanoma and patients who saw that the drug had prolonged the lives of a third of the participants in a clinical trial.

“It was devastating news,” said Trisha Wise-Draper, a dermatologist at the University of Cincinnati who had patients enrolled in the trial.

“This is life or death for maybe 2,000 patients,” added Eric Whitman, medical director of the Atlantic Health System’s oncology service. A assailed the ruling, noting that it “will have a chilling effect on drug development.”

Despite the benefit to some patients, oncologists and pharmaceutical industry analysts say there were legitimate concerns about the treatment, called RP1, that may have led the FDA to reject it in any event. The company, they noted, had ignored repeated FDA suggestions that it change the design of the trial used to seek approval for the medication.

The FDA’s decision would have raised few eyebrows before the current administration took power. But Marty Makary, who took charge as commissioner 13 months ago, altered the agency’s culture and damaged the trust it had built over decades while regulating 20% of U.S. consumer spending, said Steven Grossman, a regulatory consultant and former Health and Human Services official.

“People have to speculate about the standards and processes by which the agency makes decisions,” he said. “And that uncertainty is bad for everybody 鈥� patients and sponsors and investors.”

Under Makary 鈥� who resigned this week 鈥� senior officials have or some at the behest of President Donald Trump or HHS Secretary Robert F. Kennedy Jr., ignoring the advice of agency professionals. In defending his actions, Makary often eschewed the agency’s traditionally measured language about its decisions.

In response to criticism for rejecting the melanoma treatment, for example, Makary accused its manufacturer, Replimune, of “corruption,” saying it was “engaging in corporate spin” to make the FDA look bad.

“I don’t work for Replimune. I work for the American people,” Makary said in a May 5 interview on CNBC. Kennedy backed him up during a congressional budget hearing in which Kennedy mistakenly claimed that patients in Replimune’s clinical trial had also received chemotherapy.

Makary did not respond to requests for comment.

“All the norms have been thrown out the window, so we don’t know what underlines an agency decision,” said , a former FDA staffer and Senate aide to Sen. Edward Kennedy who’s now a pharmaceutical industry consultant in Boston. “Even when there are legitimate scientific and regulatory reasons why a drug will not be approved, we’re left guessing whether it’s legitimate grounds or just a political play.”

A Doomed Cancer Drug

Melanoma is the fifth most commonly diagnosed cancer in the United States, with about 112,000 new cases each year. The American Cancer Society projects that from melanoma this year in the U.S. If Replimune’s treatment, RP1, worked as well as it did in the clinical trial, Whitman said, as many as 2,500 of those patients could be saved.

RP1 is a genetically engineered virus designed to destroy tumor cells and alert the immune system to swing into action against them. Replimune sought accelerated approval 鈥� a sort of shortcut that allows a product to enter the market while a larger confirmatory trial takes place 鈥� by presenting data that showed a third of 140 people in the trial had their tumors shrink or disappear. But the agency had warned Replimune in July that it risked denial unless it changed its development plans. In particular, the FDA noted that the trial had no control arm to compare RP1 to an approved melanoma treatment. Instead, all patients were given RP1 along with Opdivo, a type of immunotherapy.

Replimune’s scientists don’t entirely understand how the drug works, but research indicates that, in addition to destroying cancer cells, it releases chemicals that revive Opdivo’s capacity to stimulate the immune system. The company argued it would be unethical to give Opdivo alone as a control arm, because all the patients entered in the trial had already stopped getting better while taking only Opdivo or other drugs in its class.

“Having a control arm would have been unethical,” Wise-Draper said. Some of her patients responded extremely well to RP1 and no longer have evidence of melanoma, she said.

Replimune currently has a larger trial that includes a control arm, but “the bigger question is whether the company will survive,” Whitman said. The FDA-accelerated approval would have persuaded investors to provide enough cash to finish the larger trial, he said.

Replimune did not respond to repeated requests for comment. But it is firing more than half its staff and closing some operations in the wake of the FDA ruling.

RP1 wouldn’t have been the first melanoma drug approved based on a single-arm trial. Keytruda, the best-selling Merck cancer drug, was approved to treat melanoma some 12 years ago based on such a trial design. But in its denial statement, the FDA said it wasn’t convinced that the positive effects of the combination regimen were all due to RP1 and not partly to Opdivo.

Replimune arguably could have found an ethical way to set up a control arm for its treatment, Kim said. On the other hand, the FDA could have “given them a provisional yes” with accelerated approval, he said. The whole point of the three-decade-old accelerated approval program is to “take a gamble,” Kim said. The agency’s statement, stressing the company’s methodology over the result, “is a recalibration of how confident sponsors can be with similar studies,” he said.

Vinay Prasad’s Final Days at FDA

Much of the criticism of the FDA under Trump has focused on Vinay Prasad, who was fired then rehired last summer and held various leadership roles at the agency. Prasad, an oncologist known for critiquing the statistical bases of studies, repeatedly intervened in approval processes for drugs and vaccines normally decided by lower-ranking FDA professionals.

Prasad, who did not respond to requests for comment, resigned for good May 1, three weeks after the Replimune decision. “There’s this lingering question of whether this was Vinay’s last stand, or an objective decision made by careful scientists,” Kim said.

Makary ran afoul of Trump administration officials over various decisions, the last being his reluctance to approve flavored vapes for smoking cessation. Trump’s anti-abortion supporters wanted him ousted for allowing a generic form of mifepristone on the market, and for failing to speed up studies they hoped would lead to the abortion drug’s withdrawal from the market.

But in the industries regulated by the FDA, ranging from gene therapy to vaccines and cancer, officials are frustrated by the agency’s uncertain direction. In past administrations, the agency generally swung on a narrow arc between loosening and tightening requirements for drug approvals. Under Makary, “it’s been swinging in every conceivable direction,” Grossman said.

“It’s very inconsistent; it’s all over the place,” Whitman said. “The inconsistency is part of the concern.”

During his tenure, Makary made a series of categorical statements that either claim credit for progress made during earlier administrations or exaggerate the agency’s ability to move forward on goals.

For example, he set a goal of , which is considered impractical at the moment, Kim said, and moved to artificial intelligence at the FDA 鈥� prematurely, critics say. Makary and Prasad also promised to reduce the from two to one. FDA statutes require two well-controlled clinical trials for drug approvals, but exceptions to that rule are already frequent.

“The FDA is sending signals that it wants to even further reduce the evidence needed to support drug approval,” said Aaron Kesselheim, a Harvard Medical School professor and an expert on the drug industry. “Of course, if we’re talking about vaccines, the total opposite is the case. FDA has been taking real steps to make it harder to get vaccines approved.”

The FDA fired about 4,000 staffers at the start of the Trump administration. Makary promised to hire thousands back, but considering the upheavals at HHS and the FDA, these positions may be hard to fill. “What magic trick will get that done?” Grossman asked.

“The unfortunate thing is that there has been so much chaos at FDA that this Replimune decision, which may have needed to happen, has gotten mired in the controversy,” said Evan Seigerman, leader of healthcare research at BMO Capital Markets.

51视频 Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at 51视频鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 51视频 Health News and is republished here under a .

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