Drugs Archives - 51视频 Health News /tag/drugs/ 51视频 Health News produces in-depth journalism on health issues and is a core operating program of 51视频. Mon, 28 Sep 2026 16:17:49 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.10 /wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=32 Drugs Archives - 51视频 Health News /tag/drugs/ 32 32 257378068 Republicans and Democrats Find a Unifying Target: Pharmacy Benefit Managers /health-industry/pharmacy-benefit-managers-pbms-drug-costs-common-ground-tennessee/ Mon, 28 Sep 2026 09:00:00 +0000 /?p=2281035 Amye Joseph says America’s political polarization has made it an “interesting time” in her Tennessee household. She and her husband, Charlie, have been married 35 years. She’s a Republican. He’s a Democrat.

But their shared disenchantment with profit-driven healthcare has provided a unifying target: pharmacy benefit managers, known as PBMs. The Josephs’ frustration is focused on CVS Health. The conglomerate, which reported $400 billion in revenue last year, includes a major health insurer (Aetna), one of the country’s dominant PBMs (CVS Caremark), and America’s largest retail pharmacy chain.

“We hate CVS. I’m going to be straight-up,” Amye Joseph said.

She laments the lack of face-to-face interaction with pharmacists, prices that seem to rise without explanation, and pressure from the couple’s CVS Caremark drug plan to use CVS stores instead of their local pharmacy. “They’re not even a middleman,” she said. “They’re a money grab for CVS.”

PBMs were conceived as a way to manage prescriptions and hold down costs. But these middlemen have become bipartisan punching bags, accused of sucking up profits at the expense of employers, governments, and patients.

And while healthcare debates still divide Democrats and Republicans in Washington, D.C., taking on PBMs has become a unifying cause in an era of widespread frustration over rising healthcare costs.

In recent years, every state has imposed restrictions on PBMs. The Josephs’ home state of Tennessee, where the GOP has a lock on state government, is among a growing number looking to outlaw companies that own PBMs from also owning brick-and-mortar pharmacies, as CVS does.

That’s aligned conservative, business-friendly Republicans with Democrats traditionally more open to government regulation.

This legislative push reflects a feeling even in the GOP that the market for prescription drugs is being gamed, said Antonio Ciaccia, CEO of , a nonprofit think tank that tracks drug pricing.

“Republicans are looking at this issue, saying, We know what competition is supposed to do, and it isn’t happening,” said Ciaccia, a critic of the PBM industry. “This is not a free market.”

Charlie Joseph, a retired fire captain who now works as a custodian, was miffed when he realized he could save money on his blood pressure medication if he paid cash at his local pharmacy rather than using his CVS Caremark drug plan. He now buys a 90-day supply for the same price he would have paid for a 30-day supply through the CVS plan.

Charlie and Amye Joseph stand on their porch.
The Josephs don’t like dealing with pharmacy benefit managers. PBMs, designed as intermediaries between drugmakers and insurance companies to negotiate drug prices, have become targets of bipartisan anger over health costs. (Earl Neikirk for 51视频 Health News)

“Right now, it’s more of an inconvenience than anything else as far as it goes, but there’s no consistency,” he said. “The whole healthcare thing is just frustrating, on a good day.”

CVS spokesperson Phil Blando said the price of individual drugs can vary.

“Looking at the price of a single prescription does not reflect the value of a comprehensive pharmacy benefit,” he said in a statement. “Our focus remains delivering the lowest possible total cost and the greatest overall value for members and plan sponsors.”

Unified Opposition

PBM officials say their industry has been unfairly maligned. “PBMs are the only part of the prescription drug supply chain working to lower drug costs, which makes PBMs the target of powerful groups, Big Pharma and pharmacists,” said Greg Lopes, a spokesperson for the Pharmaceutical Care Management Association, which represents PBMs across the nation.

“Drug manufacturers attempt to shift blame for high drug costs to PBMs in order to retain their profit margins and weaken PBMs’ ability to lower costs,” he said.

Drugmakers have worked for years to cast PBMs as unnecessary go-betweens, said Barak Richman, a lawyer and economist who studies healthcare competition at George Washington University. He called the fight between the two industries a corporate “cage match.”

“We have wildly passionate partisan divides on a lot of healthcare,” he said. “But there’s a lot of healthcare policy that I don’t think is obviously partisan.”

PBMs haven’t won over many Democrats or Republicans. Attorneys general from nearly 40 states and U.S. territories last year to congressional leaders arguing that “horizontal consolidation and vertical integration have transformed PBMs from useful administrative service providers into market-dominating behemoths.”

In state legislatures like Tennessee’s, shared ownership of PBMs and pharmacies has drawn particular fire. Independent pharmacies have little choice but to contract with major PBMs while also competing with the conglomerate-owned pharmacies. Many lawmakers have said they want to protect small businesses.

“If a corporation argues that its pharmacy cannot survive unless it is owned by the same entity that sets the reimbursement rate, then we’re not talking about a free market. We’re talking about control,” Tennessee state Sen. Bobby Harshbarger said in a February legislative hearing.

Harshbarger, a Republican who led the legislative push, is a pharmacist in a small city in northeastern Tennessee.

His mother, U.S. Rep. Diana Harshbarger (R-Tenn.), is also a pharmacist and has sponsored a similar PBM ownership ban . The Senate version has brought together some unlikely bedfellows, such as Sens. Elizabeth Warren (D-Mass.) and Josh Hawley (R-Mo.).

State Lawmakers vs. CVS

CVS officials argued the Tennessee legislation was misguided. “Any proposed reform should be evaluated based on whether it improves access to care, simplifies the patient experience, and enhances affordability,” Blando said.

It’s unclear whether the PBM ownership ban will do that in Tennessee. by the state legislature’s researchers concluded that the bill could drive up healthcare costs in the short term.

To fight the bill, CVS launched a $7 million , claiming it would have to close all its 134 pharmacies in the state, similar to its threat in neighboring Arkansas when state lawmakers there passed in 2025.

CVS also sent to Tennessee customers, asking them to contact their lawmakers to keep pharmacies open. from CVS helped kill a PBM ownership ban in Louisiana last year.

Sponsors of the legislation said closure wasn’t the only option: CVS could also divest either its stores or its PBM.

Tennessee lawmakers moved forward. State Sen. Rusty Crowe, a Republican from northeastern Tennessee, where the Josephs live, told his colleagues before the vote that they should consider the fierce resistance a sign that they were onto something.

“I learned when I was in the Vietnam War, when you start taking on flak, you know you’re over the damn target,” he said.

As with most votes in Tennessee’s legislature, Republicans didn’t need support from Democrats. But they got it anyway.

State Rep. Antonio Parkinson, a Democrat from Memphis, said he felt like he was voting in favor of lower drug prices and supporting “ma and pa” pharmacies. “If there’s a benefit to my people, I’m supporting it.”

CVS has not divested or closed its pharmacies in states that have passed ownership bans 鈥 the laws have yet to take effect. The Arkansas ban is being held up in court after CVS challenged the constitutionality of the law. CVS also sued in Tennessee, though the ownership ban doesn’t take effect until 2028.

This article is from a partnership that includes , , and 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 .

]]> 2281035 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 .

]]> 2285126 The Drugs and Devices Have Been on the Market for Years. But FDA-Ordered Studies Still Aren鈥檛 Done. /health-industry/fda-approval-drugs-medical-devices-postmarket-studies-safety-delays-amgen-tavneos/ Fri, 18 Sep 2026 09:00:00 +0000 /?p=2275664 When the FDA was deciding whether to approve the drug Tavneos several years ago to treat a set of , agency experts argued that would be a mistake, according to .

One problem cited: The manufacturer had provided only

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

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

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

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

A 51视频 Health News analysis of Food and Drug Administration data found hundreds of postmarket studies listed as delayed. In some cases, the work was delayed by more than a decade or the manufacturer was still developing a plan for the study.

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

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

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

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

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

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

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

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

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

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

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

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

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

An aerial photo shows a large company headquarters with various buildings.
Amgen’s headquarters in Thousand Oaks, California, in May 2023. (Mario Tama/Getty Images)

Behind Schedule

An FDA database downloaded by 51视频 Health News in August tracks the progress of postmarket studies that makers of 鈥 such as vaccines and gene therapies 鈥 were required to perform or promised to perform.

The database showed almost 600 were running behind schedule.

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

About a third of ongoing studies were listed as delayed.

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

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

The nearly 600 delayed studies involved almost 350 products, 51视频 Health News found.

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

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

Products included:

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

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

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

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

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

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

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

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

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

Today the issue may be all but moot.  

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

According to another FDA database, Oxaydo .

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

Delay Can Pay

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

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

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

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

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

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

鈥楩alse Hope’

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

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

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

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

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

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

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

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

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

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

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

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

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

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

鈥楳补苍颈辫耻濒补迟别诲’

A pair of hands holds a bottle of Amgen's drug Tavneos.
Amgen is the maker of the drug Tavneos. (Hannah Yoon/Bloomberg via Getty Images)

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

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

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

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

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

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

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

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

Nonetheless, the recently of Tavneos.

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

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

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

The FDA disagrees.

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

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

Data reporter Maia Rosenfeld contributed to this report.

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 .

]]> 2275664 3 Common Drugs Older Adults Might Be Overusing /aging/3-common-drugs-older-adults-might-overuse-new-old-age-column/ Thu, 17 Sep 2026 09:00:00 +0000 /?p=2282208 The scenario often unfolds like this: Medical researchers investigate a frequently used drug and report that it’s less effective for older patients than previously thought, or that its risks outweigh its benefits in older adults. More studies follow, confirming those findings.

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

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

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

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

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

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

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

The Drawbacks of Benzodiazepines

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

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

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

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

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

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

Overprescribing Antibiotics

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

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

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

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

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

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

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

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

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

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

When Aspirin Isn’t the Answer

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

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

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

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

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

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

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

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

The New Old Age is produced through a partnership with .

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 .

]]> 2282208 Watch: Mark Cuban Says You Can鈥檛 Fix Healthcare Until Every Price Is Known /health-care-costs/interview-mark-cuban-fix-healthcare-full-price-transparency/ Fri, 21 Aug 2026 09:00:00 +0000 /?p=2277194&preview=true&preview_id=2277194 The ongoing debate over the U.S. health system shouldn’t be based on whether the government or the private sector is the dominant player, billionaire entrepreneur Mark Cuban said this week. The bigger issue, he said, is whether the system’s participants are transparent about what they charge and what they pay.

“I’m not opposed to single-payer or universal healthcare at all,” Cuban said Aug. 18 in an interview with 51视频 Health News. But “when you don’t know all the costs, when there’s no transparency, it’s impossible to determine if it’s a better solution or not,” he said.

Cuban’s remarks came on the heels of primary election victories by progressive supporters of “Medicare for All” 鈥 most notably Abdul El-Sayed, who recently clinched the Democratic Senate nomination in Michigan.

The former majority owner of the Dallas Mavericks and a former investor on the hit TV show Shark Tank, Cuban changed the way generic prescription drugs are sold in 2022 by co-founding Mark Cuban Cost Plus Drugs. The website, which posts all its costs and takes a blanket 15% markup, sells thousands of medications, often at deep discounts compared with buying through private insurance plans or self-pay pharmacies.

“We took the transparent path for an industry where there was zero transparency,” Cuban said. “Everybody else prices to the market; we price to what we thought was fair.”

Cuban said that, in thinking about the broader problems facing the U.S. healthcare system, the key is to rebuild trust. “Trust really is a 51视频,” he said. “Trust equals transparency divided by self-interest.”

One way to build trust, he said, is to give consumers incentives to find the best price for nonemergency health services. Cuban said that means every medical purchase should count toward health insurance deductibles and out-of-pocket maximums, which is not currently the case.

He also advocates breaking up some of the vertically integrated health companies that have grown so large 鈥 owning insurers, care providers, and the companies that serve them 鈥 that they can dictate their prices. “If you break up these big, huge conglomerates, everything changes. The price of everything drops like a rock,” he said.

But so far, only a few lawmakers have been brave enough to push that goal, Cuban said, citing the co-sponsored by senators Josh Hawley of Missouri, a Republican, and Elizabeth Warren of Massachusetts, a Democrat.

In the end, Cuban said, what matters is not who is running the system but whether all the cards are on the table 鈥 in particular, whether the terms of healthcare contracts are public. Whether it’s the government or private businesses doing the negotiating, “if you don’t know how the deals are structured, it’s impossible to negotiate better ones.”

The interview was part of the “How Would You Fix It?” series featuring Julie Rovner, 51视频 Health News’ chief Washington correspondent and host of the What the Health? podcast.

An abbreviated version of this interview aired Aug. 20 in Episode 460 of What the Health? From 51视频 Health News: “Headless FDA Gets a New Nominee.”

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 .

]]> 2277194 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 .

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]]> 2273114 Newsom Promotes Affordable Insulin, but California鈥檚 Generic Label Off to a Slow Start /health-care-costs/gavin-newsom-calrx-state-branded-insulin-generic-biosimilar-drugs-rollout/ Mon, 17 Aug 2026 09:00:00 +0000 /?p=2270444 SAN FRANCISCO 鈥 At a Walgreens in this city’s bustling Japantown neighborhood, pharmacist Margaret On stocks two boxes of long-acting insulin pens from California’s new prescription drug label, , emblazoned with the state’s iconic grizzly bear.

Although she hasn’t dispensed any, On plans to keep them on hand. “It’s good to have if a patient comes in and doesn’t have health insurance,” she said. “Or just in case of emergencies.”

Seven months after the launch of its own low-cost insulin brand, state health officials said California has distributed more than 120,000 five-pen packs of insulin glargine priced at $55 each, significantly less than the $89 to $411 that the state says most popular brand names charge before any retail markups or consumer discounts.

While it represents a tiny amount of the state’s insulin pipeline, it marks the first time a state is competing against the insulin drugmakers 鈥 Eli Lilly, Sanofi, and Novo Nordisk 鈥 under its own prescription drug label. CalRx, Gov. Gavin Newsom’s experimental initiative, has dual aims: to act as an emergency supplier for people who are uninsured or can’t afford their prescriptions, and to disrupt the nation’s deep-pocketed pharmaceutical industry, which cost the U.S. in 2024, the federal government reported in June.

Newsom, a Democrat considering a presidential run in 2028, is expected to make healthcare a central pillar of his national platform as he concludes his second and final term as governor. To create the state brand of generic drugs, California inked a $50 million contract with , a Utah-based nonprofit drugmaker, to develop the CalRx insulin, known as a biosimilar. Though major distributors make the drug available in pharmacies around the state, uptake has been limited.

Newsom’s goal is to saturate the insulin market and offer generic versions of drugs either high in cost or low in supply, or that can improve public health. The state is also distributing free naloxone, used in a nasal spray to reverse opioid overdoses, and trying to bring albuterol inhalers to public schools for students with asthma emergencies. In the next two years, the state plans to launch epinephrine injectables, commonly known by the brand name EpiPen, which are used to treat severe allergic reactions, as well as a state-branded medication to treat tuberculosis.

Before he leaves office in January, Newsom said, he wants to add generic GLP-1 medications to compete with brand-name drugs such as Ozempic and Wegovy. The drugs have , but employers have about their cost.

Taking on drug costs is a winning political issue for both Democrats and Republicans, who have for years tried to rein in as Americans feel the pinch of high prices at pharmacy counters, in doctors’ offices, and from health insurance premiums. The U.S. spends roughly on prescription drugs as other industrialized countries. Six in 10 adults in the U.S. say they’re worried about being able to afford their prescription drug costs, according to a , and 4 in 10 say they’ve tried to save money such as by skipping doses and not filling prescriptions.

, President Donald Trump launched to potentially lower out-of-pocket costs for consumers. But TrumpRx doesn’t produce drugs; rather, it directs consumers to find more affordable medications with coupons or on drugmakers’ websites. Newsom, in contrast, is trying to drive down the underlying price of medicines by increasing the manufacturing and availability of generic drugs.

While some people with diabetes may benefit from CalRx insulin, California’s generic drug effort is largely symbolic at this time, said Geoffrey Joyce, director of health policy at the Schaeffer Center at the University of Southern California. “There is some value, but it’s for a very limited number of drugs for just a fraction of the population,” Joyce said.

And TrumpRx isn’t helping at a large scale either, Joyce added, because many medications it advertises have cheaper generic versions available elsewhere. It would be better, he said, to develop large-scale initiatives that tackle key drivers of the high cost of drugs, for rare cancers for instance, and produce safer and higher-quality medicines.

“What you really need is a national effort that focuses on vulnerabilities like supply shortages and increasing the supply of generic products for higher-priced drugs,” Joyce said.

Market Disruptor

CalRx aims to make insulin more affordable and accessible for the California adults diagnosed with diabetes. Newsom last year singled out the three major drugmakers that control more than 90% of the global insulin market, while also targeting intermediaries known as pharmacy benefit managers for promoting higher-priced drugs over cheaper generic alternatives.

Patients with health insurance often receive discounts at the pharmacy counter and do not pay sticker prices, yet those discount programs can be hard to navigate and patients can face restrictions. While drugmakers and pharmacy benefit managers said they’ve already initiated on out-of-pocket costs and pass price discounts on to consumers, Newsom argues that consumers still struggle to afford their medications.

He has criticized pharmaceutical companies for gouging Californians and contended that the industry’s discounting schemes don’t adequately address inflated prescription drug spending, which in the U.S. rose 7.9% in the most recent reporting year.

In his announcement last year that CalRx insulin would go on sale in January 2026, Newsom said the industry had been using discounts to distract consumers from solutions that could bring overall prices own. “One of the things that all of us should be increasingly concerned about is announcements around caps, announcements around discounts,” he said.

In January, California joined in setting . It also passed attempting to ban by pharmacy benefit managers.

Representatives for drug companies and pharmacy benefit managers said insulin is largely an affordable medicine in the U.S., arguing that consumers have benefited from discounts.

“While insulin prices, set solely by pharma companies, may be high in some instances, the amount patients are paying out of pocket has declined significantly,” said Christine Rex, senior director of state public affairs for the Pharmaceutical Care Management Association, which represents pharmacy benefit managers.

Reid Porter, a spokesperson for Pharmaceutical Research and Manufacturers of America, which represents brand-name drugmakers, said PBMs have driven up costs for consumers by excluding lower-cost medicines from their lists of covered drugs. “Too often, patients face a system in which insurers and PBMs exclude coverage of those medicines on 51视频ries because of supply-chain incentives,” he said.

Where To Find CalRx Insulin

CalRx insulin has been slow to reach pharmacies around the state, and in interviews, patient advocates said many people with diabetes aren’t aware it’s an option.

In Sacramento, pharmacist Sharon Ngo, who works at a Safeway pharmacy, was surprised to learn that California had a long-acting insulin product on the market. She didn’t know that CalRx insulin was interchangeable with Lantus, which was on back order for roughly two weeks.

“I had no idea this was available,” she said as she took notes on a pad of paper. “We’re going to give this a try.”

CalRx insulin has a suggested retail price of $55 a pack and is available with or without insurance. California has inked deals with four health insurers to cover CalRx insulin on their health plan 51视频ries, potentially making it cheaper, depending on copays. They include Anthem Blue Cross, Blue Shield of California, the Valley Health Plan for Santa Clara County employees, and the Federal Employees Health Benefits Program, according to the state Department of Health Care Access and Information.

A box of CalRx insulin.
Pharmacist Margaret On keeps two boxes of California’s new generic insulin product under the CalRx brand on hand in case of emergencies. (Angela Hart/51视频 Health News)

Elizabeth Landsberg, the department’s director, said the state is working to get more insurers to cover CalRx insulin and to provide it at more pharmacies. The state doesn’t know how many boxes have been dispensed. However, Landsberg said it was more meaningful that the state had reached agreements with to distribute its product in California. Currently, CalRx insulin is available on Amazon and at Costco, as well as at some retail and grocery store pharmacies including CVS, Walgreens, and Walmart.

“What we’re really trying to do is change market behavior and offer both affordable and transparent pricing,” Landsberg said. “The rebates and discounts are hard for consumers to understand and can change at any time, so we are trying to be straightforward and say, 鈥楲et’s not play this shell game anymore.’”

Allan Coukell, chief government affairs and public policy officer at Civica, said the company first partnered with the state on long-acting insulin that helps patients keep blood sugar steady for 24 hours or more. Next, it plans to help California develop rapid-acting insulin, which is used to pull elevated glucose down within minutes, to compete with brand names such as Humalog and NovoLog.

Health insurance companies welcomed the state’s efforts, in part because they could help save money they pay out on prescriptions.

“Making this drug available is really about helping people improve their health,” said Paul Markovich, CEO of Blue Shield of California’s parent company. “And the more supply we can get on the market, the more we can get rid of the profit motives in the pharmaceutical industry.”

One July afternoon in the Southern California city of Corona, Chris Noble went to a CVS pharmacy to get a box of CalRx insulin. The pharmacist didn’t have any on hand, but Noble, a healthcare organizer with Type 1 diabetes, was told he could get a prescription filled in 24 hours.

“I have insurance, but I see myself using this if I’m traveling and something happens like my insulin pump malfunctions,” he said. “Now I know I can go to a CVS and get insulin within a day.”

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 .

]]> 2270444 Watch: Why Abortions Are on the Rise Since 鈥楻oe鈥 Was Overturned /courts/video-five-things-abortions-increase-since-roe-overturned/ Fri, 07 Aug 2026 09:00:00 +0000 /?p=2264199 Say you live in deep-red Louisiana, a state that has effectively banned abortion. It may be easier for you to get abortion pills now than before the Supreme Court overturned Roe v. Wade. Here’s why 鈥 and what it means for future battles over abortion access.

And as a federal court mulls a case that could result in significant restrictions on a pill used in most abortions, healthcare providers say they have alternatives to preserve access even in states with bans in place. Read more here.

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 .

]]> 2264199 Watch: GOP Senator Says Trump鈥檚 Tariffs Could Mean Safer Drugs 鈥 For a Price /health-industry/bill-cassidy-interview-senate-trump-tariffs-drug-prices-rfk-promises/ Fri, 24 Jul 2026 09:00:00 +0000 /?p=2263419&preview=true&preview_id=2263419 President Donald Trump’s proposed tariffs on imported generic drugs could raise some prices for patients, a key GOP lawmaker on health issues said this week. But he said that’s a potentially worthwhile trade-off to protect the nation’s drug supply.

“The national security might be something worth paying for,” Sen. Bill Cassidy of Louisiana, chairman of the Senate Health, Education, Labor, and Pensions Committee, said July 22 in an exclusive interview with 51视频 Health News.

The U.S., which has grappled with drug shortages in recent years, relies primarily on China to produce the active ingredients in many antibiotics, according to in JAMA Health Forum. Domestic facilities have closed or shifted to producing other drugs.

“Do we want China to have that sort of leverage for these drugs to be produced principally, maybe 99%, over there, and we don’t have access to them if tension rises between the two countries?” said Cassidy, who is a physician.

On July 21, Trump said in a that he would give generic drug companies two years to move production back to the U.S., after which he would impose 100% tariffs on imported products, rising to 200% the following year. Generic drugs make up an estimated 90% of all prescriptions filled in the U.S.

Cassidy, who has served in Congress , lost his bid for reelection in May after Trump endorsed a Republican primary challenger, Rep. Julia Letlow.

Last month, more than 16 months after his vote to confirm Robert F. Kennedy Jr. as head of the Department of Health and Human Services, on CBS News’ Face the Nation that the secretary broke promises he made to the senator, including that he would not change the federal recommendations for childhood vaccines.

Asked whether he would summon Kennedy again to discuss those promises, Cassidy said he had asked for him to appear before his committee but had not heard back about whether he would do so. Kennedy in April to discuss the Trump administration’s fiscal 2027 budget request for HHS.

Cassidy told 51视频 Health News that when he agreed to vote to advance Kennedy’s nomination, he trusted that Kennedy would keep his word about not disparaging vaccines.

“If they agree to guardrails and disregard those guardrails, you can judge me,” Cassidy said. “You may decide my judgment wasn’t very good, but I don’t think you can say I acted in bad faith.”

Regardless, Cassidy added, Kennedy was going to exert influence in the administration, and he thought it would be better for Kennedy to be in an official post, where his work would be subject to oversight.

“I’m pretty sure that RFK was going to have the president’s ear whether he was in office or not,” he said.

While Kennedy’s efforts to roll back federal vaccine recommendations are being blocked by courts, this week reported that the number of measles cases confirmed in the U.S. so far in 2026 has exceeded the total for 2025 鈥 making it the highest number of cases in 35 years.

Cassidy, a principal author of the 2020 No Surprises Act targeting surprise medical bills, also said he doesn’t think Congress needs to make modifications to the law in the wake of reports that doctors and other healthcare providers are winning huge payouts under the arbitration system the law created. The No Surprises Act was intended to shield patients from receiving big bills for receiving medical care they didn’t know was outside their health plan’s network.

An analysis by this week found that providers were awarded nearly $15 billion in disputed claims in 2025, more than triple the 2024 figure of $4.08 billion.

“The initial step to make sure that people are getting their best deal is price transparency,” Cassidy said.

The HELP Committee on July 22 overwhelmingly approved advancing the Patients Deserve Price Tags Act, a bipartisan bill that would further expand the requirements that hospitals, insurers, and other healthcare providers make prices public and available to patients and employers. A House committee advanced a similar bill this week, also with bipartisan support, but it remains unclear whether either measure will be approved by the full House and Senate.

The interview 鈥 in which Cassidy also discussed his 鈥 was part of the “How Would You Fix It?” series featuring Julie Rovner, 51视频 Health News’ chief Washington correspondent and host of the What the Health? podcast.

An abbreviated version of this interview aired July 23 in Episode 456 of What the Health? From 51视频 Health News: “A Shrinking Safety Net.”

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 .

]]> 2263419 Readers Share Personal Insights on Deadly Denials and Pregnancy Centers /letter-to-the-editor/reader-response-deadly-denials-pregnancy-centers-glp1-july-2026/ Thu, 16 Jul 2026 09:00:00 +0000 /?p=2259597&preview=true&preview_id=2259597 Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

A Tragic, Deadly Denial

I read your article in The Washington Post about the woman whose Humana policy required prior authorization for a drug she’d been taking (Bill of the Month: “She Struggled To Get a Lifesaving Drug Even After Insurers Vowed To Help,” June 29).

My husband, Kenney, had chronic obstructive pulmonary disease. On June 7, he fatally shot himself after a COPD exacerbation event.

His pulmonologist had prescribed two new nebulizer prescriptions on June 2. One was a specialty medication that would come directly from the drug company. A couple of days later, we called Walgreens to see why the other one hadn’t been filled. Turns out it required prior authorization.

Why the doctor who prescribed it needed to tell his health insurer that he really did think his patient needed it, I will never understand. The pharmacist said she would send the request to the doctor. And why she hadn’t already done that, again, I do not understand. By June 7, of course, it still wasn’t filled.

That day, a Sunday, Kenney experienced the flare-up when I was out mowing the yard. How terrifying it must have been for him to be unable to breathe and me not being there at least to hold his hand. That night he killed himself, leaving a note saying that he hated to leave me but that he couldn’t keep living like that 鈥 with the constant anxiety of not knowing when he wouldn’t be able to draw a breath.

Not long ago, a “welcome” packet came in the mail about the other nebulizer treatment 鈥 25 days after it had been prescribed.

Admittedly, my husband’s health was not great. He did have COPD, but we still went out to eat once in a while, and he didn’t have to take his oxygen on those trips. He rarely used it just walking around the house.

He did make a serious suicide attempt six years ago (our daughter and granddaughter had died), but after seeing what it did to me and our son, he promised he’d never do it again. It was only when these exacerbation/flare-up events started this year that he indicated life was getting bad.

Perhaps, just perhaps, if he had received both medications in a timely manner, he would be here today, and we would have had many more years together. We met when we were 16 and had been together ever since. He was 78 when he died.

鈥 Cindy Clements Blewett; Kyle, Texas

Navigating GLP-1 Coverage

Sydney Lupkin’s thoughtful article about the obstacles in obtaining weight loss drugs was interesting (Healthcare Helpline: “Trouble Getting Weight Loss Drugs Covered by Insurance? Here’s What To Know,” June 26). It would have been more helpful had it included a discussion of Medicare’s decision to cover these drugs as of July 1, 2026, and how to navigate the rocky shores of obtaining a prescription that won’t be denied.

鈥 Sharie Hartman; Manteca, California

Beyond the Veil of Pregnancy Centers

I would like to address the article about a pregnancy resource center providing prenatal care in Sandpoint, Idaho (“Religious Anti-Abortion Center Finds Opportunity in Town Without OB-GYNs,” May 20). It is unfortunate that many still do not understand what pregnancy resource centers do, nor the high-quality care they provide. While there are some “crisis pregnancy centers” that provide limited offerings, most centers are aligned with a national organization like the National Institute of Family and Life Advocates, the Heartbeat Pregnancy Center, or Care Net. All these organizations require centers to have a medical director (a licensed healthcare practitioner) and require that the nurses who perform the ultrasounds have appropriate training. While I am not affiliated with 7B Care Clinic, I am concerned that the article may not have accurately reflected what is provided in such clinics. I offer my experiences to bring further clarity.

I work at a life-affirming women’s clinic. I am a board-certified family physician. I have delivered approximately 1,000 babies in my career. I have been performing ultrasounds for my patients for over a decade, and fought for this ability under the scrutiny of maternal-fetal medicine specialists, spending time alongside their registered diagnostic medical sonographer technicians, and having my scans reviewed by maternal-fetal medicine physicians. I have practiced medicine in three states over three decades.

Second, while I am life-affirming, I am not “anti-abortion.” I happen to believe that there are better choices, and I know that some women will still choose abortion, even after hearing all their options. I will gladly see those women for follow-up to answer questions and evaluate for complications 鈥 something that the abortion clinics in my area apparently will not do. I say this because that is what the women I see tell me. The clinic that performed the procedure or gave them the pills will not see a patient after the abortion for any follow-up. I have always willingly seen patients for any reason, whether I was working at a private clinic or hospital-owned clinic. That is no different now that I work for a life-affirming women’s clinic.

We provide a variety of services 鈥 free of charge. We are also stepping up to provide prenatal care up to 20 weeks because there is a shortage of obstetrical clinicians in our county. We encourage women to see a clinic where they can be followed throughout the entire pregnancy, if possible, and we are in no way marketing ourselves as competition. We are stepping in to fill the large gap that exists.

Just because the clinic in Sandpoint chooses to respect life does not make it a fake clinic. This clinic seeks to bring in physicians to provide prenatal care. They are bringing in OB-GYNs from Washington state, which has no restrictions on abortion. With this information taken into consideration, I ask you to reconsider any concerns about a clinic bringing board-certified OB-GYNs into an area where there is a shortage.

鈥 James Heid, Vancouver, Washington

The Root of All Good

The article Claudia Boyd-Barrett wrote about how immigrant parents’ arrests are creating a mental health crisis for children was moving and brought awareness to the mental health challenges faced by them (Growing Up Scared: “Arrests of Immigrant Parents Create Mental Health Crisis for Children,” June 18). It was important to note how every story was different but focused on how much children missed and yearned for their parents to come back home. You also wrote about how it affected them by not having a parental figure in the home. That really touched me. Specifically, Jacob’s story and when he listed all the things he missed about his mom but especially being close to her.

I am currently a master’s student in social work working to become a better ally to the Hispanic immigrant community. I’ve seen how being afraid and sad over the immigration policies has affected my friends in this community. Losing a close parent and not being able to have that security with them anymore is hard to go through, and trauma affects children as they grow.

In this article, you have recognized the worth of a person, which is a core principle in social work. These children are worthy and have the right to feel taken care of and secure.

I would love to see more mental health services accessible to immigrant communities and their families. This would benefit children as they learn to cope with their feelings and how to make sense of a new world.

鈥 Stacy Xiong, Athens, Georgia

Bagging a Bargain

Author Susan Jaffe mentioned GoodRx in the article “Thousands of Medicare Beneficiaries Thought Their Drug Plan Was Free. Then They Lost It” (July 7), but she failed to mention a much better discount drug site, Mark Cuban’s costplusdrugs.com, where a 90-day supply of 2.5 milligrams of rivaroxaban, a generic for Xarelto, is available for under $50. This could help the thousands of people who lost coverage through unpaid premiums from Wellcare Value Script obtain their medications. The problem of yearly increasing penalties for losing Part D coverage is something that has to be addressed by the Centers for Medicare & Medicaid Services.

Thanks to 51视频 Health News for the relevant coverage.

鈥 Jackie Button; Miami

Fleshing Out the Details

Your report identifying alpha-gal syndrome as a red meat allergy is accurate in that respect but inadequate in its breadth (“Would Hunters Take a Lyme Disease Vaccine? We Asked,” June 30). Alpha-gal is an allergic reaction to virtually all mammalian products. If you explore that, you’ll find an interesting story, as mammalian products are everywhere, including in pharmaceuticals, cosmetics, and other non-meat products. Alpha-gal is growing rapidly, and too many people, including doctors, do not realize that AGS is far worse than just a red meat allergy.

I suggest you help build understanding of the threat by describing the allergy in the future as an allergy to mammalian products. If you do not think your audience will understand that term, perhaps you can explain that it includes pork and anything derived from animals with hooves. As a former and now retired reporter, I encourage you to cover this allergy because its implications are surprising and scary.

鈥 John Varner, Surry, Virginia

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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