Acero Health aggregator

Kaiser Health News:Insurance: Journalists Highlight Innovations in Vaccines and Safeguarding Maternal Health

Sat, 22 Aug 2026 05:00:00 -0400

Céline Gounder, KFF Health News’ editor-at-large for public health, discussed the potential of Moderna’s melanoma vaccine breakthrough on CBS News 24/7’s The Daily Report on Aug. 19, drawing on her experience as a former melanoma patient.

Click here to watch Gounder on The Daily Report.

KFF Health News senior correspondent Rachana Pradhan discussed how an issue with Deloitte-run information technology systems denied Medicaid coverage to disabled Michiganders on NPR’s Stateside on Aug. 18.

Click here to hear Pradhan on Stateside.
Read Pradhan’s “A Deloitte-Run System Denied Medicaid Benefits for Michigan’s Disabled. Now Trump’s Law Piles On,” with reporting from Samantha Liss and Kate Wells.

KFF Health News senior correspondent Renuka Rayasam discussed how hospitals are using wristbands to help reduce maternal deaths on WUGA’s The Georgia Health Report on Aug. 14.

Click here to hear Rayasam on The Georgia Health Report.
Read Andrew Jones’ “Hospitals Say They Found a Tool To Help Reduce Childbirth Risks: Wristbands.”

KFF Health News chief Washington correspondent Julie Rovner discussed President Donald Trump’s executive order on childhood vaccines on Slate’s What Next podcast on Aug. 13. Rovner also discussed Medicare on Attitude With Arnie Arnesen on Aug. 11.

KFF Health News ethnic media editor Paula Andalo discussed how an uninsured patient saved thousands by shopping around for the best surgery price on Radio Bilingüe’s Línea Abierta on Aug. 12.

Click here to hear Andalo on Línea Abierta, starting at the 31:21 mark.
Read Andalo’s “Uninsured but Undaunted, a Surgical Patient Searched the Globe for a Deal.”

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

This article first appeared on KFF Health News and is republished here under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

HHS Gov News: HHS Welcomes Mark Cruz as 12th Director of the Indian Health Service

Fri, 21 Aug 2026 14:00:00 -0400

HHS announced Mark Cruz will serve a four-tear term as director of the Indian Health Service (IHS).

HHS Gov News: HHS Launches First National Autism Missing and Endangered Person Alert Initiative

Fri, 21 Aug 2026 13:00:00 -0400

HHS Secretary Kennedy announced the first-ever National Autism Missing and Endangered Person Alert initiative.

HHS Gov News: 18 Months of Action: President Trump, Secretary Kennedy Deliver Historic Reforms to Make America Healthy Again

Fri, 21 Aug 2026 11:56:03 -0400

In just 555 days, President Trump and HHS Secretary Kennedy have delivered sweeping changes across American health policy.

HHS Gov News: HHS Seeks Public Input on Federal Vaccine Recommendation Categories and Shared Clinical Decision-Making

Fri, 21 Aug 2026 11:51:43 -0400

HHS announced a Request for Information (RFI) for public input on federal vaccine recommendations and shared clinical decision-making.

Kaiser Health News:Medicaid: New DOJ Guidance Could Give States Cover To Cut Disability Services

Fri, 21 Aug 2026 05:00:00 -0400

People with disabilities have long fought for the right to live at home rather than in institutions. Now, the Department of Justice says states don’t have to help make that happen.

The decision by the Trump administration comes amid massive cuts in federal funding for Medicaid. Advocates worry this could be a one-two punch for disabled Americans who want to live independently.

KFF Health News senior correspondent Stephanie Armour joined WAMU’s Health Hub on Aug. 19 to explain what this change means for Americans with disabilities and their loved ones.

This article first appeared on KFF Health News and is republished here under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Kaiser Health News:Health Industry: Watch: Mark Cuban Says You Can’t Fix Healthcare Until Every Price Is Known

Fri, 21 Aug 2026 05:00:00 -0400

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 KFF 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” — 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 formula,” 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 — owning insurers, care providers, and the companies that serve them — 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 Break Up Big Medicine Act 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 — 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, KFF 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 KFF Health News: “Headless FDA Gets a New Nominee.”

This article first appeared on KFF Health News and is republished here under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Kaiser Health News:Health Industry: How Louisiana’s New Surgeon General Wants To Transform Public Health

Fri, 21 Aug 2026 05:00:00 -0400

Evelyn Griffin had led a life out of the spotlight until she testified at the Louisiana Statehouse five years ago and experienced what she called her “great awakening.”

The state health department wanted to add covid vaccines to the school immunization schedule, a move no state has ever implemented. Robert F. Kennedy Jr., then known as a leading vaccine skeptic, had already claimed the covid shot was “the deadliest vaccine ever made” during a poster board presentation at the legislative hearing.

Griffin, a longtime OB-GYN, relied on nearly identical images during her own blistering testimony against the proposal. After the hearing, she expected splashy headlines about Kennedy’s assertions, shifting the public debate over covid policies and vaccines. But that did not happen; one news outlet dismissed him as a promulgator of propaganda. Griffin was shocked.

That is “when I saw how the world worked,” she recalled in a podcast interview. Griffin said she and her husband, a vascular surgeon, decided to take action and “shine light on things.”

Now, Kennedy is the nation’s health secretary, and Griffin holds prominent roles that position her to help carry out his vision.

Last September, Kennedy appointed her to ACIP, the advisory panel for federal immunization policy, where she voted to recommend limiting access to covid vaccines and ending universal newborn immunizations for hepatitis B, steps that a federal judge has blocked. In December, Gov. Jeff Landry of Louisiana, a conservative Republican and an ally of President Donald Trump’s, named Griffin as the state’s surgeon general.

That makes her the top public health physician in Louisiana, which has the worst health outcomes among states.

She is an unconventional choice. Griffin has no background or specialty training in infectious diseases or public health. She is aligned with alternative health movements — including Make America Healthy Again, or MAHA — and has hosted some speakers promoting fringe medical views.

Griffin declined interview requests for this article. “My vision as Louisiana’s surgeon general is to help shift our healthcare system toward preventing disease, not just managing or treating it,” she said in a statement.

Eight months into her tenure, she has yet to make major changes at the health department. She has faced hurdles in her efforts to tighten access to vaccines and limit public health powers, testifying on several bills that legislators rejected.

Still, Griffin’s political rise reflects the gains of Kennedy’s vaccine agenda at the state level, a vital testing ground for laws aimed at eroding government mandates. State officials have enormous power to set health policy and beat back infectious disease outbreaks. While Griffin’s post is largely a bully pulpit, she could spur real change by advising the governor, state health secretary, and lawmakers.

Some public health and infectious disease experts warned that if Griffin eventually succeeded in curtailing the state’s authority, illnesses and deaths could escalate and Louisiana could be hamstrung in a future pandemic. At one vaccine panel meeting last year, she said it was “unclear” whether vaccines were linked to autism, as Kennedy has suggested. When asked by The New York Times, she declined to say whether she believed any vaccines should be mandated for schoolchildren.

“Someone who has expressed the views she has, who’s now in a public policy position, is very dangerous,” said Georges Benjamin, the chief executive of the American Public Health Association.

But Kirk Milhoan, a pastor and pediatric cardiologist who serves as chair of the federal vaccine panel, defended Griffin as an “excellent choice” for surgeon general. “No one should be afraid of Dr. Evelyn Griffin having the heart’s desire to take care of the population of Louisiana,” he said in an interview.

While Griffin is on a learning curve as a political novice, she has signaled big ambitions.

She called for “dramatic transformational change” during a public meeting in January, promising to focus on women’s health, rural health, and the root causes of disease. An accompanying slide presentation said Louisiana would lead through “family, faith, and fearlessness.”

Griffin, 49, often cites her family background in explaining her trajectory.

She was born Ewelina Bulczynski under Communist rule in Poland in 1976. When she was 5, her family defected to a refugee camp in Austria before immigrating to Canada. She and her two brothers later came to the United States to practice as physicians. She has credited this history with giving her a “different perspective” as a doctor and influencing her skepticism of government mandates.

“My parents escaped Communist Poland so that we could come here for the freedoms, such as medical freedom, that this country has,” she told Louisiana lawmakers in 2022.

Evelyn Griffin, Louisiana’s surgeon general, and her husband, Joseph Griffin, attend a wellness event sponsored by the Northshore Alternative Health Alliance in Mandeville, Louisiana, in June. (Christiana Botic for The New York Times)

She met her husband, Joseph Griffin, while they attended Ross University School of Medicine, then located in Dominica. After residency programs in New Orleans, they settled in Baton Rouge and raised two children.

People who have known Griffin during her 20-year career delivering babies and treating women described her as a kind, caring, and smart physician. “Patients loved her,” said Francis Dauterive, who worked with her.

In the years before the pandemic, Griffin had noticed a rise in chronic health problems among her patients. She began studying how nutrition and lifestyle choices could treat and prevent illness, and pursued online training in functional medicine. She started an Instagram account filled with images of jackfruit sloppy Joes and vegan jambalaya, her dog lounging on a yoga mat, and her backyard strawberry plants.

She also learned of Barbara O’Neill, a Christian wellness figure popular on social media. O’Neill was barred in 2019 from giving medical advice in Australia after claiming that cancer was caused by a fungus and could be treated with baking soda, and that vaccines caused “an epidemic of ADHD, autism, epilepsy and cot death.” In a 2025 podcast, Griffin called O’Neill a “sage” teacher who was ostracized for focusing on lifestyle solutions to medical issues. She said she kept O’Neill’s advice for a healthy life — including exercise, sunshine, and trust in God — posted on her fridge.

But it was the pandemic that transformed her career. In speeches and interviews, she said she began to question public health guidance and that of her former employer, Ochsner Health, Louisiana’s largest health system, on masking, vaccines, and mandates.

Griffin wanted to share research with colleagues that wasn’t “mainstream” science, as she put it, studies she said were from contacts in Europe on early covid treatments. Griffin was repeatedly rebuffed, she said.

Eventually, she resigned. “I’m going to stick to my principles,” she later recalled thinking. She now works at the Baton Rouge General health system. Ochsner officials declined to comment.

Louisiana had been hit hard by the pandemic. By December 2021, more than 14,000 people had died from covid. That summer, the Delta surge had killed six pregnant women there over two months, and maternal health organizations were urging vaccination.

But in her testimony to lawmakers that December, Griffin had questioned the vaccine’s safety after health officials had reported rare adverse reactions. She invoked a public health catastrophe: The drug thalidomide, prescribed during pregnancy in Europe (and tested in the United States) in the 1950s, had left thousands of babies with missing or malformed limbs. She also reminded lawmakers of the Nuremberg trials, where Nazi collaborators had been sentenced to death for medical experimentation.

“So everyone has to be on notice when making these types of decisions,” Griffin said, looking at the politicians. The state later dropped plans to require covid vaccines for students.

Griffin and her husband have since embedded themselves in Louisiana’s right-leaning alternative health communities. They have espoused views that, amid the swirl of social-media-fueled wellness trends, pandemic backlash, and widespread dismay over Americans’ poor health, have become ascendant in the second Trump presidency.

Jay Luneau (top center), a Democrat in Louisiana’s Senate, questions Griffin in May about a bill to prohibit businesses and schools from mandating new vaccines or other medical interventions. (Christiana Botic for The New York Times)

Griffin returned to the state Capitol over the next three years to testify for favored causes, including bills supported by Health Freedom Louisiana, a group aligned with Kennedy. One would have expanded access to ivermectin, an antiparasitic drug popular among vaccine skeptics, though numerous studies have shown it is ineffective in treating covid, and another would have banned future government health mandates, which Griffin has called “a slippery slope.” Neither got out of committee. She also testified in support of a ban on gender-transition treatments for minors, which became law.

After the U.S. Supreme Court overturned Roe v. Wade in 2022 and Louisiana’s near-total abortion ban took effect, Griffin became an ally of Louisiana Right to Life, the state’s leading anti-abortion group. She recorded videos arguing that the law did not impede pregnancy care. The ban was later found to delay miscarriage treatment and lead to unnecessary cesarean sections, according to doctors and reproductive rights groups.

Griffin and her husband struck up a friendship with Tony Spell, the pastor of Life Tabernacle Church in Baton Rouge, sometimes joining him for Bible study. Pastor Spell refused to shut his evangelical church during the pandemic, leading to criminal charges that were overturned by the Louisiana Supreme Court. Griffin called him “an absolute hero.”

Benjamin Clapper, executive director of Louisiana Right to Life (center left), speaks to Griffin at the Louisiana Capitol in May. (Christiana Botic for The New York Times)

Tony Spell, the pastor at Life Tabernacle Church in Baton Rouge, is friends with Griffin and her husband. (Christiana Botic for The New York Times)

She has spoken at annual health freedom gatherings on the church’s sprawling grounds and launched her own wellness events there two years ago. Guests have talked about backyard gardening, naturopathic medicine, the benefits of doulas and raw milk — a passion of Kennedy’s — which recently sickened nearly a dozen Louisiana residents.

One speaker, an OB-GYN, said contraception encouraged abortion. Another, an ophthalmologist, questioned the safety of wireless technology, as has Griffin. Quoting O’Neill, the Australian wellness figure, Griffin warned the crowd to “stay away from sunscreen,” adding there were “lots and lots of chemicals” in it.

Spirituality is “the foundation for health,” she said during the event in 2025, and some of her speakers have presented faith in Jesus as essential to being healthy. At the 2024 gathering, Sean Troxclair, an internist who is now her deputy, said that when he was “injured” by a vaccine, “I got with Jesus.” He added, “If you’re not with him, no matter what you do, you’re not going to get better.”

In written comments to the Times, Griffin said that faith was not a prerequisite for good health, and that she “may not share every perspective presented” by her speakers.

Griffin’s appointment is among Gov. Landry’s wider efforts to move Louisiana, already a deeply red state, further to the right. He has supported a crackdown on doctors who mail abortion pills to Louisiana patients and a lawsuit against the Food and Drug Administration to stop the practice nationwide. The U.S. Supreme Court said the pills could still be sent by mail while the FDA case continues in the lower courts.

The governor’s first appointee as surgeon general, Ralph Abraham, another supporter of Kennedy’s, blocked his staff from promoting any vaccines amid an outbreak of whooping cough that killed two babies.

Griffin has begun her tenure more quietly, seeking ties with the state’s medical community while trying to find her place in a health department hierarchy where the secretary still wields much of the power.

Griffin and her deputy, Sean Troxclair (right), attend a women’s wellness event at the Louisiana Capitol in May. (Christiana Botic for The New York Times)

For her staff, she’s recruited figures from wellness and vaccine-skeptical circles, including Troxclair and Kathleen Willis, an internist who has questioned the safety of the childhood vaccine schedule, as has Trump.

A surprising presence in the department is Griffin’s husband, whom she’s called “like-minded.” Though he is not employed by the agency, he has joined her appointments with state and federal officials and participated in department meetings, sometimes providing feedback or asking questions, according to two people present at the sessions. Griffin has also placed him on a Medicaid advisory subcommittee. Griffin said in a statement that he was “not involved in formal decision-making.”

Bruce Greenstein, the state health secretary, introduced the couple during a public meeting in January, saying, “We basically get two doctors for the price of one.” In May, Griffin’s husband joined the governor on a contentious trip to Greenland, which Trump has periodically threatened to control.

Griffin’s beliefs represent a shift away from public health policies that prioritize the protection of the wider community in favor of ones that prioritize individual choice. Like Kennedy, she has said this is necessary to restore faith in public health systems battered by the anger over pandemic restrictions.

Such a reframing of the government’s role would upend long-standing public health principles and risk harming society’s most vulnerable, said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

“Are we in no way responsible for people who we are going to sit next to on a bus or get into a crowded elevator?” he asked. “Do we have no sense of responsibility to other members of society?”

Florida’s former health secretary and surgeon general, Scott Rivkees, whose successor tried to roll back vaccine mandates, said rising vaccine skepticism was already contributing to outbreaks of measles and whooping cough. “This is something that our country will regret as we start seeing our sons, daughters, neighbors, friends, cousins, pay the price,” he said in an interview.

Even though Griffin has allied herself with some lawmakers in the Republican-controlled legislature, she testified on three bills this year that failed to proceed. One would have created new informed-consent requirements for vaccines — including banning mothers from agreeing to vaccines for 12 hours after giving birth, when Griffin said hormones and other factors could impede their thinking.

Another would have significantly limited the government’s ability to require vaccines, testing, or masks in a future outbreak, mandates that Griffin testified infringed on individual rights and were discriminatory. A third bill, her own proposal, would have given her office sweeping access to all medical records in the state, which are now protected by medical privacy laws.

Gov. Landry did not publicly push for the measures, a sign that they may not be priorities for his administration. A majority of Louisiana voters support school vaccine mandates, according to polls by Louisiana Families for Vaccines and the Center for Individual Freedom. Most proposals to weaken vaccine laws also failed in other states this year.

Since her appointment, Griffin has traveled the state to meet with residents. In June, she and her husband wandered through a wellness event, sponsored by the Northshore Alternative Health Alliance, in Mandeville. She had been invited to give the keynote address by Abigail Licatino, a member of Health Freedom Louisiana who has said that vaccines cause “most” autism.

Booths featured local farmers, reiki practitioners, functional medicine doctors, chiropractors, spiritual healers, and purveyors of peptides, supplements, and IV treatments. The event represented some of the “holistic approaches” Griffin said she planned to highlight as surgeon general.

In speeches before her appointment, Griffin had offered a far-reaching vision. While conventional medicine would still play an indispensable role, she said, the current health system was failing Americans and would “collapse.” The health freedom and wellness movements would help show “the path forward.”

The New York Times’ Kitty Bennett, Sheelagh McNeill, and Kirsten Noyes contributed research for this article.

This article first appeared on KFF Health News and is republished here under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Kaiser Health News:Health Industry: Headless FDA Gets a New Nominee

Thu, 20 Aug 2026 16:02:39 -0400

The Host

Julie Rovner KFF Health News @jrovner @julierovner.bsky.social Read Julie's stories. Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, "What the Health?" A noted expert on health policy issues, Julie is the author of the critically praised reference book "Health Care Politics and Policy A to Z," now in its third edition.

Heidi Overton, a physician and White House domestic policy adviser, is President Donald Trump’s choice to be the next head of the Food and Drug Administration. Overton, an abortion opponent and supporter of Trump’s proposed changes to the childhood vaccine schedule, has made enemies while working on health policy from the White House and could face some tough questioning from senators.

Meanwhile, prescription drug prices are dropping for some people, and the wholesale retailer Costco is entering the Medicare market. Still, overall, the problem of healthcare being too expensive remains stubbornly hard to solve.

This week’s panelists are Julie Rovner of KFF Health News, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico Magazine, Shefali Luthra of The 19th, and Alice Miranda Ollstein of Politico.

Panelists

Joanne Kenen Johns Hopkins University and Politico @JoanneKenen @joannekenen.bsky.social Read Joanne's bio.

Shefali Luthra The 19th @shefali.bsky.social Read Shefali's stories.

Alice Miranda Ollstein Politico @AliceOllstein @alicemiranda.bsky.social Read Alice's stories.

Among the takeaways from this week’s episode:

Trump’s selection of Overton to lead the FDA is prompting concerns from a diverse crowd of skeptics that includes Sen. Bill Cassidy (R-La.) and adherents to the Make America Healthy Again movement. Her lack of managerial experience and history of controversial writings could be liabilities during the confirmation process, though Trump has a decent track record of clearing nominees through a hesitant Senate.
Grant money continues to be held up at the National Institutes of Health pending political reviews, and new reporting sheds light on “zombie programs” at the Centers for Disease Control and Prevention, where money has been appropriated but there’s no staff to use it. Plus, the trend of declining childhood immunizations continues, with vaccine exemptions for kindergartners jumping to another high.
New data shows the largest drop in prescription drug prices since the 1960s, and while the Trump administration is taking credit, it’s unclear what exactly caused it. Meanwhile, the federal government is investigating major health companies for allegedly dodging taxes or engaging in anticompetitive practices. And the wholesaler Costco is getting into the health insurance game, partnering with a nonprofit insurer to provide Medicare Advantage or Medigap plans in a few states.

Also this week, as part of the “How Would You Fix It?” series, Rovner interviews billionaire businessman Mark Cuban, who has already reshaped the generic drug market and now has his eye on the rest of the healthcare system.

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

Julie Rovner: Mother Jones’ “The Orwellian Company Behind ICE’s New Electric Shock Gloves,” by Sophie Hurwitz.

Shefali Luthra: The 19th’s “Tik Tok’s Fake GLP-1 Market Preys on Women Trying To Lose Weight,” by Barbara Rodriguez.

Alice Miranda Ollstein: The Texas Observer’s “Texas Maternal Mortality Committee’s Next Report Will Skip Post-‘Roe’ Deaths. Lawmakers Suspect Political Influence,” by Mary Tuma.

Joanne Kenen: Politico’s “AI Slop Is Swamping a House Office That Drafts US Laws,” by Owen Dahlkamp.

Also mentioned in this week’s podcast:

NOTUS’ “‘Graveyard for Grants’: NIH Is Holding Up Medical Research Funding,” by Paige Winfield Cunningham.
The Associated Press’ “The CDC Has Zombie Programs. Congress Funds Them, but Few People Are Left To Do the Work,” by Mike Stobbe.
KFF Health News’ “Kennedy’s Quiet Hunt for Autism Culprits Stalls as Trump Orders Baseless Changes to Childhood Shots,” by Amanda Seitz and Stephanie Armour.
The Wall Street Journal’s “Costco Sells Vacations, Gas and, Soon, Medicare Plans,” by Anna Wilde Mathews.
Stat’s “Epic’s Alleged Anticompetitive Practices Under Scrutiny From Federal, State Investigators,” by Casey Ross and Brittany Trang.
Stat’s “UnitedHealth Faces IRS Probe Over Potential Tax Avoidance,” by Bob Herman.

Credits

Zach Dyer Audio producer

Taylor Cook Audio producer

Emmarie Huetteman Editor

Click here to find all our podcasts.

And subscribe to “What the Health? From KFF Health News” on Apple Podcasts, Spotify, the NPR app, YouTube, Pocket Casts, or wherever you listen to podcasts.

This article first appeared on KFF Health News and is republished here under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Kaiser Health News:Health Industry: How Much of a Cancer Drug Is Too Much? Patients, Researchers Challenge FDA-Approved Dosages

Thu, 20 Aug 2026 05:00:00 -0400

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 Canada, Israel, Sweden, and other countries 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 as little as one-twelfth of the labeled dosage 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 recent KFF survey, 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 30% of cancer drug prescriptions 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 — beyond patients — 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.

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 — Ibrance, Verzenio, and Kisqali — boosted revenue 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 6% of the drug’s average price 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 Aaron Mitchell of the Memorial Sloan Kettering Cancer Center. About half those profits came from immunotherapy drugs like pembrolizumab and nivolumab.

“Pembrolizumab is the lifeblood of American hospitals,” 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.”

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 KFF 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, ‘I 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 — 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, according to the study presented that day, lived nearly twice as long — a median of 13 months — 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 — one-sixth or one-twelfth the recommended dosage — 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, has a program 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 KFF Health News, said the evidence suggested that nivolumab at a lower dosage 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 leading a study 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: evaluating whether patients 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 $11 million trial, 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 Project Optimus, 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.

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 nonbinding guidelines 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 — so far with little success — 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 — 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.

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 KFF 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 KFF Health News’ reporting team.

This article first appeared on KFF Health News and is republished here under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.