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As Politicians Argue About China, US Patients Find Cutting-Edge Treatment There

Arthur Allen — Tue, 20 Oct 2026 09:00:00 +0000

Until recently, a Manhattanite might venture no more than a few dozen blocks to find the world’s most sophisticated cancer treatment. Cutting-edge American medicines have helped reduce the U.S. cancer death rate by since 1990, and New York City hospitals deliver some of the best care in the country.

But in January 2025, the city’s health systems had no good options for Debbie Doppelt, a 60-year-old jeweler with an unusual form of lung cancer that mostly afflicts nonsmokers like her. The Food and Drug Administration hadn’t yet approved sunvozertinib, a drug developed in China that targets the mutation driving Doppelt’s tumors. She had been through chemotherapy and surgery, but the cancer had now spread to her brain. And she didn’t qualify for the relevant clinical trials.

Then an option emerged, in an offhand remark.

“Too bad she’s not Chinese,” a doctor told her son Max Doppelt, who had organized his mother’s care since her 2023 diagnosis. “She could go to a pharmacy in China and buy it.”

Within hours, mother and son had reached out to friends and relatives, one of whom procured a small supply of sunvozertinib from a contact living in China. A few months later, Max flew to Shanghai to get a refill.

Other patients have followed. “No organization or doctor is guiding patients to China, but word gets out,” Max said. He said he knows of at least 30 Americans who’ve made the pilgrimage to obtain the drug, which the FDA licensed in July 2025 but wasn’t yet on the U.S. market as of mid-October of this year.

Max Doppelt has organized care for his mother, Debbie Doppelt, since her cancer diagnosis in 2023. (The Doppelt family)

Sunvozertinib, made by Shanghai-based Dizal Pharmaceutical, isn’t the only treatment drawing patients to China. Americans, Europeans, and others are trekking there to enter clinical trials for CAR-T therapy, an area in which China is .

China, until recently known more as a supplier of drug precursor chemicals and generic medicines, has become a biotech powerhouse, accounting for of new drugs tested around the world in 2025. U.S. pharmaceutical companies are testing new therapies there and signing billion-dollar contracts with Chinese firms to develop and market their drugs.

China’s progress has alarmed some politicians, who warn of lost jobs and U.S. dependency on Chinese medicines. The Trump administration in June kicked off Operation TrialBlazer, aimed at speeding up some FDA regulatory processes to lure back more clinical trials.

China’s poor showing in vaccine and drug development during the covid pandemic prompted the country to overhaul its biotech sector, dramatically altering the global industry, said Sam Rasty, a veteran of small biotech companies who now leads one called FynderBio. Venture capital now flows heavily to early-stage clinical work in China and Australia, where regulatory systems enable key first-in-human studies much more quickly than in the United States.

Chinese companies are so much faster at this process that U.S. biotechs, which used to share early advances at conferences or funding meetings, now routinely conceal their progress out of fear that competitors will take their ideas and speed them to market, said Steve Potts, CEO of Breakthru Medicine, a small biotech.

At a meeting he attended in May, nearly all the 60 biotech CEOs in the room planned to run phase 1 trials in Australia, Europe, or China, Potts said. Five or 10 years ago, most of those trials would have been carried out in the U.S.

“Slow and prohibitive” FDA requirements are driving investment to more-nimble Chinese companies, President Donald Trump’s nominee to lead the agency, Heidi Overton, warned in her opening statement at her Sept. 24 confirmation hearing.

The movement of clinical trials overseas “should give pause to every American and those who serve on their behalf,” Overton said. “When we lose this advantage, we lose our health security. And when we lose our health security, we lose everything.”

Overton pledged to continue TrialBlazer, which mirrors Australian processes begun in 1991. It is aimed at accelerating clinical trials and approvals so patients do not feel compelled to seek treatment abroad, said Department of Health and Human Services spokesperson Emily Hilliard. It is sometimes legal to obtain medication abroad for personal use, but the FDA “cautions patients about potential safety and quality risks associated with treatments outside our regulatory system,” she added.

As the FDA moves to streamline drug development, members of Congress are trying to slow Chinese firms’ integration into U.S. biotech.

Rep. John Moolenaar (R-Mich.), who chairs the House Select Committee on the Chinese Communist Party, in June co-sponsored legislation with Rep. Debbie Dingell (D-Mich.) requiring all U.S. pharmaceutical deals with Chinese companies to be cleared by the Treasury Department.

Others see biotech protectionism as misguided. China’s focus on improved medicines can only help us, said Peter Kolchinsky, managing partner of RA Capital Management, which has Chinese investments in its biotech portfolio.

“We may be adversaries in many areas, but we’re not competing with them to cure cancer. We are collaborating with them to cure cancer,” he said. “There are things that are bigger enemies than any other nation on Earth.”

Cancer Knows No Boundaries

A minor but persistent cough led to the diagnosis of Debbie Doppelt’s cancer in late 2023. Chemo, immunotherapy, and surgery kept it at bay for months, but in December 2024, scans showed the cancer had spread to her brain, with 10 tiny tumors.

The FDA earlier that year had approved amivantamab, a drug that targeted the mutation driving Doppelt’s tumor, but Max was concerned about its toxicity. Also, several doctors he consulted told him that amivantamab might not penetrate brain tissue to fight cancer there.

Doppelt tried to enter a clinical trial at Memorial Sloan Kettering Cancer Center, where she was a patient, for zipalertinib, another drug that targeted her mutation. But in January 2025, the Doppelts learned that a slight scarring on her lungs had rendered her ineligible for the study.

That left sunvozertinib, which gained approval in China in 2023. It was also being tested in the U.S., but only in late-stage trials in which half the subjects received chemotherapy only. That risk was a nonstarter for Doppelt, whose cancer had already outsmarted chemo.

So Max flew to Shanghai, returning with 26 boxes of sunvozertinib in his luggage. The drugs cost about $10,000, he said.

“Getting on the plane and bringing the medicine home felt like my life’s purpose,” Max said. “The data was so clear that this drug had significant efficacy in the brain. Anything else she might do, she might not last a year.”

On Sept. 1 of this year, AstraZeneca signed an agreement with Dizal to distribute the drug worldwide, and it plans to make it available in the U.S. by the start of 2027, spokesperson Tara Parsell said.

Doppelt, who runs a diamond business with her husband, has tried to stay positive and healthy, scarcely missing a day of work since her 2023 diagnosis. She said she’s grateful she has a loving community and the means to afford the best available therapies.

“I think I’ve been pretty successful at having, actually, an amazing three years,” she said. “In some ways a better three years, with all of it, than the three years before, because you’re so appreciative of everything.”

Doppelt’s parents were Holocaust survivors. “They were always saying: ‘This piece of bread tastes so good! Do you know what it is to be hungry?’”

�Թϲ��ing for help for his mother gave Max, a 30-year-old computer engineer, an idea for helping patients find the right treatment — which, in cases of advanced cancers, may be a clinical trial.

A year ago, he quit his tech job and that uses artificial intelligence to combine data from research and drug company sites with a patient’s health records to help them find the right study.

Similar apps are being used to help drug companies and hospital systems increase the percentage of U.S. cancer patients who enter clinical treatment trials, currently . This will also strengthen the U.S. drug industry, said CEO Kent Thoelke, whose company offers an AI program designed to help hospitals and clinics enroll trial subjects.

About 300 patients have used Max’s app. So far his clients, whom he doesn’t charge, have all been lung cancer patients like his mom. Sunvozertinib seems to help about half those who take it, he said.

A 70-year-old woman whom Max had assisted got a six-month supply of the drug earlier this year from China, only to learn after three months that it wasn’t working. “My cancer had spread,” said the woman, whom �Թϲ�� agreed not to name, to protect sensitive health information.

‘I’ll Do Everything in Our Power’

Doppelt has done well on the drug. Some 19 months after starting on it, her cancer was still mostly kept at bay, with the help of a few radiation treatments and dose adjustments.

AstraZeneca’s plans to widely distribute sunvozertinib would mean no more trips to China. But Max had few illusions that the drug would work for his mom forever.

“She has a metastasizing cancer that will learn to bypass the drug,” he said. “At that point we’ll be dependent on the latest and greatest therapies. If they happen to be in China, I’ll do everything in our power to go there.”

At his Upper East Side apartment one recent afternoon, Max examined the current clinical trial outlook for his mother. He pulled up her profile on the app and scrolled down a list scoring available trial sites according to their fit and proximity.

“This one looks good,” he said, pointing to a clinical trial for firmonertinib, a drug China approved in 2021 that’s under study in the U.S. and elsewhere.

CAR-T therapy is another possibility, particularly a variety that the University of Colorado has developed to boost patients’ immunological attack on mutations like the ones driving Doppelt’s cancer.

But Kyle Concannon, a leader of the Colorado research team, said regulatory uncertainty has slowed his progress. As new tools enable sophisticated measures of things like toxicity and tissue distribution, they add time, cost, and risk to the therapy’s development. These technologies may be better at detecting possible harms, “which is good,” Concannon said, “but the alternative to a new medicine, with a natural disease like lung cancer, is the individuals will die from their disease.”

Max Doppelt and other patient advocates, while pushing for faster FDA processes, don’t want to rule out more Chinese medicine runs.

“When drugs are approved in China but not in the U.S., of course we will deploy the China option where necessary,” said Marcia Horn, CEO of the nonprofit International Cancer Advocacy Network. “Lives depend on it.”

Max would prefer to see the drugs his mother needs developed in the United States. But he, too, opposes any effort to freeze out the Chinese biotech industry.

The discovery of new life-preserving drugs “really brings us together,” he said. “We’re all humans at the end of the day.”

�Թϲ�� 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 .

This article first appeared on �Թϲ�� and is republished here under a .

Four Red Flags and One Truth Amid the Peptide Hype

Amy Maxmen — Mon, 19 Oct 2026 09:00:00 +0000

Experimental peptides have become darlings among influencers, chiropractors, and doctors focused on longevity, antiaging, or “body optimization,” even though the FDA hasn’t approved them for safety or effectiveness. Health secretary Robert F. Kennedy Jr. and other leaders of the Make America Healthy Again movement have pushed to make unproven peptides more accessible — and they’ve gained traction.

On Oct. 14, a temporary “” appeared on a White House docket, proposing to allow licensed pharmacies to make and sell certain unapproved peptides to people. Scientists at the FDA had advised against the measure at a , warning that the drugs hadn’t been adequately vetted in clinical trials.

A panel that advises the FDA disagreed, however, voting to loosen restrictions. Many of the panel members are new appointees with in the peptide industry. In an email, Department of Health and Human Services spokesperson Emily Hilliard said that every committee member satisfies the FDA’s ethics requirements.

“I voted ‘yes’ for patient safety, the greater good, and medical freedom,” Haleem Mohammed, one of the new committee members, said at the . He’s the chief medical officer of a men’s clinic that sells peptides, Gameday Men’s Health.

To make good decisions, consumers need to rely on accurate information, but much of the hype around peptides is misleading. �Թϲ�� flags four misleading phrases commonly used by those promoting peptides — and one truth.

Red Flag: Peptides aren’t drugs.

Gary Brecka, a co-chair of the MAHA Action committee, says peptides aren’t drugs of his podcast. He talks about using them to “help regulate cortisol, improve circulation, all kinds of things.” When peptides are used to treat, prevent, or cure conditions, or to affect the body’s function, they are, , drugs.

“Peptide” is a general term for substances that are smaller than proteins but made of the same building blocks. Humans make many peptides, including insulin. Insulin is a drug when people inject it to regulate blood sugar.

“Most of the drugs we have had some antecedent in nature,” said Jacob Sherkow, a professor of law specializing in biotechnology at the University of Illinois Urbana-Champaign. “Heroin is natural. No one in their right mind would call it not a drug.”

Brecka did not respond to requests for comment, but Chris Woodward, a public relations representative for him, said in an email that the health issues discussed on Brecka’s podcast do not constitute medical advice.

Red Flag: Peptides are safe because they’re natural.

Peptide promoters that peptides are safe because they’re natural. This clip of Brecka’s discussion with Brigham Buhler, a co-author of The Peptide Revolution and owner of a that sells peptides, is an example. Some influencers go further, saying that peptides are safe because they’re made by the human body. Buhler did not respond to requests for comment.

It’s murky territory. One of the most popular experimental peptides, BPC-157, was developed by Croatian scientists who isolated what they called “body protective compound” from gastric juices in the stomach lining. However, researchers have been unable to find a trace of BPC in the human genome, meaning it’s not made by humans, said Katrin Svensson, a peptide scientist at Stanford University. Researchers in Taiwan suggest the peptide is produced by stomach microbes, according to .

Even if BPC-157 and other peptides exist in nature, Svensson said, “natural things can be toxic.” People have died from taking , for example. And drugs considered safe can still make people feel ill. To learn about safety, and whether the benefits of a drug offset the side effects, researchers conduct placebo-controlled trials. These reveal problems that might not be obvious in the short term, such as liver damage, as well as underlying conditions that could turn minor issues into something serious.

The FDA is considering lowering restrictions on BPC-157 and five other experimental peptides that have not undergone high-quality clinical trials and are not FDA-approved. “I am excited about peptides too,” said Svensson, whose lab studies several peptides that she hopes to develop into drugs. “But,” she added, “you need to show they’re not harmful.”

Red Flag: These peptides treat illnesses and heal injuries.

Kris Wusterhausen, one of the new appointees to the FDA advisory panel, that the experimental peptide BPC-157 “can reduce [acid] reflux disease” and treat “neurologic disorders.” He’s the founder of an antiaging company that sells “clinically guided peptide treatments.” He did not respond to requests for comment.

Such claims are common among peptide promoters who say that various experimental peptides treat muscle injuries, covid, inflammatory bowel disease, and more. But vanishingly few clinical trials have been conducted.

A summary of a small clinical trial testing BPC-157 as a treatment for inflammatory bowel disease was published in 2005, but it lacked critical details about how the study was conducted. FDA scientists who called it “inadequate.”

Another concluded that BPC-157 relieved knee pain for 14 of the 16 patients involved, but it lacked a control group, meaning the participants might have felt better because of other factors, or their pain simply resolved over time.

In a 2025 on BPC-157 as a treatment for musculoskeletal injuries, researchers warned that it should be “approached with caution” because of a lack of evidence. Flynn McGuire, a physical rehabilitation doctor at the University of Utah and an author of the review, said anecdotes about people having miraculous recoveries are even less reliable.

He has told patients he won’t prescribe BPC-157 until quality studies are conducted. “People want new things quickly,” he said, “but medicine and science just don’t work fast.”

Peptide enthusiasts also tout laboratory studies, such as a particular peptide stimulating blood vessel growth. Such research is critical, but it doesn’t speak to safety, efficacy, or off-target effects in people, like fueling cancerous growths. Human biology is complicated, which is why most substances that show promise in early experiments fail in clinical trials.

Red Flag: Peptides can’t be patented.

Before taking the helm of the Department of Health and Human Services, Robert F. Kennedy Jr. on X. (Screen grab of X)

A few months before Kennedy took charge at HHS, on the social media platform X that the FDA hindered access to peptides and other alternative therapies because they couldn’t be patented. It’s a common misconception about peptides: In an about the drugs, researchers found many posts suggesting that mainstream medicine has sidelined peptides because pharmaceutical companies cannot patent the substances and therefore can’t turn a profit.

Yet hundreds of peptide patents are listed in the U.S. Patent and Trademark Office database. A patent on an early formulation of BPC-157 is .

“One cannot obtain a patent on the natural thing itself,” Sherkow said, “but if you slightly modify it, link it to something that allows me to inject it, formulate it to be more stable, all of that stuff is patentable and is being patented.”

Peptide patents can be lucrative. Pharmaceutical companies are suing one another over patents surrounding GLP-1 peptides, the basis of Ozempic and other such weight loss drugs. The market for those medicines is projected to within the next decade, according to the investment bank Morgan Stanley.

So why haven’t pharmaceutical companies invested in clinical trials on popular peptides? Clinical trials cost millions of dollars, so companies first must be convinced the drugs look promising enough for FDA approval, as well as have an edge over current medications.

Companies conduct experiments before investing big bucks. They may have done so for certain peptides and been discouraged by the results, Svensson said.

Pinchas Cohen, a gerontology scientist at the University of Southern California, said investors backed out of funding trials on a peptide he helped discover, MOTS-c, because they worried its use overlapped with GLP-1 medications. “Investors felt we couldn’t compete with that,” he said.

Kennedy’s push to make experimental peptides more accessible might make clinical trials even more unlikely, researchers say, because compounding pharmacies wouldn’t need FDA approval to sell the drugs for human use.

In a letter to the FDA, the pharmaceutical trade organization PhRMA advised against easing restrictions on unapproved peptides, saying it would “erode incentives for manufacturers to undertake the substantial time and cost required for FDA approval.”

True: Americans aren’t as healthy as they could be.

Kennedy and other leaders of the MAHA movement are right when the U.S. spends per person than any other nation and ranks below all other wealthy nations in . They also rightly note the high cost of treatment. Six in 10 U.S. adults said they worried about affording prescription drugs in a , with 4 in 10 saying they’ve skipped doses or taken other measures because of the price.

Researchers have outlined policies to lower healthcare costs and improve public health, such as limiting and improving access to . What’s not on the list: skipping clinical trials to sell unproven treatments that could harm people.

This article first appeared on �Թϲ�� and is republished here under a .

People Say These Peptides Hurt Them. Their Stories Are Muffled in MAHA’s Push for Medical Freedom.

Amy Maxmen — Tue, 13 Oct 2026 09:00:00 +0000

After the third day of squirting an experimental drug up his nose, Dylan Meetze felt horrible.

“It was like I was underwater, like it took the most to do anything,” he said.

Meetze stopped taking the drug but endured fatigue and anxiety for months afterward, and his eyes and muscles twitched, he said.

He had taken BPC-157, a peptide drug popularized by podcasts about wellness, longevity, and what’s called “body optimization.” “Peptide” is a general term for substances that are smaller than proteins but composed of the same building blocks. Dozens of , including insulin and GLP-1 weight loss medicines, have garnered approval by the Food and Drug Administration. But BPC-157 and many others have not because they haven’t undergone clinical trials.

This fact hasn’t stopped online influencers from promoting them as remedies for muscle injuries, gut issues, covid, and more. Use of BPC-157 is growing in the U.S., particularly among white males, according to a of millions of de-identified electronic health records. Since 2020, the analysis, which hasn’t yet been published in a peer-reviewed journal, found that more than 1,000 people told doctors they had used the drug.

Meetze said he decided to take BPC-157 after listening to Andrew Huberman, a Stanford neuroscientist with more than 16 million followers on YouTube, Instagram, and TikTok, who talks up peptides frequently . Studies in mice suggest that BPC-157 helps muscles heal and has “very high safety profiles,” Huberman , “at least, with respect to the lethal dosing.” His guest on , Craig Koniver, a doctor who sells peptides through his wellness clinic, called BPC-157 “super safe” and recommended it for “anyone who’s working out on a regular basis.” Koniver did not respond to requests for comment.

Huberman didn’t respond to multiple queries from �Թϲ��, but an automatic reply on his Huberman Lab website that says the podcast doesn’t constitute medical advice: “Any reliance on information provided through the podcast is solely at the user’s own risk.”

Hoping BPC-157 might help him advance as a weightlifter, Meetze said he bought the drug last year from an online vendor, Researchem. A chemical supply company with that name sells experimental peptides , warning that the substances are “solely for laboratory research” and are “not intended for human consumption.” (It lists an address in Hillsboro, Oregon, that corresponds to a shared office space. A receptionist at the space said Researchem wasn’t registered there, and multiple queries from �Թϲ�� to the email address listed on the website went unanswered.)

Companies are required to warn that experimental peptides, which haven’t been approved by the FDA, are for research use only. But many companies may soon be permitted to drop the warning because of a push by health secretary Robert F. Kennedy Jr. to lower barriers to their use. He and other leaders of the Make America Healthy Again movement have promoted peptides as a way to improve the country’s health.

On the social media platform X, before he took the helm at the Department of Health and Human Services, Kennedy the “aggressive suppression” of “peptides, stem cells, raw milk” and “anything else that advances human health and can’t be patented by Pharma.” (In fact, peptides are heavily patented.)

He has repeated the pledge since taking office. On early this year, Kennedy said he was a “big fan” of peptides and wanted to make many of them “more accessible.” On a podcast with the co-chair of the MAHA Action committee, Gary Brecka, the FDA’s role should be to assess science, “but not tell people and not tell physicians what they can and cannot prescribe.”

“If you want to take an experimental drug,” he added, “you ought to be able to do that.”

This summer, Kennedy’s health department with financial stakes in the peptide industry to a panel that advises the FDA. At an in July, the new appointees voted to ease restrictions on six experimental peptides, including the trendy compounds BPC-157, TB-500, and MOTS-c. Specifically, they advised adding these peptides to a list, called 503A, that would allow specialized pharmacies to make the drugs for human use, even though the FDA hasn’t approved them.

In an email, HHS spokesperson Emily Hilliard wrote that every committee member satisfies the FDA’s ethics requirements. “FDA — not podcasts or politics — determines which substances qualify for inclusion on the 503A Bulks List,” she wrote. The FDA has yet to issue a final decision.

The vote went against FDA scientists who on the six peptides, concluding there wasn’t enough evidence to show they improved any condition. Furthermore, the scientists highlighted a potential for liver damage, allergic reactions, or other serious consequences.

“People are saying this is about medical freedom — putting decisions back in the hands of patients,” said Reshma Ramachandran, a regulatory science researcher at Yale School of Medicine. “But what we see in practice is that incentives aren’t actually centered around patients. They’re centered around selling products.”

Scientists also warned that drugmakers would be reluctant to invest millions of dollars into clinical trials on peptides if they could be sold without FDA approval.

“The chances of clinical trials getting done now are diminished,” said Eric Topol, executive vice president of Scripps Research, a biomedical science institute in San Diego. “We will have more people who are prey to predators that will sell, sell, sell.”

A lack of data leaves consumers in the dark.

Meetze sought help on Reddit, where people post about pain, headaches, vision problems, and a lack of motivation after taking experimental peptides. Peptide enthusiasts often comment on these posts with skepticism, attributing a person’s problems to contaminated products, preexisting conditions, or misuse of the drugs. The online vitriol in the Reddit conversations can be intense, so Meetze welcomed an invitation to join a private group on the social platform Discord in which people with BPC-157 side effects tried to figure out what happened to them and how to fix it.

“There are millions of success stories with these peptides,” Meetze said, “but no one wants to believe that this wrecks some of our lives.”

Experimental peptides are often sold at longevity, wellness, and “performance medicine” clinics — even though they haven’t been proved safe and effective in clinical trials. (Amy Maxmen/�Թϲ��)

Wolverines and Migraines

One member of the private side-effects group, a 46-year-old software engineer named Dominik E., said he got an excruciating migraine within days of taking BPC-157 with TB-4, another unapproved peptide — a combination called the “Wolverine Stack” because of its purported ability to heal wounds rapidly, like its namesake Marvel superhero.

“My left eye started throbbing really badly, and the left side of my face became numb,” he told �Թϲ��, which agreed to only partially identify him and others interviewed for this article who were concerned about divulging sensitive health information.

After two months of migraines, Dominik said, the pain eased, but his face felt inflamed. “It is a total nightmare,” he said.

“I’m afraid how people will judge me,” said Lois S., a woman who works at a Michigan elementary school. She hoped BPC-157 and another unapproved peptide, retatrutide, would help with weight loss, but she stopped taking the treatment when she felt pain.

“I sought out this substance from a lab that clearly labeled it not for human use, purchased a syringe, and injected this in my kitchen,” she said. “That belies all logic about what a normal person would do.”

Peptide proponents argue that shoddy manufacturing — not the peptides — causes harm. Therefore, they say, the FDA must protect the public by allowing doctors to prescribe peptides made for human use by pharmacies that specialize in . Typically, compounding pharmacies manufacture alternatives to FDA-approved drugs so a patient can, say, get a liquid version of a drug that the original manufacturer makes only as pills.

Adding unapproved peptides to the FDA’s list of compoundable drugs would mark a departure from the list’s purpose, said Peter Lurie, a former FDA official who now directs the advocacy group Center for Science in the Public Interest. He noted that federal and state oversight for compounding pharmacies is often lax, and they’ve been .

Furthermore, he added, the move would mislead consumers into thinking they’re buying drugs backed by clinical trials. People promoting peptides often point to promising laboratory research as evidence. Rats with spinal injuries after BPC-157 injections, for example, and old mice given the experimental could run longer. On average, however, fewer than 10% of substances that show promise in animal studies prove effective in clinical trials.

“A lot of this pseudoscience stuff sounds deeply impressive — inflammation this and telomere that — but at the end of the day, none of it really matters,” Lurie said. “You’ve got to show clinical benefit in humans: Does it work?”

Peptide promoters lean on anecdotes, often without verifiable numbers. In a at the White House, the MAHA influencer Brecka said: “Twenty million people have been prescribed these things without adverse events.” His guest on the episode, Brigham Buhler — who is the co-author of The Peptide Revolution and owner of a compounding pharmacy that sells peptides and a clinic, Ways2Well, that prescribes them — told Brecka that none of its 75,000-plus patients had reported adverse events from peptides.

Buhler cited even higher numbers in the movie , a documentary featuring Kennedy and other leaders of the MAHA movement and that bears the MAHA trademark. In the segment on peptides, Buhler said: “Having treated literally hundreds of thousands of people through our compounding pharmacy, we’ve never had a major adverse event.”

Topol asks why those boasting success haven’t conducted clinical studies. “If influencers and companies really believe these peptides are helping people,” Topol said, “then they should put their profits back into rigorous research.”

Chris Woodward, a spokesperson for Brecka and his company, the Ultimate Human, said in an email that the health and wellness issues discussed on Brecka’s podcast do not constitute medical advice. “Mr. Brecka consistently advises his audience to consult a licensed physician,” Woodward wrote. Buhler did not respond to requests for comment.

Not all anecdotes are rosy. At an antiaging conference last summer in Las Vegas, two women were rushed to the hospital and intubated after being injected with experimental peptides and vitamins, according to citations that Nevada’s state pharmacy board issued against the doctor running the booth and his colleagues for prescribing and administering drugs without a state medical license.

An for adverse events contains concerning reports. Although the database can’t prove that a drug, vaccine, or medical device caused harm — the reports are brief, unverified, and voluntary — it signals issues worth exploring. A 36-year-old woman was hospitalized in December after taking the experimental peptide BPC-157 for weight control and a skin disorder, for example, and a 48-year-old man was hospitalized with a “life-threatening” condition after taking the peptide.

FDA scientists presented some of these reports at the July meeting and flagged worrisome outcomes in animal experiments, such as a revealing signs of liver toxicity in rats and dogs injected with BPC-157.

Brian Lee, a liver disease specialist at the University of Southern California, was among the panel’s minority who voted against easing restrictions. Without clinical studies, he said, afflictions that take time to develop, like liver damage and cancer, might not be spotted for years: “I think this endorsement can be potentially harmful, and I cannot in good conscience vote ‘yes.’”

The panel’s newcomers disagreed. “I do not believe the FDA made a good case on issues with safety with BPC,” said Kris Wusterhausen, founder of an antiaging company in Texas, the Resurge Clinic, which sells a BPC-157 product for $149.

“Once you’ve seen the effects of BPC,” he said, “you can’t unsee it.”

Awaiting Trial

Deepak Srivastava, president of the Gladstone Institutes in San Francisco, designed a clinical trial two decades ago to see if a peptide he studies, TB-4, could repair tissue after a heart attack. Before enrollment, people volunteering for the study would be screened for early signs of cancer because TB-4 triggers vessel growth and cell migration, which might exacerbate malignant growths. He worries about the FDA panel’s vote to ease restrictions on a derivative of TB-4, before such trials have been completed, saying, “You need to have a healthy respect for the fact that drugs can be harmful.”

Pinchas Cohen, a peptide researcher at the University of Southern California, was less cautious, saying the FDA buzz might drive investors to fund trials. He’s seeking support to bring a peptide his lab identified, MOTS-c, to market. It’s “un-ideal” for people to take unproven drugs, Cohen said, but that’s what’s happening: “The world is changing and people like me need to accept that this is the new reality and find ways to make it as safe as possible.”

In the meantime, people like Meetze resort to podcasts and online forums for advice. His symptoms faded after a year, but he still had spells of feeling “zero emotions.”

Peptide users describe this condition as anhedonia. It’s come up on .

Huberman occasionally mentions other potential peptide risks, like cancer, sprinkling them into advice on how to take them. Take a with 1.2 million views: “I do not think that BPC-157 is not without its quote-unquote ‘side effects,’” Huberman says. “If you’re going to go down this path of taking BPC-157, I would encourage you to take the minimal effective dose, to not simply do it every day, and certainly to not do it continuously, and of course to monitor your other health metrics for anything that could potentially resemble cancer or tumor growth, because obviously stimulating angiogenesis for wound repair sounds like a great thing, recovering and being able to do your workouts or play your sport, or move about more comfortably, of course, a wonderfully attractive thing to do.”

“Isn’t that what we all want? But obviously not with the trade-off of growing a tumor,” he said, before interrupting the discussion to advertise a supplement company sponsoring the show.

This article first appeared on �Թϲ�� and is republished here under a .

AI, Tech Leaders Are Lobbying Trump Health Officials in a Government-Run Chat Room

Amanda Seitz, Maia Rosenfeld and Darius Tahir — Fri, 09 Oct 2026 09:00:00 +0000

A cadre of elite techies, financiers, and high-level Trump administration officials have spent a year quietly charting an extraordinary and rapid campaign to persuade Americans to use apps and other artificial intelligence-powered tools to manage their healthcare and medical records.

As that campaign has unfolded, administration officials have granted tech companies an unusual opportunity to nudge the nation’s health department toward a loosely regulated future for AI health apps in which the government reimburses them for services as it does medical professionals.

In February, federal health officials invited those businesses — including tech giants Microsoft, Anthropic, OpenAI, Apple, and Google — to a listening session on conversational AI products for patients, such as chatbots. Representatives from at least 35 industry organizations attended the meeting held by the Food and Drug Administration, which is responsible for regulating health apps as medical devices. Companies were prompted in advance to explain their AI products and how they access patients’ sensitive medical information.

But the meeting did not appear on the FDA’s public calendar or regulatory notices, nor was the public invited. Rather, the invitation for a select group to help shape federal policy governing AI in healthcare was extended in a chat room on the messaging service Slack.

“This is a great opportunity to support HHS’ goals and share your state-of-the-art understanding of safe Conversational AI development and monitoring to help FDA shape future guidance,” CMS senior policy adviser Morgan Taylor wrote in the Slack workspace.

The Centers for Medicare & Medicaid Services has not formally announced the chat room through federal regulatory channels, though CMS officials have talked about it at industry conferences. Legal experts said the chat room resembles a federal advisory panel, which would be required to operate in public view.

�Թϲ�� reviewed thousands of Slack messages, meeting transcripts, and video recordings that reveal how the Trump administration has granted the industry a direct line to top government officials — including former head of the Department of Government Efficiency .

The conversation took place behind the scenes as federal health officials publicly worked to integrate AI and other technology into nearly every aspect of healthcare, a plan they’ve branded the “.”

“We wanted to give industry a chance to play in the sandbox of government-supported healthcare,” CMS Administrator Mehmet Oz at the public launch of an initiative that allows health apps to bill Medicare for AI services such as wearable device tracking. Last week, Health and Human Services Secretary Robert F. Kennedy Jr. delivered an enthusiastic endorsement of AI in healthcare, claiming it is “much better informed than any doctor in the country.”

Meanwhile, HHS staff even promised that a recently launched would serve as a lucrative pipeline for those businesses to get new users. The library’s webpage currently promotes only two dozen commercial apps to millions of American seniors and those with disabilities.

, Americans will get easier access to their medical records so apps can swiftly provide health or wellness advice. In practice, however, so will the tech companies.

Doctors, meanwhile, are increasingly worried about how patients use and share their medical records with the nascent technology.

“Some of these tools just aren’t ready for primetime,” said John Whyte, CEO of the American Medical Association. “We don’t have enough data about them. We don’t understand how they work, how they’re using the information. There’s no liability if these tools get things wrong.”

CMS officials declined to answer several questions about the Slack workspace, including about its legality.

“CMS is focused on giving Medicare beneficiaries greater access to their health information and useful digital tools while promoting an open, interoperable healthcare system,” Gleason, now chief product officer for the newly created Office of Health Technology and Products at CMS, wrote in an emailed statement. “The Health Technology Ecosystem is an open, voluntary technical collaboration. CMS will continue working with patients, providers, payers, technology organizations, and other stakeholders to make health information more accessible and useful to the Americans it serves.”

The FDA did not respond to a request for comment.

The Conversation Begins

The behind-the-scenes effort to funnel more Americans to AI-powered health apps began in August 2025 in the Slack workspace.

“Welcome all!” Gleason wrote. “Please be sure to read the Code of Conduct and see the Channel list as well to help you find channels that are relevant to you.”

Gleason is best known as the acting administrator of Elon Musk’s Department of Government Efficiency, as it to millions of Americans’ sensitive personal and financial data, including at the Social Security Administration.

As her work with DOGE wound down last year, Gleason welcomed a variety of tech leaders, investors, and entrepreneurs to the chat room.

The Slack workspace’s participants include representatives from major digital wellness companies like Oura Health, AI companies like Palantir, and investment outfits like 8VC, associated with Kennedy’s . While the Slack’s member count has ballooned to 1,700 over the past year, only a handful of patient advocates, doctors, and hospital representatives are in it.

The code of conduct Gleason shared on Slack in August 2025 documented that CMS had quietly established a technology working group.

Documents have been reproduced from the CMS Health Tech Ecosystem Slack and highlighted by �Թϲ��.

The document also set ground rules for the Slack workspace, noting that the group does not constitute an “advisory committee,” nor would it be used “to obtain advice or recommendations for HHS, CMS, or any HHS/CMS officials.” The code also advises that federal employees “are prohibited from endorsing any product, service, or enterprise.”

Joseph Daval, a former FDA lawyer who is now a research specialist at Harvard Medical School, reviewed messages from the Slack workspace at the request of �Թϲ��. He said the chat room in some ways resembles a federal advisory committee — an independent panel that can be formally stood up by an agency head, Congress, or the president to ensure agencies act in the best interest of the public rather than industry.

The law on advisory committees “was passed in part out of a concern about interest group capture, about anticompetitive capture of agency policymaking, about corruption,” he said.

Daval said the chat group looks like a committee, with members interacting with one another and building consensus on preferred courses of action.

If it were a formal advisory committee, though, Daval said, it would be subject to certain “membership requirements having to do with independence and fair balance.”

A ‘Sales Engine’

Over a series of video calls, CMS officials promised tech leaders participating in the Slack workspace that the agency would promote their health apps.

Jacob Shiff, the chief AI and technology officer at CMS’ Innovation Center, told industry representatives in a Zoom meeting in February that he hoped the agency’s work would be a “sales engine” for the health apps.

“We’re going to have a directory of all the organizations,” Shiff said in a video recording reviewed by �Թϲ��. “The people on this call who hopefully will have amazing solutions that work will be the winners, and you have every incentive to obviously drive down your costs so you can be extremely profitable and scale. So hopefully we’re selling — or enabling you guys to thrive.”

A recording of the call had been publicly available through a Google Drive link but was made private the day after �Թϲ�� asked about comments made during the meeting.

CMS did not respond to queries about how the agency has decided which AI-powered health apps appear in the Medicare App Library or why federal employees have promised to promote the products.

Days before publicly launching the Medicare App Library, CMS officials promised AI tech leaders during an informal meeting that the new webpage would become an important distribution channel for health apps because Medicare enrollees would place trust in products listed on the CMS website.

“If medicare.gov is promoting it, for lack of a better word, then yeah, it would be an app that I would trust and explore,” CMS’ Taylor said during the April 7 meeting, channeling enrollees, according to a transcript of the call.

The Medicare App Library’s webpage encourages older and disabled Americans to manage health conditions such as obesity, cancer, or diabetes using two dozen AI-driven apps developed by some of the world’s largest corporations, including Microsoft and Google. Many of the apps promise in their product descriptions to give insight, perform analyses, or develop plans that will help patients lose weight or manage diabetes.

CMS officials have suggested to tech representatives during at least two meetings this year that those apps will be prioritized for a new agency program that reimburses companies for AI chatbot advice or wearable device tracking, according to video recordings.

CMS has not publicly divulged all the criteria it uses to decide which apps are listed in its library, but the webpage promotes apps still in their infancy.

Among them is Slothwise, a health app launched this year from a San Francisco apartment by a young, biotech entrepreneur and triple citizen of Russia, Israel, and the U.S. says it “knows your whole health” by analyzing medical records and tracking health data, offering users a free option with limited functionality or its full features for $9.99 a month. It has been reviewed on the Apple and Google app stores only a handful of times.

“I trusted slothwise with my health info because it was endorsed by medicare,” one reviewer wrote in a in August. “Connecting info was smooth and I learned a lot about my health.”

In a statement, Slothwise CEO Sofia Sigal-Passeck did not answer questions about the size and medical expertise of her current team, nor about the availability of a doctor to consult with patients who use the app. The app, she said, is only “informational” at this time.

“I’ve spent years building at the intersection of AI and complex biological data,” Sigal-Passeck wrote in an email. “A small team is not the same thing as an inexperienced team. Slothwise is built by physicians, PhD researchers and engineers.”

‘No Regulation, No Rulemaking’

What’s often less clear — and buried deep in lengthy privacy policies — is that these apps are tapping into the intimate details of patients’ medical records to fuel their AI-driven analyses.

Tech vendors have to treat these apps, once they are vetted and authorized by a third-party organization, like a patient requesting records. That position gives apps sweeping access to pull sensitive health data from the national network through which providers electronically exchange medical records, called the , or TEFCA.

A small but influential group of those tech company executives directly made the case to federal health officials during a in May, arguing that when health apps request medical records they should be treated as if they are standing “in the shoes” of a patient.

On Slack, tech vendors have lobbied for a “frictionless pathway” for verified users, after they’ve consented once, that allows the app to gain limitless access to patients’ medical records from the TEFCA network.

Ryan Howells, a healthcare management consultant who lobbies for a Washington, D.C.-based digital health tech organization called the CARIN Alliance, has spearheaded an effort for patients — vis-à-vis apps — to more easily access medical records. He has regularly noted in Slack that health apps accessing TEFCA must be vetted by a third-party organization — one of which he sits on the board of — and agree to a code of conduct, developed by the alliance he lobbies for.

“What more can you do to have trust in these apps?” he wrote in a March Slack message, responding to concerns about how much patient consent is needed for apps to access medical records on the network.

Kristen Valdes, the CEO of b.well, a company that also connects apps to the TEFCA network, made a similar argument.

“My opinion is that we need to stop protecting patients from themselves,” she wrote in the same message thread. “Full stop.”

Howells did not respond to an emailed list of questions from �Թϲ��. In an interview, Valdes told �Թϲ�� that her comment reflected her frustration at the “paternalism” of the healthcare system, which she said has historically made it difficult for patients to access their records. Although, she said, “there are going to be good and bad apps.”

Other tech leaders worried in Slack about the approach.

One startup founder cautioned the group to think about the pitfalls of giving health apps broad leeway to pull medical records.

“We might all be good, honest actors here but security & privacy systems have to be designed around the presence of malicious actors – especially if we want this system to scale up to thousands of apps,” wrote Jason Kulatunga, who runs Fasten Health, a medical records management platform.

Gleason, the CMS official, has publicly championed the vision shared by Howells and Valdes. In her speeches, she frequently urges doctors to accept patient medical records directly from apps and calls on them to “,” also the title of a 2025 co-authored by Howells that urges doctors’ offices to abandon paper records.

Last month, Gleason spoke to a crowd gathered at a swanky hotel in Washington for an event hosted by the MAHA Institute, a think tank that supports Secretary Kennedy’s agenda. She laid out her work with tech companies over the past year as she discussed the Trump administration’s efforts to make medical records more digitally accessible.

As she told it, more Americans can now download an app and access their medical records.

“Once you’ve verified your identity you can just click a simple button and say, I’d like my medical records into whatever app I choose,” Gleason said.

She continued: “That was all done just — no regulation, no rulemaking — just by challenging industry to work together.”

This article first appeared on �Թϲ�� and is republished here under a .

Food Safety Finds a Place Among ‘Kitchen-Table’ Political Issues

Stephanie Armour — Mon, 28 Sep 2026 09:00:00 +0000

The run-up to the midterm elections is turning into a food fight — literally.

The summer was marred by a massive foodborne outbreak that and the recall of of imported meat, turning the safety of the U.S. food supply into a topic of national conversation and a political cause.

Late-night talk show hosts that included explosive diarrhea. As a precaution, such as Chipotle and Taco Bell , jalapeños, and other suspected products from menus. Some food safety scientists blamed the outbreaks on federal cuts to public health.

These dynamics collectively have raised questions about whether it’s safe to order a salad or burger.

Democrats have come out on the offensive, saying voters worried about the safety of the U.S. food supply should oust Republicans in the midterm elections. The Trump administration has countered by accusing Democrats of scaremongering over food safety to score political points.

The political fracas reflects the toll that large-scale outbreaks have had on the public psyche. Midterm voters have long cared about pocketbook issues such as grocery prices, but the spate of recalls has them worried about whether the food they’re buying is safe to eat — and political leaders are paying attention.

The outbreak linked to cyclospora in lettuce led to almost 20,000 laboratory-confirmed cases of illness from May through August, compared with 1,180 cases during the same span in 2025, according to the Centers for Disease Control and Prevention. That makes it the largest recorded outbreak of the parasite.

“One of the reasons food safety is in the news this year, and people have been rightfully concerned, is the combination of high-profile restaurant names and the absolute colossal number of illnesses,” said , consumer watchdog director with the U.S. Public Interest Research Group, or PIRG, an advocacy group, referring to a recent cyclosporiasis outbreak. “It’s thousands of people. It makes it more real.”

there have been about , which is about on par at this time last year, according to PIRG data.

Following the Numbers

A majority of registered voters have little or no confidence in government oversight of food safety, with Democrats far more likely than Republicans to doubt the protections in place, by Quinnipiac University. of U.S. adults indicated they were concerned about the frequency of food recalls in a poll by GS1 US, a data standards organization.

The share of consumers who strongly agree that the U.S. food system produces food that’s safe to eat declined to about 30% in August, from 40% in November, released in September by the University of Illinois and Purdue University.

Democrats have jumped at the chance to repeat criticisms of President Donald Trump’s budget cuts and priorities.

The Democratic National Committee on social media while calling Health and Human Services Secretary Robert F. Kennedy Jr. a “complete disaster” who must resign.

“Trump is dismantling our government — and it’s harming people,” Sen. Elizabeth Warren (D-Mass.) posted , adding: “Slashed food safety agencies → cyclospora outbreak.” Just weeks earlier, she had written to Kennedy demanding answers for what she described as the administration’s “” and its connection to political contributions.

Rep. Gabe Amo (D-R.I.) : “I’m calling on Trump to stop gutting the FDA & restore its inspectors. We deserve safe food.”

The campaign for Rep. Judy Chu (D-Calif.) : “Trump is cutting our food safety funding and workforce, and we have seen far too many food recalls this summer.”

But the number of recalls doesn’t tell the whole story.

While recalls aren’t markedly up this year compared with 2025, they are up over a broader time span. The country saw 320 food recalls by the Food and Drug Administration and the U.S. Department of Agriculture in 2025, up from 296 in 2024, .

The total number of recalls grew 21% from 2021 to 2025, based on an , a provider of regulatory guidance software. A rise in Class I recalls, which are the highest priority because the products could cause serious illness or death, drove much of the increase.

But recall numbers can be misleading. For starters, federal agencies do not publicize all recalls, especially if products are no longer on the market. Recall data itself is suspect because a single contaminated food can result in multiple recalls if the item is incorporated into processed food or other products.

A far better measure is the number of people sickened, epidemiologists say. And this summer’s specific multistate outbreak from cyclospora was exceptional, affecting people in 21 states.

When it comes to bacterial contamination of food — which is more common and includes E. coli, listeria, and salmonella — the overall trend points to outbreaks in which fewer people are falling ill. That’s a promising sign, some food safety leaders say, although the CDC says an estimated each year in the U.S. experience foodborne illness.

“That’s an indication we’re finding more outbreaks and finding more when they are smaller and limiting the extent to which they can get bigger,” said , a public health professor at the University of Minnesota and leader in food safety surveillance.

Still, the perception that the food supply is riskier has been enough to ignite political rancor.

The FDA recently that recalls for fiscal year 2026 are among the lowest levels recorded in over a decade, stating, “Don’t believe the fake news.” It included a chart that showed recalls dropping to 1,836 in fiscal 2026 from almost 4,000 in fiscal year 2013.

On the same day, doubled down on the claim, that Kennedy is doing so well that Democratic operatives are slamming the FDA for doing its job by conducting food recalls.

“It makes sense that these craven, disingenuous attacks are all these influencers have,” he wrote.

But some food safety experts question the numbers, noting that the agency’s recall totals cover a range of products. The tally also includes drugs and medical devices, based on an by , who was director of the FDA’s Center for Food Safety and Applied Nutrition from 2015 to 2023. Some food safety leaders say it’s misleading to imply that food safety recalls have declined if the data the claim is based on includes recalls not related to food.

“This HHS assertion appears to be based on incorrect data,” Mayne said on LinkedIn, a job-oriented social networking site.

It’s About More Than Recalls

Food safety has occasionally taken center stage in politics. In 1993, for example, an E. coli outbreak traced to Jack in the Box fast-food outlets pressured newly inaugurated President Bill Clinton to make it an at his first Cabinet meeting. His administration wound up adopting a new approach focused on preventing foodborne illness and credited with drastically reducing E. coli infections.

Concern about food safety has especially taken hold now, public health leaders say, because the administration is portraying itself as a safety crusader while cutting staffing and funding for federal agencies responsible for surveillance and inspection.

“There’s a level of hypocrisy from the administration when they promise to make our food safer and then eviscerate the agencies and programs that detect and prevent outbreaks,” said , regulatory affairs director at the Center for Science in the Public Interest.

The FDA continues to have the staff required for outbreak investigations, and no FDA investigators were affected by staffing changes or reductions in force, HHS spokesperson Grace Davis Jamison said in an email.

The CDC lab supporting foodborne outbreak investigations also was not impacted by reductions in force, she said, and the agency maintains a dedicated team investigating foodborne outbreaks and working closely with state and local health departments.

“The Trump Administration has mounted a robust response to each outbreak, working closely with health departments in all 50 states and leading the public health response by promptly identifying known sources and providing Americans with the information they need to protect themselves,” she said.

The administration’s initiatives risk weakening food safety protections. Trump in late August said he would take action to make it easier for small livestock operations to , raising concerns among food safety leaders that the change could allow inadequately inspected beef to enter the food system.

Trump also announced the U.S. would , despite concerns about inspections and safety. The European Union has on Brazilian beef imports because of noncompliance with food safety and antibiotic use.

The administration that would have stopped the sale of raw turkey and chicken containing high levels of salmonella. And it said it would delay requiring grocery stores and companies to trace food in their supply chains, allowing for quick removal in cases of contamination. Implementation, originally set for Jan. 20 of this year, would instead occur in July 2028.

The actions came after hearing concerns from stakeholders about the time needed to comply, Davis Jamison said.

Some food safety leaders say the administration should do more to prevent foodborne illnesses, saying that failing to direct more resources into preventing problems makes it harder for Kennedy’s campaign to encourage people to eat more fresh foods.

In fact, almost half of consumers changed their habits regarding which groceries they bought and 40% modified purchases at restaurants in the past month due to foodborne illness concerns, according to the survey by the University of Illinois and Purdue University. Concerns about foodborne illness exposure via fresh vegetables increased in August compared with feedback from the previous two years.

“If you want people to eat real food, fresh fruits and vegetables, they have to be safe,” said Sandra Eskin, chief executive at , a nonprofit public health organization. “Instead, we have had farmers plowing under fields because people aren’t buying lettuce.”

This article first appeared on �Թϲ�� and is republished here under a .

The Drugs and Devices Have Been on the Market for Years. But FDA-Ordered Studies Still Aren’t Done.

David Hilzenrath — Fri, 18 Sep 2026 09:00:00 +0000

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 — and the frequent lapses in follow-through.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Amgen’s headquarters in Thousand Oaks, California, in May 2023. (Mario Tama/Getty Images)

Behind Schedule

An FDA database downloaded by �Թϲ�� in August tracks the progress of postmarket studies that makers of — such as vaccines and gene therapies — were required to perform or promised to perform.

The database showed almost 600 were running behind schedule.

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

About a third of ongoing studies were listed as delayed.

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

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

The nearly 600 delayed studies involved almost 350 products, �Թϲ�� found.

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

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

Products included:

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

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

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

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

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

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

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

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

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

Today the issue may be all but moot.

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

According to another FDA database, Oxaydo .

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

Delay Can Pay

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

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

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

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

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

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

‘False Hope’

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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 — known by the shorthand ANCA-associated vasculitis — in which, as the explains, the immune system inflicts potentially fatal damage on blood vessels and organs.

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

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

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

Nonetheless, the recently of Tavneos.

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

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

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

The FDA disagrees.

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

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

Data reporter Maia Rosenfeld contributed to this report.

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With Midterms Looming, Journalists Consider Measles, Food Recalls, and Obamacare

Sat, 29 Aug 2026 09:00:00 +0000

Céline Gounder, �Թϲ��’ editor-at-large for public health, discussed fatal measles cases on CBS News 24/7’s Mornings on Aug. 26. Gounder fact-checked Centers for Medicare & Medicaid Services Administrator Mehmet Oz’s comments about vaccines and drug prices on CBS News 24/7’s The Daily Report on Aug. 24. She also discussed food recalls this summer on CBS News 24/7’s The Takeout With Major Garrett on Aug. 24.

�Թϲ�� chief Washington correspondent Julie Rovner discussed kindergarten vaccination rates on WNYC’s The Brian Lehrer Show on Aug. 25.

�Թϲ�� contributor Mark Kreidler discussed the use of artificial intelligence for Medicaid reenrollment on KVPR’s Central Valley Daily on Aug. 24.

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Read Kreidler’s “AI Is Being Used To Boost Medicaid Enrollment, but Not Without Concerns.”

�Թϲ�� senior correspondent Julie Appleby discussed the state of the Affordable Care Act on Vox’s Today, Explained podcast on Aug. 24.

�Թϲ�� Georgia correspondent Briah Lumpkins discussed the importance of healthcare policy in upcoming elections on WUGA’s The Georgia Health Report on Aug. 21.

This article first appeared on �Թϲ�� and is republished here under a .

Trump and Kennedy’s Health Industry Deals Haven’t Been Enforced and Are at Risk of Vanishing

Stephanie Armour — Fri, 28 Aug 2026 09:00:00 +0000

In the thick of his competitive reelection race in Michigan, Republican Rep. joined Health and Human Services Secretary Robert F. Kennedy Jr. at a sprawling 400-acre . They touted Trump administration efforts to improve the American diet, including the removal of some artificial dyes from processed foods.

“We had a great discussion about healthy options for all Americans and taking back control of our healthcare,” Barrett said in a June , after sampling the farm’s apple cider.

Like the focus on artificial dyes, however, many of the administration’s highest-profile health initiatives rely on voluntary agreements. The goals, such as lower drug prices and nutrition classes for doctors, have widespread appeal, cutting across party lines and economic divisions.

But the administration-industry deals lack the enforcement teeth of more traditional federal regulation. Their details are vague, and minimal oversight makes it hard to monitor progress. In some cases, the administration has claimed victories that have yet to materialize.

Republicans consider the dealmaking a winning strategy. It fits with the party’s anti-regulatory stance, they say, and enables the administration to quickly forge agreements President Donald Trump and his allies can tout as accomplishments. In the run-up to the midterm elections, some, like Barrett, hope to woo voters by trumpeting the Trump administration’s efforts to shape health policy.

The practice also raises questions. Though the deals are announced with great fanfare — often during televised events on stages, with live audiences — there’s little documentation or follow-through, creating doubts about whether the administration’s health agenda will lead to lasting change or unravel once the political attention fades.

The distinction could prove important to voters as Republicans defend their health records in November’s midterm elections.

“These deals are often not transparent, so there’s no way for the public to judge how meaningful they are,” said Larry Levitt, executive vice president for health policy at KFF, a health information nonprofit that includes �Թϲ��.

Dealing With Dyes

The push to remove certain artificial dyes from food and drugs, for example, was a headline grabber. In April 2025, Kennedy to announce deals with food makers. He was flanked by young children and mothers holding placards reading “Make America Healthy Again.”

He and former FDA commissioner drew a standing ovation from an audience selected by Kennedy’s staff as they said companies had pledged to phase out all petroleum-based synthetic dyes from the nation’s food supply and medicines. They targeted nine synthetic dyes for removal.

Voters love the idea of stopping the use of such dyes. In a nationally representative March survey by Consumer Reports, said they were at least somewhat concerned about synthetic dyes, and two-thirds said companies should be required to phase them out.

A year after making the first announcement at HHS, during a discussion at the Conservative Political Action Conference, an annual political event.

“We’ve gotten rid of the nine synthetic-based food dyes,” he said.

Not quite. At the initial HHS event, federal officials said companies would voluntarily stop using six specific synthetic dyes . (The administration has also revoked or proposed revoking authorization for two other synthetic food dyes.)

Later, the FDA on its website quietly to the end of 2027. So, most are still in use.

In fact, the FDA posted a list of 27 companies it said had made voluntary pledges as of December 2025 to remove six synthetic dyes from products such as Doritos and Kellogg’s Froot Loops. More than a year and a half later, — fewer than 30% of those who bought in — had met their promised goals.

Many major food makers, such as the Coca-Cola Co. and Unilever, have made “” to remove the synthetic dyes, according to Consumer Reports. In addition, no pharmaceutical companies have publicly said they have plans to remove dyes from drugs.

“It’s just all talk,” said Leslie Dach, who chairs , a healthcare advocacy group that supports the Affordable Care Act. “They just govern for a day of publicity, and then it’s over. None of it happens. Yet the people don’t know because they have busy lives, so they think, ‘Just look at all these initiatives.’”

In fact, the administration , allowing companies to say their products contain no artificial colors — as long as they don’t use petroleum-based dyes. Previously, food makers could not make that claim unless their products contained no added colors. Some food dyes made from natural ingredients can contain contaminants and may pose their own health risks, .

“The federal government hasn’t taken any regulatory action on food dyes, for the most part, since the beginning of this administration,” said , vice president for government affairs at the Environmental Working Group, an advocacy group.

HHS said the voluntary approach has yielded significant action, including commitments to remove synthetic dyes from products sold in schools for the 2026–27 school year.

“HHS and the FDA are moving forward with clear timelines and concrete industry commitments, with major changes expected in foods served in schools during the coming school year and across full product portfolios by the end of 2027,” HHS spokesperson Emily Hilliard said in an email.

At the same CPAC convention event, Kennedy said “the MCAT testing companies are going to put nutrition on the MCAT for the first time, so the students will actually want to do it.” MCAT refers to the Medical College Admission Test, an exam required for admission to medical schools.

Again, not quite.

The Association of American Medical Colleges administers the MCAT. Spokesperson said Kennedy misspoke and may have meant to refer to a test taken by students to be licensed as doctors.

An Insurance Deal Falls Short of Promises

Kennedy again took to the HHS stage in June 2025, this time with Centers for Medicare & Medicaid Services Administrator Mehmet Oz, to make what was billed as a game-changing announcement. to reduce the volume of healthcare services subject to prior authorization, a practice widely used by the insurance industry that often requires patients or their medical teams to seek preapproval before undergoing treatment.

The administration said 80% of insurers pledged changes to preauthorization requirements for 80% of diseases and injuries . The administration also promised “” to track progress.

“It will happen very quickly,” Oz said at the event. “Necessary care will be delivered when it’s needed, in the right way.”

As of July, months past that January target date, health plans had reduced prior authorization for medical services by about 11%, according to AHIP, the insurer trade group. But no public dashboards have debuted to track the deal, and some insurers that signed the pledge last summer told �Թϲ�� this year that they will not implement all the promised reforms as outlined by AHIP.

Hilliard did not respond to questions about the pace of progress.

The American Medical Association, in a 2025 web-based survey, asked 1,000 practicing doctors whether they believed the voluntary pledges would make a meaningful difference. said they believed they would.

Insurers made a , during the previous Trump administration. The next year, more than 80% of doctors said the number of prior authorization requests for drugs and medical services had been increasing, based on .

Meanwhile, the administration is testing an artificial intelligence-powered for Medicare, the federal health program for people 65 and older or with disabilities. In six states, Medicare beneficiaries must get preapproval for a few treatments that CMS considers to have little clinical benefit and to be susceptible to fraud or waste, including skin substitutes and knee arthroscopy for arthritis. The program began in January, the same deadline insurers had set for curtailing preauthorization delays.

Deals and Deregulation

The healthcare industry’s voluntary agreements appeal to voters who feel government regulation drives up costs and places unnecessary burdens on businesses, some supporters say.

“Secretary Kennedy is the antithesis of a public health industry that uses coercion over communication — and has demonstrated this by taking the time and effort to push voluntary initiatives over the typical approach of governmental mandates,” said , a political consultant who was a political appointee at HHS in Trump’s first term.

But voluntary agreements with the health industry can prove ineffective. Former President Jimmy Carter in 1977 proposed a legislative plan to curb rising hospital costs. Hospitals fought back, and Congress rejected the proposal, instead favoring a desired by the industry. It ultimately failed once public attention faded.

One upside: Deals are fast. can take two to three years. And some health analysts say the tempo of the agreements advanced by Kennedy and Trump may help take voters’ attention off the Trump administration’s inability so far to produce a long-promised health plan.

Instead, Republicans can point to the array of accords reached with industry, including the with drugmakers so they’re in line with lower amounts charged in peer countries. The White House calls it the “most-favored-nation” prescription drug pricing policy.

Seventeen companies, including Pfizer and AstraZeneca, with the administration to lower prices for Medicaid enrollees and cash-paying consumers using , a narrow, government-run consumer platform.

Many details remain unknown, but the lower prices apply only to new drugs and existing drugs available through Medicaid. And prices at TrumpRx aren’t as low as out-of-pocket prices for most consumers with insurance. But the voluntary deals appeal to an industry that has railed against mandatory approaches drugmakers deride as harmful price controls.

“Each company makes its own decisions about how it prices medicines, and our industry is committed to working with the Trump administration to ensure Americans have access to affordable medicines,” said Chanse Jones, a spokesperson for PhRMA, a pharmaceutical industry trade group.

Policies that lead to reductions in drug prices typically worry investors because profits also can drop. But rather than seeing their stock prices fall after the agreements were announced, the drugmakers saw largely .

Analysts say that’s partly because the deals are narrow in scope, largely exist only in principle, and don’t apply to existing drugs used by the more than 200 million Americans with commercial or private health insurance.

The Trump administration, however, is .

“The most-favored-nation agreements on drug prices that we just did are delivering the largest drug price cuts in history,” Trump said in June at a in Pennsylvania. “That alone should win us the midterms.”

This article first appeared on �Թϲ�� and is republished here under a .

How Much of a Cancer Drug Is Too Much? Patients, Researchers Challenge FDA-Approved Dosages

Arthur Allen — Thu, 20 Aug 2026 09:00:00 +0000

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 — 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 — 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.”

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 �Թϲ��)

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, 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, 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 �Թϲ��, 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.

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 — 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 �Թϲ��)

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 �Թϲ��’ reporting team.

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Watch: Why Abortions Are on the Rise Since ‘Roe’ Was Overturned

Kate Wells and Hannah Norman — Fri, 07 Aug 2026 09:00:00 +0000

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 — 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.

A Ban Won’t Stop Abortion Pill Access, Telehealth Providers Say

By Kate Wells June 24, 2026

This article first appeared on �Թϲ�� and is republished here under a .

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With Midterms Looming, Journalists Consider Measles, Food Recalls, and Obamacare

Trump and Kennedy’s Health Industry Deals Haven’t Been Enforced and Are at Risk of Vanishing

How Much of a Cancer Drug Is Too Much? Patients, Researchers Challenge FDA-Approved Dosages

Watch: Why Abortions Are on the Rise Since ‘Roe’ Was Overturned

A Ban Won’t Stop Abortion Pill Access, Telehealth Providers Say

FDA Archives - �Թϲ��