I could never forget this patient. I knew him well.
I was in my second year of a grueling emergency medicine residency, and he came to the ER often. Each time, he was sent from an outpatient clinic with dangerously high blood pressure. And each time, we treated him and discharged him home.
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Trump deleted an AI image of himself on Truth Social looking a whole lot like Jesus after conservative Christians cried blasphemy. “It’s supposed to be me as a doctor,” Trump told reporters while stepping out of the Oval Office to get a McDonald’s delivery. Send news tips and surprising health care angles to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.
Congress returns to a packed health care agenda after two weeks off. Here’s what to follow.
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Good morning. My colleague recently had a chance to talk with former senator Ben Sasse about his experience taking Revolution Medicines’ pancreatic cancer pill. Read on for what he said.
Yesterday, we got highly promising results from a trial of Revolution Medicines’ pancreatic cancer pill, showing that patients on the medication lived nearly twice as long as those on chemotherapy.
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Good morning health tech readers!
Super interested in the list of companies that have been accepted into Medicare’s ACCESS model, the technology-enabled chronic care experiment.
Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where clear blue skies and unusually balmy breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is elderberry-infused green tea. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, suggestions, criticism, and tips. …
In a bid toward greater transparency, the U.S. Food and Drug Administration sent reminder letters to more than 2,200 companies and researchers that they are required to report clinical trial results to a federal government database or they may face fines, STAT says. FDA officials disclosed that an internal analysis found results were not submitted for nearly 30% of studies that were “highly likely” to fall under mandatory reporting requirements. The agency also noted that the letters were sent to companies and researchers associated with more than 3,000 registered trials, some of which were publicly funded. In explaining its move, the regulator acknowledged a long-standing complaint from researchers who have argued that without access to specific data, trial results cannot be easily duplicated, which inhibits greater understanding of how medicines might work.
Novo Nordisk and ChatGPT maker OpenAI agreed to work together on how to leverage artificial intelligence to discover new drugs, the latest AI partnership in the medical field as health care companies seek to harness the technology to get ahead of the competition, The Wall Street Journal tells us. The drugmaker said it would integrate OpenAI’s models across its operations to help its workforce analyze complex datasets and reduce the time it takes to move from research to delivering treatments to patients. The group said the partnership would boost efficiency across the organization, with pilot programs initially launching in research and development, manufacturing, and commercial operations ahead of a full AI integration by the end of the year.
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Good morning. Tomorrow’s the deadline for filing taxes. Godspeed to anybody who will be rushing through it tonight or tomorrow over takeout.
When Ben Sasse, a former United States senator (R-Neb.), learned he had metastatic pancreatic cancer, he quickly chose action over comfort. Whatever he could do to save his life, for as long as he could, he wanted to try it. Perhaps his only option, doctors told him, was to enroll in a clinical trial.
“If we were to have much of a chance of living longer than the three to four months they were giving us at that point, we were going to need to get into an aggressive trial,” Sasse told STAT last month.
Hanan Balkhy has a lot on her plate these days.
Balkhy is the director of the World Health Organization’s Eastern Mediterranean region, an entity that includes several of the countries caught up in the conflict between the United States, Israel, and Iran. The problems it has been posing — not just to individuals’ health and safety but to entire health care systems — are robbing her of sleep.
Benjamin Ebert became CEO of Dana-Farber Cancer Institute at an inflection point in late 2024, helming the organization in the midst of building a massive $1.6 billion cancer hospital, and winding down its partnership with Brigham and Women’s Hospital to instead pair up with Beth Israel Lahey Health.
The wheels of change were set in motion by his predecessor, Laurie Glimcher, who led Dana-Farber from 2016 to 2024. But Ebert, a medical oncologist who previously served as chair of the department of medical oncology at the institute for seven years, has no shortage of ideas and vision for Dana-Farber’s future. He recently detailed them to the Globe. This conversation has been edited for length and clarity.
You’ve embarked on this huge project set up by your predecessor. While things are coming together, it seems there’s still so much to do.
For most of my life, my family has been advocating for therapies to help my twin brother. While the recent approval of a new drug should give us reason to celebrate, there is still more work to do.
My twin brother is 28 years old and has severe Hunter syndrome, also known as mucopolysaccharidosis (MPS) type II. Hunter syndrome is a rare condition caused by the deficiency of an enzyme needed to break down sugars called glycosaminoglycans (GAGs). Due to this enzyme deficiency, GAGs accumulate to toxic levels throughout the body, resulting in progressive multi-organ disease.
Seeking to cap the cost of medicines, the Maryland Prescription Drug Affordability Board set an upper payment limit for a widely prescribed diabetes treatment, marking only the second time a state panel has taken such a step.
The board, which is designed to function like a state utility commission, will now oversee a process to lower the cost of the type 2 diabetes medicine Jardiance for the state and local governments by January 2027. At that time, the price will be capped at $204, or $6.80 a pill, for a 30-day supply. The move is estimated to save $320,000 a year.
The expected cost was benchmarked against the maximum fair price paid by Medicare, although the 2027 pricing was adjusted for inflation, according to Andrew York the executive director of the Maryland board.
In a bid toward greater transparency, the Food and Drug Administration sent reminder letters to more than 2,200 companies and researchers that they are required to report clinical trial results to a federal government database or they may face fines.
FDA officials disclosed that an internal analysis found results were not submitted for nearly 30% of studies that were “highly likely” to fall under mandatory reporting requirements. The agency also noted that the letters were sent to companies and researchers associated with more than 3,000 registered trials, some of which were publicly funded.
In explaining its move, the regulator acknowledged a long-standing complaint from researchers who have argued that without access to specific data, trial results cannot be easily duplicated, which inhibits greater understanding of how medicines might work. They also contend this can adversely affect treatment decisions and health care costs.
A federal judge has tossed one of the four pending civil lawsuits against HaloMD, a company that represents providers in No Surprises Act arbitration cases.
The ruling, which grants HaloMD’s motion to dismiss, represents a major win for the Texas-based middleman, which quickly rose to become the number one user of the federal arbitration process in the first half of 2025. The judge found that Anthem Blue Cross of California’s lawsuit failed to establish a legal basis for invalidating HaloMD’s arbitration wins against the company.
Lawsuits from four Blue Cross Blue Shield plans alleged that many of the disputes in which HaloMD prevailed weren’t actually eligible for arbitration. The lawsuits claimed to reveal a costly side effect of the process: Providers could potentially game the system to extract more money from health insurers for out-of-network services than they got before the surprise billing law passed.
A federal judge has tossed one of the four pending civil lawsuits against HaloMD, a company that represents providers in No Surprises Act arbitration cases.
The ruling, which grants HaloMD’s motion to dismiss, represents a major win for the Texas-based middleman, which quickly rose to become the number one user of the federal arbitration process in the first half of 2025. The judge found that Anthem Blue Cross of California’s lawsuit failed to establish a legal basis for invalidating HaloMD’s arbitration wins against the company.
Lawsuits from four Blue Cross Blue Shield plans alleged that many of the disputes in which HaloMD prevailed weren’t actually eligible for arbitration. The lawsuits claimed to reveal a costly side effect of the process: Providers could potentially game the system to extract more money from health insurers for out-of-network services than they got before the surprise billing law passed.
More than 150 companies and providers have been provisionally approved to participate in an experimental Medicare program meant to expand access to technology-supported chronic care. They include popular mental health apps, wearable device makers, a life sciences company tied to Google, and startups that help large health systems manage heart failure patients.
Announced late last year by the Center for Medicare and Medicaid Innovation, the ACCESS model will pay participants set rates to treat chronic conditions like diabetes, hypertension, high cholesterol, musculoskeletal pain, anxiety, and depression. The payments are tied to measurable health outcomes; the model is meant as an alternative to paying for individual technology services. The initial deadline to participate in the first ACCESS cohort was April 1, but CMMI Monday announced it will extend the deadline to allow more to join.
CMS officials say the large number of applications to participate in ACCESS exceeded their expectations and that the enthusiasm suggests modest payment rates and restrictions did not discourage digital health companies from applying. According to officials, most of the participants had not previously served Medicare patients.
More than 150 companies and providers have been provisionally approved to participate in an experimental Medicare program meant to expand access to technology-supported chronic care. They include popular mental health apps, wearable device makers, a life sciences company tied to Google, and startups that help large health systems manage heart failure patients.
Announced late last year by the Center for Medicare and Medicaid Innovation, the ACCESS model will pay participants set rates to treat chronic conditions like diabetes, hypertension, high cholesterol, musculoskeletal pain, anxiety, and depression. The payments are tied to measurable health outcomes; the model is meant as an alternative to paying for individual technology services. The initial deadline to participate in the first ACCESS cohort was April 1, but CMMI Monday announced it will extend the deadline to allow more to join.
CMS officials say the large number of applications to participate in ACCESS exceeded their expectations and that the enthusiasm suggests modest payment rates and restrictions did not discourage digital health companies from applying. According to officials, most of the participants had not previously served Medicare patients.
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We watched the Artemis II astronauts splash down safely last week. A reminder that legitimately amazing things can still happen. Parachute your thoughts here: bob.herman@statnews.com.
A few months ago, President Trump confidently said he would be meeting with the country’s largest health insurance companies to pressure them to lower their premiums. The message was just that — a message to give the appearance that Trump officials were willing to crack down on health insurers, which have been at the center of Americans’ disdain of the health care system for decades.
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It’s been a minute since I’ve wished you a good morning. Morning!
We’ve got some big news on Revolution Medicines’ pancreatic cancer treatment. But don’t miss GSK’s move to push an ovarian cancer ADC into five Phase 3 trials after striking early data. And Spyre Therapeutics released some competitive ulcerative colitis results.
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on a cuppa stimulation. Our choice today is old-fashioned vanilla. Feel free to join us. Remember, no prescription is required. Meanwhile, here are some tidbits to help you along. Best of luck accomplishing your goals today, and of course, do keep in touch. …
Metastatic pancreatic cancer patients who received a targeted pill from Revolution Medicines lived nearly twice as long as patients who received chemotherapy, a striking result in a notoriously deadly and intractable malignancy, STAT reports. Patients who took the daily pill, called daraxonrasib, lived a median of 13.2 months, compared to 6.7 months for patients who received chemotherapy. The company plans to use the data to apply for approval, although it did not say when. Revolution received a Commissioner’s National Priority Review Voucher, part of a controversial U.S. Food and Drug Administration program to review drugs in just one to two months, so the pill could be considered quickly. The pill blocks a notorious group of genes called RAS. Mutant forms of the protein are present in roughly 30% of all human cancers, including over 90% of pancreatic cancers. But nearly all efforts to curb it have failed.
The FDA — again — an experimental treatment for advanced skin cancer developed by Replimune, STAT notes. The treatment, an engineered virus designed to rev up the immune system against melanoma, has been a flashpoint in a simmering debate over shifting standards at the agency. In October, Replimune resubmitted the drug and sought accelerated approval. A spokesperson said the company added new analyses on the drug’s mechanism of action and on how patients fared relative to prior treatment with an approved immunotherapy. A rejection letter posted by the agency noted that reviewers were concerned that the effects of Replimune’s drugs couldn’t be properly teased out, because the virus is given alongside Opdivo, Bristol Myers Squibb’s approved PD-1 checkpoint inhibitor.
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Good morning and happy Monday. Thanks for being here.
Allogene Therapeutics said Monday that its off-the-shelf CAR-T treatment eliminated residual cancer cells in patients with B-cell lymphoma three times better than standard care — achieving the interim goal of an ongoing Phase 3 clinical trial.
While still preliminary, the new data bolster Allogene’s efforts to develop an easily administered cell therapy that, for the first time, could delay or prevent the recurrence of cancer in patients with a high risk of lymphoma relapse at the end of first-line treatment.
In the interim analysis, 58% of patients treated with the Allogene CAR-T, called cema-cel, achieved minimal residual disease, or MRD, negativity compared to 16% of patients who were observed but not treated.
Metastatic pancreatic cancer patients who received a targeted pill from Revolution Medicines lived nearly twice as long as patients who received chemotherapy, a striking result in a notoriously deadly and intractable malignancy.
Patients who took the daily pill, called daraxonrasib, lived a median of 13.2 months, compared to 6.7 months for patients who received chemotherapy.
It’s “very impressive,” said Benjamin Weinberg, an associate professor of medicine at Georgetown University who was not involved in the study, in an email.
An inflammatory bowel disease treatment developed by Spyre Therapeutics succeeded in its first major test, setting the company up to compete with several large drugmakers developing new medicines for the chronic digestive condition.
Spyre is currently running a Phase 2 trial testing three experimental ulcerative colitis drugs as standalone treatments and, eventually, as combination therapies. The company released the first batch of results Monday on one of the treatments, showing it was safe and met the primary goal of the study.
The therapy, SPY001, targets the alpha 4 beta 7 inflammation pathway, one of the emerging avenues drugmakers are probing to reduce inflammation in the gut. In Spyre’s SKYLINE study, subjects taking SPY001 saw a 9.2 point decrease in a disease activity index. Approximately 40% of the trial subjects went into remission after 12 weeks of use.
Every day, more than 40 million people ask ChatGPT about health care, according to OpenAI. They’re asking questions about diet, exercise, insurance — and in some cases, serious symptoms that would typically get discussed on a 911 call or in a doctor’s office.
For some health systems, that’s creating an imperative. A small number of hospitals are trying to recapture some of those clinical conversations from commercial large language models like ChatGPT, Claude, and Gemini. They’re implementing their own patient-facing chatbots, ones that draw directly from their existing medical records and can funnel patients toward care in their own system.
Hartford HealthCare this week will launch PatientGPT, a chatbot engineered by clinical AI company K Health, to its patients in Connecticut. Two health systems — California-based Sutter Health and Reid Health, serving Indiana and Ohio — have announced pilot versions of Emmie, the chatbot built by medical record mammoth Epic. The list is likely to grow rapidly.
Vinay Prasad’s short yet two-act tenure at the FDA was wild. How does anyone follow him as the new leader of biologics oversight at the agency?
Someone I know at the FDA joked to me recently that I should be the new director of the Center for Biologics Evaluation and Research (CBER) after Prasad. I literally laughed out loud at how comical that sounded, but it got me thinking: Who would be both willing to do it and could get picked? Further, what’s awaiting them?
Prasad became a favorite punching bag of many, including the Wall Street Journal editorial board and right-wing activists like Laura Loomer. They are teed up to clobber the next person, too.
As a board-certified urologist who specializes in male sexual dysfunction and men’s health, I often find that people can be pretty dismissive of treatment for erectile dysfunction (ED), as though it’s entirely a recreational problem rather than a medical one. Ask people what society should care more about, erectile dysfunction or heart disease, and it’s not hard to guess what their answer will be.
But mocking or ignoring ED presents a major missed opportunity for men and for stewards of public health. ED is an early marker and predictor of cardiovascular disease, the leading cause of mortality in the world. Investigating and addressing this crucial connection could be the key to saving millions of men’s lives by intervening before cardiovascular disease develops or progresses. But there continues to be significant challenges in treating ED as something more than a problem of aging men or a quality of life issue. It’s past time to view this disease from a different lens.
Below is a lightly edited, AI-generated transcript of the “First Opinion Podcast” interview with Isaac Rose-Berman. Be sure to sign up for the weekly “First Opinion Podcast” on Apple Podcasts, Spotify, or wherever you get your podcasts. Get alerts about each new episode by signing up for the “First Opinion Podcast” newsletter. And don’t forget to sign up for the First Opinion newsletter, delivered every Sunday.
Torie Bosch: Even if, like me, you don’t follow sports, it’s been impossible to miss the explosion in sports betting in recent years. With that rise is coming a new challenge for public health.
First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others.
To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to the Editor received in response to them. You can submit a Letter to the Editor here, or find the submission form at the end of any First Opinion essay.
With thousands of illegal e-cigarettes for sale in the U.S., both the Trump and Biden administrations have vowed to crack down on the illicit fruit- and candy-flavored vapes that hold particular appeal to minors. But a new government report suggests law enforcement efforts by the Department of Justice lag far behind the scope of the problem.
Most DOJ enforcement actions between fiscal year 2022 and fiscal year 2025 — 50 out of a total of 88 — were to add the names of remote e-cigarette sellers to a list of unauthorized businesses, according to the report from the Government Accountability Office. The second-most common type of enforcement actions (20 out of 88) noted in the report were injunctions to stop legal violations.
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Buyer beware: If you are an avid consumer of WAP Sensual Enhancement, the Food and Drug Administration says the pill “may be harmful.”
Want to learn about other dubious products under federal scrutiny? Scroll down.
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda includes promenading with the official mascots, escorting Mrs. Pharmalot to a musical happening and visiting a new eatery. We also hope to have yet another listening party, where the rotation will include this, this, this, this and this. And what about you? This may be an opportunity to enjoy the great outdoors, perhaps a stroll by the seashore or a walk in the woods. A long drive in the country may be nice, although it will cost you. Or perhaps simple pleasures such as noshing on a pastry with a hot cup of stimulation will do. You could also catch up on your reading or reach out to someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon…
A flood of cheap copies of Novo Nordisk’s blockbuster weight-loss drug in India is already reshaping the country’s fast-growing obesity medicine market, showing how quickly the patent cliff will affect GLP-1 makers like Eli Lilly, Bloomberg News explains. Within days of dozens of generics hitting the Indian market after Novo’s patent expired locally, the drug’s share in the country’s GLP-1 segment jumped to 33% in March from 25% a month earlier, according to researcher Pharmarack. That gain came at the expense of Lilly’s Mounjaro, which is still under patent protection in India and whose share fell to 64% from 71%. The data marks the first meaningful snapshot of how market dynamics will change for GLP-1 makers as their patents near expiry.
The U.S. Food and Drug Administration withdrew approval of a GSK drug that the Trump administration had promoted as a treatment for autism, adding another twist to the unusual story of a decades-old drug, Bloomberg News informs us. The agency is pulling its approval of Wellcovorin, a branded version of leucovorin from GSK, according to a post in the Federal Register. GSK had requested that the approval be withdrawn. The FDA first approved leucovorin decades ago and it has been used to blunt the side effects of chemotherapy for some cancer patients. In September, Trump administration officials endorsed leucovorin as an autism treatment. Last month, the FDA approved its use for cerebral folate deficiency, which is seen in some people with autism.
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CAR-T therapies are continuing to gain traction in autoimmune disease, with a notable new case.
Also, the FDA has withdrawn approval of GSK’s leucovorin for a rare brain disorder tied to autism, closing out an unusual episode shaped in part by political pressure.
NEW YORK — President Donald Trump’s administration this week acknowledged it made a significant error in figures it used to help justify a fraud probe into New York’s Medicaid program, a glaring mistake that undercuts a federal campaign to tackle waste, mostly in Democratic-led states.
The error, one of at least a few misrepresentations in its description of the program, prompted health analysts to question how many of the Republican administration’s sweeping anti-fraud efforts around the country were based on faulty findings. It also reflected a common criticism that’s been made of Trump’s second administration — that it tends to attack first and confirm the facts later.
The Food and Drug Administration on Friday rejected — again — an experimental treatment for advanced skin cancer developed by Replimune Group.
Replimune’s treatment, an engineered virus designed to rev up the immune system against melanoma, has been a flashpoint in a simmering debate over shifting standards at the agency.
The drug was initially rejected in July, just two months after Vinay Prasad was appointed the FDA’s head of biologics. As an academic oncologist, Prasad criticized regulators for approving drugs with limited data, and the Replimune decision was viewed as a possible sign of the stricter stance he might take at the agency.
For most of the last 80 years, sports betting was limited to Las Vegas. But after a 2018 Supreme Court decision loosened regulations on professional sports wagers, it became possible to place bets on games 24/7 — with nothing more than a smartphone and a bank account.
In 2013, just five years prior to the landmark SCOTUS case, gambling was classified in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) in a new category called “Substance-Related and Addictive Disorders.” This grouped gambling with alcohol use disorder and other addictions. Gambling is also known to have the highest suicide rate of any addiction.
I didn’t expect to find myself face to face with leaders and activists from the “Make America Healthy Again” movement in respectful dialogue, or to consider inviting one into a public health classroom. But that’s exactly where I found myself this spring.
At a national public health meeting in March, I attended a session that brought together public health professionals, physicians, and MAHA leaders for a rare, good-faith conversation. I went out of curiosity. I left with a level of clarity I hadn’t expected — and a few unexpected connections.
The past few weeks have been nothing but discouraging for those of us who helped create the Make America Healthy Again movement, including a silly executive order on glyphosate that feels anathema to what we have fought for. I’d be lying if I said that my heart hasn’t been bent toward repentance for my part in the whole thing. I helped champion Bobby Kennedy as a campaign volunteer, and when he joined up with then-candidate Donald Trump, I reluctantly decided that the trade-offs were worth what I believed Kennedy could advocate for within the walls of a Trump White House: the best fixes for a very sick and broken nation.
Yet I found myself recently, and reluctantly, headed to the citadel of arrogance: Washington (well, Arlington, Va., to be more specific). At the invitation of Brinda Adhikari — one of the hosts of the podcast “Why Should I Trust You?” — I attended the Association of Schools and Programs of Public Health’s annual meeting, where I spoke on a panel about engaging in civil conversation in a session called “A Dialogue Between Academic Public Health and MAHA.”
The past few weeks have been nothing but discouraging for those of us who helped create the Make America Healthy Again movement, including a silly executive order on glyphosate that feels anathema to what we have fought for. I’d be lying if I said that my heart hasn’t been bent toward repentance for my part in the whole thing. I helped champion Bobby Kennedy as a campaign volunteer, and when he joined up with then-candidate Donald Trump, I reluctantly decided that the trade-offs were worth what I believed Kennedy could advocate for within the walls of a Trump White House: the best fixes for a very sick and broken nation.
Yet I found myself recently, and reluctantly, headed to the citadel of arrogance: Washington (well, Arlington, Va., to be more specific). At the invitation of Brinda Adhikari — one of the hosts of the podcast “Why Should I Trust You?” — I attended the Association of Schools and Programs of Public Health’s annual meeting, where I spoke on a panel about engaging in civil conversation in a session called “A Dialogue Between Academic Public Health and MAHA.”
Zac Jiwa, a federal Medicare official, delivered a eulogy of sorts at a Thursday Medicare event highlighting the successes of the Health Tech Ecosystem initiative.
The eulogy’s subject? The clipboard.
For the past eight months, hundreds of health tech companies have been working to meet goals set out by the federal government to make patient records more portable, create systems that import patients’ data into providers’ electronic health records systems, and stand up various patient apps. The idea is that filling out a stack of paperwork at every doctor’s visit, on that ubiquitous clipboard, would be a thing of the past.
