Love it or hate it, BMI is back in the news. But that’s just the starting point in a debate over how to define obesity.

Critics have long faulted the weight-divided-by-height-squared measure as too blunt an instrument to define obesity. BMI, or body mass index, alone can group people with excess muscle mass in the same bucket as people with excess fat, all while ignoring population differences. Over a year ago, a Lancet Diabetes and Endocrinology global commission took aim at redefining obesity, relying less on BMI and more on such consensus-gaining metrics as waist circumference, waist-to-hip ratio, or waist-to-height ratio. 

What was new in the commission’s framework was drawing a bright line between preclinical and clinical obesity, all with an eye toward sharper diagnosis that starts with BMI and other body fat numbers. Someone with preclinical obesity might have excess body fat and be at risk for — but not yet be diagnosed with — cardiovascular problems, type 2 diabetes, some cancers, or other signs of organ dysfunction. Someone with clinical obesity would have already developed an ongoing illness. 

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Good morning. A new Gallup poll found that health care is back on top of the list of Americans’ domestic worries. Does staying informed on the news help combat that concern? Read on and let me know. 

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A lot of artificial intelligence tools in medicine pitch themselves as breakthroughs. But there are some that can put some extra oomph behind that claim. Since 2016, the Food and Drug Administration has handed out “breakthrough” designation to more than 1,200 devices, including many powered by AI.

The designation comes with priority FDA review, with the goal of enabling innovative devices to reach patients and hospitals quicker. But what does the agency count as a breakthrough, especially in clinical AI, a decade after it established the Breakthrough Designation Program?

An analysis of STAT’s Breakthrough Device Tracker — which tracks all publicly available breakthrough designations, not just those the FDA has authorized — shows that the agency appears to be prioritizing big-picture, multi-problem AI solutions. Algorithms that simply improve a doctor’s capabilities are no longer enough: AI breakthroughs increasingly solve problems that physicians simply can’t, like detecting multiple cancers from a single image, or predicting the risk of dying from cancer or heart failure.

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This is the online version of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.

In the nick of time

Biotech’s most-watched stock index, the XBI, was heading for a first-quarter loss until Tuesday, when Eli Lilly said it was buying Centessa Pharma, and Biogen announced a takeover of Apellis Pharma. Investors love M&A. Those deals plus an easing of Iran war concerns contributed to a huge 7% surge in the XBI on the last day of the quarter.

How are you feeling about biotech as we enter the second quarter? Are you worried about China? AI? Gas prices? The year-over-year pace of M&A activity is up, but FDA drug approvals are down.

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A recent study in the journal Radiology tested whether 17 radiologists could identify when an X-ray was created using artificial intelligence. The results were interesting — the medical professionals correctly differentiated the real from deepfake images about three-quarters of the time. STAT reporter Katie Palmer, who reported on the study last week (and is not a trained radiologist,) took the quiz and also scored about 75%. 

In this week’s STATus Report, host Alex Hogan spoke with Palmer about the study and what implications AI could have for patient safety. Hogan also took the quiz himself and sees if he can beat the radiologists’ (and apparent X-ray reading prodigy Palmer’s) score.

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NEW ORLEANS — The opening session of the American College of Cardiology’s annual gathering — one of medicine’s largest conferences, with more than 16,000 attendees —  can feel a bit theatrical. In typical fashion, this year’s conference kicked off last Saturday with a local brass band marching and playing its way through the crowd. Beads were thrown. The mood was festive. And based on the pre-conference buzz, the field seemed to be celebrating a long-forgotten section of cardiology: prevention.

Prevention is normally relegated to the periphery of national conferences. Lacking the adrenaline of interventional cardiology or the industry attention of electrophysiology, its meetings would take place in half-empty conference rooms, away from the main action. There would be no free lunch or swag.

But the attention economy of cardiology is rapidly changing. At this year’s ACC, prevention trials occupied primetime slots. At a talk covering the new cholesterol guidelines, a crowd stood behind a sea of occupied chairs. Ushers, minding fire department regulations, turned attendees away. Large industry booths advertised, among others, PCSK9 inhibitors, renal denervation therapies, and increasingly sophisticated cardiac CT scans pitched as the future of prevention. The field was having its Expo Hall moment.

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My patient Claire and I were at odds. She was 44 years old and came to my clinic for a second opinion. The diagnosis was stage 3 rectal cancer. It started with blood in her stool and quickly turned to weight loss and abdominal pain. I agreed with her previous doctors’ recommendations of surgery, radiation, and chemotherapy. She asked about mistletoe, blue scorpion venom, and infrared lamp therapy.

We spoke for 30 intense minutes, but by the end of the visit, she remained unconvinced. It was all I could do not to chase her to the parking lot. Claire, whose identifying details I’ve altered slightly to protect her confidentiality, was going to die young from a disease that was curable.

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WASHINGTON — The Trump administration has prepared an order that would impose a 100% tariff on imports of patented medications and their active ingredients, according to a draft obtained by STAT.

The tariffs could be announced as soon as Thursday, according to a person familiar with the matter. Bloomberg, which first reported on some of the order’s details, also said the announcement could come Thursday. It’s possible that the timeline or details of the plans could change.

The White House did not immediately respond to a request for comment.

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WASHINGTON — Food and Drug Administration Commissioner Marty Makary recounted his agency’s achievements and acknowledged a “challenging start” to his tenure in a speech to staff on Wednesday afternoon. 

Wednesday marked one year since the Trump administration laid off 10,000 people at the Health and Human Services Department, including 3,500 FDA employees. That day, April 1, was also Makary’s first as commissioner. It was a distressing start for staff, who weeks later listened to health secretary Robert F. Kennedy Jr. call them sock puppets of the pharmaceutical industry. 

“We had some difficulty here due to some actions just before I came into office,” Makary said, according to a recording obtained by STAT. “That’s why ensuring a good workplace culture has been something very important to me.”

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The Food and Drug Administration has often failed to share information on how it determines whether its advisory committee members have financial conflicts of interest and whether those individuals should participate in committee meetings, according to a review by the Government Accountability Office.

A key issue is that the agency never finalized guidance 13 years after a law required it to do so, the watchdog found. Meanwhile, the FDA has never posted on its website how it makes these decisions and does not publicly share how it decides whether guest speakers have financial conflicts or situations where there appears to be a conflict.

As a result, the GAO recommended the FDA establish a timeframe for issuing and publicly sharing required financial conflicts-of-interest guidance. The watchdog also suggested the FDA should disclose how it decides conflicts for committee members in the interim and publicly disclose how it determines conflicts and appearance issues for guest speakers.

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Ambient scribes were supposed to ease the burden on stressed-out doctors by automating clinical documentation from patient visits. A new study highlights the need to help clinicians make the best use of the tools.

The large new study of AI scribe use by 1,800 clinicians across five academic medical centers from 2023 to 2025 found those using the technology saved 16 minutes of documentation time and spent 13 fewer minutes in the medical record for every eight hours of patient care. The study did not find significant impacts on time spent in the electronic health record outside of work. Primary care and female clinicians benefitted more than others. Scribe adopters were able to see one additional patient every two weeks.

The findings offer the most definitive real-world data confirming earlier smaller studies. A STAT review of published work last year found scribes saved clinicians under a minute per clinical note. Surprisingly, despite the modest time savings, other studies have found that scribes drive large improvements in burnout and other measures of clinician well-being. 

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Hospitals in 16 states have sued the department, arguing a 2023 final rule underpays hospitals that treat a disproportionate number of low-income patients.

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Eli Lilly’s obesity pill was approved by the Food and Drug Administration on Wednesday, setting it up for fierce competition against Novo Nordisk’s new Wegovy pill as more people seek alternatives to GLP-1 injections.

Lilly’s drug, which is called orforglipron and will be marketed as Foundayo, was approved under the FDA’s new commissioner’s voucher program, which grants speedy reviews to drugs that are aligned with national health priorities. 

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Good morning. We’re officially in the second quarter. As always, we’ve got you covered with all the biggest events to watch this quarter if you read to the end.

Novo’s subscription model raises questions about pharma-telehealth tie-ups

Novo Nordisk said yesterday that it will start selling its obesity drugs at a lower cash price to patients if they enroll in a subscription plan through certain telehealth providers.

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They remind you to not talk during the movie, but when I saw “Project Hail Mary” last week, I was so alarmed that Ryan Gosling placed two Eppendorf tubes next to each other that I said, aghast, “He didn’t balance the centrifuge — that would have wrecked it…” while my non-scientist friends cracked up.

That one scientific flub aside, it’s still one of the best book-to-film adaptations I’ve seen, maybe ever.

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Hello, everyone, and welcome to the middle of the week. Congratulations on making it this far. It is an accomplishment, after all. The next step is to … keep going. And why not? Just consider the alternatives. On that optimistic note, please join us for a needed cup of stimulation. Our choice today is maple bourbon. Meanwhile, here are some items of interest to get you going. Have a wonderful day, and do drop us a line when you hear something juicy. …

The U.S. Food and Drug Administration is moving toward allowing compounding pharmacies to produce more than a dozen injectable peptides that were banned because of potentially significant safety risks, The New York Times reports. In 2023, 14 peptides were removed from a list of products that the agency allows compounding pharmacies to produce. The peptides had not been approved by the FDA as safe or effective and, in recent years, the agency had noted that they were increasingly being marketed with unproved claims that they had cosmetic, anti-aging, and disease-fighting benefits. U.S. Health and Human Services Secretary Robert F. Kennedy Jr. has said in recent podcast appearances that he is pushing for the FDA to reverse the prohibition on the peptides, which include some that act as growth-hormone stimulators. On Joe Rogan’s podcast last month, Kennedy said he has personally used the products to heal injuries “with really good effect.”

The scientists behind treating Baby KJ say they have hit a stumbling block in their efforts to create more custom gene editing treatments for children with rare diseases, STAT explains. They maintain that FDA reviewers are imposing high manufacturing and quality control standards that could make it too expensive and complicated for them — or any academics — to bring such bespoke therapies to approval. Instead, they warned, such efforts could require the resources of industry. The researchers received the feedback in a meeting with FDA reviewers to discuss a potential study of custom treatments using prime editors, a more complex and cumbersome gene editing technology that can treat a much wider range of genetic misspellings.

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The agency is embarking on major initiatives — including helping states implement Medicaid work requirements — with fewer workers in the wake of the federal government’s restructuring, experts say.

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Ketamine treatment clinics have proliferated following the Food and Drug Administration’s approval of the drug as a remedy for acute depression in 2019, leading to a Wild West of infusion clinics that have expanded treatment access for many Americans without much regulation. 

Providers are split on whether ketamine should be used strictly as a pharmacological intervention, or whether psychotherapy or other types of monitoring should be incorporated alongside the drug’s administration. Studies have shown that giving ketamine without psychological support can reduce depressive symptoms and suicidality within hours.

But some researchers suspect this pharmacological-only viewpoint could leave benefits on the table. A group of scientists announced on Tuesday a clinical trial at Massachusetts General Hospital that they hope will answer what, exactly, ketamine and its resulting trip provides.

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It is perhaps not surprising that the director of the National Institutes of Health would invoke the name of a man revered by scientists as the architect of a policy widely credited with driving the United States’ global supremacy in biomedical research. But Jay Bhattacharya’s claim over the weekend that the Trump administration is pursuing a vision articulated eight decades ago by that scientific leader, Vannevar Bush, has provoked pushback — even outrage — in scientific circles.

Standing before one of the country’s largest annual gatherings  of conservative political activists, Bhattacharya attempted to make the case that the administration’s science policies — particularly its efforts to diminish the research dominance of elite universities and spread federal funding more broadly across the country — are rooted in the ideas Bush proposed at the end of World War II. 

“I want to tell you a great story about how we can make America healthy again. I’m going to begin with a perspective from 1944 that still challenges us today,” he began his speech at the Conservative Political Action Conference on Saturday in Dallas, Texas. “There was a man named Vannevar Bush. He wrote a book called ‘The Endless Frontier’ that warned that the scientific progress in the United States was becoming unevenly distributed. Too much research capacity, he argued, was concentrated in a small number of institutions.”

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Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the second quarter:

Abivax: Maintenance outcomes from the Phase 3 ABTECT study of obefazimod in ulcerative colitis.

Allogene Therapeutics: Interim analysis of the ALPHA3 study of cema-cel as a frontline consolidation treatment for B-cell lymphoma. A preview can be read here.

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Few things will give a man as much of an insight into the female body as growing up with sisters. Painful, irregular periods, body hair, skin trouble: Al Barrus, a 43-year-old veteran and communications specialist from New Mexico, heard all about it growing up, the only male of three siblings. He’s also known for a while that one of his sisters had been diagnosed with polycystic ovary syndrome, an endocrinological disorder and leading cause of infertility associated with a range of issues including high androgen levels, insulin resistance, and enlarged ovaries. His other sister, too, had some PCOS symptoms. 

Recently, he’s begun to wonder: Could he have it, too? 

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The Centers for Medicare and Medicaid Services has decided to include ostomy supplies in its competitive bidding program (CBP), limiting supplier choice in the name of cost savings. Finalized last November, the policy is already moving toward implementation with key decisions on pricing and the number of contracts to award for each product category expected as soon as this spring.

The goal is understandable. The reasoning is not.

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You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays.

You got your MAGA, then you got your MAHA. Read on to learn about GAHA. And send news tips to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.

MAHA’s bad week, continued

On Sunday, President Trump told reporters it’s “possible” that the stalled nomination of Casey Means for surgeon general could be pulled as key Republican senators remain tight-lipped about their support for her.

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The Trump administration is changing the name of the federal health IT office back to the Office of the National Coordinator for Health Information Technology (ONC). The Tuesday announcement also reverts the organization of the office to focus on external IT coordination, instead of also overseeing Health and Human Services’ internal use of technology.

In 2024, the Biden administration had appended Assistant Secretary for Technology Policy (ASTP) to the office’s title, as well as moved HHS’s chief technology officer, chief data officer, and chief AI officer roles to ONC’s purview. The new announcement reverses that change, putting those offices and some cybersecurity functions back under the office of the chief information officer.

The changes streamline ONC’s purview and focuses it on the administration’s priorities of getting patients their health data and decrease the friction in sharing health records. 

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The insurer has been overhauling its executive bench as it attempts to bolster flagging profits in health benefits and capitalize on growth in Carelon, including through six new appointments on Tuesday.

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The scientists behind treating Baby KJ say they’ve hit a stumbling block in their efforts to create more custom gene editing treatments for children with rare diseases.

Food and Drug Administration reviewers, they say, are imposing high manufacturing and quality control standards that could make it too expensive and complicated for them — or any academics — to bring such bespoke therapies to approval.

Instead, they warned, such efforts could require the resources of industry.

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You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday.

Good morning health tech readers!

In today’s newsletter: mental health fundraising, a letter from Health Gorilla to ASTP, OpenEvidence’s new hospital partner, a big AI drug deal, and new AI doctor pilots. Whew!

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WASHINGTON — The Supreme Court on Tuesday ruled against a law banning “conversion therapy” for LGBTQ+ kids in Colorado, one of about two dozen states that ban the discredited practice.

An 8-1 high court majority sided with a Christian counselor who argues the law banning talk therapy violates the First Amendment. The justices agreed that the law raises free speech concerns and sent it back to a lower court to decide if it meets a legal standard that few laws pass.

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Eli Lilly is expanding its commitment to artificial intelligence-driven drug development, signing a deal with Hong Kong-based Insilico to develop and commercialize experimental drugs in preclinical development.

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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 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 raspberry hibiscus. 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, criticism, and tips. …

Drugmakers are delaying launches of some new medicines in Europe as the industry grapples with U.S. pressure ​and pricing policy shifts from President Trump, according to Reuters. The White House has been pushing to lower the cost ‌of prescription drugs in the U.S., which has traditionally paid significantly more than other wealthy countries. Trump says the industry has been unfair to U.S. consumers and has sought to tie the cost for Americans to what is paid elsewhere, including in Europe, known as most-favored-nation pricing. That has led drugmakers to press pause on bringing some drugs to European markets, where health spending is lower, to avoid lowering prices in the $700 billion U.S. market. It has also created a ​complex balancing act for chief executive officers and Europe’s health care policy makers.

Eli Lilly agreed to buy Centessa Pharmaceuticals, the maker of an experimental drug meant to combat sleeping conditions, for roughly $6.3 billion in cash, STAT notes. Centessa, which was publicly launched in 2021, started with more than a dozen programs across a range of diseases, but over the years it has focused on disorders that leave people struggling to stay awake. Its lead drug has been tested in Phase 2 studies in different types of narcolepsy and idiopathic hypersomnia. Centessa is behind Takeda Pharmaceuticals, which has submitted a drug for narcolepsy type 1 to regulators for review, and Alkermes, which plans to start a Phase 3 program for its narcolepsy treatment this year.

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Good morning. Reporters get countless email pitches every day. Just yesterday, I got one that mentioned Hannah Montana in the subject line. But the pitch that kicked off Elaine Chen’s latest story is not what we typically see. The subject line read: “URGENT: PAID BOOKING.” 

A new field of study for the mind-body connection

Earlier this year, health secretary Robert F. Kennedy Jr. claimed that changing one’s diet can “cure” schizophrenia. Experts say this isn’t true, but there is a growing cohort of scientists who are interested in the connection between nutrition, diet, and mental health.

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Good morning. I’m feeling like this malfunctioning Olaf animatronic knowing that it’s already almost April.

The need-to-know this morning: Takeover Tuesday!

Eli Lilly is buying Centessa Pharma and Biogen is buying Apellis Pharma.

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With the Massachusetts life sciences and climate tech industries facing continued weakness, the Boston tech scene could use an influx of new energy.

It may be on the way from Whoop, the maker of health and fitness tracking wristbands favored by star athletes like LeBron James and Cristiano Ronaldo.

A few weeks after announcing plans to hire 600 people, Whoop on Tuesday clocked the largest venture capital deal of the year for Massachusetts-based startups. The fitness tech company raised $575 million from investors including the Mayo Clinic and the sovereign wealth fund of Qatar. James, Ronaldo, and other athlete fans of Whoop also invested.

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Biogen said Tuesday that it would buy Apellis Pharmaceuticals for an upfront payment of around $5.6 billion, expanding its portfolio with a set of approved immunology drugs.

Biogen will acquire Apellis for $41 per share, more than double the biotech’s closing price on Monday. Apellis shareholders are also eligible to receive up to an additional $4 per share if certain sale thresholds are met for Syfovre, Apellis’ drug for an advanced form of macular degeneration.

With the acquisition, Biogen will get two commercial assets. Syfovre, approved in 2023, specifically treats geographic atrophy secondary to age-related macular degeneration, in which immune system dysfunction leads to the destruction of retinal cells and causes vision loss. The drug brought in $587 million in sales last year.

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Eli Lilly said Tuesday that it would buy Centessa Pharmaceuticals, the maker of an experimental drug meant to combat sleeping conditions, for roughly $6.3 billion in cash.

The purchase values Centessa at $38 per share, a 38% premium over the company’s closing price on Monday and a 40.5% premium over its average share price over the last 30 days. The agreement also includes additional payments if Centessa’s drugs win regulatory approval in the U.S., meaning the total purchase price could be up to $47 per share, adding another $1.5 billion to the deal.

Centessa, which has headquarters in the U.K. and in Boston, was publicly launched in 2021 and started with more than a dozen programs across a range of diseases. But over the years it has focused on disorders that leave people struggling to stay awake.

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For decades, five siblings in rural Kentucky were slowly turning to stone. After walking for just a few minutes, their legs would painfully freeze up, as if turning to rock — an agony no doctor could explain.

By the time the eldest sibling, Louise Benge, reached her 50s, she had come to believe that medicine might never figure out what ailed her family. After years of inconclusive check-ups and exams, her doctor eventually referred her to a program at the National Institutes of Health devoted to cracking the most challenging medical mysteries: the Undiagnosed Diseases Program.

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Five years after the peak of Covid-19, as the nation searches for its next Centers for Disease Control and Prevention director, the most immediate threat to U.S. pandemic preparedness may not be a novel virus, but the erosion of public trust. The country remains vulnerable as avian influenza spreads, vaccination rates decline, and outbreaks of measles and dengue reemerge.

Without restoring confidence in the CDC, even the strongest scientific guidance will fall short of protecting the public, as well as the nation’s economic stability and security.

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WASHINGTON — Sellers of health savings accounts see an opening for expanding their market, and they’re ramping up lobbying efforts to seize the opportunity.

A group of companies and organizations tied to the HSA industry this year formed a nonprofit called the Great American Health Alliance, or GAHA, a riff on Make America Healthy Again, or MAHA. As a 501(c)(4), GAHA can engage in unlimited lobbying, support political candidates, and avoid disclosing where it gets its money.

Members of GAHA include HealthEquity, one of the largest administrators of HSAs, and the American Bankers Association, which represents institutions holding about 90% of HSAs. GAHA is run by brothers Keith Nahigian, who is the group’s president and has worked for multiple GOP presidential campaigns, and Ken Nahigian, who led the Trump transition in 2017 and was health secretary Robert F. Kennedy Jr.’s liaison to senators during his confirmation process.

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The claims were astounding.

“One company may have figured out how to actually rewire the brain with 100% patient improvement in Phase 2 trials. And FDA may have just handed them a golden ticket,” a voice intoned on a YouTube video about a biotech called Helus Pharma that’s developing psychedelic drugs for mental health disorders. “This is potentially the first new mechanism in decades to show durable remission after just two doses, with FDA acceleration, elite institutional backing, and billions in unmet demand,” it later said.

The video was one of a handful that were uploaded earlier this year and that came with a disclosure that they were advertisements for Helus and paid for by a third-party marketing agency. STAT also discovered another set of recently posted videos paid for by another marketing agency on behalf of AtaiBeckley, a much larger and well-known psychedelics company.

“What if one dose of a nasal spray could do what years of antidepressants could not, and it only takes 90 minutes? That is not hypothetical. That is real clinical data,” a voice on one video said about Atai’s lead candidate.

Both videos said they were for “informational” purposes only and not meant as investment advice.

Helus and AtaiBeckley are hardly the only drugmakers paying outside marketing companies for promotion. But many of these YouTube videos make exaggerated claims about investigational drugs, at a time when psychedelic-focused biotechs, which have long combatted stigma and skepticism, are trying to gain a foothold in the medical mainstream and with established pharma companies that may be interested in acquiring them.

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U.S. venture capital firms are no longer waiting for Chinese biotech assets to surface before investing in them — they’re moving upstream, embedding themselves inside labs and courting scientists before they publish their research. In some cases, they’re vying against Chinese VCs urging scientists not to publish at all.

As multinational drugmakers flood China in search of deals, competition is intensifying, and valuations are rising sharply, according to VCs and other observers. That pressure is forcing venture capital firms to move earlier — teaming up with local partners to tap scientific discoveries before they reach the market.

Among those VC firms is RA Capital, which has invested in some of the most transformative names in Chinese biotech, including Legend Biotech, which obtained its first Food and Drug Administration approval with its cell therapy Carvykti in 2022, and Gracell Bio, which was acquired by AstraZeneca in a $1.2 billion deal in 2024.

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Chatbots can talk like therapists, but should they be used that way? One startup is betting the real opportunity lies in incorporating artificial intelligence into a behavioral health clinical team.

Startup Jimini Health has raised $17 million in seed funding as it seeks to launch its mental health AI platform Sage with large behavioral health organizations. The product interacts with patients continuously while they’re in treatment, under the supervision of a clinician.

Investors include M13, Town Hall Ventures, LionBird, Zetta Venture Partners, and OneMind. Jimini has raised $25 million to date.

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Takeda Pharmaceuticals will lay off nearly 250 workers in Cambridge, the state’s largest biopharma employer announced through a state filing.

The layoffs will begin in July, although some will take place later in the year or in 2027. All affected Massachusetts employees work at the company’s 500 Kendall St. location, according to the filing posted Friday.

The workforce reduction is part of a cost-saving plan approved by Takeda’s board of directors on March 25 that is expected to result in annual savings of about $1.25 billion by 2028, according to a company statement. Another 387 workers in other states may also be laid off as part of the plan.

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In the latest dustup over a groundbreaking HIV prevention medicine, Doctors Without Borders has harshly criticized the manufacturer for refusing to sell its treatment directly to humanitarian organizations.

The move came after months of talks in which Doctors Without Borders asked Gilead Sciences for a “limited” supply of lenacapavir. The drug has been in demand after studies showed a single set of injections every six months can offer virtually complete protection from infection, a form of prevention known as preexposure prophylaxis, or PrEP.

The organization currently obtains lenacapavir through The Global Fund to Fight AIDS, Tuberculosis and Malaria, a worldwide partnership of governments, civil society groups, and the private sector that, in late 2024, reached a deal with the company to distribute lenacapavir to 2 million people in low- and middle-income countries.

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Health secretary Robert F. Kennedy Jr. made waves in February when he opined that changing your diet can “cure” schizophrenia. His comment sparked a wave of backlash from researchers who called the secretary’s remarks “unfounded.” 

While the current scientific consensus suggests that schizophrenia cannot be cured through diet, Kennedy’s interests in nutrition and diet as tools to treat mental illness are shared by some researchers and clinicians eager to find alternatives for conditions like schizophrenia that lack good treatment options. A person’s mental health, they say, is not solely determined by neurotransmitters bouncing around inside their brain, but also by other bodily pathways.

Stanford University researcher Shebani Sethi has been at the vanguard of this group, a field she calls “metabolic psychiatry.” Her work has caught the interest of leaders in the Make America Healthy Again movement, including physician Mark Hyman, a longtime friend of Kennedy. 

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Researchers in Massachusetts are experimenting with artificial intelligence to detect signs of Alzheimer’s disease in its earliest stages, when symptoms of the dreaded illness may go unnoticed but newer drugs can modestly slow its progression.

Helping more people get diagnosed earlier could be a significant step forward in the fight against the memory-robbing disease. Currently, 90 percent of people in the earliest phase of Alzheimer’s, called mild cognitive impairment, go undiagnosed in the United States, multiple studies show.

“The biggest opportunity to improve Alzheimer’s care isn’t in a new drug — it’s in noticing the earliest signs sooner,” said Dr. Lidia Moura, director of population health in the neurology department at Mass General Brigham.

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Lead may be out of gasoline and paint but it’s not out of our hearts. 

Physicians and patients alike may assume that lead poisoning is a relic of the past, with the notable exceptions of contaminated water plaguing people in Flint, Mich., or Milwaukee in recent years. A new study analyzing lead levels in bones reminds us that lead lingers in the body for a lifetime, including in the heart’s vital arteries, where it can elevate blood pressure, injure the lining of blood vessels, and raise risk of death from heart attacks.

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We’ve got a special themed version of Health Care Inc. this week. Feedback is as welcome as ever: bob.herman@statnews.com.

Let’s talk about jobs

Adults in America exist to have jobs, or so we’re told. And there’s no industry more responsible for employing adults than health care.

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David Zaas will return to Duke Health as chief executive in May. Zaas served in various leadership roles at the health system for almost two decades.

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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 cups of stimulation. Our choice today is peach ginger. Feel free to join us. Remember, no prescription is required. Meanwhile, here are some tidbits to help you along. Best of luck today on your journey, which we hope will be meaningful and productive. And, of course, do keep in touch. …

The White House has drafted legislative text for its drug pricing policy, and officials are in the process of sharing it with more than a dozen major pharmaceutical companies, according to STAT. The legislative text closely follows the outlines of the voluntary deals the administration made with drugmakers. The draft includes a policy that would allow drugs purchased in cash to count toward a patient’s insurance deductible. The Trump administration’s push for drug price legislation is part of a larger effort to get health reforms signed into law. The president’s focus on his affordability agenda in an election year has heightened the profile of the effort. Still, despite the White House digging in to get Congress to pass its plan, lawmakers have little appetite for major changes and there is no clear path to passage.

Eli Lilly wants the U.K. government to regularly raise National Health Service drug prices ​and phase out a multi-billion-dollar rebate scheme if ‌it is to resume investment, The Financial Times reports. Patrik Jonsson, international businesses president at the company, said he was in talks with U.K. ministers and ​was “optimistic” about reaching an agreement by the ⁠summer for the government to pay more for ​its medicines. The discussions also cover “innovative” pricing plans that would link payments for ​anti-obesity drugs to whether patients become well enough to return to work. Medicine prices in the U.K. had been “far too low for far too ​long, and even with the current threshold, we ​are not back to where we started more than 20 years ‌ago,” he maintained.

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In response to an opinion piece from the American Hospital Association, Dr. Catherine Gaffigan, president of health solutions at Elevance, defends the company’s new facility administrative policy.

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Over the past five years, the American workforce has grown in large part due to the health care industry. But large, for-profit health care companies have not been driving that job growth.

Some parts of health care — notably, health insurers — are cutting jobs, some of which has not been previously reported. And considering the Trump administration and Republicans in Congress signed off on billions of dollars in Medicaid cuts in the near future, economists think it’s possible some organizations — particularly hospitals and others that actually deliver care — will lay off employees.

To understand how the health industry workforce is changing, STAT analyzed the number of employees listed in the annual filings of 50 of the largest publicly traded health care companies. They include hospitals, pharmaceutical companies, medical device firms, health insurers, distributors, and other life sciences and equipment manufacturers. The findings reveal a lot of variance by sector, and muted total job growth.

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When Barry R. Bloom was diagnosed with pancreatic cancer, he decided to be a data point. He signed up for clinical trials, and, as was his way, he read all the papers and came to his appointments with questions and wanting to learn as much as he could. When he entered a Phase 1 study of a molecular inhibitor of his tumor’s KRAS mutation and saw a tremendous response, he knew it was temporary. A single inhibiting agent was bound to select for resistance — he knew it was a matter of time.

He used that time well: writing his memoir for his 5-year-old grandson, seeing friends, going to the symphony. 

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Public health experts watching the leadership void at the Centers for Disease Control and Prevention have been predicting for a while that finding someone to head the agency would be a Herculean task.

In the first 15 months of the second Trump administration, the agency has had a Senate-confirmed director for a mere four weeks — Susan Monarez, who was fired last August in a clash over vaccination policy with health secretary Robert F. Kennedy Jr. 

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Consumer groups, independent pharmacies, and drugmakers rightly complained for years that pharmacy benefit managers (PBMs) have used their position as supply chain middlemen to benefit themselves at the expense of patients and payers.

At last, relief is in sight. Congress and the Department of Labor are now poised to align PBMs’ incentives with employers and patients, including making PBMs legally accountable as fiduciaries.

I’ve been studying PBMs for as long as the complaints have been piling up. My research with colleagues at the USC Schaeffer Center shows that PBMs negotiate, but patients and payers too often do not benefit from it. For example, between 2014 and 2018, PBMs’ share of insulin expenditures nearly tripled with no overall savings to payers. At the same time, higher rebates led to higher list prices — roughly $1.17 in higher list price for every additional dollar in rebates — which inflates out-of-pocket costs for patients whose cost-sharing is tied to list prices.

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Alex Zhavoronkov, CEO of Insilico Medicine, can’t stop complimenting Eli Lilly. “Lilly is better in AI than Insilico, and no other company is better in AI than us … except for these guys,” he said. 

He insisted he wasn’t saying nice things about Lilly just because the pharma giant has signed a new deal with Insilico that’s worth $115 million up front and approximately $2.75 billion in biobucks, which are contingent on achieving regulatory and commercial milestones. After calling Lilly’s tirzepatide, which he is on, “the best drug ever invented by humans,” he said he’s been consistently singing Lilly’s praises for a year. “Mounjaro makes me so happy every day. I want to develop the next one.”

It looks like Zhavoronkov might have the opportunity to do just that — his AI drug development company’s new deal with Lilly, announced on Sunday, includes rights for the Mounjaro and Zepbound manufacturer to develop, manufacture, and commercialize some of Insilico’s preclinical AI-discovered candidates for oral therapeutics. Though he declined to say which assets Lilly licensed, he said that the company is the “absolutely best partner” for the candidates and that “nobody is better than them” in these disease areas. Insilico’s pipeline webpage recently was updated to note that a candidate targeting GLP-1 has been out-licensed to an undisclosed partner. 

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WASHINGTON — Food and Drug Administration officials briefed senators on the agency’s plans for food policy for 2026, according to a person familiar with the meeting.

The agency plans to focus on infant formula safety, updating food labels, defining ultra-processed foods, expanding inspections of food processing plants, and bolstering seafood safety programs, according to a document shared with lawmakers, obtained by STAT.

The meeting comes amid a shift in the administration’s health agenda toward food issues and away from vaccine policy. In recent polls, food reforms have been more popular than the vaccine agenda, catching the attention of administration officials looking to sharpen their message for the midterms.

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WASHINGTON — The White House has drafted legislative text for its drug pricing policy, and officials are in the process of sharing it with more than a dozen major pharmaceutical companies, according to people familiar with the meetings.

The legislative text, according to a White House official, closely follows the outlines of the voluntary deals the administration made with pharma companies. The draft includes a policy that would allow drugs purchased in cash to count toward a patient’s deductible.

The Trump administration’s push for drug price legislation is part of a larger effort to get health reforms signed into law. The president’s focus on his affordability agenda in an election year has heightened the profile of the effort.

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Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

The NIH’s foreign subaward crackdown is scrambling global collaborations, while China’s rapid ascent is reshaping drug development. Meanwhile, Wave Life Sciences sheds half its value on underwhelming obesity results.

Also, breaking: I’m adopting a rogue backyard tortoise and will name it Philbert.

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Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.

Good morning. We’re down to the final four in our annual STAT Madness competition. In one matchup, research on a biomarker for Alzheimer’s has a solid lead over an AI cell modeling project. In the other, a smart floss that tracks hormones trails a study on the connection between triglycerides and aneurysms. Vote today, vote tomorrow!

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Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that Averna Therapeutics hired Robert Mabry as chief scientific officer. Previously, he worked at Hillstar Bio, where he was chief executive officer. And before, Mabry was global head of biologics at Takeda Pharmaceuticals.

But all work and no play can make for a dull chief scientific officer.

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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 is still shaping up, although we do plan to attack our to-do list of chores and errands, promenade with the official mascots, and escort Mrs. Pharmalot to a soiree. We also hope to hold yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? Now that spring has sprung, there is opportunity to explore the great outdoors. Depending on your mood, you could hike a trail, stroll a city street, or, our favorite activity, take a long drive to nowhere. For those of you who prefer to stay home, there is always a good book or a flick on the telly. The possibilities are endless. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Novo Nordisk appointed Poul Weihrauch, who is chief executive officer of the Mars candy company, as board observer amid a move by the drug maker to strengthen its position in the highly competitive U.S. obesity market, Reuters points out. Novo Nordisk and its majority shareholder, the Novo Nordisk Foundation, carried out a leadership shake-up last year, replacing the chief executive officer ​and restructuring the board. This included the consolidation of Lars Rebien Sorensen’s leadership role through his ⁠appointment as board chair in addition to his role as chair of the foundation. Sorensen has promised ​to strengthen the board’s pharmaceutical and commercial expertise after criticizing the previous board for being slow to address U.S. market challenges. Novo is ​trying to boost consumer credentials in the U.S. market in a number of ways under its new management. In January, it launched its Wegovy pill across multiple cash-pay channels, rather than solely through traditional insurance routes.

The U.S. Food and Drug Administration approved a gene therapy for severe leukocyte adhesion deficiency type 1 (LAD-1), an ultra-rare disease that leaves children vulnerable to life-threatening infections, STAT notes. The therapy, marketed as Kresladi, was developed by Rocket Pharma and was initially rejected by the agency in 2024 over manufacturing concerns. Recently, though, the FDA has indicated its willingness to relax some of its manufacturing requirements to ease such therapies along. Rocket is likely to charge millions of dollars for the one-time treatment, but Kresladi is not expected to be a major money maker. LAD-1 is thought to affect only around 1 in a million people, with Rocket estimating around 25 new cases per year. The approval, however, will earn the company an FDA priority review voucher that can be used to have another drug approved in just six months, rather than the typical 10.

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Decades after the Vietnam War, hematologist-oncologist Mikkael Sekeres began seeing veterans in his clinic with myelodysplastic syndromes, a group of blood cancers known as MDS. Many of the vets had been exposed to Agent Orange, a blend of herbicides that the military used to peel back dense foliage during the war.

This exposure has long been linked to many serious diseases, including several cancers, but not MDS — until now. In data published this month in Blood Advances, Sekeres and his colleagues were able to provide clear evidence that Agent Orange exposure is linked to MDS and can cause earlier, more aggressive disease.

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