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The most influential names in health and medicine will take the stage this Wednesday and Thursday at the STAT Summit in Boston. Be there (virtually or in person) or be square. Send news tips and the panels for which you’re most eager to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.

Doctors give big

The next two years could be a crucial time for doctors as Congress considers the first major overhaul of how Medicare pays physicians, and the left flank of the Democratic party rallies around Medicare for all.

With so much on the line, doctors are showing up for candidates with medical degrees.

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This is the online version of STAT’s weekly email newsletter Health Care Inc. Sign up here.

Hello! We’re here a day later due to Indigenous Peoples’ Day. A big thanks to everyone who emails in. I read all of them. And keep ’em coming: bob.herman@statnews.com.

A fireworks display

One way employers can save money on health care is by making it cheaper for their workers to visit specific hospitals and doctors. An extremely contentious example of this is playing out in North Carolina, and now is moving into the courts.

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Martin Shkreli is back. The Federal Trade Commission isn’t happy. 

The FTC and seven states on Tuesday asked a federal court to hold Shkreli in contempt for “flagrantly and repeatedly” violating a court order banning him from working in the pharmaceutical industry. 

Shkreli, who became known nationwide as “pharma bro” in the 2010s for imperiously defending his decision to raise the price of an anti-parasitic drug called daraprim by 5,000%, was sentenced to seven years in prison for defrauding investors in 2018. Before he was released in 2022, a court banned him from ever working in the drug industry again, saying he illegally tried to prevent generic competition to daraprim.

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Legislation introduced last week by Rep. Frank Pallone, D-N.J., would get rid of the arbitration process set up by the No Surprises Act entirely, the latest sign of growing interest on the Hill to reform the consumer protection law.

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Rise and shine, everyone, another busy day is on the way. And it is getting off to a pleasant start here on the Pharmalot campus, where clear blue skies and comfy breezes are greeting us. As for the official mascots, they are happily snoozing in their respective corners. As for us, we are firing up the trusty kettle for another cup of stimulation. Our choice today is butter pecan. 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 items of interest. As always, do keep in touch. We appreciate feedback, criticism, and tips. …

Two months after the release of an open letter on potential safety issues tied to a rare disease drug sold by Neurocrine Biosciences, patient advocates and some experts are expressing growing alarm over the perceived risks of the therapy, STAT reports. The drug, approved to treat Prader-Willi syndrome, which can cause an insatiable feeling of hunger, has been linked to the deaths of seven people and the  hospitalization of nearly 100 others — all since the treatment, called Vykat XR, was approved 18 months ago. Case reports on those deaths and hospitalizations that were submitted to regulators do not prove causality; many of the Vykat cases involved complex medical issues and multiple medications. But some experts say the evidence is sufficient to conclude Vykat is causing unacceptable harm.

The gifts and payments that doctors receive from drugmakers increased inappropriate prescribing and the number of prescriptions written, likely leading to rising health care costs, STAT writes, citing a Cochrane review of dozens of previous studies that have explored the influence the pharmaceutical industry has on medical practice. In addition, pharmaceutical advertising or education aimed at doctors may also increase inappropriate prescribing, probably increases the number of prescriptions written, and may increase the costs of prescriptions. But conflict-of-interest policies that restrict or manage interactions between companies and doctors probably improved prescribing practices.

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Good morning health tech readers!

I’m getting on a train to Boston in couple of hours for STAT Summit. See some of you soon.

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Good morning! You can still buy passes to the STAT Summit — kicking off tomorrow in Boston — if you act fast. The agenda is chock full of fascinating panels and conversations about the state of health care, moderated by some of the newsletter’s familiar faces. Register here.

How many ways can the Trump administration clamp down on international researchers?

In the span of two days last week, the Trump administration issued two sweeping announcements meant to crack down on international students and scholars, who make up a sizable portion of the nation’s biomedical research workforce. On Wednesday, the Department of Homeland Security announced a proposed $70,000 fee for a work authorization program that many foreign students use to gain professional experience. The next day, the Labor Department revealed that it is investigating nine universities — including Harvard, Stanford, and Yale — for alleged fraud related to visas awarded to postdoctoral researchers.

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For the first time in medical and legal history, a prisoner has “survived a complete execution attempt in the U.S.” According to the Death Penalty Information Center, Christa Pike’s failed execution was “the worst we’ve seen and unlike any other botched execution in the modern era (since 1976). There is no precedent.” This game-changing bioethics case may even end lethal injection.

About 7,000 people were executed in the U.S. between 1900 and 1976, and 1,683 people after 1976. Ultimately, since 1900, only 0.6% (55) have been women. Pike is now the second woman on death row the U.S. Supreme Court declined to rescue from a botched execution.

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Two months after the release of an open letter on potential safety issues tied to a rare disease drug sold by Neurocrine Biosciences, patient advocates and some experts are expressing growing alarm over the perceived risks of the therapy.

The drug, approved to treat Prader-Willi syndrome, which can cause an insatiable feeling of hunger, has been linked to the deaths of seven people and the  hospitalization of nearly 100 others — all since the treatment, called Vykat XR, was approved 18 months ago. 

Case reports on those deaths and hospitalizations that were submitted to regulators, and that were obtained by STAT through the Freedom of Information Act, do not prove causality; many of the Vykat cases involved complex medical issues and multiple medications. But some experts say the evidence is sufficient to conclude Vykat is causing unacceptable harm.

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Welcome to Chief Complaint, a new STAT+ column from Frances Mei Hardin, M.D. A former ear, nose, and throat surgeon, she writes about the many challenges facing those who practice medicine in a time of great change.

In some clinical settings, resident physicians have to ask for permission to use the restroom. You read that correctly: Many of these people are approaching or in their 30s, they all have M.D.s and other graduate degrees, and they are still requesting permission to accommodate basic tasks in Maslow’s hierarchy, such as leaving to grab a bite of food or drink, or use the restroom.

And when the beginning of training is marked by infantilizing treatment, even as their responsibility for patient lives quickly grows, it can often lead to something plaguing medicine: learned helplessness, a psychological state wherein a person stops trying to change an unfavorable or unsavory situation because they believe that they have no control over the outcome, even when they do.

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It’s the second time the HHS has tried to kickstart a 340B rebate program — and the second time hospitals have sued to block it, alleging rebates will threaten their financial viability.

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See how workforce and care patterns can sharpen growth decisions beyond a health plan’s service area.

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Americans have more trust in science than most of the rest of the world, according to a new survey of people in 140 countries, a finding that may seem difficult to explain in a country deeply divided by issues such as the benefits and harms of vaccines. 

According to the newest edition of the Wellcome Global Monitor, 52 percent of Americans report having “a lot” of trust in science. Across the globe, that number is a mere 26 percent. 

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An early advocate for the theory that the Covid-19 virus was engineered in and leaked from a lab in China is no longer the leading choice to be America’s top infectious disease expert, a source with knowledge of the decision told STAT.

Steven Quay, a biopharmaceutical executive with no background in infectious diseases, was being considered for an appointment as director of the National Institute for Allergy and Infectious Diseases at the National Institutes of Health, a role once held by Anthony Fauci, according to one person familiar with the discussions. However, Quay instead is expected to take on more of a consulting role for the center, the source said. 

Neither the White House nor the Department of Health and Human Services responded to requests for comment. Quay also did not respond. 

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The American Hospital Association is once again suing the Trump administration over its plan to test revamping a federal drug discount program into one that provides after-the-fact rebates instead of upfront discounts for certain drugs. 

It’s the second time the powerful hospital lobbying group has sued over such a plan. The first time, in 2025, a judge agreed to temporarily halt a more limited version from taking effect, and the Health and Human Services Department voluntarily withdrew the plan after losing on appeal. In February, the agency announced an expanded version, set to take effect Jan. 1, 2027, that would target 25 of the costliest, most widely used drugs covered under Medicare. The original plan included 10 drugs. 

The AHA’s argument is largely the same as in the first case: the government failed to accurately account for the costs hospitals would incur by having to pay market prices for drugs and then apply for rebates. The lawsuit says that the Health Resources and Services Administration, the HHS division that administers 340B, received more than 2,400 comments on the rebate model’s second iteration, including hospitals describing in “granular detail the catastrophic impact” it would have. 

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The gifts and payments that doctors receive from drugmakers increased inappropriate prescribing and the number of prescriptions written, likely leading to rising health care costs, according to a Cochrane review of dozens of previous studies that have explored the influence the pharmaceutical industry has on medical practice.

In addition, pharmaceutical advertising or education aimed at doctors may also increase inappropriate prescribing, probably increases the number of prescriptions written, and may increase the costs of prescriptions. But conflict-of-interest policies that restrict or manage interactions between companies and doctors probably improved prescribing practices, the analysis found.

However, there was not enough evidence to draw clear conclusions on whether free drug samples and other promotions affect decisions to place specific drugs on hospital formularies. These are the list of medicines approved for use and routinely stocked in a hospital or health system.

Continue to STAT+ to read the full story…

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The federal government has released new quality ratings for Medicare Advantage insurers for 2027, with Humana emerging as the biggest winner.

But deep uncertainty remains around Medicare Advantage quality measures, which come with tens of billions of dollars in extra revenue for the highest-performing plans. One health insurance company, Alignment Healthcare, has already threatened to sue the government after its star ratings were downgraded — a now-common occurrence for almost any insurer that is unhappy with its grades.

Nearly 71% of Medicare Advantage enrollees are currently in a plan that will have at least four out of five stars for quality, according to the Centers for Medicare and Medicaid Services. Getting at least four stars triggers bonuses, which total $13 billion across the industry annually. Ratings for 2027 lead to bonus payouts in 2028. 

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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.

This is the Readout. Please read it.

And don’t miss us too much Monday, when the newsletter will be paused for the holiday. We’ll be back in your inbox Tuesday.

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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, so far, rather modest. We plan to catch up on our reading, promenade with the official mascots and celebrate the turning of another page on the calendar with our remaining Pharmalot ancestor. We also hope to hold another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This is the time of year when apples and pumpkins grow lonely, waiting for someone to take them to a nice home. So perhaps a drive in the country is in order. This may also be an opportunity to simply enjoy the great outdoors, given the lovely change of scenery that is taking place. Or you could keep busy by strolling city streets and watching life go by. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon…

Argenx disclosed that its blockbuster drug Vyvgart failed to outperform placebo in a Phase 3 trial of patients with Sjögren’s disease, a chronic autoimmune disorder, marking an unusual setback for the company, STAT says. Argenx has racked up a series of wins in autoimmune disorders en route to becoming one of the world’s largest biotechs based on market cap. William Blair analysts had projected $1.4 billion in peak sales from Vyvgart in Sjögren’s disease but described the trial as high risk, in part because Sjögren’s patients often have high placebo responses. The trial was supposed to be completed next year, but it was stopped early after a data monitoring committee determined the primary endpoint would not be met.

The Food and Drug Administration flagged a potential safety signal after four deaths were reported among patients with treatment-resistant schizophrenia who received investigational evenamide in clinical trials, MedPage Today informs us. In April, the agency halted patient enrollment in a Phase 3 trial for the Newron Pharmaceuticals medicine after the sudden death of a participant. That hold remains in place at U.S. study centers but enrollment continues in other countries, and additional clinical sites are being added. The FDA concern relates to the risk that some sodium channel blockers may trigger arrhythmias that can lead to serious cardiovascular events or seizures.

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Hi there, it’s Sarah. Last night, STAT scored an awards hat trick, taking home a Gerald Loeb — the most prestigious honor in business journalism — for the third year in a row! This year’s Loeb recognized Lizzy Lawrence for her exceptional beat reporting on the Food and Drug Administration. This is also STAT’s fourth Loeb overall in our 11-year history. Not too shabby, y’all.

Does MAHA still matter to voters?

The Make America Healthy Again movement has been credited with helping to propel Donald Trump to a second term at the White House. But as midterm elections draw near, MAHA is nearly invisible on the campaign trail.

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WASHINGTON — Health secretary Robert F. Kennedy Jr.’s Make America Healthy Again movement rushed into American politics with a promise: Let an unlikely coalition of activists reach the masses, and they will deliver revolutionary gains for the Republican Party.

Yet as midterm elections draw near, the movement is nearly invisible on the campaign trail and struggling to find a financial or messaging foothold in key races. To some of its most vocal supporters, the very soul of MAHA is at stake come Nov. 3.

These problems are showing even as some of Kennedy’s ideas, including his critiques of the American food supply and corporate influence, continue to have widespread appeal. MAHA has yet to figure out how to turn those broadly popular themes into tangible policies or causes with political heft. 

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In 2030, U.S. mortality and morbidity rates will suddenly jump. This will happen not because there is a new pandemic or a sudden rise in cases of existing diseases or injuries, or a sudden decline in access to health care. These jumps in rates will occur throughout the U.S., more in some states than others. Within states, these rate changes will be especially noticeable among four groups: college-age people, retirement-age people, people of color, and immigrants.

Even more remarkable, these shocking changes in U.S. health statistics could be averted without any new treatments or changes in access to or quality of health care.

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September marked 50 years since my colleagues and I published a paper describing what became known as interleukin-2, or IL-2, one of the first cytokines to be discovered and a protein essential to the growth and regulation of T cells. Science marked that anniversary with a perspective by renowned immunologists Rafi Ahmed and Steven Rosenberg examining the discovery. Their perspective prompted me to reflect on a question I’ve been asked many times over the years: What has been IL-2’s greatest legacy?

My answer depends on how you define importance.

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Betsy Pleasants was studying one historic disruption to abortion access when a more seismic one emerged.

In spring 2022, as a graduate student at UC Berkeley School of Public Health, Pleasants was researching the effects of the Covid-19 pandemic on abortion services when a leaked draft opinion indicated that the U.S. Supreme Court would overturn Roe v. Wade. The court finalized its decision that June, ending the nearly 50-year-old constitutional right to abortion and ushering in an era of rapid change and increased state restrictions.

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The Trump administration announced Thursday that it is investigating nine universities for alleged fraud related to visas commonly used by postdoctoral researchers, a core part of the nation’s biomedical workforce.

Vice President JD Vance announced during a press briefing that Harvard, Yale, Stanford, Brown, the California Institute of Technology, Arizona State University, the Massachusetts Institute of Technology, the University of Pittsburgh, and UC Davis are under investigation by the Department of Labor. During the briefing, Vance asserted that these schools are improperly using J-1 visas, the main class of visa used by international postdocs, to bring in cheap labor rather than relying on domestic researchers.

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A new proposal in Congress to scrap a surprise billing ban’s controversial arbitration system will need to to survive an onslaught of attacks from provider groups, for whom arbitration has been a gold mine.

After Rep. Frank Pallone (D-.N.J.) unveiled his Lower Premiums, Faster Payments Act on Thursday, it quickly garnered praise from academics and consumer advocates, as well as condemnation from provider groups. It would dismantle the problem-plagued process that’s currently used to resolve disputes between health insurers and out-of-network providers and replace it with a payment system based on median in-network rates. 

Pallone, one of the authors of the No Surprises Act, said in a statement that the law has been an “overwhelming success” when it comes to protecting patients from surprise bills. 

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How has the National Institutes of Health been spending its budget? Why are biotech investors feeling gloomy? And what is the most quintessential Boston movie?

We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast. We bring on STAT reporter Anil Oza and Heather Pierce, senior director of science policy at the Association of American Medical Colleges, to discuss the how the NIH distributed its money in the latest funding cycle and the effects on U.S. biomedical research.

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About 80% of hospitals are having their Medicare payments shaved down over high readmission rates this fiscal year, compared with 78% the year prior, according to new CMS data. It continues a worrying trend.

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STAT has announced its tenth class of Wunderkinds. It’s an impressive group of researchers and clinicians who are making an impact in science and medicine early in their careers. Send news tips and go-getters to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.

Fresh faces

Dozens of Democrats are vying for seats on the House Energy and Commerce and Ways and Means committees in anticipation of Democrats winning back control of that chamber.

Several members from both parties are either leaving or in close races. If Republicans lose the House, most of the departing Republicans will not be replaced by GOP colleagues. But it’s a major opportunity for Democratic lawmakers to get a seat on the high-profile committees, both of which have broad jurisdiction over health care policies.

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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!

I had the pleasure of profiling Yasha Ektefaie, a fellow at the Broad Institute, who is newly announced STAT Wunderkind. Check out our annual list of promising young researchers here.

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WASHINGTON — The Food and Drug Administration says its ongoing safety review of the nation’s main abortion pill will continue into next year, a timeline that was quickly condemned by abortion opponents hoping to see the drug’s use curtailed.

The FDA gave a court-ordered update on its progress in a legal filing late Wednesday, providing the first substantive information about the controversial reevaluation ordered by Health Secretary Robert F. Kennedy Jr.

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Good morning. Let’s get straight to the news.

The need-to-know this morning

Roche goes beyond licensing in deal with Chinese biotech

Over the past few years, pharma companies have flocked to China to license existing drug candidates. Roche is taking a new approach, partnering with Chinese startup Defand Therapeutics to discover new medicines.

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Argenx said Thursday that its blockbuster drug Vyvgart didn’t outperform placebo in a Phase 3 trial of patients with Sjögren’s disease, a chronic autoimmune disorder.

It’s an unusual setback for Argenx, which has racked up a series of wins in autoimmune disorders en route to becoming one of the world’s largest biotechs by market cap. 

Argenx’s stock slipped 13% Thursday morning. 

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Top of the morning to you, and a fine one it is. Clear blue skies are hovering over the Pharmalot campus, where a cool breeze is wafting by and the official mascots are bounding about the grounds in search of critters. As for us, we are engaged in the usual ritual of brewing a cuppa stimulation — our choice today is English breakfast — and foraging for items of interest. On that note, please enjoy the latest menu of tidbits we have assembled for you. As always, we hope your journey is meaningful and productive, and that you conquer the world. And of course, do keep in touch. Our settings make it possible to accept postcards and telegrams …

The trade group representing brand-name drug makers in the U.S. is suing the Trump administration over a pilot program tying Medicare drug prices to those in peer countries, STAT notes. PhRMA filed a lawsuit asserting that the “most-favored nation” pilot in Medicare Part B exceeds Medicare’s statutory authority. The pilot, called GLOBE, is not expected to have much impact because the administration exempted all but a handful of companies in return for their agreement to voluntary deals to charge Medicaid MFN prices. But it would set a precedent that the industry wants to nip in the bud. PhRMA says the voluntary agreements are acceptable, but the mandatory GLOBE program is not.

The Trump administration is crafting plans that would allow the temporary sale of certain previously restricted peptides as federal health officials hammer out new regulations around the controversial products, The Washington Post reports. Such a move would allow some compounding pharmacies to dispense certain peptides marketed as new medical treatments and wellness products even as the claims for what they treat have not been fully safety tested. The plan has not yet been announced and timing was unclear, meaning it could still change.

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Roche is digging deeper into the biotech industry in China, striking a new partnership with a drug startup there. But rather than licensing the startup’s clinical-stage medicines, Roche is enlisting it to discover new ones, signaling a potential shift in global drug development. 

Chinese startup Defand Therapeutics said Thursday that it had signed a collaboration deal with Roche to develop molecular glue medicines. Under the deal, Defand will discover and develop multiple drugs for cancer and immune-driven diseases. The financial terms were not disclosed, but a source with knowledge of the agreement said it could be worth close to $1 billion between the upfront fee and payments Defand could get if it meets various preclinical, clinical, and regulatory goals. 

Molecular glue therapies are a buzzy new area of drug development, designed to create a sticky, more effective connection onto problematic proteins to destroy them. Development of these drugs has just begun to accelerate, thanks in large part to the data from Revolution Medicines, showing its molecular glue treatment Rasonque nearly doubled the survival rate of patients with pancreatic cancer. 

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

If you’re into online gambling, I think it’s worth mentioning that STAT predicted optogenetics’ success and a potential Nobel almost a decade ago. We said, “it hasn’t won a Nobel yet, but it’s been on some informal watchlists for a few years.” Skip Kalshi, subscribe to STAT, instead.

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WASHINGTON — A broad tariff on imported pharmaceuticals took effect at the end of September, and some biopharma companies and the industry group that represents them say many are being left in the dark on how to get exemptions. 

The Trump administration announced a 100% section 232 tariff in April, impacting imports of patented drugs and their active ingredients. At the time, the White House offered a number of pathways for companies to reduce their tariff burden, including striking a most-favored nation deal to sell drugs in the U.S. at similar prices to other wealthy countries or agreeing to bring production to the U.S.

Companies that made MFN agreements would have had start paying tariff costs in July, but now aren’t on the hook for payment until early 2029, per their agreements. That exempts many of the biggest U.S. drugmakers, while leaving smaller biotech firms to face the levies.

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WASHINGTON — Two powerful House committees with jurisdiction over health care policies are expected to get several fresh faces after the midterms.

The combined impact of a potential wave election and multiple departing lawmakers could open up plenty of seats on the Energy and Commerce and Way and Means committees. Similar jockeying is going on for key Senate committee roles, as STAT previously reported.

The new cast of characters will mean that lobbyists will be busy visiting the offices of lawmakers with which they might not have had much interaction. 

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Some Medicare patients owe more in coinsurance than the hospital paid for their drug. That arithmetic sounds impossible. It is a consequence of the 340B drug discount program and Medicare’s payment formula. Now the Department of Health and Human Services, where I work, is proposing to narrow that gap.

Congress created the 340B drug discount program in 1992 to financially support safety net hospitals that serve low-income patients. Drug manufacturers must give them steep discounts. But Medicare, Medicaid, and commercial insurers generally reimburse them at the full amount, allowing these hospitals to keep the spread above the discounted purchasing costs.

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In September, “Baywatch” star Pamela Anderson opened up about her hepatitis C diagnosis in the 1990s. “It was a death sentence,” she said while accepting the Award of Courage from amfAR, an organization supporting HIV/AIDS research and advocacy. When she was diagnosed, she said, her doctor told her that she might only live another 10 years.

Her story is a good reminder of the amount of global progress that has been made in preventing and treating hepatitis C in just the last decade — and how far the U.S. has to go to catch up to our European neighbors.

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“Don’t wait. Choose to be informed.” 

That’s the call to action that patients will find on the site for digital health company Everlywell, which has offered at-home lab tests directly to consumers for a decade. But last week, it wasn’t marketing a prick to measure blood glucose or screen for celiac disease: It was launching one of a new generation of AI-based risk prediction algorithms for medical images. 

For $249 in cash, eligible patients can now come to the site, share a recent mammogram, and receive a prediction of their five-year breast cancer risk. It’s generated by an AI algorithm called Clairity Breast, which received de novo authorization from the Food and Drug Administration last May. 

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