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Health secretary Robert F. Kennedy Jr. announced Thursday a new effort to improve autism diagnoses, arguing that the current model is outdated, too time-intensive, and overreliant on professionals with limited availability. 

“We are not satisfied simply for describing autism and managing its consequences. We are asking what drives the different forms of autism, and why developmental trajectories differ, why some children regress, and which interventions work for them,” Kennedy said during his keynote address at a conference for Children’s Health Defense, an anti-vaccine organization he previously led. 

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For years, researchers have known that, among people diagnosed with lung cancer, the prevalence of nonsmokers has been increasing. But they have been trying to determine what factors — whether genetic, environmental, or something else — might put these “never-smokers” at heightened risk. 

Now, researchers have identified a very rare genetic variant that is associated with 25-fold higher odds of lung cancer, they reported in the journal Science on Thursday. In the U.S., the variant is far more common among people in Southern Appalachia than in other regions. 

Experts said that the variant likely only plays a role in a small portion of never-smoker lung cancer cases. But the research provides further evidence that these types of tumors can be tied to distinct risk factors, which may in turn require thinking differently about screening programs and treatment strategies. More broadly, the new study highlights the types of narrow but crucial discoveries that can be made by turning to large datasets replete with health information from millions of people. In this case, the investigators relied on genetic data from 23andMe. 

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The Food and Drug Administration on Thursday approved a new gene therapy for Sanfilippo syndrome type A, an ultra-rare disease sometimes known as childhood Alzheimer’s.

The therapy, called Fayuvi, was developed by Ultragenyx. It is the first drug specifically approved to treat Sanfilippo. Ultragenyx did not immediately release a price.

“It’s hard to overstate what this approval would mean for everybody who is living with this really horrific disease and watching their children suffer and pass away early, and all the rest that it brings,” Cara O’Neill, chief science officer of the Cure Sanfilippo Foundation, said in an interview earlier this week. “This, gosh, would just finally mean when patients and families receive this shocking diagnosis, they wouldn’t be told to … take their kids home and love them. They would be given hope and an action plan for treatment.”

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WASHINGTON — Health secretary Robert F. Kennedy Jr. returned to his roots on Thursday during a keynote address at a conference hosted by the Children’s Health Defense, an anti-vaccine nonprofit he helped start. 

The CHD speech served as a victory lap for Kennedy at a key moment for the MAHA movement — just before midterm elections that could determine the viability of his agenda, and serve as a referendum on the GOP’s approach to health care reform. Kennedy, who previously downplayed his work sowing doubt about vaccine safety, has now made it central to his legacy as health secretary. 

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WASHINGTON — Health secretary Robert F. Kennedy Jr. on Thursday named eight new members to the U.S. Preventive Services Task Force, an influential panel of experts who assess the evidence behind a wide array of preventive medical services. 

Five of them are medical specialists in fields such as gastroenterology and oncology. That’s a major departure from the past, when the panel was made up of generalist clinicians. Another is a finance professor who has expertise in health insurance.

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International researchers got a reprieve in the courts this week. But many are still considering leaving the states for opportunities elsewhere. What does that mean for the future of American medical research?

We discuss that, plus the latest news in the life sciences, on this week’s episode of “The Readout LOUD.”

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The American Enterprise Institute spotted a potential gambling loophole in the GOP’s new Medicaid work requirements law. Send news tips and desperate schemes to keep health insurance to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.

What might Democrats’ oversight mean for the health care industry?

Democrats are widely expected to do wall-to-wall investigations of the Trump administration if they flip either the House or Senate. While there’s been talk of taking on high profile issues like Jeffrey Epstein, immigration, presidential pardons, and Trump and his family’s involvement in cryptocurrency and government contracts, there also is ample room for health care investigations.

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The FDA’s new hiring push is hitting some complications. Also, a startup is bringing a psychedelic-esque drug to Parkinson’s, and we’ve got mice with human-esque brains.

This WIRED video on Stone Age AI slop is on in the background for me right now, and I enjoy this quote from anthropologist Agustín Fuentes: “Why invent garbage when you actually have science?” 

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What would you call the mice with half-human brains detailed in Megan Molteni’s story? I chose mousensteins, but there are definitely better answers.

FDA still haunted by DOGE cuts

In April 2025, Elon Musk’s U.S. DOGE Service took a chainsaw to the Food and Drug Administration, slashing 3,500 workers and triggering a broader staff exodus. More than a year later, the FDA is trying to add more than 2,000 employees back, but it can’t — thanks to the same DOGE cuts.

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Hello there. It’s STAT reporter Andrew Joseph here, filling in for Mr. Pharmalot for the day. We’re still mulling this fascinating story from our colleague Megan Molteni about “neuro-chimeric” mice with half-human brains. While Megan’s story lays out both the scientific achievement and the ethical concerns of the new research, we’re left with the question — could these mice find a piece of cheese in a maze faster than regular mice? Something to ponder perhaps as you consider today’s headlines…. 

For all the talk of a hiring spree at the U.S. Food and Drug Administration, the reality is more complicated and filled with bureaucratic delays, STAT shares. The cause is the same DOGE cuts that wiped out thousands of jobs earlier in the Trump administration, which in turn have created bottlenecks and confusion in the hiring process. Now, prospective new employees are stuck in pre-onboarding limbo, while other routine administrative tasks, like purchase approvals and travel payments, have fallen by the wayside. 

Bavarian Nordic appointed former Sanofi executive Tarja Stenvall as its new chief executive officer, Bloomberg writes. The announcement resets the company’s leadership after a failed takeover bid led both the chairman and CEO to step down from the vaccine maker. Stenvall replaces Paul Chaplin, whose departure was announced earlier this year, and will start Oct. 15. The Danish company is best known for its smallpox shot that is also used against mpox.

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Two years ago, Mohit Gupta, an analyst who works for Adar1 Capital’s Dan Schneeberger, walked into Schneeberger’s Austin, Texas, office and pitched an idea to build from the ground up a new company to develop a better, long-acting antibody treatment for atopic dermatitis.

Schneeberger’s day job, of course, is to invest in biotech companies that are already developing drugs, not start one on his own.

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Sellas Life Sciences Group is a blowup waiting to happen. My prediction: Sellas’ experimental immunotherapy will fail to prolong survival compared to standard treatment for patients with acute myeloid leukemia in a second remission.

I’m confident in my prediction the company’s Phase 3 REGAL study will have a negative outcome; I just don’t know when it will happen. The conclusion of the event-driven study has already been delayed by nearly a year — raising significant doubts about the efficacy of the Sellas treatment, called galinpepimut-S, or GPS.

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WASHINGTON — To hear Food and Drug Administration leaders tell it, everything is going swimmingly — a far cry from the dark days of April 2025, when Elon Musk’s U.S. DOGE Service took a chainsaw to the agency, slashing 3,500 workers and triggering a broader staff exodus. 

Just over a year later, Musk is out and hiring is in. The FDA is now looking to add more than 2,000 workers.

“We’re very actively hiring,” Karim Mikhail, director of FDA’s Center for Biologics Evaluation and Research, told drug manufacturers at a conference Monday. On social media, the agency trumpets its new employees with group photos, declaring “Welcome to FDA!’’

Yet for all the talk of a hiring spree, the reality is more complicated, STAT has learned: The FDA’s hiring push is mired in bureaucratic delays, thanks to the same DOGE cuts the agency is trying to address. 

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“Can you check my child for PDA?” the mother asked me on the telephone about two years ago. Though I had been a behavioral/developmental pediatrician for more than four decades, the only PDA acronym I could recall came from my days as a general pediatrician: patent ductus arteriosus (a persistence of embryonic circulation around the heart).

“Gee, I’m not sure,” I said. “What does PDA stand for?”

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LONDON — English health authorities on Thursday agreed to provide a breast cancer drug from AstraZeneca through the National Health Service, ending a years-long dispute that stoked questions about how committed the pharma company was to the U.K.

Notably, the move — one that will extend the drug, called Enhertu, to an estimated 1,000 people in England — is in part a result of a U.S.-U.K. drug pricing deal reached late last year. Under the pact, a U.K. health agency agreed to raise the thresholds for what would be considered a cost-effective drug and worth paying for on the NHS.

Now, women with metastatic breast cancer whose tumors have low levels of the protein HER2 will be eligible to receive Enhertu, a type of next-generation chemotherapy known as an antibody-drug conjugate. AstraZeneca noted that Scotland has covered the drug since 2023, and it’s paid for in 26 other European countries. (Patients with HER2-positive cancers have been able to get Enhertu in England.)

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A group of researchers are suing the National Institutes of Health for allegedly infringing on their freedom of speech by screening grants for certain words and phrases when making funding decisions. 

The suit, brought by 13 named and four anonymous researchers, is seeking to halt the process of searching applications and current grants for specific terms to determine if they should be rejected. The screening process has largely focused on research grants on topics that the Trump administration disfavors, including efforts to diversify the research workforce, or studies on health disparities, climate change, and vaccines. Because the case was filed as a class action lawsuit, if a judge sides with the plaintiffs, that decision will apply not just to the 17 scientist plaintiffs, but to any researcher whose work has been affected by the term searches. 

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WASHINGTON — Normally, discussions about how congressional advisers study Medicare spending are quite dry. Not so at the House Ways and Means Committee on Wednesday.

In a party line vote, committee Republicans pushed forward a bill that seeks to change how the Medicare Payment Advisory Commission studies Medicare Advantage spending. In particular, this bill would direct the nonpartisan agency to study the topic of overpayments to Medicare Advantage plans in a manner that’s more favorable to insurers.

Medicare Advantage insurers have come under increased scrutiny in recent years in part for their cost to taxpayers. MedPAC this year estimated that Medicare will pay 14% more per enrollee, or $76 billion in total, to Medicare Advantage plans than it would if those same seniors were covered by traditional Medicare.

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WASHINGTON — Over two days, senators on two key committees focused on the authority Chris Klomp already wields, and how he would use this power should he be confirmed as second-in-command to health secretary Robert F. Kennedy Jr. 

Klomp, nominated to be deputy secretary of the Department of Health and Human Services, has already played a major role in the Trump administration’s Make America Healthy Again agenda. He has helped negotiate the deals the administration has made with pharmaceutical companies to offer lower prices, conducted searches for high-profile hires, and acted as a liaison between HHS and the White House. 

“Part of my responsibility is to enable the smooth operations of the department. I’m responsible for personnel, among other things,” Klomp told the Senate Finance Committee on Tuesday. “My job is to make sure that we have everything.”

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There is reason to be cautiously optimistic about the trajectory of the current Ebola outbreak in the Democratic Republic of the Congo, the director-general of the World Health Organization said Wednesday.

In a news conference in Geneva, Tedros Adhanom Ghebreyesus said disease transmission rates are declining in most of the affected provinces, though he warned there are months of work remaining to get the outbreak under control.

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For the last decade, scientists have been steadily getting better at growing “cerebral organoids,”  miniature, three-dimensional brain-like structures, from human stem cells in the lab. Now, a group from Stanford University has found a way to advance their usefulness for studying brain development and disease — by instead growing them inside mice that have had large parts of their own brains genetically removed. 

Neuroscientists say these “neuro-chimeric” mice, whose brains are half-human — by volume, not by number of neurons — are an important innovation for a field hampered by longstanding challenges in accessing human brain tissue for research. But such models also raise a host of ethical questions that will get thornier the more advanced they become. 

In a study published Wednesday in Nature, the Stanford team reported finding types of human cells inside the brains of 3-month-old chimeric mouse pups that are very hard to obtain in a dish. They included pyramidal projection neurons that had wound their way into some of the animals’ spinal cords. The scientists also found evidence of specialized, super-sized neurons involved in social cognition only found in large-brain mammals like elephants, whales, and primates, including humans. 

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Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a needed cuppa stimulation. Our choice today is pomegranate green tea, which we discovered while digging about our pantry. Meanwhile, here is the latest menu of tidbits to help you on your way. We hope you conquer the world and have a wonderful day. And as always, please do stay in touch. Tips, criticism, and all sorts of feedback is always appreciated. …

The U.S. Food and Drug Administration is opening applications for a pilot program designed to shorten the time it takes for drugmakers to begin testing their products in humans, STAT notes. The pilot was first announced in June as part of Operation TrialBlazer, a U.S. Department of Health and Human Services initiative that pledged to shorten FDA drug approval timelines and help the U.S. compete with the rapidly accelerating biotechnology industries in countries like China and Australia. The pilot program seeks to create a network of “qualified research institutions” that will partner with companies to develop and review their Investigational New Drug application packages.

Investors on the libertarian fringe of the biotech industry are making their dream of widespread access to experimental drugs a reality in Montana, Politico explains. Last year, they helped draft a state law to expand access to drugs that no regulator has deemed safe and effective. Now, Montana is relying on a privately run board to decide which treatments to offer — raising concerns about conflicts of interest and, in an industry rife with unfounded claims, whether patients will get value for their money. The company in charge works with biotech firms in a zone off the coast of Honduras that has no drug regulator. Startup biotech firms hope Montana will serve as their shortcut around the FDA’s costly and extensive drug development process.

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Good morning. We’ve got a D.C.-heavy newsletter for you today.

FDA starts program to get drugs in the clinic faster

The FDA is opening applications for a pilot program designed to speed up the timeline for drugmakers to enter the clinic.

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The Trump administration is expanding Medicare’s new technology-based payment experiment to cover more chronic conditions, including COPD, substance use disorder and tobacco cessation.

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Good morning. A family member told me he’s trying to eat 30 different plants each week for a diverse gut microbiome. The list includes whole foods, of course, but also spices and herbs. Is this backed by science? I have no idea. Is it fun to compare lists at the end of the week? You bet. 

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WASHINGTON — Democrats are vowing to aggressively pursue oversight if they win control of either the House or Senate in November’s midterm elections. Health care issues, including President Trump’s drug pricing deals, are potential targets. 

It’s common for parties to turn to oversight when they take control of a congressional chamber. Lawmakers can use oversight to tell a story about the other side. It also avoids intraparty divisions by focusing attention on what the other party has done. And if Democrats want to keep the focus on Trump, even though he can’t run again, oversight is a good way to do that.

If Democrats flip either chamber, they’ll gain subpoena authority, giving them the power to force the administration and company executives to testify and respond to inquiries. However, the administration could forcefully push back on those efforts. 

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When I teach the structure of cancer to first-year medical students, I go well beyond the causes and mechanisms of the disease. Medicine has changed since my own siloed training in pathology. Now many medical schools leap into humanism. In addition to learning about pathophysiology, cancer genetics, bloodwork, scans, and symptoms, students where I work meet a cancer patient, the patient’s family, and oncologist. They come to understand the decisions, treatments, and emotions that followed a difficult diagnosis and prognosis.

The patient they learn about is me. The tumors, test results, and treatments I present? Mine.

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Hot summer days are fading fast, but the midterm election season is heating up. In the race up to Nov. 3, among the top issues are the economy, health care, and immigration. All three are deeply connected to another issue that needs attention: dementia.

As many as 7.1 million Americans are living with dementia, and 12 million friends and family are performing the work of caregiving. Their mental anguish, out-of-pocket expenses, the time caregivers devote to their work, the wages lost from forgone work — all create spectacular costs for America’s families. In the coming years, as Americans age, this anguish and costs will only grow.

Dementia is clearly a big problem, and yet, sadly, our politicians — both Democrats and Republicans — talk about it not like adults, but like schoolyard bullies. They use the word as a vicious rhetorical cudgel to mock and deride an opponent’s mental fitness. This was especially true in 2024, when politicians accused opponents of having dementia. Sadly, the name-calling continues this midterm election.

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NEW YORK — Pennsylvania officials have reported a fourth measles-associated death.

The latest death involved an 18-year-old resident of Mifflin County, in the center of the state, the county coroner’s office said in a Facebook post. The cause was acute disseminated encephalomyelitis, a rare and severe neurological complication of measles, it said.

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Physio Solutions, which does business as medlitix, is the 17th company certified to settle out-of-network payment disputes under the No Surprises Act as arbiters face increasing scrutiny from researchers and lawmakers.

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After ProPublica reported that a Russian close to Putin bankrolled Donald Trump Jr.’s wedding on a private island, Don Jr.’s wife said the oligarch is a “dear friend” who gave a generous wedding gift. Send news tips and a stand mixer to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.

The need-to-know this week

  • Today, the Senate Finance Committee will hold a confirmation hearing to consider Chris Klomp as deputy secretary of Health and Human Services and Ge Bai as assistant HHS secretary. The Senate health committee will hold a courtesy hearing on Klomp’s nomination tomorrow. Heidi Overton, President Trump’s pick to run the Food and Drug Administration, is absent from the confirmation hearing list. She was formally nominated on Monday.
  • Today, the House Energy and Commerce subcommittee on health will hold a hearing on 17 health care bills, including proposals to increase Medicare payment to doctors.
  • The House had scheduled a health care fraud bill for a floor vote, but it was taken off the agenda. It’s unclear whether it will resurface or whether Republicans will consider a different fraud bill that is less partisan. Fraud bills generate significant savings, which could be important if lawmakers attempt to pass health care measures during lame duck.
  • On Thursday, health secretary Robert F. Kennedy Jr. will give a keynote address at a Children’s Health Defense conference. Other speakers include Sens. Ron Johnson (R-Wis.) and Rand Paul (R-Ky.).

RFK Jr., full circle

Kennedy’s speech at the anti-vaccine Children’s Health Defense conference is his first public embrace of the group since taking over at HHS, Isa Cueto reports.

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WASHINGTON — The Food and Drug Administration is opening applications for a pilot program designed to shorten the amount of time it takes for drugmakers to begin testing their products in humans, the agency announced Tuesday. 

The pilot was first announced in June as part of Operation TrialBlazer, the Department of Health and Human Services initiative that pledged to shorten the FDA’s drug approval timelines and help the U.S. compete with the rapidly accelerating biotechnology industries in countries like China and Australia.

“Too often, the U.S. pathway can be measured in years, while other countries’ pathways are measured in months,” the department wrote in the TrialBlazer roadmap. 

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A Medicare experiment in paying for technology to help people manage chronic conditions has just barely gotten underway, and already, officials are moving to expand it.

Announced last year, the ACCESS model will pay approved companies to manage the chronic conditions, including diabetes, high blood pressure, chronic musculoskeletal pain, depression, and diabetes. The model introduces outcome-aligned payments, in which providers are paid more if their patients’ conditions improve.

Regulators on Tuesday announced that they would expand the number of chronic conditions that will be eligible for the ACCESS model to include substance use disorder, heart failure, chronic obstructive pulmonary disease tobacco use, and longer-terms support for musculoskeletal conditions. The new condition tracks will start in spring 2027.

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Nurses in the U.S. can use Oracle’s clinical artificial intelligence agent to search for and navigate patient charts via voice commands and generate nursing summaries, the company announced Monday.

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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 cuppa stimulation. Our choice today is ginger peach. 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. …

Doctors, veterans, pharmacists, and therapists urged the U.S. Food and Drug Administration to establish clear safety ‌and access standards for psychedelic therapies during a four-hour public meeting on Monday convened by the agency amid efforts to speed development, Reuters reports. The hearing was the latest in a months-long push by the Trump administration to bring qualified psychedelic drug programs to market. Discussions at the ​meeting focused on practical issues that could shape how psychedelic therapies are tested and delivered, including provider training ​and credentials, patient screening and monitoring, access and reimbursement, clinic capacity, and collecting long-term ⁠safety data.

GSK has continued its drive to bulk up its pipeline, taking global rights to a multiple myeloma treatment, which was developed by China’s Chimagen Biosciences, for up to $750 million, Pharmaphorum writes. The deal focuses on a “potential first-in-class” trispecific T-cell engager that, according to GSK, promises to combine good targeting of multiple myeloma cells but also offer improved safety compared to other TCEs for the blood cancer, which it says have suffered from “difficult tolerability profiles.” Chimagen’s unidentified candidate is currently in preclinical-stage development and due to start human testing next year.

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Good morning. I was devastated to find out that we’ll no longer get sunsets after 7 p.m. until next spring.

The need-to-know this morning

  • Legend Biotech appointed Ingrid Zhang as its new CEO. Zhang is a former Novartis executive. She replaces Ying Huang, who resigned in July.

With strong data, Vera to seek full approval of kidney drug

Vera said this morning that its recently launched drug stabilized kidney function and reduced the risk of kidney-related death and other complications in a two-year trial of people with a chronic autoimmune kidney disease.

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Good morning health tech readers!

Football season is underway, and I appreciated this piece reckoning with the human toll of the game. 

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Hello, I’m Amanda Erickson! For the past year, I’ve been editing Morning Rounds. Now, I’ll be writing the newsletter twice a week, on Mondays and Tuesdays. I’m very excited to share the latest health and science news. I’m also eager to hear from you: tell me what you like about the newsletter, what’s not working, and what you want to see more of. (If you have any favorite medicine memoirs, send those over as well! I’m still working on my fall reading list.)

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Vera Therapeutics said Tuesday that its recently approved drug Trutakna stabilized kidney function and reduced the risk of kidney-related death and other complications in patients with a chronic autoimmune kidney disease, according to final, two-year results from a Phase 3 clinical trial. 

In July, the Food and Drug Administration granted accelerated approval to Trutakna for the treatment of IgA nephropathy, or IgAN, a disease caused by the buildup of immune antibodies in the kidneys. The condition leads to progressive loss of kidney function and potentially organ failure requiring dialysis.

With the final data from the study in hand, Vera said it will seek full approval of the drug from the FDA during the fourth quarter. 

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Spaceflight is a risky business. Keeping astronauts healthy, especially their hearts, has driven Benjamin Levine’s career as a top consulting cardiologist to NASA. Now that a Mars mission is on the horizon, his most recent research continues to test how well exercise maintains the heart’s structure and function during prolonged spaceflight.  

In their paper published Tuesday in Circulation, an international team reports results from 13 astronauts who performed onboard echocardiograms during their six months in space. That imaging showed mild but transient changes in the heart when moving from Earth gravity to microgravity, revealing how long-duration spaceflight affects cardiac size and function, and what happens when landing on Earth and in simulations of Martian gravity. 

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