You may not have heard of David Geier, but news that he was hired by HHS to conduct a federal study on immunizations and autism has been met with dropped jaws among vaccine experts, STAT’s Helen Branswell reports. “My first thought was … is this a hoax?” British investigative journalist Brian Deer said to Helen.Geier (who does not have a medical degree) and his father (who has the degree but, in multiple states, lost his license to practice) have long promoted claims that the use of the preservative thimerosal in vaccines led to an increase in autism diagnoses. There’s stacks of studies refuting that allegation, and the fact that autism rates have not gone down in the two decades since it was phased out of most vaccines. Read more from Helen about Geier’s resume and the concerns that experts have raised.biotechSoleno’s ‘life-changing’ drug for Prader-Willi approvedThe FDA yesterday approved the first medicine to treat people with Prader-Willi syndrome, a rare genetic disease that causes an insatiable desire to eat. The drug, a once-daily pill called Vykat XR, was developed by Soleno Therapeutics.Vykat is not a cure, but in clinical trials, the medicine was shown to reduce hyperphagia, the incessant desire to eat, and other related behaviors in people with Prader-Willi. One endocrinologist who has treated patients with the drug in clinical trials said it is “nothing less than life-changing.”Soleno has identified through claims data approximately 10,000 people with Prader-Willi in the U.S. Read more from STAT’s Adam Feuerstein. ‘Black boxy’ telehealth-pharma partnershipsAs drugmakers like Pfizer and Eli Lilly turn to telehealth platforms as a way to get their treatments to patients, the practice is drawing scrutiny from  Senators who want to determine whether the relationships violate the federal anti-kickback statute. But the deals also caught the eye of academics Ateev Mehrotra, Olivier Wouters, and Erin Fuse Brown. In a new paper in the New England Journal of Medicine, the Brown University researchers explore how the partnerships might increase access to care but may also lead to inappropriate prescribing.STAT’s Katie Palmer caught up with Mehrotra and Wouters who explained the challenge of assessing the impact of the “black boxy” deals without more information.Read more hereA diagnostic chatbot and other new ‘breakthrough’ devicesWe updated our tracker of experimental medical devices that have received “breakthrough” status from the Food and Drug Administration because they may offer more effective treatment or diagnosis than the current standard of care. The designation can ease a device’s path to marketing authorization and can help with publicity and generate interest from investors. As STAT’s Lizzy Lawrence writes, at least 15 manufacturers announced a breakthrough designation between December and mid-March.New breakthrough devices include PathChat DX, a generative AI chatbot from Modella AI that helps pathologists diagnose cases. The device is based on a model developed at Mass General Brigham. Other additions: A breast cancer test, a breast cancer imaging tool, and two Alzheimer’s blood tests.Read more hereresearchHow are AI scribes helping?Earlier this week, the Peterson Health Technology Institute (PHTI) issued a report that assesses health systems’ experience with AI ambient scribes so far and zeroing in on the technology’s “financial and operational implications.” The report says about 60 scribes are adopted in the market, and while many pitch themselves as time savers, the PHTI finds that evidence of time savings is limited. The report also explores how scribes may result in higher health care costs. My colleague Brittany Trang brings us this cheat sheet:PHTI made some great tables summarizing the companies in the AI scribe space and the studies that have been conducted so far on them. But if you’re short on time, skip to the “Looking Ahead” section on page 28, which covers the basics: Health systems adopt AI scribes to address provider burnout, which is why hardly anyone has put any effort into measuring any other sort of return on investment. But as the technology gets more popular, health systems will need to justify the spending. The report warns in multiple places that AI tools could increase costs in several ways: “On the one hand, enhanced documentation quality could lead to higher reimbursements, potentially offsetting expenses — but also leading to unintended downstream consequences for patients and the market overall. On the other hand, the cumulative costs of the software may be greater than any savings achieved through improved efficiency, reduced administrative burden, or reduced clinician attrition,” write the authors.PHTI notes that the industry “is grappling with the immense potential of these tools and the evolving understanding of their strengths and weaknesses. Critically, there is a need for more standardized methodologies and metrics to understand performance across a range of indicators and for more research to understand their long-term impact on efficiency.” The chart above describes some metrics that might be used in evaluation as well as an early look at what the evidence tells us today. from AXIOS:Health players seek tariff reliefBy Adriel Bettelheim and Tina Reed Illustration: Sarah Grillo/Axios Medical device makers, hospitals and other key health industries are pressing to gain exemptions under the Trump administration’s new tariff regime with the next and most aggressive actions to date due to be unveiled next week.Why it matters: About $303 billion of imported drug, biotech and device industry goods entered the United States in the last year — $294 billion of which entered duty-free, according to PwC.Health care’s heavy reliance on foreign countries for raw materials and manufacturing means new levies could result in higher prices for providers and consumers and supply chain disruptions, PwC said.State of play: On April 2, Trump is expected to impose reciprocal tariffs, potentially on dozens of countries, at levels still unclear. He refers to that as “the big one,” though he’s lately hedged on just how big it might be.He’s also expected to lift a pause on 25% tariffs against Canada and Mexico, which have been imposed and delayed repeatedly.The administration previously increased tariffs on imports from China to 20% (and threatened recently to go higher), targeting a key country for drug ingredients, testing and R&D.This week, Trump also said he would be announcing tariffs specifically targeting pharmaceuticals in addition to autos. On Wednesday, he announced 25% duties on imported cars.“There is one person who knows what the plan is and he’s making the decisions,” a person familiar with the discussions between industry and the White House told Axios. “A lot of people are trying to help him understand the consequences.”Between the lines: There’s growing concern that the tariffs, as envisioned, could sharply drive up hospital costs and cause upheaval for pharmaceutical and med tech manufacturers.Health industry professionals in a recent Black Book Research survey predicted health systems costs will surge by at least 15% in the next six months due to increased import expenses.AdvaMed, the medical device trade association, has been among the groups lobbying for exemptions — in its case, one that would resemble a carve-out provided for most medical devices during President Trump’s first term for tariffs on China.Major med tech companies like Abbott Laboratories and Baxter International have operations in Mexico, Raymond James analysts wrote in an investor report late last year.Other health groups that have lobbied for exemptions include the American Hospital Association and the Healthcare Distribution Alliance.More hereHHS cancels over $12B in health care grantsBy Maya Goldman and Sabrina Moreno Illustration: Annelise Capossela/Axios The Trump administration is canceling billions of dollars in grant funding to state and local health departments without warning, throwing their programs into disarray.Why it matters: The move casts doubt on states’ ability to continue substance use disorder support programs and prevent emerging infectious diseases, among other efforts.In Virginia, the state health department has already begun laying off staff as a result of the funding cuts.Where it stands: The CDC expects to claw back about $11.4 billion from states, which was largely directed toward COVID-19 testing, vaccination and initiatives to bridge health disparities, HHS confirmed to Axios.The administration also canceled about $1 billion in grants that had been made possible by COVID-19 relief legislation and dispersed by the Substance Abuse and Mental Health Services Administration, HHS said.Zoom in: Community health workers, nurses and epidemiologists in Virginia have begun receiving termination notices, several current and former Virginia Department of Health employees familiar told Axios.One worker who was laid off told Axios that the department’s central office sent out an email Tuesday night about the grant changes.By Wednesday morning, people were laid off and locked out of the agency system.Go deeper

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