In this week’s edition of InnovationRx, we look at HHS nominee Robert F. Kennedy Jr.’s first Senate confirmation hearing, the chaos at the NIH and with federal research funding, new dosages for an Alzheimer’s drug, a major tuberculosis outbreak, and more. To get it in your inbox, subscribe here.
This morning, Robert F. Kennedy, Jr. testified at a confirmation hearing in front of the Senate Finance Committee as the legislative body weighs whether to approve his appointment as Secretary of Health And Human Services, which oversees the National Institutes for Health, the Center for Medicare and Medicaid Services, the Food and Drug Administration and the Centers for Disease Control.
Predictably, Kennedy drew fire for his long-time advocacy against vaccination. Although he described himself as “pro-vaccine” at the hearing, many Senators were unconvinced. Several Senators, including Ron Wyden, D-Ore., and Elizabeth Warren, D-Mass., criticized his involvement in a measles outbreak in Samoa in which more than 80 unvaccinated people died. Warren also criticized Kennedy for refusing to decline the referral fees he gets from ongoing lawsuits against pharmaceutical companies over vaccine claims.
Abortion was also a major issue in the hearing, with politicians from both parties trying to get clarity about Kennedy’s position on abortion and other reproductive care. Republican Senators raised questions about FDA regulation of abortion drug Mifepristone as well as his commitment to Trump Administration policies on abortion. “I serve at the pleasure of the President,” Kennedy told Senator James Lankford Rep.-Okla.. “I will implement his policies.”
You can read our whole liveblog of today’s hearing here, and bookmark the link, because we’ll be following along tomorrow for Kennedy’s second confirmation hearing, this time in front of the Senate Health, Education, Labor and Pensions committee. The timing of the final vote is not yet clear.
In A Week Of Chaos And Trump’s Attempts To Freeze Funding, Scientists Fear For Critical Medical Research
Last Wednesday, around 1:30 p.m. Pacific time, Esther Choo, a professor of emergency medicine at Oregon Health & Science University, got an email that the NIH study section she was slated to sit on the next day was cancelled. Within hours, word of NIH meeting cancellations pinged across the social platform Bluesky, causing fear and anxiety among scientists as it became clear that those cancellations were part of President Trump’s “pause” in meetings and communications and involved all stages of scientific proposals in the grants review process.
The NIH is the crown jewel of American scientific research, investing most of its $47 billion budget on medical research. Without the NIH meetings, known as study sections, the agency can’t review grants and thus can’t make research awards. Those funds are critically important in helping researchers study cancer (the National Cancer Institute’s budget, at $7 billion, is the largest among NIH institutes), Alzheimer’s disease, diabetes and opioid addiction, among numerous health issues. Pretty much every major university or medical institution – from Johns Hopkins University to Massachusetts General Hospital – relies on federal grants to fund research.
“A lot of people are in limbo,” Rebeca Burdine, a Princeton professor of molecular biology, told Forbes. “That’s where you’re seeing the panic because we just don’t know.”
On Monday, acting NIH director Matthew Memoli put out a memo clarifying that clinical trials at the NIH and its funded institutions are ongoing, labs can purchase “necessary supplies” for research that predates Trump’s inauguration and meetings regarding research from before January 20 can also continue. The memo was unclear about what would happen to pending grants, but the NIH, in a subsequent emailed statement that confirmed the details in that memo, stated: “At this time, no new studies are being launched.”
Soon it was clear that Trump’s effort to halt funds wasn’t just about health and science as the White House paused all federal grants and loans in a memo from the Office of Management and Budget. The memo called for each agency to do a review to ensure its grants and loans fit Trump’s executive orders, which, among other things, want to ban all diversity, equity and inclusion efforts. On Tuesday, a federal judge granted an administrative stay in a case that challenged Trump’s funding freeze, with a hearing set for Monday.
The issues at hand go far beyond healthcare – by freezing funds, Trump was trying to assert power over the federal purse and fundamentally transform the relationship between the President and Congress. On Wednesday, OMB rescinded the freeze on federal funding in a new memo.
BIOTECH AND PHARMA
The FDA approved monthly maintenance doses for an Alzheimer’s drug, called Leqembi, from Japan’s Eisai and Biogen. Patients with early Alzheimer’s can receive the maintenance doses after 18 months of getting twice-weekly ones. A phase 2 clinical study found that the doses could be spaced out after the first year-and-a-half on the drug while still keeping the brain plaques believed to be a hallmark of Alzheimer’s disease from accumulating. The drug had received standard approval from the FDA in 2023, but its growth had been slow, in part because of the time and effort required to get more than 100 injections a year.
PUBLIC HEALTH AND HOSPITALS
An outbreak of tuberculosis in Kansas has become the largest recorded outbreak of the illness in the United States since the mid-1950s. The Kansas Department of Health and Environment said it had recorded 67 active cases this year through January 24. Health officials said the general risk to the public, even in the area of the outbreak, remains “very low.” TB is treated with antibiotics over the course of four to nine months.
DEAL OF THE WEEK
Rad AI raised $60 million at a valuation of $525 million led by digital health investor Transformation Capital – just seven months after its previous round led by Khosla Ventures. The generative AI platform hadn’t intended to raise more funds yet (it’s now raised a total of $140 million), but Transformation was eager to invest having missed out the last time, cofounder and CEO Doktor Gurson told Forbes.
There are some 30,000 radiologists in the United States, and they spend an inordinate amount of time writing up more than 100 reports a day about patients’ images. “You get really burnt out from that because it is non-stop tedious work,” said cofounder and chief product officer Jeff Chang. To ease the burden, Gurson, a 47-year-old serial entrepreneur, and Chang, a 41-year-old radiologist who was once the youngest in the country (he started college at age 13), teamed up to start Rad AI in 2018. It was very early days for generative AI, and Gurson and Chang brainstormed with their first customers about how to build a product to help radiologists.
Their main product, called Rad AI Omni, relies on an algorithm to automatically generate impressions of radiology reports based on findings that’s tailored to each radiologist. Another product helps with follow-up and tracking of results. Being early in the space gave the startup an edge as it built out these offerings to increase productivity and reduce errors, Gurson said. “Nobody thought we could automate the impression section,” he said.
With the new funds, Rad AI plans to speed up its roll out in the U.S. and look to overseas expansion. “Right now, there is such high demand for the products we offer,” he said.
WHAT WE’RE READING
CDC reportedly to stop working with the WHO immediately.
A startup claimed its device could cure cancer. Then patients began dying.
The Sackler family reached a new $7.4 billion settlement over the opioid crisis.
Trump pardons abortion clinic protesters ahead of March for Life.
UnitedHealth Group names successor for slain United Healthcare CEO.
As states diverge on immigration, hospitals say they won’t turn patients away.
The FDA approved Ozempic for treating patients with chronic kidney disease.
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