FDA approves latest Covid vaccines, and Harris makes her case

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Happy Friday! Isa here. As a Floridian, my school year always started mid-August, so my internal clock is primed to think of this time as summer’s end. It’s an agony I plan to treat with mango ice cream until the pumpkin spice people break down my front door.

Harris’ ‘new way forward’ in health care-laden speech

Vice President Harris took the stage for the final night of the Democratic National Convention on Thursday to accept the party’s nomination and rally voters to a “common sense” presidency that would protect health care freedoms.

“We are not going back to when Donald Trump tried to cut Social Security and Medicare. We are not going back to when he tried to get rid of the Affordable Care Act, when insurance companies could deny people with pre-existing conditions,” Harris said to cheers from the crowd. (Trump has said he would not cut Social Security and Medicare and would not seek to repeal the ACA “unless we can do something much better.”)

But like the other nights of the four-day DNC event, Harris mostly charged voters up about abortion rights and the Project 2025 blueprint he’s sought to disavow, warning Trump would appoint a national abortion coordinator. “Let’s be clear about how we got here,” Harris said. “Donald Trump hand picked members of the United States Supreme Court to take away reproductive freedom, and now he brags about it.”  Read more on the health care battles ahead. —Sarah Owermohle

New Covid vaccines coming soon

The Food and Drug Administration approved the latest Covid vaccines yesterday. The widely expected decision comes as Covid surges in many parts of the country. The new shots, from Pfizer and Moderna, target the circulating Omicron variant strain KP.2 (one of the “FLiRT” variants, and a descendant of the JN.1 strain that dominated earlier this year).

The updated vaccines, Comirnaty and Spikevax, were approved for people 12 and older. Moderna’s and Pfizer’s vaccines for kids continue to be available under emergency use authorizations for children six months old through age 11. Novavax is still awaiting an FDA decision on its Covid vaccine. Worth noting here that while the chances of developing long Covid have gone down since 2020 — vaccination helped — there is still a risk, including to children. Moderna and Pfizer said their updated vaccines would be available in “coming days.”

One big number: $900 million

That’s how much a couple of big donors have given Columbia University since 2010. Yesterday, the university announced its medical school had received a $400 million donation to fund a new institute for basic biomedical research to be named after alumni Roy and Diana Vagelos — on top of what the pair had previously given. It’s the largest single donation given to the school, STAT’s Usha Lee McFarling reports.

The Roy and Diana Vagelos Institute for Basic Biomedical Science will support additional research in areas such as cell engineering and gene therapy. The institute will also be yet another piece of Columbia that bears the Vagelos family name. A former Merck CEO, Roy Vagelos is the child of Greek immigrants and earned his medical degree from Columbia in 1954 — with scholarship support. “This is what inspired my career, and I am hoping we can provide these same opportunities for others,” he said. Read more.

Unproven fibromyalgia test gets pulled off market

Back in 2021, STAT’s Eric Boodman told us about EpicGenetics, a company that was using an aborted clinical trial at Mass General to sell a blood test for fibromyalgia. The FM/a Test could diagnose the famously tricky condition with 99% accuracy, the company claimed. (Experts found this dubious, especially since there are no proven tests for fibro).

Three years and a lawsuit later, EpicGenetics has agreed to stop marketing and selling the FM/a Test, along with another one it said could diagnose “immune deficiency disease.” Fibromyalgia is quite real. About 4 million U.S. adults have it. Immune deficiency disease, on the other hand…not so much, according to the lawsuit filed by the Center for Science in the Public Interest. EpicGenetics invented the condition to sell its 100Sure Test, the suit alleges. The company and its affiliates have denied all wrongdoing. But there’s a string of ventures that are attached to EpicGenetics leader Bruce Gillis’ name and that make particularly bold claims. Read more here.

Like clinicaltrials.gov, but for AI in health care

Use of artificial intelligence in hospitals is blowing up, but how it’s monitored (if at all) is entirely up to individual health systems. Enter a federal registry, maybe. Some researchers want a platform like clinicaltrials.gov but for AI tools, STAT’s Casey Ross reports. The Biden administration also proposed something similar in a White House AI blueprint last year. 

If you’ve spent any time with my colleagues’ reporting on AI in health care, you can understand the stakes here. Providers are trying to automate time-consuming administrative tasks, such as documenting patient visits and responding to emails. But the next phase of AI adoption is expected to directly impact treatment decisions, an arena where biases could worsen disparities and simple errors could result in physical and financial harm. Without adequate oversight, such usage of AI tools, especially by insurance companies looking to increase profits, could lead to further restrictions in care and even patient harm. So, what would it take to build a registry and increase transparency? Casey tells us. 

Just left chow town

Who among us hasn’t ordered a big bowl of pasta (with the intention of taking a doggy bag home) and then surprised ourselves by slurping down every last noodle? For Sophia Hua, an assistant professor of health policy at the University of Pennsylvania, spaghetti overload in a Denny’s booth led to a realization: People tend to eat and drink what’s set in front of them, even when it’s more than they intended. For some, choosing a larger meal or drink option is a way to get more bang for their buck (RIP, endless shrimp).

That overconsumption is a public health issue, Hua writes in a new First Opinion essay. And it can be worked on, maybe even to the benefit of the restaurant industry. “While excess weight gain is a complicated problem with myriad causes, reducing portion sizes is one harm reduction tool we have to address the problem,” Hua writes.

Pear is back on the menu

Remember Pear Therapeutics? The company was a pioneer of FDA-cleared prescription apps for treating psychiatric conditions, including substance use disorder. But Pear ran out of money and filed for bankruptcy last year.

Now, the company’s apps are getting another chance, STAT’s Mario Aguilar reports. Virtual addiction treatment company PursueCare bought Pear’s apps for substance use treatment and is now offering them to its patients. Taking a step back, tech-forward approaches like this could be part of the solution to the nation’s opioid epidemic, Mario says: “There’s a feeling that tools like apps can be supportive of people in care.” And tying them more directly to a provider for treatment may work better than when the products were marketed on their own. It takes some of the pressure off of companies to make treatment apps into standalone money-makers. Read more.

What we’re reading

• People with HIV cannot be categorically barred from joining military, judge rules, NBC News
• U.K. cost-effectiveness agency gives negative review of Alzheimer’s drug Leqembi, STAT
• 9 hours of training, 24-hour shifts: Why Wisconsin struggles to find and keep assisted living workers, Journal Sentinel
• Tome Biosciences, once a high-flying gene-editing startup, is floundering, STAT
• Nearly 60% of baby foods in the U.S. don’t meet nutritional guidelines, study says, NPR
• Why you may not need a checkup every year, STAT