IUD guidance, vaccine approval, NIH grants

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

Good morning. Yesterday, we learned that former President Biden has been diagnosed with an aggressive form of prostate cancer. In 2016, he told STAT in an interview that he planned to dedicate his career after politics to cancer research — and to do so for “as long as I’m alive.”

While some criticized his cancer policies while in office, most experts agreed that his Cancer Moonshot has been an important initiative. But now, as President Trump’s cuts have begun to take their toll, the future of cancer research is unclear.

The rise of Covid contrarian Tracy Beth Høeg

Five years ago, Tracy Beth Høeg was a sports medicine physician focused on ultramarathon runners. Now, she’s been tapped for a top role at the FDA, working closely with two other Covid contrarians — Marty Makary, the agency’s commissioner, and Vinay Prasad, the head of a key center — and advising on vaccines. 

Høeg dove into the thick of Covid debates herself in 2020, with the question of whether it was safe to reopen schools. She began researching transmission and writing op-eds on the side of her sports medicine work. But even though she didn’t see her position on vaccines as a political one, many others did.  

Read more from STAT’s Lizzy Lawrence on how Høeg gained a central role in shaping U.S. vaccine policy.

Some vaccines are approved, others are in limbo

The FDA has finally approved Novavax’s Covid-19 vaccine, but with restrictions that its two competitors in the U.S. market do not face. The long-awaited license limits use of the vaccine to people 65 and older and people aged 12 to 64 who have at least one medical condition putting them at higher risk of severe illness from Covid, STAT’s Helen Branswell reports. Read more from Helen on the decision.

Helen also brings us another vaccine update from last week: Health Secretary Robert F. Kennedy Jr. has signed off on three vaccine recommendations passed last month by the CDC’s vaccines advisory panel. Though it has been common practice for the CDC to issue a press release when recommendations of the Advisory Committee on Immunization Practices are adopted, there was no publicity this time. Word of Kennedy’s action was posted on the ACIP’s website, in a pulldown menu.

While the ACIP made six recommendations in April, Kennedy has only endorsed three so far; they outline who can use newly licensed chikungunya vaccines. Three others, related to a new meningococcal vaccine and broadening the group of adults for whom RSV vaccines are recommended, appear to remain in limbo. 

The scientists who are getting their grants reinstated

Like so many researchers around the country, neurologist Charles DeCarli had an NIH grant terminated in March. His was a $53 million inquiry into how vascular factors contribute to dementia among white, Black, and Hispanic people. But miraculously, a month later, the grant was back. 

Still surprised by his success, DeCarli and other researchers are trying to figure out whether they can help colleagues across the country get their own grants restored. People are spreading the word about pressing for action and lawsuits, while professional societies host off-the-record webinars offering advice to contest grant decisions. There’s no one formula for reversing Trump administration cuts, STAT’s Liz Cooney writes in her latest story, but researchers are sharing whatever tips they have. Read more. 

Point / Counterpoint: Animals in medical research

Last month, the FDA announced it would phase out the use of animals in preclinical testing of monoclonal antibodies — and eventually other drugs — and instead rely on “more effective, human-relevant methods” like AI models. Is this a good idea? Will it work? Today, STAT is publishing two First Opinions with opposing perspectives on the decision.

On the one hand: Animal models are often flawed, offering incomplete representations of human disease. The FDA’s plan is a roadmap that will help pharma move toward surrogate systems based on human biology — so argue a veterinarian and a virologist in one essay. It’s time to disrupt a baked-in system that hasn’t been serving the people who need it most, they write, and there are three main areas of challenge: policy, social, and technical.

On the other hand: Every lifesaving treatment and medical innovation we have has depended on animal research. Animals like mice, zebrafish, chickens, and frogs are the behind-the-scenes heroes of medical breakthroughs, argues a molecular biosciences professor in another essay. Researchers can’t get the full picture from cells in a dish or computer models alone, she says.

Read both essays — for and against the FDA’s decision — and let us know where you land. 

ACOG updates pain recs for IUD insertions & more

Last week, the American College of Obstetricians and Gynecologists published long-awaited guidance on pain management for procedures like IUD insertion, endometrial biopsy, hysteroscopy, intrauterine imaging, and cervical biopsy. The move comes almost a year after the CDC updated its own recommendations on IUD insertion to include lidocaine, following years of media coverage pointing out how painful it can be, and even a viral trend where women posted close-up videos of their pained faces during the procedure.

ACOG also recommends local anesthetics like lidocaine spray or cream for IUD insertions, and varying options for other procedures including more topical or injected anesthetics, NSAIDs like aspirin and ibuprofen, and a nerve block. But the guidance also acknowledges that the existing evidence is often conflicting or limited — not every option will work for every patient, and it’s hard to predict how much pain any given patient will experience. For these reasons, the guidance emphasizes the importance of shared decision-making between clinicians and patients.

Even more evidence against sedentary behavior (I typed this sitting down)

After someone is hospitalized for a heart attack or chest pain, they’re at high risk for another cardiac event, even if they’re receiving high quality medical treatment. A new study identifies sedentary behavior — generally bad for heart health — as a key, independent risk factor after hospitalization. In the study, published today in Circulation: Cardiovascular Quality and Outcomes, the least active people, who had a daily average of more than 15 sedentary hours, were two and a half times as likely to experience another cardiac event or die within a year of hospitalization than the most active group, who were sedentary for less than 12 hours a day.

Between 2016 and 2020, researchers recruited more than 600 patients who had a heart attack or chest pain from the emergency department at the Columbia University Medical Center. For 30 days after they went home, the patients wore wrist devices that tracked their movement. Researchers followed up on each patient one year later, either by contacting them or through electronic records.

According to the data, replacing 30 minutes of sedentary time with 30 minutes per day of either light activity, moderate to vigorous activity, or simply with sleep, reduced the risk of another cardiac event or death by 50%, 61%, and 15% respectively. For what it’s worth: The data is based on patients from a single medical center. Also, the wrist devices couldn’t differentiate between sitting and standing, only the intensity of any activity.

What we’re reading

• Case of a brain-dead pregnant woman kept on life support is ‘gut-wrenching,’ advocates say, The 19th

• As Congress debates cutting Medicaid, a major study shows it saves lives, New York Times

• FDA clears first blood test for diagnosing Alzheimer’s, STAT
• Why so many clinics that provide abortion are closing, even where it’s still legal, NPR
• Day 3 at ASGCT: Vinay Prasad speculation, screening newborns, promising data, STAT