Regulators hear pleas to speed approval for Covid antibody drugs

(Alexander Zemlianichenko/AP)

Time and again, immunocompromised people have felt left behind in the pandemic: They’ve gained inadequate protection from Covid vaccines and watched Covid antibody drugs lose their power against new variants. It was with those patients in mind that drugmakers and academics made the case for new standards to approve antibody treatments at a hearing yesterday with U.S. and European drug regulators.

The virus is evolving quickly, and they argue that demands a reconsideration of the rigorous trials typically required to approve an antibody treatment. Right now, patients have few options — the FDA recently pulled its authorization of bebtelovimab, the and the long-acting antibody Evusheld is unlikely to provide much benefit to people who didn't get much protection from vaccines. STAT's Jason Mast reports that FDA and European Medical Association officials indicated they were willing to adopt new standards. Read more.

Women of color less likely to get recommended pain relief in childbirth

The standard of care to ease pain during childbirth is regional anesthesia, rather than putting patients fully under. Its most familiar form is the epidural, which is linked to fewer complications, shorter hospital stays, and lower costs. A new study in Regional Anesthesia & Pain Medicine of more than 10,000 deliveries at a New York City health system's four hospitals found that women of color were less likely than white women to receive regional anesthesia.

In vaginal deliveries, African American women were 50% more likely not to receive any form of pain relief than white women. In C-sections, African American women were one-third as likely as white women to receive regional anesthesia, and Hispanic women were half as likely as white women to get that pain relief. The researchers note that differences in health literacy and values among various ethnic groups might be factors, but called for standardizing anesthesia practices.

More potent drugs tied to rise in adolescent overdose deaths

Drug overdose deaths among adolescents ages 10 to 19 soared starting in 2019, rising 94% from 2019 to 2020 and 20% from 2020 to 2021, a new CDC report says. The increase in deaths came even though illicit drug use among adolescents fell during that timespan, suggesting more potent drugs, rather than increased use, led to the increase. About 90% of deaths involved at least one opioid, more than 80% involved fentanyl, and nearly one-quarter had evidence of counterfeit pill use, which could have been fentanyl disguised as oxycodone, the researchers say.

More than 4 in 10 of those deaths were adolescents with a history of a mental illness, a history of suicidal or self-harm behaviors, or who had received mental health treatment. Although deaths appear to be declining as of late 2021, they still remain much higher than in 2019.

Closer look: Inside the lab pursuing how to fix pulse oximeters

(BRIAN FRANK FOR STAT)

It took a pandemic, but the discovery that fingertip oxygen-measuring devices might contribute to health disparities because they appear to work less well on patients with darker skin has roiled the world of pulse oximetry. The $2 billion industry now faces stricter regulations and pressure to address bias in the development and testing of its devices. But nothing about the problem is simple, STAT’s Usha Lee McFarling reports from the Hypoxia Lab at the University of San Francisco.

That’s where the lab’s visionary founder John Severinghaus helped develop modern blood monitoring tools and later was one of the first to publish analyses questioning their accuracy on darker skin. Now the lab grapples with a host of issues — from how to assess skin tone to unpredictable variations in readings among different human subjects. “If we can fix this issue,” lab leader Philip Bickler said, “it could be a model for health disparities.” Read more.

More parents balk at requiring routine vaccinations

Most Americans believe the benefits of childhood vaccinations for measles, mumps, and rubella outweigh any risks, but a growing share say they oppose requiring children to receive them to attend public school. In a new KFF poll, 28% of parents say they should be able to decide not to vaccinate their children against these diseases. That’s up from 16% in 2019, largely driven by shifts among people who identify as or lean Republican: 44% now say parents should be able to decline those vaccines, up from 20% in 2019.

You might think attitudes about Covid vaccines and public health in general would track with the drop in support for MMR vaccines, but the poll found that even among people who didn’t get a Covid shot, 70% still say childhood vaccines’ benefits outweigh the risks.

Opinion: How the ‘deceased note’ might better capture patients’ final moments

Here’s what a “deceased note” typically entails: a few details about what brought a patient into the hospital, major updates during their stay, a sentence about what led to their death, then the time of death, written firmly in a separate paragraph — a final step of closure. “That’s it,” gastroenterologist Trisha Pasricha writes in a STAT First Opinion. Two years after her grandmother died alone in a hospital early in the pandemic, Pasricha read her deceased note and found its coldness deeply disturbing.

“Sometimes what isn’t written in medical notes is the very thing patients and family members need most,” she says. And it helps doctors, too, she found out as a senior resident when she asked medical students to include a first line like this: “Mr. J is an otherwise healthy four-time Broadway performer who presents with stomach pain.” Read more.

What we're reading

How a sprawling hospital chain ignited its own staffing crisis, New York Times
Health officials revise BMI tool to track severe obesity in kids, Associated Press
Biden administration takes aim at Medicare Advantage care denials, misleading ads, STAT
Covid spurs boom in genome sequencing for infectious diseases, Nature
Science, Cell issue notices of concern on challenged papers co-authored by Stanford president, STAT