Breaking News

FDA advisers take up OTC birth control, a vote for more newborn genetic screening, & living with a partner's chronic illness — and your own

May 9, 2023
Reporter, Morning Rounds Writer
Good morning. We have deliberations from FDA advisers, a first U.S. study of safe-injection sites, and success in reducing severe bleeding in childbirth.

FDA

FDA advisers to debate two hot-button drugs

FDA advisers have two significant deliberations on their dockets this week, starting tomorrow when they consider making a contraceptive pill available over the counter and then Friday when they take up a gene therapy for Duchenne muscular dystrophy. Here's what we're watching:

  • Hormone-based contraceptives date to the 1960s and have long been the most common form of birth control in the U.S., but they require a prescription. As access to abortion shrinks across the country, the OTC  decision takes on new urgency. The drug in question, HRA Pharma's Opill, contains progestin, which prevents pregnancy by blocking sperm from the cervix. The FDA's decision could come before summer's end.
  • In the FDA advisory panel hearing for Sarepta's Duchenne treatment, the biotech is seeking accelerated approval for its gene therapy, a framework  long used for HIV and cancer drugs provisional but not yet for a gene therapy. STAT's Jason Mast has more, including a contentious history. The FDA is set to issue its decision by May 29.

genetics

Doctors who treat rare disease favor expanding newborn genetic screening

How helpful is newborn genetic screening? As the cost of DNA sequencing falls and the ability to identify meaningful mutations rises, it becomes a more relevant question while balancing possible benefit versus harm. A newborn's risk for a condition can be spotted, but whether it turns into disease isn't so certain. And ambiguous results, not to mention false positives and false negatives, can cause confusion or worse if needless worry or treatment follow. A new study in JAMA Network Open asked 238 rare-disease doctors across the U.S. what they thought about expanding newborn screening.

The answer was yes from 88% of them, who agreed that DNA sequencing to screen for certain treatable childhood disorders should be made available to all newborns. More than three-quarters agreed on including 42 pairs of genes and the diseases they cause, including hemophilia, Duchenne muscular dystrophy, and glycogen storage disease, illnesses for which treatments exist. STAT's Megan Molteni has more.


addiction

U.S. agency underwriting study of safe-injection sites

In a historic step, the U.S. is funding its first study to test whether safe-injection sites can prevent overdoses if people have a place to use illegal drugs under medical supervision. A four-year, $5 million grant from the National Institute on Drug Abuse will pay for New York University and Brown University to study two current sites in New York City and one opening next year in Providence, R.I. The goal is to enroll 1,000 adult drug users to study the sites' impact on overdoses as well as any potential savings for the health care and criminal justice systems.

Opponents fear such sites promote taking drugs while advocates say they can save lives and point people toward treatment. "We need data to see if they are working or not, and what impact they may have on the community," NIDA Director Nora Volkow said. Read more from the Associated Press.



Closer Look

'Painting is a kind of digestion': Living with your partner's chronic disease — and your own

LIVING_WITH_0504Photo illustration: Casey Shenery for STAT

For Lauryn Welch, painting was a way to make sense of what her partner, Samuel Geiger, was feeling once diagnosed with a connective tissue disorder called hypermobile Ehlers-Danlos syndrome. Then she learned she had an autoimmune disease. Their intertwined story is told in the film "The Body Is a House of Familiar Rooms." STAT's Isabella Cueto asked Welch about their life.

How did you discover painting?

I didn't really start painting seriously on my own until shortly after Sam got sick. Painting is a kind of digestion. With chronic illness, it's often a moving target day to day. So painting has been a way to reclaim that experience.

How do you figure out your own, unspecified autoimmune condition?

I've been working through this in my art, too, realizing that there is a spectrum of how people deal with illness and disability. And we all deal with it at some point to some extent. 

Read the full interview.


global health

Early detection and bundled treatment can reduce hemorrhage after childbirth, study finds

Postpartum hemorrhage is the number-one cause of maternal mortality around the world, striking an estimated 14 million women each year and leading to about 70,000 deaths, mostly in low- and middle-income countries. A NEJM study out today reports success with a method that reduced heavy bleeding by 60% when combining a drape to measure bleeding with simultaneous — not sequential — use of four WHO-recommended treatments.

The trial at 80 hospitals in Kenya, Nigeria, South Africa, and Tanzania split patients having vaginal deliveries into two groups. One group got a calibrated blood-collection drape and if needed, uterine massage, medicines to contract the womb and stop the bleeding, IV fluids, and an examination and escalation to advanced care if necessary. Hemorrhages were detected in 93% of patients in that group compared to 51% in the control group, who got usual care. In another report today, the WHO says progress has stalled on reducing maternal and infant deaths.


health

Adolescents living through adverse experiences early in the pandemic were more vulnerable later

Since the pandemic began, people have been concerned that school closures and lockdown policies might have harmful effects on children who are exposed to serious problems at home. A new survey in Pediatrics of teens found that those who said in the fall of 2020 they'd been through adverse childhood experiences were more likely to say they'd lived through another one when contacted in spring 2021.

The researchers defined these preventable, potentially traumatic events as direct violence or neglect or indirect, as in witnessing violence or substance use in the home, parental incarceration, or mental illness. In the first survey, 64% reported having experienced more than one such event. Six months later, 28% said they'd been through a new one. Those who'd had four or more events were more than twice as likely to say it had happened again. The authors urge prevention and intervention across school, home, and community settings.


Correction: An item in Friday's newsletter misstated how many Americans still smoke cigarettes. It's 11.5% among adults, not all age groups. 


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What we're reading

  • Legal pot is more potent than ever — and still largely unregulated, KFF Health News

    Q&A: Sen. Sanders on insulin costs and his committee's generic drug kerfuffle, STAT
  • He helped craft the 'bounty hunter' abortion law in Texas. He's just getting started, NPR

  • 'Robbing Peter to pay Paul': Obesity experts debate risks of new weight loss drugsSTAT

  • Too many older men are still screened for prostate cancer, New York Times
  • Opinion: Health care coaches are the next big thing. They're also completely unregulated, STAT

Thanks for reading! More tomorrow,

P.S.: If this doesn't make you smile, there may be a solution (if that's not too meta). HT to my colleagues Sarah Todd and Rick Berke.


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