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Legal quagmire ahead for abortion pill access, what a post-Roe world means for perinatal pathologists, & HIV vaccine trial halted

   

 

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Access to abortion pills at pharmacies could be a legal quagmire

Earlier this month, when the FDA lifted a longtime restriction that only doctors could dispense mifepristone, a pill approved for abortions up to 10 weeks, that opened the door for pharmacists to supply abortion pills. It also bolstered protections for mail orders, key for abortion access after Roe was overturned last summer. But it’s not so simple, legally, in 12 states where the procedure is banned from conception to six weeks, or in other states where restrictions effectively do the same.

It’s not clear whether state laws can prevent people from accessing a drug that the FDA has approved, and, to make it even murkier, it will take a lawsuit to put the mifepristone argument to the test to see if FDA would prevail. “It’s going to be a hot mess,” Kirstin Moore of the advocacy group Expanding Medication Abortion Access, told STAT’s Sarah Owermohle. Read more.

Trial halted for HIV vaccine developed by J&J

Another experimental HIV vaccine has failed. A late-stage clinical trial was halted because the vaccine, developed by J&J’s vaccine division Janssen, was no better than placebo at preventing HIV infection, NIAID reported yesterday. In 2021, a Phase 2b trial of a similar candidate HIV vaccine was stopped when its data and safety monitoring board determined that it was not preventing infections.

The Janssen vaccine was based on “mosaic” immunogens targeting HIV subtypes to prompt immune responses to a broad range of HIV strains. It used the same antigen delivery system as J&J’s Covid-19 vaccine. “These results are disappointing,” Susan Buchbinder, co-chair of the Mosaico trial, said in a statement. “Although HIV continues to prove uniquely challenging for development of a vaccine, the HIV research community remains fully committed to doing just that, and each study brings us a step closer to this realization.” STAT’s Helen Branswell has more.

Study: Mental health benefits of gender-affirming hormones for teens persist for two years

Augmenting a substantial body of research that shows gender-affirming care improves mental health and coming at a time when the therapy is under fire, a new study in NEJM concludes that trans and nonbinary teenagers who receive gender-affirming hormones experience less depression and anxiety and more satisfaction with life than before the treatment. Unlike previous studies that were smaller, shorter, and focused on multiple care options, the new research followed more than 300 adolescents across the U.S. for two years after initiating hormone treatments. 

Nearly 70% of participants who started the study with severe depression saw it reduced to minimal or moderate after two years of hormone therapy and almost 40% of participants who started with clinical anxiety saw it reduced to non-clinical. “This is another big contribution to saying that gender-affirming care is in fact evidence-based and has benefits and should be standard of practice,” Carl Streed Jr., of Boston Medical Center’s Center for Transgender Medicine and Surgery and who was not involved in the study, told STAT’s Theresa Gaffney. Read more.

Closer look: Post-Roe, pathologists examining pregnancy loss brace for legal involvement

(Sandy Huffaker for STAT)

When Mana Parast (above) examines a placenta, she knows she may never find the answers she seeks. One of the few physician-scientists in the U.S. specializing in perinatal pathology, she sees her job analyzing fetal tissue, placentas, and other “products of conception” after a miscarriage as a way to tell a parent what she thinks went wrong and prevent further losses. But modern medicine still has much to learn about pregnancy loss.

Parast and other pathologists with perinatal expertise are now increasingly worried about the pressure they face from law enforcement officials across the country to produce definitive cause of death determinations. Police and prosecuting attorneys have always had an interest in investigating pregnancy loss, but in a post-Roe era, legal experts worry more cases may gain more traction going forward. STAT contributor Eleanor Cummins tells us how pathologists hope to be prepared.

More is better: For hip and knee replacements, your surgeon’s volume counts

Practice really does make perfect when it comes to surgery. That connection isn’t new, but a new study from the Clarify Health Institute of almost 180,000 hip and knee replacements makes that link stronger. Some striking findings:

  • Post-surgical readmissions: Rates for high-volume surgeons (more than 100 replacements) were 37% to 51% less than their low-volume (fewer than 10 procedures) peers.
  • Revision surgery rate: 39% to 41% lower for high-volume surgeons.
  • Post-surgical emergency department visits: 38% lower with high-volume hip surgeons and 23% lower with high-volume knee surgeons.
  • Post-surgical inpatient days: 66% lower with high-volume hip surgeons and 54% lower with high-volume knee surgeons.

“It’s just human nature: We need practice,” Leah Binder, CEO of the patient safety organization The Leapfrog Group (and not involved in the study), told STAT’s Tara Bannow. “We need to do things repeatedly in order to be the best at them.” Read more.

One year later, hybrid immunity offered strongest protection against Covid

If you’ve been wondering how well or how long immunity against Covid-19 lasts after infection, a new paper out in The Lancet Infectious Diseases yesterday offers some answers. A review of 26 studies looked at immunity from infection as well as hybrid immunity, from the combination of infection and vaccination. After one year, hybrid immunity was best, meaning a 95% lower chance of developing severe Covid or needing admission to a hospital, compared to unvaccinated and uninfected people.

Immunity only from an infection one year before gave unvaccinated people a 75% lower chance of severe illness or hospitalization. Protection against being reinfected with Covid wasn’t as strong: Hybrid immunity conferred a 42% lower chance of reinfection after one year and previous infection alone meant a 25% lower chance of reinfection after one year, compared to unvaccinated and uninfected people.

 

What we're reading

  • Exclusive: Verily leans into Onduo as it looks to enter the lucrative world of running medical research, STAT
  • 'I don’t want to die’: Fighting maternal mortality among Black women, New York Times
  • HHS needs better oversight of research that alters pathogens, government watchdog says, STAT
  • Don't fear the handshake, The Atlantic
  • A new study suggests social media use may change teenagers’ brains. Is that a bad thing? STAT
  • U.S. plans crackdown on nursing homes that sedate patients with unnecessary antipsychotics, Associated Press

Thanks for reading! More tomorrow,

@cooney_liz
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