Breaking News

Why mifepristone matters, one pill to make childbirth safer, & what a hospital oligopoly looks like

February 10, 2023
Reporter, Morning Rounds Writer
Good morning. We have the latest on what Biden officials are saying about the public health emergency's end. 

reproductive Health

Ruling on abortion pill delayed 

A staffer at the Women's Reproductive Clinic in Santa Teresa, N.M., prepares a dose of mifepristone.
Paul Ratje/The Washington Post

A federal court decision on the FDA's approval of the abortion pill mifepristone has been delayed after a company that makes the drug sought to intervene. The Trump-appointed judge is now expected to rule later this month, at the earliest, in a case that could revoke nationwide access to one of the two drugs used for medication abortions. Such a change would utterly transform the landscape of pregnancy in the U.S., even in states where reproductive rights are currently protected.

In response, some abortion providers have said they're prepared to switch from using the standard two-drug regimen — mifepristone and misoprostol — to using misoprostol alone. That might come as a surprise:  If you can get the job done with one drug, why have we been using a cocktail of two? Both regimens are extremely safe, it turns out, and very effective. But the data about one turns out to be more complicated than the other, Eric Boodman reports.


pandemic

Biden officials insist Covid emergency's end won't usher in large changes

The Biden administration is preparing to end the nation's Covid-19 public health emergency on May 11, but officials are insisting it won't mark a shift in Covid treatment, coverage, and care — at least for now, STAT's Sarah Owermohle reports. Biden officials told reporters late Thursday that they're "doing everything in their power" including a "special enrollment period in the [Affordable Care Act] marketplace" to ensure that one major shift, the end of Medicaid coverage for thousands of people whom states weren't allowed to remove from rolls, will be softened.

Emergency-authorized vaccines and treatments will still be available, though they'll be transitioned this summer from government-bought, free products to insurance-covered, officials also said. But myriad other measures, like relaxed provisions to prescribe buprenorphine to people with opioid use disorder, are still in limbo. "We have been working incredibly hard and collaboratively with our DEA colleagues to make certain that we do not have a gap in access to care," one official told reporters, adding that the administration is working on new rules on this front.


health

A single antibiotic pill cut the risk of sepsis during childbirth in lower-income countries

It's inexpensive, it's easy to use, and it works. A single dose of the generic antibiotic azithromycin could dramatically reduce the number of women in low- and middle-income countries who develop life-threatening sepsis during childbirth, a large new NEJM study says. Giving just one pill during labor lowered the risk of sepsis by about 35%, the trial in Bangladesh, the Democratic Republic of Congo, Guatemala, India, Kenya, Pakistan, and Zambia found.

That reduction was so remarkable the trial was stopped early. A funder of the study estimates the practice, if adopted widely in low- and middle-income countries, could prevent up to 2 million cases of maternal sepsis annually. It follows earlier work showing azithromycin cut sepsis in half among U.S. mothers having a planned C-section. "I was pleased to see some good news in the area of global maternal mortality," Denise Jamieson of Emory University told STAT's Helen Branswell. Read more.



Closer Look

Generics companies fought the drug-pricing law, but it may end up helping them

A plastic bag of assorted pills and prescription drugs.Patrick T. Fallon/AFP via Getty Images

The sky may not be falling for makers of generic drugs after all. Despite dire warnings that legislation granting Medicare the power to negotiate drug prices would gut their business, it now appears those elements in the Inflation Reduction Act could be beneficial for the generics industry. The change in tone comes as experts say the law may keep brand-name drugmakers from fighting off generic competitors, the way they often do now. Tactics can include patent thickets and pay-to-delay settlements to make generic businesses wait years before competing.

"The negotiation provisions of the IRA are clearly a concern for us," Craig Burton of the generic lobbying group Association for Accessible Medicines told STAT's John Wilkerson. "That said, there are other provisions of the IRA that are quite helpful." Read more about other wrinkles that may come up when the law takes force in 2026, including the impact on biosimilars.


n the lab

DNA sequencing could reduce infant deaths from genetic diseases, study suggests

In a scientific version of what-might-have-been, a new study looking at more than 100 infants who died concludes that some of them could have been treated, perhaps even saved, had genetic sequencing diagnosed their genetic diseases quickly and early. The findings, published yesterday in JAMA Network Open, add data to an ongoing debate about how to implement sequencing in health care, given its cost and current gaps in understanding how certain genetic variants contribute to disease.

For the study, researchers examined DNA sequencing data from 112 infants who died, 40% of whom had genetic diseases. For 30% of those conditions, treatments exist. The authors believe five of eight deaths might have been avoided. "We're still missing children who have genetic diseases, and who go on to die," Stephen Kingsmore, CEO of Rady Children's Institute for Genomic Medicine in San Diego and a study co-author, told STAT's Jonathan Wosen. Read more.


hospitals

Here's what one hospital oligopoly looks like

It's not everyday that you see "oligopoly" in a headline. But that's the term of art for what's happening in Orlando, Fla., where two hospital systems exert the kind of power that casts shade on duopolies like Google and Facebook or Coca-Cola and Pepsi. Some of the evidence STAT's Bob Herman found from his perusal of financial documents filed by Orlando Health so it can borrow $300 million to build new facilities and make upgrades:

  • Orlando Health and AdventHealth together control 77% of the inpatient hospital market in metro Orlando. 
  • The two not-for-profit systems also own two-thirds of the pediatric hospital market.
  • They control closer to 90% of inpatient services in a narrower slice of Orlando.

Some perspective: "It's certainly high, but not at the top of the list by any means," Chris Whaley, a health economist at RAND Corp. told Bob. The Health Care Cost Institute's index of hospital market power ranks Orlando 70th of 186 metro areas. Read more.


by the numbers

feb. 9 cases covid-chart-export - 2023-02-09T171912.435


feb. 9 deaths covid-chart-export - 2023-02-09T171947.507


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What we're reading

  • Cigarette, vape maker Reynolds American calls on the FDA to pull Puff Bar, Elf Bar, and other disposables off store shelves, STAT
  • The pandemic missing: The kids who didn't go back to school, Associated Press
  • Originalism is going to get women killed, The Atlantic
  • Engineered virus shows promise against aggressive form of breast cancer, STAT
  • Molnupiravir mutations in the wild, Science
  • Senate panel passes drug patent reforms, but not without dissent, STAT

Thanks for reading! More Monday.

P.S.: Scientists have come up with a way to study the feeding behavior of disease-spreading  mosquitoes — aka biting us — without volunteer human arms. Here's the paper and here's a video from Rice University. I watched it and didn't scratch once.


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