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Good morning. Yesterday was the first official day of autumn. “Fall, leaves, fall; die, flowers, away,” Brontë wrote for those of you who have been thinking about pumpkin spice lattes since July.
HHS unveils new initiatives on animal testing
HHS laid out its latest strategies to speed the shift away from using animals in medical testing. Beginning next February, research methods other than animal testing can be used when “appropriate” for determining the safety of drugs and biologics, according to a final FDA rule issued yesterday. At the same time, the NIH unveiled several initiatives designed to encourage the use of non-animal approaches such as cell-based assays, organs-on-a-chip, and computer models.
STAT’s Ed Silverman wrote about the new policies and spoke with advocates on both sides of the long-running debate. Read more.
700,000
That’s how many seniors have started taking GLP-1s since July, when Medicare began covering the drugs, Eli Lilly CEO Dave Ricks told CNBC on Monday.
Medicare is technically prohibited from paying for weight loss drugs, but the Trump administration circumvented the law by making the drugs available through a demonstration program, sort of like an experimental pilot. But as John Wilkerson reported over the summer, this theoretically temporary program may prove difficult to actually end.
Drugmakers look to bolster brittle bones again
Osteoporosis used to be a top priority for pharmaceutical companies. Big players like Eli Lilly, Merck, and Novartis each had their own treatments designed to stop bones from weakening. But a lot of eligible patients don’t take the existing medications, likely due to a long list of side effects, along with the simple fact that they can be annoying to take. Patients are often required to stay upright for 30 minutes and avoid eating for up to an hour.
But late last year, drug developers were handed a fresh incentive to address those concerns: The FDA said in December that it would allow companies to use a new clinical endpoint that could shave years off of development timelines. And several companies already seem to be jumping at the chance. Read more from STAT’s Allison DeAngelis.
A private equity-owned hospital chain goes nonprofit
It’s unheard of: Quorum Health, a private equity-owned hospital system, is in the process of converting to a nonprofit organization. While individual institutions have made the change before, Quorum will transition all 11 of its hospitals, most of which serve rural areas.
There are concrete benefits to the nonprofit structure, including tax advantages, discounted drugs, and the ability to apply for grants. But some are concerned that the deal is structured to benefit Quorum’s current investors to the detriment of the hospitals and their patients. “The question is, are the creditors taking enough of a discount to leave a hospital company that is viable?” said Jim Baker, executive director of the Private Equity Stakeholder Project, a nonprofit watchdog group. Read more from STAT’s Tara Bannow on the high stakes transition.
The state of youth gender-affirming care
Last Friday, the Justice Department announced that it had reached settlement deals with NYU Langone and the University of Pittsburgh Medical Center over the provision of gender-affirming care to young people. Both hospitals agreed to stop providing puberty blockers, hormones, and rare surgical procedures to minors. At least six institutions have made such deals, though none have admitted to or been convicted of any wrongdoing. For the Trump administration, ending the services is the point, as health officials have repeatedly asserted their desire to stop what they call “sex-rejecting procedures.”
The chilling effect of the government’s dogged offensive against transgender health care has been swift. Dozens of hospitals have stopped providing care, even if they haven’t directly been targeted by legal action. NYU Langone said in a statement that the settlement protects patients from the threat of extensive government subpoenas that had been directed at the institution. The AP has more on the agreements.
How to support mentally ill pregnant people
A decade before she began pursuing pregnancy, Meg LeDuc had a harrowing break with reality. She stopped taking her antipsychotic medication, leading to multiple overdoses, including twice within two weeks. Even with years of stability separating her from that experience, LeDuc worried that, if she became a mother, she would be a danger to her own child.
She and her husband were cautious, seeking prenatal counseling on the safety of her medication regimen in pregnancy and her potential for relapse. But as LeDuc notes in a new First Opinion essay, this sort of care remains out of reach for many women with serious mental illness, 20% of whom are uninsured.
“People experiencing such devastating delusions deserve humane, quality care. With such care, we are capable of leading rich, fulfilling lives,” she writes. “And even being good parents.” Read more about the limits of reproductive psychiatry.
What we’re reading
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A Western Mass. lesbian bar required KN-95 masks. When it changed the rules, all hell broke loose, Globe Magazine
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Federal judge orders Texas to air condition all prisons by the end of 2029, Texas Tribune
- UnitedHealth, CVS push back on Medicare plan to curb remote patient monitoring abuse, STAT
- More veggies, more unprotected sex: Government survey of teens shows mixed risk picture, Politico Pro
- Former FDA commissioners: Heidi Overton has an opportunity to strengthen the FDA, STAT