Pharma's silence on abortion pill case, FDA's action against unapproved vapes, & how to buy 'weed' in Kansas

As a judge prepares to rule on a case challenging FDA's approval of mifepristone, abortion pills teeter on the edge of a legal precipice.

February 23, 2023 Check out STAT+

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By Elizabeth Cooney Reporter, Morning Rounds Writer

Good morning. Read what else is at stake in the abortion pill lawsuit: other drugs.

reproductive Health As an abortion pill lawsuit threatens to undercut the FDA, pharma stays largely silent Molly Ferguson for STAT As a judge prepares to rule on a closely watched case challenging the FDA approval of mifepristone, abortion pills are teetering on the edge of a legal precipice. If they fall, that would mean the immediate loss of the safest, most effective, least invasive method of first-trimester abortion, which is also the safest, most effective, least invasive method of treating miscarriage. But the ruling could affect all sorts of other drugs — from those that have been prescribed for decades to those that haven't even been developed yet.  Still, the pharmaceutical industry has been largely silent on the subject, with some notable exceptions, including Paul Hastings, CEO of Nkarta. "What's next?" he asked STAT's Eric Boodman. "Is it hormone therapy for a transgender person? Is it birth control? Is it a certain drug for an inflammatory disease, because it was made from a stem cell that gets misinterpreted as a fetal stem cell?" Read more. health FDA fines 4 companies for selling unapproved vapes  In a first, the FDA has fined four businesses that have continued to sell unapproved vapes after ignoring orders to stop. Two of the four companies fined by the agency's tobacco center, VapEscape and Great American Vapes, were cited in an October investigation by STAT's Nicholas Florko into vape companies disregarding the FDA's orders. That project found that more than half of the 120 companies warned by the FDA about selling illegal vapes were still selling their products.  It's not uncommon for the FDA to fine companies when they're caught selling their products to underage customers, but before yesterday, the agency hadn't fined vape manufacturers for selling illegal products. The move comes four months after the FDA took six other vape shops to court for selling illegal products. It's unclear what effect yesterday's action will have on the larger industry. Read more. global Health Declining maternal mortality hit a plateau in 2015, U.N. report says In 2020, on average, someone died from pregnancy- or childbirth-related issues every two minutes. Maybe more shocking, most of these deaths are preventable or treatable with access to quality care, a new U.N. report says. The world had been making progress in reducing maternal mortality, but that's stalled in recent years, and some regions — including Europe and Northern America — have gone backward since 2015. Some details: Maternal deaths fell globally an average of 2.7% each year between 2000 and 2015 before plateuing since 2015. From 2016 to 2020, deaths rose 17%  in Europe and Northern America and increased 15%  in Latin America and the Caribbean.  Data from 2021 will help reveal the impact of Covid-19. "Maternal deaths increase when women have less access to quality, timely services, particularly around the time of delivery," said Jenny Cresswell, an epidemiologist at WHO and report author. STAT's Andrew Joseph has more.

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Closer look It's easy to buy 'weed,' even in as state where marijuana is illegal Nicholas Florko/STAT In Topeka, Kan., it's not hard to find cannabis products for sale. You can buy "Trips Ahoy" cookies, THC "Snickers," or THC-O to get high. All these and more are for sale even though Kansas is one of the few states that don't allow access to cannabis products: Kansas has no medical marijuana program, hasn't decriminalized weed, and could send you to jail for carrying a pipe or rolling papers. That doesn't stop merchants who get around the law by selling slightly tweaked versions of marijuana containing the chemicals Delta-8 THC, Delta-10 THC, THC-O, or HHC. The trend worries public health officials, who fear that the minor changes made to the chemical structure of cannabis to make it technically legal can also change the way it impacts the body. "It's very much a 'buyer beware' kind of market," Stephen Thornton of the University of Kansas Health System told STAT's Nicholas Florko. Read more. infectious diseases Early RSV activity came from the same old strains, researchers report Before the Covid-19 pandemic, annual epidemics of illness caused by respiratory syncytial virus, or RSV, were a winter event. But for the past two years, RSV activity has taken off extraordinarily early — in the late summer and early fall. In 2022 in particular, pediatric hospitals were overrun in September and October with kids struggling to breathe. Why the change in RSV's pattern? We still don't know the answer, but some researchers from Massachusetts General Hospital and the Broad Institute have taken one possibility off the table, STAT's Helen Branswell tells us. The scientists studied viruses from some patients to see if they had become more transmissible or virulent. But the viruses were from strains that have been circulating since before Covid, they reported in NEJM yesterday. Mask wearing and social distancing efforts earlier in the pandemic may have lowered levels of immunity to RSV among kids, making them more vulnerable to the virus and spurring early spread, they suggested. health Aggressive end-of-life care is more common for cancer patients in nursing homes than at home Former President Jimmy Carter's decision to receive hospice care at home comes to mind when reading this study on how Americans die. Despite decades of efforts to lessen aggressive care at the end of life, such measures are still common for older people with metastatic cancer. A new study in JAMA Network Open says the prevalence of such aggressive care for cancer patients is higher (64% vs. 58%) among nursing home residents than those who die at home. More than one hospital admission in the last month of life was one of the main factors found in such cases of aggressive care, also defined as cancer surgery, radiotherapy, or chemotherapy within that 30 days. Those hospital stays are linked to a bigger burden of symptoms, delays in hospice enrollment, and higher costs — with no benefit for survival. These findings are consistent with years of research, but aggressive care being more common in nursing homes was "contrary to our hypothesis," the researchers write. by the numbers

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Thanks for reading! More tomorrow,

elizabeth.cooney@statnews.com

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