Closer Look
A new era: Benefits and risks are confirmed for another Alzheimer's drug
In another sign that it's a new world for Alzheimer's treatment, Eli Lilly confirmed both good and bad news about its drug donanemab yesterday. Detailed scientific disclosures published in JAMA come while the FDA reviews the drug, whose approval is expected by year's end. It would join Eisai and Biogen's Leqembi, which also has modest benefits in delaying cognitive decline combined with concerning side effects.
Donanemab slowed Alzheimer's disease progression by 35% relative to placebo, but 37% of participants treated with donanemab experienced the brain swelling and bleeding called ARIA. Neurologist David Knopman of the Mayo Clinic said the drugs offer a similar and small benefit, with donanemab maybe looking slightly better on efficacy than Leqembi, but with more concerning safety risks. "How does one balance some of the logistical and possible efficacy benefits of donanemab against the doubling of ARIA? I don't have an answer," he told STAT's Adam Feuerstein. Read more.
health tech
Blood tests recalled over risk of missed heart attacks
"Time is muscle" is a phrase familiar to emergency clinicians racing to treat patients before oxygen-starved heart muscle is lost. That saying comes to mind now that QuidelOrtho has recalled nearly 8,000 potentially faulty blood tests designed to help doctors quickly determine whether a patient is having a heart attack. The tests inaccurately showed low levels of troponin, a protein that indicates damage to the heart. A false negative could lead doctors to mistakenly conclude their patient is not having a heart attack, delaying diagnosis or treatment.
The device maker, which also sells products like the QuickVue Covid-19 antigen test, sent letters to health systems in May telling them to immediately stop using the test. The FDA classified the recall as serious because these problems could lead to serious injury or death. QuidelOrtho has reported 41 complaints, but no injuries or deaths so far, STAT's Lizzy Lawrence reports.
global health
Childhood immunizations bounce back a bit
The number of children receiving childhood immunizations has recovered from a pandemic dip, but 20.5 million children worldwide still missed at least one vaccine dose in 2022. That's down from 24.4 million who fell behind in 2021, and rates in low-income countries are stagnant or declining, a report from UNICEF and WHO says.
Despite the overall rebound, coverage falls far short of the U.N.'s goal to cut the global number of "zero-dose children" in half by 2030. The only bright spot came in HPV vaccination, which protects teens from the vast majority of cervical cancer cases. The latest rates came in better than before the pandemic: 21% of girls in 2022, up from 19% in 2019, but those figures are still a long way off from the U.N.'s goal of 90% by 2030. STAT's Annalisa Merelli has more.
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