| | By Elizabeth Cooney | Good morning. Go along with Usha Lee McFarling to Texas' Rio Grande Valley to see a bold plan to diversify Alzheimer's research unfolding — and understand why it's needed. | | ‘You need to go to the population’: Upending Alzheimer’s research to include Hispanic people (VERÓNICA G. CÁRDENAS FOR STAT) For as long as the field has existed, Alzheimer’s researchers have recruited patients for clinical trials in largely the same way: pulling them from specialty clinics, often at elite medical institutions that house the bulk of the nation’s federally funded Alzheimer’s Disease Research Centers. That’s led to patients in these trials, which sometimes offer new therapies available through no other channels, being overwhelmingly privileged, well-insured, and white. Hispanic people make up more than 18% of the U.S. population, and are among groups more likely to get Alzheimer’s disease, yet account for just 2% of participants in Alzheimer’s clinical trials. Gladys Maestre (above) came to Texas’ Rio Grande Valley to change that. “You need to go to the population,” the Alzheimer’s disease researcher told STAT’s Usha Lee McFarling. Read more on Maestre's mission and the story of family caregivers. | Alzheimer’s treatment slowed decline in closely watched trial An experimental drug to treat Alzheimer’s disease from Biogen and Eisai slowed the rate of cognitive decline by 27% in a closely watched clinical trial, the companies said yesterday, meeting the goals set for the intravenous medicine, called lecanemab, and strengthening its case for approval as early as January. The positive result is a big win for patients — and also for Eisai and Biogen after Biogen’s disastrous rollout of the Alzheimer’s treatment Aduhelm. In the study, which enrolled roughly 1,800 patients with early-stage Alzheimer’s, lecanemab outperformed placebo. The treatment also reduced toxic plaques in the brain and slowed patients’ decline on three other measures of memory and function, making the trial the largest to date testing the long-debated amyloid hypothesis. STAT’s Damian Garde and Adam Feuerstein have more. | Aduhelm fiasco causes drop in Medicare premiums Medicare announced yesterday that for the first time in more than a decade, premiums patients pay for services in physicians’ offices will be a little cheaper than last year. President Biden trumpeted the drop in a Rose Garden speech, but it had very little to do with his administration’s policies, my colleague Rachel Cohrs reports. Medicare last year enacted record-high premium hikes in Part B in part because it was expecting crushing expenses from Biogen’s controversial drug Aduhelm. But after coverage restrictions drastically lowered the number of people who could get the drug covered, the program was left with a whole bunch of extra money on hand. For context, the 2023 Medicare premium is still 11% higher than it was in 2021. The whiplash in Medicare premiums illustrates the huge challenges ahead for how the program will pay for costly, brand-new drugs, which wasn’t addressed in Democrats’ new drug pricing law. | How biomarkers have the potential to enhance precision for neurodegenerative disorders The complex biology of neurological disorders has made precision medicine difficult to apply in clinical neuroscience. However, the successful application of biomarkers may help scientists overcome the field’s historic R&D obstacles. Janssen is committed to leading the precision revolution in neuroscience not only with new therapeutic entities but also by advancing the understanding and use of biomarkers as tools to transform the way neurodegenerative disorders are identified, treated, and ultimately prevented. Read the article here. | Closer look: A call for full-spectum Medicare coverage of substance use disorders The way Medicare does — and doesn’t — pay for treating substance use disorders makes little sense: It’s like covering care for stage 1 and stage 4 cancers, but nothing in between, Fred Riccardi of the Medicare Rights Center, Judith Stein of the Center for Medicare Advocacy, and Ellen Weber of the Legal Action Center write in a STAT First Opinion. Paying for only the least and most intensive level of substance use care denies millions of people access to lifesaving treatments, despite the escalating overdose crisis and its disproportionate effect on older Black people. People over 65 and younger people with disabilities (also covered by Medicare) are not immune. “Parity for treating substance use disorders should have been applied to Medicare long ago to ensure that older adults and people with disabilities can access and afford the full scope of treatment and providers they need and deserve,” they write. Read more. | Early work links aluminum in childhood vaccines to asthma, but with caveats Caveats first: The findings are preliminary, and both the study’s authors and others who have reviewed the data urge caution. What the new observational study in Academic Pediatrics suggests: There may be a link between aluminum used in vaccines given to young children in the first two years of life (not Covid or flu shots) and the risk of developing asthma before age 5. The possible association needs to be further explored, the authors said, while they worry that in an era of rampant vaccine misinformation and parents’ expanding hesitancy, results at the start of a scientific exploration may instead be viewed as its conclusion. CDC won’t alter its recommendations based on the study, nor will co-author and pediatrician Matthew Daley. “I’m still going to advocate for vaccines as strongly as I did before we had these findings,” he told STAT’s Helen Branswell. Read more. | Aerobic exercise is good for older adults. Adding weightlifting is better, study suggests Older adults would be wise to add weightlifting to their exercise routines, based on a new study linking muscle-strengthening activities to a lower risk of death from most causes (not cancer). Combining weightlifting with moderate to vigorous aerobic activity was even better, the large observational study in the British Journal of Sports Medicine concludes. Weightlifting alone was linked to a 9% lower risk of death, moderate to vigorous aerobic activity alone was tied to a 32% lower risk, and doing both regularly was associated with a 41% lower risk of death, all compared to people who did neither. The data came from questionnaires answered by nearly 100,000 U.S. adults enrolled at an average age of 71 in a cancer-screening trial. Weightlifting is tied to lean body mass, itself a sign of good health, but the authors note that weightlifting could also bring social benefits if people work out in a gym with others. | On this week's episode of the "First Opinion Podcast," First Opinion editor Patrick Skerrett talks with Synlogic CEO Aoife Brennan about how the Supreme Court’s decision to overturn Roe v. Wade is forcing people involved in clinical research to rethink something as simple as pregnancy tests. Listen here. | | | What we're reading - In new guidance, FDA says AI tools to warn of sepsis should be regulated as devices, STAT
- A new shot guards against HIV, but access for Africans is uncertain, New York Times
- Top FDA official acknowledges agency’s slow process for reviewing health app updates, STAT
- The morning-after pill gets a Gen-Z rebrand, Wall Street Journal
- Congo declares end of latest Ebola outbreak in east, Reuters
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