| | | |   By Elizabeth Cooney | Good morning. It was a pivotal day for ALS patients and a drug maker at an FDA advisory panel's meeting. | | | In a close vote, FDA panel advises against approving a drug for ALS In the end, yesterday’s advisory panel vote on a new drug to treat ALS was closer than expected. Six experts agreed with the FDA that data on AMX0035 from Amylyx’s single clinical trial were not persuasive enough on their own to warrant approval. Four of the invited experts voted in Amylyx’s favor. Before the daylong meeting, where powerful testimony from patients and families followed hours of scientific presentations, the FDA had made public its significant reservations about the drug, concluding it provided only a modest benefit for ALS patients and “may not be sufficiently persuasive” to support approval. Agency reviewers also noted that because ALS is a fatal disease with few treatments, “regulatory flexibility” is required. As Phil Green, a patient who spoke at the hearing, said, “We truly have nothing to lose.” A ruling is expected by June 29. Read more in STAT+ from Adam Feuertstein and Nicholas Florko, who followed yesterday’s deliberations. | Main authors in elite medical journals remain mostly white and male A new analysis of two elite medical journals shows that women and people of color rarely served as lead or senior authors of research articles published during the past three decades, lagging behind the increasing presence of these groups within medicine. Fewer than 1 in 4 lead or senior authors of articles in JAMA and NEJM were women, Black researchers likely accounted for 2% to 7% of these main authors, and Hispanic researchers for 2% to 4%, the study found. “It wasn’t surprising the numbers were low, what’s more disturbing is the slow rate of change,” said Moustafa Abdalla, a Harvard Medical School student and lead author of the paper, which he said was rejected at both JAMA and NEJM. (Both journals said they could not confirm or deny this.) STAT’s Usha Lee McFarling has more. | Obesity can turn a helpful drug into a harmful one, mouse study shows Researchers have long known that obesity rewires the immune system. Now a new study in Nature suggests these effects can turn a drug meant to treat a common inflammatory disease into one that makes things worse. Scientists discovered that mice with atopic dermatitis, a painful and itchy skin rash often triggered by an allergic reaction, were worse off if they were obese. A closer look led to a surprise finding: Different immune cell types drove the disease in obese versus lean mice. That caused a standard treatment to exacerbate symptoms in heavier animals, but adding another drug made the treatment regimen work again. The authors found some preliminary evidence that obesity alters immune responses to allergic diseases similarly in people, too. But as STAT's Jonathan Wosen writes, it’ll take additional work to show whether the findings hold up in humans. | Smarter intelligence, faster improvement, and better results PINC AI™ is powering the future of healthcare through a groundbreaking combination of data, technology, services, and scale designed to accelerate ingenuity in healthcare. At the end of the day, we believe healthcare is about doing what’s right and what’s best for our communities. Healthcare needs a radical change, and PINC AI™ will be the engine behind it. Learn more. | Closer look: Medtech companies want to take a swing at Alzheimer's  (adobe) In the wake of the first Alzheimer’s drug approval in nearly two decades, pharmaceutical companies have been reinvigorated in their effort to tackle the neurodegenerative disease. But it’s clear their struggles are far from over — leaving an opening for software and device companies to take aim. While pharma companies continue to investigate drugs targeting the disease’s hallmark sticky clumps of protein in the brain, many medical technologies don’t need to understand the disease’s root causes to target its symptoms. A digitized version of psychosocial therapy could help manage agitation and depression associated with the disease, for example, or a noninvasive global brain stimulation technique could slow cognitive decline. Heavy emphasis on “could,” STAT’s Katie Palmer warns us. Read more about how digital tools for Alzheimer’s could be valuable additions, even if they focus on secondary symptoms such as agitation or mobility challenges. | Lung cancer screening linked to earlier diagnosis Screening older smokers for signs of non-small cell lung cancer has been recommended since December 2013, but has it made a real-world difference? A new study in BMJ links CT scans to earlier diagnosis and better survival, but the benefit has been unequal. The researchers found stage 1 diagnoses went up 3.9% each year from 2014 to 2018 and survival increased 11.9% over that period. People lived from 15.8 to 18.1 months after diagnosis from 2010 to 2013, but that changed to 19.7 to 28.2 months from 2014 to 2018. By 2018, stage 1 was the most common diagnosis among non-Hispanic white people and those living in the highest-income or best-educated regions. But a stage 4 diagnosis was still more likely for non-white people and those living in lower-income or less-educated regions. | People worry about inflation — and paying for unexpected medical bills Inflation is the top concern among Americans, but paying for unexpected medical expenses (58%) comes right behind worries about gas prices (71%), a KFF Health Tracking Poll out today says. While most people picked inflation as the country’s most pressing problem, other issues were more distant: the Russian invasion of Ukraine (18%), climate change (6%), and even Covid-19 (6%). Some examples of how people said they coped with health care costs in the past year: - 51% have delayed or skipped health care
- 35% didn't get dental care
- 18% went without mental health care
- 9%, including 43% of those with annual household incomes below $40,000, did not fill a prescription, cut pills in half or skipped doses, or took an over-the-counter product instead of a prescription.
| | | | | What to read around the web today - Why people are acting so weird. The Atlantic
- ‘Large-scale fraud’ and lax oversight plague California’s hospice industry, audit finds. Los Angeles Times
- 5 technology trends drawing investment as health care moves into the home. STAT+
- Covid and schizophrenia: Why this deadly mix can deepen knowledge of the brain disease. KQED
- Roche anti-TIGIT cancer immunotherapy fails in first late-stage clinical trial. STAT+
| Thanks for reading! More tomorrow,  P.S. As someone who admits to being lost more often than not, this Nature paper on growing up with or without streets on a grid speaks to me. P.P.S. And I swear I’m not a crazy cat lady, but I couldn’t resist this iScience study saying a squirt of oxytocin up the nose helped lions chill out. | | | | Have a news tip or comment? Email Me | | | | | |
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