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Morning Rounds Shraddha Chakradhar

Good morning! STAT reporter Kate Sheridan here, filling in for Shraddha.

How Biogen used an FDA back channel to win approval of its polarizing Alzheimer’s drug

(Mike Reddy for STAT)

Before the FDA approved Biogen’s controversial Alzheimer’s drug, Aduhelm, both parties were involved in back-channel discussions far earlier and more extensive than previously disclosed, STAT’s Adam Feuerstein, Matthew Herper, and Damian Garde write in an exclusive story. Their special report reveals discussions — including an off-the-books meeting between Biogen executive Al Sandrock and FDA official Billy Dunn —  that preceded unusually proactive and supportive efforts on the regulator’s part. Dunn’s office, for example, was where the contentious idea of an “accelerated approval” for Aduhelm originated in 2019, almost two years earlier than the FDA has claimed it began to consider this pathway. Biogen told STAT the company respected and followed the FDA’s guidance during Aduhelm’s approval process. The agency declined to comment.

Juul settles with North Carolina attorney general

Juul will pay $40 million to settle a lawsuit with North Carolina’s attorney general, according to a settlement announced yesterday. As part of the agreement, Juul’s products can be sold only behind the counter in North Carolina stores — and the company must pay for teenage "mystery shoppers" to test adherence to the policy. Juul also can’t use models who are younger than 35 in its advertisements. In return, the company may deny that it has broken a law or has done anything wrong. The case is just one of several the company is fighting over allegations that its advertisements targeted children and young adults. Lawmakers are also calling for additional federal regulations.

Safety concerns the top reason parents refuse HPV vaccines

One in four parents of U.S. teenagers cited safety concerns as the top reason their child wouldn’t be vaccinated against human papillomavirus strains responsible for about 80% of cervical cancer cases, according to a new study. Between 2015 and 2019, there was a big jump: from 12.9% of parents to 26.2%. The data were collected from 2008 to 2019, but as the authors of the paper note, some of these concerns echo ongoing discussions about the safety of Covid-19 vaccines right now. Children living in certain states may choose to be vaccinated against Covid-19, HPV, or other conditions without their parents’ consent — but that choice isn’t available to every U.S. teen.

Inside STAT: What the world could learn from Florence Nightingale


An illustration of Florence Nightingale making her rounds in the Barrack hospital at Scutari, during the Crimean War. (LONDON NEWS/HULTON ARCHIVE/GETTY IMAGES)

Florence Nightingale became a legend by fighting lethal infections in battlefield hospitals — and fighting against the medical status quo of her time. But a new First Opinion written by Danielle Ofri — a primary care physician at New York’s Bellevue Hospital — argues that the world has neglected for too long Nightingale’s other major career focus and contribution: her data-driven approach to social determinants of health. “As Covid-19 begins to recede in the U.S., Nightingale’s observations could hardly be more prescient,” she writes. “The staggeringly uneven toll of infection and death we have witnessed is a bitter confirmation of the interrelationship between health care and society.” Read more.

Black men receive curative therapies for prostate cancer less often

Black men who would have benefited most from curative treatments — younger men with more aggressive cancers — received them about 11% less often than non-Black men, according to a new study. For prostate cancers, definitive treatments include surgery to remove the prostate or radiation therapy. The study was done with six years of data from Veterans Affairs hospitals. Although the existence of a race-based disparity seems pretty evident, it’s not entirely clear what is driving it, the authors note — and in this study, a significant difference in treatment patterns only existed for people in this high treatment benefit group. “The influence of patient race at high treatment benefit levels invites further investigation,” they write.

New survey crowns the ‘healthiest’ U.S. county 

Los Alamos County in New Mexico is home to the healthiest community in America, according to a new ranking from U.S. News and World Report and the Aetna Foundation. Los Alamos’ high scores on housing, population health, and infrastructure propelled the county — which is indeed home to that Los Alamos — to the top spot. (Other metrics include public safety, community vitality, environment, and food and nutrition.) But as with many maps and rankings of the U.S., this one looks a lot like a ranking of something else: wealth. Six of the top 15 counties in the ranking are among the 15 counties with the highest per-capita incomes in the country; eight are among the top 15 by median income per household.

Covid-19 in the U.S.

New cases yesterday (two-week average): 11,020
New deaths yesterday (two-week average): 282

What to read around the web today

  • Why no one is sure if Delta is deadlier. The Atlantic
  • Will Gilead's early data for its CAR-T therapy give it an edge over Bristol Myers? STAT+
  • The race-based adjustment for kidney functioning that's harming Black Americans. Slate 
  • Experts debate the value of digital coaching for type 2 diabetes. STAT+
  • There's only 1 drug for postpartum depression. Why does Kaiser Permanente make it so hard to get? KQED 

Thanks for reading! More tomorrow,

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