Breaking News

VA's surprise move on new Alzheimer's drug, food fight over chocolate milk, & 102 hours of chaos in biotech

March 14, 2023
Reporter, Morning Rounds Writer
Good morning. Be sure to check out today the 2023 STATUS List, STAT's annual compilation of influential leaders in life sciences.

pharma

VA will cover the latest Alzheimer's drug

In a surprising move that puts it at odds with Medicare, the VA said yesterday it would cover a new Alzeheimer's drug granted accelerated approval by the FDA on the condition that further studies be conducted. The drug is Leqembi, developed by Eisai and to be marketed with Biogen. The VA will cover any veteran who meets certain criteria, including an MRI scan within the previous year, amyloid PET imaging consistent with Alzheimer's, and a test indicating mild Alzheimer's dementia. There is also a long list of criteria that would exclude veterans.

You'll recall that Biogen's drug Aduhelm also won accelerated approval, but conflicting data on its safety and effectiveness as well as concerns about FDA's process made for a disastrous rollout. Medicare has restricted coverage of Leqembi and all monoclonal antibody drugs that target amyloid, a protein believed responsible for Alzheimer's, pending full FDA approval. STAT's Ed Silverman has more.


Biotech

102 hours of chaos: How SVB's failure shook biotech

While Paul Rennert was flying over the Atlantic Ocean after some investment meetings abroad, the Aleta Biotherapeutics CEO had no idea the bank his and scores of other startups relied on had suffered a historic bank run. The first in a flurry of text messages asked, "Where are Aleta's bank accounts?" The answer was Silicon Valley Bank, of course, amid 102 hours of chaos after the FDIC took control of the failed bank.

"A lot of these are first-time founders," Perlara CEO Ethan Perlstein told STAT. "They don't know what the hell to do. And a lot of them weren't even adults yet in 2008, so they don't know what this is like." STAT's Allison DeAngelis asked entrepreneurs and venture capitalists with varying levels of experience how it all went south so quickly, despite hints that the bank wasn't running as smoothly as it may have appeared. Read more.


science

Genome summit shifts from 'should we' to 'how can we' edit embryos 

There's a 42-foot-high sculpture in front of the Francis Crick Institute in London from which questions emerge about genome editing, part of an art exhibit called "Cut + Paste": "Would you eradicate disease? Would you enhance your body? Where would you draw the line?" Last week's Third International Summit on Human Genome Editing was meant to address those questions, but while scientists, ethicists, and legal scholars wrestled with issues of equity and access to treatments in development for genetic conditions such as sickle cell disease, they were more muted on germline editing — changing the DNA of sperm, eggs, or embryos.

The summit opened with a session saying the "CRISPR babies" scandal wouldn't happen again, but the rest of the meeting moved away from asking whether they should to asking how they might edit embryos, bioethicist Benjamin Hurlbut said. "It seems to me that we are worse off than when we started," he told STAT's Megan Molteni. Read more.



Closer Look

'Leave the chocolate milk out of this': How making school lunches healthier turned into a food fight

Photo illustration of an anthropomorphic chocolate milk carton holding on to a lunch tray while being pulled awayAlex Hogan/STAT

The kids are mad. And so are parents, school cooks, and local administrators stretching limited dollars to offer nutritious lunches to elementary and high school students. The food fight kicked up after the Biden administration proposed new guidelines limiting added sugar and sodium in school lunches and breakfast. USDA reimburses schools for some of the food kids get, so it matters to their budgets. 

Chocolate milk might be the third rail in this dispute — which looks a lot like the 2010 battle the last time guidelines changed — because its 20 grams of sugar per carton come close to the recommended daily ceiling of 25 grams in added sugar. Parents, teachers, and school officials are saying no. "Leave the chocolate milk out of this," Michelle Wickstrom, a teacher from Green River, Wyo., said. And kids agree, complaining they're getting dehydrated, according to one fourth-grader. STAT's Nicholas Florko has more.


health inequity

Cardiac arrest during delivery more common among older, Black, and low-income pregnant patients

Cardiac arrest in pregnant women hospitalized to deliver their babies is relatively rare, at 1 in 9,000 cases, but it's part of a larger story of poor outcomes in childbirth that are much worse for Black women in the U.S. The new study, in Annals of Internal Medicine, found that compared with other hospitalized patients, those who had a cardiac arrest were more likely to be older, Black, insured by Medicare or Medicaid, and have underlying health problems such as chronic hypertension, mental health disorders, substance use disorder, and acquired heart disease. 

The new study, conducted from 2017 through 2019, found that two-thirds of these patients survived cardiac arrest. But as the Commonwealth Fund reported last year, U.S. women have the highest rate of maternal deaths among high-income countries, and Black women are nearly three times more likely than white women to die from pregnancy-related complications.


health

Getting a good night's sleep could strengthen your vaccine response

As Covid vaccines rolled out beginning in December 2020, their effectiveness appeared to wane faster among men, older adults, people with obesity, smokers, and people with high blood pressure because they developed fewer antibodies. A new study in Current Biology identifies another possible risk factor for vaccines more broadly, one people might be able to more easily change: how much sleep they get. The researchers reached that hypothesis after analyzing seven studies measuring how much sleep people got and how they responded to flu or hepatitis B or C vaccines.

Those who slept fewer than six hours around vaccination had fewer antibodies than those who got seven or more hours, which translates into two more months of protection. Caveat: The difference was statistically significant only for men, with much variation among women (the studies didn't account for sex hormones), and it was stronger for adults under 60, who tend to sleep better.


More around STAT
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What we're reading

  • The next stage of Covid is starting now, The Atlantic

  • NIH top job still empty as candidates back out, Wall Street Journal

  • Matt's Take: Illumina has been ignoring its investors, but it can't ignore Carl Icahn, STAT
  • Opioid settlement hinders patients' access to a wide array of drugs, New York Times
  • Pfizer buys Seagen, maker of targeted cancer drugs, for $43 billion, STAT

Thanks for reading! More tomorrow,


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