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How an Alzheimer's drug and health equity intersect, Covid dangers for unvaccinated pregnancy, & a viral trigger for MS

 

Morning Rounds Elizabeth Cooney

Good morning. Two things:
1. Nominations are due Tuesday for STAT Madness, our annual bracketed competition in which colleges, universities, and institutions compete to have their biomedical research named the best innovation of the year. Here are the rules, FAQs, and where to send those nominations.
2. We're pausing the newsletter in observance of Martin Luther King Jr. Day but we'll be back on Tuesday.

Medicare's proposal on Aduhelm reignites another long-standing issue: health equity

Medicare’s proposal to restrict access to a controversial Alzheimer’s drug has quickly reignited a long-smoldering debate over how best to address the long-standing, systemic inequities in Alzheimer’s care experienced by Black and Hispanic patients. The draft plan would cover Aduhelm only for patients enrolled in a randomized clinical trial. The drug’s maker, Biogen, and major Alzheimer’s patient groups all panned the proposal, saying it would make it harder for vulnerable populations to access the medicine. The Alzheimer’s Association called it “shocking discrimination.” But health equity and Alzheimer’s researchers told STAT’s Nicholas Florko they don’t buy that argument. “It sounds a little performative and I don’t hear any action behind the real issues of inequity in Alzheimer’s management,” said Sharon Brangman, professor of geriatrics medicine at SUNY Upstate Medical University. Read more.

No one has any idea how much seniors could pay for Aduhelm

Medicare has outlined how it plans to cover Aduhelm, but the proposal is missing a crucial detail: how much money Medicare patients who receive the drug would actually pay. Normally, patients do not pay to participate in clinical trials, as trial sponsors bear the cost of medication and related services. But these wouldn’t be normal clinical trials. The draft coverage policy would severely restrict the number of seniors who can access the drug at all, as Medicare plans to cover the drug only for patients participating in rigorous, agency-approved clinical trials. But Medicare remained mum on the potential cost of the drug for patients enrolled in the clinical trials, not to mention who gets a placebo. STAT’s Rachel Cohrs has more.

Supreme Court halts vaccine mandate for businesses and White House promises N95s

The Supreme Court has stopped the Biden administration from requiring employees at large businesses to be vaccinated against Covid or undergo weekly testing and wear a mask on the job, the Associated Press reports, while allowing a vaccine mandate for most health care workers. Earlier yesterday, President Biden said the government plans to make high-quality N95 masks available for free. There may be many takers: In a poll conducted by the think tank Data for Progress last week, 8 out of 10 people said N95 masks provide the best protection, but nearly 6 out of 10 hadn’t tried to find any. More than 6 in 10 respondents favor the government supplying them, and more than 7 in 10 approve of the government shipping free home tests — which Biden also pledged to do. 

Inside STAT: Scientists are designing the next generation of CAR-T cell therapies for cancer

(Molly ferguson for stat)

CAR-T cell therapy has been a boon for treating blood cancers, offering patients months or years of life after they had exhausted all other treatment options and would have died within weeks. It works by using a chimeric antigen receptor — the CAR — to identify and kill cancer cells. These synthetic proteins bind to a specific target, like a protein on a cell surface membrane, and then activate the T cell to kill any cell carrying this target. But CAR-T does have shortcomings, including cost and side effects, limiting its use for now. Scientists are imagining and experimenting with new synthetic biology to engineer a more advanced cell, or engineering other ways to make it work better in the challenging environment around a tumor. STAT’s Angus Chen previews some of the potential solutions, including armored and controllable CARs.

In MS, strong new evidence for a viral trigger

MRI scans of people with multiple sclerosis show ghostly signs of inflammation dating back many years and many millions of dead neurons. “Like city blocks going dark during a power outage, these cells blinked out one by one after an immune storm stripped off the insulating myelin sheath that helps them send and receive electrical signals,” STAT’s Megan Molteni writes. The mystery of what causes the immune system to turn on itself is closer to being solved, she reports, with research implicating infection with the Epstein-Barr virus, best known for causing mononucleosis. The connection is not new, but scientists looking at more than 10 million young adults on active military duty show in their new paper in Science that infection with Epstein-Barr increased the likelihood of developing MS by more than 32-fold. Read more.

Being unvaccinated during pregnancy heightens risk of Covid complications and newborn death

Unvaccinated pregnant people who get Covid-19 are at much higher risk for complications from the disease and death of their babies than their vaccinated counterparts, according to a new study from Scotland published yesterday in Nature Medicine. The researchers, who examined data across Scotland from December 2020 to October 2021, found that almost all of the pregnant people who needed critical care for Covid-19 — 102 out of 104 — were unvaccinated. There were more than 450 total fetal and newborn deaths that coincided with Covid-19 — all among unvaccinated mothers. Beyond underscoring the value of vaccination, the sobering numbers have another message, Kjersti Aagaard of Baylor, who was not involved in the study, told STAT’s Theresa Gaffney. “For the love of Pete, pregnant people need to be included in vaccine trials,” she said.

 

What to read around the web today

  • With its Alzheimer’s drug in turmoil, Biogen eyes a list of potential acquisitions. STAT+
  • Biden's FDA nominee advances through key Senate committee. The Hill
  • He once stabbed a man seven times. Now he’s a pig heart transplant pioneer. Washington Post
  • Doctors debate whether trans teens need therapy before hormones. New York Times
  • Long-excluded uterine cancer patients are step closer to 9/11 benefits. Kaiser Health News
  • Opinion: Patient engagement: The true benchmark in clinical trials. STAT+

Thanks for reading! Til Tuesday,

@cooney_liz
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