Breaking News

A new gene therapy is 'amazing to see.' Its price sets a new record

March 20, 2024
Reporter, Morning Rounds Writer
Good morning. Today STAT reporters look at concerns about limits on fetal tissue research, dig into a medical mystery, and follow families and others affected by approval of a new gene therapy at a record price.

 in the lab

'The U.S. is falling behind': Scientists fear restrictions on fetal tissue research will remove a crucial toolimage_123650291-5

Molly Ferguson for STAT

Some pursuits of biomedical science can't proceed without studying fetal tissue, which can help scientists learn about stem cells and understand cancer biology and brain development. But several scientists say fetal tissue research is increasingly untenable in the U.S. with the possible return of former president Donald Trump to office. His previous administration set up roadblocks that President Biden overturned, but federal funding of studies relying on fetal tissue has not fully rebounded. 

"The U.S. is falling behind," Dan Doherty, a pediatrics professor at the University of Washington, told STAT's Olivia Goldhill. In one example, fetal tissue has gained importance thanks to advances leading to the creation of sophisticated human organoids — organ-like blobs of tissue grown in labs — to study the emergence of diseases and potential treatments. Fetal tissue is needed to validate results. Read more.


genetics

A medical mystery or a blind spot? 

What does "rare" mean? It depends on the context. When that context is the world of genomic datasets dominated by European samples, it requires deeper sleuthing to determine what's a mystery and what's not. A preprint paper illustrates this point with the cases of two people who died young from heart problems and shared a particular variant of a gene that helps the heart beat. According to available datasets, the variant qualified as rare. And without knowing its meaning, one lab concluded it was likely disease-causing. 

That was before looking harder. Researchers who authored the new report  found that the two patients were of Oceanian ancestry, among the least represented populations in DNA databases, meaning their genetic variants likely aren't reflected in rates saying how common they actually are. And it turned out the variant was not so rare after all. STAT's Andrew Joseph explains.


chronic disease

Baby aspirin cuts fat buildup in liver disease patients

In a small study, patients with metabolic-associated liver disease who took low-dose aspirin saw a reduction in liver fat compared to patients who took a placebo. The results are too preliminary to change practice, lead author Tracey Simon said of the study published yesterday in JAMA, but it points to potential progress in metabolic dysfunction-associated steatotic liver disease, or MASLD. About 1 in 5 people with MASLD has a more severe form of the disease, called metabolic dysfunction-associated steatohepatitis, or MASH, for which the FDA approved Rezdiffra last week.

Formerly known as non-alcoholic fatty liver disease, MASLD is a growing health threat. One in three Americans has a troublesome amount of fat in their liver. That lipid buildup feeds into a toxic cycle of inflammation, tissue damage, and, ultimately, irreversible scarring. How aspirin might decrease fat or scarring isn't known, but the research adds another chapter to aspirin's evolving story of recommended use. STAT's Isabella Cueto has more.



closer look

A new gene therapy is 'amazing to see,' a mother says. Then there's the priceAdobeStock_64083570

Adobe 

Victoria Rasberry sees the difference a gene therapy can make every morning. Her 8-year-old daughter Addi needs thick mucus sucked out of her airways so she can breathe. She eats breakfast from a feeding tube and must take 28 different medications to prevent pain, infections, and seizures. Her brother Oliver, age 3, is a typical giggling toddler. The children share a genetic mutation that causes a fatal neurodegenerative disease called metachromatic leukodystrophy, or MLD, but as a baby he was treated in Italy with what its maker said today will cost $4.25 million in the U.S., making it the most expensive drug in history. 

"When Addi was this age she had lost the ability to speak and was already using a ventilator to sleep at night," Raspberry said. "It's amazing to see how well Ollie is doing in comparison. And it's all because of the gene therapy."

On Monday the U.S. FDA approved Orchard Therapeutics' gene therapy Lenmeldy, an achievement decades in the making from parents' efforts, researchers' experiments, and a company's experience with other gene therapies that failed. Now there's the hurdle of that price. "It may take months sometimes to get those things worked out," Paul Orchard of the University of Minnesota said about insurers. "And some of these kids aren't going to have months to screw around." STAT's Jason Mast and Megan Molteni have more on the complicated story. 


climate

Heat waves hit already vulnerable counties harder, study finds 

A new research letter published yesterday in JAMA Network Open reminds us that summer is coming, and, with it, heat waves driven by climate change that challenge health and health care. You might be familiar with heat islands in cities, but this analysis looked more broadly at counties in the U.S., measuring how many activated emergency medical services to cope with heat-related illnesses, which can include cardiovascular problems, heat stroke, sepsis, and kidney failure.

Across the country during a July 2023 heat wave, the researchers found,  nearly one-quarter of counties had high EMS activation. The burden was higher in socially vulnerable and disadvantaged communities, as defined by CDC metrics and an index from the University of Wisconsin. "These communities are already at greater risk for cardiovascular disease, with lower access to primary care compared with other counties," the authors write, urging investment targeting these communities to improve their heat resilience.


science

Intermittent fasting is making people drop dead, a study says. Really?

At the risk of giving more oxygen to a study of dubious merit, I do think you should read my colleague Matt Herper's takedown of coverage saying a popular fad diet is apparently lethal, citing scientific research to be presented at an upcoming conference. Maybe you saw headlines and stories pinning a 91% higher risk of death due to cardiovascular disease on intermittent fasting. Here's why he says it's nonsense and not worth your brain cells: The study, now available only as a press release, depends on observational research, the kind we know cannot establish cause and effect.

That's a particular weakness of nutritional research because it's hard to randomize people to eat or not eat something for years — and accurately recall if they did. Crucially, it leaves out what might be different about people with different results. Case in point: the French paradox, the hypothesis "that red wine let Parisians down croissants, foie gras, boeuf bourguignon, raclette, and moules frites without the heart attacks the researchers expected." Au contraire, mon frère. Read more. 


More around STAT
Check out more exclusive coverage with a STAT+ subscription
Read premium in-depth biotech, pharma, policy, and life science coverage and analysis with all of our STAT+ articles.

What we're reading

  • More than six in 10 U.S. abortions in 2023 were done by medication — a significant jump since 2020, Associated Press

  • Four years on: the career costs for scientists battling long Covid, Nature

  • UnitedHealth appears to be upping loan offers to providers, after Change cyberattack, STAT
  • Horseshoe crabs, prized by the biomedical industry for their blood, to get new protections in Massachusetts, Boston Globe
  • Opinion: Sabbaticals for nurses could help fight worker shortages and burnout, STAT

Thanks for reading! More tomorrow,


Enjoying Morning Rounds? Tell us about your experience
Continue reading the latest health & science news with the STAT app
Download on the App Store or get it on Google Play
STAT
STAT, 1 Exchange Place, Boston, MA
©2024, All Rights Reserved.

No comments