STAT investigation: The FDA stands by as vaping industry flouts its orders

(Hyacinth Empinado/STAT)

If you’ve been following the rise of vaping, you’ll know the FDA has spent more than four years trying to decide whether retailers should be able to sell cotton-candy-flavored liquids, or disposables filled with more nicotine than 200 cigarettes. The agency has ordered hundreds of products off the market. But STAT’s Nicholas Florko and Elissa Welle found that vape companies regularly flout those orders. They’re making, stocking, and selling the illicit goods. And the agency is just letting it happen.

Here’s how one legal expert describes the FDA’s approach: It’s like a cop pulling someone over for running a red light while drunk — then writing them a ticket for the traffic violation and sending them on their way. The FDA declined STAT’s request for an interview with either FDA Commissioner Robert Califf or the head of the FDA’s tobacco center, Brian King. Read more.

Religiosity and spirituality linked to better heart health among Black Americans

Participating in religious activities, from church services to private prayer, as well as holding deep spiritual beliefs are linked to better cardiovascular health among Black Americans, a study out today in the Journal of the American Heart Association concludes. The researchers say the correlation could help guide efforts to improve health among Black people, who as a group have poorer overall cardiovascular health than non-Hispanic white people, including higher rates of death from cardiovascular diseases.

Based on responses from nearly 3,000 participants in the Jackson Heart Study, the country’s largest single-site, community investigation of cardiovascular disease among Black adults, the study says those who reported more religious activity or having deeper levels of spiritual beliefs were more likely to meet key measures for cardiovascular health including physical activity, diet, smoking, weight, blood pressure, blood sugar, and cholesterol levels.

Facial — not just family — resemblance can be mirrored in the genes

(François Brunelle)

Twin studies are fascinating in their own right, but what about virtual twins? A new study in Cell Reports discovered that genotypes are shared by pairs of people whose faces look so much alike that they could be twins. Researchers turned to photography by Quebecois artist François Brunelle, who has been collecting lookalike photos (above) since 1999. The researchers studied black-and-white pictures of 32 duos, confirming the similarity with three facial-recognition programs and ruling out their being long-lost relatives.

Among 16 of those pairs, DNA analysis revealed common genotypes but two differences: how those genes were expressed (epigenetics) and what made up their microbiomes (except one pair). Still, weight, height, smoking, and education were also correlated, “suggesting that shared genetic variation not only relates to shared physical appearance but may also influence common habits and behavior.” A caveat: 13 of 16 pairs were of European ancestry so results might not apply to all people.

Closer look: A new biomarker could spark neuroscience drug discovery — and controversy

(adobe)

Is neurofilament the new “it” protein? “It’s an up-and-coming biomarker,” Holly Lynch Fernandez of the University of Pennsylvania told STAT’s Jason Mast. “Whereas amyloid was on its way out.” Jason recounts the history of neurofilament’s discovery, likening it to debris in a river after a brain injury kills neurons. Fished out of bovine brain stems, purified, and then injected into rabbits some 30 years ago, a Swedish researcher eventually created the first neurofilament test that today is central to drug development and regulatory approval.

Sounds good, right? But the FDA has to confront conflicting evidence over whether — and when — the biomarker found in blood samples can really say a treatment helps. After the polarizing debate over Aduhelm and the amyloid hypothesis, the agency now faces a decision on an ALS drug application from Amylyx that relies on neurofilament. Read more.

Maybe good sleep makes us better people

I confess: When I saw this study in PLOS Medicine linking grogginess after the clocks fall back to diminished charitable giving, I was skeptically searching for examples of correlation not being causation. But maybe I’d have been more generous if I’d gotten more sleep last night. Also, the authors' quoting Muhammad Ali is a nudge: “Service to others is the rent you pay for your room here on Earth.”

To wit: The researchers found that more than three-quarters of study volunteers were less likely to help others after being deprived of sleep in a lab than when they were well-rested. Functional MRIs focused on brain regions involved in social cognition showed lower task-related activity levels tracked with sleep loss. At home, the volunteers were less willing to help other people after they reported nights when their sleep was worse. And the week after daylight saving time ends and steals one hour of sleep, donations to charitable organizations fell 10% in the U.S. from 2001 to 2016, compared to the month before and after.

Opinion: The FDA is at a crossroads for tobacco

As cigarette smoking has declined over the last several decades, it’s easy to forget about tobacco and the nearly half a million lives lost to smoking each year. Consider this: Since the onset of the Covid-19 pandemic, more Americans have died from tobacco use than from Covid. New and existing combustible and noncombustible tobacco products continue to pose public health challenges, Michael B. Farber, a Harvard Law School and Harvard Business School student, and Anand Shah, an oncologist and former FDA deputy commissioner for medical and scientific affairs, write in a STAT First Opinion.

They say the U.S. is at a crossroads for tobacco use. While the FDA has plans to eliminate menthol flavoring and cap nicotine levels, a recent court decision in West Virginia v. EPA may slow efforts. Read more to find out why.

What to read around the web today

Biden administration plans for new booster campaign soon after Labor Day, New York Times
Your first brush with coronavirus could affect how a fall booster works, Washington Post
Yelp to add more flags to anti-abortion pregnancy centers, Associated Press
Timely mental health care is a key factor in strike by Kaiser Permanente workers, California Healthline
Opinion: To improve children’s health in low-income countries, put pediatric surgery on par with preventing malaria or HIV, STAT