Expert panel urges FDA to pull premature birth drug off the market

After an extraordinary three-day hearing, an expert panel of advisers to the FDA voted to uphold the agency’s effort to withdraw a controversial drug for preventing premature births. The decision touches on two flashpoints: health inequities and skepticism about the accelerated approval pathway for drugs whose benefits are not well established. Yesterday’s 14-to-1 vote came after the agency and the drug’s manufacturer, Covis Pharma, offered opposing views of clinical evidence on Makena, approved in 2011. The FDA said the original clinical trial failed to show the expected benefit, but Covis said a later trial helped some Black women. The FDA disagreed.

Premature birth — before 27 weeks of pregnancy — is about 50% higher among Black women than white or Hispanic women. But as panel member Susan Ellenberg of the University of Pennsylvania put it, “unmet need is not a basis for keeping a drug available when you don’t know if it works.” STAT’s Ed Silverman has more and oncologist Mikkael Sekeres comments on the vote's meaning in this STAT First Opinion.

Large insurer will cover some prescription digital therapies

It’s a watershed moment for prescription digital health therapeutics. Highmark, a large commercial insurer based in Pittsburgh, has decided to cover this controversial class of software-based treatments for psychiatric and other conditions. Until now, insurers have been reluctant to pay for the treatments, skeptical that the new technologies are as effective as their makers claim. As STAT’s Mario Aguilar reports in this exclusive story, Highmark quietly put in place a policy in August describing when these treatments may be “medically necessary,” making the health insurer the first to cover the category for a population of millions.

Highmark’s policy lists eight products, including Pear Therapeutics’ cognitive behavioral therapy apps to treat substance use disorder, opiate user disorder, and insomnia, and Akili Interactive’s video game treatment for pediatric attention deficit hyperactivity disorder. Read more.

Black Death may have left its mark on genes involved in immune responses

Here’s a phrase you don’t encounter very often, even with Halloween around the corner: Archaeologists call a graveyard in London “the lasagna of Black Death” because of the way the graves were meticulously layered on top of each other. The mass burial site dates back to the height of the bubonic plague pandemic, so it holds crucial information in the form of DNA samples from people who died in that era and the bacterium that caused the Black Death, Yersinia pestis. There lie lessons about how this medieval pandemic shaped our modern immune responses.

Researchers writing in Nature report that the plague not only created selective evolutionary pressure for genes that promote better immune response to Y. pestis but also may have contributed to humans’ current susceptibility to autoimmune diseases like Crohn’s disease. STAT’s Brittany Trang has more on how the scientists came to their conclusion, including the role of an “Edward Scissorhands" protein.

Closer look: Alzheimer’s patients in a successful drug trial feel lucky

(adobe)

They consider themselves lucky. They’re participants in clinical trials of lecanemab, an experimental Alzheimer’s therapy whose rare success has sparked hope. After some got the drug and some got a placebo, all are now receiving the drug, meaning early access to a treatment others might get months from now, should regulators approve it.

One participant, 80-year-old John “Jack” Driscoll, told STAT’s Andrew Joseph it was “being able to be in the front of the line for what may be a major change for everyone who has my problem.” Participants know the medication neither cures Alzheimer’s, nor reverses cognitive losses. It did slow the rate of cognitive decline by 27%, but has side effects including brain swelling and bleeding. Any delay is welcome, participant Curt Casteel said. “If it means a few more weeks, a few more months, at the human level, that’s going to be significant.” Read more.

Homicide is greatest risk to U.S. pregnant women

This fact is both shocking and not: Homicide is the leading cause of death in pregnant women in the U.S. That puts it ahead of pregnancy-related problems like disorders from high blood pressure, hemorrhage, or sepsis. Intimate partner violence may be common around the world, but its higher prevalence in the U.S. combined with the easy availability of firearms greatly increase the risk to women, an editorial in BMJ says — thus the lack of surprise given those facts of life in America.

Now that the U.S. Supreme Court has overturned Roe v. Wade and access to abortion is shrinking, the situation is more urgent, Rebecca Lawn of Harvard and Karestan Koenen of Massachusetts General Hospital write: “Restricting access to abortion endangers women because unwanted pregnancies potentially amplify risks in abusive relationships.” Hope lies in pregnancy usually meaning women will see health care providers more often, they say, when screening might help avert deadly outcomes.

Nature's guest editors have a 'message in a bottle' about racism in science

The prestigious scientific journal Nature has devoted its most recent issue to racism in science, a topic whose prominence has mushroomed since the murder of George Floyd — in good ways and bad, as STAT’s Usha Lee McFarling wrote a year ago about “health equity tourists.” But for the first time in its more than 150-year history, Nature’s special issue was guest edited, by Melissa Nobles, Chad Womack, Ambroise Wonkam, and Elizabeth Wathuti. They write that “for too long, science’s textbooks, along with the author and reference lists in research papers, have neglected to include Black, Indigenous, and other historically marginalized peoples.”

Science curricula, research, and academic spaces must go through decolonization processes, Philip Ball writes in the issue. “These are not political or ideological acts, but part of science itself — an example of science’s self-correcting mechanism in the pursuit of truth,” the editors write, calling the special issue “our message in a bottle,” hoping others will find and use it.

What we're reading

FDA authorizes booster shot for Novavax’s Covid-19 vaccine, STAT
Texas schools are sending out DNA kits, stark reminders of Uvalde shooting, Washington Post
As AI grows in medical image analysis, concern about building trust with doctors grows too, STAT
WHO to switch to one dose of two-dose cholera vaccine amid rising outbreak, Reuters
As Covid hit, Washington officials traded stocks with exquisite timing, Wall Street Journal
Tobacco companies shower Black Democrats with campaign cash, STAT