health
When drugs look (and taste) like candy
Adobe
M&Ms, Reese’s, gummy bears, and cotton candy. Sounds like a fun day at the FDA, especially on the day before Halloween, no? Regulators were debating the potential benefits and pitfalls of “candy-like” nonprescription drug products such as vitamin gummies, particularly for children who often cannot, or do not want to, swallow actual pills. A dentist did speak passionately about the potential benefits of sedating kids for dental work with medicated gummy bears, STAT’s Nicholas Florko tells us, but the rest of the meeting’s speakers stressed the potential pitfalls of these products, particularly accidental overdose.
Don’t tell the kids, but some suggested less-fun ways to medicate those who can’t swallow pills, ranging from intranasal to rectal administration. “Why does it have to be candy-like?” asked Rachel Meyers, a clinical professor at Rutgers University. “I think we have to get away from this idea that all kids can’t swallow oral solids.” Read more.
health Tech
White House orders up a plan to vet AI in health care
Threading the needle between providing protection and encouraging innovation, President Biden has ordered federal health agencies to come up with a plan for regulating artificial intelligence tools that hospitals, insurance companies, and other health businesses are already using. Under the directive, part of a broader order covering AI in government, a safety program would be created to receive reports of AI-related harms and unsafe practices while other agencies would fund research to support AI in drug discovery and other domains.
The order calls for efforts to fight discrimination and harmful practices, but it may be late to the game, trailing standards in Europe and the practices of some U.S. businesses, STAT’s Casey Ross notes. Earlier this year, he and Bob Herman reported that the nation’s largest health insurers are using an algorithm to issue payment denials to Medicare beneficiaries struggling to recover from serious illnesses and injuries. Read more.
health
Bone mineral density returned to normal levels long-term after puberty blockers, study says
Transgender youth who use puberty blockers followed by gender-affirming hormones do not have reduced bone mineral density in the long term, according to a new study published yesterday in JAMA Pediatrics, STAT's Theresa Gaffney tells us. The study helps address at least one question regarding the long-term health impacts that may or may not arise as a result of the treatment, which halts the physical developments of puberty and has been FDA-approved for cisgender children going through precocious puberty since 1993. In a study of 75 transgender people at one Amsterdam health center from 1972 through 2018, researchers found that bone mineral density measurements were largely restored to pretreatment levels by the time participants reached adulthood.
Participants who received puberty blockers continued with gender-affirming hormones for at least nine and an average of about 11 years, with a median age of 28 at follow-up. Bone mineral density was measured in the lower back vertebrae, hip, and femoral neck (which connects bones at the top of the thigh near the hip). In participants assigned female at birth, measures of bone mineral density returned to normal levels for the participants’ affirmed gender in all locations. For those assigned male at birth, measures returned to normal in all except the lumbar spine. The authors note that to strengthen bone density, trans people assigned male at birth should be encouraged to play sports, avoid smoking, and ensure adequate calcium and vitamin D.