POLITICS
FDA staffers are wary of America's newest drug regulator
Alex Hogan/STAT
HHS says Tracy Beth Høeg is the right choice to lead the FDA's Center for Drug Evaluation and Research, a role in which she must dispassionately review complicated scientific evidence about the benefits and harms of medical treatments. But Hoeg's nine-month stint at the agency has raised questions internally about her ability to oversee the operation without bias.
Høeg, a sports medicine physician and Ph.D. epidemiologist, lacks the typical professional experience required to oversee one of the FDA's most important centers. But she is close with FDA Commissioner Marty Makary, a bond forged by their mutual skepticism of Covid boosters and other countermeasures.
Come for the killer lede, stay for another barn burner from STAT's Lizzy Lawrence, who fell down the rabbit hole — which is to say, plumbed Høeg's personal blog — for this story.
VACCINES
Hep B vaccine changes could confuse families, limit protection against other diseases
When a Centers for Disease Control and Prevention committee voted last week to jettison a recommendation that all babies get vaccinated at birth against hepatitis B, the members didn't seem to consider the potentially deadly knock-on effects of their votes, according to medical experts.
Committee members' doubts that most babies need the vaccine will almost certainly lead to an increase in the number of parents who decline to vaccinate their infants against the virus. Subsequent doses of the hepatitis B vaccine are often bundled into combination shots that protect against other diseases, so parents who opt not to vaccinate their infants may find it difficult to immunize their children against other deadly diseases, like polio or pertussis, which has claimed the lives of at least two children in Louisiana this year.
And there is potential for further confusion too. The American Academy of Pediatrics told its membership to ignore last week's votes. Dozens of other medical organizations have loudly denounced the decision. Read more about this head-spinning situation from Helen Branswell.
PLEASE CLAP
Gonorrhea, be gone!
Do you have gonorrhea? Great news! New drugs are on the way to treat the country's second most commonly reported sexually transmitted infection.
A new antibiotic was as effective as the previous standard of care at treating urogenital gonorrhea, according to a study published in The Lancet yesterday. If approved for use, zoliflodacin would be a welcome addition to an armamentarium that contains precious few tools to treat Neisseria gonorrhoeae, the wily bacterium that causes the infection. The Food and Drug Administration will decide on the drug's approval in the next week, writes Helen Branswell.
The FDA also announced yesterday that it has expanded the use of GSK's Blujepa as an oral treatment for gonorrhea. The bacteria's resistance to certain antibiotics has been growing in recent years, so it's increasingly important that doctors have new treatment options for the more than 600,000 cases of gonorrhea reported annually, according to the CDC.
I guess the only downside of these drugs is that it likely means fewer anti-STI advertisements. And, well, that's a shame, because they are often hilarious. But yesterday's clap-related news shows that even if people "give gonorrhea a ride," they have options to ensure a full recovery.
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