Fluoride and IQ, first U.S. bird flu death, and FDA guidance drop

Plus: The many barriers to cancer warnings on alcohol

January 7, 2025 Check out STAT+

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By Theresa Gaffney Morning Rounds Writer and Podcast Producer

Good morning! Today is my first in-office day this year. One of my goals for 2025 is to turn my cubicle into a garden of greenery — but one that doesn't necessarily require direct sunlight. Send suggestions for desk shrubs and beautiful weeds: theresa.gaffney@statnews.com

policy New year, new docs: FDA drops dozens of draft guidances Yesterday, the FDA put out about two dozen draft guidance documents and policies. "In my 15+ years of analyzing the FDA, today is unquestionably one of the busiest days for the release of new guidances and policies that I have ever seen," industry expert Alexander Gaffney (no relation to me) posted on X. These provide instruction — that, to be clear, is not legally binding — on topics like drug compounding, limits on lead in baby food, and more. STAT's Katie Palmer wrote about the FDA's first draft guidance on the use of artificial intelligence in the development of drugs and biological products. STAT's Usha Lee McFarling and Anil Oza wrote about long-awaited guidance on how manufacturers should test and label pulse oximeters to improve their accuracy for all skin tones.  I was particularly interested in the new draft guidance emphasizing the importance of gathering more diverse sex and gender data in clinical studies for medical products, and including pregnant people in those trials as well. The agency doesn't have a definitive answer to the larger question of how to collect this data, however: "One approach may be to ask study participants for both their sex assigned at birth and their current gender identity," the guidance states. The guidance suggests a few strategies to improve sex and gender diversity in study enrollment, like targeting more diverse clinics and building relationships with community groups. It also recommends assessing existing literature on a disease or condition to inform if, or how, to look for sex-based differences in its prevalence or treatment.  Some researchers argue that rather than sex, it's more measurable factors —  like the presence of a uterus, hormone levels, and genetics — that researchers should track in clinical trials. "We often talk about sex as though it's an actual part of the body that can be located, that can then have an effect on that individual's health," Madeleine Pape, a sociologist of gender, told me last year. "Actually, sex is something that we assign as a set of categories."  If you have thoughts on the new guidance, I'd love to hear them. infectious disease U.S. records first-ever bird flu death The U.S. has recorded its first fatal case of H5N1 bird flu with the death of a person in Louisiana believed to have contracted the virus from infected chickens and wild birds in a backyard flock. The death was reported yesterday by the Louisiana Department of Health.  The virus has claimed over 450 lives worldwide since 2003, but this is the first death in North America. The U.S. has recorded 67 human cases of H5N1, almost all of which occurred last year. STAT's Helen Branswell has more on this developing story.

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science What to know about a controversial new fluoride study Last fall, STAT's Anil Oza wrote about the science on water fluoridation in response to criticisms of the practice from Robert F. Kennedy Jr., President-elect Trump's pick to head HHS. Now Anil reports on a new study that found a slight decrease in children's IQ scores as their levels of fluoride exposure increased. You read that right. But wait: The study authors acknowledged that many of the papers included in their meta-analysis had a "high risk of bias," and none were conducted in the U.S. The report, published yesterday in JAMA Pediatrics, is part of a larger effort to understand the literature on fluoride and IQ.  Two editorials — one praising the study, another critiquing it — show "the general divide within the field, at large," a researcher told Anil. Read more about the controversial research. one impactful quote On the burden of medical costs in prison "It was all about co-pay. It was very difficult to see a doctor. … It had to be [an] extreme emergency situation … you had to be suffering from a heart attack or stroke or at least something that severe in nature … or it was just virtually impossible to see a doctor."  Researchers spoke with 25 African-American people who were formerly incarcerated in Illinois State Prisons or Cook County Jail for a study published yesterday in the Journal of General Internal Medicine. Co-pays were a surprising but persistent barrier to care, the study authors wrote, in addition to an overall lack of access, a lack of trustworthy systems, and gaps in understanding about cancer and chronic health.   health The many barriers to cancer warnings on alcohol Surgeon General Vivek Murthy on Friday recommended an update to the decades-old warning labels printed on alcohol containers in the U.S. He proposed the labels be placed and designed more prominently, and warn users that drinking increases cancer risks. But it's not a simple fix. The alcohol industry has a powerful lobby and most politicians have never expressed interest in taking up the fight. As Murphy finishes his term as the nation's top health educator, he is placing a historically inert issue at the feet of a second Trump administration, STAT's Isa Cueto writes. Read more on the road ahead.

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What we're reading Are the foods in your cart ultraprocessed? New York Times Less than 0.1% of U.S. minors take gender-affirming medication, study finds, NBC News The long history of distrust for American insurance companies, STAT Americans' rage at insurers goes beyond health coverage – the author of 'Delay, Deny, Defend' points to 3 reforms that could help, The Conversation Wearable maker ActiGraph acquires assets from Biofourmis to boost clinical trial offerings, STAT

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Thanks for reading! More tomorrow,

theresa.gaffney@statnews.com

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