FDA is taking on tampons and 'misleading' ads starring Serena Williams

Plus: H5N1 found in wastewater samples across Texas

September 12, 2024 Check out STAT+

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By Theresa Gaffney Morning Rounds Writer and Podcast Producer

Good morning! I've decided today is the day that I must tell you about my favorite Instagram account: poeticpuppets. It's an account (run by a Teresa with no H, not me!) where puppets present you with some delicious poetry bites. Enjoy!

rare disease A lifeline or a pharma handout? Either way, this program is set to expire Adobei There's an obscure U.S. government voucher program due to sunset at the end of this month. Designed in 2012 to encourage drug development for rare childhood diseases, the program provides vouchers to groups who get a drug in that area approved. The voucher is like a fastpass at Disneyland, allowing whoever has it to request the FDA review a drug within six months, vs. the usual 10.  In the past dozen years, the program has been criticized as ineffective, convoluted, and a handout to pharma. (A key point here: vouchers can be sold.) But for some researchers, it's the only way to fund their work. "Unfortunately, if the voucher goes away — I don't want to say it'll doom rare disease, but it'll be a significant hit," said Terry Pirovolakis, whose son was diagnosed with a devastating ultra-rare disease five years ago. Read more in STAT+ from Jason Mast and John Wilkerson. menstruation FDA to investigate toxic metals in tampons This summer, a study published in Environment International found evidence of toxic metals like arsenic and lead in over a dozen commercially available tampons. After a deluge of media coverage airing concerns about the potential harm there, the FDA announced this week that it has commissioned an independent literature review to evaluate the existing data on chemicals in tampons and any associated health effects. If the study got you worried about the products in your medicine cabinet, STAT's Brittany Trang has these words of advice: "Remember that the study itself admits that it can't be used as evidence of harm to menstruators because there isn't research on how much of these metals are absorbed," she said. That's why the FDA also announced an internal laboratory study to test whether metals are released from tampons when used.  Epidemiologist Gideon Meyerowitz-Katz put it more bluntly in Slate: "Even if you ate dozens of tampons, you'd still probably not be able to absorb enough of the metal to harm you." The FDA did not say when the research might be completed, but noted in the announcement that any tampon legally sold in the U.S. has met the agency's safety requirements.

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regulation FDA says AbbVie's ad featuring Serena Williams was 'misleading' Screen capture  The FDA has issued a letter scolding the pharmaceutical company AbbVie for making false and misleading claims in a TV ad featuring G.O.A.T. Serena Williams. The agency had a couple complaints about the promotion for the company's migraine pill, but noted in particular that the use of a celebrity athlete "amplifies" the commercial's misleading suggestions about the drug due to Williams' perceived credibility. Read more in STAT+ from Ed Silverman.  mental health High doses of Adderall tied to higher risk of psychosis People who took high doses of amphetamines in the past month are at five times higher risk for developing psychosis or mania than those who didn't take anything, according to a study published today in the American Journal of Psychiatry. The risk was highest for those who took 30 mg or more of dextroamphetamine, which is equivalent to about 40 mg of Adderall. Experts already knew that the prescription of amphetamines was linked to an increased risk of psychosis generally. But to understand how dosing affects the relationship, researchers reviewed the electronic health records of thousands of patients admitted to McLean Hospital from other facilities within the same Mass General Brigham hospital system between 2005 and 2019. They compared patients with first-episode psychosis or mania to those hospitalized for other conditions like depression or anxiety. Caveats: All of the people in this study were hospitalized for a mental health condition, and at just one facility in Boston. Still, the findings suggest that clinicians should use caution when prescribing high doses of amphetamines, the authors write. infectious disease H5N1 found in wastewater samples across Texas An effort to do surveillance for H5N1 bird flu in Texas wastewater has turned up some rather surprising results. Researchers from Baylor College of Medicine in Houston reported Wednesday in the New England Journal of Medicine that they found H5N1 viruses in all 10 Texas cities where they drew samples, in 22 of 23 sampling sites. (Which 10 cities is not disclosed.) And fully 25% of the samples taken between early March and mid-July were positive for the virus, which has been causing an unprecedented outbreak in dairy cattle in the U.S. this year. "The widespread detection of influenza A(H5N1) virus in wastewater from 10 U.S. cities is troubling," the authors wrote. "Although the exact origin of the signal is currently unknown, the lack of clinical burden along with genomic information suggests multiple animal sources." (The Baylor team won the 2024 STAT Madness competition for their wastewater surveillance work.) Texas has reported 24 infected herds. Nationally the USDA has confirmed 201 infected herds in 14 states, including three new herds in California reported on Wednesday. — Helen Branswell awards Three women win award for young scientists Three women have received the Blavatnik National Awards for Young Scientists. It is the second time in the award's history over almost two decades that women have won in all three categories: life sciences, chemical sciences, and physical sciences and engineering. Cigall Kadoch (a molecular biologist at the Dana-Farber Cancer Institute), Markita del Carpio Landry (a chemical engineer from UC Berkeley), and Britney E. Schmidt (an earth scientist at Cornell) won in each category, respectively.  Each winner receives a cash prize of $250,000, no strings attached. It's an enticing sum for young researchers, who for years have been leaving academia in droves for more lucrative industry jobs.

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Thanks for reading! More tomorrow,

theresa.gaffney@statnews.com

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