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An 'emerging drug threat,' the price of misinformation, & a 'Wiley' moment for digital mental health

April 12, 2023
Reporter, Morning Rounds Writer
Good morning. Today we have news about an emerging drug threat, another salvo aimed at medical misinformation, and some history on drug regulation that could inform the future of digital mental health.

addiction

Biden administration sounds the alarm on xylazine 

The White House is issuing an unprecedented warning about xylazine, the veterinary tranquilizer increasingly found in the illicit opioid supply. Beginning today, the substance will be classified as an "emerging drug threat" — the first designation of its kind. Today's announcement and accompanying notification to Congress from Rahul Gupta, the White House's top drug policy official, comes as xylazine — also known as "tranq" — continues to spread throughout U.S. cities. In Philadelphia, especially, it has caused a public health crisis by causing overdoses and painful, dangerous skin wounds in people who inject drugs adulterated with xylazine. 
 
The announcement has little immediate impact, Gupta conceded in a press call with reporters. But the White House will publish a "whole-of-government, nationwide plan" to address xylazine within 90 days, he said. And moving forward, Gupta added, the White House and Congress will work to evaluate adding xylazine to the controlled substances schedule, as well as improve testing, data collection, and public awareness.

health

Misinformation is shortening lives, FDA chief says

Another leading health official has taken a swing at medical misinformation, blaming it for lower life expectancy in the U.S. compared to other high-income nations. FDA Commissioner Robert Califf told CNBC's Meg Tirrell the three- to five-year deficit is getting worse, and it's not just Covid, or bad information about it, as White House Covid-19 adviser Ashish Jha suggested late last month. Misinformation is joining disparities among racial and ethnic groups and income and education levels to shorten lives, Califf said in the interview published yesterday.

"Why aren't we using medical products as effectively and efficiently as our peer countries? A lot of it has to do with choices that people make because of the things that influenced their thinking," Califf said. "You think about the impact of a single person reaching a billion people on the internet all over the world, we just weren't prepared for that … and I think it's impacting our health in very detrimental ways."


health

EPA proposes limits on a carcinogen that sterilizes some medical devices

Yesterday the EPA proposed new limits on ethylene oxide, a carcinogenic gas used to sterilize medical devices that can't be exposed to steam, and that is known to cause gene mutations and break chromosomes. Long-term exposure, whether among people working in factories that use it or living in communities nearby, leads to breast cancer, non-Hodgkin's lymphoma, myeloma, and lymphocytic leukemia. Up to 20 billion pacemakers, catheters, and ventilators, and other devices in the U.S. are cleaned with ethylene oxide every year. (Oddly, the gas also sterilizes spices.)

The new rules, intended to to reduce ethylene oxide emissions by 80%, would affect 86 sterilizing facilities nationwide and require real-time monitoring inside the sterilizing factories that use it. Device makers tasked with capturing and reducing emissions have urged the EPA to continue allowing them to use the chemical while giving concrete targets on lowering emissions. STAT's Brittany Trang and Lizzy Lawrence have more



Closer Look

Opinion: It's time for a 'Wiley' moment to set standards in digital mental health

Five mental health apps in an iPhone folder on screenAdobe

First, some history. The groundbreaking 1906 Food and Drug Act set standards for safe and effective medications and food additives in the U.S. It followed an utter lack of regulation, when formaldehyde preserved meat and morphine was an ingredient in infant "soothing syrups." Known as Wiley's Law in tribute to Harvey Washington Wiley, a chemist who advocated for regulations to protect the public, it later led the FDA to establish its gold standard for defining safety and efficacy of new drugs.

"We have arrived at a similar 'Wiley' moment today for digital mental health," psychiatrist and neuroscientist Thomas R. Insel writes in a STAT First Opinion. He's a co-founder and adviser to more than a dozen companies in that space as well as a former director of the National Institute of Mental Health. Read his ideas on how a public-private effort might set standards for digital mental health.


reproductive health

Pregnancy rates — overall and unintended — have dropped

Reproductive health has dominated the news since the U.S. Supreme Court overturned Rose. w. Wade last June, accelerating restrictions on abortion. In what may serve as a benchmark to measure the future impact of those legal changes, a new CDC report (the first since 2015) documents a 9% drop in overall and unintended pregnancy rates in the U.S. from 2010 through 2019. Pregnancies ending in abortion declined 17%, unintended pregnancy rates declined by 15%, and the percentage of pregnancies ending in live birth and of those ending in loss (miscarriage or spontaneous abortion, ectopic pregnancy, and stillbirth) each increased 3%. There were differences by age and race and ethnicity:

  • Overall pregnancy and unintended pregnancy rates for teens ages 15 to 19 fell by 52%. 
  • Unintended pregnancy rates dropped by 23% among Hispanic women; 17% among non-Hispanic women of races other than Black or white; 12% among Black, non-Hispanic women; and 11% among white, non-Hispanic women.

The report didn't explore why rates dropped, but added, "Future updates to this analysis will be challenging given all of the changes that occurred in 2020 and later."


health

What weight loss can mean for older adults

Amid all the attention focused on new weight-loss drugs, it's worth remembering not all weight loss is desirable, especially for older adults, a recent study in JAMA Network Open tells us. In results that further complicate defining what a "healthy" weight might be, significant weight loss — more than 10% of body weight — was linked to a higher risk of dying than stable weight or weight gain during the study's average 4.4 years. The causes of death included cancer, cardiovascular disease, and other serious conditions. How much a person weighed at the study's start didn't make a difference.

Among the study's nearly 17,000 Australian adults 70 or older and more than 2,000 U.S. adults 65 or older, this association was stronger for men than women. Participants were screened for illness before the study began, but the researchers say "a likely explanation for these findings is that weight loss can be an early prodromal indicator of the presence of various life-shortening diseases." They advise clinicians to watch weight loss.


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Thanks for reading! More tomorrow,


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