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Top FDA official comments on companies “hell bent” on breaking the rules (re: applesauce)

July 17, 2024
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Morning Rounds Writer and Podcast Producer

Good morning! It's one of those days (Wednesdays) where it both feels like the week will never end and also like it's already gotten away from you. But don't let the news get away from you (lol) and read on for the latest on insulin, applesauce, postpartum health, and more.

diabetes

Insulin users worry manufacturers are prioritizing weight loss drugs instead

Arden Parrish sits on a brown bench swing in a lush, green yard.

EDDIE QUINONES FOR STAT

In January, Arden Parrish's pharmacy started running out of vials of Novo Nordisk's Novolog, a short-acting insulin that he uses to fill his pump. As winter turned to spring, Parrish (above) grew anxious that he wouldn't be able to get new vials in time, so he filled his pump with some leftover insulin that was slightly past its expiration date. But the next morning, he woke up with intense full body pain, extremely thirsty, and with no energy — he was in diabetic ketoacidosis, and had to be rushed to the emergency room. He's back home now, and his local pharmacy still doesn't have Novolog vials. He's been extracting insulin from Novolog pens, but they weren't designed for that. 

Across the world, people are facing insulin shortages. The reasons for the shortages are complex, STAT's Elaine Chen writes, but the diabetes community worries there's one factor driving the phenomenon: Insulin manufacturers might be less interested in making it. Read more from Elaine about how the rising popularity of weight loss drugs has both patients and industry experts thinking about the future of insulin access.


chronic disease

How air pollution raises the risk of psoriasis

Experts already know that there's a link between air pollution and chronic conditions like psoriasis. But there isn't a ton of long-term research on how it specifically affects risk for the skin condition. A new study published yesterday in JAMA Network Open found that the more a person was exposed to air pollutants like particulate matter, the higher risk they had for psoriasis.

The data comes from the U.K. Biobank, which includes almost half a million people. Over about 12 years of follow-up, people experienced more than 4,000 psoriatic episodes. While air pollution alone seems to pose a risk, the researchers also found that the highest risk was among those who already had a genetic risk for the condition and were also exposed to air pollution. You've heard it before, but we'll say it again: the results indicate an urgent need to mitigate air pollution, the authors wrote.  


nutrition

Top FDA official speaks on applesauce lead contamination

FDA Deputy Commissioner Jim Jones said on Tuesday that the agency could not have done much more to prevent the recent contamination of children's applesauce with lead. If companies like the producer of the lead-laced cinnamon in the applesauce "are hell bent about breaking the rules," he said, then "they're usually going to get away with it for a little while before they're stopped."

The comments from Jones, who delivered a keynote address at the annual gathering of the Institute of Food Technologists, are likely to ruffle the feathers of lawmakers and food safety advocates, some of whom have highlighted the recent outbreak as the latest instance of the FDA's failure to adequately protect the food supply. Read more from STAT's Nick Florko on Jones's remarks and how the FDA is approaching nutrition-related work.



First opinion

Requiring travel to Texas puts OB-GYN trainees at risk

A stethoscope lays on a glass table next to a laptop.

ADOBE 

Technically, doctors don't have to get board-certified by a professional group like the American Board of Obstetrics and Gynecology. It's a different credential than a medical license, but one that essentially all hospitals require for physicians who want a job. For OB-GYNs, the only way to get a stamp of approval from ABOG is to travel to the group's testing facility in Dallas, Texas. 

But in a First Opinion essay, two medical trainees argue that it's unfair to demand reproductive health professionals go somewhere like Texas, which has put harsh restrictions on abortion and targeted clinicians who perform the procedure. The same trainees who are required to travel to Texas are also required to have experience with abortion and the management of early pregnancy in order to practice medicine. This puts them in a stressful position that could be relieved by instating virtual board examinations, the authors write. Read more on the risks OB-GYN trainees take and how ABOG has responded.


mental health

Researchers look at the brains of young people with conduct disorder 

"Conduct disorder" is a slippery mental health diagnosis identifying youth who display antisocial and aggressive behavior. While potential biological origins of the condition are unclear, it is associated with the highest burden of any mental disorder for youth — meaning it is most associated with early death. A study published yesterday in The Lancet looked at MRI scans from more than 1,100 youth with conduct disorder and another 1,200 without. The researchers found "subtle yet widespread" differences in brain structure between the two groups, they wrote.

Compared to the youth developing typically, those with conduct disorder had lower surface area in 26 regions of the brain's outer layer — which is critical for emotional processing and decision making — and in total surface area. Affected youth also had a smaller amygdala, nucleus accumbens, thalamus, and hippocampus, if that means anything to you. While more research on the condition is needed, the study authors say that the identified differences could be useful down the line in further defining the condition.


maternal health

How to address the "postpartum cliff" (hint: it's simpler than you think)

When someone is pregnant, they're always talking to their doctor. As nine months progress, there are more and more visits, tests, and scans. But after delivering a child, this attention practically vanishes. It's the "postpartum cliff," as Jessica Cohen, a health economist at the Harvard Chan School of Public Health, calls it. 

A new study co-authored by Cohen tests a different approach to helping postpartum women transition to regular health care: texting. In the study, patients received automated messages explaining the importance of follow-up care with a PCP, and offering help scheduling an appointment. Reminders were sent one month after the delivery date, and one week prior to the visit.

The improvement was significant: 40% of patients in the intervention group completed their follow-up primary care physician visits, compared to 22% of the control group, which received no messages. Read more from STAT's Nalis Merelli.


More around STAT
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What we're reading

  • Before Michigan legalized surrogacy, families found ways around the ban, KFF Health News and Michigan Public

  • Listen: Empathy should be the first response to people with vaccine injury, fears, STAT
  • Tuskegee syphilis study whistleblower Peter Buxtun has died at age 86, AP
  • Sen. Menendez's conviction may cost pharma a key ally in Congress, STAT

Thanks for reading! More tomorrow,


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