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Packaging the first OTC birth control, McConnell's freeze, & why the mammography wars aren't over

July 27, 2023
Reporter, Morning Rounds Writer
Good morning. It was a busy day on Capitol Hill yesterday (as you'll see below, we're watching for more information about Senate Minority Leader Mitch McConnell's health after a concerning few moments yesterday). Here's what Rachel Cohrs and John Wilkerson covered:

reproductive health

Designing the first OTC birth control pill's look

A package of Opill on a red background

Illustration: Alex Hogan/STAT 

Winning FDA approval to sell birth control over the counter was a historic achievement. Designing its branding and packaging was a different story. The challenge was to make the Perrigo product distinctive on crowded pharmacy shelves, easy to use, and appealing to trans, nonbinary, and young people as well as women. And meet FDA requirements, too. The results of years of testing: the name Opill and bright teal, saturated pink, and yellow  packaging, plus the rounded font resembling millennials' ubiquitous favorite Gotham. 

The progestin-only pills have a downside: They're less effective if they are not taken at the same time daily. Design critic Karen Korellis Reuther thinks the Opill's design would benefit from a better way to keep track of the day and time the pills are taken. "The current packaging does not reflect a solution that puts the user front and center," she told STAT's Annalisa Merelli. Read more.


politics

McConnell's freeze during remarks stirs concern

Senate Minority Leader Mitch McConnell froze and stared into space for an alarming few moments just after beginning his remarks at a press conference yesterday afternoon. Fellow senators asked if he was OK, and then he left the podium. A McConnell aide later told STAT the Kentucky senator, 81, "felt light headed and stepped away for a moment." When McConnell returned to the press briefing minutes later, he said, "I'm fine," and continued to take questions.

McConnell has been shadowed by health concerns, STAT's Sarah Owermohle reminds us. He was hospitalized with a concussion this March after a fall in a D.C. hotel, suffering broken ribs and doing inpatient rehabilitation for several weeks. In 2020, after a week of speculation over photos showing bruised hands, told the Washington Post that he was "just fine." A year earlier, he had a different fall that resulted in a fractured shoulder.


pandemic

People with long Covid shouldn't pursue procedure to remove microclots, review of evidence says 

People living with long Covid may be willing to try anything to lift the brain fog, fatigue, or other life-altering symptoms that have persisted months or years after their original infections. But they shouldn't try plasmapheresis hoping to eliminate microclots in their blood, a new Cochrane review says. The expensive procedure, which takes blood out of the body and returns a filtered version, is sometimes used to treat autoimmune disorders. Oxygen-starving microclots and autoimmune responses have been proposed as long Covid drivers, but the Cochrane researchers pour cold water on both microclots and plasmapheresis.

The Cochrane researchers said microclots aren't true clots, so they used the term amyloid fibrin(ogen) particles instead. The five studies they analyzed concluded these particles, found in acute infection, weren't unique to long Covid patients. Turning to plasmapheresis, the subject of this BMJ and ITV investigation of medical tourism to get it, the Cochrane team could find "no rationale" for the procedure to remove the particles.



closer look

Opinion: Why the mammography wars aren't over

If you've been watching the guidelines for the age when breast cancer screening should begin, you might have a case of mild whiplash over the years. The most recent recommendations from the U.S. Preventive Services Task Force have returned to beginning mammograms age 40, instead of age 50 as guidance had said since 2009. Age 40 is also what the American College of Radiology says, but frequency after that is another point of contention.

And when to start is hardly a settled question, Asia Friedman of the University of Delaware writes in a STAT First Opinion. That's because experts still disagree on defining the benefits (early diagnosis) and harms (overdiagnosis) of screening mammography, falling into camps of interventionism and skepticism. "More data alone will not change the fundamental fault lines of this disagreement," she writes. Read more on what she thinks might.


drug safety

Another drug supply issue: suspected contamination at compounder

There has been no shortage of news about gaping holes in the medication supply chain. Drugs to treat ADHD are scarce, diabetes drugs that also induce weight loss are in high demand, and cancer patients have to hope they can survive when their treatments vanish. This crisis may overshadow another problem: possible contamination at compound pharmacy operations. The FDA recently recalled injectable medicines used by hospitals after its inspection of a Pennsylvania plant run by Central Admixture Pharmacy Services.

Medicines intended to be sterile but don't meet that threshold can cause life-threatening infections, the California Board of Pharmacy wrote in a notice about the company, which has also had quality control issues at plants in Phoenix and San Diego. This history brings to mind a scandal in 2012 when a fungal meningitis outbreak killed 64 people who got injectable drugs made by a fast-growing compounding pharmacy. STAT's Ed Silverman explains.


research

Pocket protectors? Study says young women fall down stairs more often as they talk and carry things

Going down stairs can be risky business. Perusing this PLOS One paper, I learned falls actually have three peaks: in kids under 3, 20-somethings, and adults over 85. The current study focused on young adults on a university campus, videotaping 2,400 of them and comparing men to women because women have an 80% higher injury rate than men. The researchers concluded that not holding the handrails, talking (women are more social), wearing sandals or high heels (none on men's feet), and holding things (like phones or to-go coffee) in their hands was more common in women than men, even if they didn't skip stairs as much.

With all due respect to the researchers, want to know what we at STAT unscientifically concluded? Pockets. As a rule women's clothes do not contain nearly enough of them beyond the merely decorative, thus the things they carried. We do have one citation: Usha Lee McFarling's 2019 op-ed in the LA Times that declared pockets "the ultimate feminist issue."


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What we're reading

  • DeSantis suggests he could pick RFK Jr. to lead the FDA or CDC, Politico
  • Private equity backers of Plan B morning-after pill weigh $4 billion sale of company, Bloomberg
  • UHS finance chief said company favors patients whose insurance pays more, STAT
  • VC firm starts a new synthetic biology incubator, headed by a former Broad Institute scientist, STAT

Thanks for reading! More tomorrow,


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