FDA finally considers pulling phenylephrine

The FDA admits that phenylephrine doesn’t work — it said so last week^*. In fact, the world has known since at least 2006 that it’s simply not a decongestant. It looks a lot like pseudoephedrine on labels, though, so a lot of consumers didn’t know better.

Now, finally, an FDA advisory committee is meeting to look at the data and decide recommend “whether the oral nasal decongestants phenylephrine hydrochloride and phenylephrine bitartrate should be reclassified as not Generally Recognized as Safe and Effective due to lack of efficacy.”

That would mean that phenylephrine would come off the market, leading to “significant downstream effects” for both manufacturers and consumers, who would be left only with pseudoephedrine as a decongestant — and that’s behind the counter.

[P]eople will need to learn to “make the appropriate choices for alternative treatments,” the FDA document noted, albeit without spelling out what that should be.

^* The agency said after more than 15 years, “[W]e have now completed a thorough review of all those data.”

Bullet dodged

Hurricane Lee is headed north — now targeting New England instead of the mid-Atlantic coast.

FDA recommends Covid boosters

The FDA is officially recommending that everyone who can should get an updated Moderna or Pfizer/BioNTech Covid vaccine this year (sorry, Novavax); the CDC is expected to approve it.

Interesting note: Experts don’t think it’ll make much of a difference because most people have been vaccinated, exposed, or both. That said, they agree FDA approval is important because it means insurance companies will cover the shot for the people who need it or want it.

The next anti-PBM bill

There are, at last count, 42,681 bills in Congress (±42,678) aimed at reining in PBMs one way or another. It’s difficult to keep track because there are multiple committees and subcommittees at work in two chambers and 535 egos.

That said, the latest bill is a bipartisan piece that … honestly, it’s hard to see exactly what’s different about this bill than the others that have been introduced.

The 231-page bill, known as the Low­er Costs, More Trans­paren­cy Act, in­cludes pro­vi­sions that would ban spread pric­ing in Med­ic­aid and re­quire PBMs to se­mi-an­nu­al­ly pro­vide em­ploy­ers with de­tailed da­ta on drug spend­ing, out-of-pock­et spend­ing, for­mu­la­ry place­ment ra­tio­nale and ag­gre­gate re­bate in­for­ma­tion.

Eventually all these PBM bills will probably be narrowed down to either a single bill or part of some other piece of legislation. Until then, we’re just watching the sausage being made.

Eyes on CCBs

If you’ve got patients taking calcium-channel blockers, here’s a note: They seem to be associated with a higher risk of glaucoma. British researchers found that the glaucoma risk increased with the use of CCBs, but, interestingly, not with other antihypertensive agents.

“This,” they said, “warrants further investigation.”

Testosterone and transitioning: Don’t wait

The sooner a transgender adult starts taking testosterone, the better it is for their mental health. Aussie researchers found that “there was a significant decrease in gender dysphoria in individuals who began testosterone treatment immediately.”

“We also report a clinically significant decrease in depression, and an over 50 per cent decrease in participants with suicidality with immediate testosterone therapy.”

By immediate they mean “following extensive clinical assessment” — i.e., once the decision has been made, don’t wait three months as the current standard of care would do.

ACA enrollment sets record

Enrollment in Affordable Care Act marketplace insurance plans is up yet again, setting another record since Obamacare took effect.

After rising from 2017–2020, the number of uninsured Americans has continued to drop, but ACA enrollments are likely to increase as states remove millions from Medicaid rolls … and so will the uninsured rate.

Apropos of nothing….

UGA and Georgia Tech researchers have found that Generation X — the generation that gave us personal computer revolution, “The Silence of the Lambs” and “Jurassic Park,” the Internet^*, ’80s music, cell phones, and much of what’s good in the world — is also responsible for the end of the Southern accent in Georgia. (The change is actually happening across the South and even other parts of the country.)

The researchers observed the most notable change between the baby boomer generation (born 1943 to 1964) and Generation X (born 1965 to 1982), when the accent fell off a cliff.

[…]

The team found that older Georgians pronounced the word “prize” as prahz and “face” as fuh-eece, but the youngest speakers use prah-eez and fayce.

^* But not social media. Blame the millennials.