Bill would let FDA target influencers

Two senators — a D and an R — have decided they don’t like how pharma companies are skirting FDA rules by having infomercials influencers on social media spread false and misleading info.

They’ve written the Protecting Patients from Deceptive Drug Ads Online Act, which will give the FDA authority to target content that influencers get paid for but “contain false statements, omit facts, or fail to disclose risks and side effects.”

The companies would also have to report those payments to the Open Payments database.

Speaking of FDA warnings…

The agency issued a rare warning to AbbVie for having Serena Williams say that “one dose [of Ubrelvy] works fast to eliminate migraine pain” in a TV ad.

Why issue such an unusual warning? First, using a celeb makes the (unproven) message sound more believable. Second, this is the second time the agency has raised concerns about Ubrelvy marketing — the first time was in 2020 when the drug was owned by Allergen.

Gender and GLP-1s

Good news for women: They lose more weight than men when taking tirzepatide according to Eli Lilly research: Over about a year and a half, women lost an average of 24.6% of their body weight, compared to just 18.1% for men.

Bad news: They also “experienced nausea and vomiting […] at significantly higher rates than their male counterparts.”

Prize-winning pain

Congratulations to the winners of the 2024 Ig Nobel Prize in medicine: Lieven Schenk, Tahmine Fadai, and Christian Büchel, “for demonstrating that fake medicine that causes painful side-effects can be more effective than fake medicine that does not cause painful side-effects.”

Oral GLP-1 moves along

Novo Nordisk reports that a phase 1 trial of its oral weight-loss drug, amycretin, showed it’s at least safe and tolerable — which is what a phase 1 trial tests for.

Amycretin is a combo of a GLP-1 agonist and a drug that also targets the hunger hormone amylin. The company reports “a 13.1% weight loss with a side effect profile comparable to what we normally see with incretin-based therapy.”

Fezolinetant dangers

The FDA is warning prescribers to be careful giving women fezolinetant for hot flashes. Apparently it can cause “rare but serious liver injury.”

Symptoms include new-onset fatigue, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or right upper quadrant pain.

Fear not, though. Stopping fezolinetant “may potentially return liver function to normal.”

Jaundice is an issue.

DEA ponders telehealth limits (again)

A leaked document from the DEA indicated that it’s planning to reinstitute limits on telehealth prescriptions for controlleds — essentially requiring in-person visits.

Those limits had been lifted during the pandemic, and when the DEA first suggested reinstating them (in early 2023) it was met with, well, 38,000 comments, mostly saying, “Don’t do it.” So the agency kept the limits off until the end of 2024.

Well, that’s approaching, and once again people and organizations are sending a clear message: Telehealth is working, so don’t mess with it.

Numerous organizations — including Amazon, Mass General Brigham, Cleveland Clinic, Hims & Hers Health, Bicycle Health, and the College of Healthcare Information Management Executives — have now signed letters asking for the telehealth prescribing flexibility to be extended.

The best laid plans

Georgia’s plan for Medicaid work requirements — Pathways to Coverage — may have been a good idea on paper, but it’s apparently run headlong into something no one saw coming: bureaucracy.

The complexity of the program means patients are having trouble enrolling, and the agency running Pathways can’t keep up with the backlog of applications. On the other hand, it’s not kicking anyone off the program either, because it’s not able to verify that people continue to meet requirements.

As much fun as it can be to poke fun at government, though, new programs often have growing pains — there are a lot of moving parts to juggle. It’s not fair to judge a long-term program on short-term hiccups. But Georgia has about a year to get those kinks out before it needs CMS’s permission to continue.

Non-pharma, vaguely medical headline that caught our attention

“Man found dead inside catering oven at hospital; Police not treating man’s death as suspicious”