11 Dec 2020
Posted by Andrew Kantor
In a major victory for independent pharmacies, the U.S. Supreme Court ruled 8-0 (!) in favor of the state of Arkansas — and against PBMs — in the landmark Rutledge v. Pharmaceutical Care Mgmt Assoc. You can read the full ruling (PDF) here.
Out of the loupe? The case was about whether states could regulate PBMs, or — as the PBMs claimed — state laws were pre-empted by the federal ERISA law.
The 8th Circuit Court of Appeals sided with PBMs, and the case went to the Supreme Court … which overturned it. States can regulate PBMs. SCOTUS has spoken.
“The Court holds that the Act [the Arkansas law] has neither an impermissible connection with nor reference to ERISA and is therefore not pre-empted.”
Pharmacy groups are very, very happy: “Pharmacy Groups React to Landmark Supreme Court Hearing“.
GPhA had supported our friends at the Arkansas Pharmacists Association, asking that it overturn that lower court decision … which SCOTUS just did.
You can read background on the case here, at GPhA.org.
Our thoughts and prayers are with the PBMs at this difficult time.
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Got pregnant patients? It seems that they need to be careful with asthma meds. Taking them during pregnancy and then stopping could lead to and increased risk of preterm birth and lower birth weight.
Best: Stop taking them before getting pregnant.
Second best: Keep taking them while pregnant, and pay attention.
Worst: Stop taking them while pregnant.
The FDA has some new guidance for naming drugs to avoid mixups — 42 pages of it, in fact, and that’s just for prescription drugs. (OTC products get a mere 17 pages.)
It wants drug makers to make sure their new products don’t confuse patients with similar names. To help, the agency is using its Phonetic and Orthographic Computer Analysis (POCA) software to “determine the orthographic and phonetic similarity between two drug names.”
(It’s actually interesting reading. The guidelines go into things you may not have thought of, like not to use “Letters and Numbers That Are Unpronounceable as a Word” or “incorporate any reference to an inert or inactive ingredient.”)
Two women in Chicago are responsible for just about every generic drug name? While marketing departments come up with “Humira” or “Trulicity,” they’re the ones who name “adalimumab” and “dulaglutide”.
And they get their guidance from a list of “United States Adopted Names approved stems.”
You get hurt, you get tired. But why? German and French researchers, eager to find out (or just to torture worms), looked into it.
It turns out that, when wounded, genes in C. elegans worms increase cells’ production of antimicrobial peptides — natural antibiotics. Nothing huge there. But they found that those same AMPs also “act as a messenger and activate receptors in the brain” that tells neurons it’s time to sleep.
In other words, those peptides do double duty — fighting infection and telling the body to sleep. And that finding was worth a paper in Current Biology
If you know some depressed rats, and you think ibogaine would be a good treatment — but you’re worried about them having hallucinations and heart attacks — we’ve got good news!
UC Davis researchers have rejiggered ibogaine into an analog they call “tabernanthalog*.” It fights depression, appears safe (at least in cell cultures and zebrafish) and “sharply reduced both alcohol- and heroin-seeking behavior in mice and rats.”
And because it doesn’t trigger the brain’s reward center, it’s (probably) not addicting.
[T]he results are noteworthy in part because they show TBG binds to a subset of receptors for the neurotransmitter serotonin—receptors also targeted by LSD and psilocybin. That suggests TBG might use a similar mechanism, providing the beneficial effects of psychoactive drugs without hallucinations.
Bonus: Includes the phrase “game changer”!
Got patients with cluster headaches? Prednisone is your huckleberry.
The multicenter, randomized, double-blind, placebo-controlled trial at 10 headache centers in Germany included patients with episodic cluster headaches aged 18 to 65 years who were within a current pain episode for no more than 30 days.
Result: “Oral prednisone led to a greater decrease in the number of episodic cluster headaches within the first week of treatment.”
Oregon has just decriminalized all drugs. “Possessing heroin, cocaine, methamphetamine, and other drugs for personal use is no longer a criminal offense in Oregon.” Why? Prohibition has never worked, the money spend policing is better used elsewhere, and the ‘war’ on drugs has been discriminatory since day one.
Keep in mind, “decriminalized” just means first and small offenses don’t incur a criminal record or prison time — much like a traffic ticket.