Impending inhaler kerfuffle

GSK’s Flovent is gone, and in its place is GSK’s identical (but non-branded) fluticasone. And that’s gonna be a problem.

Yes, it’s the same medication; only the box has changed. Yet not every insurer that covered Flovent will cover the version without the fancy box.

Insurers get kickbacks from drug makers on branded meds but usually not generics, so they often steer patients toward brand-name drugs. If those insurers aren’t up-to-date on what happened with Flovent, patients could face … let’s call them “coverage hurdles.”

Prepare for a lot of conversations.

Oh, and why is GSK making the switch?

Experts who follow the industry […] point out GSK is making the switch at precisely the time a change in Medicaid rebates could cause the company to have to pay large penalties because of price increases on Flovent over a number of years.

[…]

Or, put another way, it’s the same product without the branding and also without the history of price increases that would leave the medicine vulnerable to such large rebates to Medicaid.

17 days left!

Remember, you only have until January 19 to nominate someone for one of GPhA’s 2024 awards!

Seniors, driving, and drugs

Sure, we’ve all seen the warnings about driving after taking certain types of medication, but when you get down to brass tacks what are the real risks?

Researchers at Washington University’s School of Medicine found out the hard way — with a 10-year study of older folks. They tracked their meds, gave them driving tests, and figured out which drugs really presented the most danger.

Biggest risks: Antidepressants, sleep aids, and to a lesser extent NSAIDs.

Not risky after all: Antihistamines^* and anticholinergic meds.

Scary stat: “35% received a failing and marginal road test grade at some point.”

^* The newer, non-drowsy kind

Automatic insulin

So you know about insulin pumps — technology that monitors glucose levels and automatically injects insulin as needed. Pretty cool. But what if you could modify the insulin itself to release depending on a person’s (or at least a minipig’s) glucose levels?

That’s just what a team of scientists in China and at UNC have done. In broad strokes, they modified normal insulin with gluconic acid, which in the body reacts with blood and forms a polymer around the insulin molecules. That polymer will then react with blood glucose in such a way that it releases insulin based on glucose levels.

So far it’s been tested on minipigs and mice, where it worked as well as standard insulin injections. More animal tests are planned, then they’re moving on to humans.

Making a new vaccine tech work

Rather than let mRNA vaccines hog the spotlight, there’s another new kind of vaccine technology that could allow the development of targeted, safe, and cheap vaccines.

Where mRNA uses a virus’s messenger RNA to trigger an immune response, these vaccines use protein fragments called epitopes.

The good: They can be made quickly and cheapy, and they’re safe.

The bad: Different people’s immune systems will react differently to proteins, so an epitope might only trigger an immune response in some people.

But now German researchers have found a way to only include the important bits of the protein fragments, so one vaccine can include a whole lot of epitopes and thus work for just about everyone.

[The lead researcher] compares the problem with a chef who needs to create a new dish for a large event: “Some guests have allergies, while others do not like certain ingredients, so the chef needs to select ingredients that as many of the guests as possible can eat and will enjoy.”

Testing the technology on (of course) a SARS-CoV-2 virus, they think “we would be able to reach — and immunise — more than 98% of the world population.”

Benzos and pregnancy

Women should probably avoid taking benzodiazepines while they’re pregnant. Why? Looking at the data for almost 2 million women (and 3 million pregnancies), Taiwanese researchers found that there was a notable increase in the risk of miscarriage — 69% higher than women who didn’t take benzos.

The authors wrote, somewhat unnecessarily, “These findings suggest that caution is warranted when using benzodiazepines during early pregnancy.” Indeed.

Here come the price hikes

2024 is almost upon us, and you know what that means: Drug price hikes!

Drugmakers including Pfizer, Sanofi and Takeda Pharmaceutical plan to raise prices in the United States on more than 500 drugs.

Part of that is because of inflation, although that’s only been about 3%. Part is “because we can.” Part is because they’re going to have to cut prices on insulin. And part is because they know that they’re going to have to negotiate prices on 10 drugs starting in September.

(As much as we’re willing to take them to task, even when inflation was high a couple of years ago, pharma companies still kept annual increases to below 10%, and an average of 5% overall. So kudos where they’re due.)

But wait! Other companies are lowering prices. GlaxoSmithKline is planning price cuts for on some asthma, herpes, and anti-epileptic drugs, and then there are those insulin price cuts (although that’s kind of because they have to now).

Cholesterol vaccine?

Sure, statins and PCSK9 inhibitors are great for lowering LDL cholesterol, but why not take it a step further? That’s what University of New Mexico researchers did, creating a vaccine that gets your body (well, the bodies of mice and monkeys) to attack PCSK9 itself.

How, you ask? They “stuck tiny pieces of the PCSK9 protein to the surface of [non-infectious] virus particles” :

“So your immune system makes a really strong antibody response against this protein that’s involved in controlling cholesterol levels. In the animals that we vaccinated, we see strong reductions in cholesterol levels — up to 30%.”

They’ve actually been working on this for 10 years (!) and are now hoping to start human trials. The goal, said the lead researcher, is to have a cholesterol vaccine available within 10 years at less than $100 per dose.

(The one question that wasn’t addressed is whether this is a once-and-done shot, or something that has to be taken regularly. I guess we’ll know in 2034.)

Bonus: Yes, it’s a “game-changer”!

Could oral peptides be coming?

We wouldn’t ask if the answer wasn’t Yes. The thing about peptides is that they have to be injected — the large molecules tend to fall prey to the acid bath that is the human gut.

But Swiss researchers say they’ve developed a cyclic peptide that can be taken orally without being shredded by the digestive system.

The first step was, of course, obvious: “synthesizing linear peptides and subjecting them to cyclization so they formed ring-like chemical structures connected by a metabolically stable thioether (carbon-sulfur-carbon) bond.”

Naturally.

Then came a bunch more science, with the result being “a comprehensive library of 8,448 cyclic peptides” that were small enough to be absorbed by the body before being destroyed.

They showed an oral bioavailability of up to 18%, meaning that 18% of the drug entered the bloodstream and had a therapeutic effect when administered orally. While it might not sound particularly impressive, consider that orally administered cyclic peptides generally show a bioavailability of below 2%.

So that’s the major step — creating small, tough peptides. Next up will be using the technique to target more diseases. “They’re confident they can develop orally administered cyclic peptides for at least some of them.”

Omadacycline beats vancomycin for C Diff

So there’s a new antibiotic called omadacycline that’s based on good ol’ tetracycline. But only now did someone think to see how well it would work against Clostridioides difficile, the bacteria that causes a lot of hospital-acquired infections.

That someone was a University of Houston pharmacist researcher, and he found something surprising: Not only did omadacycline work a treat against C. diff, but it worked better than the current last-line of defense, vancomycin.

Omadacycline was well tolerated by patients, but the key was that it “caused a distinctly different effect on the microbiome than Vancomycin” — it didn’t hurt the beneficial gut microbes nearly as much as vancomycin does, which allowed the good gut bacteria to maintain a resistance to C. diff. (Vancomycin often doesn’t kill enough of the bacteria, so it bounces back.)

Says he: “I would hope that this becomes a normal part of the antibiotic drug development process.”

Supplementing supplements

Healthcare folks like you know that folic acid is important for pregnant mothers, and supplements are usually recommended. Ditto for taking a multivitamin. But that might not be enough.

A new study out of Australia found that standard supplements given to expectant moms, even the ones that include folic acid, didn’t give the women as much as they needed, especially riboflavin and vitamins B6.

By giving the women an “enhanced” supplement, the Aussies also found that women’s vitamin B12 levels stayed nicely elevated for at least six months after giving birth. (“This is probably important for the mother’s ability to supply her baby with vitamin B12 if she breastfeeds.”)

Takeaway: Pregnant women will likely need more than a standard multivitamin, so it’s worth either adding an extra jolt of riboflavin, B6, and B12 (and vitamin D, too), or asking their OB/Gyn for a blood test to check their micronutrient levels.

Captain Obvious tips his hat to Nancy Reagan

“It’s OK To Decline An Invitation, Study Says”

I refuse to write a “good vibrations” headline

Aminocyanine is a dye used for medical imaging, but Rice University scientists found it has an interesting property: When exposed to near-infrared light, the molecules vibrate in unison.

That vibration, it seems, can destroy cancer cells by rupturing their cell membranes — what they call a “molecular jackhammer.” And the cool thing about near-infrared light is that it can penetrate the body deep enough to activate the aminocyanine.

According to the Rice researchers…

[T]he method had a 99 percent efficiency against lab cultures of human melanoma cells, and half of the mice with melanoma tumors became cancer-free after treatment.

“This study,” said the lead researcher, “is about a different way to treat cancer using mechanical forces at the molecular scale.”

Psst … our anonymous working-conditions survey is still open

In case you haven’t weighed in, you still can take our anonymous survey on working conditions at your pharmacy. (And when we say “anonymous,” we mean it — we do not want any personal information, period.)

It’s all of four questions, plus a chance to tell us your story, if you like.

We want to share this information with the Board of Pharmacy so it will be crystal clear the kind of conditions Georgia pharmacists and technicians are dealing with.

Just head over to GPha.org/workingconditions and take the 5 minutes to share your story.

Old antibiotic, new target

Erythromycin has an interesting side effect (if that’s the right term). It can apparently help RNA when that RNA has trouble doing its splicing job. What makes that interesting is that ‘dysregulated splicing’ is a hallmark of muscular dystrophy.

In other words, erythromycin could become part of the arsenal against MS. Japanese researchers found that…

”…erythromycin reduces the toxicity of abnormal RNA and ameliorates the aberrant splicing and motor phenotype in DM1 model mice.”

They then moved to a small human trial, just to see. Good news, there: “[S]everal patients who received erythromycin showed major improvements in splicing markers.” This isn’t a huge breakthrough (and more research is needed), but they think it means erythromycin could help some patients, and it may lead to a new avenue of therapy.

B12 vs colitis

Spanish researchers were looking at how the body regenerates and reprograms its tissues when they noticed something odd in the gut biota. The bacteria in mice’s colons “presented changes indicative of a shortage of [vitamin] B12.”

You know the most important phrase in science: “That’s odd.” So they tried giving the mice B12 supplements, and they found that it increased the efficiency of that reprogramming.

In other words, vitamin B12 was essential to cellular repair, and supplementing it helped speed the process.

Then they took it further and tested it on mice with ulcerative colitis. (The body’s intestinal repair system is similar to cellular reprogramming.) What d’ya know, “[T]hey reported vitamin B12 supplementation accelerated tissue repair in the mouse model of ulcerative colitis.”

Right now the mechanism isn’t entirely understood, but the Spaniards are at least comfortable saying that low levels of B12 could slow the intestines’ ability to repair themselves.

Don’t forget to think of a great pharmacy pro

Instead of making a New Year’s resolution to do something nice for a colleague, why not save yourself the trouble and nominate someone for a slick 2024 GPhA award — from a Student Pharmacist of the Year to someone who deserves the Bowl of Hygeia. We need your nominations!

Nominations only take a few minutes (but you can spend some more time to really sell ’em). The award winners will be announced at the 2024 Georgia Pharmacy Convention.

Head over to GPhA.org/awards to see the list of awards, the criteria, and how to nominate someone. The deadline for nominations is January 19, 2024, so don’t wait too long!

Vaccines in nursing homes

The CDC has released the latest results of its data on vaccine uptake in nursing homes. The basics:

• Flu vaccines have the highest uptake, ranging from about 23% to 43% depending on the state.
• Covid vaccination is next on the popularity list, followed by RSV.
• Despite being the most vulnerable to RSV, only about 6% of Georgians in nursing homes have been vaccinated.
• The smaller the nursing home, the greater the vaccination rate, but it was still low across the board.

The low RSV vaccine uptake could be a result of its relative newness, implementation challenges, limited time to train providers and develop protocols, and less staff familiarity with the risk of outbreaks and severe disease.

What’s in your intestinal tract?

Anxiety from the gut

What can having the wrong gut bacteria do for you? How about cause social anxiety?

Irish researchers found that people with social anxiety disorder (SAD, as opposed to seasonal affective disorder (SAD)) have a different collection of bacteria in their guts.

That in mind, they channeled their inner sadists and transplanted those microbes into mice to see what would happen. What happened is that the mice had “an increased response to social fear.”

To investigate social fear, the team gave the mice small electric shocks when they approached a new mouse, and then observed how the animals behaved around new mice when the shocks were no longer applied.

The ones with healthy microbes got over their anxiety quickly, while “those with microbes from people with SAD continued to be fearful of approaching other mice.”

“They never fully recovered to be able to be social again.” Science!

From guts to bones

What can having the wrong gut bacteria do for you? How about cause osteoporosis? That’s what Tulane researchers discovered after examining 517 peri- and post-menopausal Chinese women.

It’s all about valeric acid, which is important for keeping bones healthy. A common gut bacteria called Bacterioides vulgatus interferes with the production of valeric acid, and that can lead to brittle bones and possibly osteoporosis.

Bad news: Giving your gut the right bacteria isn’t easy no matter which yogurts you eat, and B. vulgatus is too common to eliminate easily.

Good news: “Mice that received valeric acid supplements, however, saw reduced bone resorption and stronger bones overall.”

Reality check: This doesn’t mean anyone should rush out to buy Valerian root or sprinkle their Cheerios with valeric acid powder. It just means that — wait for it — more research is needed.

Weight loss: Shake it, shake it up

You know what’s missing from all those new weight loss drugs? Machinery. Fear not, as MIT engineers are here to help. They’ve developed a vibrating pill that tricks your* stomach into thinking it’s full.

“I wondered if we could activate stretch receptors in the stomach by vibrating them and having them perceive that the entire stomach has been expanded, to create an illusory sense of distension that could modulate hormones and eating patterns.”

So said the bioengineer who led the development team, and who then discovered that yes, yes it could. “The researchers tracked hormone levels during the periods when the device was vibrating and found that they mirrored the hormone release patterns seen following a meal, even when the animals had fasted.”

Next up: Trying to scale production so they can start human trials.

^*  Hopefully not yours. Maybe a grad student’s.

Tylenol, pregnancy, and language

Pregnant women might want to be careful with taking acetaminophen (aka paracetamol, aka Tylenol). It can, it seems, delay the child’s language development — especially for boys and especially if Mom took it during her third trimester.

Caveat, per the Northeastern researchers who discovered this: It may not actually be the acetaminophen; it could be whatever is giving Mom a reason to take it, e.g., a fever or illness. So … more research is needed.

Statins in the news

Statins vs asthma

Besides lowering cholesterol, statins also have an anti-inflammatory effect, so UC Davis pulmonologists thought they might work against asthma. But … no joy. At least not with oral statins.

But when you take the liver out of the equation by giving the statins in an inhaled form, they work as a bronchodilator — just via a different mechanism than steroids.

You want the science?

Instead of working through the cell surface receptors, the statins target the signaling cascade inside the ASM [airway smooth muscle]. This targeting happens partially through the cholesterol pathway and partially through cholesterol-independent pathways related to ASM’s protein structure.

Considering the side effects of steroids, and of course the excitement of finding a new treatment, the UC folks are hoping to move to human trials Real Soon Now, for both asthma and COPD.

Pairing statins with hormones

When women take hormone treatment after menopause, there’s a risk of venous thromboembolism (VTE)— dangerous blood clots that can occur with certain hormones.

Good news: Statins, it seems, can help reduce that risk, based on data from 224,000 women crunched by University of Texas Medical Branch researchers.

That not only means the obvious (women taking hormone therapy can reduce their risk), but that women who have avoided hormone treatment because of the clotting risk might be able to use hormones after all, as long as they also take a statin.

Side note: These same researchers found that the risk of VTE was greater with oral estrogen than with other delivery mechanisms. For what that’s worth.

The Long Read: Vitamin D Reality Check edition

There’s been a lot of hype about what vitamin D can do for a body (and we’ve sung that song a few times ourselves). But a lot of that hype has been, well, hype.

Thus an article in Scientific American goes into the rise and fall of vitamin D as all-purpose hero. Much of the “evidence” was based on observational studies, and when a randomized controlled study was run, the results were very different:

Not only did vitamin D not make a dent in rates of cancer or heart disease, but the trial also found that vitamin D did not prevent falls, improve cognitive function, reduce atrial fibrillation, change body composition, reduce migraine frequency, improve stroke outcomes, decrease age-related macular degeneration, reduce knee pain or even reduce the risk of bone fractures.

Toss in some confusion about the right amount a person should have (and the fact that the head of the group that wrote the vitamin D guidelines “has received at least $100,000 from various companies involved in making vitamin D supplements and tests”) and it turns out that we might be doing just fine, D-wise.

“Avoid bad decisions” is Captain Obvious’s resolution

“‘Morning After’ Pill Sales Surge on Day After New Year’s Eve”.

So this is a class 1 recall

Philips, fresh off recalls and lawsuits over its CPAP machines, has announced another one. This time it’s MRI machines … because of the risk of explosions.

Not only could an explosion be strong enough to cause significant damage to the scanner and its surroundings, but it could also result in chemical exposure and suffocation by displacing the room’s oxygen. Dangerous flying debris could cause brain and eye injuries, lacerations, fractures, bruises and even death, the FDA said.

“The company has told customers to immediately stop using their affected Panorama systems.” Ya think?

Steroid cream concern

Sure, topical steroid creams are great for treating skin conditions, but apparently they have a significant downside — at least if you use them for a long time and at a high dose. According to Taiwanese researchers, it can lead to osteoporosis and “major osteoporotic fracture.”

It’s a pretty significant risk, too. Based on almost 130,000 osteoporosis cases, they found that high cumulative doses of steroids (that is, a combo of dose and time) was associated with a 34% greater risk of osteoporosis and at 29% greater risk of a fracture.

“Using topical corticosteroids to treat inflammatory skin conditions should be done very carefully,” said one of the researchers. “[C]linicians should be aware of these potential side effects.”

Surprising MS fighter

In the latest example of a drug for one disease working against another, we have HIV antiviral therapy, which (found a Swedish study) might help fight multiple sclerosis.

The idea isn’t new, but existing studies were too small to draw any meaningful conclusions. Now, though, the Swedes went all in — they looked at the health records of “virtually every person in British Columbia, Canada and Sweden who was medically recognised as HIV-positive dating back to 1992 in Canada and 2001 in Sweden.”

(Side note: This is why we use the serial comma. If you were confused, the study looked at all of Sweden plus Canada’s British Columbia province.)

What they found: People taking HIV drugs were 45% less likely to have MS. That’s overall — for women it was a whopping 72% lower risk.

At first they thought it could be the HIV itself that suppresses MS by reducing the number of CD4+ T cells. But then the HIV therapy should have counteracted that, so (they hope) it might be the therapy itself.

Current hypothesis:

The antiviral properties of HIV therapy might limit Epstein-Barr virus activity, thereby minimising both the risk of getting MS and of the disease progressing in those who have it.

You know the mantra: More research is needed.

Turning masks into landfills

When the pandemic started, the US was woefully unprepared; the national stockpile of personal protective equipment was more of a molehill than a mountain. Cue the rush by states to stock up on gowns and N95 masks.

But now that we’ve gone from pandemic to endemic, all that equipment is gathering dust, and a lot of it has expiration dates. So now “States are trashing troves of masks and pandemic gear as huge, costly stockpiles linger and expire.

In just the states that had figures to share with the Associated Press, more than 18 million masks, 22 million gowns, 500,000 gloves, and more were thrown out. More were auctioned off.

You might ask the obvious question: How does an N95 mask expire? It doesn’t, really, although it’s possible that the elastic bands (or rubber seal if it has one) might deteriorate a bit. That’s why they have expiration dates, although in reality if stored correctly this stuff is perfectly good for a long time. (The GPhA Buzz research department even looked at prepper websites to confirm this.)

But warehouse space isn’t free, and expiration dates are scary, so to the landfill they go.

PreP questions, unanswered

Back in April we wrote about a ‘morning-after pill’ called doxy-PEP that can prevent STIs after unprotected sex.

It’s worked very well … at least for men who have sex with men and transgender women. But a new University of Minnesota study found it may not work as well for cisgender, i.e., non-trans women. In fact, the study of 450 women in Kenya showed no significant reduction in new STIs at all.

That sounds like bad news, but it might be premature. It seems that there might be another explanation: Adherence.

Hair sample analysis revealed that while many participants claimed they were taking doxycycline regularly, only about a third actually had the drug in their system.

In other words, it’s as if the study didn’t happen at all. But at least they got to publish.

Overdosing on Ozempic

Poison control centers are reporting a surge in overdoses of Ozempic and other GLP-1 weight loss drugs.

From January through November, the America’s Poison Centers reports nearly 3,000 calls involving semaglutide, an increase of more than 15-fold since 2019.

What’s happening? Dosing errors, for the most part, that usually result in … let’s call it “non-insignifcant gastrointestinal distress.” It’s usually fixed with fluids and anti-nausea meds.

And who should we blame? According to CNN, it’s compounding pharmacies, of course! The article goes into all the reasons compounded versions could be part of the problem, burying at the bottom this tidbit:

Poison control centers say the reported symptoms don’t allow them to know whether the calls stem from the patented drugs or the compounded versions.

On the other hand, the Los Angeles Times, covering the same story, points its finger (more realistically) at “multiple factors contributing to the increase in overdoses” including rising popularity, more approved uses, different formulations and dosages, and patient error.

Scent of a woman’s tears

Guys, if a woman’s crying is annoying you, sniff her tears. Apparently that can make you less aggressive.

A new study out of Israel found that “Sniffing emotional tears from women reduced male aggression by more than 40% in computerised tests.” It carried over to the real world, too, with actual brain changes.

Further tests in a brain scanner revealed that tear-sniffers had more functional connectivity between regions that handle scents and aggression, while activity in brain networks for aggression was lower. “

Why would this work this way? Their guess is that it might have evolved as a defense mechanism for babies. But before they can jump to any conclusions they want to isolate the chemical that’s having the effect.

Paxlovid and rebounds

Enough people have had Covid rebound — a second infection on the heels of the first — that there was speculation that it might have been caused by the antivirals patients took (e.g., Paxlovid). It was a reasonable trade-off, because that second infection was much milder.

The speculation might end now, though, as a pair of new studies published by the CDC found “no consistent association” between antivirals and Covid rebound.

Together the reviews the agency did included more than 21,000 patients, so there’s plenty of data. The most likely cause of a Covid-19 rebound was simply a weakened immune system.

They said that viral rebound might occur in patients receiving antivirals because they’re at high risk for severe illness and might have factors such as a weakened immune system that could influence viral dynamics.

Trulicity is for quitters

When people quit smoking, weight gain can be an issue. (You know this.) Now Swiss researchers have found a drug to help prevent that: dulaglutide, aka Trulicity.

After quitting smoking…

Women on dulaglutide lost around 1–2 kilos compared with weight gain of around 2–2.5 kilos for women in the dummy treatment group.

Men taking dulaglutide shed just over half a kilo compared with weight gain of around 2 kilos among those in the dummy treatment group.

This isn’t entirely surprising, as dulaglutide is yet another GLP-1 drug that can help with weight loss. The better bit, say the researchers, is that the drug didn’t hurt patients’ short-term quit rates.

For smokers afraid to quit because of weight gain, the Swiss think a bit of Trulicity can help overcome the worry.

PharmPAC back in action

Now that the recently called Special Session is over, we can resume with giving donations to state lawmakers. Chairman Noel Williams made a visit to Adams Drug Store in Cordele where owner and GPhA Past President Jonathan Sinyard presented him with a PharmPAC check.

Chairman Williams is the vice chair of the House Insurance Committee, so he will likely hear bills relating to PBMs in 2024. Chairman Williams definitely supports GPhA because his wife, Laura, is pharmacist and works with Jonathan at Adams Drug Store! We appreciate his continued support! —Melissa Reybold

Thumbs-up for inhaled vaccines

There’s been good reason to think that inhaled vaccines for respiratory illnesses would work better than injections — they get the drugs right to the lungs where they’re needed, after all.

Now we’ve made the jump from educated guess to evidence, with three separate studies. They confirm that, if you want to protect a monkey from Covid-19, an inhaled, mucosal vaccine can last longer and possibly offer broader protection.

Together, the studies show that how and where vaccines are delivered can have a profound effect on the immunity generated and the protection conferred. The latest results also raise hopes that mucosal vaccines that offer ‘sterilising’ immunity — complete blockage of infection — could become a reality.

Will that hold true for humans? Finding out is next on the list.

An interesting (and long-lasting) anxiety drug

A company called MindMed is planning to begin phase 3 trials of a new drug called MM-120 that can treat both generalized anxiety disorder and ADHD.

Interesting bit #1: MM-120 appears to provide relief for at least a month on just a single dose.

Interesting bit #2: Unlike some other new psychoactive drugs, patients saw “clinically meaningful improvements” without therapy.

Burying the lede: MM-120 is a tartrate form of lysergide D — which you (and your friends with the sugar cubes in the little plastic bag) know as LSD.

Patients probably won’t even realize they’re taking a psychodelic except possibly on day one, with “side effects such as hallucinations and euphoric mood only occurring on dose day.”

Barbie plays fast and loose with safety

It wouldn’t be 2023 without at least one Barbie story related to pharmacy (sort of). You’re welcome.

A study out of Indiana University — published in the BMJ — looked at the medical professions Barbie has held, and it found some serious shortcomings.

For one thing, she’s never been a pharmacist, although she has been various types of physician (including an ophthalmologist three times), nurse, dentist, and paramedic. She’s almost always adult and female^*, and she’s usually white.

But perhaps most shockingly…

[N]o doll fully met professional safety standards for their respective fields. For example, 98% of the Barbie brand doctor dolls came with stethoscopes, but only 4% had face masks and none had disposable gloves.

It gets worse. More than two thirds of medical-pro Barbies…

… also wore loose hair, and more than half wore high heeled shoes, even in settings where this would be discouraged or actively prohibited for safety reasons.

It gets even worse when Barbie’s younger sister, Chelsea, gets involved. Wrote the study’s author:

“She looks to be under age 10 but is working with an alcohol burner and glassware, and it doesn’t look like there is an adult there to help her. I just thought, ‘who would leave a kid alone with alcohol burners?’”

^* Well, duh.

The Long Read: Underused Arthritis Test edition

A lot of rheumatoid arthritis patients don’t respond to methotrexate, and even a TNF inhibitor doesn’t help. Often their rheumatologists know this. But insurers and PBMs don’t care, and they require patients to try one drug after another even when a physician knows the right drug to use (Orencia): “Insurers lean toward TNFis such as adalimumab, commonly sold as brand-name Humira, in part because they get large rebates from manufacturers for using them.”

But now there’s a test that can “identify the roughly 60% of patients who are very unlikely to respond to a TNFi drug.” Called PrismRA, it’s the first of a new class of diagnostics that can save patients time and pain … but will insurers let doctors use it?

Today’s non-pharma horrific medical story

Every year at holiday time the media rolls out the same warnings: seasonal depression, flammable trees, alcohol poisoning, kissing the hobo under the mistletoe, and so on.

Here’s a new and, frankly, terrifying one: “Risk of penile fractures rises at Christmas, doctors find.”

The fractures are often heralded by an audible crack, followed by severe pain, rapid loss of erection and severe swelling and bruising. “When [patients] present to their doctor their penis often looks like an eggplant.”

Gentlemen, let’s be careful out there.

Tylenol lawsuit dismissed

A federal judge ruled against plaintiffs who claimed that acetaminophen during their pregnancy caused their kids to have autism, ADHD, or other issues. The “evidence” they presented wasn’t evidence at all, she ruled. Without evidence to present, the suit will likely be dismissed.

“The unstructured approach adopted by the plaintiffs’ experts permitted cherry-picking, allowed a results-driven analysis, and obscured the complexities, inconsistencies, and weaknesses in the underlying data.”

How did this start in the first place? “[A] a 2021 statement in the medical journal Nature Reviews Endocrinology […] that called for increased awareness and research into the potential risks of prenatal exposure to the drug.”

A different kind of Christmas miracle?

File under “Go figure”: When a new Doctor Who episode is aired during the holidays, fewer people die in the UK the next year. That’s what biostatisticians at the University of Birmingham found — and it was good enough to get published in the BMJ.

In time series analyses, an association was found between broadcasts during the festive period and subsequent lower annual death rates.

In particular, episodes shown on Christmas Day were associated with about six fewer deaths per 10,000 person years in England and Wales and four fewer deaths per 10,000 person years in the UK.

If you think that’s a stretch, their hypothesis is even stretchier: The Doctor Who findings “highlight the positive effect doctors can have when working during the festive period.”

CMS: Go easy taking kids off Medicaid

Georgia is one of nine states that CMS has warned about its Medicaid unwinding — specifically because of a lot of children have lost their health coverage. The administration is asking those states to take advantage of federal options designed to make it easier for people to renew.

• Those nine states are responsible for 60% of the kids who’ve been removed from Medicaid.
• About 9% of Georgia’s kids on Medicaid were removed from the program.
• About 3 million kids across the country have lost coverage^* since states were allowed to pare back after the pandemic.
• The 10 remaining states that have not expanded Medicaid “have disenrolled more kids than all of the expansion states combined.”

The agency can’t force the states to do anything differently (unless they’re found to break federal guidelines) but the feds are doing their best to try to ensure no one can’t get healthcare because of procedural errors, which have been responsible for a large portion of disenrollments.

^* Some of them have likely been able to get coverage through an Obamacare marketplace or via a parent’s employer’s policy. 

The Long Read: Milking the Cash Cow edition

States are getting billions in opioid settlement money, so out of the woodwork come the companies ready to help them spend it. From pill-disposal pouches, to unproven therapies, and even to a lasso for detaining people who are overdosing, officials are being flooded with sales pitches. Everyone wants a slice of the settlement pie.

A big concern is that officials will be swayed more by flashy presentations than by the organizations that might actually make best use of the money.

For example, fancy, lockable prescription bottles sound great, but…

Today’s crisis of fatal overdoses is largely driven by illicit fentanyl. Even if studies suggest the companies’ products make people more likely to safely store and dispose of medications, that’s unlikely to stem the record levels of deaths seen in recent years.

As one person put it, “Safe storage and disposal can be accomplished with a locking cabinet and toilet.”

Non-pharma medical news you could probably do without

When snails are stressed^*, their slime — left on a lettuce leaf — is more likely to carry rat lungworm larvae. That bit of research comes out of the University of Hawai’i.

Their advice: “Washing produce, to dislodge and remove any snails or snail slime, is recommended to prevent possible infection.”

^* “including heat, snail/slug bait (a pesticide) and physical disturbance”

Snorting your vaccine?

It makes sense, when you think about it — if you’re protecting against respiratory viruses, you want that protection in the lungs. So why not breath in a vaccine so it goes straight to where it’s needed?

That was the thinking of Chinese scientists who developed not a nasal spray vaccine, but — in a possible fit of ’80s nostalgia — an inhaled powder.

Tomorrow’s vaccine clinic

It sounds science-y enough — a “a single-dose, dry powder, inhalable vaccine platform using nano-micro composite multilevel structures.” And their study was published in Nature, so it’s serious stuff.

It’s better, they say, for several reasons. Intramuscular injection “fails to trigger a mucosal immune response and establish a robust immune barrier in the respiratory tract.” Liquid vaccines can take time to be reformulated, and they also have strict storage needs too.

In contrast, their “nano-micro composite structure” powder is flexible, delivers the meds where they’re needed, and can be shipped and stored easily. Just be ready to explain all that to customs officials.

CMS to PBMs: Please be nice to pharmacies

With the new ban on PBM clawback in effect, CMS has heard from pharmacies about fears that PBMs will reduce up-front payments to make up for what they can’t get later. So the agency asked, politely, that PBMs work out the deals ahead of time to avoid giving pharmacies some nasty shocks.

We continue to hear urgent concerns from pharmacies, and we strongly encourage Part D plan sponsors and their PBMs to make necessary cash flow arrangements with network pharmacies in preparation for these upcoming changes.

In addition, we will closely monitor plan compliance with pharmacy access and prompt payment standards to ensure that all people with Medicare Part D continue to have access to pharmacies and medications.

But the letter was more than just a friendly suggestion that PBMs play nice. It was also a warning that CMS has been hearing of other payment issues, such as pharmacies not been reimbursed properly for vaccines or birth control. It included what in government-speak was a pretty clear warning:

We urge plans and PBMs to engage in sustainable and fair practices with all pharmacies — not just pharmacies owned by PBMs — and we are closely monitoring plan compliance with CMS network adequacy standards and other requirements.

Think of the foundation before the year ends

The Georgia Pharmacy Foundation usually does its work quietly in the background, but it does a lot of it. It’s how GPhA members can give back to the profession, help fellow pharmacy pros in need, and help future pharmacists get a boost in their careers.

Foundation Chairman Thomas Sherrer lays out all the good the foundation has done this year — a reminder of what we can accomplish and an invitation to help before the year ends.

Read his message here, and please…

Revving up melanoma treatment

Moderna has developed an mRNA-based treatment that seriously boosts Keytruda’s effectiveness against melanoma — we’re talking a 49% improvement over Keytruda alone.

The article incorrectly calls it a vaccine, probably because it uses mRNA technology, but Moderna’s all-but-unreadable press release calls it “individualized neoantigen therapy.” Call it what you want, it’s going into phase-3 trials and it’s got an FDA breakthrough-therapy blessing. Considering that melanoma kills nearly 8,000 Americans a year, it’s a Very Good Thing.

Healthcare costs twist

Here’s an unexpected perspective on healthcare costs in the US of A: When you look at what insurance companies actually pay for it, rather than list prices, the cost has risen less than inflation.

US inflation was about 1.9% for the past 9 months. Meanwhile — according to data compiled by Turquoise Health — the prices for CMS’s 500 “shoppable services” rose only 2.0% over that same period.

There were some significant price variations among specific services, though. For example, the price for chickenpox vaccines rose by about 30%, as did the price for measles, mumps and rubella vaccines. On the other hand,the prices for allergy tests, vaginal delivery of placentas and off-hours medical services actually decreased.

The report was possible because of CMS’s price transparency rule, in place since 2021, which allowed Turquoise to compare prices.

The link above goes to the news story. For the full report from Turquoise click here.

Making a baby: Go dry, guys

Gentlemen, if you’re planning to have a baby with your special lady, here’s a bit of advice: Stopping drinking at least a month before buying flowers and cuing up the Barry White. Your sperm will appreciate it.

Texas A&M researchers already knew that alcohol affects sperm quality, but now they’ve learned that withdrawal can also be an issue. The Aggies found is that “it takes much longer than previously believed, longer than a month, for the effects of alcohol consumption to leave the father’s sperm.”

“During withdrawal, the liver experiences perpetual oxidative stress […] The reproductive system interprets that signal and says, ‘Oh, we are living in an environment that has a really strong oxidative stressor in it. I need to program the offspring to be able to adapt to that kind of environment’.”

Those adaptations may have helped a couple of hundred thousand years ago, but today they might lead to issues as serious as fetal alcohol syndrome, so you definitely want your little buddies to be at their best before dimming the lights.

FDA considers considering MDMA

Should the FDA consider MDMA (known on the mean streets as ecstasy or molly^*) as a treatment for PTSD? The Multidisciplinary Association for Psychedelic Studies (MAPS) has filed a new drug application — the first ever for any kind of psychedelic-assisted therapy.

The assisted part is important, as the drug would be “used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider.”

MAPS says it’s got 30 years of research, including phase 3 trials, to back up its application. The FDA now has 60 days to decide whether to accept the application for review or even priority review.

^* Today I learned there’s a difference. Both are MDMA, but ecstasy is usually a pill and molly is purer and thus a powder (or capsule).

Another item about male birth control

A phase 1 trial of a male birth control has just begun in the UK, where YourChoice Therapeutics is testing out a hormone-free pill that blocks vitamin A, which sperm need to … well, to live.

When tested in male mice during preclinical trials, the male contraceptive showed 99% efficacy in preventing pregnancy, was 100% reversible without any side effects and the mice were fertile again four to six weeks after stopping the pill.

This trial is expected to list into the middle of next year. After that, who knows? If it pans out, though, the question will be how much you trust the guy who says, “Don’t worry, I’m on the Pill.”

Congress and the FDA

The Senate: Spurred by the too-late recall of Philips’s (allegedly) deadly CPAP machines, two US senators are asking the head of the Government Accountability Office to open a probe into the FDA — specifically, to update a 2011 GAO report on how the agency handles recalls.

Since 2011, their data show…

Recalls have gone up about 125%, from just under 400 events in 2012 to nearly 900 last year, while adverse event reports have risen more than 500% from almost 500,000 a decade ago to nearly 3 million in 2022.

The House: Republicans on the House Committee on Energy and Commerce are demanding that the FDA answer their earlier request “for information related to the agency’s foreign drug inspection program” — specifically “insufficient foreign drug inspections conducted in India and China.”

We never noticed this before

Apparently there’s not just long Covid, there’s also long flu. Researchers at Washington University School of Medicine found that “people hospitalized with seasonal influenza also can suffer long-term, negative health effects, especially involving their lungs and airways.”

The flu, it seems, can also jump from being acute to being chronic, but no one thought to actually look for that until the pandemic.

Many people think they’re over COVID-19 or the flu after being discharged from the hospital. That may be true for some people. But our research shows that both viruses can cause long-haul illness.”

The good(ish) news is that the risk of long-term issues caused by the flu is much lower the the risk from Covid.

UGA looking to honor diversity

Hey, UGA folks: Do you know someone in the College of Pharmacy community — alumnus/a, faculty, staff, student — who you think deserves the William T. Robie III Diversity, Equity, and Inclusion Award?

The criteria is straightforward: “Nominees should have led efforts and advanced conversations around making their communities more inclusive as it pertains to diversity and equity.”

Nominate him, her, it, or them ASAP, ’cause the award is being presented Thursday, February 8 at 12:30 pm at the award luncheon. Click here to do just that.

The Long Read: Depression is Complicated edition

The weird thing about SSRIs is that no one knows just why they work against depression. (The how is in the name.) The “serotonin hypothesis” is the best we have. Recently, though, that’s come under scrutiny as biochemists and their kin rethink whether tweaking serotonin is how you treat depression.

Then again, SSRIs often do work, so what’s going on? As one neuropharmacologist put it, “Just because aspirin relieves a headache, [it] doesn’t mean that aspirin deficits in the body are causing headaches. Fully understanding how SSRIs produce clinical change is still a work in progress.”

Read on, MacDuff.