May 25, 2023     Andrew Kantor

A new kind of pain treatment

If you have a rat suffering from neurological pain — perhaps from chemotherapy or diabetes — there’s good news out of Duke.

Autologous conditioned serum (ACS), which athletes apparently swear by to treat sports injuries because of its anti-inflammatory effects, seems to help with rodents’ pain — and the effects are long-lasting, as in several weeks.

What’s weird is that the mechanism by which ACS is thought to work shouldn’t last long, so something else is going on. That something else is exosomes:

Instead, the Duke researchers found that exosomes appear to be the component that gives ACS its durability. These tiny vesicles contain a host of molecules that fight inflammation, including micro-RNAs, and they become highly activated through the conditioning and incubation process of ACS.

Now that they’ve discovered this unexpected mechanism, the Dukians say, “we can explore a number of additional therapeutic uses.”

Short take: better buprenorphine

The FDA has approved Braeburn’s Brixadi — a long-acting injectable form of buprenorphine — “for use in patients with moderate to severe opioid use disorder.”

Change the delivery, change the dose

After a particular type of stroke, patients are often given nimodipine to prevent complications — specifically, delayed cerebral ischemia. But not every patient can swallow a pill, and, found University of Alberta pharmacy researchers, when other delivery methods are used the outcomes can be completely different.

Part of that is because nimodipine is light-sensitive, part because there’s no standard for mixing it into an injection. But the overall point goes beyond just one drug: There are often mitigating factors when changing how a medication is administered, and that can have a profound impact.

Of the patients involved in the study, 31 per cent experienced delayed cerebral ischemia. However, the prevalence was 59.1 per cent among the patients who received crushed tablets and 45.8 per cent among those who received liquid drawn from capsules at the bedside.

Nutrition news

Multivitamins for memory

Older folks who took a multivitamin for a year had a mild improvement to their memory, according to a new study out of Columbia and Harvard universities.

[T]he study found people who continued to take a daily multivitamin were able to remember, on average, nearly one extra word compared with those who took a placebo. While the effect was small, it was statistically significant.

Of course, a little perspective helps. As one researcher put it, ‘While the less-than-a-word improvement was statistically significant, it would be hard to tell if such a small change would improve a person’s life.’

Also, multivitamins have a lot of ingredients, so figuring out which of them (or which combos) makes the difference will have to be on the agenda.

Flavonoids for frailty

Eating foods with lots of the flavonoid quercetin might help stave off frailty, at least according to a new study out of Harvard’s Beth Israel Deaconess Medical Center.

“Our findings suggest that for every 10 mg higher intake of flavonols per day, the odds of frailty were reduced by 20%. Individuals can easily consume 10 mg of flavonols intake per day since one medium-sized apple has about 10 mg of flavonols.”

It was quercetin in particular that did the heavy lifting, suggesting “that there may be particular subclasses of flavonoids that have the most potential as a dietary strategy for frailty prevention.” (Also, if our math is right, having 50 mg of flavonoids would reduce your frailty risk to zero!)

Captain Obvious thinks, “When vaping is outlawed….”

Full ban on the sale of flavored tobacco products associated with lower use”.

Sex and anesthesia drugs

Anesthesia drugs including diazepam, midazolam, nitrous oxide, and propofol can cause patients to have sexual hallucinations, according to a literature review by pharmacology researchers at the University of Connecticut.

That sounds embarrassing, but in fact it’s much worse. Some patients can hallucinate being sexually assaulted, while some patients may actually be sexually assaulted. If that’s not bad enough, the repercussions last long beyond the procedure, whether for patients or their surgeons.

The emotional turmoil a patient undergoes is likely the same whether actually experiencing sexual assault under anesthesia or having vivid hallucinations of the event. And practitioners too can experience distress: Some medical professionals accused of real or perceived sexual assault have been brought before regulatory boards or the courts and lose their license to practice.

May 24, 2023     Andrew Kantor

Naloxone alternative nabs approval

Hot on the heels of its approval of a nasal-spray version of Narcan, the FDA has approved Opvee, a nasal version of nalmefene that, like naloxone, can reverse an opioid overdose. The studies show it works just like naloxone.

Will anyone care? Unlike naloxone, Opvee will require a prescription and as yet there’s no standing order like there had been for naloxone.

Good: Unlike naloxone, which often requires several doses over several hours, Opvee lasts longer and thus might require fewer doses.

Bad: Because the drug lasts longer, its side effects do too — and they’re similar to naloxone’s: “intense withdrawal symptoms including nausea, diarrhea, muscle cramps and anxiety.” And by longer we mean up to six hours.

Opvee is expect to be available this fall.

Pain relief from nausea med

Drugs that target cells’ NK1 receptors can relieve nausea, but the science suggests they should also help relieve pain. But, oddly, they don’t.

It turns out (NYU researchers discovered) that NK1 receptor antagonists can’t get past the surface of cells to help with pain. So they did what scientists do: They tweaked the molecular structure* of the anti-nausea drug netupitant so it was able to penetrate the cell and last long enough to do its work.

Result: The altered netupitant relieved pain … in mice at least. If the results extend to humans, similar drugs might also benefit from the tweak and act as a new kind of analgesic.

* Yes, they used nanoparticles. How else would they do it?

The Long(ish) Read: Mental Health in Georgia edition

Can Georgia’s exceptional 988 mental health hotline survive cuts as the state plans for a potential recession?

Nitrate nuance

Readers of a certain age might remember the Great Nitrate Panic of the 1970s, when it was shown that nitrates could cause cancer. Nitrates = bad.

But since then other studies have quietly shown that nitrates might have health benefits, specifically for the cardiovascular system. Nitrates = good?

Aussie researchers decided to look at all those studies and figure out what was up. The answer (they think) is that 1) those original studies never showed a connection in humans, but more importantly, if nitrates come from plants, rather than processed food, they have those heart benefits.

“[U]nlike meat and water-derived nitrate, nitrate-rich vegetables contain high levels of vitamin C and/or polyphenols that may inhibit formation of those harmful N-nitrosamines associated with cancer.”

Ticks keep on giving

The age-old question: If you could eliminate one species from Earth with a wave of your hand, would it be mosquitoes, bedbugs, or ticks? If you’ve been leaning toward mosquitoes, here’s a fun fact: “Ticks may be able to indirectly spread chronic wasting disease.”

As if Lyme disease and anaplasmosis wasn’t enough.

A new study out of the University of Wisconsin found that a single tick can carry enough of the prions that cause chronic wasting disease to infect a deer. The good news (well, not for the deer) is that CWD doesn’t infect humans. Yet.

Short Takes

Shed some tears

If you have patients whose tears evaporate too quickly, there’s good news. The FDA has approved Novaliq’s MIEBO (perfluorohexyloctane ophthalmic solution, if you most know) — “the only FDA-approved treatment specifically targeting excessive tear evaporation, which affects 86% of people with dry eye disease.”

Anthem goes virtual in Georgia

Anthem BCBS is rolling out “virtual-first” health plans in Georgia (and California) for its commercial members. What’s that mean? Starting in July, “Eligible commercial members will gain access to virtual care options, including an AI-powered symptom checker, routine wellness care, chronic condition management and behavioral care.”

May 23, 2023     Andrew Kantor

Fraud alert from the commish

Georgia Commissioner of Insurance and Safety Fire John King sent a bulletin to all Georgia pharmacies: Be on the lookout for fraudulent audit notices purporting to come from “Express Scripts” or “CVS Caremark.”

Pharmacies operating in Georgia, particularly independent pharmacies, who receive audit notices should verify that those audit notices are authentic.

Read the bulletin here.

What else can Ozempic do?

For every story about the bad side effects of semaglutide — “Ozempic face,” anyone? — there seems to be one about the unexpected good side. The latest: Anecdotal evidence (i.e., anecdotes) suggest that it might help with addictive behavior, as “People taking Ozempic for weight loss say they have also stopped drinking, smoking, shopping, and even nail biting.”

As one woman put it:

[S]he walked out of Target one day and realized her cart contained only the four things she came to buy. “I’ve never done that before,” she said. […] For the first time — perhaps the first time in her whole life — all of her cravings and impulses were gone. It was like a switch had flipped in her brain.

It’s possible — and, of course, more research is needed — that GLP-1 agonists “ may alter the brain’s fundamental reward circuitry” and be able to fight addiction in a broad sense. In fact, clinical trials are already underway.

Speaking of semaglutide …

Adding another block to its blockbuster, Novo Nordisk says the oral version of semaglutide it’s been testing works just like its injectable brother to help people lose weight.

In the study, which enrolled nearly 700 adults classified as having overweight or obesity, patients treated with a daily semaglutide tablet lost 15.1% of their body weight over the course of 17 months, while those on placebo lost 2.4%.

It plans to file for FDA and EU approval later this year.

Vote early, vote … well, vote once

GPhA members: This coming Thursday, May 25, you’ll be receiving your board-election ballot from AssociationVoting. (In other words, look for a message from that address, not gpha.org.)

Board voting runs from May 25 to Thursday, June 15 at 11:59:59 pm.

The results will be announced at the blockbuster general session at the Georgia Pharmacy Convention.

Ketamine questions continue

Could ketamine help depression just via the placebo effect? Maybe so, although the study that found this hasn’t yet been peer reviewed, and it uses ketamine in a different way.

What that means: A Stanford University study gave ketamine to patients with depression, but they did it while they were under general anesthesia (the patients, not the researchers) so patients wouldn’t know whether the got the drug or just saline.

Unlike in other trials, the ketamine didn’t do any better than a placebo. What’s up?

The authors interpret this as evidence that ketamine’s effects on depression are strongly tied to a patient’s experience of being seen by medical professionals.

BUT … other researchers say that, by having it under anesthesia, the patients didn’t experience ketamine’s psychedelic effects — and that could be a big part of why it works: “The dissociative effects of ketamine have been linked to a stronger antidepressant response, possibly by helping patients reframe their experience from an outside perspective.”

The jury remains out, although it does imply that it’s not ketamine alone that helps.

Old drug, new acne fighter

Women with persistent acne can safely use spironolactone to treat it, finds a new study out of Britain.

When topical treatments don’t work, antibiotics are often the next in line — but then there’s that whole issue of fostering antibiotic resistance. Some practitioners have prescribed spironolactone off-label, but there hadn’t been a definitive study on whether it was safe and effective.

Until now.

The Brits ran a trial with more than 400 patients over 24 weeks and … bingo. The fluid-buildup drug did a number on the women’s acne.

“The results showed that the women taking spironolactone saw a significant improvement in their acne after 12 and 24 weeks compared to those on the placebo. […] and any side effects were uncommon and very minor.”

Every year we get this reminder

About 20% of people in the US over 65 skip medications because they can’t afford them, according to a nationwide poll led by Nashville’s Vanderbilt University School of Medicine. That’s up from about 14% in 2016.

More than 8% of respondents said they went without basic needs — like gas and groceries — to afford their medication, while 4.8% of respondents said they went into debt to get their medication.

The Long Read: Curing hep C

Egypt screwed up 30 years ago and used contaminated needles to give vaccinations to children, resulting in the country having the world’s highest incidence of hepatitis C.

And then it cured the entire country — Egypt eliminated hep C in less than a year. Read how.

Short Takes

Lilly returns to Twitter

After pulling its advertising from Twitter in November — after a debacle where someone spoofed its account and caused a massive headache — Eli Lilly says it’s back buying ads on the platform … using a new handle, @EliLillyandCo.

Don’t skip leg day

Tell your patients with heart issues that “People with strong legs are less likely to develop heart failure after a heart attack,” according to a new study out of Japan.

Specifically, they should work on their quadriceps because “Compared with low quadriceps strength, a high strength level was associated with a 41% lower risk of developing heart failure.”

 

May 20, 2023     Andrew Kantor

Kids are OD’ing on melatonin

Melatonin overdoses are becoming a problem with kids, especially the youngest ones. It’s a multipronged issue: The popularity of sleep aids (could anxiety be a factor?), the perceived safety of natural products (arsenic is natural), the fact that melatonin gummies look like candy, and that because they’re unregulated, melatonin supplements may have more or less of the hormone than what’s on the package — and don’t need to be childproof.

Perhaps a verbal comment to parents buying them is in order: “Just be sure to keep these away from your kids.”

K is for diabetes

Vitamin K (the real stuff, not ketamine*) might have an unexpected upside. It might protect against diabetes.

No one ever thinks of poor vitamin K, stuck there after all the early letters (heck, how many ‘B’ vitamins are there?). But Canadian scientists found — after 15 years of research — that the mechanism vitamin K uses to affect blood clotting also affects the production of insulin.

Here comes the science: Vitamin K helps kick off a process called gamma-carboxylation. Gamma-carboxylation helps create a protein called ERGP. ERGP is important “in maintaining physiological levels of calcium in beta cells.” And those calcium levels are needed to keep insulin secretion humming along.

Knowing about ERGP, they say, means “opening a new field of research in this area.”

* (shakes fist) Darn you kids and your confusing slang!

E-6 for Narcan

How do you make naloxone and other lifesaving or “harm reduction” drugs easier to get? You put them in vending machines.

It’s a new idea and uptake is limited so far; the FDA only just approved OTC Narcan. But for local governments looking to provide lifesaving tools without spending a lot on infrastructure and personnel, they’re gaining plenty of interest.

Said one vending machine manufacturer:

“We’ve worked on machines that dispense Narcan nasal spray, fentanyl testing strips, HIV testing kits, prescription disposal bags and then even some first aid kits and safe sex kits. Really anything that they’re looking to get into the hands of the public.”

Leqembi: the price we’d pay

So what happens if the FDA approves lecanemab for Alzheimer’s and CMS agrees to pay for it for eligible patients? Ka-ching.

Medicare would spend an extra $2.0 to $5.1 billion annually, according to a research letter published online May 11 in JAMA Internal Medicine.

Essentially there would be 44 million Medicare beneficiaries eligible for lecanemab, which would cost taxpayers about $33,000 per patient per year. (Remember, it has to pay whatever Eisai and Biogen feel like charging.) Those patients would each need to shell out $6,600 a year for co-payments. And this for a drug that hasn’t proven to make a significant impact in quality of life.

The Long Read: I Can Hear You Now edition

The approval of over-the-counter hearing aids has led not only to the proliferation of the devices, but to turning them into “lifestyle” products as big names like Bose get into the business. (Fun fact: A recent poll found that half of Americans turn on subtitles to watch movies at home. It’s sometimes impossible to keep the loud noises reasonable while still being able to hear the dialog.)

The non-prescription products were found to increase uptake and were cost-effective as long as they’re at least roughly half as beneficial to patient quality of life as traditional hearing aids […] Another study last month in the American Journal of Audiology found individuals with mild to moderate hearing loss were able to use self-fitted hearing aids effectively.

Short Takes

PBMs’ second front in the war

While Congress works on measures to limit PBMs’ cash grabs, the FTC is also expanding its probe into their practices.

The FTC said Wednesday that its fact-finding inquiry aims to shed light on questionable PBM practices that include directing patients towards PBM-owned pharmacies, unfair auditing of unaffiliated pharmacies, and the use of undisclosed pharmacy reimbursement methods, among other tactics.

ICYMI: RSV vax gets panel approval

An FDA advisory panel has recommended the agency approve giving the RSV vaccine to pregnant women to protect infants. Of note, while the committee agreed unanimously that it was effective, four members were concerned about its safety — specifically that in rare cases it can cause premature birth or possibly make some childhood vaccinations less effective.

 

May 19, 2023     Andrew Kantor

PBM bill inches along

Slowly but surely, the House’s PBM smackdown bill is moving through the Capitol. It passed the Energy and Commerce Committee’s subcommittee on health 27-0 (W00t!) and is now headed to the full committee.

The bill’s major impact is “Imposing new transparency requirements on PBMs and banning ‘spread pricing’ in Medicaid, where PBMs charge more than they pay for a drug and keep the difference.”

Congrats (again) to Lindsey Welch!

Not only has GPhA member Lindsey Welch been named UGA’s Faculty Advisor of the Year, this is her second time receiving the honor. Way to go, Dr. W!

Here she is with members of the UGA’s APhA-ASP chapter

Semaglutide’s compounding confusion

With Ozempic in shortage, FDA rules seem to say that it can be compounded by compounding pharmacies (although the FDA hasn’t exactly been clear about that, according to the folks at the Alliance for Pharmacy Compounding*).

That means that some pharmacies are selling compounded versions of semaglutide, which would be fine — that’s what compounding is all about.

Problem: There online … businesses (not actual 503A compounding pharmacies — APC calls them “sketchy websites”) that are selling what they claim to be the same semaglutide as in Ozempic. Those might be ineffective or worse; when you buy from Cousin Jimmy’s Gud-E-Nuf Mail Order Drugs, you can’t be sure what you get.

Then the waters get muddier. Some compounding pharmacies use the salt form of semaglutide — semaglutide sodium — which the science isn’t 100% clear works the same way, although it probably does. [insert hand-wringing here]

Oh, and Novo Nordisk says it doesn’t sell generic semaglutide [more hand-wringing], which is true but misleading: Novo sources the semaglutide API “from FDA-registered manufacturers (just as pharmacy compounding API wholesalers and compounding pharmacies do).”

All of this leads to click-bait headlines like the one from the New York Times, “Ozempic Is Hard to Find. Some Pharmacies Are Offering Unauthorized Alternatives.” (sigh)

* Disclaimer: I do consulting work for APC.

A travelling biome lab

What’s happening in the gut is important, but finding out what’s going on in the digestive system, especially the small intestine, is tough without invasive surgery.

So why not send a sensor in instead?

Researchers at UC Davis and Stanford have developed a swallow-able capsule called CapScan (sorry, no points for originality) that makes its way through the digestive system “and collects a small volume of biofluids and microorganisms on the way from the upper intestine to the colon.” Bingo: an easy way to study “the gut metabolome and its interactions with the gut microbiome.”

The Long Read: Green edition

Johnson & Johnson is tweaking the formula for its bedaquiline anti-TB drug as a way of getting around patent law and keeping its monopoly. Never mind that public funds paid for the drug’s research and development.

John “The Fault in Our Stars” Green explains why this is sentencing millions of people to death.

I’m glad Johnson & Johnson has profited from manufacturing and selling bedaquiline. Pharmaceutical companies need to see the value of investing in new tuberculosis treatments. But a decade after the drug’s emergence, it is high time for the company to relinquish its extended patent claims.

Short Takes

Coverage expands … for now

The US uninsured rate fell 18% from 2019 to 2022, according to the latest CDC data. Note that it fell by 18%, not to 18%. The latest figure is that 8.4% of Americans don’t have health insurance, including about 3 million children. Of course, with the lifting of pandemic-era Medicaid requirements that uninsured figure will climb again, but we can at least enjoy the moment.

Radiologists look over their shoulders

The ChatGPT AI passed the Canadian Royal College and American Board of Radiology exams. (In testing, that is.) The latest version of the software scored 81% overall, including on higher-order thinking questions, describing imaging findings (85%), and even applying concepts (90%). Yikes.

 

May 18, 2023     Andrew Kantor

Down and out in the land of the free

A new Gallup poll found that more than a quarter of American adults are or have been depressed — that’s a 10% jump from 2015. And that’s not “people who feel depressed” — these are patients who have been diagnosed with clinical depression.

(Sure, some of those are probably over-enthusiastic prescribers. But then again, there were over-enthusiastic prescribers in 2015, too, when the number was lower.)

For some reason we just can’t fathom, the rate jump starting in the spring of 2020, almost as if there was some event triggering it. But while it dipped a bit by 2022, it’s been rising since then.

Blame what you like — social media, isolation and loneliness, fear of the future, social media — it’s clearly a problem.

Shortages are still an issue

Drug shortages continue to be a problem and now they’re becoming a concern and could even be a crisis. But unlike other issues, this one is harder for government — i.e., society as a whole — to solve, because it’s mostly in the hands of private industry and the laws of supply and demand.

Officials have been debating possible measures like tax incentives for generic drugmakers and greater transparency around generic drug quality. The current incentives favor drugmakers with the lowest prices, which includes those that might cut corners — leading to disruptive plant shutdowns if the F.D.A. demands a fix.

(One plan that has bipartisan support is making it easier for generics to come to market “by addressing tactics or loopholes [used by drugmakers] that cause delays.” We shall see.)

If you give a mouse a mushroom….

Good news if you have mice you’re worried about getting poisoned by death cap mushrooms: Chinese scientists have uncovered the process by which the toxin kills, and then a possible antidote: indocyanine green, which is used in medical imaging and FDA approved for human use (in small doses).

Half the mice survived the poisoning when given indocyanine green, compared to a 90% death rate without it.

The biggest problem, though, is human testing. See, subjects would need to be poisoned first….

What’s old is new

Cancer drug makes a good partner

Once upon a time, angiogenesis inhibitors were a hopeful candidate for cancer treatments, but they didn’t do well in clinical trials; today they have only limited benefits. But it seems they might have a new life: When combined with checkpoint inhibitors, angiogenesis inhibitors delayed recurrence of the nasty liver cancer hepatocellular carcinoma. That’s a first.

And it’s just one of the ways the angiogenesis/checkpoint inhibitor combo is being tested on various cancer types:

So far, dozens of clinical trials have evaluated checkpoint inhibitor-angiogenesis inhibitor combos. Some proved toxic, and others failed. However, the studies also led FDA to approve new therapies for types of liver, kidney, lung, and endometrial cancers. The drug combinations are not curative, but they restrain tumor growth. And some extend patients’ lives by many months over angiogenesis inhibitors alone.

Improving an old antibiotic

A “new” weapon in the fight against antibiotic resistance might be 80 years old. It’s nourseothricin (b. 1942) which is kind of a complex form of streptothricin. Sure, back in the ’40s it did kidney damage, but this ain’t the ’40s.

“What scientists were isolating in 1942 was not as pure as what we are working with today. In fact, what was then called streptothricin is actually a mixture of several streptothricin variants.”

And one of those variants, streptothricin-F, “was significantly less toxic while also working against present day pathogens that are resistant to multiple drugs.”

Smart sutures could be comin’

Take a suture. Make it of catgut, which naturally dissolves in a few months. Great — it’ll close a wound. But what if the wound becomes infected? And what if it’s a particularly dangerous gut wound?

If you’re an MIT researcher, you coat that suture with a hydrogel that “can be embedded with sensors, drugs, or even cells that release therapeutic molecules.” Yep — the suture itself could detect inflammation or infection, then release drugs to counter it.

(How can it detect inflammation? By containing a peptide that reacts in the presence of inflammation-associated enzymes.)

The researchers envision that these sutures could help patients with Crohn’s disease heal after surgery to remove part of the intestine. The sutures could also be adapted for use to heal wounds or surgical incisions elsewhere in the body.

Short Takes

Goodbye, J&J vax

The Johnson & Johnson one-shot Covid vaccination has left the building.

AstraZeneca quits PhRMA

It’s the latest pharmaceutical manufacturer to leave the trade group.

Monkeypox won’t quit

Health officials: The monk— the mpox emergency is over. As you were.

Mpox: You couldn’t kill Rasputin, what makes you think you can stop me?

Health officials: That is a terrible analogy.

May 17, 2023     Andrew Kantor

Universal flu vax getting closer

It’s been a long time coming, but human trials on a potential universal flu vaccine are about to get underway. It’s just a phase 1 (‘does it work?’) trial, but the fact that there’s a vaccine candidate — mRNA, of course — is worth at least a smile and thoughtful nod.

20 hours of CPE, plus a nifty certificate

It’s your last chance before the Georgia Pharmacy Convention to get the world’s best update on immunization skills! What you get:

  • 20 hours of CE (!)
  • the latest immunization skills taught by experts you know
  • a stand-out line on your CV
  • a certificate to impress your patients (and your boss)

…all from GPhA, Sunday, May 21. It’s APhA’s Pharmacy-Based Immunization Delivery: A Certificate Program for Pharmacists.

It’s popular for a reason! You’ll walk — nay, strut out of the class with comprehensive knowledge, skills, and resources to provide patients with the best immunization services, period.

That 20 hours of CE includes the live seminar, hands-on training and assessment, and online self study. The seminar and training is Sunday, May 21, 2023 from 8:00 am – 5:00 pm in the Georgia Pharmacy Association Classroom, Sandy Springs (map).

Don’t miss out and end up with a sub-par résumé!

UGA finds possible retinopathy treatment

Treatments tested for diabetic retinopathy often have a problem: To keep the body from adding too many new blood vessels to the retina (neovascularization), they shut down the process completely by shutting down a molecule called Akt. But the retina needs some new blood vessels to continue to function.

Enter UGA College of Pharmacy researchers, who think they’ve identified a ‘Goldilocks’ drug to treat retinopathy.

[A] perfect balance is struck between decreasing inflammation and the neovascularization processes without completing shutting down Akt activity and the vascular network required for normal retinal function.

The drug: triciribine, a select Akt inhibitor that’s being studied as a potential cancer fighter. The select Akt inhibitor is the key here; it can reduce the formation of new blood vessels without shutting it down completely. But you know the drill: More research is needed.

Marijuana and arteries

I know what you’re thinking: There couldn’t possibly be a downside to marijuana. Just because it hasn’t been studied and there’s no regulation of ingredients or THC levels doesn’t mean it can’t treat just about any issue on the planet. (← That is sarcasm.)

After decades of no research, we’re just now beginning to learn Mary Jane’s upsides and downsides. The latest downside: “Marijuana Users Have Triple the Odds for Leg Artery Disease” according to a study out of Hackensack University Medical Center. It’s based on the health data of 30 million (!) patients, 620,000 of whom were marijuana users.

They don’t know exactly why — “It’s possible marijuana use changes how blood clots or affects peripheral vascular tone,” but there was definitely a correlation that needs looking into.

Menthol on your mind

Here’s a weird one: When mice with Alzheimer’s were given menthol to smell, their cognitive ability improved. Thus, suggest the Spanish researchers who discovered this, it brings up “the potential of odors and immune modulators as therapeutic agents.”

[T]hey observed that when smelling this aroma, the level of interleukin-1-beta (IL-1β), a critical protein mediating the inflammatory response, was reduced. Furthermore, by inhibiting this protein with a drug approved for the treatment of some autoimmune diseases, they were also able to improve cognitive ability in these diseased mice.

Even more surprising, not only did a bit of menthol exposure prevent cognitive decline in the mice with Alzheimer’s it “also improved the cognitive ability of healthy young mice.”

A reminder about kids and cough syrup

A pair of Aussie pharmacists want to remind the world that cough syrup for the under-six crowd is probably a bad idea. And parents who do want to give it to the little ones should only do so “in consultation with a doctor, pharmacist or nurse practitioner.”

Overuse may result from parents misreading the label, intentionally using more in the hope it will work better, inadvertent extra doses and the use of inaccurate measuring devices such as household spoons.

They do have one interesting recommendation:

Simple syrups containing no medication can also be effective: up to 85% of the effectiveness of cough medicines has been put down to the “placebo effect”. This could be due to syrups coating the throat and dampening that irritating tickling sensation.

The battle against jargon continues

Can antioxidants found in fermented beverages impact tissue transcriptomics and modulate the heart’s response to an oxidative stress challenge induced by myocardial ischemia?

In other words: Can drinking beer help after heart damage?

The answer: Yes, maybe. Apparently fermented beverages — in low to moderate amounts — affect the expression of genes involved in both immune and inflammation responses, and appear to “ impact the heart’s response to oxidative damage” in a positive way.

Why couldn’t they just say that?

Short Take

An FDA advisory committee has recommended approval of ARS Pharmaceuticals’ Neffy epinephrine nasal spray, “a spray that would give users a 2-milligram dose to treat allergic reactions, including anaphylaxis, as an alternative to an injection with a needle.” The FDA will take this into account and decide in the next few months whether to approve the drug.

May 16, 2023     Andrew Kantor

Georgia cannabis dispensaries open

It may have taken years for Georgia to go from “we’ll approve medical-cannabis oil dispensaries,” to “here are the first licenses,” but once those licenses were issued, the first two pharmacies were open within a day (in Macon and Marietta), and two more are scheduled for June and July.

The [medical-cannabis oil] registry currently has around 27,000 patients. But it’s expected to grow quickly now that the first pharmacies are open.

Do you know where you’re going?

On May 17, Mollie Durham will help you figure that out. It’s part 2 of our spring-cleaning webinar special, following “Where Am I, and Where Do I Want to Be?” (now available on demand) — it’s How do I Get Where I’m Going?

Put together an action plan with specific goals to give your pharmacy business the boost it needs to thrive.

It’s just an hour long (and gives 1 hour of CPE credit), but it’ll pay years of dividends.

Spring Cleaning: How do I Get Where I’m Going? is Wednesday, May 17 from 7:00 – 8:00 pm via Zoom. It’s just $35 for GPhA members and $45 for non-members.

The oxytocin-autism connection

Amongst other uses, oxytocin is important for the kinds of ‘social interaction and emotional control’ that often plague people on the autism spectrum. (It’s been assumed that oxytocin deficiency might play a part in autism.)

Swiss researchers have found an interesting connection. They found that people with a rare disease that causes vasopressin deficiency has those patients showing similar issues to autism — but here’s the important part — those issues remain even with vasopressin treatment.

That means two things. First, “[D]isorders that cause vasopressin deficiency could also affect the neurons that produce oxytocin.”

Second, a bit of testing with MDMA proved* that yes, oxytocin deficiency is a thing, and that it has those autism-like effects. What treatments could this lead to? More research is needed.

* All right, this is science so maybe “Seems to clearly indicate, at least in these early stages.”

Alzheimer’s treatment still begs questions

Yes, the latest Alzheimer’s treatment, Eli Lilly’s donanemab, has had some solid trial results. It certainly seems to slow the disease, and do it better than other treatments. But the big question remains: How much difference will that really make on the ground? The benefits are modest, the cost is sky-high, and the potential dangers are real.

When we look at a trial and we see this slightly different increase or slowing down in the clinical score … it’s hard to tell what that means for a patient. For a patient who has early Alzheimer’s, it’s very difficult to understand how that minor change in score correlates with their function.”

GLP-1s can help cancer treatment

First they were diabetes drugs, then weight-loss drugs, and now GLP-1 analogs might also be anti-cancer drugs.

Not that they attack cancer directly, but by fighting obesity, they allow the body’s natural killer immune cells to better do their jobs.

As one Irish researcher put it: “We are finally reaching the point where medical treatments for the disease of obesity are being shown to prevent the complications of having obesity.”

Insert a ringworm-pun title here

Ringworm a yucky and very contagious skin disease, as you know. But luckily it’s easily treated and contained with a bit of antifungals and not shaking hands for a bit.

Unless its the treatment-resistant kind, which just appeared in the US of A. Two patients, and now their close family members were infected, “raising alarm” with health officials. (They were eventually treated, but it wasn’t easy.)

The good news is that they were in New York City, which is enough of a backwater that it’s unlikely to spread by travellers to other regions.

Short TakeS

Saving you a click: Pinpointing suicidal thoughts

The title: “Research pinpoints the time of year and hour when people have the strongest suicidal thoughts”.

The answer: The thoughts are strongest in December, between 4:00 and 5:00am, but it takes months for people to act, meaning the highest suicide and suicide-attempt rate is in spring and early summer.

Short on vitamin D, long on Covid

A new addition to the possible risk factors for long Covid: vitamin D deficiency.

Italian researchers wanted to see if vitamin D might play a role in long Covid, so they tested their idea on 100 Covid-19 outpatients. And what d’ya know, the ones who ended up with long Covid had overall lower vitamin D levels. This was just a preliminary study, but it opens a door for more research (which is always needed).

Our data suggest that vitamin D levels should be evaluated in Covid-19 patients after hospital discharge. The role of vitamin D supplementation as a preventive strategy of Covid-19 sequelae should be tested in randomized controlled trials.

(Really, at this point it’s obvious you don’t want to be vitamin D deficient.)

May 13, 2023     Andrew Kantor

In vitro ain’t in vivo

When researchers test a drug that fights bacteria, they typically test it in a monoculture — a cage match between the drug and the bug. The problem, found University of Wisconsin-Madison biochemists, is that when the drugs are in a real, live human gut, the gut bacteria can limit how effective a drug is against C. diff.

It’s kind of like testing noise-cancelling headphone in a room with a fan, but expecting them to be used at a rave.

Essentially, the drug will kill different bacteria first, leaving C. diff to thrive. Or, put more science-like:

“[P]athogen growth can be altered by inter-species interactions across a wide range of antibiotic concentrations, which should be considered in the design of antibiotic treatments.”

Artist’s conception

A better hot-flash med

The FDA has approved the first medication for hot flashes that doesn’t rely on hormones.

The medication, which goes by the brand name Veozah and generic name fezolinetant, works by blocking the neurokinin 3 receptor, which helps the body regulate temperature.

That “non-hormonal” bit is important — hormone therapies work great, but there are a lot of women who can’t take them — e.g., “patients with a history of stroke, heart attack, vaginal bleeding, blood clots, or liver disease.”

Hang up and relax

Maybe you can tell your patients with hypertension, “Have you considered hanging up the phone?” Chinese scientists — in a retrospective study even they say is chock full of caveats — found that…

… adults who spent that at least a half-hour per week on their mobile phone had a 12% increased risk of developing hypertension, whereas those who spent more than 6 hours weekly had a 25% increased risk, compared with a weekly usage time of under 5 minutes.

The data came from the UK Biobank, so it’s mostly from White middle-aged or older adults, and there were a lot of other limitations. Also, there’s no causal connection — just an association. As usual, more research is needed.

The Long Read: the PBM story

Sure, you know PBMs, but do you really know how they get/got their fingers into the healthcare pie? Vox has everything you wanted to about “How pharmacy benefit managers found themselves the targets of a bipartisan push on drug prices.”

Short Takes

The shortages will continue

Health officials around the world would like to remind people that drug shortages aren’t just related to the pandemic — they’re an ongoing problem thanks to issues “including scarce raw materials, sole-source suppliers, a concentrated market, quality problems and product recalls, labor issues, geopolitical conflict, and natural disasters,” among other issues.

Rexulti label expands

The FDA has expanded its approval for Rexulti to include treating agitation in dementia patients.

Antibacterial plastic

Why spray disinfectant on plastic when you can use nanotechnology to bind chlorhexidine to ABS plastic (i.e., the hard stuff, like Lego) “to create a new antimicrobial coating material that effectively kills bacteria and viruses”?

May 12, 2023     Andrew Kantor

Georgia families lose lawsuit

Georgia families that sued drug distributors over their role in the opioid crisis — “the first lawsuit brought by individual victims of the opioid epidemic against pharmaceutical companies” — have lost their case.

After barely a day and a half of deliberation, the jury concluded that the companies — two of the nation’s largest medical distributors, McKesson and Cardinal Health, and a third regional company — were not liable. The plaintiffs – 21 relatives from six families – had filed a lawsuit under a rarely used state law that allows relatives of drug addicts to sue drug dealers.

(We covered the suit back in February.)

Know your mental health first aid

Mental health is not to be trifled with. If people around you — patients, co-workers, friends — need help, you should at least be able to identify the problem and be a first responder.

PharmWell, a professional health & wellness program of the Georgia Pharmacy Foundation, is pleased to make Mental Health First Aid training available as a CPE course for pharmacists and pharmacy techs.

Mental Health First Aid is a 7.5-hour course that teaches you how to identify, understand and respond to signs of mental illnesses and substance use disorders.

[ logo ]

Get the skills not to solve the problem, but to help someone take the first steps toward treatment. Yes, it’s priceless info, so the foundation is just asking to cover its costs. It’s making this training available to pharmacists, pharmacy techs, and student pharmacists for $49.00.

It’s live, Saturday, July 29 in Tifton. CLICK HERE for more info and register today!

A personalized cancer vaccine

Scientists in New York and Germany have — unexpectedly, even to them — created what appears to be a vaccine against pancreatic cancer. It’s an mRNA-based vaccine, manufactured by BioNTech, that uses patients’ tumors to create the proteins that the immune system is instructed to attack. Yes, that means each vaccine is personalized, so it’s not a simple off-the-rack solution. But if you’ve got pancreatic cancer, this could be — dare we say it? — a game-changer. Or at least, as one expert put it, “a milestone.”

Building a better phage

Bacteriophages kill bacteria. But finding the right phage for the specific bug you want to kill is hit or miss (more often it’s miss). But you can use CRISPR/Cas to edit genes, including genes in phages.

You see where this is going.

An international team of biomed engineers found phages that attacked E. coli in general, then used CRISPR to tweak the phages to attack specific strains of the bacteria. By using phages to kill the infection, patients’ gut biomes aren’t destroyed at the same time.

A cocktail of four of these phages […] effectively targeted bacteria in biofilms and reduced the number of E. coli in a manner that surpassed that of naturally occurring phages. Further, they showed that the cocktail of phages was tolerated well in the gut of mice and mini pigs while reducing the emergence of E. coli.

Don’t smell like dinner

It’s obvious when you think about it: If your soap makes you smell like flowers, you smell like flowers to mosquitos. Virginia Tech biochemists figured that out, and decided to see which soaps mosquitos didn’t like.

The answer: coconut. Skeeters don’t like it, but they sure as heck liked the floral scents.

“Just by changing soap scents, someone who already attracts mosquitoes at a higher-than-average rate could further amplify or decrease that attraction.”

The preliminary research focused on just four products (three floral, one coconut), so now they need to confirm the finding applies across brands.

The Long(ish) Read: Why are they chronic?

Why are some diseases and conditions curable, but others chronic? A UC San Diego medical professor has a theory about why “the root cause of the chronic symptoms is not changed by treatment.”

[He] posits that the root cause of many chronic diseases lies with disruption in the normal sequence of mitochondrial transformations needed to initiate and complete the healing cycle. He has called this universal response to infection, stress, or injury, the cell danger response or CDR.

[…]

[But sometimes] CDR continues to sound the alarm even after the originating threat is gone. Inflammation and cell dysfunction persist, resulting in chronic symptoms.

Short Takes

No backsies

Eli Lilly appealed a $61 million penalty for “skimping out on Medicaid rebates,” but it backfired: The company was instead ordered to pay $183 million because the judge ruled it fell under the False Claims Act which provides for treble damages.

Long Covid: Where you live and what you do

People in healthcare professions (patient-facing or not) and in poorer areas are more likely to suffer from long Covid, according to a big British study. In fact, the risk for healthcare workers was 76% higher. (It didn’t make clear whether the people themselves were lower income, or just that they lived in a low-income area.)