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.

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.

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.)

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”?

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.)

FDA panel votes in favor of OTC birth control

After discussing concerns about patients’ ability to follow directions, the panel voted unanimously (17-0) to recommend the FDA approve Perrigo’s Opill for over-the-counter sales.

This is the advisory panel; the FDA itself will probably make its decision this summer.

DEA postpones telehealth rule till late 2024

It’s official, sorta — the DEA says it will keep its “telehealth flexibility” rules in place, or at least grandfather in anyone using them today. Meaning “Any existing provider-patient telehealth relationship established before Nov. 11, 2023 then can continue through November 2024.”

So if you have telehealth patients who get controlled meds, let them know they’re set till at least then.

When the orphan is Bruce Wayne

If a company gets a big ol’ tax credit to develop a drug for a rare disease, but then that drug turns out to be a blockbuster of a money-maker, should the drug companies have to pay the taxes? Yes, argue Harvard researchers. What they found is that “drugs ini­tial­ly ap­proved for an or­phan des­ig­nat­ed con­di­tion were just as lu­cra­tive for their man­u­fac­tur­ers as drugs de­vel­oped for more com­mon con­di­tions.”

So how could the rare dis­ease drugs be just as lu­cra­tive? The aca­d­e­mics point to high­er launch prices, and from 2008 to 2018, launch prices for or­phan-des­ig­nat­ed drugs were sev­en times high­er than for non-or­phan drugs, they wrote.

Their suggestion was simple: “[Require] man­u­fac­tur­ers to re­pay tax cred­its when or­phan-des­ig­nat­ed prod­ucts are com­mer­cial suc­cess­es.”

A lifelong Covid vax?

Even the latest, Omicron-specific Covid vaccinations only last about 9 months, according to the latest data. (Ditto for immunity gotten from infection.)

But Rutgers researchers^*, tired of the thought of getting boosters, say they have an alternative: A new vaccine they developed and tested in animals that they say might “[provide] years of robust protection with fewer booster shots against a variety of SARS-CoV-2 strains.”

Called MT-001, it seems to “elicit ‘broadly neutralizing’ antibodies that confer protection against SARS-CoV-2 strain variants currently circulating in the human population and future variants that have not yet appeared.”

“In theory, it’s possible that a booster shot of our variant-updated version of MT-001 could provide lifelong protection. The animal data indicate that it should, at the very least, provide protective antibody levels for at least a year or more, which is a vast improvement over today’s vaccines

They also say it’s inexpensive to make and doesn’t require special cold storage.

^* I always say that in a Scooby-Doo voice

Polypharma and stimulants

Be on the lookout for patients who are taking stimulants along with drugs like benzos, opioids, or antidepressants. Johns Hopkins researchers are concerned about the number of patients taking two or more drugs that affect the central nervous system.

Close to half of the stimulant users were taking an antidepressant, while close to one third filled prescriptions for anxiolytic/sedative/hypnotic meditations, and one fifth received opioid prescriptions.

Stimulants work for ADHD, sure, but their concern is that they’re being used off-label not as a monotherapy as intended by as an unproven combo therapy. “[B]ecause there are so few studies of these kinds of combination therapy, both the advantages and additional risks remain unknown.”

How statins work

Statins are ostensibly for treating high cholesterol by targeting the liver, but they also seem to have a wide range of other benefits — clearing arteries, reducing inflammation, and more.

How does one class of drug do so much for the cardiovascular system? Stanford researchers think they have the answer. It seems that statins help keep flexible endothelial cells in the lining of blood vessels from becoming rigid mesenchymal cells.

[E]ndothelial cells treated with simvastatin in a dish formed more capillary-like tubes, a sign of their enhanced ability to grow into new blood vessels.

The science is complex to say the least, but the gist is that statins affect the expression of certain genes that affect vascular function, and they even reduce the potential for developing cancer cells.

With the mechanism unearthed, the next step is to develop even more targeted drugs for cardiovascular issues.

Short Takes

Yet another GLP-1 drug

The latest almost-entry into the weight loss drug bonanza comes from Boehringer Ingelheim and Zealand Pharma, which have a drug called BI 456906 that just completed phase-2 (“What’s the right dose?”) trials. Like the others in the category, it does a pretty good job: “up to 14.9% weight loss after 46 weeks.” Of course it has to be taken for life.

Pancreatic cancer predictor

Those shifty Danes — along with Harvard scientists — have developed an artificial intelligence that can predict when someone is at high risk of pancreatic cancer three years before it’s diagnosed.

The computer found combinations of diseases (and their timing), often with nothing to do with the pancreas, that nevertheless indicated at-risk patients.

One particular advantage of the AI tool is that it could be used on any and all patients for whom health records and medical history are available, not just in those with known family history or genetic predisposition for the disease.

OTC birth control on the table

A group of FDA advisors considered yesterday whether to approve the first over-the-counter birth control: HRA Pharma’s Opill. The pushback within the advisory committee isn’t that the drugs aren’t safe or effective (we know they are) but that patients might not take them correctly.

Taking the pill at around the same time every day is “essential” for the pill’s efficacy, the staff noted.

[…]

FDA staff also urged the expert panels to discuss whether women with health conditions like breast cancer that might make them inappropriate candidates for the pills would be able to conclude that the product might not be right for them.

OB-GYNs, however, are strongly in favor of OTC birth control, especially in rural areas where “over-the-counter oral contraception is ‘critical’ so that more people can ‘control their own reproductive futures, including avoiding pregnancy’.”

After the pandemic, what happens?

Today’s explainer: With the pandemic emergency ending, what does that mean for, well, everyone? From who will pay for what, to which programs are changing and shutting down, NPR’s got the details.

OTC meds: What’s recommended most?

Drug Store News has some interesting survey results about OTC meds, but before you click make a note of this: The respondents are called “retail pharmacy workers,” but they are by and large nurse practitioners (mostly from Kroger and a third from Ohio).

Some quickie highlights:

• Tylenol is the top choice for pain, except for migraines where Excedrin is the pick.
• Zyrtec rules for allergy meds, and the -quils — DayQuil and NyQuil — win for “cough, cold, and flu combinations.”
• Something about Allegra: It’s down the list behind Zyrtec, Claritin, and even Benadryl.

Why so many brand names? Probably because that’s what patients will recognize. Note the exception: ibuprofen is recommended more than Advil or Motrin.

Lyme vax postponed

We were soooooo close to a (new) Lyme disease vaccine, but then Pfizer and Valneva’s phase-3 study was hit with troubles thanks to the trial’s operator. Now the companies are saying it won’t be till 2026 that they apply for FDA approval, assuming the (relaunched) trial shows good results.

Senators support tele-prescriptions

Six US senators have “expressed concern” about the DEA’s plan to make some telehealth prescriptions more onerous. The agency is considering requiring in-person visits for controlleds including buprenorphine, which treats opioid-use disorder (OUD), but it said last week that it would hold off on changes after being flooded with letters from patients and prescribers asking that pandemic-era rules remain in effect.

With the rule change in limbo, “Our concerns are echoed by many medical organizations, stakeholders, and OUD treatment recipients worried about the transition from the COVID-19 Public Health Emergency to a post-pandemic era,” the senators wrote.

The in-person medical appointment requirement is especially problematic. Individuals may face barriers attempting to secure an in-person appointment with a medical provider, particularly in rural areas and medically underserved communities, due to lack of availability, stigma associated with OUD, and transportation challenges.

Captain Obvious doesn’t inhale

“Quitting Smoking Earlier Is Always Better for Lung Cancer Survival”

The Long Read

The Atlantic’s normal editors must be on vacation because it actually has a positive story. Instead of grumbling about all the things the US did wrong during the pandemic, the magazine looks at “23 Pandemic Decisions That Actually Went Right.”

The real Covid killer

All through the pandemic, we thought it was a cytokine storm that killed patients — an overwhelming inflammation throughout the body. But when Northwestern University scientists asked their computer to look into it, a different culprit emerged: unresolved secondary bacterial pneumonia.

What the AI teased out of the data points a pretty clear finger:

• “Nearly half of patients with Covid-19 develop a secondary ventilator-associated bacterial pneumonia.”
• “Those who were cured of their secondary pneumonia were likely to live…”
• ”… while those whose pneumonia did not resolve were more likely to die.”

So the virus itself doesn’t do the killing directly, but rather causes that secondary bacterial pneumonia, which is often deadly. They hope knowing this can save lives by giving physicians a better target for treating Covid patients.

Needed: a new kind of pharmacy tech

In case you haven’t noticed, technology — especially information systems — is (are) playing a bigger role in how pharmacies run. And that means a pharmacy can’t rely on the 12-year-old wunderkind to stop by on her way home from school to fix your computer problems.

And that’s why Becker’s Hospital Review covers “The growing demand for pharmacy informatics technicians.”

Pharmacy informatics technicians […] provide “oversight and integrity of computer systems and software applications involved in pharmacy order entry, dispensing, compounding systems, automation, telehealth and digital and virtual care.”

And that’s why pharmacy techs should think about tweaking or adding to their training. Here’s what pharmacies need — your choice whether you see it as an overwhelming list, or a deep pile of opportunity (and résumé lines): experience in “predictive analysis, process improvement, budget expectations, cost containment, standardization, inventory control, governance, and automation education and training.”

Wengovy and friends

Yeah, I’m getting tired of these stories too, but GLP-1 agonists are in the news and we’re all stuck with that until a celebrity dies of some rare disease.

More than just a lifestyle drug

Novo Nordisk would love its Wegovy to be classified as having a medical benefit rather than as a ‘lifestyle drug.’ So it’s focusing on showing the heart benefits: “It doesn’t take a lot of leaps of faith to understand if you lose weight, you will have a lower risk of heart disease.”

A five-year study “to assess whether Wegovy reduces the risk of major cardiovascular events” is ending this summer, and the results could change who gets the drug … and who’s willing to pay for it.

But there’s a downside

Losing weight (when it’s healthy) is a good thing, but there’s a side effect if it happens quickly like, say, with a drug like Ozempic: hair loss. The body treats it as a major stressor, and (as one dermatologist explained), “Telogen effluvium is a diffuse shedding of hair that occurs approximately three months after a major stressor.”

The good news is that it generally goes away. The hair loss, that is, not the hair itself. But weight-loss-drug users should be prepared.

Drops could be dropped

A new eye spray just got FDA approval for dilating pupils — Eyenovia’s Mydcombi, “a fixed-dose combination of the two popular dilating meds tropicamide and phenylephrine.”

The thought is that having a chemical sprayed into your eye is more comfortable than getting drops.

All right, there’s more: It uses a much smaller dose, a much smaller overall spray (“about a fifth of the volume of a traditional eye drop”), and fewer preservatives.

The gut-Parkinson’s link

Finnish researchers have found a cause of Parkinson’s disease: a bacteria called Desulfovibrio that can be found in the gut. This could be big news — the exact cause of Parkinson’s is unknown. Until, perhaps, now.

What they found is that “The disease is primarily caused by environmental factors, that is, environmental exposure to the Desulfovibrio bacterial strains.” But not every strain — there are certain strains of Desulfovibrio that didn’t cause any issues, while the troublesome ones created larger aggregates of the alpha-synuclein protein that’s a hallmark of the disease.

And genetics? “Only a small share, or roughly 10%, of Parkinson’s disease is caused by individual genes.”

Caveat: This was only tested in C. elegans worms, but still they hope that targeting this particular bacteria could lead to “potentially alleviating and slowing the symptoms of patients with Parkinson’s disease.”

The Long Read: Skeeter Beater edition

For people who seem to be mosquito magnets, help is on the way in the form of new repellants that are safer, longer lasting, and even better than the DEET gold standard.

Short Takes

What else can they do?

Weight-loss drugs could be brought to bear against Alzheimer’s and other diseases. How? By “improving glucose utilisation and tamping down inflammation in the entire body — including the brain.”

Depression and anxiety can make long Covid worse

Anxiety and depression can cause “thinking deficits,” and people with thinking deficits are more likely to suffer from long Covid. “This perception of cognitive deficits suggests that affective issues — in this case anxiety and depression — appear to carry over into the long Covid period.”

We’ll check in in about five years

Japanese researchers say they’ve had success with a different kind of antidepressant. One of these delta opioid receptor agonists, a drug called KNT-127, had “significant anti-depressant activity, quick action, and minimal side effects.” Not surprisingly with antidepressants, they don’t know why it works.

Unexpected A1c fighter^*

Here’s a surprising potential treatment for type-2 diabetes: Cialis. Apparently (found Swedish researchers) PDE5 inhibitors like tadalafil taken daily…

… caused a clear improvement in metabolic control, based on measurements of HbA1c in blood samples. On average, the level of HbA1c fell by 2.50 mmol/mol.

This was only a pilot study, so — you know the drill: More research is needed.

And the lead researcher warns about patients reading too much into this: Self-medication with PDE5 inhibitors must never take place,” he said.

^* What, you expected some bad pun? Writing those is … difficult.

Congrats to the 2023 PharmDawgs!

A big shout-out to the UGA PharmD Class of 2023, commencing their new lives today with an average GPA of 3.5 and almost three-quarters already having secured their next steps — jobs or “other postgraduate opportunities.” Congrats, all 136 of you!

And also….

… to GPhA members William Huang and Jordan Khail (as well as Sharmon Osae and Brian Seagraves) who will be hooding the grads as part of the ancient tradition of commencement. W00t!

The new polypharmacy guide for seniors

The American Geriatrics Society has released the latest version of its AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults — the combined list of meds that older people should use with caution, use differently, or avoid altogether, “because they often present unnecessary risks for this population.”

The link above is for the news release. Click here if you want to skip right to the full paper/report.

The best message to combat Covid vax-hesitant parents

There are reasonable parents who, perhaps scared by anti-vax misinformation, are iffy about getting their kids vaccinated against Covid, especially if it might mean Bill Gates will control their minds.

The folks at the Children’s Hospital of Chicago did some research and found that some messages worked better than others to convince parents to protect their kids.

What doesn’t work: Explaining that the vaccine is “well-tolerated” and has few side effects, even when delivered by the child’s doctor or nurse. Ditto for trying to counter all the misinformation spread by anti-vaxxers.

What does work: Hearing from other parents they trust that they vaccinated their kids. And hearing…

Some of them say that they weren’t sure at first about whether the vaccine is safe for kids. But they ended up deciding that it was the best way to fight COVID-19, and the vaccination went fine. They want to keep their kids protected.

So knowing other parents struggled with the decision and ultimately decided it was important to protect their children — that’s the ticket. (And hearing that the vaccine is safe can even help after they get that message.)

Better eggs with Prozac

Have you considered giving your pet roundworms fluoxetine? You might want to — apparently SSRIs can improve the quality of their eggs and “[decrease] chromosomal abnormalities in surviving offspring by more than twofold.”

But what if you’re more of a fruit fly person? It works for them, too.

How? They aren’t 100 percent sure, but they think the cells involved in egg development use serotonin as a messenger, so they take advantage of serotonin’s hanging around longer.

Coffee for your vision

How thick are your retinal nerve fibers? If you drink coffee or tea (two to three cups of coffee or more than four cups of tea per day) it appears to increase the thickness of the macula’s nerve layer — that’s the part of the retina that handles our central (as opposed to peripheral) vision. That’s per some new research from Chinese and Australian scientists.

Thicker is better in this case: “The thinner the layer, the higher risk of neurodegeneration.” So think of coffee and tea drinking as a way to protect those nerve cells … and your vision.

Short Takes

Covid-19 deaths down

Yes, we know they’re down in general, but the big picture is that, while in 2021 Covid caused 12% of deaths in the US, in 2022 it was down to just 5.7% — and it’s undoubtedly lower this year. In raw numbers, Covid “was the underlying cause of” the deaths of 417,000 Americans in 2021, but 187,000 Americans in 2022.

Perspective: 292,000 Americans died in all of WWII.

And that’s why…

The WHO has officially declared that, after killing 7 million people around the world, the Covid-19 pandemic is no longer a public health emergency.

Alzheimer’s drug — how big a deal?

Eli Lilly announced that its experimental anti-beta-amyloid drug donanemab cleared away brain plaque while patients “showed 35% less decline in thinking skills compared to those given a dummy drug.”

This is obviously big news. It doesn’t just show a chemical benefit, but a life-changing one. Approval may come later this year or early 2024; pricing hasn’t been set.

Caveats:

• The info was only in a press release, not trial results, so experts haven’t had a chance to pore over the details.
• At least two trial participants died, likely due to the drug. Will that deter patients? Probably not, but it might affect approval.
• On that same note, similar drugs have been linked to brain damage and other nasty side effects.
• The slowing of cognitive decline was important because it’s still not clear how much of a role beta-amyloid or tau plaques actually play in the disease.

Coming up fast: Spring Cleaning with Mollie

Now’s the perfect time to look ahead and give your pharmacy business the boost it needs to thrive.

This two-part virtual course will give you the tools you need (and the enthusiasm to use them!) to know where you are and where you want to be and then take smart, actionable, realistic steps to get there.

Each part is just an hour long — and gives 1 hour of CPE credit — but it’ll pay years of dividends.

• Part 1: Where Am I, and Where Do I Want to Be? — Wednesday, May 10; 7:00 – 8:00 pm via Zoom
• Part 2: How do I Get Where I’m Going? — Wednesday, May 17; 7:00 – 8:00 pm via Zoom

Each part is just $35 for GPhA members and $45 for non-members.

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LINK IMAGE: https://www.gpha.org/springcleaning

Alzheimer’s: Beyond drugs

Go online, old man

An NYU study of 18,000 patients for up to 17 years found that, while 4.68% of participants were eventually diagnosed with dementia, “Regular internet usage was associated with approximately half the risk of dementia compared with non-regular usage. This link was found regardless of educational attainment, race-ethnicity, sex, and generation.”

… then go to sleep

A simple way to fight Alzheimer’s memory loss might be to get a good, deep sleep, at least according to UC Berkeley researchers.

Deep sleep, also known as non-REM slow-wave sleep, can act as a “cognitive reserve factor” that may increase resilience against a protein in the brain called beta-amyloid that is linked to memory loss caused by dementia.

In case that wasn’t clear, they provided this not-terribly helpful image:

Beta blockers may not make a difference

After a heart attack, the standard treatment is long-term beta blockers to prevent another. But — Swedish researchers say — that might be unnecessary as long as the patient doesn’t have heart failure.

They looked at the data for almost 44,000 people, 21% of whom weren’t prescribed beta blockers after a heart attack (i.e., the sample size was pretty darned good). Their finding:

The real time data showed that long term treatment with beta blockers wasn’t associated with improved cardiovascular outcomes during an average monitoring period of 4.5 years.

The difference was tiny:

• On beta blockers: 19% had another major heart problem
• Not on beta blockers: 22% had another major heart problem

“And after accounting for potentially influential factors […] there was no discernible difference in the rates of these events between the two groups.”

Link above is to the news story. The editorial in Heart is here (2-page PDF) and the paper itself is here (18-page PDF).

Weight-loss drugs in the news (again)

It’s a small(er) world after all

“Weight-loss drugs. There must be a new negative we can focus on,” said^* the editors of the Atlantic. “We’re supposed to be the World’s Most Depressing Magazine™.”

“I know!” said^* staff writer Sarah Zhang. “How about a story on how Ozempic can ruin a Disney vacation?”

“But Disney vacations are already nightmares if you’re over 12.”

“Yes, but Ozempic can make it worse.”

“You have our attention.”

Presenting: “Can You Have a Fun Vacation on Ozempic?”

^* Not really. Well, probably not. 

Speaking of Ozempic downsides…

Knowing the demand, makers of these drugs have set the price way, way high — and that means higher insurance premiums for employers if their plans cover the drugs.

Semaglutide — sold under the brand names Ozempic, Wegovy and Rybelsus — ranked fourth for total drug expenditures in the U.S. in 2021 at $10.7 billion, up 90% over the year before.

Some insurers have set up “gatekeeping tools” like BMI requirements or step therapy as, unlike bariatric surgery, these drugs aren’t once-and-done — they have to be paid for every month. That’s likely to be even more common as more GLP-1 drugs are approved.

Novo holds back supply

Novo Nordisk, is limiting new doses of Wegovy to existing patients — i.e., it won’t sell starter kits —“to ensure a steady supply for people already on the medication.”

Elsewhere: Drug drones to deliver

The University of Michigan’s Michigan Medicine is going to start (testing) drug delivery by drone next year, at least to patients within a 10-mile radius of one of its facilities.

The drones “will silently hover 300-feet above the ground” and lower their packages “on a tether that precisely delivers to their doorstep or balcony or other place of choice from the patient.”

Packaging mix-up with a 90-day supply