Many cancers, one simple test

A new study has confirmed a technique — called the Galleri test, from a California-based company called Grail — can “detect multiple types of cancer through a single blood draw“ by finding DNA markers of several kinds of cancer in the blood.

The Pathfinder study offered the blood test to more than 6,600 adults aged 50 and over, and detected dozens of new cases of disease. Many cancers were at an early stage and nearly three-quarters were forms not routinely screened for.

Even better, the test can predict where the cancer is, allowing an oncologist to confirm the results and start treatment. The Brits even dropped the phrase “game-changer,” and a larger study (165,000 people) is underway.

If you think that’s pretty high-tech…

How about diagnosing cancer (or depression, or pneumonia) by the sound of your voice?

A group of US and French medical and artificial-intelligence researchers (at a dozen institutions) is working on a program called “Voice as a Biomarker for Health.”

It aims to develop an extensive database of human voices, both healthy and sick, that can be used to train AI algorithms to detect changes that could be a sign of cancer, neurological and psychiatric disorders like Alzheimer’s or depression, respiratory illnesses such as pneumonia, and voice/speech disorders, including language delay and autism.

Coming soon: “Hello, this is T-Mobile. We noticed from your last conversation that there’s an 82.4 percent chance of having a Latvian Toe Worm infection. You may wish to consult a medical professional.”

Covid can double Alzheimer’s risk

People over 65 who catch Covid are twice as likely to be diagnosed with Alzheimer’s in the next year than those who stay healthy.

That sounds alarming (and it’s certainly notable), but keep in mind that it means the risk jumps from 0.35% to 0.68%. Doing the math, if you had 300 healthy seniors in a room*, one of them would develop Alzheimer’s in a year. If you had 300 seniors with Covid, two of them would develop it.

* In the US, a group of senior citizens is called a “grumble.” In the UK it’s a “mutter.”

Beer, pharmacists, and an afternoon to chill

Employee pharmacists! Come join your fellow Academy of Employee Pharmacists members (and students! and friends!) at Atlanta’s amazing Monday Night Brewing — an afternoon of fun, beer, snacks, and just plain R&R!

We didn’t bother with a cool name, so we just call it…

It’s open to AEP pharmacists, students, and friends, and it’s just $10 — which includes two (2, II, ✌) drink tickets. What a deal!

The details

It’s on Saturday, October 22, from 3:00 – 6:00 PM.

It’s at Monday Night Brewing‘s Hop Hut Lounge: 670 Trabert Avenue, Atlanta (map).

AEP events are always a blast, and hardly ever have to be broken up by the police. So …

(You can check out GPhA.org/mondaynight for a few more details — but really, what more do you need to know?)

Doubling the life of DMD patients

A drug being tested to treat kidney disease also provides significant improvement for people with Duchenne Muscular Dystrophy.

Johns Hopkins researchers found that calcium is a big part of the problem with the condition, when a normally helpful protein called TRPC6 (an ion channel) allows too much calcium through, eventually killing the cell and weakening the muscles overall.

Because DMD also affects heart muscle, people who have it generally don’t live past their early 30s.

But a drug called BI 749327 (currently in clinical trials) blocks that TRPC6 channel, thus protecting the muscles — and that “substantially improves their skeletal and cardiac muscle function, bone deformities, and survival.” And by “substantially improves,” they mean — at least in mice — it literally doubled their lifespan.

Anti-Covid gum

The Covid-19 virus binds to the ACE receptor, right? So (thought Penn dental researchers) why not make a gum chock full of ACE receptors to trap the virus so you don’t breathe it onto others?

In effect, the gum is designed to trap and neutralize SARS-CoV-2 in the saliva and, ideally, diminish the amount of virus left in the mouth. It is hoped that less virus would mean a lower likelihood of passing the infection on to others.

They’re about to begin tests on people who believe they’re Covid-positive.

(The big problem, though, is that the gum helps keep the infected from spreading the virus. If people refuse to wear a simple mask to protect others, would anyone bother to chew gum?)

Pharmacy in the midterms

Do you know what this year’s elections will mean for pharmacy? Maybe you do, maybe you don’t — but you certainly will if you join NACDS for a virtual webinar event with U.S. elections expert and political analyst Charlie Cook.

On Tuesday, September 20 — National Voter Registration Day — he and NACDS President & CEO Steve Anderson will explain the most important issues in this year’s election, and what they could mean for the future of pharmacy.

The exciting event starts at 1:00 pm ET via Zoom, and of course it’s free.
Click here to register now!

The 9,800 steps

Walking 9,800 steps a day can cut your risk of dementia by 50%, according to a study by those shifty Danes. (Too much? Doing just 3,000 also helps, although that cuts your risk by just 25%.)

Those 9,800 steps also cut your risk of heart disease and cancer, as the Danes’ collaborators in Australia point out. But the pace is important — walk faster. ”[A] faster stepping pace like a power walk showed benefits above and beyond the number of steps achieved.”

(Medical researchers in Wisconsin agree about focusing on the pace: Think 112 steps a minute. “’112′ is conceivably a much more tractable and less intimidating number for most individuals than ’10 000’.”)

A pill for exercise

Just because you can’t be active doesn’t mean you don’t deserve the benefits of exercise, amirite? The folks at Tokyo Medical and Dental University agree.

They identified a compound — an aminoindazole derivative called locamidazole — that’s “capable of stimulating the growth of muscle cells and bone-forming cells.” Exercise in a pill. (The science: Locamidazole “mimics calcium and PGC-1α signaling pathways,” in case you were wondering.)

The upshot is that people who can’t exercise — like those with osteoporosis or sarcopenia — could eventually have a pill to ensure their muscles and bones don’t atrophy, and even reverse “locomotor frailty.”

Captain Obvious would like some privacy

In what is hopefully a surprise to no one at all, people looking to test for colon cancer prefer — based on a survey of 1,000 people — to use an at-home test (e.g., Cologuard) rather than have a colonoscopy.

As long as he isn’t watching

Non-pharma but eyebrow-raising story out of Georgia Tech

Georgia Tech researchers were working on a way to use microneedle technology (the kind that can deliver drugs through skin) to create tattoos for pets — a simple and painless alternative to implanting a chip in case Fido goes walkabout.

Then they thought, Hey, why not use this for human tattoos? Result: “a painless and bloodless tattoo patch that’s simple enough for people to stick to themselves.”

Coming soon: Instant, pain-free, permanent, over-the-counter, self-administered tattoos.

Coming soon after: Deep, deep regret.

Covid boosters: Get your reading glasses

If you’re making a vaccine booster to replace an older booster, it’s important that they look different, right?

If you agreed, that’s because you have common sense: New booster, new package, less chance of error.

Meanwhile, at a couple of multinational, multi-billion-dollar drug companies…

Pfizer-BioNTech’s updated booster for people 12 and up comes in vials that have a gray cap with gray labeling — the same color scheme as its original vaccine, which is still being used for people’s primary vaccinations.

Moderna’s updated booster for adults comes in vials that have a dark blue cap with gray labeling; its vaccine vials for children 6 through 11 — which contains the drugmaker’s original formulation — have the same dark blue cap.

When the rare double-facepalm comes into play

Gonorrhea treatment update

For treating gonorrhea, ceftriaxone good; ceftriaxone plus azithromycin bad.

A new study out of the University of Washington backs up a 2020 CDC decision to remove azithromycin from its treatment recommendation. Using azithromycin, they found, increases the risk of developing resistant gonorrhea — not in a theoretical way, but in the real world .

Adding azithromycin to the treatment plan seemed like a good idea at the time — the idea was “preserving the efficacy of ceftriaxone ‘for as long as possible and until new antimicrobials are available’.” But now the cure is worse than the disease, so to speak.

Will Buzz end for you?

If you’re getting GPhA Buzz as a GPhA member (as opposed to bribing Andrew), and you haven’t renewed your membership, you’re about to lose your daily Buzz!

That’s the word from on high: After a bit of a grace period, non-members will be removed from the mailing list and their phone numbers given to the people looking to talk to you about your car’s extended warranty^*.

So if you haven’t renewed your GPhA membership yet (it expired August 31), do it today. Click below, go to GPhA.org/renew, or reach out to Mary Ritchie at mritchie@gpha.org or (404) 419-8115.

* We’re kidding ^†.
^† Or are we?

Two kinds of obesity

There isn’t just obesity. There are (say scientists at Michigan-based Van Andel Institute) two distinct kinds. And one of them has a surprising twist.

In short, the first type of obesity is simple: It’s “characterized by greater fat mass.” But the second is “characterized by both greater fat mass and lean muscle mass.” Both show up in humans of all ages.

The second type, the found, is associated with inflammation and higher insulin levels and all the health issues those can cause. But that’s not the weird part.

The weird part: People who have that second type? It’s purely by chance — or, rather, “epigenetically triggerable.” Nurture, not nature. In fact, one identical twin might get it and the other might not, “with no gradient between them.” (That’s not speculation; they actually examined identical twins.)

Takeaways: First, BMI is bogus, “because it doesn’t account for underlying biological differences.” Second, treating obesity and its effects is more complex. We need “more precise ways to diagnose and treat obesity and associated metabolic disorders.”

The second type?

The Bavarians respond

Yesterday we told you about a Dutch study that found the current smallpox vaccine does bupkis for monkeypox.

Now Bavarian Nordic, maker of the vaccine, is saying nein nein nein! In fact, its study found the vaccine works just great — it “induced durable neutralizing antibody responses in healthy volunteers”. Obviously world governments should buy it — and buy it by the bucket.

BN also says that, contrary to the Dutch study, the vaccine also boosted the antibody response of people who had received the older generation of smallpox vaccines “in the distant past^*”.

Who to believe?

* Today I learned that I was born in “the distant past.”

Perspective (and math)

US monkeypox deaths jumped 50% Tuesday with the passing of a patient in California, bringing the nationwide death toll to three.

Irisin news

Adding it: Preventing Parkinson’s?

Endurance exercise can alleviate some Parkinson’s symptoms — that’s been known for a while. But why? The answer could be irisin, according to Johns Hopkins researchers; it’s released into the blood during endurance exercise.

The Hopkins folks found that, when treated with irisin, mice engineered to have Parkinson’s-like symptoms “had no muscle movement deficits.” The thinking is that the irisin breaks up the proteins that can clump in the brain, killing the cells that produce dopamine; that cell death triggers Parkinson’s. Break up the clumps, save the cells.

“If irisin’s utility pans out, we could envision it being developed into a gene or recombinant protein therapy.”

Removing it: Helping cancer patients?

People with advanced cancer often suffer from severe muscle loss and weakness — cachexia. It happens because the body starts converting white fat (which stores energy) into brown fat (which burns it).

For someone looking to lose weight, that’s good. For cancer patients, not so much.

But it could have an Achilles heel: irisin.

Indiana University researchers found that the fat-conversion process needs the hormone irisin, and irisin needs a protein called FNDC5, which is coded by, conveniently, a single gene.

They blocked that FNDC5 gene (in mice), the protein wasn’t produced, irisin wasn’t produced, and cachexia never set in. Well well well.

But one big problem: It only worked in male mice. So … an interesting breakthrough, but plenty more research is obviously needed.

The long-term blood sugar risk

People with diabetes are, as you know, at risk of developing eye and kidney complications.

But now Swedish researchers have found a simple way to determine who’s most at risk.

Simply put, if they can keep their blood sugar below 53 mmol/mol (7%), they have little risk of those complications. But the longer they stay above that level, the higher the risk — and notably, that ‘safe’ number drops over time, so even 53 is too high to keep for, say, 40 years.

Captain Obvious knows 1+7 = 17^*

“Concussions at school may affect academic performance.”

* And how Eisenhower and the Rough Riders crossed the Delaware in the Spanish-American War

Smallpox vaccine doesn’t prevent monkeypox: study

If you got a smallpox vaccine back in the day — as most people born before 1974 did — will that protect you against monkeypox?

Here’s the gist of a study out of the Netherlands:

• If you had that vaccinia virus vaccine in the ’60s or ’70s, you almost certainly have antibodies against monkeypox. Yay.
• If you got monkeypox even with that older smallpox vaccination, you got an antibody boost (as you might expect). Yay, again.
• But if you got the new smallpox vaccine (known as the modified vaccinia Ankara or MVA vaccine, such as MVA-BN from Bavarian Nordic) … bad news. It doesn’t work.
• If you had ye olde smallpox vaccine and the newer MVA-BN shot … that MVA-BN shot doesn’t even act as much of a booster.

[T]he findings of the study question the efficacy of the MVA-BN vaccine in protecting against monkeypox.

But …

The researchers believe that a third dose of the MVA-BN vaccine will improve immunity.

Covid’s worse if you have gout

People with gout — especially women — are at higher risk of not only catching Covid-19, but of having a severe case. And that’s true even if they’ve been vaccinated. So found a joint Chinese-Harvard study that analyzed health records of about 3 million individuals in the UK.

Help fight the threat to compounding

Whether you do simple compounding or are part of a full-fledged facility, that entire side of the pharmacy profession is under threat.

From the possibility that the FDA might curtail (or even ban) compounded hormone therapy, to potential restrictions on veterinary compounding (and more), Congress needs to know the dangers facing patients.

This Thursday, September 15, take a minute to contact your member of Congress, and to spread the word on social media: Compounding pharmacies are important for Americans’ health!

Get talking points, graphics, and more from our friends at the Alliance for Pharmacy Compounding.

Surprise drug treats autism’s social side

Back in 2020, we told you how an anti- diarrheal drug, loperamide, might fight cancer. Apparently it’s got more tricks up its sleeve. Loperamide, it seems, might help autistic people improve their social-interaction skills.

Norwegian researchers, with help from some of those shifty Danes, used computer modeling to guess which existing drugs might be repurposed; they looked at protein structures and other stuff that only computers are really good at.

When it reached loperamide, the computer (based on the movies I’ve seen) flashed a green light and the words “MATCH FOUND” while dramatic music played.

The scientists found that loperamide binds to and activates a protein called the μ-opioid receptor. And the μ-opioid receptor, it seems, affects social behavior.

In previous studies, genetically engineered mice that lack the μ-opioid receptor demonstrated social deficits similar to those seen in ASD. Interestingly, drugs that activate the μ-opioid receptor helped to restore social behaviors.

This doesn’t make loperamide a treatment for autism spectrum disorder … yet. But it does open “a new way to treat the social symptoms present in ASD.”

FTC chair to speak at NCPA convention

Thinking about attending the NCPA convention in KCMO this October 1–4? Here’s another cool reason: FTC Chair Lina Khan will be speaking at the October 3 general session.

It’s the FTC, you might remember, that could put a halt to pharmacy-biz mega-mergers — aka “consolidation and vertical integration of health insurance plans and pharmacy benefit managers,” and Khan has already been more than receptive to independent pharmacists’ concerns.

Besides a fireside chat with NCPA CEO Doug Hoey (sans fire for safety reasons), Khan will take questions from the audience. So if you’ve got questions, you’ll want to be in that audience. Click here for more convention info.

ICYMI

Using a mechanism scientists only recently discovered, it seems that “small pollutant particles in the air may trigger lung cancer in people who have never smoked.”

The bad news, obviously, is that air pollution can cause lung cancer.

But the good news is that discovering this mechanism is “paving the way to new prevention approaches and development of therapies.”

Help your senior patients find help

If you have older patients who you know are having trouble paying bills, there’s a decent chance they aren’t taking advantage of all the benefits available.

From SNAP assistance to Medicare savings programs and subsidies (and even legal assistance), there’s a lot out there. One starting point is a local Area Agency on Aging — they can find the one near them with the Eldercare Locator.

The other place to start is the National Council on Aging’s BenefitsCheckUp, which helps older adults find and apply for benefits. It’s at benefitscheckup.org or (800) 794-6559.

Captain Obvious will call Santa if you don’t behave

“Studies show children don’t believe everything they are told”

The Long Read: Boost or Not? edition

Hurry, hurry, hurry — get your Omicron booster before the fall Covid surge!

Or … maybe not? “Did the US Jump the Gun With the New Omicron-Targeted Vaccines?”

[A]s society moves into the next phase of the pandemic, the pharmaceutical industry may be moving into more familiar territory: developing products that may be a smidgen better than what came before, selling — sometimes overselling — their increased effectiveness in the absence of adequate controlled studies or published data.

TikTok users rejoice

The FDA has approved Revance’s Daxxify — an alternative to botox that hides frown lines twice (and sometimes three times) as long. This means social media users will have a whole new drug to self-inject and offer untrained medical advice about!

Bonus quote, attributable to either Revance’s CEO or Vladimir Putin: “The most unmet need with toxins is duration.”

Technically true, but …

The headlines: Getting a flu shot reduces your risk of a stroke! (Example)

The reality, if you read the study: Getting the flu increases your risk of stroke, ergo, getting the shot reduces your risk of the flu, which therefore reduces your risk of a stroke.

“This observational study suggests that those who have a flu shot have a lower risk of stroke. To determine whether this is due to a protective effect of the vaccine itself or to other factors, more research is needed.”

Get your flu shot, especially if you’re a man. A ‘man cold’ is bad enough; ‘man flu’ is worse.

The math is easy

If you’re reading this, you (hopefully) appreciate GPhA Buzz for pharma/medical news (and maybe a morning smile).

Imagine Buzz is worth, say, 25¢ a day. That’s about $125 a year.

Toss in a couple of CE discounts or member pricing at the convention, and your GPhA membership just paid for itself. And that’s not counting the laws GPhA helps pass (or the bad ones we stop).

It’s basic math. If you haven’t renewed your GPhA membership yet, now’s the time.

Keep getting Buzz. Keep getting discounts. Keep making connections.

Skin color and temperature

Black people who use those forehead (i.e., temporal artery) thermometers might not be getting accurate readings. Skin color makes a difference.

Emory researchers found that a forehead thermometer was 26% less likely to detect a fever in Black patients than an oral thermometer would. For white patients? Equal odds. The differences in absolute temperature weren’t huge, but when for ‘fever cut-offs’ for triage, it’s a bigger deal.

Their guess is that it’s due to skin emissivity — how human skin radiates heat, which is affected by pigmentation*. But more-detailed research is needed, including whether and how Asian and Hispanic patients are affected.

* If you started thinking about black-body radiation from high school physics, you’re not alone, but this isn’t that. If that were the case, darker skin would read at a higher temperature.

The omicron variant is so bad…

How bad is it? It’s so bad that being unvaccinated means your risk of hospitalization is 10.5 times higher than someone who’s had their shots. (And if you haven’t had a booster? You’re 2.5 times more likely to end up there.)

It wasn’t hard to figure that number — it’s based on data from 192,000 hospitalizations from January 2021 through April 2022.

End the accumulators!

Three patient advocate groups have sued HHS and CMS, asking them to stop allowing copay accumulators.

If you know what those are, you can skip to the next story. If not…

Copay accumulators allow insurers and PBMs to not deduct copay assistance from patients’ deductibles. If someone uses a $100 Pfizer coupon to help pay for a drug, that isn’t counted toward their deductibles. Ergo, they still (sorta) end up paying it.

The insurer receives a windfall by being able to collect payments from the manufacturer and then still collect the full deductible and copayment amounts from the patient.

A 2019 rule broadened the use of copay accumulators, but similar rules from the Trump administration have already been struck down as violating the ACA (which limits how much compensation an insurer can receive). Now these groups want this one gone, too.

Sniffing the honey

How do you treat a Mycobacterium abscessus infection, which affects cystic fibrosis and bronchiectasis patients? How about inhaled honey?

Not any ol’ honey, of course. Researchers at Britain’s Aston University (mascot: Cyril the Squirrel) found that nebulized manuka honey — which was already known to have antimicrobial effects — can be combined with the drug amikacin to make the drug work at lower doses (an 87.5% reduction!), thus reducing side effects.

Preliminary experiments

No protein, no baby

For half of couples having trouble conceiving, there’s no explanation for the infertility. But now British and Czech biologists have found what might be an important clue.

A new protein they discovered — they named it Maia, after the Greek god of motherhood — is important for allowing a sperm to fuse to an egg. If there isn’t enough of Maia, most sperm will have a hard time doing what they were meant to do.

That doesn’t mean low levels of Maia are the cause of all the unexplained infertility, but does open a path for study.

[It] will not only allow scientists to better understand the mechanisms of human fertility, but will pave the way for novel ways to treat infertility and revolutionise the design of future contraceptives.”

Identical, potentially big, Covid breakthroughs

Researchers have produced antibodies that neutralize all known types of Covid-19. What’s crazy is that it was done twice — by two separate research teams, using different methods, published in different respected peer-reviewed journals, days apart.

Where: Boston Children’s Hospital. Molecular biologists there used genetically engineered mice to produce “a wide repertoire of humanized antibodies” including one lineage (called SP1-77) that “demonstrated extremely wide activity, neutralizing Alpha, Beta, Gamma, Delta, and all prior and current Omicron strains.”

How: By binding to the SARS-CoV-2 spike protein in a different manner than other antibodies, and in a way that “prevents the virus from fusing its outer membrane with the membrane of the target cell.”

Where: Israel’s Tel Aviv University. Microbiologists there isolated antibodies from the immune system of recovered Covid-19 patients. Called TAU-1109 and TAU-2310, together they’re almost 100% effective “in neutralizing all known strains of the virus.”

How: By binding to the spike protein in a different region than other antibodies — one “that for some reason does not undergo many mutations.”

Help patients choose and use point-of-care testing

Have you seen how many point-of-care tests there are these days? When a customer asks, “Can you help me?” be ready to say, “You bet!”

Earn 20 hours of CPE with the NASPA Pharmacy-based Point-of-Care Testing Certificate Program program for pharmacists and pharmacy technicians.

It’s 16 hours of home study and 4 hours of live training, and it covers tests for flu, strep, HIV, hep C, and coronaviruses (but the knowledge applies to lots more).

The live training is at GPhA’s World Headquarters in Sandy Springs on Sunday, October 2.

Get more info and sign up today at GPhA.org/pointofcare. And look, there’s even a cool ad with a guy doing, you know, science stuff:

Mask, goggles, gloves, and cool ’80s hairstyle not included

Try to look on the bright side of Covid

“Psychological distress before COVID-19 infection increases risk of long Covid”. That’s what Harvard researchers found in a study of more than 54,000 people in April 2020, more than 3,000 of whom contracted the disease.

[T]he researchers determined that distress before Covid-19 infection, including depression, anxiety, worry, perceived stress, and loneliness, was associated with a 32%–46% increased risk of long Covid.

Are your devices stylish enough?

If you sell compression gloves or knee braces, here’s something to be aware of: Customers care more than you might think about how they look, feel, and even smell.

That’s what North Carolina State University researchers found by analyzing more than 2,000 reviews of assistive devices over three years.

“Aesthetics of assistive devices are often not taken into account despite the fact that research shows one reason for abandonment is that users feel embarrassed or stigmatized by their devices.”

Color is pretty important because, just as with Band-Aids, the old ‘pale peach’ doesn’t work for a lot of folks. If they can’t hide it, they at least want it to look stylish. As for feel and smell: Rough and scratchy is out, as is sealing the product before the plastic has time to “off-gas.”

Give a penny, earn a buck

The idea of the anti-kickback statute is that pharmaceutical manufacturers can’t pay patients’ out-of-pocket expenses for the drugs they sell. (That would be an unfair incentive, especially when Medicare pays most of the ticket price.)

The big loophole: They can give to charities that pay those costs. Even better (for them, not us) is that those donations aren’t reported.

Still, researchers from Harvard, Northwestern, and USC crunched the numbers to see if it was actually worth drug makers’ while to give to charities. Oh yes, yes it was.

We found that donations by the leading manufacturer of drugs for each condition were often likely to be profitable, even if relatively few patients were induced to use the manufacturer’s drugs as a result.

Perhaps the most egregious example is Takeda’s $300,000-per-year Gattex, which treats short bowel syndrome:

In 2010, a charity for short bowel syndrome did not exist, but the authors note that within ten days of Gattex’s approval by the FDA in December 2012, a fund for short bowel syndrome appeared.

Beauty care trend of the month

If you’re still selling the same ol’ skin creams, you need to keep up. The hot new beauty trend out of Korea is — wait for it — beauty products containing salmon testicle DNA (listed on the package as “salmon pdrn*”).

The claim, from a study of some sort, is that “salmon sperm was associated with increased skin elasticity and stronger collagen levels—both of which are crucial for anti-aging skin.”

[S]almon testicle DNA has been found in many luxury K-beauty products, including the KAHI Wrinkle Free Multi Balm. […] As the name implies, you glide the balm across your face for a dewy, luminous look.

* Short for polydeoxyribonucleotides

BPH to talk Covid, monkeypox

Georgia’s Board of Public Health will be meeting this coming Tuesday, September 13 from 1:00– 3:00 pm. As usual, it’s open to the public in person or via Zoom. The topics:

• Epidemiology updates on Covid-19 and Monkeypox
• Monkeypox vaccination updates
• The DPH strategic plan

The Long(ish) Read: Rewards for Recovery edition

If you play computer games, you know that even small rewards (+1 gloves!) give that dopamine rush and keep you playing. The same is true with addiction recovery.

Even addicts who want to recover can have a lot of trouble — that’s why “one day at a time” is a thing. And…

More than 150 studies over 30 years have shown rewards work better than counseling alone for addictions including cocaine, alcohol, tobacco and, when used alongside medications, opioids.

One reason it works: Many of the people who are prone to addiction’s small, immediate rewards are also helped when those rewards — cash, gifts, even candy — are for *recovery.

All in their heads?

Microdoses of psilocybin are getting press for helping patients with depression an anxiety. But how much of that effect is real? Not all, it seems — there’s the placebo effect at work.

Argentinian neuroscientists found (in a small double-blind study) that psilocybin didn’t affect creativity, cognition, or self-reported mental well-being and in fact “may have hindered performance on certain cognitive tasks.”

There was one slight difference: The subjects who figured out they had taken the actual drug reported more acute effects (e.g., “My sense of space and size was distorted”).

• • •

Get ready for Medicare 2023

Are your patients ready for Medicare Part D enrollment? It begins October 15 for the 2023 plan year. If they aren’t, you should be, an NCPA has a couple of useful resources for ya:

• 2023 Medicare Part D Pharmacist Quick Reference Guide (2-page PDF)
• Printable bag-stuffer for patients (1-page PDF)

He who hesitates doesn’t have a pharmacist on staff

Prescribers seem hesitant to prescribe biosimilars for drugs like Remicade, even though those alternatives have been around for years. Some prescribers, but not all. What makes the difference? Having a pharmacist in the practice.

Looking at the records of almost 1,000 patients, researchers at Rhode Island Hospital found that “provider[s] with a pharmacist affiliation were 39% more likely to use a biosimilar than those who weren’t.”

[P]harmacists “have a baseline understanding” of biosimilars that enables them to address and in many cases overcome prescriber hesitancy. “Having pharmacists [with] this influence in these clinic spaces is really significant.”

Parkinson’s test nears

Until now, there’s only been one test for Parkinson’s: the nose of a 72-year-old woman from Perth, Scotland*. A rare condition allows her to smell it on people, starting with her husband.

But now researchers at the University of Manchester, England, England have made a test based on her ability that can identify the disease much earlier using a simple cotton swap along the back of the neck. (Currently, by the time someone is diagnosed they have significant neurological damage.)

“What we are now doing is seeing if (hospital laboratories) can do what we’ve done in a research lab in a hospital lab. Once that’s happened then we want to see if we can make this a confirmatory diagnostic that could be used along with the referral process from a GP to a consultant.”

* If you’re in the mood for Italian, try Broth3rs Restaurant on George St.

Help your patients not kill their dogs

If you fill a prescription for fluorouracil cream, warn your patients: If they have dogs, don’t leave the tubes anywhere Fido or Rover can get to them (e.g., a nightstand). The FDA has been receiving reports of dogs dying after licking or chewing the tubes.

Signs of fluorouracil poisoning in pets can start within 30 minutes, and include vomiting, shaking, seizures, difficulty breathing, and diarrhea. Death can happen in as little as 6 to 12 hours after a pet is exposed.

Seeing past the masks

Wearing a mask, it seems, doesn’t affect everyday social exchanges. That’s the conclusion of a newly published University of Kansas study; it found mask wearing “had no effect on the ease, authenticity, friendliness of the conversation, mood, discomfort or interestingness” of interactions between 250 student volunteers.

Notably, the work was done in 2012, before basic health precautions became a political issue. “Masks are suffused with meaning [today] — political, social, health — in a way they weren’t then,” said the lead researcher. “People have the skills to look past things that block the face — a mask, a hat, sunglasses and so on. We’re still able to get through to people.”

Soon to be appealed

A federal judge in Texas has ruled that the part of the Affordable Care Act that requires insurers to cover preventative services and drugs for free is unconstitutional.

Business owners shouldn’t be forced to buy insurance that pays for some preventative medications and procedures they don’t like, he ruled, even if they themselves will never use them.

Plaintiffs had said it violates their religious freedom if they have to provide employees with coverage that includes zero-co-pay “PrEP drugs, contraception, the HPV vaccine, and the screenings and behavioral counseling for [sexually transmitted diseases] and drug use.”

The Long Read: Flu’s a-Comin’ edition

The Atlantic — World’s Most Depressing Magazine™ — is warning that this year’s flu season is going to be really really bad. (Maybe — the words “could” and “may” appear 18 times in the piece.)

After skipping two seasons in the Southern Hemisphere, flu spent 2022 hopping across the planet’s lower half with more fervor than it’s had since the Covid crisis began. And of the three years of the pandemic that have played out so far, this one is previewing the strongest signs yet of a rough flu season ahead.

To be fair, it’s been bad in Australia, but … well, pre-pandemic normal in South Africa. The question is how bad will the virus be, and how willing people up north will be to take precautions.

Not good enough

The latest FDA Report on The State of Pharmaceutical Quality (PDF) has an eyebrow-raising number: More than a third of samples checked for quality — 35% — weren’t compliant. And that’s a big jump.

In FY2020, only 16% of the samples tested were non-compliant. Throughout FY2021, that number increased by approximately 2.19 times to 35%.

The good(ish) news is that there’s a reason — the pandemic rush to produce meds and hand sanitizer. “Covid-19 drugs composed 25% of the non-compliant samples. Additionally, hand sanitizers amounted to 19%, while opioids accounted for 0%.”

Step up and be a leader

There are still a couple of slots open for the 2022 class of LeadershipGPhA. This is the training ground for the men and women who’ll be helping set the direction of pharmacy in Georgia.

Don’t just read about changes to your practice, your employer, or your patients. Be part of the team at the steering wheel.

Get info about the program and apply at GPhA.org/leadershipgpha. Or just hope for the best.

This year’s kids’ flu shots

The American Academy of Pediatrics has released its recommendations for flu shots for the kids. Essentially, it’s 620 words about how the flu is bad, shots are good, but sadly not everyone gets them. Then it gets to the important stuff, like new strains.

What’s probably of most interest to you is the table of which ages should get which vaccine — Afluria, Fluarix, FluLaval, Fluzone, etc. — and how much of it.

The vaccine formulations available for children are unchanged from last season, except the age indication for the cell culture-based inactivated influenza vaccine (IIV) Flucelvax Quadrivalent has been lowered to 6 months and older (previously indicated for 2 years and older), providing one more option for young children.

The boosters are coming! (To arms! To arms!)

The Omicron-specific Covid boosters are arriving en masse this week, according to US health officials.

By the end of this week, 90% of Americans will live within five miles (8 km) of sites carrying updated vaccines, U.S. health secretary Xavier Becerra said.

The boosters will of course be free, and getting one with a flu shot is a good idea.

As for the future, the official rhetoric is now ‘We’ll probably just need boosters from now on’ … at least “in the absence of a dramatically different variant.”

Bots are breaking into pharmacies

A cybersecurity company has found that thousands of bots — computer programs that act like humans — have been using stolen credentials to log into accounts of major online pharmacies to steal prescription meds from real patients.

People often use the same password on multiple websites, so when it’s stolen from one, bots will try that same username/password combo on other sites. Like pharmacies’.

When they find a match, they can sell that access for big bucks to illicit drug dealers: “Wanna buy an XYZ Pharmacy account that has oxycodone?”

A criminal would log in to an account, initiate a fill, select the pharmacy at which they want to pick it up, then have someone collect it for them that’s not the intended customer.

So, which “major pharmacies” are being targeted? The company won’t say, “but among them were the top 10 pharmacies in the world.”

Juul takes another big hit

E-cig maker Juul continues to pay the price for marketing an addictive drug to kids. After an earlier payout to Arizona, Louisiana, North Carolina, and Washington, it’s now reached an “agreement in principle” to pay $440 million to 33 more states — yes, including Georgia — as a settlement for marketing high-nicotine vapes to kids.

It ain’t over, though. Juul is still facing lawsuits from nine other states, plus hundreds of personal suits by teenagers and others who say they became addicted to the company’s products.

A new pathway for pain treatment

Treating chronic pain is usually about trying to make life a little better; as one Austrian researcher put it, “often ineffective palliative treatments.” Opioids can help, but (as you might have heard) there are some issues with those.

Molecular biologists at the Austrian Academy of Sciences have made a bit of a breakthrough. They found that sensory neurons produce a metabolite called BH4, which is a driver of at least some kinds of chronic pain.

“The concentrations of BH4 correlated very well with the pain intensity. So, we naturally thought that this was a great pathway to target.”

But why make a new drug when there are a zillion existing ones? They screened 1,000 of them, and bingo! It turns out that fluphenazine — the antipsychotic — blocks the BH4 pathway and stops the pain. And not only that, it requires a very low dose … at least in mice.

Weird bonus: That BH4 pathway is also connected to lung cancers, meaning they’ve opened up a research opportunity there, too.

With drug news, choose your source

Yet another reason not to get your news from social media. As Forbes reports, according to mixed martial artist fighter Jake Shields, “the National institute [sic] of health added Ivermectin to the list of covid treatment [sic].”

No, no it didn’t. And yet, that was retweeted more than 15,000 times (although to be fair, many of those were probably laughing at him).

In unrelated news

Australian neuroscientists reported in a new study that “Repeated Concussions Can Thicken the Skull”.

Farm in a pill

Kids brought up on farms tend to have many fewer allergies later in life. Although this was once thought to be a result of exposure to all sorts of pathogens (the “hygiene hypothesis”), it’s now thought to be from exposure to certain good germs.

But, as much fun as it might be to grow up with Orville, Luzerne, Eliger, and kin on the farm (and Fluffy, who went to live there when she got sick), there are downsides, especially downwind when the manure is being spread.

So why not have the best of both worlds? Give kids the benefits of a farm, but in a pill, Jetsons-style.

An international consortium of researchers is now working on potential treatments from farm dust and unprocessed [but not raw] milk that may combat the reported increasing prevalence of food allergies, with a target to deliver a product within the next five years.

Farmers from the 1880s (plus Fluffy, bottom right), in front of what is now GPhA Buzz World Headquarters

Fighting Covid: All in, or live with it?

Some countries went for ultra-strict “zero-Covid” policies. Others were a bit more relaxed. How much a difference did it make? Chinese scientists wanted to find out.

They had an easy way to do that. Four countries — Australia, New Zealand, Singapore, and South Korea — switched policies from “zero Covid” to “living with Covid” at some point during the pandemic. (And, conveniently, have a mix of population densities.)

Using pre-pandemic statistics as a baseline, the researchers compared how those two policies impacted death rates. The result: “Zero-Covid” policies resulted in virtually no excess deaths. But when they switched to “living with Covid” — LWC — mortality jumped.

After shifting to the LWC policy, PEM [percent excess mortality] usually exceeded 10%, and countries with high population density experienced a peak PEM of 20-70%.

So depending on the population size, living with Covid meant a lot more people aren’t living with it.

(Where this applied least: New Zealand, where the excess mortality after switching policies never exceeded 10% — something the authors suggest “might be a result of the ultrahigh [95%] vaccination rate” there.)

It was Legionella all along

The “mystery respiratory illness” in Argentina turns out to be Legionnaire’s Disease. That is all.

Cut croup risk in the womb

Attention, mom-to-be: It seems that taking fish oil or vitamin D supplements while you’re expecting can lower your kid’s risk of croup*.

That’s what those shifty Danes found in a three+ year randomized trial of 736 women (and their babies). Their findings: Children whose mothers took either high-dose vitamin D supplements (2,800 IU) or 2.4 grams of fish oil per day had only an 11% chance of getting croup.

Taking olive oil or lower-dose vitamin D (i.e., 400 IU/day) gave kids a 17-18% chance of croup

Bottom line: Taking the right supplement could mean about a 40% reduction in risk of croup.

“We are not sure of the exact mechanisms behind the beneficial effects of vitamin D and fish oil, but it could be that they can stimulate the immune system to help babies and young children clear infections more effectively.”

* If you’re over 60, you might call it “the croup.”

A new low is a new high

Only 8 percent of Americans are now without health insurance — that’s a new low, according to data from HHS. After rising from 2016 through 2020, the uninsured rate has dropped due to a combination of subsidies from the pandemic’s American Rescue Plan (that are now permanent), more states expanding Medicaid (to a total of 38), and greater outreach efforts.

Georgia has the country’s fourth highest uninsured rate (15.3%); only Texas, Oklahoma, and Florida are worse.

Bats aren’t out to kill us after all

Sure, we’re quick to blame bats for a lot — belfry damage, Romanian tyrants, overcrowding at Arkham Asylum — but when it comes to getting us sick, the idea that bats are reservoirs of viral pathogens seems to be wrong.

The question (asked by Israeli zoologists): “Are bats really pathogen reservoirs or do they possess an efficient immune system?”

The answer: B. Media reports of bats threatening public health are overblown when, you know, you look at the facts. And the fact is, bats have a pretty powerful immune system, “able to confront viruses, recover, and remain immune by developing a potent titer of antibodies, often without becoming a reservoir.”

For example, they say…

Report: The coronavirus isolated from bats in Wuhan (China) was 96% genetically identical to the virus that started the pandemic!!!

Reality: When you look at mutation rate, the “temporal distance” between what the bats have and what humans got was several years at a minimum.

Although we do not claim that bats are never the origin of human pathogens, we suggest that their role has been consistently exaggerated and often without the necessary scientific basis.

Start your app and cough

The latest in the category “Surprising Ways to Detect Covid”: A phone app that can detect Covid-19 infection based on your voice.

Dutch data scientists used about 900 audio samples collected from 4,350 people to train an AI system to recognize signs of Covid. When tested…

… the AI model was accurate 89% of the time, whereas the accuracy of lateral flow tests varied widely depending on the brand. Also, lateral flow tests were considerably less accurate at detecting COVID infection in people who showed no symptoms.

Since that first study, they’ve expanded their database to more than 53,000 audio samples they plan to “improve and validate the accuracy of the model.”

Fun for the family: You can help make the app better by uploading short recordings of cough and breathing with an app from the University of Cambridge — “Healthy and non-healthy participants welcome.”

Boosters: What you need to know

The CDC followed the FDA in approving Omicron-specific booster vaccines, meaning they’ll be delivered shortly.

As with everything else pandemic-related, there’s some confusion.

A big thank you to reader Brent Lake at Augusta University, who provided a link to a comprehensive and (yay!) easy-to-understand guide, straight from the CDC’s Advisory Committee on Immunization Practices.

The biggest takeaways:

• The original mRNA vaccines are no longer authorized as boosters.
• People must have had two shots of the original vaccines before getting a booster.
• You can mix and match — it’s okay to get either a Pfizer or Moderna booster no matter which shots you got originally.
• The Pfizer/BioNTech booster is approved for 12 and older; Moderna’s for 18 and up.
• If someone got a third or fourth “original” shot as a booster, they can also get one of the new boosters; i.e., “a bivalent should not be denied based on total number of doses.”
• There are different recommendations for immunocompromised people, and for people who had a severe adverse reaction to the original shot. Read the CDC’s presentation.
• It’s AOK to give a Covid vaccine or booster with other vaccinations, e.g., a flu shot.

Captain Obvious would like to weigh in, if she may

“Three Covid-19 vaccines may provide greater protection from Covid-19 infections than two”
—Public Library of Science

Paxlovid questions

Does taking Paxlovid cause a ‘rebound’ infection before curing Covid? Um … maybe? It still works, though, so there’s that.

Covid rebound has also been observed in people who have not taken Paxlovid, and some experts believe it might be a natural course of the infection to see symptoms ebb, then return.

Perspective: Winners or losers?

People are using marijuana instead of painkillers, antidepressants, sleep aids, antacids, and other drugs. Thus the paper’s title: “U.S. cannabis laws projected to cost generic and brand pharmaceutical firms billions.”

Or, put another way: “U.S. cannabis laws projected to save consumers billions.”

A step toward a Down syndrome treatment

A small human trial has found that increasing the production of a protein called gonadotropin-releasing hormone (GnRH) improves some brain function in people with Down syndrome.

Low levels of GnRH — you may recognize it as being used in fertility treatments — can cause infertility and loss of the sense of smell. French neuroendocrinologists, knowing both of those affected people with Down syndrome, experimented on mice. They and found that restoring GnRH production “reverse[d] the rodents’ smell and memory deficits.”

So, too, did giving them Lutrelef (a drug that can replace GnRH). They then tried it on seven men, and found that Lutrelef had a similar effect.

After 6 months, the men showed a 10% to 30% improvement on the Montreal Cognitive Assessment, a standard measure of intellectual disability. The test challenges spatial and verbal memory with tasks such as drawing a 3D cube or remembering a short string of words.

This isn’t a treatment or cure, of course, but a potential step toward improving the everyday life of people with Down syndrome.

Another red herring?

…or are the writers teasing a future season?

“Third person dies of mystery pneumonia in Argentina.”

Health officials have expressed their mounting concerns after tests for 30 infections including Covid, flu and influenza types A and B came back negative.

(Remember, Covid-19 was once a “mysterious respiratory illness.”)

Weird science for your long weekend

Salamander: “I can regenerate my limbs!”

Axolotl: “Is that all?”

Boosters: Keep this in mind

Yes, we’re all tired of reading about Covid-vaccine boosters, so I’ll keep this info quick (and you may already know it): Remind your patients that the forthcoming boosters are for people who have already had the original vaccine shots — they are low-dose boosters, and won’t do much on their own.

• • •

This October, get your CE from slices of pharma history!

GPhA breaks out the creepy font with Pharmacy Tales from the Crypt: Four CE courses that connect history with today’s pharmaceutical world.

From the story of the first use of anesthesia — it was a UGA grad! — to Agatha Christie’s love of poison and more, at just $16 each for GPhA members ($19 for non-members) it’s a great dose of creepy continuing ed.

We couldn’t get permission to use Savannah’s Colonial Park Cemetery, so these are all taught via Zoom. Light your candles, find your cloak, and sign up today at GPhA.org/crypt.

Some pigs

If someone is diagnosed with the flu this year, the CDC would like healthcare providers to ask one simple question: “Were you at a state or county fair recently?”

Why? Pigs. Exposure to pigs might mean they’ve got themselves infected with a different flu variant, and — for obvious reasons — CDC would like to keep tabs on that.

Five cases of human infection with influenza viruses that usually spread only in pigs, also known as variant influenza virus infections, were reported to CDC in August 2022.

PS: If this made you call out, “Hey, when’s the state fair this year, honeybuns?”, the Georgia State Fair runs September 30 to October 9 in Atlanta.

Engineering a drug factory

The anti-cancer drug vinblastine has had supply problems — it comes from a lovely flower called the Madagascar periwinkle (aka rose periwinkle). Making the med requires a lot of flowers — “500 and 2,000 kilograms of dried Madagascar periwinkle leaves to produce one gram of vinblastine and vincristine, respectively.”

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Vinblastine is a “monoterpenoid indole alkaloid” (MIA) — great stuff, but impossible to create synthetically. Until some shifty Danes arrived on the biomedical scene: They engineered a yeast that can make the same precursor molecules as the plant, and do it faster, cheaper, and in an environmentally friendly way.

Even better, now that they have the basic system working, they can expand it.

“In addition to vinblastine, this platform will enable production of anti-addiction and anti-malarial therapies as well as treatments for many other diseases.”

Vaccine pill moving along

A small biotech company in California, Vaxart, says its Covid-19 vaccine pill did well in a small stage-2 (‘Does it work in humans?‘) trial. It’s the first oral vaccine to get this far, and the even-better news is that it works against at least some Omicron variants. Or strains. Or whatever you call the BA-this/that.

Larger studies are planned before it moves to phase 3 (“Is it safe?”) trials, perhaps in 2023.

Refreshing an old lung cancer drug

Some of you might remember cyclophosphamide — an drug for small cell lung cancer that disappeared in the 1980s. Its big issue was that cancer developed immunity pretty quickly.

But this is 2022, and Washington University researchers have discovered how cancer was able to block cyclophosphamide. And then they found a way to keep the cancer from doing that.

The way-too-short version: Small cell lung cancer has high levels of a protein called SMYD3, which helps them repair damage. Inhibiting the SMYD3 slows the tumor growth. But inhibiting it and treating it with cyclophosphamide “stopped the tumors in their tracks.”

This is only in mice so far, but as cyclophosphamide is already approved (if old), they’re already looking to start human trials of the inhibitor/cyclophosphamide combo.

“People with small cell lung cancer are in desperate need of better treatments, and I’m very excited about the possibilities here.”

The scary way fentanyl kills

Why is fentanyl so deadly? Because — and yes, this is as creepy as it sounds — “the drug stops people’s breathing before other noticeable changes” before they lose consciousness.

Investigators at Mass General found that …

… fentanyl begins to impair breathing about four minutes before there is any change in alertness and at 1,700-times lower drug concentrations than those that cause sedation. “This explains why fentanyl is so deadly: it stops people’s breathing before they even realize it.”

Stroke and your blood type

While people with type A blood are commonly considered witty, engaging, and smart, there is a downside: Having type A blood means you have a higher risk of stroke before age 60.

Doing a meta-analysis of 17,000 stroke patients, University of Maryland neurologists …

… found those who had blood type A had a 16 percent higher risk of having an early stroke than people with other blood types. Those who had blood type O had a 12 percent lower risk.

Why is this the case? They don’t know. “[I]t likely has something to do with blood-clotting factors like platelets and cells that line the blood vessels as well as other circulating proteins.”

And people with B or AB? They’re in the middle — just average.

Another anti-seizure drug (seems to) cause autism

Cutting to the chase: “[P]renatal exposure to topiramate roughly triples a child’s likelihood of having autism or intellectual disability.”

That’s what that UK’s equivalent to the FDA is investigating now, after a Norwegian/Australian/Icelandic/Finnish study found the connection. If true, it means topiramate joins another anti-seizure drug, valproate, that was already found to contribute to autism.

Then there’s this comment from a epidemiologist in Pennsylvania concerned about sharing this news:

“Hearing notice about this safety review may cause women to discontinue medication, and epilepsy itself is known to present risks to both the mother and fetus.”

Why yes, yes it might stop them from taking topiramate. But considering it’s based on a large, legit, peer-reviewed study published in JAMA, (not Cousin Tiffany’s Facebook post), doesn’t that make sense?