Pharmacists are #25

On the latest list of “50 Highest Paying Medical Jobs in the U.S.” that is, just below prosthodontists and just above optometrists. (Topping the list are cardiologists and anesthesiologists, if you’re thinking of a second career.)

PBM to provide $35 insulin

Optum (the PBM) is going to be offering Sanofi’s insulin products at $35 a month for people who don’t have health insurance.

All they have to do is go to the Optum Store (essentially the retail pharmacy), “get qualified,” and they’ll get a card allowing them to get Sanofi insulin for $35 at any retail pharmacy.

Could Optum be doing this out of the goodness of its heart? Maybe. But then there’s this: “A mail service option will soon be available for people who prefer home delivery through the Optum Store.”

We reported, you decide.

Medicare changes in a chart

So what exactly does the soon-to-pass Inflation Reduction Act mean for Medicare pricing and drug companies? The folks at the Kaiser Family Foundation have a handy chart. (It’s part of a deck of charts and info on the effects of the bill.)

Remember, if you’re against allowing Medicare to negotiate drug costs, they’re price controls; if you’re in favor of the new rules, they’re spending controls. Something for everyone!

Stop. Can you smell the roses?

It’s not yet clear why some people get long Covid and others don’t, but here’s a potentially scary finding: The greater a person’s loss of the sense of smell — anosmia — the more likely they are to suffer from long-term cognitive impairment.

That’s what an Argentinian research team found after studying long Covid and cognitive impairment in about 766 people, most of whom tested positive for Covid-19. The connection became clear.

“All the subjects that had a severe cognitive impairment also had anosmia. We established an association between olfactory dysfunction and cognitive performance and impairment.”

And their analysis showed which way the cause-effect went: “[S]everity of anosmia, but not clinical status, significantly predicted cognitive impairment.”

Why this is the case, well, that’s not clear. Yet. At the moment, though, maybe you shouldn’t let someone make major life decisions if they’ve lost their sense of smell.

The kidney disease hormone

The body uses a hormone called aldosterone to regulate salt and water (this is good). Too much of it, though, like any good thing, is a problem. For patients with chronic kidney disease, it can lead to kidney failure.

It gets worse. The Boston University researchers who discovered this also found that “aldosterone plays a role in the progression not only of [chronic kidney disease] but also heart and blood vessel problems*.”

[E]ach doubling of aldosterone concentrations in the blood was linked to an 11% increased risk of CKD progression. […] The risk was similar regardless of whether or not patients also had diabetes.

The good news is that the existing kidney drug finerenone can counteract the overabundance of aldosterone and help prevent that kidney disease from getting worse.

* Because aldosterone activates the mineralocorticoid receptor, which can lead to high blood pressure, among other issues. But you knew that.

Should you call the clotbusters?

Good news! A combination of aspirin and an anti-platelet agent (e.g., ticagrelor) works a treat to prevent clotting after coronary artery bypass surgery.

Bad news! A combination of aspirin and an anti-platelet agent (e.g., ticagrelor) “carries a significant risk of clinically important bleeding” after coronary artery bypass surgery.

“So,” said the cardiothoracic surgeon and lead author of the study, “the benefit comes at a price.” The advice: “Physicians should base their decisions on patients’ individual circumstances.”

ICYMI: Some (zombie) pig

Charlotte’s Web could’ve had a very different ending.

(Psst: Soviets did it.)

Lyme vax almost ready for prime time

Pfizer is getting ready to start phase-3 trials of the Lyme disease vaccine it bought from Valneva (soon to be called the “Pfizer vaccine,” of course). Millions of hikers and lawn-mowers across the country await the results.

They tested both two- and three-dose regimens and found that three doses works better — that’s what they’ll be testing now. (Doses two and three are given two months and six months after the first, in case you’re interested.)

Obligatory: There was once a Lyme vaccine (Lymerix), but thanks to a combination of anti-vaxxers, hypothetical side effects, price, and a bit of sensationalism, it was pulled from the market in 2001.

FDA slaps Amazon

The retailer got itself a strongly worded letter because some third-party sellers — whose products were ful­filled by Ama­zon — were selling mole-removal products. And that’s a no-no.

“There are no over-the-counter (OTC) drugs that can be legal­ly sold for mole or skin tag re­moval,” the agency said, wagging a metaphorical finger.

Despite the letter, at press time a GPhA Buzz investigation* found you could still buy the stuff:

* I searched on “mole removal” on Amazon

It annoys me that these stories get press coverage without a disclaimer

“Eating grapes could hold remarkable potential for health benefits” … according to a study funded by the California Table Grape Commission.

Could we have the diabetes/heart disease connection backwards?

Current wisdom: Insulin resistance (through unknown-as-yet mechanisms) causes changes in the endothelial cells lining blood vessels, and that leads to fat buildup and cardiovascular disease.

But what if that’s (as the headline says) backwards? That’s what researchers at Boston’s Joslin Diabetes Center are suggesting. Their finding: That it’s the endothelial cells in control and driving metabolism, rather than being on the receiving end.

In a reversal of scientific dogma, the findings suggest that vascular dysfunction may itself be the cause of undesirable metabolic changes that can lead to diabetes, not an effect as previously thought.

And then, to complicate matters, there’s a sort of feedback-ish loop in effect. Problems with the endothelial cells lead to insulin resistance (they found). That’s problem one. Problem two: Insulin is also what comes back to those same endothelial cells and causes them to produce nitrous oxide. Nitrous oxide triggers the production of brown fat cells — the good fat.

So … 1) problems in blood vessels lead to 2) insulin resistance, then insulin resistance 3) means those blood vessels produce less nitrous oxide and 3) that means less calorie-burning brown fat.

Or, as the chief researcher put it, “Everything is connected.”

Monkeypox vaccine update

Five-for-one split

With demand for the Jyenneos smallpox vaccine skyrocketing, the FDA is considering allowing one dose to be split into fifths, quintupling the supply. How can that work? By giving it intradermally instead of subcutaneously.

“There’s some advantages to intradermal administration, including an improved immune response to the vaccine,” [FDA commish Robert] Califf said. “It’s important to note that overall safety and efficacy profile will not be sacrificed with this approach.”

What about you?

The American Society of Health System Pharmacists is asking HHS to allow pharmacists to deliver the smallpox/monkeypox vaccine (via a PREP Act declaration, like with Covid vaccines) to make it easier for people to get it. You know the reasons; no word from HHS yet.

Pump it up (the implant, that is)

If you’re a gang member or mob boss, scars are good. If you’re trying to pump insulin, no so much.

The problem: Implantable insulin pumps are a great idea, but the immune system will attack them, form scar tissue around them, and eventually clog the pump.

MIT engineers came up with an unusual solution: They surrounded the pump with a balloon that could be inflated and deflated. It doesn’t need to be often, either — just every 12 hours, in testing, was enough to drive away the immune cells that lead to scar tissue formation, like trying to paint a balloon that inflates before the paint can dry.

And while scar tissue did form eventually — you can only fool Mother Nature so long — the collagen fibers were aligned, which (they believe) allowed the meds to get through anyway.

It’s been tested on mice and cadavers, so (live) human tests are next.

Everybody wins … sort of

The big news this weekend was the passage of the Inflation Reduction Act of 2022. Despite the headlines, there were actually wins on both sides of the aisle when it comes to the pharma-related portion of the bill.

For Democrats, CMS will finally be able negotiate drug prices like the rest of the world … on 10 older drugs that don’t yet have a generic version. That’s all. (The bigger deal is that it’s a foot in the door of drug-price negotiation.)

But Republicans got wins too, although they’re being overshadowed by the press around the price-negotiation news. The GOP prevailed by preventing the imposition of a $35 out-of-pocket cap on insulin on private insurance plans, as well as in other, non-pharma parts of the bill (e.g., there will be no requirements for paid family leave, nor funding for universal preschool or an expansion of the child tax credit).

As for price negotiations, despite one side saying it will mean unicorns and rainbows and the other predicting angry dragons and rains of despair, chances are the effects will be, like the weather, partly cloudy or partly sunny.

A useful plague of locusts

Cats predicting death. Dogs detecting Covid. They are sooooo last year. Now we have the world premiere of “Locusts Detecting Cancer.”

Locusts, it seems, can distinguish between cancer cells and normal cells and even distinguish different kinds of cancer.

And as tempting as it may be to send swarms of locusts through doctors’ offices*, the reality is boring: “[T]his work could provide the basis for devices that use insect sensory neurons to enable the early detection of cancer using only a patient’s breath.”

* Especially during Passover

Next in nicotine

This’ll be a Big Deal soon enough: In an effort to get their hit of nicotine, teens are turning to gum, lozenges, and gummies, often flavored just for them (mmm, “fruit medley”!). They contain plenty of drug, are easier to hide in school than vapes, are entirely unregulated, and are now second in popularltiy only to e-cigarettes , according to research out of USC.

It’s almost as if companies want to hook them on an addictive drug while they’re in middle school.

Can D do this too?

Latest on the list of “what can vitamin D do for you” is … reduce inflammation. Maybe. The whole cause/effect thing isn’t entirely clear.

When you’ve got chronic inflammation, the liver produces more C-reactive protein. But (say Aussie researchers), if you take vitamin D, the levels of that protein go down.

Their conclusion: “[T]he findings suggest that boosting vitamin D in people with a deficiency may reduce chronic inflammation.”

But note the weasel words “suggest” and “may.” That’s because there’s a black box in operation here. Does vitamin D affect the inflammation, or could it be affecting the protein? Or maybe it’s backwards — low C-reactive protein means lower vitamin D? Right now there seems to be a connection, but more work is needed to figure out just what it is.

Making vaccines last

A problem with many vaccines is that they don’t last long once they warm up. That’s why the whole cold chain thing is such a big issue.

The result, say Swiss researchers, is that half of vaccines go to waste. So, being Swiss, they came up with an elegant solution. It’s a hydrogel — “a biocompatible, synthetic polymer known as ‘PEG’ that serves as a protective, ‘cloaking device’” for large molecules like vaccine proteins.

So instead of wrapping the vial in a blanket of cold that has to be maintained, the Swiss wrap the individual molecules in the polymer, which can keep the proteins safe up to about 150°F. And to remove the coating? Just dissolve it with a sugar solution.

It’s still in the lab phase (i.e., “more research is needed”) but the Swiss Federal Institute of Technology is already flinging around Buzz’s favorite phrase: “game changer.”

A marker for diabetes (and cancer)

Here’s a weird one: People who have a high level of the protein prostasin in their blood are significantly more likely to have diabetes. Why? The Swedish and Chinese researchers who discovered the connection aren’t sure. Is it somehow helping cause the diabetes? Is it a marker for a different cause?

Regardless, “those with the highest levels of prostasin […] were almost twice as likely to have diabetes than those with the lowest levels.”

But wait, there’s more. Those who also had a high level of blood sugar (perhaps the were already diabetic) were at much higher risk of dying from cancer.

For every doubling in prostasin concentration, the risk of cancer death rose by 24% in those without high blood sugar, and by 139% in those with high blood sugar.

The diabetes-cancer connection was already known, but this might give insight into the mechanism. And it certainly makes for a blood test to pay attention to.

What else has Covid?

Wondering which animals around the world have been infected with Covid-19? There’s now an interactive dashboard for that.

After fentanyl

As adding fentanyl to street drugs becomes passé, the latest deadly additive is … xylazine. Yeah, the animal tranquilizer is showing up (ironically) as an additive to fentanyl and cocaine.

It started being reported in Puerto Rico, Philly, and now Massachusetts (in anywhere from 28 to 90% of the drugs tested — but we all know it won’t be long before it’s everywhere. The danger is not that someone might OD on xylazine, but that, as a sedative, it will make an opioid overdose worse by slowing the heart.

There’s a lot of speculation about how and why xylazine is on the rise. It may be added to fentanyl or heroin to help extend the effects of an opioid high. Dealers also may be using this relatively inexpensive and easy-to-order sedative because of supply chain gaps with other drugs.

Oh, yeah, and it’s not easily detectable with a test strip (like fentanyl) nor affected by naloxone.

mRNA for monkeypox

Moderna says it’s considering turning its mRNA-vaccine muscle toward making monkeypox vaccines. It depends, of course, on whether cases continue to rise and spread and, presumably whether those deep government pockets will be where the payment comes from.

“Our platform is pretty well established and our ability to rapidly scale has been demonstrated. If we were to go after a monkeypox clinical development program, it would be to very quickly progress toward an approvable set of endpoints in a clinical study.”

But can the mRNA tech handle that large monkeypox viral protein? Perhaps we’ll find out.

The addiction drugs they can’t get

People who have an opioid-abuse problem aren’t getting the meds they need to quit. In fact, say NYU researchers, “Almost 90 Percent of People with Opioid Use Disorder [are] Not Receiving Lifesaving Medication.”

Part of the problem is obvious: More than 70% of residential treatment programs don’t offer methadone, buprenorphine, or extended-release naltrexone — drugs that can cut (or potentially eliminate) half or more of overdoses while helping people quit.

“We need to rethink how treatment for opioid use disorder is delivered, eliminate stigma, make it easier for people to enter and remain in treatment, as well as ensure that all treatment programs provide and encourage use of evidence-based medications that we know save lives.”

Quickie Covid data

The most reliable info to date on long Covid: 1 in 8 people infected end up with it. That’s based on a Dutch study of more than 76,000 people and 23 symptoms that are officially (or semi-officially) associated with persistent symptoms.

What makes this study different is that the Dutchies took into account that some of these symptoms existed before Covid infection, so they can’t really be attributed to long Covid. (“Symptoms such as fatigue and headaches might be worsened during the pandemic also in people without Covid-19, for example.”)

Killing bacteria

A new kind of germ killer

There are lots of ways to try to tackle the issue of antibiotic resistance including phages (see below) and augmenting or repurposing old drugs. But Aussie researchers have an new idea: proteins.

Specifically, they’re looking at guanylate-binding proteins, which the human immune system uses as one of its weapons to kill bacteria. By themselves or combined with antibiotics, GBPs could be — after much more research of course — another new weapon. Resistance may eventually be futile after all.

“We are now finding more and more GBPs that can kill different types of drug-resistant bacteria. This includes bacteria that can cause meningitis, pneumonia and sepsis. […] The ultimate goal is to use these proteins to eliminate meningitis, pneumonia and sepsis entirely.”

You can’t fight the phage cocktail

Bacteriophages — bacteria-killing viruses — are one of the most promising tools against drug-resistant germs. But once you introduce them to kill the bacteria, you start an arms race between the good viruses and the bad bacteria.

Israeli and German microbiome researchers have a possible solution, and it almost seems obvious: One phage good? More phages better! Looking to fight gut inflammation, they’re “using a cocktail of phages that use multiple lines of attack against Klebsiella pneumonia bacteria, preventing them from evolving resistance to the mixture.”

And because phages target a single bacteria (unlike broad-spectrum antibiotics) this cocktail doesn’t affect anything else in the gut. The downside? Phages have to be found, and it took them five years (“a a painstaking fishing expedition”) to isolate phages that attack K. pneumonia.

A tiny change to drug pricing looms

Congress is set to pass the “Inflation Reduction Act” which would allow Medicare to negotiate the prices of [insert drumroll] a whopping 10 drugs … in 2026. That would go up to a staggering* 20 drugs by 2029. (For comparison, the rest of the world can negotiate the prices of every drug.)

The pharmaceutical industry is against the bill, of course, threatening to stop trying so hard to develop new drugs if their executives and shareholders face lower paychecks.

* This is sarcasm.

Covid kiosks

It’s 3:00 am and you’re not in a Denny’s mood. How about getting a Covid test instead? Good news: The Georgia Department of Public Health has opened a bunch* of 24/7 kiosks throughout the state offering free tests. (Here’s the map.)

Fill out the quick form and the kiosk dispenses a kit. Swab, dip, etc., and put it back in the kiosk. The next day it’ll be picked up and given a super-accurate PCR test — you’ll be notified of the results by email or text.

* We didn’t bother to count.

It’s a license renewal year

Pharmacists, do you have enough continuing ed under your belt to renew your license? If not, no worries — GPhA has ways of making you talk helping you meet your requirements tout de suite, and get some spiffy certificates for your wall while you’re at it.

APhA’s Pharmacy-Based Immunization Delivery Certificate Training Program

Gives you 23.0 hours of CPE (in person plus home study)!

In-person sessions: Sunday, August 21 —or— Sunday, December 11 (8:00 am – 5:00 pm) in GPhA’s Sandy Springs classroom

Click here for details and to register.

APhA’s Delivering Medication Therapy Management Services Certificate Training Program

Gives you 21.0 hours of CPE (in person plus home study)!

Live via Zoom; Sunday, September 18 (8:00 am – 5:00 pm)

Click here for details and to register.

NASPA’s Pharmacy-based Point-of-Care Testing Certificate Program

Gives you 20.0 hours of CPE (in person plus home study)!

In-person session: Sunday, October 2 (8:30 am – 12:30 pm) in the GPhA Sandy Springs classroom Click here for details and to register.

You can call him Al

A big GPhA Buzz shout-out to GPhA member Al Dixon of Richmond Hill Pharmacy in Bryan County, who was featured in a WSB-TV story on rising drug prices. Specifically, it was based on AARP of Georgia s reminding everyone that drug prices have risen “73% in the last seven years, hurting Georgia’s seniors.”

And who’s to blame? PBMs.

(Yeah, the article misspelled his name. Over and over. )

CDC say relax

The CDC is expected to update it’s don’t-get-Covid guidelines in the next few days “to ease quarantine recommendations for people exposed to the virus and de-emphasize 6 feet of social distancing.” It’s also going to “de-emphasize regular screening testing for Covid-19 in schools” and stick with its test-to-stay strategy.

All this, of course, assumes that there won’t be a major surge when students return to school and an unexpected definition of “cultural studies.”

Monkeypox updates

Urgent, urgent, emergency

It’s now officially a public health emergency in the US. That just means more hyperactive news stories … and more importantly, “Federal health officials can now expedite preventative measures to treat monkeypox” and have some more flexibility in how they do it.

Luckily, it’s rarely fatal (but very uncomfortable) and only spread through intimate skin-to-skin contact.

Whither TPOXX?

There’s a monkeypox vaccine (although it can be hard to get), but what about treatments? One that’s out there is TPOXX (aka tecovirimat) which is approved to treat monkeypox’s nasty cousin, smallpox. And while TPOXX has been tested for monkeypox on animals, it’s still officially an investigational drug when it comes to humans. So if you want to use it here in the US of A, that means paperwork. Lots of paperwork.

Will that change now that this is an emergency? Should it? Read on.

Eeew

The Brits have identified new symptoms of the disease. Upon reading the headline, I thought to share those new symptoms with you. Upon reading the article, however, I prefer to simply provide the link.

For those of you who clicked and read, here’s a picture of a bunny and a kitten:

When moles go bad

Some moles don’t know their place. Rather than sit still and maybe be the subject of an awkward glance, they start to grow until they become melanoma, the really bad skin cancer.

Why do some have to be that way? Who hurt them? Who did this to them?

Boston University researchers think they know. If they’re right, it could open the door to treatments not only for melanoma (and pre-melanoma) but potentially other types of cancer.

It’s all about the Hippo tumor suppressor pathway which, to oversimplify, tells cells when to stop growing. When the Hippo tumor suppressor pathway is itself suppressed, “those cells rapidly go on to form melanoma in multiple experimental models.” Keep it working properly, and moles stay moles.

Next up, as always, more research.

CVS on the bandwagon, but who’ll drive it?

CVS announced that it’s joining Amazon, Walgreens, and that group of hobos under the bridge and getting into the primary care business.

The company wants to offer longer hours at its doctor [sic] offices so people can visit as early as 6 a.m., as late as 9 p.m., or on the weekends.

Completely unrelated, America’s physician shortage continues to the point that Time magazine is offering solutions.

Also unrelated, a new study out of the University of Chicago found that “It would take a primary care physician 26.7 hours per day to follow national recommendation guidelines for preventative, chronic disease and acute care for an average number of patients.”

Disinfecting: Better, stronger, faster

The Brits are simply not satisfied with how well bleach works to kill germs. It’s just too slow. A northern-England hospital had an idea: a disinfectant based on hypochlorous acid, a natural compound that also comes from chlorine and is used in the U.S. as a disinfectant.

They call their product Pathisol, and researchers at Teesside University (home of Barry the Beaver) are testing it in a clinical environment for the first time, misting entire wards with the stuff.

The benefit, if it pans out: “Pathisol can disinfect a surface in two minutes, which is five times faster than bleach. It can also kill 99.99% of pathogens, including hospital superbug Clostridium difficile.”

It’s also cheaper to make than bleach and more environmentally friendly — and you get to apply with a cool spray gun.

Potential slow start to the school year

As the school year starts, an Adderall shortage is the last thing we need, and yet here we are.

Both 20-mg and 30-mg tablets of Teva’s branded ADHD drug Adderall are currently on back order in the U.S., with the company eyeing a release date in early- to mid-August.

Teva not only makes Adderall, it also makes most generic amphetamine salts, but the company says not to worry, “[We] expect full recovery for all inventory and orders in the coming weeks.”

Dues renewal is nigh!

It’s almost time to render unto Mary that which is Mary’s. (Meaning Mary Ritchie, GPhA’s director of membership.) Your GPhA 2022–23 dues invoice will be coming to your mailbox soon, so keep an eye out.

And please, if you would be so kind as to send it back quickly, it’ll make Mary’s life a bit easier. Thank you!

If you show me yours…

Would you like your pharmacy to appear in on a reality show called “Show Me” — if we promised that it would not require compromising your virtue? If so, NCPA is looking for you.

Think of it like “Kitchen Nightmares” or “Bar Rescue” but with less cursing and alcohol, and more lab coats and plastic bottles. “Show Me” will feature “NCPA members facing typical pharmacy challenges who get the help they need from some peers who’ve been there and done that.”

You and your pharmacy could be on it — you just need to apply with a video to prove you’ve got what it takes for your close up. Click here for the details, some tips, and the submission form.

Good news for Walt Disney

Being cold, it seems, inhibits cancer growth. That’s what Swedish researchers discovered, and the mechanism is actually quite simple:

[C]hilly temperatures activate heat-producing brown fat that consumes the sugars the tumors need to thrive. Similar metabolic mechanisms were found in a cancer patient exposed to a lowered room temperature.

They even did some preliminary human testing and found that being at about 60°F vs. 82°F makes a difference — “The imaging scans picked up increased brown fat and lowered tumor glucose uptake during the lower versus the higher temperature.”

The Short Read: CivicaScript Debuts edition

Yesterday, the hospital-owned nonprofit Civica Rx launched CivicaScript, and it began selling it’s first drug, abiraterone, for a lot less that the list price.

A month’s supply of abiraterone 250 mg will be sold to pharmacies for about $160 a bottle with a maximum retail price of $171 — about $3,000 less than the average price for someone with Medicare Part D coverage.

More interesting for those with crystal balls is that CivicaScript is part of a larger trend of non-profits arising to take on the pharmaceutical companies — and high drug prices — by offering cheaper generics and price transparency.

Latest Covid vaccine news

Three studies, one variant family

Separate studies out of Israel, the US, and Japan all conclude — to one degree or another — that three (or preferably four) doses of an mRNA vaccine protects people from Omicron. Not perfectly, but it reduces the risk of symptoms and hospitalization enough to say, “It’s effective.”

Novavax warning

This wouldn’t be the Covid pandemic if there wasn’t one snag after another. Today’s (well, yesterday’s) hiccup: Although the EU, like the US, has approved Novavax’s Covid-19 vaccine as an alternative to the two mRNA shots out there, the European Medicines Agency now wants that vaccine to carry a warning that both myocarditis and pericarditis are potential side effects, in addition to the existing “severe allergic reactions.”

Bring cheeses into your life?

Eating a bit of Jarlsberg cheese — and only Jarlsberg cheese — “may help to stave off bone thinning,” according to a study out of the Norwegian University of Life Sciences. But before you rush out to the dairy section, note that the study was funded by Tine, “Norway’s largest producer, distributor and exporter of dairy products.”

(Oh, and if you’re thinking, “I‘d rather have Camembert than Jarlsberg,” I have bad news for you.)

Side reading: Experts call into question some significant limitations of the study.

Rogue chemo drugs

Here’s a surprising bit of news: There are apparently a bunch of online pharmacies — “rogue” pharmacies, mind you — selling chemotherapy drugs like imatinib without proper prescriptions.

The research (by UNC School of Pharmacy researchers) was straightforward: They simply searched online for where to buy chemo meds to get an idea of the scope of the problem.

“By simply searching Google, Bing, Yahoo, and DuckDuckGo, we found 44 websites that sold and shipped imatinib in the U.S.; 13 of these websites sold imatinib without a prescription, and more than three-quarters did not offer a way for patients to speak with a pharmacist. This is a significant concern for patient safety.”

And that’s based on just the first 10 pages of search results. (Fun fact: You can actually look past the first page of results. Who knew?) They didn’t actually buy any of these drugs, but they point out that … well, let’s just say that quality control might be lacking, although the prices were often significantly lower than patients would normally pay — the very reason these sites exist.

Big new drug-interaction database

Columbia University researchers have created a database of nearly 20,000 potential pediatric adverse drug events (ADEs) — interactions that can occur at all stages of development, many of which haven’t been reported yet.

That last part is the gem: Existing databases, such as the FDA Adverse Event Reporting System, “only capture data from patients who experienced adverse events,” while the Columbia database uses computer modeling to identify issues before they occur.

The database, which is made freely available (via a site called PDS Portal), isn’t meant for clinical use; it’s designed for drug researchers, although “Clinicians can use it as a gut check.”

ICYMI: Banananana Boat recall

Banana Boat is recalling some batches of its Hair & Scalp Sunscreen because it may contain benzene, which you don’t want anywhere near you.

It’s only three lots, and it doesn’t (yet) affect any other Banana Boat products. Get the deets from the official FDA recall page.

Heat, meds, and heart attacks

Two types of meds — beta blockers and antiplatelet drugs (including aspirin) — increase your risk of heart attacks in hot weather. Somehow (the Yale researchers who discovered this don’t know how) they make the heart more susceptible when the weather gets warmer.

Antiplatelet medication use was associated with a 63% increase in risk and beta-blockers with a 65% increase [in heart attacks]. People taking both drugs had a 75% higher risk. Non-users of those medications were not more likely to have a heart attack on hot days.

To get even more complicated, statins tripled the risk of heart attack for younger people on hot days, but didn’t have that effect on older patients.

Stopping stones: Water good, calcium better

If you’ve had a kidney stone, there’s a good chance you never want another. The folks at the Mayo Clinic have some advice: Make sure you’re getting enough calcium and potassium.

Their new study looked not at preventing first time kidney stones, but at stopping recurrence. Some of their findings aren’t surprising, such as “drink more fluids.” But the surprise was that “Low dietary calcium and potassium was a more important predictor than fluid intake of recurrent kidney stone formation.”

The study concludes that diets with daily intake of 1,200 milligrams of calcium may help prevent first-time and recurrent kidney stones. [It didn’t have a specific recommendation for potassium, so take your best guess.]

What cannabis can do (entry 261)

As the legalization of marijuana spreads, so too do the number of studies on the stuff — including some with eyebrow-raising conclusions. (Not, like, shocking. Just unexpected.)

For example, smoking marijuana might reduce incidence of sinus problems like congestion, sneezing, and sinus pain … at least according to a study from USC’s Keck School of Medicine.

The study of nearly 2,300 U.S. adults found that while cigarette smokers were often plagued by such symptoms, the same did not hold true for regular marijuana users.

Actually, they don’t know which way the causation goes, so it’s possible “people who already have nasal or sinus symptoms might steer clear of marijuana.”

The mantra, as always: “The only way to find out […] is with further research.”

Why is red meat bad?

Why does eating too much red meat increases the risk of heart problems? We know it does, but what’s the mechanism?

A surprising (possible) answer comes out of Tufts University: It’s the gut bacteria. “Chemicals produced in the digestive tract by gut microbes after eating red meat may help explain part of the higher risk of cardiovascular disease associated with red meat consumption.”

Not that cholesterol and salt are helping, but gut bacteria produces trimethylamine N-oxide (TMAO) when it digests red meat, and high levels of TMAO are double-plus ungood for people, with links to cardiovascular issues, kidney disease, and diabetes.

In other words, by eating red meat you’re feeding bacteria that, er, expels poison into your gut.

Smart IVs, safe patients

A lot of hospitals have “smart” IV infusers that can automatically calculate the correct dose and rate for delivering drugs, but — at least in Britain — many aren’t used “because they are difficult to configure and maintain.”

So instead of a pump that’s configured by a pharmacist and smart enough to sound an alarm if something’s amiss, you have a dumb pump “set by ward staff who calculate and input infusion rates themselves — increasing the risk of drug errors.”

That’s what researchers from Manchester, England, England* found based on data from the UK’s National Health Service; they calculated that “1 in 10 IV drug administrations are associated with an error, and up to 1 in 10 of those were associated with harm.”

* Across the Atlantic sea

Unexpected insulin danger

Diabetics taking higher doses of insulin have a higher rate of cancer, especially if they’re insulin-resistant. Yeah, read that again. The findings, out of Ohio University, are based on health records of 1,300 patients over 28 years, so the increase can take a long time to appear. (And the it’s further muddied by the idea that having diabetes itself might raise the risk of cancer.)

Of note is that insulin-resistance. The epidemiologists who ran the study suggest that, to mitigate cancer risk, “improving insulin sensitivity may be preferred than simply increasing the insulin dose.”

Hutton is waiting

Is it time to renew your workers’ compensation or business liability insurance? Talk to Hutton Madden first: (404) 375-7209 or hutton.madden@phmic.com.

U.S. hits a positive milestone

The U.S. hit a new low for the number of uninsured people — only about 8 percent of Americans are now without some kind of medical coverage according to the latest CDC data (PDF). This is the lowest level in … well, in the modern, employee-based-healthcare era.

The bad news: A lot of people will be unable to afford coverage when this calendar year ends, because that will also end pandemic-related measures to help people pay for insurance. The good news is that Congress might vote to keep them in place, along with support for people in states that haven’t yet expanded Medicaid coverage.

A different anti-smoking tool?

For quite a while (i.e., more than 50 years), Asians and Eastern Europeans have been using cytisine as drug to help quit smoking; it’s a partial agonist against nicotinic acetylcholine receptors*, like Chantix (aka varenicline), but it’s “natural” in the sense that it’s a plant alkaloid.

Canada only just approved it a few years ago, but in most of the Western world it’s eclipsed by Chantix — in fact, my spell-checker recognizes varenicline but not cytisine. Why is that?

For one, previous studies found that while cytisine is better than placebo, it’s not quite as good as varenicline. For two, varenicline makes some companies a lot of money. But varenicline has issues (suicidal behavior, anyone?) so in 2018 the FDA approved a study of cytisine on our freedom-blessed shores.

So, does it work? The result is an rock-solid, unequivocal “It seems to, yeah”: “At the 12-month follow-up, the quit rate was 32.1% in the intervention arm and 7.3% in the control arm.”

One interesting note: The researchers who conducted the previous study suggest that “populations more accepting of ‘natural’ products would respond better to cytisine than to varenicline.”

* I think I got that grammar right.

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Did Israelis find the key to immortality?

If you have a roundworm (C. elegans) that you want to live forever, what’s the trick? One way: Improve its mitophagy — the mechanism for replacing worn-out mitochondria*. That mechanism, though, wears out with age, leading to a lot of dead mitochondria lying about, and thus unhealthy cells.

But now Israeli researchers say they’ve found a way to keep the mitophagy going strong, using molecules they created (“distinct designer diamines”) that …

… promote mitophagy, and thereby enhance healthspan in C. elegans and protect human cells against oxidative damage.

Naturally, they’ve already formed a company to try to turn the discovery into an actual drug. Eventually.

* All together now: “The powerhouse of the cell.”

Today’s potential Alzheimer’s cause

Could it be a “one-two punch” from the varicella zoster virus (VZV) ‘waking up’ the herpes simplex virus (HSV-1)?

Both viruses were known to maybe kinda sorta have a connection with Alzheimer’s, but now a collaboration between researchers at Oxford and Tufts universities found that individually they aren’t a danger but …

… exposing brain cells harboring dormant HSV-1 to VZV led to a reactivation of the herpesvirus and a cascade of the toxic plaques known to be signs of Alzheimer’s.

The fact that VZV can reactivate the herpes virus doesn’t mean that other viruses can’t do the same. The critical bit of info, they feel, is that reactivating dormant HSV-1 might be a trigger for Alzheimer’s disease, and that needs to be explored.

Between the rack and your counter space

Not many drugs have gone from prescription to over-the-counter lately, and here’s an interesting reason: The U.S. doesn’t have much of an “behind-the-counter” alternative, where customers must ask for a medication and (in theory) get advice or consultation with a pharmacist.

That might be changing, as the FDA considers a new rule called “Additional Condition for Nonprescription Use.” (Then again, the idea has been around for at least a decade, so don’t hold your breath.)

If the rule is approved, though, it could open the gateway to a lot more no-prescription-needed drugs, giving the FDA a way to split the difference when it comes to meds that seem almost safe enough to be on the rack, but not quite.

What’s the right amount of exercise to live longest?

The answer will keep changing as new studies come out, but the latest — courtesy of the American Heart Association, and based on “An analysis of physical activity and medical records for more than 100,000 people over 30 years” — says the answer is [insert drumroll here] …

… at least 300 minutes of moderate physical activity per week, or 150 minutes of vigorous activity.

“What?” you say, “That’s not what the headline reads.” True — the headline is the current guideline. What the story says is that there’s an increased benefit for doing two to four times that.

The reduction [in mortality] was 21-23% for people who engaged in two to four times the recommended amount of vigorous physical activity, and 26-31% for people who engaged in two to four times the recommended amount of moderate physical activity each week.

Teriparatide: All you need is just a little patience

Post-menopausal women dealing with osteoporosis can take teriparatide — but there’s an important note. The synthetic hormone will restore their bones’ mineral quality, but it has to be taken for 24 months — not fewer.

“[T]he full benefits of teriparatide treatment on forming bone quality are realized only with a full-course treatment,” said the leader of the Austrian team whose study figured this out.

And there’s good news: After two years, the women’s bone quality was “similar to that of healthy premenopausal women.”

UGA’s plan enters competition finals

Congrats to the team from the UGA College of Pharmacy, who — along with the University of Arkansas for Medical Sciences (last year’s winner) and University of South Carolina (don’t call it “USC”) — are finalists for NCPA’s 2022 Student Business Plan Competition.

It’s not clear what the next step is, but whatever it is, we’re pulling for the Dawgs! The winners will receive two cash prizes (amount unknown) — one for the team’s NCPA student chapter, and one for the team’s school to promote independent pharmacy. More importantly, they get a year of bragging rights.

* Technically the Good Neighbor Pharmacy NCPA Pruitt-Schutte Student Business Plan Competition (GNPNPSSBPC)

Fall booster plans

So here’s where we stand with Covid booster shots for the fall:

The FDA said that people under 50 won’t need a booster yet — it’s saying wait till the fall when Omicron-specific boosters are available.

To make sure they are available, the U.S. has arranged for 66 million doses of an updated version of Moderna’s vaccine.

Combined with 105 million doses the government already agreed to buy from Pfizer […] the latest deal puts the U.S. booster dose supply at about 171 million shots.

Shields up! (or not)

Transparent face shields are popular among the more cautious people when in a potential Covid-catching situation. They add an extra layer of protection without interfering with breathing or speaking.

Well, bad news. Turns out most of them don’t do much after all. British researchers put them to the test using a “coughing machine” (really) that spewed out dyed droplets onto shielded mannequin heads.

Result: “The lab tests showed that all of the face shields provided some protection, but none gave high levels of protection against external droplet contamination.”

That’s because there were gaps, and people turn their heads (and droplets get caught in air movement). You need a pretty big shield — “closed across the forehead and extended well around the sides of the face and below the chin” — to be effective.

This’ll work — flower not required

Ketchup can lead to dementia

That’s the headline I would use if I was running a tabloid. The reality is that “Eating More Ultra-processed Foods [is] Associated with Increased Risk of Dementia,” and ketchup happens to be one that’s mentioned.

Ultra-processed foods are high in added sugar, fat and salt, and low in protein and fiber. They include soft drinks, salty and sugary snacks, ice cream, sausage, deep-fried chicken, yogurt, canned baked beans and tomatoes, ketchup, mayonnaise, packaged guacamole and hummus, packaged breads and flavored cereals.

(Note that the article’s definition of “ultra-processed food” doesn’t quite jibe with the typicaldefinition. Add salt to peanuts and they’re “processed”; to be “ultra-processed” they need to have several additives, and possibly colors and flavors, too.)

I see trouble on the way

There have been three waves of opioid deaths over the past two decades — that’s the “opioid crisis.” We’re entering a fourth wave now, say researchers at Northwestern, and it’s going to be a bad one.

The first three waves were caused by (in large part) opioid pills, heroin, and fentanyl, respectively. The fourth wave is fueled by “combining synthetic opioids with stimulants such as cocaine and methamphetamines.”

“This is a bigger problem because you have people misusing cocaine and methamphetamines along with an opioid, so you have to treat two things at once, and the fentanyl is horribly volatile.”

Nutrition news

I hope they have lots of grains of salt at Texas Tech

First: “Peanuts Help Weight Loss, Blood Pressure, Glucose Levels” (funded by the Peanut Institute of Albany, Georgia).

Second: “Daily Avocados Intake Improves Diet Quality, Lowers Cholesterol Levels” (funded by the Avocado Nutrition Center).

But what about strawberries?

A study out of Rush University found that strawberries — actually, a compounded they contain called pelargonidin — might reduce the risk of Alzheimer’s by reducing the “neurofibrillary tau tangles” in the brain: “The data suggests that pelargonidin may protect the aging brain from developing Alzheimer’s disease pathology.”

“We suspect the anti-inflammatory properties of pelargonidin may decrease overall neuroinflammation, which may reduce cytokine production.”

Notice all the “mays” and “mights”? Yeah, this is a bit preliminary.

The big question here at Buzz HQ: Who funded the study? It would cost €27.50 to find out, which is €27.50 more than our budget for scientific papers.

Not everyone’s worried about healthcare privacy

Results of a survey released by the American Medical Association found there’s a small percentage of Americans with very interesting views about their healthcare data.

• Almost 8% do not believe privacy is a right, and are okay with having their health data available for purchase.
• 6% of patients don’t think companies need to be held legally accountable for how their health data is used.
• 7% don’t care if app developers tell them how those apps might use and share their personal health data.
• More than 20% don’t care if they can’t opt out of sharing some or all their health data with companies.
• 41% aren’t worried about their personal health data being used against them or their loved ones, e.g., for insurance coverage, employment, or legal reasons.

Taking the F out of the FDA?

Some people forget that the “F” in FDA stands for food — not federal or farmaceutical. So a pair of U.S. congresscritters — one in the House, one in the Senate — are proposing that FDA be split, with the food portion becoming its own agency: the Food Safety Administration.

…to protect the public health by ensuring the safety of food, preventing foodborne illness, maintaining safety reviews and reassessments of food additives, enforcing pesticide residue tolerances, improving the surveillance of foodborne pathogens, and for other purposes.

Trigger warning: Some people may be disturbed by the fact that one of the legislators has purple hair.

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FDA could revise NDC system

The FDA is proposing a big ol’ revision to the National Drug Code Format — and by big, we mean converting 10-digit NPCs to 12 digits. It would be similar to the existing format, but the company (“labeler”) and package sections would have an extra digit, and all the digits would be used (i.e., the product code would be four digits, not three or four).

It’s a bit like the Y2K problem (kids, ask your parents); the 10 digits in current NDCs are no longer enough. Also, this would standardize the country’s entire drug-numbering system.

[T]he proposed standardized format would facilitate the adoption of a single NDC format by all stakeholders. Such an adoption would eliminate the need to convert NDCs from one of FDA’s prescribed formats to a different standardized format used by other sectors of the healthcare industry (e.g., healthcare providers and payors).

And in case you’re wondering, “FDA intends to convert existing NDCs on its own […] by adding leading zeros to the appropriate segments.”

Rabid development

A single-shot rabies vaccine has passed its first hurdle — it “performed even better than we had expected” in phase-1 trials, according to the University of Oxford researchers working on it.

If it continues to succeed, it could replace the expensive, multiple-dose vaccine we have today.

A vitamin for better fat

Could vitamin B5 help mice lose weight? We wouldn’t ask if the answer wasn’t Maybe.

Pantothenate acid, B5 to most of us, seems to stimulate the production of the brown — i.e., the good — fat in mice. Brown fat burns calories, as opposed to white fat which just sits there and embarrasses you at the beach.

But white fat can be converted to brown fat, and Chinese biologists found that B5 might just help that happen. It worked in human cells in vitro, and in mice in cage-o:

The vitamin B5-treated high-fat mice showed reduced fat not only overall but, specifically, less fat just under the skin and in the liver compared to those not given vitamin B5. The two groups had a comparable amount of muscle, a sign the weight loss was from reduction in fat.

Their work was published in the American Journal of Physiology-Endocrinology and Metabolism, and includes this helpful graphic:

q

Don’t throw out that frog skin

Looking for a better way to help your diabetic patients treat skin ulcers? Have you considered purified, pureed frog skin? Singaporian scientists did! They found that collagen extracted from blended frog skins can be made into a biodegradable, biocompatible patch that…

…will speed healing by providing a porous layer for white blood cells and healing agents to coagulate within. It will then also serve as a protective barrier, which will further enhance healing by keeping the wound moist.

(If you’re up to date on this stuff, you might know that cows are being tested for similar purposes. But amphibian-derived collagen might be more compatible with humans. Take from that what you will.)

Be ready to write that Paxlovid script

You should know that you can write prescriptions for Paxlovid (under certain circumstances). But with greater power comes greater responsibility — that is, paperwork.

The good folks at NCPA have a four-page PDF that’ll help you cross your i’s and dot your t’s to be sure you’ve got your Paxlovid workflow flowing in terms of documentation, billing, and space requirements.

Skin in the vaccine game

Instead of delivering a Covid vaccine via needle, using a patch seems to be a lot more effective — no matter what kind of vaccine it’s delivering.

Aussie molecular bioscientists were testing a new vaccine that’s delivered by skin patch, and they found it “appeared to counteract new variants more effectively than the current SARs-CoV-2 vaccine delivered by injection.” Good news!

Even better: The patch system, they say, also improves the efficacy of other vaccines — likely because it “precisely delivers the vaccine into the layers of the skin which are rich in immune cells.”

“We found that vaccination via a patch was approximately 11 times more effective at combatting the Omicron variant when compared with the same vaccine administered via a needle.”

Wild science: Lip-locking legacy

Cold sores — caused by the herpes simplex virus — affect nearly half the globe. British scientists, curious how it evolved, were finally able to sequence the virus’s genes for the first time.

That led to an interesting finding: Despite herpes affecting us and our ancestors for millions of years, about 5,000 years ago one particular strain became dominant; the others disappeared.

So what happened 5,000 years ago? Two things. First, humans’ big migration into Europe. But more importantly, we started kissing.

Instead of occasional mom-to-infant transmission of many strains, once we started snogging behind the metaphorical bleachers, today’s HSV-1 took over and hasn’t changed.

[A] virus like herpes evolves on a “far grander timescale” than COVID-19, which the world has watched mutate in a matter of months. “Facial herpes hides in its host for life and only transmits through oral contact, so mutations occur slowly over centuries and millennia.”

Hepatitis cases (sort of) solved

Two separate but equally important teams of researchers in the UK have independently discovered what seems to be the cause of the mysterious hepatitis cases affecting young children around the world.

In short, the kids were infected with a common virus called adeno-associated virus 2 or AAV2. Normally it’s benign — unless it has a helper. And that’s the twist: They were infected with a helper, herpesvirus HHV6.

Normally kids would have immunity to both, but thanks to pandemic precautions, they hadn’t. Bad timing meant they were infected with them concurrently.

They believe that the infection resulting from both AAV2 and the herpesvirus HHV6 offers the best explanation for what caused the unexplained hepatitis.

Our nightmare could be coming to an end

In what could be the biggest health breakthrough of the past 50 years, University of California Riverside researchers have discovered the cause of baldness: A single protein called TGF-beta “is key to controlling when hair follicle cells divide, and when they die.”

Control over this protein and the process could be a cure. (And could also be used with stem cells to promote wound healing.)

Double Duty: Metformin edition

Metformin, it seems, can also help treat bipolar disorder. That’s not too surprising, considering that more than half of people with bipolar disorder also have insulin resistance, and metformin increases the body’s sensitivity to insulin.

In the case of this study out of Canada’s Dalhousie University, bipolar patients taking metformin improved after just 6 weeks and “remained significantly improved or in remission,” for at least 26 weeks.

An eyebrow-raising drug company saga

So biotech company Cas­sa­va Sci­ences has an Alzheimer’s drug candidate (simufilam). It got FDA approval to begin testing based on published research it conducted.

But a couple of doctors outside the company looked at that research and found … issues. They decided the company had manipulated its data, and thus were lying to various federal agencies, and the drug would never work.

They did what any red-blooded Americans would: They figured out how to make money. They shorted Cassava’s stock, then told the Wall Street Journal what they did, which piqued the Security and Exchange Commission’s interest.

Then they lawyered up and filed a petition with the FDA saying simufilam’s clinical trials should be stopped. (The FDA denied it, saying they didn’t have standing to file such a petition.) But word of the petition got out, and Cas­sa­va’s stock crashed.

And now the Justice Department is looking into the whole mess, while Cassava denies wrongdoing and the researchers who started it all say they cashed in (which Cassava, oddly, tried to paint as a “conflict on interest”).

Prophylactic news

A quick course of antivirals helps the coronavirus go down

Even if you aren’t sick, it’s a good idea to take a course of antivirals (Paxlovid or molnupiravir) if you test positive for Covid-19. Mild symptoms can turn worse, and a review out of Canada found that taking the antivirals reduced noticeably the risk of hospitalization.

A morning- (or hour-) after pill

Taking a single dose doxycycline after unprotected sex — a post-prophylactic, if you will — can help prevent common STDs (chlamydia, syphilis, and gonorrhea) that have picked up steam in recent years. The issue, suggests the Emory-led research team, is whether that risks “trigger[ing] antibiotic resistance in the three bacteria that cause these diseases.”

Score one for the old school

What’s the best way to determine someone’s risk of heart disease? It’s 2022, so using a genetic profile is certainly the most accurate way, right? Wrong.

It turns out (say Duke data scientists) that “genetic tests do little to accurately identify cardiovascular risks compared to a simple risk equation that uses basic health measures.”

So forget the new-fangled hocus-pocus, and stick with keeping an eye on blood pressure, cholesterol, and glucose.

“While genetic tests use new technology, they can be high-priced. People should instead visit their doctor and have their actual, clinical factors measured, because this will do a much better job of determining their state of health.

Omicron variant notes

It’s all BA.5 now

The subvariant now controls more than 80% of the U.S. Covid market. So if you read about something that ‘works against Omicron,’ check to see if it mentions BA.5.

For Novavax, the number of the counting shall be three

South African researchers have confirmed that three doses of the new Novavax vaccine provides protection against even the hot new Omicron subvariants.

Covid origin found

Not that it really matters at this point, but it seems the question of Covid-19’s origin has been answered. As much fun as it was to believe it escaped a Chinese lab (intentionally or not), an international team led out of the University of Arizona …

…has confirmed that live animals sold at the Huanan Seafood Wholesale Market in Wuhan, China, were the likely source of the Covid-19 pandemic.

That’s based on examinations and samples from the market as well as tracing genomic sequences of the virus from the first patients infected. The result “virtually eliminate[s] alternative scenarios that have been suggested as origins of the pandemic.”