Ira Katz: Still spreading the word

GPhA member and naloxone champ Ira Katz was in the news again, this time on Atlanta’s Fox 5 as part of a story on the 107,000 Americans who died of overdoses in 2021. His Little Five Points Pharmacy is one of many making naloxone — Narcan — available to whomever needs it.

“We get it for free, and we give it away for free, to anybody who asks,” he says. “You don’t need a prescription for this any longer. It is free of charge. This will save lives.”

Baby formula going forward

The FDA is not only allowing baby formula to be imported (from some other countries and suppliers) until November 14, it’s also working to make it easier for those imports to continue afterwards. That’s called learning your lesson about having too many of your eggs in one Abbott-shaped basket.

Tiny worm delivery drivers

Some nematodes — microscopic worms — have an unusual ability: They’re attracted to cancer cells.

Normally when a nematode enters a human (via undercooked fish) it’s A) disgusting, and B) a possible cause of … less just say “gastrointestinal issues.” But Japanese researchers had an idea: What if you could get a worm to carry a drug payload right to a tumor?

While tiny backpacks were out of the question, coating the worms with a hydrogel allowed them to protect the worms in the body, while at the same time carrying meds while they, er, wormed their way to the cancer cells.

Why yes, yes it did: “[T]he worms became parasitic soldiers that could deliver anti-cancer treatments directly to cancer cells, which are tracked using their natural ability.”

As you might imagine, further research is needed.

Bacteria and drugs: Make it, taste it, report it

Getting bacteria to make drugs is an idea that’s been around a while, but it’s not easy. The biggest issue: When you have a vat of bacteria, it’s hard to determine and isolate the ones actually producing the drug you want them to produce.

But now University of Texas molecular biologists say they’ve cracked the problem. Their solution is to give the bacteria built-in biosensors — the bacteria themselves would not only make stuff, but would be able to indicate if it was the right stuff.

“We’re figuring out how to give bacteria ‘senses,’ similar to olfactory receptors or taste receptors, and use them for detection of the various compounds they might make.”

Essentially the bacteria, er, output something, sniff it, and report whether it’s what it’s supposed to be. If it continues to work, that could be a huge step towards efficient biosynthesis of all sorts of meds.

Polypharmacy problems

Back in 2004, a Pretty Big Study found that about 6.5% of hospital admissions “were found to be associated with adverse drug reactions.”

Since then, more people are taking more meds for more conditions. Result: British researchers updating that 2004 study found that today “16.5% of admissions [are] being caused by, or complicated by, an adverse reaction to a medicine.”

Drug patents are about to get scrutiny

One way drug makers are able to keep jacking up the price of their products is by gaming the patent system — they make a minor chemical tweak and re-release Abracadab as Abzracadab XR. New patent, new protection, more profits.

But now the United States Patent and Trademark Office says it’s had enough. It’s working with the FDA to “crack down on patenting of “incremental, obvious changes to existing drugs that do not qualify” for new protections.

Patents are supposed to protect and reward innovation, not stifle competition. Writes the USPTO director:

Our intent is to ensure our government’s innovation system strikes the appropriate balance, encouraging meaningful innovation in drug development while not unduly delaying competition that provides relief from the high cost of medicines.

Elsewhere: Big Apple edition

New York City is combining Covid testing with Covid treatment — dispensing Paxlovid antivirals (free, of course) immediately at testing sites for anyone who tests positive. The idea could be expanded, it would seem, to any location that offered Covid tests and could immediately prescribe and provide Paxlovid. Any ideas?

Why is there no staph vaccine?

There’s no vaccine for staph infections, but there have been a lot of attempts at one — all failures, even when they worked in animals. What’s the deal? And with MRSA on the rise, could there be a breakthrough?

UC San Diego researchers think they know the answer to the first question. The deal, it seems, is that humans get a lot of exposure to Staphylococcus aureus. Our immune systems learn to fight it off, but at the same time the S. aureus has evolved protection.

When a bad variant comes along, it picks up that resistance. Vaccines get our immune systems going, but that immune system isn’t effective. And even “Subsequent boosters primarily amplified the ineffective antibody response.”

The good news is that now we know why these vaccines don’t work, opening avenues to break through the defenses. “If we are proven correct, an effective staph vaccine may not be too far away.”

Do you care? Of course you do

Medication therapy management — it’s one of the best ways you can care for your patients (and it’s a potential revenue stream, too).

A big step to providing MTM, though, is making sure you’re giving— and getting — the most you can. Patients will appreciate that, not to mention the lovely certificate on your wall.

Learn how to provide the best MTM you can when GPhA presents, “APhA’s Delivering Medication Therapy Management Services: A Certificate Training Program for Pharmacists.” There are even two dates available!

Sunday, September 18, 2022
Live via Zoom 8:00 a.m. – 5:00 p.m.

Click here to get the details, see the instructor, and register!

Channeling the Keystone Kops

Watching the FDA try to regulate nicotine products is kinda like watching Wil-E-Coyote chase the Road Runner.

FDA: Juul has to come off the market. It’s getting kids addicted to nicotine, and the company didn’t provide enough evidence its safe.

Federal appeals court: Hol’ up. We need more time to decide if this is okay.

FDA: Y’know what, we’re gonna pause that ban after all. “There are scientific issues unique to the Juul application that warrant additional review.”

Juul: Yay!

FDA: But we’re still gonna regulate premium cigars like cigarettes — they need pre-market review and have to carry the same health warnings.

US district court judge: Yeah, about that. No. Premium cigars are, like, super special, so you’re being “arbitrary and capricious” by requiring health warnings and not giving them an easier review process.
Also, Congress only officially said you can regulate “all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.” Cigars are special (and premium cigars are super special), so you need a stronger case to regulate them.

FDA: But…

US district court judge: I have spoken.

Ready for your link in the chain?

So the FDA has issued two guidance documents its upcoming implementation of the Drug Supply Chain Security Act (DSCSA). The good folks at NCPA have the details, but here’s the gist.

The first guidance doc (link) is all about the standards pharmacies will need to follow to be authorized trading partners, including “enhanced drug distribution security requirements, electronic only methods, and product tracing and verification of product at the package level.”

The second guidance doc (link) covers the “5 percent rule” regarding providing office-use drugs to licensed practitioners. Even if you keep your office-use deliveries below 5 percent, “such a licensed retail pharmacy may still be considered a wholesale distributor based on other activities.” You’ll want to check it out for the details.

Comments about both are due to FDA by September 6, 2022 via regulations.gov.

Taking the iron fist to prostate cancer

An Augusta University molecular biologist has a plan to attack prostate cancer: Take down its defenses, then clobber it with iron.

Iron + free radicals destroy lipids, depriving cells of energy and killing them — it’s called ferroptosis. The Augusta team’s plan is to do some gene manipulation to make prostate cancer tumors more susceptible to stress, thus more vulnerable to the iron. (The body has a “natural mechanism to cope with this unhealthy pairing of iron and [free radicals] so that a lot of good cells don’t die as a result.”)

Captain Obvious is in it for the long haul

Wait’ll they learn how much insulin diabetics are taking: “Opioid prescriptions significantly higher for patients with lifelong disabilities, study finds”.

Double Duty™

Cancer drug vs Covid

Covid treatments are still somewhat limited, so the hunt goes on for what might work. New on that list: sabizabulin, the cancer drug, which reduced the risk of death by Covid by 55 percent. Caveat: The study was small and it was done by the drug maker. Said one expert, “Overall, I think this is very exciting, although I would welcome larger and independent confirmatory studies.”

ADHD drugs vs dementia

Some mental-health drugs — specifically noradrenergics — seem to improve the effects of Alzheimer’s disease. Norepinephrine-using neurons are part of the very kinds of process disrupted by Alzheimer’s: “including attention, learning, memory, readiness for action, and suppression of inappropriate behaviours.”

This is a preliminary, “Hey, this might work” study, so more research on specific subgroups will be needed.

Too much of a good thing

We keep learning how important vitamin D is: fighting “all-cause mortality,” protecting us from the worst of Covid, even affecting mood. But keep in mind that there is a limit, as one gentleman in Britain discovered when listening to the wrong nutritionist.

The man was taking high doses of more than 20 over the counter supplements, which included 50,000 micrograms of vitamin D; the recommended daily dosage is 600 micrograms. His regimen also included higher than recommended doses of vitamin B6, Omega 3 and vitamin B9.

A month after starting, he began getting sick, but continued to take the supplements.

Doctors said the man’s symptoms — vomiting, nausea, abdominal pain, leg cramps, ringing in the ear and diarrhea — lasted three months.

He was in hospital for eight days, “during which time he was given intravenous fluids to flush out his system and treated with bisphosphonates.”

Pharmacists can give Paxlovid

The FDA has said that licensed pharmacists can prescribe Pfizer’s antibody pill. If given early enough in a Covid infection, Paxlovid can significantly reduce the risk of hospitalization or death.

Score one for the drug distributors

A group of the biggest distributors — AmerisourceBergen, Cardinal Health, and McKesson “are not responsible for fueling an opioid epidemic in a part of West Virginia, a federal judge ruled on Monday.”

The gist of the ruling: The prescriptions and orders were legal, so the companies can’t be held liable. (The problem is with the prescribers.)

This was a case involving one West Virginia city and one county, not the Big Opioid Case from last year. Bad news for them, though: “[C]ommunities in hard-hit West Virginia opted against joining a national opioid settlement in favor of seeking a bigger recovery.“

There are other, similar trials pending.

“Better” doesn’t mean “over”

The pandemic certainly feels over (just like the First Schleswig War feels over). But the Danes are still shifty, and Covid-19 is still killing people.

In fact, it was the leading cause of death of 45–54 year-old Americans in 2021, and the third leading cause of death of all Americans for most of 2020 and 2021.

From March 2020 to October 2021, Covid-19 accounted for 1 in 8 deaths in the US and was a top 5 cause of death in every age group aged 15 years and older.

And that’s assuming every Covid death was counted. (It’s not.) Point being: With another surge expected this fall, don’t let your guard down completely.

Monkeypox update

More than 6,000 cases in 58 countries. That is all.

With age comes wisdom, apparently

Once upon a time (kids, ask your parents), health and politics didn’t mix, at least on the individual level. We all listened to the doctors (and yes, sometimes they were wrong), tried to be smart about taking care of ourselves, and realized that a sick neighbor was bad for us, too.

Now, of course, it’s different. For many people, healthcare decisions are based on politics. Except, found UGA researchers, if you’re older. In that case, the risk is more likely to override side of the aisle you’re. Or, as UGA put it, “[A]ge and risk perception may have as much of an effect on Covid-19 vaccine acceptance as party affiliation.”

Covid vaccine news

This virus and the next

The latest entry on the list of potential broad vaccines comes from CalTech, where — as you might expect from CalTech — nanoparticles are involved. They’ve made an entirely new type of vaccine, one they say “provides protection against a variety of SARS-like betacoronaviruses, including SARS-CoV-2 variants, in mice and monkeys.”

The best part: If it works, it will protect against new viruses and their variants.

What we’re trying to do is make an all-in-one vaccine protective against SARS-like betacoronaviruses regardless of which animal viruses might evolve to allow human infection and spread. This sort of vaccine would also protect against current and future SARS-CoV-2 variants without the need for updating.”

Through the nose

And the latest inhaled vaccine candidate comes from North Carolina State. This one “shows promise” in rodents, which is a step or two below “works.” Still, it can last three months at room temperature, can be self-administrated, and goes directly to the site of the infection.

Downside: The exosome-based delivery system is barely proof of concept, and could be difficult (read: expensive) to scale up. But we have to start somewhere, right?

Senate bill could mean lower drug prices

Democrats may be poised to pass a bill that would require Medicare to negotiate prices with drug makers, rather than paying whatever they demand. It would also cap patients’ out-of-pocket costs at $2,000 per year, and add penalty of sorts for drug companies that raise prices on old drugs faster than inflation.

Drug makers, through their association, PhRMA, spouted the usual nonsense: If our shareholders don’t make billions, consumers will be hurt! (Study after study has shown that pharma manufacturer profits go to stock buybacks, dividends, and marketing, not research and development.)

It was only a matter of time before someone studied it

It’s not just a joke: Being hangry, say British psychology researchers, is a real thing.

[T]he researchers found that fluctuations in anger, irritability and unpleasantness were strongly linked with hunger. In fact, hunger was responsible for 34 per cent of the variation in feelings of anger for participants. For feelings of irritability, hunger was 37 per cent responsible.

Amusingly, the lead author said, “[The research] came about partly because my wife is often saying that I’m hangry, but I didn’t think being hangry was real.” He has presumably learned his lesson.

Avocados (with a grain of salt)

Eating an avocado a day will “improve diet quality, help lower cholesterol levels” according to a five-university* study … funded by the Hass Avocado Board. (In fact, if you look at the study itself instead of the news story, the effect was marginal at best.)

* Penn State, Texas Tech, plus Loma Linda University, Tufts University, UCLA, and Wake Forest University

CVS leaves NACDS

The company says it’s parting ways with the National Association of Chain Drug Stores. Why? No idea. Both of their press releases are empty — they just repeat the standard platitudes about helping people and doing Good Things, but don’t address the question.

The answer, wonks believe, is that CVS owns the nation’s largest PBM, and NACDS isn’t exactly PBM-friendly.

SCOTUS and the FDA

A Supreme Court decision* could have some interesting effects on pharmacy.

A quick-and-dirty explanation: SCOTUS ruled that the EPA couldn’t create regulations that seem to set policy, even if Congress charges it with a task (e.g., keep the air clean). Regulations of “major economic and political importance” need to be based on specific laws passed by Congress, not broad mandates.

Because this was the Supreme Court, obviously this decision — which goes against decades of How the Government Works — is going to apply to other agencies … like the FDA.

The FDA is going to have trouble using its broad authority, thanks to the major questions doctrine the Court invoked. It will have to “point to specific Congressional authorization for [its] actions.”

[I]f new regulations go against existing practice and conflict with certain stakeholders’ interests, they could be subsumed under the major questions doctrine. Accordingly, these regulations could be subject to litigation.

In short, any ruling that smacks of regulatory overreach is likely to be challenged until Congress passes a law, and Congress isn’t exactly known for being subject-matter experts.

* Again, did you think we meant a different decision?

A different target for tomorrow’s Covid vaccines

I’ve been watching too much cheesy science-fiction.

“Our Covid-19 vaccines were working great, but the virus is mutating faster than we can keep up!”

“Have you tried adding the new spike-protein variants to the mRNA mix?”

“Of course! But the spike protein is the problem — that’s what’s mutating! Eventually we’ll get a variant that will evade the vaccine entirely. What can we do?”

“Wait … wait just a second. What if we targeted the virus’s nucleocapsid protein instead? We could do it as either a “homologous prime boost or as a heterologous prime boost in combination with spike-based vaccines!”

“My gosh, you’re right! And it sounds scientific enough that it just … may … work!”

Smooth as a baby’s (supplemented) skin

Do you want eczema-free babies? Sure you do. The trick (per British researchers) is easy:

[B]abies had a lower risk of developing atopic eczema in their first year if their mothers took 1000 international units of Vitamin D a day from when they were 14 weeks pregnant until they delivered.

Oh, and the study also found that “taking the Vitamin D supplement during pregnancy also had lasting benefits for the child’s bone density at four years old.”

Kids and their weight

A new study out of Emory University found that the childhood obesity rate in the U.S. is higher now than it was 12 years ago — and that’s with all the push toward healthier eating. Fail.

If we can’t smack the Oreos out of their hands (or in the case of Son of Buzz, those Swedish Trollis), there’s always Qsymia*, a chronic weight management drug just approved by the FDA for kids over 12. (It was previously approved for adults.)

Here’s an interesting tidbit from that same article:

The CDC also found that, between 2011 and 2014, pediatric obesity rates are inversely proportional to the education level of the head of the household. Similarly, as the average household income increased, the rate of pediatric obesity decreased.

* Be careful. If you mispronounce it, you might accidentally summon an elder god.

Double-duty drug

This will be a new category soon, because there seem be so many: a drug for condition A that also (surprise!) works for condition B.

In this case, Canadian researchers found that a CSF1R inhibitor, normally used to treat some cancers, also seems to help treat Duchenne Muscular Dystrophy “by changing the type of muscle fibers to be more resilient.”

[W]hen they depleted the macrophages of mice, they found that the animals’ muscle fibers surprisingly changed into a type that’s more resistant to the damage induced by muscular dystrophy.

And they described that improvement in muscle resiliency as “profound,” which has to be good news for DMD sufferers.

Viruses are evil (reason #481)

Mosquito-borne viruses (like Zika and malaria) have a nasty trick up their sleeves: They can increase the amount of acetophenone a host (that is, you) produces, which then attracts more virus-carrying mosquitoes.

How? By altering the microbiome of your skin, introducing bacteria that release acetophenone and turning you in to a neon sign for the local skeeter population.

What might be done about this? Well, the UConn researchers studying this found that vitamin A can help the skin produce more of a molecule that kills acetophenone-producing bacteria. So vitamin A supplements might be the ticket.

At least, in theory. More studies, as always, are needed.

The Long Read: Good Company edition

“How Pfizer Won the Pandemic, Reaping Outsize Profit and Influence”

Listeria … times 2

First, the FDA has recalled Vidalia onions sold by A&M Farms (specifically the Little Bear brand) because they might carry the listeria bacteria (Listeria monocytogenes). In Georgia, it affects Publix stores in Barrow, Clarke, DeKalb, Forsyth, Fulton, Gwinnett, Hall, Jackson, Oconee, and Walton counties.

Second, the FDA has also found the cause of Florida’s listeria outbreak (which has infected people across 10 states, including Georgia): Big Olaf Ice Cream. The company has warned retailers, but there’s no official recall.

Another potential universal flu vaccine

This one is from Georgia State, and (they say) works against a wide variety of strains: H1N1, H5N1, H9N2, H3N2, and H7N9. It’s also cheap and easy to produce. Downside: It’s only in the lab so far.

Set your Google alerts to “M2e-stalk protein vaccination.”

Florida’s health woes continue

Now it’s a potential meningitis outbreak caused by — wait for it — Giant African Land Snails.

Here’s a sentence you don’t want to hear: Giant African Land Snails can carry the rat lungworm parasite, which can cause a form of meningitis in humans — a form called “rat lungworm disease.”

[I]f someone challenges you to eat a live slug during a Truth or Dare game, choose “truth” instead. So what if you admit that you are in love with your best friend? It’s better than getting meningitis.

Dementia: When medication fails

One after another, potential treatments for dementia (broadly) and Alzheimer’s (specifically) have failed in clinical trials. That means, say (some) neurologists, that we need to look at other ways to prevent and treat it.

One of the best, somewhat surprisingly, is eye care. Bad eyesight is one of a bunch of “modifiable risks” of dementia — and one of the more potent. (Some others include excessive alcohol consumption, smoking, traumatic brain injuries, and air pollution.)

Altogether, modifying those modifiable risks could prevent a whopping 62 percent of dementia cases, according to researchers at the University of Michigan and Johns Hopkins. And almost 2 percent could have been prevented with better glasses or cataract surgery.

“Even small percentages — because so many people have dementia and it’s so expensive — can make a huge difference to individuals and families, and to the economy.”

The Long Read: Blocking the Sun edition

Why Americans are “Not Allowed to Have the Best Sunscreens in the World.” (Spoiler: The approval process here is must more stringent … too stringent, perhaps.)

The FDA hasn’t added a new active ingredient to its sunscreen monograph—the document that details what is legally allowed in products marketed in the U.S.—in decades. The process for doing this is so onerous that L’Oreal, a French company, chose to go through a separate authorization process to get one of its sunscreen ingredients onto the consumer market in 2006.

Huge breaking news

A molecule called SCUBE3 appears to stimulate hair growth — and even better, it’s produced by the body already. University of California researchers hope it could be turned a baldness treatment, and they’ve filed for a patent for the naturally occurring molecule’s use in treating hair loss.

Booster decision

The FDA has formally recommended new Covid-19 vaccine boosters for the fall. The decision: These boosters should add protection against Omicron’s BA.4 and BA.5 sub-variants to the existing booster. (The question was open whether the new boosters would be Omicron-specific or would add protection. Now that’s settled.)

Better than saline

Bags of IV saline are the standard by hospital beds and as props on TV dramas. Saline (plain ol’ sodium chloride) is used for rehydration, med delivery, and much more, to the tune of 200 million liters a year in the U.S.

But it may not be the best solution.

In a new study of nearly 150,000 hospital patients, Intermountain Healthcare researchers found that patients who received lactated Ringer (LR) solution instead of normal saline for IV fluids had a lower risk of kidney injury and death than when they were given saline.

Just switching to Ringer’s lactate, they found, cut major adverse kidney events — including death — by 2.2%. Spread over those 200 million liters, that’s a lot of events avoided, and “The impact was even greater on patients with sepsis, a severe infection, and patients who received more fluids as part of their treatment.”

More trouble from the neighbor

Following on the heels of Covid-19, monkeypox, and meningitis, Florida’s latest outbreak is … listeria. The CDC hasn’t figured out what food products are contaminated, just that whatever it is, it comes from the Sunshine State.

So far it’s affected people in 10 states (including one in Georgia), with 23 people sick (including five pregnant women), and resulted in 22 hospitalizations, one death, and one miscarriage.

Cool your nerves

Why take chances with opioids after surgery? Instead, how about having the surgeon wrap a cooling sleeve around your nerve fibers — a sleeve you can control to relieve the pain?

That’s just what Northwestern researchers have invented.

The biocompatible, water-soluble device works by softly wrapping around nerves to deliver precise, targeted cooling, which numbs nerves and blocks pain signals to the brain. An external pump enables the user to remotely activate the device and then increase or decrease its intensity.

Even better, no removal necessary. Eventually the body just absorbs it.

“Sir, the deposit window is over here”

We can’t over-stress the importance of gut bacteria, but your microbiome will change as you age — usually not in a good way.

That’s why Harvard researchers (publishing in Trends in Molecular Medicine) recommend a plan for “Rejuvenating the human gut microbiome.” Their idea: Individual ”stool banks” created while people are young, allowing the, er, contents to be transplanted when they’re older. The alternative — finding a compatible donor — has a variety of issues.

Emerging studies suggest that stool banking and autologous fecal microbiota transplantation (FMT), using the recipients’ own stool samples collected at a younger age when they are disease-free, may be a better — or at least an alternative — solution.

(How would you go about doing this? Just ask the Dutch: They’ve already published a paper, “How to: Establish and run a stool bank.”)

The mighty fall

Cosmetic giant Revlon has filed for bankruptcy.

How anti-anxiety drugs hurt the brain

Long-term use of anti-anxiety drugs like diazepam seem to increase the risk of dementia, but why? It could be because — contrary to current thinking — that they don’t actually work on the brain’s nerve cells directly. Rather, they affect the microglial cells.

The microglia affect the nerve cells (so the drugs reduce anxiety), but “the drug changed the normal activity of microglial cells and indirectly the maintenance function that microglia have around synaptic nerve cell connections.”

In other words, Aussie researchers found that, over the long term, the drug causes the microglia to damage some neural connections and affect “the overall functional integrity of the brain.”

The Long Read: Drug Pushers edition

How marketing consultancy McKinsey & Company helped opioid makers push and push and push their pills, even as the opioid crisis was in full swing.

It profiled and targeted physicians, in some instances trying to influence prescribing habits in ways that federal officials later warned heightened the risk of overdose.

And when opioid prescriptions began to decrease during a government crackdown, the records show, McKinsey devised new approaches to drive sales.

Weekend safety

Priorities, folks! If you’re about to do something foolish with fireworks this weekend, please prepare: Have friends nearby holding their phones steady (and horizontal) to record you. If you end up in hospital, the views, likes, and karma you get will make it worthwhile*. (Seriously, be safe!)

* Not for you. For us.

Always read the fine print

You may have read about the new gun safety bill passed by Congress and signed by the President. But did you know that someone slipped in a section to help PBMs?

Yep, toward the end of the gun safety bill is a section that has nothing to do with guns or safety. It simply extends the PBMs’ protection from anti-kickback rules for another year.

Congress, for whatever reason (cough—money?—cough) shielded PBMs from the Federal Anti-kickback Statute until 2026, so PBMs could continue to accept bribes rebates from drug makers to include their products in formularies.

But now someone has quietly extended that until 2027.

The virus my friend, is blowin’ in the wind….

Scottish researchers had an idea: Using data from the Met Office (the UK’s version of the National Weather Service), they tracked wind direction vs Covid cases after a hotspot was recorded.

And what did they find? An “Increase in COVID-19 downwind following a wind change.”

Yay.

Universal vaccines

For flu

The National Institutes of Health is beginning the first human trials of a potential universal flu vaccine. It worked gangbusters in mice (we’re talking 100 percent effective against death from six strains) as both an injection and a nasal spray.

The novel vaccine has been dubbed BPL-1357 and is a multivalent, whole-virus vaccine containing inactivated copies of four particular strains of influenza: H1N9, H3N8, H5N1, and H7N3. The viruses have been inactivated using a chemical known as beta-propiolactone (BPL).

For coronaviruses

Once upon a time, “coronavirus” didn’t mean “Covid-19” — there are other coronaviruses out there. Pfizer and BioNTech didn’t forget. They’re preparing human trials of vaccines against a wide variety of coronaviruses.

That’s vaccines, plural.

[They] include T-cell-enhancing shots, designed to primarily protect against severe disease if the virus becomes more dangerous, and pan-coronavirus shots that protect against the broader family of viruses and its mutations.

Please make a note of this

Walgreens now identifies as AllianceRx Walgreens Pharmacy.

Not only will this put it higher in alphabetical lists, it cements the company’s relationship with the National Retail Store Sign-Changer’s Union.

You don’t tug on Superman’s cape, you don’t spit into the wind….

Noroviruses aren’t just spread through fecal matter. It turns out (NIH scientists found) that they can infect the salivary glands — of mice, at least — and be spread through saliva.

The transmission of these so-called enteric viruses through saliva suggests that coughing, talking, sneezing, sharing food and utensils, and even kissing all have the potential for spreading the viruses. The new findings still need to be confirmed in human studies.

Monoxide to the gut

Sure, carbon monoxide can kill you if you inhale it, but if it doesn’t kill you it can make your stronger. Specifically, it can reduce inflammation (and help tissues regenerate) in the digestive tract.

But how do you get a gas into the gut? Two words: Pop Rocks. Yes, the fizzy candy. MIT researchers “came up with the idea of incorporating the gas into a foam, much the way that chefs use carbon dioxide to create foams infused with fruits, vegetables, or other flavors.”

They were able to control the dose and the delivery rate, and deliver the gas so it could reach the lower GI tract and even the liver, where (in mice) it “greatly reduce[d] the amount of inflammation and tissue damage seen there.”

Another potential Alzheimer’s breakthrough

An antidepressant (imipramine) and an antipsychotic (olanzapine) seem to have a significant effect on people with Alzheimer’s. Researchers at the University of Colorado were looking to target something other than amyloid-beta and tau buildups. They focused on the the APOE4 protein, which increases Alzheimer’s risk.

Both imipramine and olanzapine “block the catalytic effect of APOE4 on the formation of amyloids in the brain,” so they hoped their retrospective study would find some effect. It turned out to be a lot stronger than they expected.

“The people who received these drugs developed better cognition and actually improved in their clinical diagnosis. Compared to those who did not take these drugs, they reverted from Alzheimer’s disease to mild cognitive impairment or from mild cognitive impairment to normal.”

Next up: rodent tests and possibly human trials.

Elmo doesn’t know APA citation style

Fresh off his battle with Big Bird, United States Senator Ted Cruz is now picking a fight with … Elmo. The issue: Elmo urged that kids be vaccinated against Covid, but didn’t cite the scientific evidence in his tweet.

Neurons of nausea

Fun fact: We don’t exactly know what causes nausea, which makes anti-nausea drugs hit-or-miss. But now a Harvard neuroscience postdoc has found a major clue.

Meet the brain’s area postrema, part of the medulla oblongata. Some neurons there, it turns out, induce nausea*. Good to know. But even better, some others inhibit it. And even better better, a hormone called glucose insulinotropic peptide (GIP) activates those inhibitory neurons. And when they’re activated — presto! No nausea!

Finding the neurological target is step one; confirming it comes next. And then … you know the mantra: “Further research is needed to translate the finding into anti-nausea therapies.”

* “Electrical stimulation of the region induces vomiting” — fun!

When you can’t decide between “Nautilus” and “Queen of the Sea”

Get ready for your booster (maybe)

A panel of FDA advisers has sorta kinda recommended Covid-19 vaccine boosters for the fall.

Important notes:

• This was an advisory panel, not (yet) the full FDA.
• They didn’t decide whether the recommendation will cover everyone or just vulnerable people.
• Still up in the air is how the booster will tackle Omicron — what subvariant(s) it will target, and whether it will also include the original variants as well.

While we’re talking about the vaccine…

Covid vaccines have saved almost 20 million lives (and probably more) according to a model out of Kings College, London — most importantly, that included 1.9 million Americans.

It’s full of math, and it’s based on excess deaths, vaccine effectiveness,

There are a bunch of caveats that will keep statistics geeks happy for months, e.g., if there hadn’t been vaccines, would mask-wearing patterns have been different? Would there have been more lockdowns? Did Bill Gates’s microchips encourage riskier behavior*?

Still, “We may disagree on the number as scientists, but we all agree that Covid vaccines saved lots of lives.”

* E.g., upgrading to Windows 11 before the kinks are worked out

Faster, better, easier stroke treatment

A clot-busting drug used against heart attacks also works to treat strokes.

Canadian researchers found that not only did tenecteplase work quite nicely in a clinical trial, unlike the current treatment (alteplase), tenecteplase “can be administered as a single immediate dose” — no infusion pump or hour-long wait needed.

That, say the Canucks, makes it — wait for it — a “game-changer.”

Diabetes target switcheroo

In diabetes, the immune system attacks the beta cells that produce insulin. (You knew this.) So it makes sense to try to fix the immune system.

But what if in this case we should blame the victim? What if — as University of Chicago researchers figure — it makes more sense to target the beta cells? What if they’re doing something to trigger the immune system?

“The immune system doesn’t just decide one day that it’s going to attack your beta cells. Our thinking was that the beta cell itself has somehow fundamentally altered itself to invite that immunity.”

You bet they did it. The key in mice is a gene called Alox15 that makes an enzyme that causes an immune response. Knock out Alox15 and the immune response is reduced — and the mice didn’t develop diabetes. “[T]he immune onslaught was completely suppressed, even though we didn’t touch the immune system.”

So… wow?

The spy in your pocket

In the fine print of many of the apps women use to track their periods (for example, to plan a pregnancy) is a little clause — it says that the app makers “reserve the right to share data with law enforcement at their discretion.”

So, should women in states where abortion is illegal worry? Yep.

This time let’s try to be ahead of the curve

“Biden administration to widen access to monkeypox vaccine” — to vulnerable people, and to areas where the pox is spreading.

Water cooler facts: There are two version of the vaccine:

1. The “old school” version, developed for smallpox. It’s not just a shot, it’s a special two-pronged needle that needs to be dipped and applied and … whatever. The point is, not everyone knows how to give it. We have a lot of this available.
2. The new, modern, monkeypox-specific version, called Jynneos and manufactured by those shifty Danes. We don’t have much of this, but more is being made and shipped.

The Long Read: Price Gouging edition

How do drug companies keep raising and raising the price of drugs, far faster than inflation and claiming (falsely) that those prices are necessary for innovation (while maintaining a crazy 77% profit margin)? By “Breaking The Rule Of Drug Pricing In America.”

“I think it’s a moral requirement to make money when you can … to sell the product for the highest price.”

Pain, schmain, let me sleep

If you’re in pain, wait till morning if you need the ER. Physicians working late into their shifts — i.e., who are sleep-deprived — have less empathy for patient pain and thus prescribe fewer painkillers. So found a joint U.S.-Israeli study of prescribing habits.

Looking at more than 13,000 medical records…

The study found the physicians’ propensity to prescribe analgesics to patients presenting with severe pain during the night shift was 11% lower in Israel and 9% lower in the U.S.

Who’s the best pharmacist you ever saw?

Do you know an amazing independent pharmacist? Of course you do — but do you know one who should be the independent pharmacist of the year?

Don’t tell us — tell NCPA. It’s looking for nominations for the Willard B. Simmons Independent Pharmacist of the Year, and you have until July 13 to submit your nomination.

Laird Miller received the award in 2018, and Ira Katz snagged it last year. Let’s go for the trifecta!

Click here to download the PDF nomination form. Then fill it out, gather any supporting documentation you can (news clippings? photos? letters?) and either email it to donna.johnson@ncpa.org or fax it to (571) 549-4013.

Questions? Email Donna Johnson at that address, or call her at (703) 683-8200.

D is for diabetic bone density

Vitamin D, the gift that keeps on giving. The latest: Diabetics taking canagliflozin (or another SGLT2 inhibitor) can suffer from bone loss as a side effect, and vitamin D supplements can help.

University of Maryland researchers found that people with low vitamin D levels “have an even higher risk of bone loss and possible fracture when taking SGLT2 inhibitors.” But given supplements helped reduce that risk by boosting levels of a hormone that regulates calcium levels in the blood.”

More research is needed, as always, but for now:

“[W]e recommend that patients and physicians consider the possibility of taking vitamin D supplements to restore normal vitamin D status in vitamin D-deficient patients receiving (or who will receive) SGLT2 inhibitors.”

Supreme Court ruling* — what you should know

This isn’t directly about pharmacists, but it’ll affect you: The capital-C Court has ruled that prescribers can only be held liable for illegal prescriptions if they knew it was not lawful … and the government can prove that.

In other words, per SCOTUS, the government can’t say “they should have known” — it has to be “they did know.” As for you, dear pharmacists:

This consolidated case has implications not only for prescribers of controlled substances but also for pharmacists and pharmacies who are subject to a “corresponding responsibility” to only fill prescriptions issued for a legitimate medical purpose.

Disclaimer: This is an occasionally snarky pharmacy newsletter, not a legal opinion. Seriously, talk to your attorney if you have questions.

* What, you thought we were gonna talk about a different ruling?

Money money money

Premiums set to jump (how high?)

The income cap for Obamacare subsidies was removed because of the pandemic, but it’s set to come back after this year. In short, that means about 13 million Americans could be looking at a huge jump (we’re talking 50%) in their health insurance premiums unless Congress renews the tax credit that was part of the two-year American Rescue Plan. As usual, yeas and nays fall along partisan lines.

Diabetics: borrowing to live

A new survey finds that almost 4 out of 5 diabetics in the U.S. have borrowed money, usually from credit card companies, to pay for their insulin, “with the average credit card debt reaching $9,000.”

According to CharityRx, the average American diabetic currently spends about $400 per month on insulin. A bill that passed the House in March would cap consumer out-of-pocket costs for insulin at $35 a month, but it wouldn’t affect people without insurance.

An HIV med could help with … Down syndrome?

Mice with Down syndrome that were given lamivudine — a common HIV antiretroviral drug — showed improved cognition.

Biomedical researchers in Spain believe that both HIV and retrotransposons (which cause some of the effects of Down syndrome) require the same enzyme to function — an enzyme that lamivudine blocks. “Therefore, we thought that it could be useful to counteract the cognitive impairment associated with Down syndrome.”

And — at least in a preliminary experiment, it worked: “They found that mice receiving lamivudine showed improved cognition.”

Next up are clinical trials for people with Down syndrome and Alzheimer’s.

MRSA news

The bad news

A highly antibiotic-resistant strain of MRSA — called CC398 — is dominant in European livestock, has persisted for decades … and can jump to humans.

The good news

After a successful phase-3 trial, Switzerland’s Basilea Pharmaceutica has filed for FDA approval for its antibiotic ceftobiprole.

If it gets a green light, it will be the first antibiotic in the beta-lactam class to [be approved for] the treatment of SAB S. aureus, including hard-to-treat infections caused by methicillin-resistant strains (MRSA).

Weird science: Intermittent fasting repairs nerves

Nerve damage is often permanent — they don’t regenerate, and surgery is rarely effective. But here’s an odd twist: Mice with damage to their sciatic nerve were put on an intermittent-fasting diet (alternating eating as much as they like one day, fasting the next).

The result: The mice’s gut bacteria began producing more of a metabolite called 3-indolepropionic acid, or IPA. And IPA is used by the body to regenerate the axons in nerve fibers.

In fact when British researchers examined the mice, “The length of the regrown axons was measured and was about 50% greater in mice that had been fasting. […] This suggests that the IPA generated by these bacteria has an ability to heal and regenerate damaged nerves.”

If you said, “Wait, what?” you’re not alone.

“I think the power of this is that opens up a whole new field where we have to wonder: is this the tip of an iceberg? Are there going to be other bacteria or bacteria metabolites that can promote repair?”

Preventing long Covid?

One potential culprit for long Covid — symptoms lasting for months after the disease is done — is (are) microscopic blood clots. So the Brits are looking into whether blood thinners might protect people from getting long Covid in first place, or treat those who are dealing with.

“There needs to be more dedicated studies looking at the efficacy of anticoagulants [for long Covid], just like how we did with [treatments for] the acute unwell patients.”

The flu shot and Alzheimer’s

Vaccination twist: Getting the flu vaccine appears to cut your risk of acquiring Alzheimer’s by 40% over the next four years. And the more years you get the vaccine, the better the protection. “[T]he rate of developing Alzheimer’s was lowest among those who consistently received the flu vaccine every year.”

During four-year follow-up appointments, about 5.1% of flu-vaccinated patients were found to have developed Alzheimer’s disease. Meanwhile, 8.5% of non-vaccinated patients had developed Alzheimer’s disease during follow-up.

Researchers at the University of Texas Health Science Center tracked the health records of almost 2 million people to figure this out, although they don’t know why it’s the case. In fact, they don’t think it’s about the flu part of the flu vaccine — they’ve found evidence that other shots produce the same effect.

Money quote: “Clearly, we have more to learn about how the immune system worsens or improves outcomes in this disease.”

The mice are alright

If you’ve been worried about how your mouse friends might be handling the latest Covid surge, we’ve got good news.

Georgia State University biologists found that mice who caught the omicron variant got less sick, had half as many deaths, and lived longer than those exposed to the alpha, beta, or delta variants — despite having far more mutations.

Six months to quit smoking

If someone is discharged from the hospital and told to quit smoking, a ‘quit smoking’ hotline doesn’t work as well as a program run by a health system that that combines medication and therapy.

Hopefully, that’s not much of a surprise.

But an interesting tidbit that researchers at Mass General Hospital found: The advantage lasts about six months. Thus, they suggest, three-month smoking-cessation programs should become six-month programs to do the most good.

Monkeypox updates

It’s evolving faster than a 16-year-old’s Pokémon collection

There was a monkeypox outbreak a few years ago (2018–19), but the strain going around today is different — a lot different, virus-wise. Depending on the headline you choose, it “may have undergone ‘accelerated evolution’,” or it “Has Mutated at an Unprecedented Rate.”

In all, the virus carries 50 new mutations not seen in previous strains detected from 2018 to 2019 […]. Scientists usually don’t expect viruses like monkeypox to gain more than one or two mutations each year.

If this was a cheesy sci-fi movie, you might yell at the screen, “That’s not how it works!” Apparently, you’d be wrong.

… and there’s probably a lot more out there

The U.S. does a lot of things right (national parks, Hollywood, free ice in restaurants), but one place we’re always playing catch up seem to be wide-scale healthcare. It’s no different with monkeypox: Lack of testing (who expected this‽) means the number of actual cases is probably a lot higher than the number of reported cases.

“We have no concept of the scale of the monkeypox outbreak in the U.S.,” says biologist Joseph Osmundson at New York University.

One big problem: “[T]he testing system set up by the CDC stopped functioning well, because it actually deters doctors from ordering a monkeypox test.”

Gut bacteria vs salt

Let’s say you love salt. But you also love your kidneys and your (low) blood pressure. Can you have your potato chips and eat them too?

Maybe, say researchers from Augusta University — if you’re a rat. Particularly a female rat. They found that the gut bacteria of rats given inulin supplements (a prebiotic fiber found in artichokes, chicory root, and onions) fermented the fiber in their large intestines. For whatever reason*, that fermentation protected the rats’ from the effects of salt.

Female rats on the inulin diet had lower blood pressure than their counterparts fed non-fermenting fiber. Though male rats did not show this same reduction in blood pressure, both sexes had less protein in their urine and damage to their kidneys than controls.

* More studies are needed.

Covid booster news

Pfizer has joined Moderna in announcing an updated Covid-19 booster that it says is more effective against Omicron. In Pfizer/BioNTech’s case, it’s two boosters: One targets just the omicron variant, one is an original vaccine with Omicron protection added. (Both work well, says the company.)

The question is, will the updated vaccines offer more than the six months protection the current ones provide?

Stay tuned, as health officials are considering what to recommend for the fall back-to-incubator season.