And then there were none

The FDA has ended the emergency use authorization for bebtelovimab — the last remaining antibody therapy for Covid-19. It doesn’t work against the variants now circulating.

This means if Paxlovid doesn’t work for someone, and they end up in hospital … there’s not a lot to be done. The best remaining treatments are molnupiravir (not very effective) and intravenous remdesivir.

Why they serve

Meet a couple of the amazing folks who are serving as volunteer board members for the Georgia Pharmacy Foundation. Why do they give their limited time to serving the foundation?

Sharon Deason, GPhF Board Member

“Pharmacy has provided so much for me in my life. It was not just a job, but a profession. After retiring, I still felt I could give something to help and serve others — so now I volunteer my time on the Georgia Pharmacy Foundation board. Meeting the students and newly graduated pharmacists has given me hope for the future of pharmacy.”

Tracie Lundie, GPhF Board Member

“I want to ensure I find ways to give back and help shape the profession I love so much. Serving on the Georgia Pharmacy Foundation board allows me to contribute to my profession in a meaningful way and to help shape the profession with scholarship opportunities for students and development opportunities through Leadership GPhA.”

Please click here to give a gift to the Georgia Pharmacy Foundation this year, and support a legacy of service in the pharmacy profession, and the people volunteering their time to ensure it lasts.

Garbage in, pharma out

Let’s say you have a garbage patch. A Great Pacific Garbage Patch. It’s filled with microplastics and other debris.

And let’s say you want to do something with that plastic. Unfortunately, a lot of it is polyethylene, which is only about 30 percent recyclable.

The obvious solution is to create a two-stage process: First you use pressure and chemicals to break down the the plastic into diacids, then you genetically engineer a fungus (Aspergillus nidulans) to turn those diacids into “significant quantities of antibiotics, cholesterol-lowering statins, immunosuppressants and [ironically] antifungals.”

And that’s exactly what USC pharmacy/chemical researchers did.

“We developed conditions where it is possible to get 83% of the mass of the polymer recovered as discrete, useful products. We can even take a low-density product like a plastic grocery bag and recover about 36% of those discrete monomers — that’s unheard of in polyethylene recycling.”

Gravity sucks

The good news: Gastroenterology researchers at Cedars-Sinai have a theory about the cause of irritable bowel syndrome.

The bad news: It’s gravity. Yep, that pesky fourth force of nature could be one of the causes of IBS simply by tugging our guts down. At least in theory.

“Our body systems are constantly pulled downward. If these systems cannot manage the drag of gravity, then it can cause issues like pain, cramping, lightheadedness, sweating, rapid heartbeat and back issues — all symptoms seen with IBS. It can even contribute to bacterial overgrowth in the gut, a problem also linked to IBS.”

Making chemo tolerable

For patients taking cisplatin — the OG cancer drug — side effects can be a huge problem. Huge as in “stop taking the meds” huge. But an existing drug may reduce those side effects without affecting the important stuff.

It’s istradefylline, according to Michigan State researchers. The Parkinson’s treatment.

They aren’t 100% sure why it works, but the prevailing theory is that cisplatin stresses cells so they release adenosines; istradefylline stops that release.

So far it’s only been tested in preclinical trials, but the fact that istradefylline is already FDA-approved will mean human testing can happen a lot faster.

AMD meds: One is better

One of two drugs for treating age-related macular degeneration is better than the other. A study out of Johns Hopkins found that aflibercept was better than bevacizumab.

[N]early half of patients treated with aflibercept could safely stop eye injection therapy after one year without further vision loss. Only 17% of patients taking […] bevacizumab, were able to safely wean from the drug at a year.

In fact, they say, “[P]otentially a third of patients with wet AMD could safely pause therapy after one year of monitoring by a physician.”

Non-pharma science

Questions I never thought to ask: Do color-blind people experience seasonal affective disorder as much as regular folks? (Yes, probably. The mechanism for SAD isn’t known, but it seems to be via a different pathway than color perception. It might even be related to vitamin D production. (Reddit thread.)

Looks like the folks at Medical Xpress have an opinion

Oh no no no no no^*

The CDC is tracking a new Covid omicron subvariant: XBB, “which has grown to make up an estimated 3.1% of new infections nationwide.”

It’s “believed to be a recombinant of two different Omicron subvariants — BA.2.10.1 and BA.2.75,” so naturally they named it XBB.

(Seriously, folks, Wikipedia lists dozens of alphabets. If Greek isn’t cutting it, what’s wrong with, I dunno, Ge’ez — Hoy, Läwe, Ḥäwt…?)

(They refer to the variant-detection effort as “part of an ‘Avengers-Like’ program” — because after “Operation Warp Speed” they ran out of Star Trek metaphors. Good grief.)

^* This is literally what I said when I saw the headline.

You can help stop monkeypox (and get CPE, too)

It’s part 2 of GPhA’s Unwanted Gifts CPE series — helping pharmacists and technicians prevent the spread of infectious diseases, that is. (Although we’re available to help stop the spread of

Tuesday, December 6 debuts a new holiday classic: MmmPox (ba duba dop, ba du pox)^*

Pox in box? Or socks? Or rocks?

From 7:30 – 8:30pm, Tracy Dabbs from the Georgia DPH will teach you everything you need to know about monkeypox — where it came from, how it’s treated, and when and how to vaccinate.

Help stop the spread of this very annoying disease and get an hour of CPE from the comfort of your living room or Panera booth. Click here for info and to register!

^* I don’t get it, but Teresa and the education folks do. It has something to do with Hanson or the Children of the Corn or something. Whatever. It’s a timely subject, so you don’t have to understand the name.

Biomarker news

For Alzheimer’s

Chinese researchers have identified what could be a simple, early marker for Alzheimer’s — formic acid.

The study found that urinary formic acid levels were significantly increased in all the Alzheimer’s groups compared with the healthy controls, including the early-stage subjective cognitive decline group, and correlated with a cognitive decline. This suggests that formic acid could act as a sensitive biomarker for early-stage Alzheimer’s disease.

For long-term Lyme disease

Only about 80 percent of people who get Lyme disease have it eradicated — that other 20 percent end up with long-term complications. Worse, Lyme isn’t always identified as the cause until the disease progresses.

But researchers at Mount Sinai ’s Icahn School of Medicine have found a set of genes that express more when the immune system responds to Lyme infection. By narrowing down the genes that patients expressed, they eventually “identified 35 genes that could be used as biomarkers to potentially diagnose patients with long-term Lyme disease.”

The goal is a simple test that could allow for the disease to be identified and treatment to begin more quickly.

Stop the presses!

Having a dull day? Let Drug Store News put some zing back into your life with “12 exciting generic introductions that recently hit the market.” Heck, according to the article, they aren’t being introduced so much as unleashed.

It’s actually 12 companies and 17 new products — generics for: Avastin^*(x2), Clindagel, Combigan, Compazine, Dotarem, Epiduo Forte, Faslodex, Lucentis, Neupogen^*, Oxacillin, Pathocil, Revlimid, Samsca, Solaraze, Vesicare, and Zovirax.

^* Technically a biosimilar, not a generic

How bacteria resist

We know that bacteria can become resistant to antibiotics, but exactly how that happens isn’t always clear. It’s important to know, though, because that can inform the next line of treatment.

Aussie researchers just discovered one way bacteria resist — a new way, in fact. Instead of making their own folates (which they need to grow), they learn to take them from the human host instead.

That’s a Big Deal because some antibiotics work by preventing bacteria from producing folates. Once the germs learn to steal them instead, that kind of drug won’t work anymore.

There’s bad news: This kind of resistance is undetectable with routine checks, so prescribers might simply offer more of the same ineffective drugs. And…

“Unfortunately, we suspect this is just the tip of the iceberg — we have identified this mechanism in Group A Strep but it’s likely it will be a broader issue across other bacterial pathogens.”

And the winner of the Best Illustration of the Amoxicillin Shortage goes to …

MPR News and Getty Images!

FDA releases guidance on compounding amoxicillin

Technically it’s not amoxicillin that’s in shortage so much as ‘pre-packaged amoxicillin delivery’ — the pills, capsules, and liquids that are easily dispensed. Thus the FDA has released guidance for pharmacists to compound amoxicillin to help alleviate that shortage.

(Monstrous caveat: As the good folks at the Alliance for Pharmacy Compounding told us, this isn’t something you can do without training. “The amoxicillin thing is challenging even for a compounder to do right.” If you want to get training in compounding, you’ll need to reach out to a company that provides it, like Letco (now part of Fagron), Medisca, or PCCA.)

What did China do wrong?

A (mostly) compliant population, an authoritarian government, nationwide lockdowns, mass testing, vaccine availability, and its trademark Zero-Covid™ policy … and yet China is reporting tens of thousands of new Covid-19 cases for the first time since the start of the pandemic.

So what went wrong? It (mostly) boils down to three issues:

• A substandard vaccine — reliance on a home-grown vaccine rather than turn to Germany (BioNTech) and the U.S. (Moderna) like the rest of the world.
• Not vaccinating the elderly (partly a result of a focus on reducing transmission rather than protecting people)
• The rise of the ultra-transmissible omicron variant

The underprepared health system doesn’t help, either.

Elsewhere (ICYMI): How Could This Be Happening? edition

At least 19 children in Ohio have the measles (many of them under 5 years old) — and half have been hospitalized. Because their parents didn’t vaccinate them.

Measles had been virtually eradicated in the U.S. in the early 2000s. Two doses of the vaccine are 97% effective and the immunity lasts for life; the microchips and chemtrail emitters were removed in the late ’70s.

Good news for people taking ADHD meds

Squirrel! Also, there doesn’t seem to be any cardiovascular risk to taking ADHD meds like Adderall or Ritalin— at least according to “a meta-analysis of 19 observational studies with more than 3.9 million participants” out of Sweden.

An earlier study older people had found an increased risk, but the thought is that older folks’ risk might be higher because of the other drugs they’re taking (and whatever interactions those might cause).

Is this the final word on stimulants and CV risk? Hahahahahahahaha … no.

Kids and iron: Supplement early

Having an iron deficiency is bad for kids’ brains; it essentially makes them not as smart as they could be. But here’s an even more important reason for parents to check their kids’ levels: University of Toronto researchers found that kids with chronic iron deficiency showed lower cognitive scores than their peers even a year after dietary and supplement intervention.

Urgent, urgent (but no emergency)

Both the American Academy of Pediatrics and the Children’s Hospital Association want the White House to declare a national emergency over the widespread and growing waves of respiratory viruses — flu, RSV, and Covid-19 — that are filling hospitals.

But the Biden administration said, “Not yet.”

The organizations are hoping to get access to federal emergency funds to help alleviate capacity and staffing issues, but HHS said that at this point it’s helping on a case-by-case basis.

(CDC figures show that the pediatric hospitalization level in mid-November was peaked at “twice as high as any other season on record.”)

Quinoa and the gut

Like most people, you’ve probably been at a party where someone asked, “How does quinoa affect the gut microbiome of men?” If you were at a loss for an answer, good news: Now we know, thanks to a British study published in the journal Nutrients.

The conventional wisdom held that, as a whole grain that’s popular with hipsters, quinoa would benefit the gut biome and thus the body. But that turns out not to be the case.

The current study revealed that four weeks of consuming quinoa-enriched bread did not alter specific bacteria phyla and genera composition or the [diversity] of the gut microbiome.

So there’s nothing wrong with eating quinoa (provided you can pronounce it properly), but don’t expect huge health benefits.

Your post-Thanksgiving news story

“Bloating Common Issue Among Americans, Study Reports”

Cannabis in the news

Did you know that legalization of marijuana is “linked with increased alcohol drinking”?

Or how about that cannabis oil, unfortunately, doesn’t help improve pain or quality of life for cancer patients in palliative care?

In fact (despite claims from Skeeter at the mall) a new meta-analysis of randomized trials found that nope, there was “no significant difference between cannabis and a placebo for reducing pain.”

And young adults are quitting smoking (it’s down to 11% in the U.S.), while switching to pot — and so are their parents.

The bottom line: Cannabis studies get a lot of media coverage (according to Swedish neuroscience researchers).

Pfizer CEO’s oopsie

See if you can figure out where Pfizer CEO Albert Bourla crossed the line:

“Covid in schools is thriving,” he told the BBC in an interview a year ago. And that, he said, made him believe that Covid vaccines should be available to five- to 11-year-olds, as they already were in the U.S. “[T]here is no doubt in my mind that the benefits, completely, are in favour of doing it.”

Did you catch his big mistake?

A complaint filed with the UK’s Prescription Medicines Code of Practice Authority called those statements “disgracefully misleading” (kids don’t really need the vaccines, they said) — and the PMCPA seems to agree. Bourla apparently broke the UK’s rules…

…including by misleading the public, making unsubstantiated claims, and by failing to present information in a factual and balanced way.

Imagine how quickly social media would collapse if people here were punished for “misleading the public, making unsubstantiated claims, and […] failing to present information in a factual and balanced way.”

The conspiracy theories will see you now

If you’re tired of getting accurate information about Covid-19, you can always turn to Twitter. Elon Musk quietly ended the platform’s policy of removing medical misinformation, saying that freedom of speech also protects lying.

Most major companies have already pulled their advertising from the platform; the Twitter death watch continues.

None dare call it monkeypox

The WHO has officially renamed monkeypox to mpox because the name apparently has “some negative connotations and stigma associated with it.”

Left unchanged are buffalopox, camelpox, canarypox, chickenpox, cowpox, dogpox, fowlpox, goatpox, horsepox, mousepox, pigeonpox, quokkapox (!), rabbitpox, sealpox, sheeppox, squirrelpox, swinepox, and turkeypox.

You’ll still be able to search the ICD for monkeypox, and there are no legal implications.

Time for DHA to check its mailbox

Last week we told you about the letter — led by Georgia Representative Buddy Carter — being sent to the Defense Health Agency, asking for it to come to a December 7 listening session and, well, listen.

Sure, Tricare has invited independent pharmacies back into the fold, but it’s still offering low reimbursements — sometimes lower than the wholesale price of the meds. Carter et al. ain’t having it, calling that an “impossible choice” for both community pharmacies and Tricare beneficiaries.

The letter (see it here) has officially been sent to Lt. Gen. Ronald Place, who will hopefully respond….

HIV be upon you

Fruitcake, ugly ties, Veiny Cheese of the Month Club — there are plenty of unwanted gifts being given. HIV doesn’t have to be one of them.

You can help, o pharmacy professional!

GPhA is offering “Getting PrEPared for the holidays,” a new CE course on HIV pre-exposure prophylaxis — a live webinar tonight from 7:30 – 8:30pm. It’s part of our holiday season “Unwanted Gifts” series of courses.

Grab an hour of CE on a hot topic before the year is out. Check out the details at GPhA.org/unwanted, sign up, and join us tonight!

Future vaccines

The latest potential universal flu vaccine

This one comes out of the universities of Pennsylvania and of Pittsburgh, and is based on the same mRNA technology as today’s Covid vaccines.

In tests in mice, the team found that the animals generated antibodies specific to all 20 strains of the flu virus, and these antibodies remained at a stable level for up to four months.

The team also created mRNA vaccines for specific flu strains, and those protected the mice (and, later, ferrets) even better.

All this is good news for mice and ferrets, but previous tests of “universal flu vaccines” have failed when it came to humans, so as always, wait and see.

UTI vaccine (for rodents)

If you have a mouse or rabbit and worry about it contracting a UTI, good news! Duke researchers have developed a vaccine to prevent UTIs by training the immune system to attack UTI-causing bacteria.

[T]he vaccine delivery method was found to elicit an immune response in the urinary tract due to similarities between the mucous membranes lining the urinary tract and the mouth. The pills the team created were administered under the tongue and are dissolved in saliva.

Even better, no pesky injections needed (and we know how vicious rabbits can be). The vaccine comes in a shelf-stable pill that dissolves under the tongue.

Next up: human trials.

Lamarck continues to laugh in his grave

If you give a rat ifosfamide, it’s going to ask you to keep an eye on its children and grandchildren^*.

It seems that young (rodent) patients that received chemotherapy have children and grandchildren that are more susceptible to disease. “[T]his is one of the first-known studies showing that susceptibility can be passed down to a third generation of unexposed offspring.”

What’s to be done for patients? Not much.

Given this study’s implications, the researchers recommend that cancer patients who plan to have children later take precautions, such as using cryopreservation to freeze sperm or ova before having chemotherapy.

^* And a cookie

Needles in the brain

How do you attack brain tumors without killing the (rather important) tissue around them? If you’re a University of Saskatchewan biomed engineer, you stick long needles into patients’ skulls and electrocute the tumors. (But you don’t put it that way, of course.)

The important piece of info: Glioblastoma cells “can be killed with a smaller electrical field than would kill surrounding healthy tissues.”

The bonus prize: The technique also disrupts the blood-brain-barrier, allowing anti-cancer drugs to be delivered in lower, targeted doses.

The next step: Combine the treatments into a viable one-two electricity/immunotherapy punch.

ICYMI: Oyster health warning

We try not to fetish-shame here at Buzz, but there are apparently people who willingly eat raw oysters. If you know someone like that, during the next visiting hours make sure they avoid eating any, lest they discover the joys of sapovirus^*.

Georgia is one of 13 states where the FDA says restaurants have been sent shipments of contaminated oysters.

The good news is that it only applies to oysters harvested from South Korea’s Designated Area Number II. The bad news is that you have no idea what that means.

^* There are no joys of sapovirus.

Named for Pandora (as in “Pandora’s Box”)

Once again we learn that today’s scientists simply do not read enough science-fiction or watch enough horror movies.

The latest gaffe: French scientists have “reawoken” a 48,500-year-old pandoravirus from melting permafrost in Russia’s Yakutsk region (see map). They’ve isolated several other ancient viruses, but have not yet revived those.

The team introduced the viruses into a culture of live amoebae, showing that they were still capable of invading a cell and replicating.

Their goal, they say, is to reawaken these microbial threats so they can be studied before they awaken on their own.

Science marches on

“Genetically modified tobacco plant produces cocaine in its leaves” (“…which could help people manufacture the drug for scientific study.”) Mm hmm.

Next up: “THC-producing gene grafted into kudzu.”

Dealing with the amoxicillin shortage

The amoxicillin shortage is expected to last for months, so the American Academy of Pediatrics has released its guidelines for alternatives.

First, because physicians don’t seem to be getting the message, don’t prescribe antibiotics for viral illnesses.

Second, there are amoxicillin formulations that aren’t in shortage, where doses can be adjusted. Compounding is another option — even something basic: “they can open capsules and split chewable formulations and mix them with liquid or a semisolid such as applesauce.”

And, of course, there are other antibiotics. The AAP has a helpful page with the details, including a handy chart.

You have another target? An anti-Covid target?
Then name the protein!

European and British researchers have discovered a “pocket” on the SARS-CoV-2 virus that they say offers a new and better target than the spike protein for delivering medication.

The Nsp1 protein was ignored as a target because it didn’t seem to have any holes/cavities/doors to send a drug into. But that’s because no one used experimental screening and X-ray crystallography techniques. Until the Swiss.

[They] revealed the existence of a ‘‘hidden’’ cavity on the surface of Nsp1, which could be the target of future drugs against SARS-CoV-2.

Why is this better? Because the spike protein can change between variants, and this gives drug developers another target for a potential universal Covid vaccine.

Why diabetics go to hospital

People with type 2 diabetes tend to be hospitalized more than other folks, and there’s a surprise reason: anemia. That’s what Aussie researchers found when they decided to look into why type-2 diabetics were hospitalized more.

“While it’s known that diabetes can contribute to anaemia through reduced iron absorption, gastrointestinal bleeding and through complications that cause anaemia, it was unexpected to see the association between diabetes and iron deficiency anaemia feature so significantly as a complication.”

Another reason: Other hospitalizations are declining. “Because we now have better diabetes management, the proportion of those presenting to hospital with cardiovascular disease and kidney disease is reducing.”

Skin in the game

It puts the lotion on its skin…

…so your baby doesn’t get eczema.

Researchers in China analyzed data from 3,500 infants in 11 trials and found that “early application of skin emollients can effectively prevent atopic dermatitis development in infants.”

But which is best? In general, creams, emulsions, and combos all worked well, but if pressed they would say “emollient emulsion may be the best option.”

Antibiotics and acne

Treating severe acne with systemic antibiotics is a bad idea. Or at least an idea that needs to be weighed against the effects on a teen’s skeleton.

It’s the good ol’ gut biome at work again. Long-term use of, say, minocycline, obviously affects gut bacteria. What Medical University of South Carolina researchers found is that those sustained changes to the gut biome will “lead to reduced bone maturation.”

Which one had acne?

Oh, yeah, and once the treatment has been going on a while, there’s no turning back. “[T]he microbiome and the skeleton aren’t able to recover fully after antibiotic therapy.”

Artificial sweeteners — saving you a long read

The paper (in the journal Nutrients):

“No Association between Low-Calorie Sweetener (LCS) Use and Overall Cancer Risk in the Nationally Representative Database in the US: Analyses of NHANES 1988–2018 Data and 2019 Public-Use Linked Mortality Files”

The gist: Low-calorie sweeteners — including saccharin and aspartame — don’t increase cancer risk, but they do increase the risk of obesity and diabetes.

It’s called “investing”

Healthy people pay more taxes. They work more, produce more, and are generally nicer to be around. So investing in healthy neighbors makes sense.

Tree planting in Portland

They (a non-profit group called “Friends of Trees”) planted 50,000 trees in Portland, Ore., just to make neighborhoods look nicer. But they also kept careful records. A decade later, U.S. and Spanish researchers looked into this “natural experiment.” They found that the more trees were planted in an area, the lower the mortality rate, especially for cardiovascular and respiratory causes and “particularly for males and people over the age of 65.”

And even though it can cost thousands of dollars a year to maintain 140 trees (one in each of Portland’s areas). No matter. Those 140 trees give back “around $14.2 million annually in lives saved.”

Even better: The older the tree, the more it does; a10-year-old tree has double the effect of a new one.

Covid vaccinations in New York

What was the return on investment for the almost $30 billion New York City spent on its Covid-19 vaccination program? When you take into account how much was saved just on healthcare spending and productivity loss, a big big study published in JAMA Network Open found that the ROI was — wait for it — 1019 percent.

[E]very $1 invested in the New York City vaccination campaign yielded an estimated $10.19 in cost savings from lower infection and mortality rates, fewer productivity losses, and averted health care use.

And that’s direct effects. As the ripples spread — more police on the job, more airport workers, more sales people, more production — that savings is even more.

Congress to Tricare: Listen up

Led by Georgia’s own Buddy Carter, 49 members of Congress have signed a letter inviting Defense Health Agency Director Ronald Place to a listening session regarding the the Tricare/Express Scripts contract.

They expressed their “grave concerns about the impact our service members, military retirees, children, and many others are facing” with the current contract that, as written, will force many independent pharmacies to leave the network.

DHA’s decision has come at the expense of small businesses, independent community pharmacies, specialty pharmacies, long-term care pharmacies, and most importantly the beneficiaries they serve.

So they invited Gen. Place to a December 7 listening session ‘with impacted stakeholders, members of Congress, and staff’. Will DHA attend? What will come out of it? Stay tuned. In the meantime, click here to read the letter (PDF).

How high can we go?

The FDA has approved Australian drugmaker CSL’s gene therapy for hemophilia B. And CSL has set the price at three (point 5) … million … dollars.

CSL CEO Paul Perreault in an undated photo

This makes it the world’s most expensive treatment (thankfully it’s a one-time thing), edging out a previous gene therapy^*.

Hemophilia B affects about 1 in 40,000 people, so [does math] that’s about 9,200 Americans, or 32.4 billion-with-a-B dollars.

^* As well as a bottle of Mother Teresa’s tears and a cartridge of magenta printer ink.

In unrelated news…

The pharmaceutical industry’s reputation is diving like the Russian military’s. It’s not quite yet at it’s pre-pandemic low (when 32% of Americans viewed it positively), but it’s way off its high in February 2020 (62%) — and it’s dropped 10% since this time last year.

Who’s gonna pay for all this?

All of us, of course — that’s how insurance works. But imagine if there was only one body shop in town, and car insurers had to pay whatever it felt like charging, no negotiating. How high would your premiums be?

High healthcare costs don’t just affect Medicare. Private insurers have a little more negotiating power, but they’re still on the hook — and that means employers’ premiums go up, and, like other things, that’s gonna roll downhill.

What’s the endgame? With a divided Congress, who knows?

Whatever doesn’t kill you

Mild to moderate stress — like Cousin Rodney’s plus-1 becoming a plus-6 (as opposed to, say, expecting the Spanish Inquisition^*) — might actually be good for your brain.

That’s what UGA researchers found based on interviews, cognitive tests, and MRI imaging of more than 1,000 people.

“Our findings show that low to moderate levels of perceived stress were associated with elevated working memory neural activation, resulting in better mental performance.”

What can help even more? Support from family and friends. Other than Rodney, anyway.

^* Nobody ever does.

Do you want a Covid spike? Because this is how you get a Covid spike

Have a big football game.

Researchers at University College London and Texas A&M University found counties where NFL stadiums held games with at least 20,000 fans had rates of Covid spikes 2.23 times greater than stadiums with fewer fans or no fans.

This either jibes or dovetails with an earlier MIT study that found that stadiums that required masking and distancing (i.e., limiting attendance) “had no impact on local Covid-19 infections.”

Important note: This doesn’t (necessarily) apply to games this season, when most people are vaccinated, recovered, or dead.

Captain Obvious takes a back seat to Lieutenant Logical

Harvard Medical School study: “Organ Donations, Transplants Increase on Days of Largest Motorcycle Rallies” (to be published in the November 28 JAMA Internal Medicine).

The Long Read: B12 Exhaustion edition

If someone is complaining about being tired all the time, why not suggest a B12 test? A nutritionist explains how B12 deficiency is often overlooked, but it has serious consequences — starting with tiredness.

One primary symptom of B12 deficiency is fatigue — a level of tiredness or exhaustion so deep that it affects daily life activities.

Other symptoms are neurological and may include tingling in the extremities, confusion, memory loss, depression and difficulty maintaining balance. Some of these can be permanent if the vitamin deficiency is not addressed.

There’s a new MMR vaccine

The CDC has updated its MMR vaccine recommendations. No longer is M-M-R II the only game in town. Say hello to Priorx.

• It’s for kids 1 year old or older.
• It’s a two-dose series: One at 12 to 15 months, the second at 4 to 6 years.
• Priorx can also be used as a second dose for kids who got M-M-R II as their first dose.

“[T]he CDC considers Priorix and M-M-R II to be fully interchangeable.”

How they come out and how they turn out

Here’s an interesting tidbit: Kids born via C-section may not respond to immunizations as well as kids born the traditional way.

Apparently the vaginal microbiome affects the baby’s intestinal microbiome, and those bacteria [insert science here] allow the body to produce higher antibody levels.

In addition to higher antibody levels against pneumonia and meningitis in saliva, infants born via vaginal delivery showed changes in their populations of good and bad gut bacteria that reflected the higher antibody responses to the two vaccines.

Will that make a big difference, or only one that shows up in the lab? “More information is needed to draw any firm conclusions.”

Neurotic People May Suffer From One Deadly Physical Symptom!

High blood pressure.

A study out of Shanghai “published in the journal General Psychiatry, has found that high diastolic blood pressure is likely to cause neurotic personality traits.” (The study itself is here.)

The white and black of HDL

Forget everything you know about HDL being “good” cholesterol! Well, not everything. But the general idea that your HDL level is related to your heart-disease risk — well, that turns out not to be the case. Not for everyone.

Based on 10 years of data from nearly 24,000 U.S. adults, the NIH-funded study found an interesting disparity:

For White people: Low HDL levels — below — 40 ml/dl — were bad (“ linked with higher odds for developing cardiac problems”) but higher-than-normal levels didn’t add any protection from heart disease.

For Black people: Neither high nor low levels of HDL made a notable difference in heart disease. Lower levels weren’t bad, but — as with white folks — higher levels weren’t good.

(And if you’re wondering, what we know about LDL cholesterol still holds true: It’s bad.)

Stop the presses!

Bayer has launched Children’s Afrin! It comes in “Extra Moisturizing” and “No Drip Extra Moisturizing” varieties.

It’s perfect for divorced and separated couples — squirt it into Junior’s nose before sending him to visit your ex and let someone else deal with “Afrin rebound.”

Whippit, whippet bad

The latest drug scourge sweeping Europe: Nitrous oxide. Instead of just those little cartridges for whipped cream, it’s becoming available in larger cylinders — the beer keg of laughing gas, if you will.

In the United Kingdom, nitrous oxide is the second most prevalent drug among young adults aged 16 to 24 years, after cannabis^*.

How bad is it? Those shifty Danes reported a staggering 134 cases of nitrous oxide poisoning in 2020. And the Dutch say there was a “sharp rise in car accidents caused by driving while intoxicated or trying to fill balloons.”

^* Not counting alcohol and caffeine

Smokers’ babies can C their way^* to breathing a little easier

Smoking during pregnancy is double-plus-ungood — we all know that. But addiction is hard to beat (that’s why it’s addiction and not something you do).

That said, it seems that smokers can help their impending offspring by taking vitamin C supplements while pregnant. By “help” the mostly Oregonian researchers mean it may “decrease the effects of smoking in pregnancy on childhood airway function and respiratory health.”

^* That headline is too cheesy even for us, but we’ll let it stand.

The Long Read: Anti-Pax edition

There are people out there who, even if they test positive for Covid-19, won’t take Paxlovid — the best medicine out there. But get this: It’s not about politics^*. Sure, there are wonky reasons (e.g., not believing the data), but mostly the “anti-pax” logic is … logical.

^* Which has to be the dumbest reason to risk your health evah.

Some good news about this winter’s viruses

They might be battling each other. Well, interfering — enough so that no one of them can gain dominance for long because “One virus tends to bully the others.”

Although waves of each virus may stress emergency rooms and intensive care units, the small clique of researchers who study these viral collisions say there is little chance the trio will peak together and collectively crash hospital systems the way Covid-19 did at the pandemic’s start.

Diabetes: Kneel before Tzield!

The FDA has approved Provention Bio’s Tzield — the first drug (an injection) designed to delay (and in some cases prevent) the onset of stage 3 type-1 diabetes in patients with stage 2.

It’s being called a “pathbreaker” and of course a “game-changer.”

After more than four years…

• 44% of patients receiving teplizumab went on to develop stage 3 type 1 diabetes, compared to 72% of placebo patients.
• Those who developed the disease could have more than two years of extra time before the onset of stage 3.

(If you want to try making your own, the formula is C₆₄₆₂H₉₉₃₈N₁₇₃₈O₂₀₂₂S₄₆.)

NSAIDs can backfire

Here’s a surprise: NSAIDs don’t help reduce osteoarthritis, according to a study out of the Radiological Society of North America. In fact…

The results showed no long-term benefit of NSAID use. Joint inflammation and cartilage quality were worse at baseline in the participants taking NSAIDs, compared to the control group, and worsened at four-year follow-up.

That’s not to say they don’t help with pain, but as far as the anti-inflammatory effects? That, says the paper’s author (from UC San Francisco, if you’re interested) “should be revisited.”

Could psilocybin and MDMA go legal?

Probably not legal, but they may be made available for some terminally ill patients, if a bi-partisan bill passes.

The Breakthrough Therapies Act […] would allow the Drug Enforcement Administration to make the necessary findings to reclassify breakthrough therapies such as MDMA or psilocybin as Schedule II drugs.

Right now they’re C-I, even though there now is some accepted medical use. (The DEA considers them as dangerous as heroin, LSD, and — gasp! — marijuana^*.

^* Also mescaline and peyote. Seems like the list hasn’t been updated in a bit.

Covid notes

Covid vaccines and periods

It’s been known for a while that the Covid vaccine affected some women’s periods, but it was mostly anecdotal. Now there’s actual data thanks to British researchers.

The gist: Yes, it does … a little. It’s meant a small increase in the number of women who have a very late period, and it’s doubled (from 7% to 14%) the number who had a heavier period.

The most important part, though: “[I]n all cases these effects were only temporary.”

(Link goes to a news story. If you’d like the study itself, it’s here.)

You really don’t want this thing

This is a case where I’ll just let the news summary do the talking: “Neuroimaging study reveals significant brain changes in areas associated with language comprehension, cognition, and circadian rhythm control six months after Covid-19 infection.”

Big variant, no treatment

The BQ.1.1 Omicron subvariant is one of the two dominant strains circulating in the U.S. right now — it makes up almost a quarter of infections. And it’s “resistant to all of the available monoclonal antibody treatments. Yes, all of them.”

So if you get it, hopefully you’re vaccinated (or previously infected) and that makes your body strong enough to fight it.

Compounding rules are changing

Do you do any compounding? Are you ready for the freshly updated USP Chapters <797>, <795>, and <800>? Pharmacy Times wants you to be, and it’s got an interview (video and text) with one Annie Lambert, the clinical program manager of clinical surveillance and compliance^* at Wolters Kluwer Health.

“Every section of the chapters have been changed with both chapters <795> and <797>, even from the published drafts that we have been working on over the last year. But I think they can really be summarized by saying what were once best practices are now being held as standards.”

^* She must have a very large business card.

Another vaccine idea

What if you could create a live, weakened virus for a vaccine, but tweak its DNA so it couldn’t replicate? Could that give you the best of both worlds — a powerful and safe vaccine against viruses like chickenpox and herpes … and any other virus that hijacks our DNA?

Rutgers microbiologists thought so. And they went and did it.

Once injected into lab mice, the weakened virus infects cells but didn’t spread. Over time, the mouse immune system produced sufficient antibodies to shut down the virus and eliminate the infection.

Only problem: It’s called a “live-attenuated, replication-defective DNA virus vaccine,” and you just know that anti-science types will be all over those scary, scary words.

Have your grain of salt ready

Almonds can help you lose weight … according to an Aussie study published in the European Journal of Nutrition — and funded by the Almond Board of California.

STI … or monkeypox?

For women, it can take longer to get a diagnosis of monkeypox, because they account for a much smaller number of infections (so far). As a side note — and a possible peek at the future — in contrast to men, a quarter of women’s^* monkeypox infections do not come from sexual contact.

Because it’s unexpected, monkeypox in women is often diagnosed as a different STI/STD, leading to delays in treatment.

^* Interestingly, this only applies to people born female, not those who transitioned. Trans women, like men, acquire monkeypox almost exclusively through sexual contact.

Georgia’s sort-of Medicaid expansion approved

The Biden administration has tacitly allowed^* Georgia to move forward with a plan to have work requirements for Medicaid coverage — making it the only state in the country to do so.

Well, not exactly work requirements; they’re actually “qualifying activities” according to the Department of Community Health, including self-employment, job training or “readiness assistance,” community service, or attending higher or vocational education.

The good news is that it means more Georgians might be eligible for coverage (although the only other state to ever run such a program, Arkansas, saw coverage drop).

The bad news is that it will cost the state more to insure people, as the federal government will only cover 67% of the cost, as opposed to 90% under ‘standard’ Medicaid expansion.

At least, that’s all on paper. There are many questions remain that won’t be answered until the program rolls out and data comes in.

Disclaimer: GPhA does not have a position for or against Medicaid expansion.

^* It decided not to appeal the latest court ruling, which had approved the plan.

Be prepared for the fruitcake
(and other unwanted gifts)

What do you want for the holidays (besides world peace)? How about … an infectious disease? How about four new CE courses all about infectious diseases?

Good news! GPhA just launched the Unwanted Gifts Series — our holiday webinar series focused on how pharmacists and technicians can help prevent the spread of those unwanted gifts.

Get this: Each course is a mere $20 for GPhA members^*!

Disgusted girl holding a gift in her hand

What topics, you ask?

• HIV PrEP
• Monkeypox
• Antimicrobial stewardship
• Expedited partner therapy

The webinars run Tuesdays from November 29 through December 20. Check out the details and sign up today at GPhA.org/unwanted!

^* $45 for non-members

Cholesterol med: best of both worlds

What if there was a medication for lowering cholesterol that was as easy to take as a statin, but as fancy as a PCSK9 inhibitor? Well guess what‽ Researchers out of Case Western have created a pill “that reduces PCSK9 levels and lowers cholesterol in animal models by 70%.”

“Statins only lower cholesterol so far. This is a drug class that we think would represent a new way to lower cholesterol, a new way to hit PCSK9.”

How so? By using nitric oxide. Sure, they already knew it could inhibit PCSK9, but their drug makes it work even better. In mice, at least. As always, more research is needed.

Another Lantus switcheroo

The FDA has approved Eli Lilly’s insulin biosimilar Rezvoglar for at-the-counter interchangeability with Sanofi’s Lantus.

Lantus runs about $300 for 10 ml (in the US); Rezvoglar’s price hasn’t been set.

We have to call this out

“Aside from public and political pressure, diabetes drugmakers themselves are now calling for the need to control the medicine’s cost.” That’s right — the drugmakers who set the prices are saying that prices should be lower. Gosh, any idea who could do that?

The future of home STD kits

Except for HIV, there are no FDA-approved at-home tests for STDs, while the nation is dealing with an all-time high in infections. Those two facts lead to two related stories (conveniently in a single KHN article):

First, health pros are pushing for that to change — with health departments overwhelmed, it’s critical to get more people tested and treated quickly, they say.

Second, despite the lack of FDA approval, three states (Alabama, Alaska, and Maryland) will mail tests to residents, and CVS even sells one (of questionable legality) over the counter; you can also buy them online. In all these cases, patients need to collect samples and send them to an outside lab, and not every lab will process them because of the lack of the FDA’s blessing.

Still, you don’t need Aunt Zorya’s tarot cards to see where this is headed — it’s just not clear how long it will take the FDA to give the go-ahead.

When it comes to vapes, the FDA says “No kidding”

The FDA has made it clear that it doesn’t want vapes marketed at kids. Companies that make devices shaped like a Game Boy^* (the Wizman Puffboy, if you’re curious) or that have a “Family Guy” theme are gonna have a hard time arguing that’s not what they’re doing.

Now the the agency has sent formal warnings to the companies, although it may need to do more — at least one company “briefly stopped selling its product, but then quietly began selling it again.”

^* Do kids today even know what a Game Boy is? Wouldn’t a Switch have made more sense?

Privacy on the docket

When the next Congress congresses, one thing both sides sorta-kinda agree on is healthcare privacy — expanding it, that is. They might have different reasons, but the common goal will be to expand HIPAA and HIPAA-like privacy protections.

The gaping hole: HIPAA applies only to health care providers, insurers, and data clearinghouses, not to any of the gadzillion apps that collect, track, and share health data … with or without the user’s consent.

As one trade group spokesman put it, “There’s gonna be an explosion [of legislation] in the new Congress.”

What’s with FDA oversight?

It seems to be a bit lax, according to an investigation in the British Medical Journal. During Operation Warp Speed, despite whistleblower complaints, the agency cut back on inspections and let slip what would otherwise have been cause for at least a strongly worded letter.

[O]nly nine out of 153 Pfizer trial sites were subject to FDA inspection prior to licensing its COVID-19 mRNA vaccine. Similarly, 10 out of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected.

Problems reported (but not investigated by the FDA), the BMJ says, included “falsified data, unblinded patients, and inadequately trained vaccinators who were slow to follow up on adverse events.”

Side note

This is nothing new. Way back in 2020 “A Science investigation shows that FDA oversight of clinical trials is lax, slow moving, and secretive—and that enforcement is declining.”

Back to the past!

Continuing our coverage of the world’s health slipping into the 1640s, two more Olde Time diseases are reappearing:

• Dengue fever: “Arizona’s Maricopa County reports local dengue case.”
• Scarlet fever: “UK government warns of rise in Victorian illness”.

We don’t want to go back to tomorrow, we want to go forward. —J. Danforth Quayle

Addicts gonna addict

As cigarettes get more expensive and the cool vaping flavors are taken off the market, nicotine addicts are turning to another source: nicotine pouches. Sales of the pouches, according to data from the American Cancer Society, have been rising since 2019, especially of the highest potency versions.

The ACS, for its part, would like to see more messages about the dangers of nicotine, rather than the delivery method.

Of note: No manufacturer has received FDA authorization to market the pouches as either a tobacco product or a smoking-cessation drug. So it’s all word of mouth. So to speak.

Keeping your gut in shape

1. The right gut bacteria is important for many-many-lots of reasons.
2. Antibiotics kills a lot of gut bacteria — both good and bad.
3. Probiotics help restore the good (or at least non-bad) gut bacteria.

With this in mind, who can give me a recommendation for patients on antibiotics? Anyone? You, in the back, from the Journal of Medical Microbiology. You have an answer?

“Take probiotics alongside your prescribed antibiotics to reduce damage to your gut microbiome.”

Captain Obvious already got her workout

“Mums with many children and young children struggle to get their exercise in”.

Limiting uppers

What’s the best medication to treat amphetamine dependency? According to Swedish neuroscientists, one stands out: Vyvanse.

The ADHD medication lisdexamfetamine was associated with the lowest risk of hospitalisation and death in people with amphetamine addiction.

What’s notable is that there aren’t any official-ish treatments for treating addiction to amphetamines, including meth. The Swedes hope to change that with their big study (N=14,000). This means that we might consider Vyvanse as kind of the methadone for amphetamine addiction.

Elsewhere: Oregon Trail edition

Oregon will soon become the first state to make affordable health care a constitutional right.

“It is the obligation of the state to ensure that every resident of Oregon has access to cost-effective, clinically appropriate and affordable health care as a fundamental right.”

Sweet and salty

Sweet: “[H]oney improves key measures of cardiometabolic health, including blood sugar and cholesterol levels — especially if the honey is raw and from a single floral source.”

That’s according to a study out of the University of Toronto and — wait for it — sponsored in part by the US National Honey Board.

Salty: “A diet containing lots of salt can contribute to increased levels of stress, a new study shows.” The RDA for salt is about 6 grams, but most people eat at least 9g. Salt, it seems, increases the activity of genes that produce stress proteins in the brain.

(Caveat: According to the paper, they’re only talking about sodium chloride. As we’ve written before, swapping some NaCl for KCl has some significant benefits.)

Video of the week (month?)

The full story of fentanyl from the excellent Simon Whistler — how it started, how it works, why it’s addictive, why it kills, how it fits into the epidemic … you get the idea.