Fentanyl vaccine

Researchers at the University of Houston have created a vaccine against fentanyl. It does exactly what it says on the tin (in rats, at least) — blocks the effects of the high-powered opioid.

If a vaccinated person consumes fentanyl, the antibodies could attach to the drug, preventing it from getting to the brain and inducing a “high” or potential overdose.

One shot lasted at least 20 weeks in rats, meaning — if this was ever approved for human use — it could be a much better alternative to methadone or buprenorphine for preventing accidental overdose deaths.

Oh, and it only works against fentanyl. The antibodies it produces ignore methadone, buprenorphine, morphine, and oxycodone.

An anti-Covid plant

Emory University researchers are still finding compounds that combat Covid. The latest are extracts from tall goldenrod (flowers) and eagle fern (rhizomes), both of which blocked the SARS-CoV-2 virus from entering human cells.

Of course, that’s just in the laboratory dish, “The active compounds are only present in miniscule quantities in the plants,” and — as an aside — the eagle fern is toxic.

Still, finding the molecules means someday it could be scaled up as a potential treatment, yada yada yada.

Remember with this ’shroom

While we’re talking about The latest entry in the category of “Traditional Treatments That Actually Have a Scientific Basis” comes from the Lion’s Mane mushroom — Hericium erinaceus.

Apparently, found Australian neurobiologists, an extract from the mushroom can boost nerve growth in the brain and help maintain memory.

Mmm, tasty

More specifically:

“[W]e found the mushroom extract and its active components largely increase the size of growth cones, which are particularly important for brain cells to sense their environment and establish new connections with other neurons in the brain.”

Pfizer’s new ad

Suddenly realizing that “Paxlovid” rhymes with “Covid,” the folks at Pfizer have launched a new ad campaign to remind people to buy their product if they test positive (or feel like they do):

Government to buy more Novavax

Ah, yes, Novavax — the red-headed stepchild of Covid vaccines. The federal government, though, is buying a million and a half more doses, and it’s funding further development in the face of emerging variants.

Why, when both Pfizer’s and Moderna’s mRNA vaccines work so well? Mostly for people skeptical of the new technology of the other vaccines. (Novavax is an old-style protein-based vaccine.)

Pharma jumps on sustainability bandwagon

Did you know there’s an entire trade show dedicated to pharmaceutical packaging? Now you do; it’s called Pharmapack. And the Big Deal this year is sustainability — showcasing packaging products that are “more sustainable, recyclable, and reusable than any before.” (One company won an award for a recyclable blister pack, so it’s really getting down to the nitty-gritty.)

“What’s interesting is that sustainability is not only integral to pharma companies’ strategies but also a key part of their promotion, marketing, and positioning now.”

The Long Read: PBM Battles edition

States are taking on the fight against PBMs rather than leaving it to the federal government. Note: Georgia isn’t mentioned because the article looks at 2022 regulations, and Georgia has been years ahead of the pack in terms of fighting and limiting PBM abuses … no matter what some attorney quoted might say.

First step to Medicare clawbacks

Drugmakers will no longer be able to raise their prices faster than the rate of inflation. Well, they can, but Medicare won’t pay it — and the pharma companies will have to refund the difference if and when they overcharge. CMS has released its draft guidance on the new law, which is expected to save the government $170 billion over a decade.

Fun fact: A recent HHS report found that even when inflation was at 8.5%, there were 1,200 drug price increases above that.

The plan is similar to what Medicaid has been doing for three decades (although the Medicare version will hopefully close the loopholes pharma companies have exploited to avoid penalties).

Whatcha gonna do when the emergency is over

When the Covid public health emergency ends, chaos will reign. How can you, o pharmacists and technicians, help bring civilization out of the confusion and rubble?

Artist’s conception

By spending 30 minutes in a free GPhA webinar, The end of the public health emergency: What does it mean to pharmacy?

It’s Wednesday, February 22, at 8:00 am, and of course there will be Q&A afterwards (with UGA’s Jordan Khail, who coordinates the PharmD program’s pharmacy law, pharmacy management, and Essentials of Pharmacy Practice courses).

If you’re wondering about who will be able to give immunizations, or whether prescriptions are needed for vaccines and antivirals, or anything else related to Covid-19, this is the time to get your answers.

Click here to register today!

Farmer named to Board of Pharmacy

GPhA’s 1998-1999 president — and 2008 winner of the Bowl of Hygeia — Michael Farmer has been named to the Georgia Board of Pharmacy by Governor Brian Kemp. Congratulations, Michael!

First bills targeting pharma

The Senate will soon be considering five bills that, as Endpoints put it, “will prohibit and slow some of the games pharma companies often play to extend their monopolies before generic competition comes to market.”

One, for example (S. 1428), will ban “pay-for-delay” deals, where a drug makers pays a genetic competitor not to enter the market.

• Another (S. 113) would require the Federal Trade Commission to investigate PBMs “and provide Congress with appropriate policy recommendations.”
• S. 1425 would empower the FTC to “deter filing of sham citizen petitions” — that’s when pharma companies file petitions pretending to be from ordinary folks.
• S. 1435 would ban “product hopping” — when drug companies make clinically insignificant changes to a drug to deter generic competition.
• S. 79 would create “an interagency task force between the United States Patent and Trademark Office and the FDA.”

Kids’ Covid vax is official

Annual Covid vaccinations (i.e., boosters) are now an official part of the CDC/American Academy of Pediatricians recommendations for childhood vaccines. That is all.

Bio bots deliver drugs

Getting drugs exactly where they need to go is a big deal these days, with all sorts of new tech (biological and nanotechnological) being aimed at the problem.

One trick is to use bacteria to deliver drugs, steering them with magnetic fields. But that’s so 2018.

UC San Diego engineers instead are using swimming microscopic algae that they coated with drug-containing nanoparticles — what they call a microbot. Because it’s algae, the immune system mostly ignores it, and the ’bots can be steered to the right place using light.

Treatment with microalgae worked despite a dose of antibiotics 3,000 times smaller than was needed intravenously, which could reduce side effects,

The problem they’re working on now is the best way to deliver the algae — inhalers of some sort are currently topping the list.

Plain algae on the left; microbot on the right

The Long Read: No Interferon For You edition

An interferon drug — pegylated interferon lambda — works as well as Paxlovid in cutting Covid hospitalization, is “variant proof” unlike monoclonal antibodies, and can even stop other viral infections. Excellent trial results were just published in the New England Journal of Medicine. But you won’t be seeing it in the US anytime soon.

PhRMA loses another court battle

Florida, Colorado, and other states: We want to let companies import cheaper drugs from Canada.

FDA and HHS: Maaaaaybe. Show us your plans and we’ll decide.

Pharma companies (via PhRMA): No way, José! Off to court!

DC Circuit Court: Has this program hurt you, PhRMA?

PhRMA: Not yet, but it could.

DC Circuit Court: Can you use this doll and point to where the bad plan hurt you?

PhRMA: Well, there aren’t any plans yet. But if there were, they could hurt!

DC Circuit Court: Go away. “Plaintiffs nowhere allege that their ability to provide services has been ‘perceptibly impaired’ or describe any ‘inhibition’ of their ‘daily operations’.”

Breast-cancer treatment in a pill

Women with late-stage, treatment-resistant breast cancer can now take a pill instead of enduring monthly injections. The FDA has approved Orserdu (its friends call it elacestrant). Here’s the kicker: It’s a 30-year-old drug that failed as a dementia treatment and for helping with hot flashes.

But the reason it failed against those hot flashes is the same reason it works against cancer: It breaks down estrogen receptors, preventing tumors from growing and metastasizing.

Six months after treatment started, about 34% of patients on elacestrant had survived without their cancer progressing, compared to about 20% of patients on other treatments.

STOP THE PRESSES

Whooping-cough vaccine for newborns protects newborns from whooping cough.

Know your codes

If you’re dispensing a GLP-1 analog — dulaglutide, semaglutide, tirzepatide — NCPA and the Pharmacy Audit Assistance Service strongly recommend that you document the ICD-10 diagnosis code.

If the prescription doesn’t have a diagnosis code, don’t take the patient’s word for it; call and get the code from the prescriber’s office and document the conversation, including the date and the full name of the person who gave the information.

“If it seems like a hassle,” writes NCPA, “think about the bigger hassle of getting an audit.”

Two peanut-allergy breakthroughs

From Notre Dame and Indiana University

Chemical engineers have developed an injection that protected mice against peanut-allergy reactions for two weeks. It’s a cHBI inhibitor that…

”…effectively masks the immune system’s ability to recognize the allergen, allowing it to fly under the immune system’s radar without initiating a dangerous response or compromising its ability to fight real pathogens.”

Even better: It can also be used to stop an allergic reaction soon after it starts, kinda like an EpiPen.

Even better better: The technology is actually a platform that can also be used for “developing inhibitors to treat a range of other allergies such as shellfish and penicillin.”

From the University of Chicago

Knowing that butyrate can prevent food allergies, and that it’s produced by certain bacteria in the gut, molecular engineers created micelles — a special type of polymer — that can deliver butyrate to the intestines instead of being destroyed in the stomach, as a pill would be.

Cool beans: Changing the charge on those micelles can determine where in the GI system they release their payload. Once there, the butyrate does double duty: It can help prevent allergies on its own, but is also helps Clostridia bacteria in the gut thrive — and Clostridia also produces butyrate.

When mice that were allergic to peanuts were treated with the butyrate micelles, they did not have an anaphylactic response when presented with a peanut challenge.

Human trials are next.

The Long Read: CBD Mythbusting edition

A pharmacologist unpacks what CBD can (probably) do … and what it (probably) can’t.

CBD is what pharmacologists call a promiscuous drug. That means it could be effective for treating a number of medical conditions. In broad strokes, CBD affects more than one process in the body — a term called polypharmacology — and so could benefit more than one medical condition.

Take two aspirin and call me at halftime

Being a rabid fan can be bad for your heart, and Bayer wants to take this fact as an opportunity to remind people of that — it’s sponsoring a new ad campaign.

Bayer said in a press release that it is “showing up for fans who put their whole hearts into their fandom” and is encouraging fans (and non-fans) to “prioritize their heart health by assessing their risk factors for cardiovascular disease.”

Click here to watch the video it sponsored.

Did you know there’s a generic Chantix?

About 18 months ago, Pfizer stopped making Chantix while it works out some production issues — carcinogens appearing in the pills. Soon after, though, the FDA approved a generic varenicline that would fill the Chantix-sized gap.

You would think the number varenicline prescriptions would remain about the same, as when any generic enters the market. But that’s not what happened. Instead, a study by pharmacy researchers found that “After Chantix production was halted, a significant reduction in the prescribed varenicline was observed.”

Why? Because people — including prescribers and pharmacists — don’t know about the generic varenicline. The recall got the press, but the alternative didn’t.

When metformin fails

Metformin treatment doesn’t work for a lot of patients with type 2 diabetes. In fact, looking at data for more than 22,000 patients, Mayo Clinic researchers found that failure is pretty darned common.

The study […] found that over 30% of the study population experienced metformin failure, defined as either failure to achieve or maintain HbA1c less than 7% within 18 months or the use of additional glucose-lowering medications.

The strongest predictor: baseline HbA1c. When it’s high, failure is a more-common option. Oh, and this all held true across a “large, diverse population.”

Same old song

Once again, a study (this one out of Washington University) finds that a lot of adults — 56 percent — have received antibiotics for viral infections.

Laws can’t keep up with the times

In 1993, the Comprehensive Child Immunization Act (CCIA) provided free vaccinations to kids whose parents couldn’t afford them — more than half of American children, in fact. W00t.

But with an RSV vaccine for babies called nirsevimab on the horizon (and expected to be FDA approved this year), a bit of wording in the law might mean a lot of kids can’t get the shot.

The “for babies” part is important. That’s when kids are most vulnerable to RSV; when they’re older it’s more like a nasty cold. Of the three RSV vaccines coming down the pike, only nirsevimab is an monoclonal antibody and only nirsevimab is likely to be approved for infants.

Unfortunately, the CCIA doesn’t include antibody shots, meaning the Vaccines for Children program might not cover nirsevimab.

Failing to do so would “consign thousands upon thousands of infants to hospitalization and serious illness for semantic reasons despite existence of an immunization that functionally performs just like a seasonal vaccine.”

The CDC will have to decide, and then there might be even be legal challenges from the usual suspects. Wait and see.

Coffee and BP

Regular coffee consumption, say Italian researchers, leads to lower blood pressure. That’s based on an observational study of about 1,500 men and women and no, it wasn’t funded by the coffee industry.

As usual, it wasn’t the caffeine — other compounds in coffee play a role. The study was published in the journal Nutrients, if you want to check out the science.

“The results are very clear: peripheral blood pressure was significantly lower in individuals consuming one to three cups of coffee a day than in non-coffee drinkers. “And for the first time, we were also able to confirm these effects with regard to the central aortic pressure, the one close to the heart, where we observe an almost identical phenomenon with entirely similar values for habitual coffee drinkers compared to non-coffee drinkers.”

Today’s non-pharma, cool medical story

It’s not just celebrities and legislators who are stealing the blood of the young in order to live forever. (Did you know Tom Cruise is 84 years old?) Researchers in California now have the oldest living lab rat: Sima, who is almost four years old thanks to infusions of blood plasma taken from young animals. She’s almost a year older than most rats live — the equivalent of a 120-year-old human.

Good news: The trial therapy doesn’t require human plasma; pigs, cows, goats, and sheep are potential donors.

^* Technically the oldest living Spague-Dawley rat, if that matters.

Suit claims pharma paid terrorists

Did big pharma companies sponsor terrorism? We may soon know, as a lawsuit accusing them of just that is going forward. A federal appeals court has given the go-ahead to the suit, brought by staff sergeant Joshua Atchley and more than 100 other plaintiffs who “alleged that several massive pharmaceutical companies were making ‘corrupt payments’ to Iraq’s Ministry of Health in order to gain contracts.”

The gist: After Saddam Hussein’s government fell, a terrorist group a called Jaysh al-Mahdi took over the ministry charged with drug imports, and companies including AstraZeneca, J&J, Pfizer, and Roche paid that group to allow it to import drugs.

“Those payments [reads the complaint] aided and abetted terrorism in Iraq by directly financing an Iran-backed, Hezbollah-trained militia that killed or injured thousands of Americans.”

Bring a student to dinner (on us)

Pharmacists: We need you to share your experience with student pharmacists, and we’ll take you to dinner so you can do it in style.

Dinner With a Pharmacist is a food and networking evening, brought to you by GPhA’s Student Leadership Board — it’s at the 1818 Club in Duluth on March 11 from 5:30 – to 8:30 pm.

Dinner is free, your knowledge is priceless — but space is limited.

Inspire a student pharmacist and make a difference. Click here to sign up while there are still seats left!

Kiss kiss, bang bang

Sometimes a news story just screams, “Put this in Buzz!” In this case, British researchers have found that injections of the hormone kisspeptin (discovered in Hershey, Penn. (seriously)) can “boost sexual desire in men and women.”

When folks with low sexual desire received kisspeptin shots, areas of their brains charged with feeling sexual desire lit up on scans when they watched erotic videos.

The paper was published in JAMA Network Open. And you can bet that studies will be ongoing.

From the vitamin D files

…vs prediabetes

An analysis out of Tufts Medical Center of about 4,000 patients found that those who took vitamin D supplements (4,000 IU daily) had a 15 percent lower risk being newly diagnosed with diabetes.

There are some caveats. They didn’t consider the safety of taking that much vitamin D, and it was conducted on people already at high risk for diabetes. And “After the trial ended, approximately 30% of the participants’ glucose levels returned to their levels before the study.”

…and birth

Taking extra vitamin D during pregnancy — we’re talking 1,000 IU daily — seems like it might increase your chance of a natural delivery. And by “natural delivery,” the British researchers who did the study mean that it didn’t require assistance, e.g., a suction cup or forceps are to help deliver the baby. (There was no difference in the number of women who had C-sections.) They also had less blood loss.

What wasn’t taken into account was whether any of the women were vitamin D deficient.

…and asthma

For all the good vitamin D seems to do, one thing it can’t do is reduce the risk of asthma attacks. That’s the conclusion of healthcare data-review company^* Cochrane, in which British researchers who once thought supplementation could help, looked at newer data and now concluded the opposite.

When they compared patients who were assigned to take a vitamin D supplement with patients who were assigned to take a placebo, the researchers found no statistically significant difference in the number of people who experienced an asthma attack.

^* I can’t really come up with a better way to describe it.

The lymphatic system does what?

Apparently, it can make blood. Yep, that’s not just up to bone-marrow stem cells. An Aussie-led team of biologists was investigating the causes of lymphoedema when it found that “the same gene that controls the development of lymphatic vessels also controls the production of blood cells.”

What does this mean? Just hold your wallabies — I mean, they just discovered this, so give ’em a chance to do some more research.

Everyone’s getting into healthcare

Amazon, Mark Cuban, Dollar General — they’re all jumping on the money train that is healthcare. Now you can add Daniel Ek, the founder of Spotify. He’s launching Neko Health in Europe.

Neko Health will offer advanced full-body scanning to help doctors find and prevent disease. It’s launching after four years of research and development — and hopes to be a gamechanger for Europe’s beleaguered^* healthcare systems.

^* Aside from Britain’s mess, it’s not clear how the rest of Europe is “beleaguered,” but we wish him well regardless.

Elsewhere: Mushrooms Down Under edition

Australia has become the first country — heck, the first continent — to approve the medicinal use of both MDMA and psilocybin for some mental health conditions.

Starting July 1, Australia’s FDA-equivalent Therapeutic Goods Administration “will permit specifically-authorised psychiatrists to prescribe MDMA […] for PTSD and psilocybin, the active ingredient in psychedelic mushrooms, for treatment-resistant depression.”

(And no, not everyone is thrilled about it.)

PhRMA loses another one

The fallout from the PhRMA’s failure to stop the Medicare-can-negotiate provisions of the Inflation Reduction Act continues to plague the trade group.

Now that they’re being reminded that capitalism is about buyers and sellers, member companies are apparently not happy with the Pharmaceutical Research and Manufacturers of America (PhRMA). The latest to quit the association is Teva, following in Abbvie’s December footsteps.

Of course, Teva doesn’t give a particular reason for leaving the group, but considering the move (like Abbvie’s) was made soon after PhRMA’s big defeat, one might draw a conclusion….

Drugs by contact lens

Forget about using those old-fashioned eye drops to treat glaucoma. How about a contact lens that monitors inter-ocular pressure and releases drugs as needed?

That’s what South Korean researchers have developed, although to be fair they’ve only tested it on rabbits so far.

The contact lens […] is fitted with hollow nanowires made of gold, which serve as sensors that constantly track intraocular pressure. It’s powered by an integrated circuit chip, which allows the lens to release amounts of a drug on demand.

FDA news

EUAs will keep a-goin’

A lot will happen when the Covid-19 emergency ends in May, but one thing that won’t, says the FDA, is its ability to approve tests, treatments, and even vaccines on the fast track if necessary.

That’s because (it reminds us) the FDA’s emergency powers aren’t tied to the official declaration of a health emergency; they’re simply part of it’s bailiwick under the good ol’ Food, Drug, and Cosmetic Act.

FDA feeling more heat over Aduhelm

The agency is coming under yet more pressure over it’s controversial approval of Biogen’s Aduhelm treatment for Alzheimer’s. (You might remember that the FDA granted an accelerated approval even when its own advisory panel gave the drug a thumbs-down. And Aduhelm’s high price is one of the biggest reasons for Medicare’s 2023 premium hikes.)

Now, experts and pointing to new data — and several deaths (unexplained by the company) — and asking the agency to do a better job when considering final approval.

For starters, they want experts to address safety concerns. But they also want the issue of Aduhelm’s lack of effectiveness put on the table.

[T]he underlying concern is the FDA’s decisions could undermine medical standards and give millions of patients false hope, because greenlighting more drugs just because they might work could unleash perverse incentives.

Long Covid declines

Slowly but surely, the number of people with long Covid — the symptoms of Covid-19 after having been infected — is declining.

Previous studies have found that those symptoms can last more than a year in some unlucky folks, so the number of long Covid cases will track Covid itself — just with several months’ lag.

Elsewhere: South of the Equator edition

Next time a “mysterious virus” starts spreading, it could well be the Global South — countries below the equator — that identify it to give the rest of us a head start on containing it.

“One good example was how long it took the United States to have an effective genomic surveillance network. It took years.” By contrast South Africa set up its surveillance network to look for Covid variants within months.

Flu updates

Influenza B has disappeared

The last time anyone in the world was infected with the influenza B virus (IBV), it was 2020. That means — because it doesn’t have an animal reservoir — that IBV could potentially be gone for good.

Dealing with just the ‘A’ variants would be good news, as it would open the door to making annual vaccines more quickly, and in theory more effective. But don’t write off B too quickly; experts point out that “IBV lineages have been known to periodically enter a state of ‘dormancy’ for long time intervals.”

The waning continues, but…

So far this season, 45 Georgians have died from the flu, with the vast majority being over 65. That’s true across the country: Cases continue to drop, and now 90 percent of those being hospitalized also have a chronic condition “such as heart disease, history of stroke, diabetes, obesity, and chronic lung diseases.”

The end of the season is the good news. The bad news is that “Compared to last year’s mild flu season, the U.S. has already seen more than three times the number of flu-related deaths.”

The Long Read: Late-Stage Capitalism edition

CVS isn’t making enough money on parenteral nutrition, so it’s firing pharmacists, nurses, and dieticians — and leaving patients in the lurch — so it can focus on more-profitable sectors.

CVS abandoned most of its less lucrative market in home parenteral nutrition, or HPN, and “acute care” drugs such as IV antibiotics. Instead, it would focus on high-dollar, specialty intravenous medications such as Remicade.

CVS “pivots when necessary,” spokesperson Mike DeAngelis said.

Optum, too, decided to pivot away from patients and toward the higher-profit market.

CVS, Walmart sued over fake meds (and yes, it could affect you)

The DC Court of Appeals has ruled that a consumer-protection group’s lawsuit against CVS and Walmart “for selling FDA-approved, over-the-counter medications alongside homeopathic products” can continue. The group, the Center for Inquiry, is suing the retailers over a “continuing pattern of fraudulent, deceptive, and otherwise improper marketing practice […] regarding the marketing and sale of homeopathic products.”

The DC Court of Appeals agreed that the group had legal standing, and also that “the placement of [homeopathic] products on a store shelf does, in fact, communicate information to consumers that can potentially deceive them.”

The lawsuit will now continue with the discovery phase.

A tale of two GLP-1 agonists

Mounjaro: Eli Lilly is tightening its marketing — and its discount program — to ensure that only people with diabetes are getting rebates or other discounts. (The price difference for consumers is something like $975 per month.) The company realizes it might cut sales, but with the “robust demand” supplies are short anyway. “

Wegovy: Novo Nordisk said it’s increasing production to meet the demand of both Wegovy and its identical cousin, Ozempic.

No test needed for Paxlovid

The FDA has revised its emergency use authorization for both Paxlovid and molnupiravir, now saying that prescribers — including pharmacists — can order it for patients even without a positive Covid test.

The update was made to cover instances where a health care provider might deem it appropriate to prescribe oral antiviral treatment to an individual with a recent known exposure who develops signs and symptoms consistent with COVID-19 and is at high risk for progression, but tests negative for the virus.

Eye drop follow-up

Yesterday we told you that the CDC suspected that preservative-free EzriCare Artificial Tears was contaminated, and to pull it from your shelves. Today it’s official: The manufacturer, Global Pharma, has issued a voluntary recall of all lots of the drops.

Bird-based pain treatment

Everyone’s looking for an alternative to opioid painkillers. The latest candidate comes out of a simple observation: Birds aren’t bothered by capsaicin. Jimmy-Joe’s Atomic Sauce will keep squirrels out of birdseed, but it won’t bother the birds.

That’s thanks to a pain receptor called TRPV1. Birds have a variant of that receptor that’s resistant to pain, and pain researchers at Stanford Medicine found a (rare) analog in mammals.

So they did a little gene editing on mice, and they found that the edited mice were much less bothered by capsaicin. Next they created a drug that had the same effect — altering the function of TRPV1.

When they gave the drug, a peptide named V1-cal, to mice by injection or infusion, it reduced their sensitivity to capsaicin and lessened chronic pain from nerve injury.

Next up: Making the drug last longer before they even consider human trials.

Today’s non-pharma somewhat-disturbing science story

Researchers at the University of California (with help from Boston U) have transplanted human brain tissue into mice and seen that tissue respond to stimuli.

Vitamin D cuts suicide risk

Way back in 2011, researchers thought they found a link between vitamin D levels and the risk of suicide. In 2014, other researchers also found that low levels of vitamin D ‘appears to be associated with’ suicide attempts.

Now Veterans Affairs researchers have found it works the the opposite way, too: People who take vitamin D supplements are less likely to try to hurt themselves. And they mean a lot less likely:

Overall, vitamin D3 use was linked to a 45% lower risk of suicide attempts and self-harm, and vitamin D2 was linked to a 48% lower risk.

That’s based on the records of more than 600,000 vets over eight years.) Based on this, they suggest that depression is a good reason to screen patients for low vitamin D.

Two notes: First, not surprisingly, the lower someone’s vitamin D level before supplements, the greater the effect. Second, the effect was greater with D3 than with D2.

Warning: The eyes shouldn’t have it

It’s not a recall, but the CDC is warning people not to use preservative-free EzriCare Artificial Tears. It seems that people using them have been infected with the drug-resistant Pseudomonas aeruginosa bacteria — and at least three were blinded in an eye and one person has died.

North Georgia OD cluster

The DPH is warning about what it thinks is a cluster of overdoses in Catoosa and Walker counties, including some that were fatal, from street drugs possibly laced with fentanyl.

It is critical that persons who use drugs understand there is a risk of overdose when using stimulants or other drugs that may be mixed with fentanyl or other synthetic opioids.

Covid’s killing kids

Covid-19 is now the eighth most common cause of death among people under 18 in the US. That’s kind of a big deal, because kids typically don’t die from any cause. It knocks flu and pneumonia down the list, meaning Covid now causes “substantially” more deaths than any vaccine-preventable disease, and is the most deadly respiratory disease.

The top seven: perinatal conditions, unintentional injuries (often gunshots), congenital malformations, assault (ditto), suicide, malignant neoplasms, and heart disease.

Don’t worry, be happy pharmacy workers!

For International Day of Happiness, GPhA is offering a free CPE webinar: From Work to Play.

Happy workers (including you!) are less stressed, more motivated, and generally more pleasant to be around. So From Work to Play will show you how to be that happy person using Positive Psychology and Positive Reinforcement.

It’s free — thanks to the Georgia Pharmacy Foundation’s PharmWell program — and it gives an hour of CPE credit.

Who’s the speaker? That’d be Theodore Rosen, PhD.

When’s it at? Live via Zoom, Monday, March 20 from 7:00 – 8:00 pm.

Click here for the details and to register!

(If, however, you choose to celebrate March 20 as National Alien Abduction Day, when you return you’ll be able to take the webinar on-demand. You just won’t be able to ask questions.)

Reservoir deer

Like the discount rack of DVDs in the back corner of Best Buy, all those old Covid variants haven’t disappeared — they’re just tucked away. Tucked away in white-tailed deer.

Scientists analyzing samples collected from white-tailed deer in New York state have identified the Alpha, Gamma, and Delta SARS-CoV-2 variants well after they caused widespread Covid-19 in people, representing a reservoir for the strains and a potential future risk to humans.

It’s not just New York, by the way — the viruses ware found in deer in six other states.

Antidepressants and pain

More and more, doctors are prescribing antidepressants for some kinds of chronic pain. It seems to work in some cases, but Aussie researchers caution that there’s not a lot of evidence that they work, and the evidence that does exist doesn’t jibe with common prescribing.

Meaning: Tricyclic antidepressants (e.g., amitriptyline) are the type most often prescribed for pain, but “but the review showed that it is unclear how well they work, or whether they work at all for most pain conditions.” In contrast, SSNIs like duloxetine seem to be the most effective.

They caution that prescribers shouldn’t be lumping all antidepressants together when it comes to treating pain, and that more research is needed to determine which work best.

Georgia opioid lawsuit resumes

There’s been lots of press about the Big Opioid Lawsuit (and various Big Opioid Settlements), but let’s not forget the smaller ones.

Here in Georgia, a Covid-delayed trial has resumed that pits families of people hurt by opioids against Cardinal Health, McKesson, and JM Smith Corp, which they say acted as illegal drug dealers — and Georgia law allows people to sue drug dealers.

[The plaintiffs’ attorney] said the distributors fueled illegal opioid use by filling illegitimate pharmacy orders and failing to report suspicious opioid purchases to law enforcement.

Not named are pharmacies or prescribers, though. “A pharmacy can’t fill a prescription if these distributors are not breaking the law, which they did over and over and over again.”

For their part, the distributors say they can’t be held responsible, as they were just following the orders.

UGA targets fungus

Fungal infections are becoming a much bigger deal these days as they become resistant to drugs — they’re literally killing people because of it.

UGA researchers, though, have developed a vaccine against the three most deadly fungal infections — Aspergillus, Candida, and Pneumocystis — which together are responsible for more than 80% of fatal fungal infections. Candida in particular has been getting a lot of press as it keeps being found in hospitals.

So far it’s been tested on animals (it showed “broad, cross-protective antifungal immunity”), so human trials are on the horizon.

Apnea and brittle bones

If one of your patients mentions snoring a lot, direct ’em to the supplements aisle for some calcium. It seems that — per research out of the University of Buffalo — “Obstructive sleep apnea may be linked to low bone mineral density in adults.”

(Why and how? That “has yet to be fully explored.”)

Beta-blocking the violence

Being on beta blockers reduces someone’s tendency for violent behavior. Yep, that’s what British and Swedish researchers found when examining the medical and criminal records of 1.4 million Swedes over eight years.

Periods on β-blocker treatment were associated with a 13% lower risk of being charged with a violent crime by the police […] Additionally, an 8% lower risk of hospitalization due to a psychiatric disorder was reported as well as an 8% increased association of being treated for suicidal behavior.

There were some caveats, though, notably “past psychiatric problems, as well as the severity and type of the cardiac condition the β-blockers were being used to treat.”

Good news for some

Monkey(pox) done

The mpox Public Health Emergency has expired. That is all.

GoodRx wasn’t being good

The FTC has charged GoodRx with providing users’ personal health information — medications and health conditions — to the likes of Facebook, Google, and Twilio so those companies could better target their advertising.

In 2019, the company gathered a list of users who bought specific medications like blood pressure or heart disease drugs, and shared email addresses, phone numbers, and mobile advertising IDs with Facebook so their profiles could be tagged for health-related advertisements.

The cost of doing business: The company will pay a $1.5 million penalty … although it would not admit it did anything wrong.

In other news, companies including Facebook, Google, and Twilio see nothing wrong with buying individuals’ personal health information so they can better target their advertising.

The oddest medical test you’re likely to hear about today

Ants, it seems, can detect cancer in urine.

Really, what more is there to say? French researchers trained ants — total

… exposed 35 Formica fusca ants to the scent of urine from the cancerous mice and trained them to associate it with a sugary reward. Later, when presented with urine from both sick and healthy mice, the ants spent 20 percent more time around the urine from the sick mice, without the sugar present.

Total training time? About 10 minutes. Their paper was published in Proceedings of the Royal Society B.

Early testing had some issues

A law that does what it’s supposed to

Allowing Medicare to negotiate the price of a handful of drugs is supposed to save the program — and thus taxpayers — a lot of money.

And now a new study out of Harvard and Brigham and Women’s Hospital finds that those provisions of the Inflation Reduction Act will actually … save Americans billions of dollars.

The IRA will allow price negotiations on 10 drugs in 2026, 15 more in 2027, and 15 more in 2028. (After that it adds 20 drugs a year.) If it took effect in 2018 instead of 2026, the researchers found, “it would have saved the U.S. $26.5 billion, about 5% of all drug spending.”

End of a juggernaut

The Humira monopoly is over, as AbbVie’s most popular drug now has biosimilar competition in the form of Amgen’s Amjevita.

To make sure the market remains confusing, Amgen has two list prices:

• $1,558 for a two-week supply — 5% less than Humira’s list price, for payers using discounts, kickbacks, coupons, rebates, and the like
• $3,288 for a two-week supply — 55% less than Humira, for insurers that don’t take advantage of those discounts and rebates

Amjevita is just the first; there are seven other Humira biosimilars expected to debut this year: Idacio, Cyltezo, Abrilada, Yusimry, Hadlima, Hulio, and Hyrimoz. Yes, that will be on the final exam.

A different kind of mile-high club

If you’re going to track how Covid (or other diseases) travel, why not take a page from the wastewater-surveillance playbook?

That’s what the CDC is thinking as it looks at testing airplane wastewater for Covid-19. It’s an anonymous early-warning system for finding infections before they become widespread — and knowing where they came from.

Unlike sewer-wide surveillance, which shows us how diseases are spreading among large communities, airplane surveillance is precisely targeted to catch new variants entering the country from abroad.

And yes, if you’re thinking that China’s “No Covid here, no sir!” stance might be a reason for the interest, you’re spot on.

The seven annoying symptoms of long Covid

We’re at the point where just about any chronic health issue after a Covid infection is considered “long Covid” — the reported list has 47 symptoms.

But Missouri University data scientists weren’t convinced. They wanted actual data, so they looked at the health records of more than 52,000 people, considering whether they had Covid, another respiratory infection, or neither. After cross-referencing the symptoms, they discovered not 47 but only seven symptoms that were consistently associated with long Covid.

As we know you’re curious, they are: fast-beating heart, hair loss, fatigue, chest pain, shortness of breath, joint pain, and obesity.

Technicians: Know your new CPE requirements

Starting on June 30, 2025, pharmacy technicians in Georgia will need to meet new CPE requirements to renew their biennial registrations.

You’ll be required to have at least 20 CPE hours to renew your license — but you’ll need to have at least 10 hours per year; i.e., you can’t cram it in all at once.

The first time you’ll need CPE is for your June 30, 2025 renewal.

• You’ll need to get 10 hours between July 1, 2023 and June 30, 2024.
• You’ll need another 10 hours between July 1, 2024 and renewal on June 30, 2025.

Awesome sauce: If you get more than 20 hours, you can roll over those extra hours into the next year!

(New technicians will have CPE requirements of zero, 10, or 20 hours based on their first registration month. It’s complicated.)

Of course, all existing requirements for pharmacy technicians — i.e., board approval — remain in place.

What to do, what to do

Start by creating an NABP eProfile if you don’t have one already, so you can track your CE credits using CPE Monitor (and print transcripts).

Look for CPE courses that are accredited by either ACPE or the Georgia Board of Pharmacy. (All GPhA’s CPEasy courses are accredited.) There are also PowerPak and other Web-based services that offer free or low-cost CPE.

Pay attention to GPhA announcements of new CPE courses. Most of them are available as webinars, many are on-demand, and there are new courses being offered all the time. (Did you know you can get a hour of CPE by learning the history of Coca-Cola?)

Just remember: No cramming — you need to spread your hours out over the two-year period!

Questions? Reach out to J. Ross Hays, CPhT, the chair of GPhA’s Academy of Pharmacy Technicians. He’s at apt@gpha.org.

ICYMI: Emergency to end in May

The Biden administration will finally end the Covid-19 public health emergency on May 11.

(What happens then? That’s a long read, but here you go.)

Café au lait keeps the inflammation away

Coffee is good for you, but now those shifty Danes say that coffee with milk might be even better.

It’s all about coffee’s polyphenols — the antioxidants that are part of what makes coffee healthy. But when you combine polyphenols with proteins like the ones found in milk, the result is really, really good for immune cells.

[A]s a polyphenol reacts with an amino acid, its inhibitory effect on inflammation in immune cells is enhanced.

And they mean significantly enhanced:

[I]mmune cells treated with the combination of polyphenols and amino acids were twice as effective at fighting inflammation as the cells to which only polyphenols were added.

Of course this is all in the lab, so, as always, further research (first in animals, then humans) is needed.

Court: J&J can’t two-step

Johnson & Johnson tried to limit the pain of those talcum powder lawsuits by spinning off those liabilities into a new company, then having that company declare bankruptcy — the “Texas Two-Step.” (Named because Texas law allows it.)

But now a federal appeals court has reversed a lower-court decision and told J&J it’s going to have to face the music sans spinoff.

Feds target Medicare Advantage fraud

A new CMS rule gets aggressive with Medicare Advantage audits. In short, it allows the agency to review a subset of a Medicare Advantage provider’s records, determine how much fraud it committed, and extrapolate that to all the provider’s billing since 2018.

In other words, if the subset showed the company overcharged by an average of 1 percent, the government would assume that it was overbilled by 1 percent on every patient since 2018.

Providers — for which Medicare Advantage is the most profitable product — aren’t happy, and they’re doing the “World Will End if This Happens” dance.

But supporters of the rule point out that it was originally planned to go back to 2011, so insurers should count their blessings … which include hundreds of millions of dollars taxpayers overpaid them.

If you’re overweight, at least get your vitamin A

The paper: “Vitamin A preserves cardiac energetic gene expression in a murine model of diet-induced obesity”

The news: “Vitamin A May Protect Heart from Some Effects of Obesity”

The finding: Mice who are both obese and vitamin-A deficient have “greater disruption to genes involved in heart function,” according to German researchers.

‘[T]the vitamin-deficient obese mice had repression of genes in the heart that are associated with extracting energy from fat, extracting energy from glucose, and the production of [ATP].’