The necklace will rat you out

If — with your phone in your pocket — you don’t think you’ve given up quite enough privacy, Northwestern researchers are here to help.

They’ve devised “a smart neck-worn device resembling a lapis blue pendant that detects a user’s smoking.” It uses sensors to track the wearer’s throat’s heat signatures.

“This goes way beyond how many cigarettes a person smokes per day. We can detect when the cigarette is being lit, when the person holds it to their mouth and takes a puff, how much they inhale, how much time between puffs and how long they have the cigarette in their mouth.”

Don’t worry! Just like Google and Facebook and TikTok, “The necklace, called SmokeMon, completely maintains a smoker’s privacy.”

The end of pharmacy techs?

“Will we start seeing prescription lockers at some CVS pharmacies [in Georgia]?” asks Channel 11 in Atlanta. Will they replace technicians?

No, no they won’t.

CMS testing lower pay for accelerated drugs

Drugmakers sometimes get accelerated approval from the FDA; the idea is that full trial results will come soon. But often the pharma companies conveniently forget to submit those results, or just never bother to.

Now CMS has a big incentive: It’s going to pay less for drugs that get accelerated approval — until they turn in their results and get full approval.

It’s a test at the moment (and there are some questions to be answered). Drugmakers, of course, are already complaining, while state Medicaid agencies have already asked that they not be required to cover accelerated drugs at all, so this might make everyone equally (un)happy.

Kidneys and caffeine: all about one gene

Note: The news story about this plays fast and loose with coffee and caffeine. The story is actually about caffeine.

Is caffeine good or bad for your kidneys? There’s actually conflicting evidence, but now an international research group thinks it knows why.

The bottom line: Half the population has a variant of a particular gene that “can result in coffee [sic] being three times more likely to cause kidney dysfunction” because they metabolize caffeine more slowly. Caffeine does have some toxic properties, and if you don’t get it out of your system quickly enough, it can cause damage.

“It was remarkable to see just how striking the effects of [caffeine] were in the group that had this genetic variant, yet no effect whatsoever in those who did not.”

They do everything else, so why not?

Since the 1860s, the average human body has been dropping — it’s currently about 97.7°F. No one knew what was behind the drop. Now, though, researchers at the University of Michigan Medical School think they know.

It’s gut bacteria. Of course it is.

Looking at hospitalized patients, they found that the composition of a patients gut biome correlated with their fever response — specifically the presences of Lachnospiraceae bacteria.

“While we certainly haven’t proven that changes in the microbiome explain the drop in human body temperature, we think it is a reasonable hypothesis. Human genetics haven’t meaningfully changed in the last 150 years, but changes in diet, hygiene, and antibiotics have had profound effects on our gut bacteria.”

Get up and get moving

If you have fat mice, you want them to exercise. Pro tip: Have them do it in the morning.

Swedish researchers (with some help from those shifty Danes) found…

…that mice that did exercise in an early active phase, which corresponds to morning exercise in humans, increased their metabolism more than mice that did exercise at a time when they usually rest.

The heart can go on*

Donor hearts don’t always last long enough to get to the people who need transplants; four hours seems to be the limit for survival outside the body … or at least it was. University of Michigan researchers found that valproic acid, the anti-seizure medication, can be used to “reprogram” donor hearts to produce more of the anti-inflammatory metabolite itaconate. (That reduces the heart’s stress from, you know, being removed from the body.)

“[W]e found that valproic acid can reprogram the donor heart to produce beneficial itaconate during preservation. We showed previously that hearts are in fact biologically very active while stored on ice, which opens up the therapeutic opportunity to help it protect itself from metabolic stress during this time.”

^* Sometimes these headlines write themselves.

Diltiazem recall

Sun Pharma is recalling 34,000 bottles of its generic diltiazem extended-release capsules because the batch failed FDA testing. Click here for the details, including the affected lot numbers.

Today’s “game-changer” — yet another male contraceptive

It’s all about a protein called soluble adenylyl cyclase (sAC). Inhibit it, and sperm can’t swim. So, this in mind, Cornell scientists created an sAC inhibitor they called TDI-11861.

TDI-11861-treated male mice paired with female mice exhibited normal mating behavior but did not impregnate females despite 52 different mating attempts. Male mice treated with an inactive control substance, by contrast, impregnated almost one-third of their mates.

What’s interesting is that it’s an on-demand contraceptive — it takes about 30 to 60 minutes to work and lasts about three hours; “the effects persist in the female reproductive tract after mating.”

So far TDI-11861 has only been tested on mice, but you can bet more research is happening.

How CBD stops seizures

If you believe the hype, CBD can treat anything from poor SAT scores to ear-wax buildup. If you look at the science, though, there isn’t much data.

One condition it does seem to treat is seizures, and that’s not anecdotal — NYU researchers (with some British help) have found how that works. Ready? It “modulates excitatory-inhibitory ratio to counter hippocampal hyperactivity.”

In English: CBD blocks signals carried by lysophosphatidylinositol (aka LPI) which normally help amplify nerve signals, but in the case of seizures can be like turning the amp up to 11.

The body can normally regulate those signals, but too much LPI also interferes with the regulators, so blocking it is kind of a double-whammy.

^* An anagram of “slipshod loony hospitality” in case you’re interested.

Captain Obvious is tired of those strawberry hard candies

“Study Reveals Grandparents Spoil Grandchildren with Sugar-Loaded Foods and Drinks”

Wash your face, brush your teeth, take your eye drops

Can a drug prevent — or at least delay — nearsightedness? Perhaps so. The drug in question: an eye drop containing 0.05% atropine. (Yep, that’s the drug used to dilate pupils, but in a lower concentration.)

Researchers in Hong Kong found that low-concentration atropine could “[slow] the progression of myopia in 4- to 12-year-olds who already had the condition.”

The study tested the drops on 474 kids who used them nightly.

At the 2-year mark, more than half of children who received the placebo drops had developed myopia, as had nearly half of those given 0.01% atropine. But fewer than one third of children who had received the drops with 0.05% atropine developed myopia.

The study is ongoing, but the results are obviously promising.

Diabetes post-Covid

Yet another study has confirmed that Covid-19 increases your risk of developing diabetes. This one comes out of the Cedars-Sinai Health System in LA, and it’s based on health records of nearly 24,000 adults. The good news is that being vaccinated can reduce that risk.

Looking back, if you’re interested: “Diabetes risk rises after COVID, massive study finds” from March 2022, and “Covid-19: Infection raises risk of diabetes and heart disease diagnoses in following weeks” from July 2022.

Cynicism Today™: CGM edition

A celebrity endorses a medical product, so what does that mean? News coverage! In this case it’s Nick Jonas — one of the Children of the Corn — hawking Dexcom’s continuous glucose monitoring system in a Super Bowl ad. (Bonus: Story includes our favorite phrase — game changer.)

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.