Bill would let FDA target influencers

Two senators — a D and an R — have decided they don’t like how pharma companies are skirting FDA rules by having infomercials influencers on social media spread false and misleading info.

They’ve written the Protecting Patients from Deceptive Drug Ads Online Act, which will give the FDA authority to target content that influencers get paid for but “contain false statements, omit facts, or fail to disclose risks and side effects.”

The companies would also have to report those payments to the Open Payments database.

Speaking of FDA warnings…

The agency issued a rare warning to AbbVie for having Serena Williams say that “one dose [of Ubrelvy] works fast to eliminate migraine pain” in a TV ad.

Why issue such an unusual warning? First, using a celeb makes the (unproven) message sound more believable. Second, this is the second time the agency has raised concerns about Ubrelvy marketing — the first time was in 2020 when the drug was owned by Allergen.

Gender and GLP-1s

Good news for women: They lose more weight than men when taking tirzepatide according to Eli Lilly research: Over about a year and a half, women lost an average of 24.6% of their body weight, compared to just 18.1% for men.

Bad news: They also “experienced nausea and vomiting […] at significantly higher rates than their male counterparts.”

Prize-winning pain

Congratulations to the winners of the 2024 Ig Nobel Prize in medicine: Lieven Schenk, Tahmine Fadai, and Christian Büchel, “for demonstrating that fake medicine that causes painful side-effects can be more effective than fake medicine that does not cause painful side-effects.”

Oral GLP-1 moves along

Novo Nordisk reports that a phase 1 trial of its oral weight-loss drug, amycretin, showed it’s at least safe and tolerable — which is what a phase 1 trial tests for.

Amycretin is a combo of a GLP-1 agonist and a drug that also targets the hunger hormone amylin. The company reports “a 13.1% weight loss with a side effect profile comparable to what we normally see with incretin-based therapy.”

Fezolinetant dangers

The FDA is warning prescribers to be careful giving women fezolinetant for hot flashes. Apparently it can cause “rare but serious liver injury.”

Symptoms include new-onset fatigue, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or right upper quadrant pain.

Fear not, though. Stopping fezolinetant “may potentially return liver function to normal.”

Jaundice is an issue.

DEA ponders telehealth limits (again)

A leaked document from the DEA indicated that it’s planning to reinstitute limits on telehealth prescriptions for controlleds — essentially requiring in-person visits.

Those limits had been lifted during the pandemic, and when the DEA first suggested reinstating them (in early 2023) it was met with, well, 38,000 comments, mostly saying, “Don’t do it.” So the agency kept the limits off until the end of 2024.

Well, that’s approaching, and once again people and organizations are sending a clear message: Telehealth is working, so don’t mess with it.

Numerous organizations — including Amazon, Mass General Brigham, Cleveland Clinic, Hims & Hers Health, Bicycle Health, and the College of Healthcare Information Management Executives — have now signed letters asking for the telehealth prescribing flexibility to be extended.

The best laid plans

Georgia’s plan for Medicaid work requirements — Pathways to Coverage — may have been a good idea on paper, but it’s apparently run headlong into something no one saw coming: bureaucracy.

The complexity of the program means patients are having trouble enrolling, and the agency running Pathways can’t keep up with the backlog of applications. On the other hand, it’s not kicking anyone off the program either, because it’s not able to verify that people continue to meet requirements.

As much fun as it can be to poke fun at government, though, new programs often have growing pains — there are a lot of moving parts to juggle. It’s not fair to judge a long-term program on short-term hiccups. But Georgia has about a year to get those kinks out before it needs CMS’s permission to continue.

Non-pharma, vaguely medical headline that caught our attention

“Man found dead inside catering oven at hospital; Police not treating man’s death as suspicious”

Fish vs autism

Omega-3 supplements have a lot of good science behind them for long-term cardiovascular health, and recommending them to patients is a good idea.

—BUT—

There seems to be one case where fish-oil supplements lose out to eating the fish themselves: for pregnant women. A new study funded by the National Institutes of Health found that…

Eating any amount of fish during pregnancy was associated with about a 20% lower likelihood of autism spectrum disorder diagnosis [in children].

1. The same wasn’t true for supplements.
2. The effect was greater in female children.
3. Mom doesn’t need much: “These results were consistent across all levels of fish consumption,” including less than once a week.

CVS to House committee: “Nuh uh.”

Last week we told you how House Oversight Committee Chair James Comer told PBMs he found out their CEOs lied to Congress when they testified that they didn’t treat their own pharmacies differently than they treated independents.

He offered them a mulligan — he demanded they correct their testimony or there would be … trouble.

Now CVS has responded, and it’s doubling down. It says the CEO told the truth, and that CVS Caremark doesn’t show CVS pharmacies any kind of favoritism. It said the FTC report that found otherwise was “lacking sufficient empirical data and analytical rigor” and that the people who wrote it were eating their neighbors’ dogs and cats^*.

Now the Oversight Committee is reading CVS’s response carefully before deciding what to do. Earlier Comer had threatened the CEOs with fines or even jail time. We shall see.

^* Kidding! Sheesh, take a joke!

Antidepressant doesn’t help breathing

Sometimes mirtazapine is prescribed off-label to help patients with breathlessness from various respiratory diseases. That’s a bad idea, at least according to British researchers, despite some early studies showing it could help.

They conducted a large-scale trial and found…

… that mirtazapine does not improve breathlessness in patients with respiratory disease compared with placebo. They also found that patients receiving mirtazapine had slightly more side effects and needed more care from hospitals and family members.

They also worry that those results could carry over to other antidepressants or benzos (although the trial focused on mirtazapine). But as there are no treatments for that breathlessness, the only effective option might be physical therapy.

Maybe they like the balloons

“Medical clowns shorten hospital stays for children with pneumonia” is the story. Whether they help the kids recover faster — or simply terrify them into getting out — isn’t clear.

Diabetes news

A new weekly insulin

Two new phase-3 trials have found that weekly shots of a new type of insulin— efsitora alfa — can control both type 1 and type 2 diabetes as well as daily or weekly injections of insulin degludec.

The only downside to efsitora is that there seemed to be more instances of hypoglycemia than with degludec, but that might be a matter of tweaking the dosage. As always, more research is needed.

The voice of diabetes

Using about 25 seconds of someone’s voice, AI can determine whether a patient has type 2 diabetes “with 66% accuracy in women and 71% accuracy in men.” And it’s almost as good as the American Diabetes Association’s questionnaire-based risk score. Coming soon, perhaps: A smartphone app to diagnose it at home.

Congrats to the ACA

For the first time, Obamacare enrollment is going to hit 50 million people according to the Treasury Department, with almost 21 million enrolling in 2024. (And 18.2 million of them have enrolled in an ACA plan for the first time.) That’s 1 out of every 7 Americans.

Elsewhere: Baltimore’s gamble pays off

The city of Baltimore wouldn’t sign on to Teva’s $4.25 billion national opioid settlement last year, instead opting to to negotiate on its own. It worked — now, instead of getting about $11 million over 13 years, the city will get $80 million over two years.

ICYMI: Bird flu news

A Missouri man has tested positive for H5N1 flu “despite having had no known contact with dairy cows or other animals associated with an ongoing outbreak.”

Cold comfort: salt

Here’s a simple solution to the common cold: saline nasal drops. Yeah, that easy. It turns out that, at least in kids, Scottish researchers found that “hypertonic saline nasal drops can reduce the length of the common cold in children by two days,” and also reduce the chances of transmitting it to family members.

Recipe: They used sea salt^* and (presumably) distilled water given three drops per nostril at least four times a day.

Science: “Salt is made up of sodium and chloride. Chloride is used by the cells lining the nose and windpipes to produce hypochlorous acid within cells, which they use to defend against virus infection.”

^* Sodium chloride, as opposed to regular salt (which is also sodium chloride), or Himalayan salt (which is also sodium chloride).

Next-gen GLP-1s

Now that we know what GLP-1 agonists can do, it’s time to move past the first-generation drugs, innit?

Slow-release semaglutide?

Instead of weekly injections, a French biotech company has developed a hydrogel version of semaglutide that can be given once a month with a subcutaneous injection. So far it worked in six lab rats, and the Frenchies are going to move to pig tests next.

Another pill contender

California-based Terns Pharmaceuticals says its oral weight-loss drug reduced patients’ weight by an average of almost 5% in early trials. The company joins Pfizer and Roche in the race to bring oral GLP-1 drugs to market. It expects to go to phase-2 trials next year.

Easy to predict

Last month: Bloomberg reported there’s benzene in Walgreen’s generic version of Mucinex.

This month: The lawsuits begin.

Walgreens customers Miriam Birdsong and Cheryl Mikel, both South Carolina residents, say they would not have purchased the products or would have paid less for them had they known they contained benzene, and are seeking damages and restitution.

A universal Covid antibody

Scientists led by the University of Texas say they’ve isolated an antibody from a patient that protects against every variant of SARS-CoV-2. Called SC27^*, like other antibodies it binds to the virus’s spike protein to keep it from attaching. What’s different about SC27 is that it binds to the spike protein of every Covid variant (that we know of).

The Longhorns “obtained the exact molecular sequence of the antibody, opening the possibility of manufacturing it on a larger scale for future treatments,” and — not wanting a financial opportunity to go to waste — have already filed a patent application for the antibody … which they took from a patient.

^* As opposed to SCP-027

Not-so-universal vaccines

American exceptionalism: Thanks to Congress gutting the federal Bridge Access Program, which provided Covid vaccines to low-income people, something like 25 million Americans can’t get Covid shots.

They don’t have private insurance and fall through the Medicaid cracks because they make just a little too much (especially in states that didn’t expand the program) and they obviously can’t afford the $200 out-of-pocket for the vaccine..

So they aren’t getting vaccinated, and that raises their risk of infection (and serious infection), and of course risks transmitting the virus to others — because these are the people who can’t afford to take time off work if they’re sick.

If you thought falling was bad…

Spare a moment to think of the people who experience “exploding head syndrome.” That’s where you’re jerked awake by the feeling of a bomb going off in your head. Fun.

Lyme vax update

Pfizer and Val­ne­va are very happy about the results from a phase-2 trial of their Lyme disease vaccine. Specifically, it was for a booster given a year after the initial shot.

Not only did subjects show “strong im­mune re­spons­es” from the booster (good for patients), but the trial shows that they’ll probably need an annual shot to keep up with the disease (good for the bottom line).

Goldilocks and the BP cuff

At-home sphygmomanometers^* are great for the home-health kit, but cuff sizes can be a big issue. How big? A new study out of Johns Hopkins found that “the standard arm-size ranges for these devices won’t appropriately fit millions of U.S. consumers.”

Yes, yes, mostly the cuffs are too small, but it points to a potentially bigger issue: Patients may not realize the fit is a problem and thus get erroneous readings. Some products come with multiple cuffs, while others (like one at Buzz HQ) include a coupon for a free larger cuff. If you’re selling them, it might be worth a word about accuracy.

^* I have to brag. I spelled that right on the first try. 

The Long(ish) Read: Diabetes and Dementia edition

People with type 2 diabetes who take SGLT-2 inhibitors are less likely — 35% less likely — to develop dementia than those who take DPP-4 inhibitors. (That’s what came out of a Korean study of 220,000 people with type 2 diabetes who were followed for about 2 years.)

Why would this be the case, though? What’s the connection? An Australian dementia expert looks into it.

5 is enough

When it comes to uncomplicated respiratory infections, a shorter course of antibiotics is probably all you need. There’s been mixed evidence supporting these shorter courses, so Dutch researchers decided to find the answer once and for all (until the next study, anyway).

What they found, in broad strokes, is that previous studies showed “moderate-quality evidence that 5 days of antibiotics is clinically non-inferior to a longer course” for either mild community-acquired pneumonia or acute exacerbation of COPD.

The number of the counting shall be five, though — ‘evidence for shorter durations was scarce.’

Potential big caveat — the source material the Dutchies used wasn’t great: “[T]he quality of the reviews was generally low and the quality of evidence varied between type of infection.”

Old antihistamine, new seizures?

Some kids are still given first-generation antihistamines — think chlorpheniramine maleate, hydroxyzine hydrochloride, or piprinhydrinate — usually for runny noses, itching, or, you know, to get them to fall asleep. But that might not be a good idea.

According to a study out of Korea, because these drugs cross the blood-brain barrier, they affect brain waves and result in a higher risk of seizures.

In particular, they can induce symptomatic seizures, affect electroencephalographic (EEG) activity and seizure thresholds in adults with inherent seizure susceptibility, and alter resting EEG activity.

An editorial accompanying the paper highlights the questions this study brings up, from “How should a relatively small risk translate into clinical practice?” to questioning whether newer antihistamines have similar effects and “Should antihistamines be avoided altogether in younger children?”

Gut check

We’ve often said that 95% of all diseases are either caused by inflammation or gut bacteria. Now Mayo Clinic scientists have developed a way to check #2. It can’t diagnose a specific disease, but it can analyze the bacteria and determine healthy vs. not so healthy with about 80% accuracy.

The process was simple in the age of AI: analyze 8,000 samples, tell the computer which belong to healthy people, and let it learn.

The tool, called Gut Microbiome Wellness Index 2, could detect even subtle changes in gut health, identifying whether a person may be progressing toward or recovering from a disease.

Because it’s AI-based, the researchers themselves don’t necessarily know what constitutes a healthy gut biome, just that the computer can sort it out for them.

Third Covid vax approved

The FDA has approved Novavax’s updated non-mRNA Covid shot for the FLiRT variants circulating nowadays.

While there’s a good argument for waiting on this year’s flu shot — the season doesn’t peak for a couple of months — getting the latest Covid shot now makes sense, what with cases continuing to tick up across the country.

Ozempic shortage to continue

It’s gotten worse, not better, for supplies of Novo Nordisk’s Ozempic, the company said, especially for lower, starter doses. The company also expects intermittent shortages for all strengths to continue “into the final quarter of 2024 due to increased demand and along with capacity constraints at some of its manufacturing sites.”

In other words, while there’s plenty of semaglutide out there (as compounding pharmacists know), Novo can’t seem to get the filling and manufacturing of its spiffy Ozempic pens on track.

How morphine works

It is — well, was — one of the weird bits of medical trivia: Scientists knew that morphine worked, but they didn’t know how. And now they do.

Apparently, Swedish scientists found…

… morphine affects a selected set of neurons in the brain in the part called the rostral ventromedial medulla (RVM). Together, these neurons form a kind of ‘morphine ensemble’. This is a group of neurons whose change in activity leads to pain relief.

They’re hoping that knowing exactly how morphine works can lead to a similar type of pain reliever that doesn’t come with morphine’s baggage.

(If you want more details, the paper’s abstract is available here.)

Say it ain’t so, PBMs

It’s possible — now hear me out here — it’s possible that PBM executives lied in their testimony before Congress when they defended their business models.

I know, shocking, right? Apparently what the PBM CEOs said turns out to contradict what the committee learned on its own, as well as Federal Trade Commission research.

Ruh-ro.

James Comer (R-KY), the chair of the House Committee on Oversight and Accountability, is Not Happy At All about this.

During the hearing, [PBM CEOs] Conway, Kautzner and Joyner testified that their PBMs treat affiliated and unaffiliated pharmacies equally when setting rates, negotiating contracts and telling patients where to dispense their medications.

Those statements were lies, suggests Comer’s letters, which cite committee and FTC evidence to argue that PBMs increase revenue at their own pharmacies at the expense of other businesses.

Comer has threatened them with fines (i.e., “the price tag for lying to Congress”) or even jail time. So how can they avoid a trip to the Big House? By … correcting their statements.

Bird flu watch

The first cluster of cases has been reported. It’s among workers at two poultry facilities in Colorado. Still no human-to-human transmission, though, and the workers are all doing fine. As you were.

Seniors poised to save big

The AARP is very happy about upcoming annual caps on Medicare out-of-pocket drug costs. The association had the numbers crunched and found that the Biden administration’s $2,000 cap “will lower prices in 2025 for more than 3.2 million people, or around 8.4% of Part D beneficiaries who do not receive other subsidies.”

Even better, more than a million older people will save more than $1,000 a year.

Before the Inflation Reduction Act, beneficiaries who did not qualify for low income subsidies were required to pay 5% of drug costs regardless of how much they had already paid.

Vyvanse is coming back (a bit)

The DEA is increasing the production limit for brand-name Vyvanse and generic lisdexamfetamine by 24%. That’s good news for a lot of people who’ve been having trouble getting their ADHD drugs.

The new production limit is also good news for the 11 companies that make lisdexamfetamine, which has been in shortage since October 2022.

Wegovy vs. Covid

For reasons unknown, people taking Wegovy didn’t die from Covid complications as often as the rest of us according to a big international study led by Harvard Med.

People on Wegovy still got Covid, and at the same rate as people randomly assigned to take a placebo. But their chances of dying from the infection plunged by 33 percent, the study found.

In fact, the study found that treating obesity reduced death from all causes, suggesting “that lower life expectancy among people with obesity is actually caused by the disease itself.” Still, Wegovy had a much bigger effect on Covid deaths — “It’s something more than just losing weight,” said one cardiologist.

Neffy: What you need to know

Like the headline says, as neffy hits the shelves as an alternative to EpiPens, what do you need to know? Glad you asked; a pediatric allergy and immunology specialist has your answers.

Time to take your BP med

When’s the right time to take hypertension meds? That depends on who you asked and which study you read last. Now Canadian researchers say they have the answer: It doesn’t matter.

The Canucks ran a two-part trial, one with 3,400 adults out in the wild, and one with 776 older patients in nursing homes, all of whom were taking BP meds. Result: No difference in major cardiovascular events. There did seem to be an advantage in older folks taking their meds at bedtime — a 26% lower rate of “all-cause unplanned hospitalisation/ED visits.”

Despite that last bit, the lead researcher said that timing isn’t important. “We can now dismiss the treatment timing as being important and advise patients to take their BP medication when they are least likely to forget.” (Why he would say that, considering the lower all-cause hospitalizations, isn’t clear. Maybe he doesn’t like old people.)

Rite Aid returns

Quietly, so as not to disturb predators, Rite Aid is emerging from Chapter 11 bankruptcy, naming former exec VP and CFO Matt Schroeder as its new CEO.

“I am honored to lead Rite Aid on its journey as we continue serving our customers and communities,” Schroeder said, reading from a boilerplate press release prepared by the marketing team.

It don’t make my brown eyes blue

How can you tell when an idea is probably deeply stupid? When it starts with, “I saw on TikTok….”

In this case, the American Academy of Ophthalmology is warning people not to believe claims that there are drops that can change your eye color. In short, there’s no evidence that they work (before-and-after photos of strangers don’t count) and plenty of reason to think they “could potentially harm the eye, causing light sensitivity, eye inflammation, and eventually vision loss.”

As Forbes’s Bruce “No Relation” Lee points out, destroying melanin is a bad idea anyway:

Melanin can help protect your eye cells against light. Plus, other parts of your eye like your retina can use melanin to function properly. Eye drops typically won’t stay in only one part of eye even if you tell them to do so.

Previously, the AAO has warned people not to put food coloring or castor oil in their eyes, rub their eyelids with menthol lip balm, or use a hairdryer as an eyelash curler. Seriously.

Call me, maybe (but really, you can)

Remember way back when, when there was a fear that keeping a mobile phone glued to your ear could cause cancer? According to a review of 63 studies by the Australian Radiation Protection and Nuclear Safety Agency, you don’t have to worry^*. “We concluded the evidence does not show a link between mobile phones and brain cancer or other head and neck cancers.”

The review found no overall association between mobile phone use and cancer, no association with prolonged use (if people use their mobile phones for 10 years or more), and no association with the amount of mobile phone use (the number of calls made or the time spent on the phone).

^* Even though a lot of folks either text or hold their phones in front of them to make sure everyone in the restaurant can hear both sides of the conversation.

Lilly sells Zepbound DTC

Taking a cue from compounding pharma, Eli Lilly is going to offer Zepbound direct to cash patients. It won’t be in the fancy injectors, but in standard vials with plain ol’ needles … and at a deep discount: $399 for a month of the 2.5 mg dose and $549 for a month of the 5 mg.

The decision is likely because Lilly can’t supply those injectors right now (hence the shortage), so this way they can cut into the compounding marketplace. So much for “lower prices will kill innovation.”

Side note 1: Lilly raised the cash price of its Zepbound pens from $550 to $650.

Side note 2: Like Taylor Swift tickets, Zepbound is technically “available,” but officially still in shortage — good luck actually getting it.

Pfizer says “I’m in, too!”

Pfizer is launching its own direct-to-consumer platform called PfizerForAll. It has coupons for Pfizer meds and then uses online pharmacy Alto Pharmacy to fulfill orders.

Need a prescriber? No problem — telehealth company UpScriptHealth is part of the deal. Need a consultation to help you make decisions? Not sure how to use your meds properly? Will that Pfizer drug interact with your other prescriptions? Having a side effect? Well … good luck with that.

TechU is back!

Are you ready for 2024’s biggest event for Georgia pharmacy technicians?

Mark your calendar for Saturday, October 19 — it’s a day of socializing, networking, and learning — developed by pharmacy techs for pharmacy techs.

One low price^* gets you breakfast, lunch, 4 hours of CE, a professional headshot, and the networking event at the 57th Fighter Group restaurant in Atlanta!

Click here for the details!

* Just $40 for GPhA members, $65 for non-members

Glucose automation

OTC CGM goes on sale

Back in March we told you that the FDA has approved Dexcom’s Stelo — the first OTC continuous glucose monitor. Now the Stelo is available at stelo.com “for adults 18 years and older who are not taking any insulin therapies.”

Dexcom has pitched the Stelo as a more “health-focused” version of its top-of-the-line CGM, the G7, which made its debut early last year. Though built on the same sensor platform, the Stelo will operate without the low blood sugar alerts or software features needed by people with Type 1 diabetes.

Automate the insulin

The FDA has approved Insulet’s Omnipod 5 automated insulin delivery system for people with type 2 diabetes. (It has previously been approved for people with type 1.)

[A] wearable, tubeless product provides up to three days of nonstop insulin delivery without the need to handle a needle. The Omnipod 5 integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks and can be controlled by a compatible smartphone or by a controller.

Captain Obvious has enough to worry about

“Knowing you have a brain aneurysm may raise anxiety risk”

Breaking pancreatic cancer’s ‘wall’

Old idea: Most cases of pancreatic ductal adenocarcinoma (PDAC) don’t trigger an immune response, making immunotherapy ineffective.

New news: Scientists at Cold Spring Harbor Laboratory found that PDAC does trigger a response, but there’s no point as the immune cells can’t actually get inside the tumors to do any good. (Science: The tumor has a “defensive wall” made of two proteins—CXCR4 and CXCL12.)

Breakthrough (literally): Using folinic acid causes the body to produce more type-I interferons. Those interferons then …

“…acted like trail markers, highlighting a way past PDAC’s defenses. Cancer-killing immune cells that had been kept outside the wall were able to slip into the tumor and start fighting back.

Now knowing about that defensive wall (and how to break it), they hope to develop therapies to take advantage of it.

Here, something else to worry about

Bird flu, monkeypox, sloth fever, election stress … not enough for ya? How about human cases of eastern equine encephalitis? It’s about 30% fatal, and there’s no vaccine and no treatment. So far it’s just in the Northeast, but how long will that last?

It’s bad enough that, even with pollinator populations crashing, Massachusetts is doing mass spraying of insecticide. Yikes.

Neffy iffyness

A couple of weeks ago we told you about neffy, the nasal-spray epinephrine alternative to EpiPens that was approved by the FDA.

Apparently there was one liiiiiiitle bit of info left out — info that has prescribers a bit unsure about it. “[S]tudies have not yet been done on people who are in the throes of life-threatening allergic reactions, known as anaphylaxis.”

That makes sense — although the FDA approved neffy for anaphylactic shock, that wasn’t tested. (You can’t ethically trigger an anaphylactic reaction, even in grad students.) And it’s possible someone’s nose could be clogged, preventing the med from getting in.

And then there’s American exceptionalism: “[D]octors say they may avoid prescribing the new spray just after it hits the market, in part because they would need to devote employee hours to getting on the phone to press insurance companies to cover it.”

Still, neffy has a lot going for it. It has a longer shelf life (two years!). The cold doesn’t bother it anyway. Neither does the heat; no special storage is required. Nor is training beyond “Find your nose,” which studies have shown most people can do^*.

Got it in one

^* “[neffy maker] ARS found no harm to the eyes if the user accidentally squirts the medicine into them.”

Always a few years away

The latest universal flu vaccine candidate comes from [puts on blindfold, spins globe] the Cleveland Clinic’s Lerner Research Institute. Their tack: Go big.

First, they used a database to look at thousands of strains of the flu and (using the scientific version of Ctrl-F) found which amino acids are present in every strain of the influenza virus.

With that info, they identified eight proteins from the H1, H2, H3, H5, and H7 types — “It’s like creating a greatest hits album” — that they used to create a whopper of a vaccine. They called the process COBRA, for Computationally Optimized Broadly Reactive Antigens.

Then they tested the vax on mice, and it worked. Which means they’re looking at beginning human testing; they’re hoping to launch clinical trials within the next few years. They’re also hoping their protein-finding technique can be used for other viruses.

The Long Read: Local (non-pharma) hospital news

Two Georgia hospitals that have closed — the urban Atlanta Medical Center and the rural Southwest Georgia Regional Medical Center — might have a new lease on life thanks to bipartisan legislation that eased the certificate of need rules for building new hospitals.

What’s next for drug-price negotiations?

Speculation has already begun for which 15 drugs CMS will mark next for price negotiations. It’s required to release that list by February 2025, and the negotiated prices will take effect in 2027.

Topping the list (and keep in mind this is all speculation) is Ozempic. Remember, it’s only approved for diabetes, and it’s been on the market since at least 2017.

Other possible 2027 candidates include Pfizer’s cancer drugs Ibrance and Xtandi, GSK’s asthma and chronic obstructive pulmonary disease (COPD) treatment Trelegy Ellipta, Teva’s Huntington’s disease treatment Austedo, and Abbvie’s irritable bowel syndrome drug Linzess, according to five analysts as well as researchers and company executives.

These are what taxpayers, via Medicare, spend the most on. Ozempic alone costs so much that it has a noticeable effect on the deficit: “Medicare spent over $4.6 billion on the drug in 2022.”

Short takes

Free Covid tests are back

Covid’s picking up, so HHS is renewing the ‘free tests by mail’ program. Starting next month, people will be able to order four free tests via covidtests.gov.

In case you care

“CVS Health has recently overtaken Walgreens as the most popular drugstore retailer among drugstore/pharmacy shoppers.” (But “It’s not clear whether CVS will be able to sustain this lead.”)

GLP-1s suicide connection?

What’s with semaglutide and suicidal thoughts? The current answer is “There might be a link, but there might not be.”

During trials of another GLP-1 agonist, liraglutide, researchers found a tiny increase in suicidal ideation among patients (0.3% compared with 0.1% of those taking placebo). But when semaglutide hit the mainstream, more reports came in — back in January we told you that that the FDA was looking into some reports.

The latest is … dueling studies, both based on worldwide health data, albeit from different sources. One in January did “not support higher risks of suicidal ideation with semaglutide.” But another, which came out this month, found there was a disproportional amount of suicidal thoughts among semaglutide users.

So what’s to be done? Keep an eye on patients, everyone says, especially those with depression or an anxiety disorder. And, of course, do more research.

Covid vaccine news

As expected, the FDA has given emergency use authorization to update Covid-19 vaccines from Pfizer and Moderna. They should be available within the next few weeks.

For people five and over, a single dose of the new vax will do the trick, but for kids 6 months to 4 years old the number of shots is based on whether they’ve been vaccinated before — see the FDA release for details.

In other vaccine news, though…

Getting the Covid vaccine after infection seems to protect patients — at least primates — from hyperglycemia, one of the (many) issues faced by people who develop long Covid.

Tulane University researchers “found that administering the Covid-19 mRNA vaccine four days after infection showed a significant positive effect on blood sugar levels that was sustained over time.”

They’re thinking that the Covid vaccine might be indicated for treatment for at least some of Covid’s long-term issues, although it’s not clear yet how quickly you would need to get the shot for it to be effective.

Technicians! Get your immunization training now!

GPhA is offering its top-of-the-line immunization course for techs — the aptly named “GPhA’s Immunization Delivery Training for Pharmacy Technicians” — twice in the next couple of months.

Techs, you want this training (and the spiffy certificate it comes with). Respiratory virus season is coming up fast, and immunizations will be in demand.

What does it cover, you ask?

The latest info on flu and Covid-19 vaccines, how to give those jabs the right way (of course), the legal details of tech vaccinations, a bit of background on vaccines and immunology, practical stuff like ordering vaccines with inventory management standards, billing and reimbursement, and the documentation you need to use.

(Whew!)

The course will also help you sit for PTCB’s Advanced Skill Exam, and yes, it’s ACPE accredited for 8 hours of CPE, which includes 5 hours of self-study.

The deets

Two sessions to choose from:

Saturday, September 21, 2024 Jekyll Island Convention Center, Jekyll Island, Ga. 9:30am – 12:30pm

— or —

Sunday, October 20, 2024 GPhA World Headquarters, Sandy Springs 9:30am – 12:30pm

Cost: GPhA Members: $199; non-members: $235 (which includes a full GPhA membership through December 31, 2025 … but only if you live in Georgia)

More info: Hit up GPhA.org/techimmunization.

Fruit for the liver

If you’ve thought to yourself, “I wonder which exotic fruit might help treat non-alcoholic fatty liver disease,” a group of researchers in Quebec has got your back. The answer, they say, is the camu-camu — or at least its extract.

The Quebecois did a basic test: Over 12 weeks they gave 30 participants either some camu-camu extract or a placebo, then used an MRI to measure their liver fat.

Scientists observed a 7.43% reduction in liver lipids when study participants took camu-camu extract. With the placebo, they noted an 8.42% increase in liver fat. (Emphasis ours for clarity.)

They think it’s because the camu-camu’s polyphenols boost certain gut bacteria, and that bacteria “metabolizes the large polyphenol molecules that cannot be absorbed by the intestine, transforming them into smaller molecules that the body can assimilate to decrease liver fat.”

Next up: seeing whether camu-camu and cranberries can work together to get even better results.

Two degrees above zero

You want to be a pharmacist, but your mother has her heart set on your becoming a lawyer. Well there’s good news from UGA — you can do both.

Starting this fall, UGA will offer a Pharmaceutical Sciences and Juris Doctor (BS/JD) degree program, “for students with a passion for pharmaceuticals and law, offering an accelerated pathway to earn both degrees in just six years.”

Short Takes

Ebola vaccine worked

A real-world test of Merck’s Ebola vaccine in the Democratic^* Republic of the Congo “was 84% effective against infection during the country’s 2018-2020 Ebola outbreak,” according to a study by French and DRC researchers. Previously the vaccine had only been tested in clinical trials.

^* Uh-huh.

Coffee compilation

We’ve talked about all the benefits of drinking coffee (i.e., not just caffeine, but coffee in particular), and now a British biomedical professor puts it together in “All the reasons a cup of coffee really can be good for you.”

Live long and prosper (but maybe in Hawai’i)

The latest life expectancy numbers show that Georgia ranks #41 in the country, with a life expectancy at birth of 74.3 years. (Hawai’i is #1 at 79.9 years, while Mississippi is at the bottom at 70.9 years.)

Saving you a click

“Study reveals best exercise for diabetes patients” is the headline. Annoyingly, the story takes more than 200 words to get to the answer(s): moderate aerobic exercise.

For men, either continuous or interval aerobic exercise will reduce blood glucose, while for women only continuous exercise showed the same benefit.

You’re welcome.