Little Brother to watch you

Cops wear body cameras to help them do their jobs. So what about doctors and pharmacists in ORs and ICUs? Not to record what they do, but fitted with AI to stop them from making a mistake.

University of Washington researchers have developed just that: “the first wearable camera system that, with the help of artificial intelligence, detects potential errors in medication delivery.”

And, as with a lot of what AI does, it’s creepily good. It can identify what medications are being drawn and administered even while clinicians are moving fast — they’re not holding anything up to the camera.

The video system does not directly read the wording on each vial, but scans for other visual cues: vial and syringe size and shape, vial cap color, label print size.

And the AI is good. It “achieved 99.6% sensitivity and 98.8% specificity at detecting vial-swap errors.”

Insurance merger back on the table

They may have cancelled their wedding last year, but Cigna and Humana might be back at the wedding planner, talking about a merger. Well, it’s more that Cigna would assimilate Humana. Cigna is finalizing the sale of its Medicare Advantage business, so it hopes regulators would allow it to buy its smaller competitor once that sale is complete.

mRNA news

Vomit vaccine

Good news for anyone planning a cruise: An international group of researchers has begun stage-3 trials of an mRNA vaccine against norovirus, aka the “vomiting bug.” The trial is set to run for two years and include 25,000 subjects across Australia, Canada, Japan, and the UK.

Even faster vaccines

Developing mRNA vaccines is (as we’ve learned) a lot quicker than developing traditional ones, but there are still bottlenecks, notably synthesizing the mRNA itself. Doing the synthesis requires both a chemical process (fast) and an enzyme-based process (slow). But now Japanese scientists say they’ve found a method^* “capable of producing high purity, fully chemically synthesized mRNA.” If it pans out, it could mean faster production of existing mRNA vaccines, and even faster development of new ones.

^* As you probably guessed, they “devised a novel phosphorylation reagent with a nitrobenzyl group that serves as a hydrophobic purification tag.”

You’ll like this

The New York Times pulls no punches in its feature on PBMs, “The Powerful Companies Driving Local Drugstores Out of Business.”

[A] New York Times investigation found P.B.M.s, which employers and government programs hire to oversee prescription drug benefits, have been systematically underpaying small pharmacies, helping to drive hundreds out of business.

You knew that already. But take a moment to appreciate the deep dive the Times takes — this was a 3,200-word, front-page story that crosses the country and goes deep into the devastating impact of PBMs on independent pharmacies.

Short takes

Surprising Parkinson’s findings

Rutgers researchers found two unexpected connections between common drugs and the risk of Parkinson’s:

1. “[P]eople who took multiple courses of penicillin antibiotics had a 15% lower risk of developing Parkinson’s disease.”
2. Those who took antifungal meds, though, “had a 16% higher risk of Parkinson’s.”

Both those findings came out of a review of medical records of more than 93,000 Brits.

Preventing delirium after surgery

There might be a simple solution to post-op delirium — a condition that 15% of surgical patients can get, where they experience confusion that can last a week or more after surgery. That solution? Ibuprofen (or other non-salicylate NSAIDs like celecoxib or ketorolac).

Johns Hopkins researchers found that those non-salicylate NSAIDs were better at heading off delirium than acetaminophen, and way better than aspirin.

The Long Reads: Why you might want to worry about the bird flu

The bird flu, which has been spreading to cows and humans (slowly) doesn’t feel like a big deal — more of a “Meh, keep an eye on it, I guess” situation. But there’s more going on behind the scenes, implying the situation might be a lot worse than we all think.

The bottom line: Rather than help stop the spread in dairy cattle, the USDA is actually blockading testing efforts and information sharing to protect short-term profits.

• Vanity Fair: “Inside the Bungled Bird Flu Response, Where Profits Collide With Public Health”
• Reuters: “Exclusive: State and industry input led US farm agency to relax bird flu testing order for cows”

The good news is that we have a lot of experience with flu vaccines, so hopefully even a major human outbreak would be containable … as long as people get vaccinated.

The risk of beta blockers

There’s more evidence that beta blockers given before surgery increase patients’ risk of stroke, according to research out of Montefiore Medical Center.

Looking at the records of almost 206,000 patients over 16 years, they found that using beta blockers for the first time in the month before surgery increased stroke risk by 25%, while patients already using them had a 17% increased risk.

A couple of notes: This doesn’t apply to cardiac surgery (beta-blockers did help protect against myocardial infarction and cardiac revascularizations). And Black and Hispanic patients seemed to be prescribed beta blockers more often, even though they weren’t sicker.

RSV vax works

A big new study (230 hospitals and 245 emergency departments across the country) found that the RSV vaccine works well in the real world — it was “80% effective in protecting against hospitalizations and deaths during the 2023-2024 RSV season.”

You might think “Wait, they’re just now looking at how effective it is?” The idea is that this is a real-world study, as opposed to the study-based ones the approval was based on.

Short Takes

USA Today discovers pharmacy deserts

To be fair, the deserts are growing as more and more independent pharmacies close, and chains start cutting back on their locations.

The X for Y Files

Radicava (aka edaravone), which was approved to treat ALS, seems to stop brain-tumor stem cells from proliferating. That means — Canadian researchers say — “repurposing the drug may prove to be a potent weapon against glioblastoma.”

In a sad irony, despite that approval, edaravone may not even provide a “clinically relevant benefit” to ALS patients.

When seven days is enough

Patients with blood infections only need a 7-day course of antibiotics — not the 14 days that’s often prescribed. Only a week is not only just as good, it actually might be slightly better, according to the study out of the University of Toronto.

Among patients with bloodstream infections who received 7 days of antibiotics, 14.5% had died at 90 days, versus 16.1% of those who received 14 days of antibiotics.

The data held true, they said, regardless of whether patients were in the regular hospital or the ICU, and no matter the severity or type of the infection.

What’s better than GLP-1s?

With all the hubbub about GLP-1 drugs, it turns out they’re not really cost-effective for weight loss — at least not compared to surgery. A Northwestern University study found that bariatric surgery is the way to go if money is an issue (e.g., if you’re an insurance company), “delivering two more healthy years of life and saving patients about $9,000 a year.”

Of course GLP-1s will eventually be less expensive, but they still have to be taken for life while surgery is once-and-done, although you might have to take some extra supplements to make up for the GI changes.

ICYMI: Part D changes

There are big changes afoot for Medicare Part D plans next year, making it important for recipients not to just keep doin’ what they’ve been doin’. Notably, there’s good news — with a caveat. The good news is that, thanks to provisions in the IRA…

• Out-of-pocket costs for beneficiaries are capped at $2,000 per year.
• The deductible is capped at $590.
• Low-income folks may be eligible for subsidies to help pay for it.

The downside is that about 70% of insurers have raised their premiums (although there’s an incentive for insurers to keep that premium increase to $35), and some may reduce coverage of certain drugs in favor of less expensive options. They may also “eliminate pharmacies, doctors, or other services from the provider networks beneficiaries must use.”

Bottom line: Recipients really need to read the details of plans before choosing one — it’s the biggest change in coverage since 2003.

You know it’s 2024 when someone has to write this opinion piece

“Doctors, Not AI, Should Authorize Treatments”

Benzo overprescribing

Stroke survivors may be getting too many benzos, according to a new paper out of Harvard Med.

Giving them drugs like lorazepam to help deal with recovery anxiety is fine. The trouble, the paper suggests, is that…

More than half of the new prescriptions of benzodiazepines were written for a supply of 15 to 30 days, rather than the smaller number of pills for short-term, as-needed use.

That extra, oversupply “would be enough for patients to become long-term users or possibly addicted,” they wrote.

Telehealth rules update

Remember when it was leaked that the DEA was considering reinstating in-person requirements for getting controlleds via telehealth? That didn’t sit well with a lot of people. Most people, in fact, including HHS.

Quick refresher: Telemedicine rules were relaxed during the pandemic to ensure continuity of care, but everyone liked them so much the DEA extended that relaxation twice. The ‘temporary’ rules were set to expire at the end of this year, though.

The latest: A bipartisan group of senators has written to the Biden administration, “calling such restrictions ‘detrimental to patients and a barrier to accessing care’.”

Coincidentally, the very day the letter was sent, DEA submitted a proposal to extend the relaxed requirements for another year, probably grumbling under its breath while it did that.

^* If you want to go down a rabbit hole, note that the senators referred to President Biden as “The Honorable,” but it’s not clear that the title should be given to the president himself.

What, them worry?

The public — that great, teeming mass of rabble — is still a bit worried about Covid-19 and the flu, but not so much about RSV. That’s according to a survey out of Penn’s Annenberg Public Policy Center. It’s unfortunate, because RSV kills 6,000 adults and at least 100 young children die every year, and it’s preventable with a quick vaccine.

Still, most people aren’t concerned:

• Only 26% are worried about getting or having a family member get RSV in the next few months
• 33% are worried about Covid-19
• 37% are worried about the flu

Of note is that the worry about RSV has dropped since last year for no good reason — it’s not as if the disease has waned in any way. (Worry about Covid and the flu have remained steady, though.)

Compounding update

FDA: All compounders can still make tirzepatide

While it sits in the corner and thinks about what it did, the FDA has said that yes, all compounding pharmacies can create and dispense compounded tirzepatide. (Its statement the other day wasn’t clear whether smaller, 503A pharmacies were allowed to renew dispensing it. Now the agency clarified that.)

Novo is still on the attack

Meanwhile, although it’s still unable to supply Ozempic, Novo Nordisk has filed “18 law­suits against GLP-1 com­pounders in 44 days.” That’s despite the fact that compounding semaglutide is perfectly legal while it’s in shortage. (It’s not legal, though, to refer to a compounded product as “Ozempic” — that’s a trademark violation.)

Standing doesn’t deliver

If you stand a lot at work, you might be tempted to silently mock those people who buy standing desks just to get the benefits you enjoy. Well, you might want to keep your mockery silent. A new Aussie study finds that, contrary to anecdotal reports …

… over the long-term, standing more compared with sitting does not improve cardiovascular health (coronary heart disease, stroke and heart failure), and could increase the risk of circulatory issues related to standing, such as varicose veins and deep vein thrombosis.

Not that sitting is any better — it’s still pretty awful for your body to be on your butt more than 10 hours a day —so getting up and getting physical is important. But a standing desk isn’t going to help.

The Long Read

The first ED treatment gel is available over the counter. Forbes’s Bruce “No Relation” Lee ponders “How New OTC Eroxon Gel May Affect Erectile Dysfunction And Sex”.

If it’s a gel, you figure that someone somewhere will smear it on all kinds of things in all kinds of amounts.

Walgreens plans to shrink

After losing another $3 billion, Walgreens says it’s going to close 1,200 retail stores over the next three years to try to become profitable again.

Why the big hit? Well, there was losing billions on VillageMD when the company wanted to get into the primary care business. Then there were the lawsuits for its role in the opioid crisis. And then there was “a non-cash impairment charge related to equity investment in China,” whatever that means.

So now the company is planning to close 14% of its stores under a “transformational cost management program,” starting with 500 stores between now and next August.

Tirzepatide compounding saga continues

Compounding pharmacists, it seems, can continue to make and dispense compounded tirzepatide.

Eli Lilly’s brand-name Mounjaro and Zepbound have officially been in shortage for a couple of years. But there was plenty of the active ingredient, tirzepatide, so compounding pharmacies were able to dispense it to patients, albeit without the fancy injectors. A huge business sprung up filling the need.

On October 3, though, Lilly convinced the FDA that the shortage was over, and the agency removed Mounjaro and Zepbound from its shortage list, meaning compounders could no longer make it. Except that the shortage wasn’t over; wholesalers and pharmacists weren’t actually able to get the drugs.

An organization representing compounders, the Outsourcing Facilities Association, filed suit against the FDA and its decision to remove Mounjaro and Zepbound from the shortage list. It claimed the agency made a “reckless and arbitrary decision — lacking any semblance of lawful process” because it only took Lilly’s word that the drugs were available. In reality, it pointed out, wholesalers barely had any stock.

The latest: Before a federal judge could even make a ruling, the FDA essentially said, “Hold up, we’re going to review our decision.” So the judge put the suit on hold, and tirzepatide is essentially back on the shortage list. Compounders can compound it while the FDA considers what the supply actually looks like, perhaps collecting data from wholesalers and pharmacies, rather than just the manufacturer.

Combo vax trial paused

Novavax was one of several companies working on a combo flu/Covid vaccine. I say “was” because the FDA has paused the company’s trial after one subject reported nerve damage.

Notably, the person got the vaccine in January 2023, and there’s no evidence the vaccine had anything to do with it. Still, the trial was put on hold while Novavax and the FDA look into what happened. (The company’s stock plunged almost 20% by the end of the day.)

Short takes

Covid and flu down

The latest CDC data has good news: Wastewater monitoring shows that both Covid and flu are on the decline. Covid is at “low” levels in the South (and “medium” overall) and continuing to decline, while flu levels remain low and are holding steady.

Whooping cough ‘surging’

On the other hand, the CDC also found that rates of whooping cough (i.e., pertussis) are already four times higher than they were last year, with more than 16,000 cases reported so far this year, including two confirmed deaths. Health officials attribute the rise to missed vaccinations during the pandemic.

Weekly hemophilia treatment

The FDA approved Pfizer’s Hympavzi — the first weekly treatment for hemophilia and “the first antitissue-factor pathway inhibitor.”

Medical stuff:

Pfizer’s new drug is aimed at adult and pediatric patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors (neutralizing antibodies). It is administered via a pre-filled, auto-injector pen.

A simple way to save millions

Medicare could save between $133 million and $336 million a year on the Alzheimer’s drug lecanemab with one minor change: smaller vials.

[B]ecause the drug is currently available only in single-use 500 mg and 200 mg vials, substantial amounts of the expensive medication are discarded when the dose a patient is prescribed is lower than the amount contained in the vials.

UCLA researchers calculated how much patients use (based on average age and weight), and did the math to figure how much of those 200-mg and 500-mg vials are thrown out. The answer: about 5.8%. But that could be cut by almost three-quarters “by adding a third, 75-mg vial without significantly harming quality of care.”

Disney didn’t cover this part

Sanofi wants girls and women in Portugal to be comfortable pooping — there’s apparently a stigma about it — so it’s launched a campaign with AI-generated images called “Pooping Princesses” to promote its Dulcolax laxative.

Really, there’s nothing more to say here^*.

^* Actually, that’s not true. If you miss the letter “A” in the tagline at the bottom, it appears to read “Ducolax — Release.”

Acne-med danger is more widespread

Back in March it came to light that benzoyl peroxide products can break down and produce benzene, a carcinogen and thus something you don’t want on your face.

Now some more info: It seems that “can break down” is more aptly “does break down.” The folks at Valisure, an indy lab that tests pharma products, found that acne products taken off local store shelves had “very high levels” of benzene.

Among 111 benzoyl peroxide products purchased from various retailers across the U.S., about a third (34%) had benzene above the “conditionally restricted” FDA limit of 2 ppm.

Then the benzene levels go up at a rate of about 4.36 ppb per hour^*.

What can be done? They found that cold storage stabilizes the benzoyl peroxide, which jibes with the American Acne and Rosacea Society’s guidance that recommends refrigerating products.

^* Note that the first number was parts per million and the second is parts per billion. So it increases, but not by a crazy amount.

Speaking of Valisure…

That’s the lab that first flagged the dangers of Zantac back in 2019. Just this week, GSK “agreed to pay up to $2.2 billion to resolve approximately 80,000 lawsuits brought by users of Zantac who claimed the heartburn drug caused their cancer.”

GSK will also pay Valisure $70 million to resolve Valisure’s whistleblower lawsuit.

A clue to metastasis

One of cancer’s deadliest features is its ability to spread around the body — breast cancer spreading to the lungs is all too common. But now scientists may have found a clue to stopping cancer from metastasizing.

It’s been unclear why, after cancer cells spread, some can lay dormant for years before developing into tumors. Looking into why that happens, researchers at Montefiore Einstein Comprehensive Cancer Center discovered the answer: macrophages. They found that the macrophages in mouse lungs essentially prevent any disseminated cancer cells (DCCs) from metastasizing — at least for a while.

How do they pull that off? It seems the macrophages secrete a protein called TGF-β2 that keeps the cancer cells dormant. Well, that sounds like a helpful bit of information, doesn’t it?

If the finding holds true for every organ (all of which have their own macrophages), this could be a big step on the road to preventing cancer from metastasizing in general.

Baxter IV-drug update

Since Hurricane Helene knocked out the Baxter plant in Marion, NC — the one that supplies 60% of the country’s IV medications — it’s been unclear when the plant may be back in action.

Now the company has at least a little more info. It says it hopes to be able to produce 90% to 100% of what’s allocated to customers of certain IV solutions by the end of the year.

For its “highest demand IV fluids,” Baxter says it’s currently supplying direct customers about 40% to 60% of their normal ordering, with the hope to meet the majority of regular demand by year-end.

Who wants cannabis?

Prescribers are iffy about medical cannabis, but you know who’s a lot less iffy? Patients with chronic pain. A study of “1,600 people with chronic pain and 1,000 physicians in states with medical cannabis programs” by Rutgers researchers found that the majority of both supported medical marijuana, but with a noticeable difference:

Researchers found that 71% of chronic pain patients supported federal legalization of medical cannabis, compared with 59% of physicians.

A couple of other tidbits:

• Federal legalization for recreational use: 55% of chronic pain patients support it, but only 38% of physicians
• Requiring insurance coverage of medical cannabis treatment: 64% of patients support it, and 51% of physicians

A new combo test

The FDA has approved the first another at-home combo test for Covid-19 and the flu. The difference is that this one is outside an Emergency Use Authorization. (What difference that makes, we don’t know. But we’d already started writing this item when we noticed that it wasn’t the first.)

Healgen Rapid Check COVID-19/Flu A&B Antigen Test takes 15 minutes to detect proteins from both COVID-19 and influenza A and B in nasal swabs.

Oh, do they?

“Eating Nothing But Sardines May Help You Lose Weight, But Experts Say It’s a Bad Idea”

Captain Obvious puts his headphones on “Hear Through” mode

“Texting while walking puts pedestrians in danger”

Money savers won’t save much

Lawmakers have come up with all sorts of ways they say will reduce drug prices: allow importation from Canada, reducing or eliminating direct-to-consumer advertising, speeding the process for generics and biosimilars, and increasing pricing transparency, for example.

But when the Congressional Budget Office ran the numbers, it found that those ideas would have negligible impact. The only proposal that made a notable difference would be capping U.S. prices based on what other countries pay — that would result in about a 5% savings. Why so little? “[D]rugmakers could respond to the policy by delaying launches outside of the U.S. or withdrawing their products in smaller countries.”

(Price negotiations can save only 1-3% because the Inflation Reduction Act includes penalties when drug makers raise prices above the rate of inflation.)

Flu vax may be so-so this year

Based on reports from South America, this year’s flu vaccine seems to be about 34.5% effective at preventing hospitalization. That’s not great, but still better than not getting the vaccine.

(Preliminary) $2 drug list released

CMS has released the preliminary list of 101 generic drugs that will cost Medicare recipients only $2 per month. It’s a test of a program that “aims to test whether offering low-cost generics can boost seniors’ medication adherence and health outcomes, while giving them more certainty on out-of-pocket costs.”

The list covers common prescriptions like penicillin, metformin, lithium and albuterol asthma inhalers. Thirty-five of the drugs treat blood pressure and other cardiovascular conditions.

This is a ‘companion’ plan of the Biden administration that complements the $2,000 annual cap on out-of-pocket drug costs for Medicare recipients. As Axios points out, though, “A future administration could decide to change courses or halt the initiative.”

There’s a Swiss cheese joke to be made here

If you want to get a medication through the skin, the only way right now is via a microneedle patch; the epidermis is pretty good at keeping out large molecules, like a lot of drugs.

A patch is effective, but it’s limited to a small, smooth area, making it useless for conditions like psoriasis that covers a lot of skin. What you need is a mechanism as flexible as a cream, but that can send larger drug molecules though the skin.

How about a cream filled with Chinese throwing stars? That’s what researchers in Switzerland came up with. They’re three-pointed, 3D stars made of nanoceramics that, when added to a gel, roll over the skin creating “micro-wounds” that heal quickly, but not before allowing large molecules to enter. (Said one researcher, “It feels like a skin scrub.”)

Next up: making the material biodegradable (or at least disintegrable), and possibly testing it as an alternative for the needle-phobic.

Easy-to-swallow chemo?

Stanford researchers say they’ve found an “embarrassingly simple” method of turning injectable chemo drugs into pill form.

Through early trials in mice, they showed that their version of oral paclitaxel, one of the most prescribed chemotherapy drugs for many common cancers, performed better than the typical IV dose.

Honestly, the science is a bit too much to get into here, so you’ll need to read the article. Essentially, the addition of a “chemical tag” that covers the part of the drug molecule that attaches to the target. The tag only dissolves when the drug is in the right place, making the bioavailability nearly 100%.

Compounding news

Suing the FDA

A group representing outsourcing facilities — the aptly named Outsourcing Facilities Association — is suing the FDA over the agency taking Mounjaro and Zepbound out of shortage. The group points out that the FDA is basically taking Lilly’s word for the availability and should have taken public comments first, as the drugs are still hard to come by for a lot of pharmacies.

Weight Watchers hops on the bandwagon

Weight Watchers — or WW if you prefer the slimmed-down version — is offering compounded semaglutide, joining a bunch of telehealth companies that are dispensing it. WW will sell it for $129 for a month’s supply. (Novo Nordisk expects the shortage of Ozempic/Wegovy pens to last for at least several more months.)

ICYMI: BP and arm position

You probably don’t take your patients’ BP that often, but when you do — and if you counsel them on using home cuffs — be aware that arm position matters. A lot. A new study out of Johns Hopkins found that BP readings can be artificially high unless a patient’s feet are flat on the floor and the arm with the cuff is at heart level and supported (e.g., by a desk or table). No holding their arms, and no putting the arm in their laps.

Researchers found that BP measurements obtained with arm positions frequently used in clinical practice — an arm on the lap or unsupported at the side — were markedly higher than those obtained when the arm was supported on a desk.

Surprise diabetes trigger

Could type 1 diabetes be caused by … bacteria? British researchers think so. They found that certain bacterial proteins triggered a response in killer T-cells that caused those T-cells to attack insulin-making cells.

That doesn’t mean diabetes is caused by bacteria, just that in certain circumstances it might be caused by it. The good news is that a person would need a particular gene to be susceptible to this kind of reaction, and that gene is only present in about 3% of the population.

The idea, though, is the important part because it reveals a mechanism for the disease that might be a target for future treatments.

Dockworker strike ending

Good news: The East Coast port strike that would have clobbered the drug pipeline (among others) looks like it’s ended after just one day as the two sides have reached an agreement.

Prescribers still overusing antibiotics

Pediatricians still aren’t getting the message about prescribing antibiotics properly, according to a new study of almost half a million kids in Tennessee.

[It] found that only 31.4% of the antibiotics prescribed in outpatient settings were optimal for choice and duration. Furthermore, 39% of pediatric antibiotic prescriptions were for diagnoses that rarely require antibiotics.

“Optimal” in this case means it was the right drug for the right duration for the kid’s diagnosis, according to the current guidelines. (And those guidelines now recommend shorter durations for several conditions.)

Prescribers got the drug right 38.5% of the time and the duration right 51.3% of the time, but both? That was that 31.4% number.

Caveat: These were Tennessee kids, and Tennessee prescribers give antibiotics to kids 50% more often than the national average. Yikes.

Stay safe

Hurricane Milton is headed toward Florida^*, but southeast Georgia is currently close enough to the path that you’ll likely get some weather out of it. Just be prepared, folks — both for yourself and for Florida patients who may have evacuated.

Important: Georgia’s state of emergency — and Georgia Board of Pharmacy Policy #14 — expire on Wednesday, Oct. 9, at 11:59 pm. But with Milton bearing down, it might be reactivated. Stay tuned.

^* Unless the government decides to change its course, naturally.

Short Takes

Medicare covers PrEP with Part B

Oral HIV-PrEP drugs had been covered under Medicare’s Part D (sort of), but now CMS has moved coverage to Part B, meaning the injectable meds are available to a lot more people.

Ovarian cancer vax in the works

British researchers just got some more funding to develop a vaccine for ovarian cancer. They think the tools available today are good enough for them to be able to teach the immune system to recognize early signs and attack the tumors.

If successful, OvarianVax could train a person’s immune system to attack any abnormal ovarian cells as they arise, without the person even knowing anything was awry.

If it works — and it’s still a big if — that kind of vaccine would be a Big Deal for women with BRCA gene mutations, who are significantly more likely to develop it.

CMS readies to negotiate

CMS is getting ready for the 2025 drug-price negotiations; by February 1 it’ll reveal the 15 medications it’ll be negotiating on. This time around it’s going to give drug makers a little more time by starting the process earlier.

A supplement against aggression?

People take omega-3 fatty acid supplements to help themselves live longer, and one mechanism at work might be keeping them from hustlin’ people strange to them^*.

Neurocriminologists at UPenn found that taking omega-3 supplements can reduce aggressive behavior. And it’s not a small reduction, either. The lead author “estimates this intervention translates to a 30% reduction in aggression—across age, gender, diagnosis, treatment duration, and dosage.”

“Omega-3 is not a magic bullet that is going to completely solve the problem of violence in society. But can it help? Based on these findings, we firmly believe it can, and we should start to act on the new knowledge we have.”

^* Even if you do got a two-piece, custom-made pool cue.

Captain Obvious puts her finger on the scale

“Bias found when drug manufacturers fund clinical trials”

Psychiatric drugs are reported to be about 50% more effective in clinical trials funded by the drug’s manufacturer than when trials of the same drug are sponsored by other groups.

(That’s according to research from an Ohio State University.)

ICYMI: Mounjaro and Zepbound are back

The FDA has officially removed tirzepatide from it shortage list. That’s good news and bad news. Good, obviously, for Eli Lilly — the company has obviously resolved the shortage of its injectors.

It’s more complicated for patients, though. The ones who’ve been getting compounded tirzepatide will need new prescriptions to switch to Mounjaro^® and Zepbound^® … and maybe pay the higher price.

And not every pharmacy is going to have it available. The ASHP still says supplies are short, so it can be a roll of the dice.

Compounding pharmacists obviously have to stop dispensing it, unless they find a way to, for example, dispense a version that includes a vitamin supplement and have docs prescribe that. (Would that work? Who knows?)

And then there’s the potential for see-saw availability. How long will the supply of injectors last? Will tirzepatide go back into shortage once they run out?

Many questions, but answers (to use an editor’s abbreviation) TK.

(Side note: If you compound GLP-1 drugs, you might want to read the Alliance for Pharmacy Compounding’s statement on the announcement.)

Infect me once, shame on you

If you got the flu last year, good news! UGA researchers found that getting the flu one year can make the next year’s vaccine more effective.

The idea that getting infected with one strain provides some protection from other strains — well, that makes sense; the flu is still the flu. What’s interesting here is that the UGA folks found that prior infection also boosts vaccine immunity the next year.

Don’t forget TechU 4.0!

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.

And don’t forget that all licensed pharmacy technicians in Georgia must have 20^* CPE hours to renew their license before June 30, 2025.

One low price — just $40 for GPhA members, $65 for non-members — 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!

^* The actual amount of CE credit needed varies on license date. Check our website for details. 

New sunscreen could be coming

We’ve written before how sunscreen ingredients in the US have been lagging a lot of the world. That might be changing, as the FDA is considering approval of the first new sunscreen ingredient in … well, in a long time.

The ingredient is bemotrizinol, and it’s been used worldwide for decades. Now European skincare company DSM-Firmenich is asking for approval here.

If the FDA agrees with DSM-Firmenich’s request, the next step will be for the FDA to propose adding bemotrizinol to the list of over-the-counter drugs that are “generally recognized as safe and effective” to be sold to Americans.

Bemotrizinol has a lot of benefits, including fewer questions about safety and less of a pasty look or feel — that might mean more people are willing to wear them.

The FDA is awaiting all the data on bemotrizinol, and is expected to make a decision by March 2026.

Elsewhere: Lone Star lawsuit

The attorney general of Texas is suing both insulin makers and PBMs, claiming they have colluded collaborated to keep the price of insulin high.

In the Texas lawsuit, [Texas Attorney General Ken] Paxton accused that manufacturers artificially raised the prices of insulin and then paid a significant, undisclosed portion back to the PBMs for preferential treatment in return.

The PBMs subsequently awarded preferred status to the manufacturer with the highest list prices, while excluding lower-priced drugs, the press release from the attorney general’s office said.

Drugmakers and PBMs responded — paraphrasing here — “Nuh-uh.”

You would think people would be dropping like flies

Apparently, per Irish/Canadian/more research, drinking too much coffee (more than 4 cups, i.e., two mugs), too many fizzy drinks, or too much fruit juice can significantly increase your risk of stroke.

CVS ponders breaking up

Could CVS Health commit mitosis? Maybe. The company’s investors are apparently “exploring options that could include a break-up of the company to separate its retail and insurance units.”

The plan to potentially split the company’s pharmacy chain and the insurance business has been discussed with the board of directors, which is yet to decide on the best course of action for CVS to pursue, the sources said, cautioning that the plans have not been finalized and CVS may opt for a different strategy.

It’s not that CVS isn’t incredibly profitable — it’s that investors are annoyed it isn’t more profitable. And we all know how important profit motive is for the companies that decide what health care we’re allowed.

Stopping the step

Migraine sufferers are pushing Congress to curtail step therapy by passing the Safe Step Act. The bill would require insurers to make exceptions to their normal ‘try everything that’s cheaper’ approach when a doctor says there’s no point, and when delaying the right treatment “would lead to irreversible consequences” including preventing a patient from, you know, living a normal life.

GLP-1s’ real world reality check

For all the hype about how much weight people can lose on GLP-1 drugs — 15%! 17%! 20% — it seems a lot of that might just be, well, hype.

When researchers look at real-world experience (i.e., outside of drugmakers’ studies) they find that weight loss from Ozempic, Zepbound, and kin are more like two to four percent.

The latest of these real-world studies, out of the Cleveland Clinic, looked at about 3,400 people with obesity. Those taking semaglutide for a year lost an average of just over 5% of their weight. Not bad, of course, but far short of what people have been led to believe.

Can you imagine the shakeup if GLP-1s turned out to be not such a big deal after all?

Short Takes

Mercer to study tranq-induced skin lesions — fun!

Two Mercer CoP researchers scored themselves a $388,000 grant from the NIH to look into xylazine — aka tranq — the latest Drug Scourge Affecting Our Communities. Specifically, the grant is “to explore how xylazine affects the human body, especially its role in causing dangerous and life-threatening skin lesions.”

Respiratory season’s slow start

Good news from the latest CDC report: “seasonal influenza and RSV activity are low nationally, and Covid-19 activity is elevated but declining.” It’s still early, of course, but we’ll take the good news where we get it, especially with vaccination rates looking to be low.

Senators push for more PBM oversight

Two US senators have asked the FDA and the FTC to keep up their scrutiny of PBMs. The FTC lawsuit in September was a good start, they said, but now they “urged the com­mis­sion to ex­am­ine ‘new PBM tac­tics that ap­pear to cre­ate fur­ther bar­ri­ers to com­pe­ti­tion and harm the abil­i­ty of con­sumers to ac­cess low­er cost pre­scrip­tion drugs’.”

What new tactics? They’re referring to how at least two PBMs (CVS and Express Scripts) are also getting into biosimilar manufacturing which may be “a veiled at­tempt by PBMs to con­trol ad­di­tion­al parts of the sup­ply chain.”

AI tackles rare diseases (in a big way)

Repurposing existing drugs, the ancient method: Notice anecdotal reports over years that indicate a drug might have an off-label use, then test it against other diseases.

Recent method: Train an AI on a rare disease or two, then have it go through a list of existing drugs to see if any might treat it.

New method: Give an AI a list of thousands of ‘untreatable’ rare diseases, a list of thousands of medications, and let it find matches.

That’s what researchers at Harvard did with a tool they call TxGNN — they trained it to “[identify] shared features across multiple diseases, such as shared genomic aberrations” and extrapolate how an existing drug might work on a different disease.

[T]he tool identified drug candidates from nearly 8,000 medicines (both FDA-approved medicines and experimental ones now in clinical trials) for 17,080 diseases, including conditions with no available treatments. It also predicted which drugs would have side effects and contraindications for specific conditions.

Hey, students, there’s an AI study-buddy for you

It’s called Pharm Tutor AI, and it’s basically ChatGPT that’s been additionally trained on pharma-specific info. The company describes it as “Your AI assistant for Pharmacy School,” and it’s apparently meant to be your know-it-all friend for those late night study sessions:

[T]his application serves as an interactive study partner, capable of delivering comprehensive knowledge across a range of pharmaceutical subjects. It is purpose-built to aid in the understanding and retention of complex concepts, facilitate extensive subject exploration, and help students excel in their academic endeavors.

Disclosure: We didn’t look into pricing (it seems to be free) or even how good it is, but the idea seems kinda cool and worth exploring.

Metformin vs long Covid

For people who’ve been vaccinated, taking Paxlovid doesn’t do much to prevent long Covid. (It’s also expensive for a lot of people, so for mild cases it’s probably not worth it.)

What might be worth considering to prevent long Covid is metformin. It’s cheap, safe, and — per several studies — effective at reducing the risk of long Covid significantly.

One study found that….

If metformin was started within the first three days of illness and continued for 14 days, [the] study showed a 41% reduction in the incidence of long Covid, with an absolute decrease of 4·1%, compared with placebo.

Others found that metformin reduced patients’ viral load as well. “At a minimum,” wrote the author of the Forbes piece, an infectious-disease specialist, “I believe all adults with acute Covid-19 should be offered metformin.”

A stem-cell cure for diabetes?

Chinese scientists say they’ve effectively cured type-1 diabetes by creating pluripotent stem cells, turning them into pancreatic islet cells, and transplanting them into a patient’s pancreas.

After the transplant of CiPSC-islets, she [a diabetic patient] regained the capability to autonomously regulate her blood sugar. Seventy-five days after the transplant, she became insulin independent and has remained insulin injection-free for over a year. All her diabetes-related indicators have reached the levels of a healthy person, confirming the clinical cure of this type 1 diabetes patient.

Transplanting islet cells has been known to be a treatment for diabetes, but it’s tough to find donors. The big breakthrough here was turning plain ol’ somatic cells into stem cells — the lead author won China’s Future Science Prize for the process — then making those into islet cells for transplant.

Short Takes: Medicare prescription coverage

Premiums are going down: According to CMS, the average premium for a standalone Part D plan will drop by about 4% in 2025 (from $41.63 to $40), while Medicare Advantage prescription coverage will drop about 7% (from $18.23 to $17). That’s thanks to competition and “regulatory reforms and key provisions from the Inflation Reduction Act.”

But patients don’t compare: Despite the average Medicare recipient having 43 Medicare Advantage plans and 21 standalone Part D drug plans to choose from (in 2024), “nearly 7 in 10 (69%) Medicare beneficiaries did not compare their own source of Medicare coverage with other Medicare options offered in their area.” (And 43% didn’t even review their plans for changes in premiums or out-of-pocket costs.)

Baby steps

Private insurance companies are slowly but surely beginning to cover prescriptions written by pharmacists, as more states allow the practice.

Health insurers see an opportunity to make sure their patients get needed prescriptions quicker in an effort to improve health outcomes. Thus, insurers are paying pharmacists as they have physicians in states where laws allow for such expanding prescribing.

ICYMI: Fluoride questions

A federal judge wants the EPA to reduce the risk of fluoride in drinking water … although he didn’t say how. The ruling comes after a report found that consuming high levels might stunt intellectual development.

Keep in mind that the questionable fluoride levels are twice what’s allowed in drinking water, so it’s unclear what exactly the EPA is supposed to do. Reevaluate? (US drinking water has about half the fluoride that the WHO recommends to prevent tooth decay.)

The judge seemed cool with fluoridation in general — “a practice that has been hailed as one of the greatest public health achievements of the last century” — but he wanted to be sure there was enough of a safety margin between what’s allowed in water and what might cause developmental issues.

Half baked

Dermatologists: “Targeted, careful use of UV radiation can treat some skin conditions.”

TikTok: “So sunburning your face can remove acne!”

Dermatologists: “No, that’s not what we—”

TikTok: “Aieee! The sun — it burns!”

Oncologists: “You wanna schedule your appointment now?”

Weird science

Hearing an unexpected sound triggers a dopamine release (found Yale researchers), and that can lead to poor decision making.

The Elis tested this hypothesis in the most boring way possible^*: First, they played the test subjects a sequence of tones. Then they changed one of those tones and asked the subjects to make a decision that could reward them more if they took more risk.

“We found that surprising sensory events, these unexpected sequences of tones, increased people’s risk-taking,” said the lead researcher.

“Think about say an urban environment where there are so many sounds that are mostly irrelevant to our daily decisions. Maybe those sounds are affecting decisions even when we don’t notice.”

^* We would have used an air horn.