October 12, 2024     Andrew Kantor

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

October 10, 2024     Andrew Kantor

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.

 

October 08, 2024     Andrew Kantor

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.)

October 05, 2024     Andrew Kantor

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.

October 03, 2024     Andrew Kantor

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.

October 01, 2024     Andrew Kantor

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.

September 28, 2024     Andrew Kantor

Helene: What Georgia pharmacists need to know

As you recover from Hurricane Helene, remember that the Georgia Board of Pharmacy has activated Policy 14, which covers emergency situations like this one. Here’s the gist:

Emergency refills

You may give patients up to a 30-day supply of their medication.

Caveats:

  • This does not apply to controlled substances.
  • In your professional judgment, the prescription drug must be essential to the maintenance of the patient’s life or to the continuation of therapy.
  • You must make a “good faith effort” to record all pertinent information as required by law, indicate that it is an “emergency refill prescription,” and keep those records.
  • You must inform the patient that the prescription drug “is being provided without the practitioner’s authorization and that authorization of the practitioner is required for future refills.”
  • As soon as possible, as conditions permit, you must notify the patient’s prescriber.

Click here for the official statement from the Board of Pharmacy (PDF).

Out of state pharmacy staff

During the state of emergency, pharmacists and pharmacy technicians not licensed in Georgia (but licensed in other states) may do their jobs in Georgia.

Such a pharmacist “may obtain a temporary license to dispense prescription drugs in areas affected by the declared disaster during the time that the state of emergency exists.”

Such a technician or intern “may assist the pharmacist in dispensing prescription drugs in affected disaster areas” during the emergency. There are important caveatsread that official statement — and most important, stay safe!

No drugs, no viruses

We’ve written before how using a simple saline nasal spray can go a long way toward preventing respiratory diseases, including Covid-19. Now researchers at Harvard think they can go one better. They’ve created a “drug-free nasal spray that forms a gel-like matrix that captures and neutralizes germs.”

It’s called PCANS, and it uses a bunch of ingredients that are in the FDA’s Inactive Ingredient Database. As a co-author explained:

“We developed a drug-free formulation using these compounds to block germs in three ways — PCANS forms a gel-like matrix that traps respiratory droplets, immobilizes the germs, and effectively neutralizes them, preventing infection.”

Caveat: It hasn’t been tested on humans, just “a 3D-printed replica of a human nose.”

CMS hit with data breach … in 2023

More than a year ago, the MOVEit data breach came to light, with a huge list of victims including banks, law firms, and even the University System of Georgia.

And now you can add CMS to the list.

The agency has now confirmed suffering a data breach incident as a result of the MOVEit vulnerability that saw sensitive data belonging to 3,112,815 people stolen. Many of those are either deceased, or not Medicare beneficiaries, since CMS only notified roughly 950,000 people.

New schizophrenia drug

The FDA has approved the first new drug for schizophrenia in decades. Bristol Myers Squibb’s Cobenfy is different because it targets the brain’s cholinergic receptors (instead of dopamine receptors) by affecting acetylcholine. It shouldn’t cause the common antipsychotic side effects like weight gain or tiredness.

But … the studies of Cobenfy have been pretty small and short term.

Only three controlled studies of the drug’s efficacy have been published, and all three lasted for only five weeks. So it is not clear how effective Cobenfy will be over longer periods, or whether it has long-term neurological side effects.

Alzheimer’s/cancer connection

People with Alzheimer’s seem to have a lower risk of contracting certain types of cancer, notable the colorectal variety — sometimes that risk is actually cut in half. Now Chinese scientists think they’ve found the reason.

And what d’ya know, it’s all about gut microbes. Specifically, mice that had more Prevotella bacteria in their intestines were more likely to develop Alzheimer’s but less likely to develop GI cancers.

When mice were treated with Prevotella-derived compounds, the animals showed cognitive dysfunction and resistance to tumor development in their rectum and colon.

They think that Prevotella suppresses gut inflammation (and thus suppresses tumor formation), but at the same time makes the gut “leakier,” allowing more microbial byproducts to enter the bloodstream, where they “may create a toxic environment that damages dopamine neurons.”

The Long Read: GLP-1

You might have noticed that GLP-1 agonists seem to treat a lot of issues, from the obvious (diabetes, obesity) to less obvious (alcoholism, sleep apnea). What’s up with that? Nature explains in “Why do obesity drugs seem to treat so many other ailments?

Saving you a click

This Many Crosswords Each Week Could Benefit Our Brains as We Age” — more than three times a week.

September 26, 2024     Andrew Kantor

Americans aren’t iron-y enough

Something like 1 in 6 Americans are iron deficient, at least according to a new US/Egyptian/Saudi study. Specifically, it “estimated that absolute iron deficiency affects 14% and functional iron deficiency affects 15% of adults in the US.”

They based that on the analysis of a survey of more than 8,000 adults between 2017 and 2020. Women, it seemed, were affected much more than men … at least until they were about 50. In fact, after age 50 the prevalence of iron deficiency dropped across the board.

Being overweight increased a person’s risk of being iron deficient, but interestingly alcohol use, food security, or even the amount of iron in a person’s diet had an effect.

The implication: Physicians should test more people for iron deficiency, not just children and pregnant women.

Targeting anxiety, not trips

We know that psychedelics can reduce anxiety, but it hasn’t been clear exactly what was affected that allowed them to work. Now Cornell researchers, with help from colleagues in India, think they know.

They studied a psychedelic called DOI (2,5-dimethoxy-4-iodoamphetamine) that helped mice and rats chill out. They found that when the drug hits the ventral hippocampus, it reduces anxiety but doesn’t cause any of the hallucinations that recreational DOI is known for. And there you have it … for now, at least.

As research on psychedelics as depression and anxiety treatments continues, knowing what area needs to be reached could allow for the development of targeted therapy, sans Lucy, the sky, or diamonds.

Treat inflammation, treat depression

When it’s not gut bacteria, it’s inflammation — and that just might be the case with … depression? Emory researchers found that the anti-inflammatory drug infliximab seems to help improve motivation in people with untreated depression. Motivation is kind of a big deal with depression as it can get patients into a downward spiral of inactivity.

But a bit of infliximab over a couple of weeks made a difference.

Patients who received infliximab demonstrated a greater willingness to exert effort in pursuit of rewards compared to those who received the placebo. This increase in effortful behavior was closely tied to a reduction in signaling pathways directly targeted by infliximab, particularly TNF.

And it wasn’t just self-reported — the changes were visible via fMRI as “alterations in brain activity within key regions associated with motivation, such as the dorsomedial prefrontal cortex, ventral striatum, and putamen.”

OD deaths drop

For the first time in … well, a long time, overdose deaths in the US dropped in a big way — about 10% from April 2023 to April 2024, according to CDC data. Health experts are cautiously optimistic that “a widespread, meaningful shift appears underway” for the first time since the opioid epidemic really took hold. As the White House drug czar put it, “This is the largest decrease on record and the fifth consecutive month of recorded decreases.”

Easier methadone access

New federal rules will allow people to take home a 28-day supply of methadone, rather than have to pick it up at a clinic every day. It’s the first major rule change for the addiction treatment in 20 years, and it takes effect Oct. 2.

Some states will need to update their laws to allow the new rule to take effect. Others may have to change their Medicaid payment system so clinics don’t have a financial incentive to deny patients the take-home meds. But most importantly:

Research showed the looser practice was safe. Overdose deaths and drug diversion didn’t increase. And people stayed in treatment longer.

The Long(ish) Read: Winners and Losers edition

Some Medicare recipients might soon be eligible for GLP-1 drugs for weight loss (not just for diabetes), but which ones? Everyone with obesity? Just those who also have diabetes? Heart conditions? Billions of dollars are at stake depending on the answers.

Shut up!

Study finds staff and visitor voices are major source of excessive noise in hospital ICUs

September 24, 2024     Andrew Kantor

Coming: at-home flu shots

Of course, as soon as we closed the Buzz newsroom for the weekend, this story came through:

The FDA has approved the first self-administered flu vaccine. MedImmune’s FluMist has been approved for more than 20 years, but it had to be given by a professional. Now its approval has been expanded to allow for either doing it yourself or having some other adult do it for you at home.

It won’t be available at your pharmacy, though — at least for now, patients will need to go through MedImmune, which will do a quick screening and ship it to their home. Or office. Or wherever they want it, starting sometime next year.

Come for Tech U, stay for immunization training!

Technicians! GPhA’s got a great educational weekend for you — TechU on Saturday (Oct. 19) and Immunization Training for Pharmacy Technicians on Sunday (Oct. 20). Two great courses that taste great together!

TechU

Four hours of CE credits, a continental breakfast, lunch, a professional headshot, and a fun networking event. (The full list of CE sessions, hotel suggestions, and registration is at GPhA.org/techu.)

It’s Sat., October 19 from 8:00 am – 5:30 pm at the PIHC Pharmacy Corporate Office in Atlanta (map). $40 for GPhA members, $65 for non-members*.

Immunization training

It covers the latest info on flu and Covid-19 vaccines, including how to give those jabs the right way (of course). We’ll also cover the legal details of tech vaccinations and a bit of background on vaccines and immunology — then toss in practical stuff like ordering vaccines with inventory management standards, billing and reimbursement, and all the documentation you need to use. And it’ll help you sit for PTCB’s Advanced Skill Exam.

It’s Sun., October 20 from 9:30 am – 1:30 pm at GPhA HQ in Sandy Springs (map). $199 for GPhA members, $249 for non-members*.

* Non-member rate includes a full GPhA Membership through December 31, 2025, for all attendees residing in the state of Georgia.

Short Takes

Try lullabies instead

The American Academy of Sleep Medicine suggests “Rethinking the use of melatonin as a sleep aid for kids.” That’s mostly because dosing is difficult to manage; supplements aren’t regulated, and 2022 saw a jump in overdose calls.

Antidepressant beats brain tumors

The bad news: Only in the lab and in mice.

The good news: Vortioxetine appears to be “one of the most effective agents” against glioblastoma, according to Swiss researchers, who are now preparing clinical trials (which are made easier because the drug is already approved).

Bone cancer breakthrough

If you add a little gallium to certain bioactive glasses — a filling material used for bone and tooth repair — you get a material that eliminates bone cancer. That’s what British researchers found, and when they say ‘eliminates,’ they mean it.

Tests in labs have found that bioactive glasses doped with the metal have a 99 percent success rate of eliminating cancerous cells and can even regenerate diseased bones.

Basically the glass particles get into the bone, where the cancer cells soak it up … with the gallium, which kills them. And then the glass gets to work rebuilding the bones. Said the orthopedic oncologist who led the team, “We believe that our findings could lead to a treatment that is more effective and localised, reducing side effects, and can even regenerate diseased bones.”

Shrooms beat Lexapro

A new study finds that, over the long haul, patients who take psilocybin for major depression do better than those who take escitalopram.

That’s what British researchers reported, and they imply it might hold true for other SSRIs. They found that both drugs reduce depression, but “psilocybin outperformed escitalopram in several measures of well-being, meaning in life, work, and social functioning” including not messing with patients’ libidos.

(The idea of psilocybin as a long-term treatment for depression isn’t news. Back in 2022, Johns Hopkins researchers reported that psilocybin treatment for major depression was effective for at least a year.)

Should we worry about this? It feels like we should worry about this

So there’s a guy in Missouri who got the H5N1 bird flu without having contact with infected animals. That’s mildly concerning. But now three people who have been in contact with him — a household member and two healthcare workers — have also contracted the flu. And these are only the symptomatic cases. (Thankfully the symptoms were mild.)

TikTokers gonna TikTok

Their latest health advice: Eat dirt! It’s got, you know, microorganisms! (They call themselves — I kid you not — “crunchers*.”)

As Forbes’s Bruce Lee puts it:

[I]sn’t having a lot of microorganisms also kind of the reason why you typically try not to eat dirt? It’s the whole reason why if someone were to drop a burrito on the ground, roll it in the soil and then offer it to you, you wouldn’t immediately say, “Thanks” and not worry about getting a bad case of the runs or worse.

* We have a different name.

September 21, 2024     Andrew Kantor

Georgia pharmacist to DEA: Come get me, bro

The owner of Living Well Pharmacy in Augusta, Vic Johnson, is dispensing medical marijuana to Georgians who have a medical marijuana card … even though the DEA says that’s illegal.

Quick background: Georgia passed a law allowing certain independent pharmacies to dispense low-THC products to patients who have been approved to receive a medical marijuana card. That’s about 22,463 people so far.

But before the program could take off, the DEA stepped in and said pharmacies couldn’t dispense it, stopping the program in its tracks.

Now here comes Johnson willing to defy the feds.

Johnson said he is prepared to take drastic measures to keep selling medical marijuana products if the DEA takes steps to force him to stop.

“It’s a new frontier. I really think pharmacies are an ideal outlet for dispensing medical cannabis because if you come to my pharmacy already, we can talk about what medications you already are taking,” said Johnson.

FTC fires back

Tuesday: We wrote that PBMs were demanding that the FTC retract its conclusion that PBMs help increase the price of drugs.

Now: The FTC filed suit against Caremark, Express Scripts, and Optum “for Artificially Inflating Insulin Drug Prices.” The agency found that PBMs “chase the rebates” and thus steer patients to more expensive medications, making insulin unaffordable to millions of Americans.

The FTC alleges that the three PBMs created a perverse drug rebate system that prioritizes high rebates from drug manufacturers, leading to artificially inflated insulin list prices.

The complaint charges that even when lower list price insulins became available that could have been more affordable for vulnerable patients, the PBMs systemically excluded them in favor of high list price, highly rebated insulin products.

(The FTC also puts blame on drug makers for “driving up list prices of life-saving medications” and might sue them later.)

Triptans beat newer migraine drugs

As good as new migraine drugs like lasmiditan (Reyvow), rimegepant (Nurtec), and ubrogepant (Ubrelvy) are, it seems that older, less expensive drugs are actually better.

A British review/analysis with 90,000 participants (!) found that certain triptans — but not all — were actually the best drugs for acute migraine. According to the lead researcher:

“Our analysis identified eletriptan, rizatriptan, sumatriptan, and zolmitriptan as the most effective medications for treating acute migraine attacks.”

Meanwhile, the newer drugs were “comparable to paracetamol [acetaminophen] and less than the aforementioned four triptans.”

Ozempic up for negotiation?

Novo Nordisk says it expects Ozempic to be part of the next round of Medicare price negotiations. Considering the high price the company set (and the frightening effect on Medicare’s wallet), the good it can do for people’s health, and the high demand, that’s not surprising.

No, it’s not good for you

Even moderate alcohol

More and more the idea that moderate drinking is good for you is falling by the wayside. Yeah, it might reduce some cardiovascular issues, but — as a new report from the American Association for Cancer Research explains — the recent rise in certain cancers might be attributed to alcohol use.

In fact, there have been several studies lately that have solidified the link between alcohol and cancer while finding the cardiovascular effects are minimal.

As one epidemiologist put it, when it comes to moderate drinking, “[T]here are many ways to keep your heart healthy, and these potential benefits don’t really outweigh your cancer risks.”

Fruit and oats

Don’t give your kid(s) oatmeal or fruit for breakfast — you’re raising their risk of type 1 diabetes. A new Finnish study followed 5,700 children who had a genetic predisposition to type 1 diabetes and had their parents track their diets.

When they parsed the data, they found that “the more fruit, oats or rye children ate, the more their risk of T1D increased.”

But there’s good news:

In contrast, eating strawberries, blueberries, lingonberries, raspberries, blackcurrants, and other berries appeared to provide protection against T1D. The more berries a child ate, the less likely they were to develop T1D.

Commercial premiums are going up … again

Employers are going to see the cost of employees’ health plans jump an average of 5.8% in 2025 according to a projection from Mercer (the company, not the university).

  • That would be the third year in a row of costs rising more than 5%
  • It would be about 7% without employers’ cost-savings measures, like switching to higher-deductible plans or raising employee contributions.
  • It’ll be worse for smaller businesses — 9% before any cost cutting.

Why the jump? Prescription drug costs, of course. And what’s leading the pack? GLP-1 agonists.

Correlation vs causation

Apparently there’s a link between slap fighting and brain trauma. (Captain Obvious wonders, though, which way it goes.)

Hard to imagine why.

Elsewhere: Sunshine State confusion

Trigger warning: This is a story about abortion. Remain calm.

Florida has effectively outlawed abortion, banning it after 6 weeks. Okey doke*. There are exceptions “to save the life and health of the mother” and “when the pregnancy results from rape, incest, or human trafficking, or has a fatal fetal abnormality.”

But now the state’s health department has sent a memo to doctors saying that failure to provide an abortion in those circumstances is illegal and can result in malpractice charges.

* That doesn’t mean we support or oppose it, just that it’s the law — let’s go on with the rest of the story.