Unexpected(ish) skin-gut connection

The more severe someone’s psoriasis is, the more likely they are to have some type of inflammatory bowel disease. That’s what Israeli researchers looking at the health records of 61,000 patients found. In fact, someone with psoriasis is 47% more likely to have IBD than someone without it.

More importantly, perhaps, was the connection with severity: “Patients with severe psoriasis exhibited a notably higher risk of developing IBD compared to those with mild psoriasis.”

Why? The details aren’t clear, but it’s likely because the two conditions “share common underlying inflammatory pathways.” Regardless, they say, it’s worth keeping an eye on folks with psoriasis in case they develop Crohn’s disease or ulcerative colitis.

Low iron, long Covid?

The long-Covid mystery continues, and the latest suspect is iron. Well, the lack of it. A team of researchers from Cambridge and Oxford universities found whether someone contracts long Covid seems to be determined by how quickly their iron levels recover after their infection.

People who took a longer time to demonstrate regulation, and had more severe initial infections, were at an increased risk of long Covid.

Iron levels drop during infections, but the body’s method of making more red blood cells to compensate is thwarted by Covid’s inflammation. (That also explain why long-Covid sufferers are so tired.)

Treating the inflammation might help, but iron supplements won’t: “It isn’t necessarily the case that individuals don’t have enough iron in their body, it’s just that it’s trapped in the wrong place.”

Move over, Wegovy

Why lose only 6% of your weight in a few months (and have to use an injection) when you can lose twice that with a pill, Jetsons-style? Novo Nordisk wondered the same thing, and now the company says it’s got that high-powered pill. Well, in testing. The company claims that early data show its Amycretin “helped patients in the trial drop 13% of their weight over 12 weeks” with just a daily pill that “targets two hormones involved in regulating hunger and blood sugar levels: GLP-1 and amylin.”

Of course, this was just an early trial; phase 2 testing won’t begin until later this year. It was enough to send Novo’s stock price soaring, though, and that’s what really matters.

ICYMI: Clearasil releases benzene

Independent lab (and product watchdog) Valisure says it “found high levels of benzene formed in acne products containing benzoyl peroxide,” and if you remember your 9th grade chemistry, benzene is something you want to avoid.

Valisure tested dozens of prescription and over-the-counter benzoyl peroxide products and found that they were “fundamentally unstable and can generate unacceptably high levels of benzene when handled or stored at higher temperatures.”

And by “unacceptably high,” they mean 800 times the FDA’s “conditionally restricted” concentration.

The issue isn’t with impurities or the quality of the products, but the chemistry of benzoyl peroxide itself — that fundamental instability means it breaks down into benzene. Said the company, “This means the problem broadly affects benzoyl peroxide products, both prescription and over-the-counter, and necessitates urgent action.”

40Hz is the frequency, Kenneth

“[S]ensory gamma rhythm stimulation clears amyloid in Alzheimer’s mice,” reads the headline. What it means in English is that a combo of flickering lights and clicking clicks at the right frequency — 40 Hz, aka the brain’s “gamma rhythm” — “can reduce Alzheimer’s disease (AD) progression and treat symptoms in human volunteers as well as lab mice.”

That’s not from some shady website, either: It’s from a study out of MIT that found his particular frequency had surprising beneficial effects. Why it works … well, that they’re not clear about, although they think stimulating particular neurons at 40 Hz might improve the brain’s waste-removal — specifically “promot[ing] increased amyloid clearance via the glymphatic system.”

But, as always, more research is needed.

Inhalers: the price of a deep breath

After CFCs were banned as propellants in asthma inhalers in the 1980s, drug makers used the switch to new propellants to extend their patents, especially for HFC inhalers. That means high prices for people without insurance … well, in the US anyway.

The same asthma medication for which US patients pay top dollar is available elsewhere at much cheaper prices. Consider the following case for inhalers. The pharmaceutical company Teva sells QVAR RediHaler, a corticosteroid inhaler, for $286 in the US.

In Germany, Teva sells that same inhaler for $9.

Some uninsured patients cross the border to Canada or Mexico to get , but that’s not possible for most people — they’re stuck with un- or barely-affordable asthma meds.

The good news

Following the introduction of a generic version of its Spiriva HandiHaler — and accusations by the FDA of patent shenanigans — Boehringer Ingelheim has suddenly announced that starting in June it will cap the out-of-pocket prices of its inhalers at $35 per month.

The Long Read: A different psychedelic

Low doses of ibogaine, a seriously powerful psychedelic, might be a major tool to fight opioid addiction. Lots of people around the world swear by it, but there’s one problem: It’s not legal in the US … yet.

In the United States, the renewed interest in ibogaine has largely been fueled by the thousands of Americans who have sought treatment abroad and returned home with tales about overcoming addiction after a single session. The fact that many of them are military veterans has helped ease some of the longstanding institutional resistance to psychedelic medicine.

Capitalism in play

Last month HHS made its first offer for what Medicare would pay for 10 expensive drugs. The drugmakers have now spit on the ground, implied that the offers insult the memories of their dear grandmothers, and made counteroffers that are still cuttin’ their own throats … but acceptable (barely) because HHS is a dear friend of uncle Horace.

HHS will now roll its eyes, point out that it could do better in the back alley of a Detroit street market, and respond with a counter-counteroffer that’s still way better than those nogoodniks deserve.

And so it will go.

How GLP-1 drugs really work

Old assumption: GLP-1 drugs slow down the workings of the digestive system, which is what makes people feel full — they are full.

New reality: That’s true of natural GLP-1, but the artificial stuff lasts a lot longer in the body; that’s why it’s a weekly injection and not a daily one.

By indiscriminately flooding the body with long-lasting molecules, the injections likely allow engineered GLP-1 drugs to penetrate parts of the body that the natural gut hormone cannot—namely, deep in the brain.

The brain also has GLP-1 receptors that respond to the drugs. That’s why mouse studies have shown that Ozempic and kin suppress more than the desire to eat (e.g., the desire for alcohol), something that’s echoed in anecdotes from patients who say they’ve quit addictive behaviors. As the headline says, “Ozempic Is a Brain Drug.”

Speaking of Ozempic …

Novo Nordisk says it might also slow the progression of chronic kidney disease. Those shifty Danes report that a phase 3 trial found Ozempic “[cut] the risk of death from that and major cardiac events by 24%.”

First OTC CGM

The FDA has approved the first over-the-counter continuous glucose monitor — the Dexcom Stelo Glucose Biosensor System. It uses a wearable sensor (replaced every two weeks) and a smartphone app and, well, continuously monitors their glucose levels. The company says it’ll be available this summer, but hasn’t disclosed the price.

The caveat: It’s not for people taking insulin. It’s only approved for people who have diabetes but are managing it via lifestyle changes, e.g., losing weight, exercising more, skipping the Oreos, etc.

Free Covid tests end March 9

March 8 is the last day people can ask for them — at least until the feds start the program again in the fall.

Double trouble for fatty liver

A new drug fights fatty liver disease with “a one-two punch that shuts down triglyceride production and fatty acid synthesis.”

Punch #1: The drug inhibits an enzyme called DGAT2^* that the liver needs to make triglycerides.

Punch #2: It also decreases the amount of a protein called SREBP-1^†, that regulates the expression of genes required for the liver to make fatty acids and triglycerides.

The combined effect of stemming DGAT2’s role in triglyceride synthesis and blocking SREBP-1’s role in activating genes involved in fatty acid and triglyceride synthesis stops fat from depositing in the liver, reversing MASLD [metabolic dysfunction-associated steatotic liver disease, aka nonalcoholic fatty liver disease].

The University of Texas Southwestern Medical Center folks who developed the drug are already looking at phase 3 trials “in the near future.”

^* diacylglycerol acyltransferase 2, since you asked
^† sterol regulatory element binding protein 1, of course 

Quad flu vax will probably be retired

The US will probably be switching from quadrivalent flu vaccines to trivalent ones, as it’s been four years since we’ve seen the influenza B/Yamagata virus — one of the four ‘quads.’

Not seeing that strain means there’s no point including it in the vaccine, and removing it “gives us the space to replace B/Yamagata virus with a component that will give improved protection against the circulating influenza viruses.”

Not the most well-thought-out headline, if you think about  it

“Firearm ownership is correlated with elevated lead levels in children, study finds”

Chillin’ with CBD

Marijuana can help with anxiety — insert cliché comment here — but it might not be the THC that does the job. According to Colorado University researchers, CBD alone works even better.

They split about 300 participants with anxiety into four groups, each using a product with a different combination of THC and CBD. After a month…

… all four groups reported decreased anxiety. But the cannabis groups saw greater reductions in perceived anxiety than the non-cannabis group, and those using CBD-dominant products showed the most improvement of all.

Fun fact: The research had to be done in students’ homes because federal law prohibits the possession of cannabis on college campuses, even for research.

* * *

ICYMI: Opill OTC

The first OTC contraceptive, Opill, is now shipping to retailers — drugstores, convenience stores, and supermarkets — nationwide.

Infliximab for Crohn’s — don’t wait

British researchers looking for a Crohn’s disease biomarker made a surprising finding. Newly diagnosed patients who were given infliximab showed dramatic improvement.

This is surprising because infliximab isn’t typically a first-line treatment; it’s given when patients experience flare-ups that don’t respond to other treatments. But the Brits found that it’s best not to wait. Instead, a “top-down” treatment, starting with infliximab, was a heck of a lot better.

80% of people receiving the top-down therapy had both symptoms and inflammatory markers controlled throughout the course of the entire year compared to only 15% of people receiving the accelerated step-up therapy.

Getting infliximab sooner meant fewer ulcers, “higher quality-of-life scores, less use of steroid medication, and lower number of hospitalisations” — and were less likely to need abdominal surgery.

The X-for-Y Files: TB vax and liver cancer

If you have mice with liver cancer, make sure they’ve been vaccinated for tuberculosis. Just one dose of the BCG TB vaccine reduced liver tumors and helped mice live longer.

UC Davis researchers found that the BCG treatment boosted immune T cells — notably helping them (and macrophages) get into the liver tumors. Or, turning up the science….

“It also activated the body’s immunity and enhanced IFN-γ signaling, which contributes to an anti-HCC [hepatocellular carcinoma] effect.”

As the vaccine is a century old and absolutely safe, and liver cancer is notoriously difficult to treat, this can be used right away while more research is done on improving its effectiveness.

Captain Obvious plays the kazoo

“Study finds more pleasant-sounding medical device alarms could reduce annoyance without compromising effectiveness”

The scent of therapy

Here’s an interesting finding: UC Riverside researchers found that exposing fruit flies to certain scents actually changes the expression of some of their genes.

What was even stranger was that the compound they used — diacetyl, which can add a bit of buttery flavoring to food — made these changes in cells that don’t have olfactory receptors. Next they tried it on mouse and human cells. Same thing: The odor affected gene expression.

Well, huh.

Then it gets better. They found that not only did a sniff of diacetyl affect genes, it affected them in a good way. In fruit flies…

…exposure to diacetyl volatiles substantially slowed degeneration of photoreceptor cells linked to Huntington’s disease. In transgenic mice […] gene levels that are upregulated in cancers like neuroblastoma showed a significant reduction in mice exposed to diacetyl.

This is all proof-of-concept stuff, but the idea that there’s a chance of using scents as medicine on the genetic level … well, that’s intriguing, isn’t it?

Face-palm of the day

Prepare to sigh deeply and shake your head in wonder that humanity has made it this far. There are, it seems, people on TikTok who are promoting “budget Ozempic.” That should be a red flag right there. So what are these people suggesting? Are ya ready? If you can’t afford Ozempic, just use laxatives and stool softeners instead!

Spoiler: This is a bad idea.

CONVENTION REGISTRATION IS OPEN

You got that right: It’s time to sign up for the 2024 Georgia Pharmacy Convention — June 13 to 16 on, of course, beautiful Amelia Island, Florida.

If you’ve been to the convention, you can just click here to register for this year’s extravaganza — you know you don’t want to miss out.

Never been? Get the deets about the event and why it’s the biggest one of the year: Click here to check out the convention website. Then you can register — and don’t forget to grab your hotel room or villa at the same time.

Lots of Optum/Change Healthcare news

1. Optum is rolling out a temporary loan program — sorry, “funding assistance program … to help with short-term cash flow needs.”

For clarity, this is not a program for providers who have had claims submission disruptions but rather for those whose payment distribution has been impacted.

2. The company has also set up “a new instance of Change Healthcare’s Rx ePrescribing service” — kind of a parallel version of what was taken down. “[W]e have enabled this service for all customers effective 1 p.m. CT, Friday, March 1, 2024.”

3. Hackers say they’ve extracted 6 terabytes of data from Change Healthcare “including information like medical records, insurance records, and payment information.”
4. The Justice Department is looking into the company from an anti-trust angle.
5. An opinion piece from Axios: The cyberattack against Change Healthcare isn’t just a problem for patients now, it “exposed a major vulnerability facing health care: consolidation.”

Small but mighty legislative update

Not only did one of our most important bills sail through committee, we’ve also signed on a hot new advocacy champ to help us in the state senate. Read all about it in Melissa Reybold’s latest legislative update.

Some tetanus shots about to be in shortage

The CDC is urging healthcare providers to conserve their supply of the Td vaccine (aka TdVax) for tetanus and use the Tdap vaccine instead.

The new guidance follows a recent announcement from the vaccine’s manufacturer, MassBiologics, that it would discontinue production of the shot. Grifols, the sole supplier of TdVax, anticipates running out of the vaccine by June 2024.

The good news is that the two vaxes are used interchangeably, and the Tdap also protects against pertussis.

ICYMI: Spring Covid boosters

As expected, the CDC is recommending a spring Covid-19 booster shot — but just for people 65 and older. That is all.

Another Alzheimer’s flop

First Biogen and Eisai released Aduhelm as a treatment for Alzheimer’s. But the price tag was so high and the benefit so small that it failed like a Bills’ field goal attempt.

But the companies bounced back with Leqembi — another Alzheimer’s drug that was supposed to be even better than Aduhelm.

And now that’s flopping too, as neurologists give it a big ol’ shrug. According to life sciences consultancy Spherix, “few surveyed neurologists consider Leqembi to be a significant medical advance over other historical AD treatments.”

And the people who did get it weren’t happy:

It also found that satisfaction with Leqembi “is relatively low,” with the average satisfaction rating being a full 15% lower than the typical rating for a new neurology market entrant.

If at first (and second) you don’t succeed….

Congratulations to the aorta

It’s been upgraded to a full-fledged organ, no longer just part of the heart. So say the European Association for Cardiothoracic Surgery and the US Society of Thoracic Surgeons.

Why does this make a difference? It means that aortic specialists can be a thing now, rather than a branch of cardiologists or vascular surgeons. Whether these, um, aortacists will be invited to the same golf games has yet to be determined.

The two types of prostate cancer

The headline says it: There are, it seems, two overall types of prostate cancer, according to a British AI run by scientists at two universities across the pond.

Said one of the humans taking credit:

“This study is really important because until now, we thought that prostate cancer was just one type of disease. But it is only now, with advancements in artificial intelligence, that we have been able to show that there are actually two different subtypes at play.”

At the moment this is filed under “That’s interesting,” but soon they hope it’ll lead to tailored treatments dependent on which subtype is in play.

You don’t have to put out the red light, but it might actually help your blood sugar

It might be the oddest bit of diabetes news you hear this week: “Shining a specific frequency of red light on a person’s back for 15 minutes can significantly reduce blood sugar levels.”

You read that right. And it comes from actual researchers (neurobiologists) publishing in a legit journal (the Journal of Biophotonics) from a real place (the UK).

“Explain how!” I hear you say.

It’s all about the mitochondria^*, which are affected by red light. Specifically, light in the 650-900 nm range (i.e., red through near-infrared) increases the amount of ATP the mitochondria produce “which reduces blood glucose and also improves health/lifespan in animals.”

That in mind, the Brits did a small study (30 people), shining 670 nm red light onto some and no light on others.

People who received red light exposure 45 minutes prior to drinking glucose exhibited a reduced peak blood glucose level and reduced total blood glucose during the two hours.

The interesting side note is that in the modern world with its blue light everywhere, people’s ATP production might be skewed — “the authors suggest that this may be a potential public health issue.”

^* Obligatory “the powerhouse of the cell.”

Time is running out!

Apply or nominate someone to the 2024–25 GPhA Board of Directors — the deadline is Wednesday, March 6!

You have a week to step up! Apply to join the board members and help set the direction for GPhA’s advocacy efforts, choose the issues to focus on, and create the association’s agenda. It’s a chance to make a difference to the entire pharmacy profession in Georgia.

Click here to read more about qualifications, responsibilities, and the process — then apply or nominate someone quickly!

Speeding sperm

No man wants to think his sperm are slow, but sometimes you have to confront reality: Sluggish sperm accounts for almost a third of couples’ infertility. Aussie researchers, though, think they’ve found a way to stomp on the metaphorical accelerator.

The trick? Ultrasound. High-frequency ultrasound waves, it seems, make sperm more motile.

20 seconds of ultrasound at 800 mW and 40 MHz increased measures of sperm motility by up to 266% and reduced the proportion of inactive or ‘nonprogressive’ sperm from 36% to just 10%.

[…]

“Ultrasound not only increased the swimming velocity of sperm but also promoted almost two-thirds of lower-grade sperm to a higher motility grade.”

Teens and meds

Weight loss drugs

There’s a surge of kids — teens and pre-teens — turning to the new crop of weight loss drugs. They’re dealing with the damaging effects of obesity, both physically and psychologically, and now there’s an easy(ish) treatment.

Getting kids on semaglutide, tirzepatide, or their kin has the blessing of the American Academy of Pediatrics (which still suggests starting with lifestyle changes). The AAP is primarily concerned with the health issues of obesity, and understands that genetics can play a major role. There’s been some pushback, though — mostly concerns about unknowns (will they affect growth?) and cost.

Note the transformation that occurs with a combination of GLP-1 drugs, better lighting, a clean background, a touch of makeup, clothes that fit, losing braces, and a new hairstyle.

Antidepressants

During the pandemic, girls and young women went all in on antidepressants. A new study out of the University of Michigan looked at data covering the vast majority of US prescriptions and found that…

While a growing number of young people ages 12 to 25 were receiving antidepressants before the pandemic, the antidepressant dispensing rate rose nearly 64% faster after March 2020.

And yes, it was the girls. For boys and young men the antidepressant dispensing rate “changed little” and even declined among younger boys. Why? The researchers don’t know, but they speculate that boys may have skipped more doctor’s visits during the pandemic, so they just weren’t diagnosed with depression as often.

Respiratory virus update

Covid-19 and RSV cases continues to drop, but flu just won’t go away; outpatient visits held steady nationwide. (Georgia was one of the states that saw a small decline, though.)

The next next GLP-1 drug

This one comes from Viking Therapeutics, and looks to be a biggie. Unlike others, “VK2735” is a dual agonist against both GLP-1 and GIP that also sports a longer half-life than current GLP-1 drugs.

Test results show that VK2735 helped people lose up to 14.7% of their weight after just 13 weeks, which is a lot faster than semaglutide — after 13 weeks those patients hadn’t lost even 10%. (And “Viking believes further weight loss is possible beyond Week 13.”)

The data come from a phase-2 trial, so there’s still a bit of work to do before this gets out into the public.

The Long Read: GLP-1 Coverage edition

Which insurers will cover semaglutide and tirzepatide for weight loss is still shaking out. At last check (in October 2023) only about 27% covered them, “But 13% of plan sponsors indicated they were considering coverage for weight loss.” The devil is in the details of cost, premiums, and making plans attractive. Read the details from CNBC.

The X for Y Files: brain cancer

Patients taking glitazones for cholesterol or diabetes could be seeing an extra benefit: They might lower the risk of brain cancer.

Or, put another way, glitazones “could be repurposed to prevent brain metastasis in cancer patients who are at high risk of secondary cancers.” That’s what British neuropathologists concluded after a study of more than 10,000 patients, including 7,500 with brain tumors:

The researchers found long-term glitazone drug use by diabetic patients was associated with reduced primary and secondary brain tumour risk compared with diabetic patients on other medications.

Interesting bits about the flu vaccine

October is the sweet spot

Kids tend to be vaccinated in their month they were born — that’s when they’re likely to go back for an annual checkup. And that led researchers at Harvard Med to check out how well they were protected from the flu.

Based on how many of those kids got sick, they were able to figure out that “The lowest rate of influenza diagnosis was seen for children born in October,” suggesting that October is the best month to get vaccinated.

Effectiveness fades

After about 41 days, the flu vax loses about 9% of its effectiveness every month.

That’s what Canadian researchers found based on “data from lab and health administration databases in the province [Ontario] from the 2010-11 through the 2018-19 flu seasons.”

The twist: That only applies to adults; the Canucks found the vaccine didn’t lose effectiveness in kids (i.e., people through age 17) at least up to about 153 days after vaccination.

The next big cancer treatment

CAR-T treatment was a major milestone for blood cancers, but now come tumor-infiltrating lymphocytes, or TIL — a potential Very Big Deal for solid tumors.

TIL works by taking immune cells from a patient’s tumor, beefing them up (“giving them the Club Med treatment,” as one researcher put it), then reinserting them into the tumor — kinda like the little weakling leaving the corrupt kingdom only to return as a conquering hero.

TIL isn’t new in the lab, but for the first time the FDA has given accelerated approval to a TIL therapy called Amtagvi.

Granted, the therapy isn’t simple — it involves chemo, the weakening of the immune system, and interleukin-2 — but this is just the beginning.

Drug interaction science

Which drugs might interact with one another? A lot of what we know is based on experience, but now there might be a way to determine interaction ahead of time.

It’s all about the transporter proteins that take the drugs out of the GI tract. Researchers at MIT, Brigham and Women’s Hospital, and Duke have found a way — using tissue samples and, of course, AI — to determine which transporters carry which drugs.

Identifying the transporters used by specific drugs could help to improve patient treatment because if two drugs rely on the same transporter, they can interfere with each other and should not be prescribed together.

Right now this process is pretty much in the proof-of-concept stage, but it could mean an easy way to flag interactions before they occur.

The Long Read/Elsewhere: Portugal

While the U.S. struggles to contain the opioid epidemic, Portugal took an entirely different tack. While here we turned to arrests and prison sentences, there they focused on “health care, drug treatment, job training, and housing.” And it’s working.

The contrast is striking. In the U.S., drug deaths are shatteringly common, killing roughly 112,000 people a year. In Portugal, weeks sometimes go by in the entire country without a single fatal overdose.

Here’s a comparison: Georgia, which has about the same population as Portugal, averages about 1,408 overdose deaths per year. (In 2021, more than 1,700 Georgians died of opioid-related overdoses.) Portugal sees about 80.

One word

Every single placenta tested by University of New Mexico Health Sciences researchers contained microplastics. Every. Single. One.

The researchers found the most prevalent polymer in placental tissue was polyethylene, which is used to make plastic bags and bottles. It accounted for 54% of the total plastics. Polyvinyl chloride (better known as PVC) and nylon each represented about 10% of the total, with the remainder consisting of nine other polymers.

In unrelated news, endocrine issues — including obesity, metabolic syndrome, and early puberty — have been rising steadily and concerningly over the past decades.

Quick Colorado follow-up

Just in case you’re interested: The other day we told you how Colorado’s Prescription Drug Affordability Board determined that the price of Enbrel was too high for patients to afford. Now the board has taken the next step and approved setting a price cap for the drug. Not the actual dollar amount, just the idea of a price cap.

The vote by the Prescription Drug Affordability Board kicks off a six-month process to determine what price would be appropriate for Enbrel. The board also has the option to ultimately vote against a price ceiling at the end of the process.

In case you’re somehow unaware….

UnitedHealth Group’s Change Healthcare division has been hit by a cyberattack from a “suspected nation-state associated cybersecurity threat actor” — e.g., Russia, China, or North Korea … not that we’d point fingers.

The cyberattack has thrown a wrench into the healthcare system’s operations, leaving many pharmacies unable to verify patient insurance coverage or determine copayment amounts.

And then comes the understatement of the day: “This inability to process prescriptions has caused considerable distress among pharmacists and patients alike” because pharmacies can’t verify insurance coverage or copays and thus some patients can’t get their meds.

Check out the story from Fox 5 Atlanta, featuring GPhA’s own Jonathan Marquess, VP of the Academy of Independent Pharmacy, or read the Reuters story for a bit more detail.

The X-for-Y Files: Propecia edition

Check it out, guys: The same drug that fights male-pattern baldness and enlarged prostate (finasteride, known as Propecia on the streets) also seems to reduce cholesterol, delay atherosclerosis, and lower liver inflammation.

Well, definitely in mice and probably in humans.

University of Illinois researchers noticed that men taking finasteride had cholesterol levels — 30 points lower than men not taking it. That was based on a survey, though, not a study. So off to the lab, where they tested the drug on mice. And it worked.

“Mice that were given a high dose of finasteride showed lower cholesterol levels within the plasma as well as in the arteries. There were also fewer lipids and inflammatory markers in the liver.”

Next up is a more thorough trial to prove the same effect on humans, but hopefully at a lower dose.

GLP-1 drugs are so effective…

How effective are they? So effective that Goldman Sachs thinks they’ll make workers much more efficient — enough to potentially boost the country’s GDP by a full 1% in the next few years. (“Academic studies find that obese individuals are both less likely to work and less productive when they do.”)

Elsewhere

Rocky Mountain High Prices edition

For the first time ever, a state — Colorado — has determined that a drug is officially unaffordable for patients. The drug is Enbrel, an injection that treats autoimmune diseases.

The state’s All-Payer Claims Database found Enbrel cost more than $46,000 a year per patient, with patients responsible for an average of $2,295 in 2022 if they were covered by commercial insurance or Medicare Advantage. The database found at least 3,400 people in the state used Enbrel that year.

That leaves it open for the state’s Prescription Drug Affordability Board to set a maximum price for Enbrel in Colorado, “which would be the first time any state took that step with any prescription drug” and will of course lead to months or years of court battles.

California tackles pharmacist overload

The Golden State has passed a new law “aiming to address understaffed chain pharmacies and reduce medication errors” by giving pharmacists an extra bit of clout.

The gist of the Stop Dangerous Pharmacies Act is making pharmacists in charge actually in charge. It starts by giving them the right to make staffing decisions “to ensure that the right personnel or at least enough personnel are present in the store.”

And if there aren’t enough staff (or there’s another dangerous situation)? The PiC is required to notify management, and management is required “to take immediate and reasonable steps to address these issues and resolve these conditions” within 24 hours. If that doesn’t happen, there’s a centralized reporting system for pharmacists to notify the state board.

There’s more to it, including reporting requirements for medication errors — hit the link above to read the Pharmacy Times article for the deets.

FDA: If it don’t prick, the results don’t stick

Smart watches or rings or bracelets or any other doodad that says it can monitor your glucose without a needle? No way, says the FDA — it hasn’t evaluated, let alone approved, any such device; patients can’t trust the readings.

Such devices are manufactured by dozens of companies and sold under multiple brand names. Their makers often claim the gadgets can measure blood glucose levels without requiring users to prick their skin.

The danger, of course, is that a patient would use a device like that to manage diabetes, and who know what would happen?

Long-Covid breakthroughs

Irish researchers have found what they think is the cause of long Covid’s brain fog: leaky blood vessels in the brain.

Using a new type of MRI scan, they discovered “that there was disruption to the integrity of the blood vessels in the brains of patients suffering from Long COVID and brain fog.”

Meanwhile, British researchers have found what they think is the cause of long Covid: a protein called interferon gamma (IFN-γ), that appears during an immune reaction. It usually disappears once the infection clears, “but the researchers found that high levels of IFN-γ persisted in some long Covid patients for up to 31 months.”

“Interferon gamma can be used to treat viral infections such as hepatitis C but it causes symptoms including fatigue, fever, headache, aching muscles and depression. These symptoms are all too familiar to long Covid patients. For us, that was another smoking gun.”

They aren’t sure if IFN-γ levels are the direct cause of the symptoms or a biomarker of some other process. Regardless, it’s something clear that can be tested for.

The Long Read: Empty Adderall Factory edition

Ascent Pharmaceuticals in New York makes generic Adderall, Concerta, and opioids. But the DEA, to show it was doing something about the opioid epidemic, shut the factory down because of “discrepancies” in record-keeping. Like what?

For example, orders struck from 222s [forms] must be crossed out with a line and the word cancel written next to them. Investigators found two instances in which Ascent employees had drawn the line but failed to write the word.

Horrors! Despite not a single pill going missing, the DEA shut down the plant, refusing to distinguish the ADHD-med production from opioid production. Now the company is suing, while other federal agencies are pressuring it to help ease the Adderall shortage … which it can’t.

Covid spring boosters may be coming

When it comes to Covid boosters, you can almost say “the more the merrier” — boosters don’t last forever, and no one wants to deal with long Covid. Thus the CDC is now weighing whether to recommend a spring booster for people who are at risk of serious Covid complications.

An advisory panel to the CDC is expected to vote on whether to recommend a spring booster during a Feb. 28 meeting. […] The panel is expected to focus on the safety of high-risk Americans, including people 65 and older and anyone with a weakened immune system.

The recommendation is important because that’ll determine whether insurance covers the shot, helping keep “the people who are most accepting of public health recommendations” safer.

Fertile summers (courtesy of UV)

We all know that UV radiation, especially when it comes from the big yellow ball in the sky, isn’t good for you. (You can insert the list of reasons here.) But Israeli biochemists think they’ve found an interesting exception: women between 30 and 40 who want to get pregnant.

It seems that during the summer, “likely due to increased exposure to ultraviolet radiation from the sun,” women’s ovaries secrete more of the anti-Müllerian hormone (AMH), which is linked to ovarian function — AMH level is one of the first tests fertility clinics run.

The researchers are super-very cautious to point out that this is a preliminary study and that (in a surprise to some) “Humans are not the same as mice.”

And if you think results might be skewed because Israel is, you know, near the equator, keep in mind that it’s at the same latitude as Amelia Island, Fla.^*

^* Site of the Georgia Pharmacy Convention. What? We’re allowed a shameless plug.

Senators want influencer crackdown

Face it, “influencers” are really just infomercials with G-list celebrities. Still, they’ll push whatever they’re paid to, including drugs. And now some US senators think pharma companies are skirting advertising laws by having people on TikTok and Snapchat promote their products. They’re asking the FDA to crack down on the “alarming proliferation of dangerous and misleading content promoting prescription drugs.”

“FDA’s guidance needs to clarify that these platforms are subject to its jurisdiction and should reflect the way that advertisements on these platforms must comply with federal requirements—such as conspicuousness and duration of statements, and size/contrast of imagery, including accounting for character counts and other limitations.”

RSV vax passes halfway mark

The latest CDC data show that more than half of newborns have received protection from RSV — the second leading cause of infant death.

• 40.5% of children 8 months or younger got the shot (Sanofi’s Beyfortus).
• 16.2% of women 32 or more weeks pregnant got theirs (Pfizer’s Abrysvo).

Reversible sperm disarmer

The hunt for a reliable, reversible male contraceptive continues, and the latest breakthrough comes from the Salk Institute.

There’s a process for sperm to mature: Retinoic acid binds to receptors, those receptors bind to a protein called SMRT, then SMRT brings in an enzyme called HDAC.

The trick is to stop at least one link in that chain. You can’t block retinoic acid because that’s used elsewhere in the body. So the Salk folks targeted that HDAC instead. Why? Because there’s already an HDAC inhibitor out there (MS-275, waiting for FDA approval and for the Blue Fairy to give it a real name).

Result? “By blocking the activity of the SMRT-retinoic acid receptor-HDAC complex, the drug successfully stopped sperm production without producing obvious side effects.” Even better, just 60 days off the drug and the mice they tested it on got their fertility back.

Now that they’ve found the pathway (in mice, at least), the next step is to see if a human drug can be developed. Stay tuned.

Halitosis solved

Japanese scientists have figured out which bacteria cause bad breath. They knew the compound that stinks (methyl mercaptan, or CH3SH), but now they know that it’s produced when two bacteria interact: Fusobacterium nucleatum and Streptococcus gordonii.

Unlike other researchers, these folks decided to go big — they “developed a large-volume anaerobic co-culture system” — which we assume had some of their colleagues wishing they had chosen the “go home” option instead.

But hey, if you think the road to halitosis is a simple one, think again:

Niacin and heart disease?

Vitamin B3 (aka niacin) used to be recommended to help lower cholesterol, but how the turns have tabled. A new study out of the Cleveland Clinic found that too much contributes to heart disease.

Here comes the science: Excess niacin breaks down into a metabolite called 4PY. And — via a new pathway the Clevelandians just discovered — “4PY directly triggers vascular inflammation [that] damages blood vessels and can lead to atherosclerosis over time.”

The new findings also might help explain why niacin is no longer a go-to treatment for lowering cholesterol. Niacin was one of the first treatments prescribed to lower LDL or “bad” cholesterol. However, eventually niacin showed to be less effective than other cholesterol-lowering drugs and was associated with other negative effects and higher mortality rates

A positive byproduct of the finding is that this new metabolic pathwa might be something that can be tested for, which could lead to new treatments. But you know the drill: More research is needed.

Science!

Chinese researchers, using US data, conclude that “Watching at least five hours of TV a day associated with higher risk of nocturia, or needing to get up and urinate twice or more a night.”

FDA approves food-allergy PrEP

No, there’s no cure for food allergies, but the FDA has finally approved Xolair — omalizumab to its enemies — to at least help when someone is accidentally exposed. (It’s been used this way off-label for a while.) Patients get an injection every few weeks to gradually build up a bit of immunity to a bunch of food allergens.

People who use Xolair must continue to avoid the foods that cause them reactions, such as peanuts, cashews, hazelnuts, walnuts, milk products, and eggs. The medication allows them to tolerate higher amounts of such foods without causing major reactions.

In case you forgot where you live, Xolair “ranges from about $2,900 a month for children to $5,000 a month for adults,” but hopefully is covered by insurance.

Inching toward an Alzheimer’s test

The medical world continues down the road that leads toward a simple blood test for dementia. The latest comes from a team of British and Chinese scientists who turned to the data — specifically, the UK’s Biobank research database.

They started with almost 53,000 blood samples more than a decade old, then looked at who among those sample-givers ended up developing dementia. Then they examined those patients’ proteins to see if there were biomarkers lurking within.

The good news: There were.

The less-good news: There were a whopping 1,463 proteins associated with dementia.

The good news: They were able to narrow it down to a handful.

They found that people whose blood carried higher levels of the proteins GFAP, NEFL, GDF15, and LTBP2 were consistently more likely to have developed Alzheimer’s disease, vascular dementia, or dementia from any cause.

What sets this apart from other Alzheimer’s blood tests is that it can predict the disease a decade before it actually shows up. They’re hoping to turn the info into a simple blood test that can help patients get a jump on treatment … and maybe even prevention.

Speaking of simple tests, there’s breast cancer

The paper: “High sensitivity saliva-based biosensor in detection of breast cancer biomarkers: HER2 and CA15-3”.

The gist: a handheld device that can detect breast cancer from a bit of saliva. It comes out of the University of Florida (with help from Taiwanese engineers) that “works by placing a saliva sample on a test strip, which is treated with specific antibodies that respond to cancer biomarkers” and takes about five seconds to give a result.

Oh, and it uses off-the-shelf components, including for the brains. Said the team that developed it, “The method is user-friendly and holds significant promise for widespread use by the general public in the future.”

An ounce of cure, a pound of prevention

Abatacept injections can be used to treat rheumatoid arthritis — that’s not news, although it’s a second- or third-line treatment.

But why wait till the arthritis is established? Why not give at-risk patients the abatacept before they get it? That’s what British researchers tested, and lo and behold, abatacept kept patients from coming down with arthritis in the first place.

After twelve months of treatment, 6% of patients treated with abatacept had developed arthritis compared to 29% in the placebo arm. By 24 months, the differences were still significant, with a total of 25% progressing to rheumatoid arthritis in the abatacept arm compared to 37% in the placebo arm.

The army around the lungs

Evolution doesn’t leave a lot of unnecessary parts lying around. If something seems useless, you should probably dig deeper (looking at you, appendix). The latest example is the pleural cavity — the big sac around the lungs. It was thought to just be a cushion, but it turns out it might be an organ in its own right.

UC Riverside researchers were surprised to find macrophages — immune cells that “gobble up bacteria, viruses, cancer cells, and dying cells” — where they hadn’t been seen: in the lungs of sick people. A bit of digging later, and they discovered that the macrophages were hanging out in the pleural cavity, ready for action.

[D]uring an influenza infection, macrophages leave the exterior cavity and cross into the lungs where they decrease inflammation and reduce levels of disease.

Down the road: perhaps a drug that can signal to those macrophages to enter the lungs sooner and in bigger numbers. But as always, more research is needed.

Your non-pharma medical breakthrough of the week

If you’ve never read the Amazon reviews for Sugarless Haribo Gummy Bears, you might want to take a gander. The operative phrase is non-insignificant gastrointestinal distress.

That said, UC Davis researchers think they’ve figured out why sugar-free gummy bears can rival Taco Bell for clearing a bathroom quickly.

Not surprisingly, it’s all about gut bacteria. It seems that some people don’t have enough Clostridia microbes in their digestive tracts. Clostridia breaks down the sorbitol used to sweeten the candy. No bacteria means sorbitol overload, and…

At high levels, sorbitol can cause bloating, cramps and diarrhea. For some people, even a small amount causes digestive upset, a condition known as sorbitol intolerance.

They call it “sorbitol intolerance,” but the Amazon reviewers have more, er, colorful phrases. (“Gastrointestinal Armageddon” was one.)

The latest dementia risk

It’s herpes simplex — aka cold sores. At any time in life. Yep, Swedish researchers found that “People who have had the herpes virus at some point in their lives are twice as likely to develop dementia compared to those who have never been infected.”

Once again, it’s a “correlation doesn’t mean causation” scenario, but that correlation part is strong. The Swedes’ conclusion is based on a study of 1,000 of their countrymen (all age 70) for 15 years, so there’s data a-plenty. What it means, though … well, that’s not clear. Next on their agenda is testing whether anti-herpes drugs might reduce the risk of dementia.

Two big cancer breakthroughs

Against breast cancer

The typical breast cancer treatment involves blocking estrogen, because the cancer needs it to spread. But that, for obvious reasons, leads to complications. So Australian researchers — being upside-down and all — tried something different. They targeted androgen receptors instead.

Specifically, they used a drug called enobosarm (which used to be called ostarine for some reason) that stimulates cells’ androgen receptors. And that, via [insert science here^*], “trigger[s] a natural defence mechanism in breast tissue.”

In a sense, instead of trying to starve the tumors (which causes all those side effects), they’re mustering the body’s troops to go on the attack.

In a test on 136 postmenopausal women with advanced breast cancer…

Enobosarm showed significant anti-tumour activity and was well-tolerated by patients, without adversely affecting their quality of life or causing masculinising symptoms.

^* Here’s the paper. Knock yourself out, but it’s beyond us.

Against mesothelioma

They’re calling it “the biggest breakthrough in two decades” against mesothelioma — it quadrupled test subjects’ three-year survival rates. That’s according to the British boffins who led a major^* study of a new drug called pegargiminase (or simply ADI-PEG20 if you want to fit it on a license plate).

To be clear about the numbers: ADI-PEG20 increased the median survival rate by just 1.6 months, but quadrupled number of patients who survived to 36 months. It works with good ol’ cisplatin to deplete the body’s arginine, an amino acid that mesothelioma needs to survive.

Oh, and even better, ““Pegargiminase-based chemotherapy was well tolerated with no new safety signals.”

^* Four years, 43 cancer centers, five countries

• • •

A drug to save and arm and a leg

ICYMI: The FDA has approved the first pharmaceutical treatment for frostbite. It’s an vasodilator injection called Aurlumyn (active ingredient: iloprost), that can reduce the chance of a limb having to be amputated.

“Side effects of the new frostbite treatment include headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness, and hypotension,” which we think is a good trade-off for, you know, not losing a limb.

A different kind of lupus treatment

Canadian researchers have made what they think is a major breakthrough in lupus treatment. Instead of using broad immunosuppressants, they’ve developed a way to teach patients’ bodies not to attack certain proteins.

Both healthy people and those with lupus have a protein called “Sm”. The immune systems of healthy people know to leave it alone — they have immune regulators called regulatory T cells (aka T-regs) to limit the immune response. But people with lupus have a lot more of that Sm protein, and they’re also short on the T-regs that would keep their bodies from attacking it.

The Canucks figured the solution would be to 1) figure out how T-regs identify Sm, and 2) “train” the T-regs in lupus patients to do the same. Kind of like teaching soldiers to identify the friendlies they’re supposed to protect.

And that’s what they did — they found a way to program lupus patients’ T-regs “into the same powerfully protective T-regs that keep healthy people healthy.” Next step: Turn the technology into an actual testable treatment, which they hope to do in the next couple of years.

Pfizer settles anti-trust suit

Pfizer has settled a lawsuit by drug wholesalers that accused the company of conspiring with an Indian generic-drug maker to delay generic versions of Lipitor from entering the market. The company agreed to pay $93 million for the pay-to-delay shenanigans.

On the one hand, Pfizer denied any wrongdoing. On the other hand it said the settlement was “fair, reasonable, and the best way to resolve this litigation^*.”

^* “I didn’t steal the cookies, but sending me to bed without dessert is a fair and reasonable punishment.”

Sandalwood vs. cancer

Good news if you have mice with prostate cancer: Sandalwood oil — you know, the stuff that comes with your aromatherapy diffuser — appears to contain a compound that fights it. It’s another example of “olde timey treatments that actually have something to ’em.”

In this case, pharmacologists at Florida Atlantic University found that one of the many compounds in sandalwood, alpha-santalol, can convince prostate cancer cells to kill themselves. (More science-y, it “decreased the incidence of prostate tumors by decreasing cell proliferation and inducing apoptosis, without causing weight loss or any noticeable side effects.”)

Of course this is only in Petri dishes and lab mice, so you know the mantra: More research is needed.

A bone med for diabetes

Here’s an interesting correlation: People who take denosumab (aka Prolia) for osteoporosis are less likely to develop diabetes — 16% less likely, in fact, if they’re 65 and over. Such is the result of a Taiwanese cohort study of 65,500 patients over almost two years that found it was true across sexes and despite other health conditions.

“Our study suggests that when choosing anti-osteoporosis medication, physicians might also consider the potential benefit of lowering diabetes risk. This could be especially relevant for patients at high risk of diabetes or those with preexisting metabolic conditions.”

Health insurance news

Good news for Medicare enrollees

Starting next year, as part of the Inflation Reduction Act, people with Medicare Part D will have their out-of-pocket prescription drug spending capped at $2,000 per year.

That’s kind of a big deal because in 2021 about 1.5 million Americans spent more than that. In Georgia, between 2007 and 2021, something like 215,000 people spent more than $2,000 at least one year.

For those with catastrophic coverage it’s even better. Because the 5% co-pay has been removed, they’ll save big on expensive meds for serious conditions.

Preparing for climate change

There are people who believe that climate change is a conspiracy among 99.9% of the world’s climatologists. But you know who is sure it’s real? Insurance companies — specifically health insurers. The Wall Street Journal reports.

After the hottest year on record and increasingly extreme weather events, health insurers are battling to figure out how climate change is going to affect their business. The companies are building new models to reassess premiums, estimate risk and meet incoming climate reporting standards as coverage costs rise in a warming world.