October 31, 2023     Andrew Kantor

Kinda big eye drop warning

In case you missed it: The FDA has issued a warning about 26 (!) OTC eye drops because of the risk of infection “that could result in partial vision loss or blindness.”

The factory that made them not only had insanitary conditions, but product testing found actual contamination. The brands:

  • CVS Health
  • Leader (Cardinal Health)
  • Rugby (Cardinal Health)
  • Rite Aid
  • Target Up&Up
  • Velocity Pharma

The details and full descriptions are here.

Fighting bipolar meds’ side effects

Weight gain is a common side effect for kids taking meds for bipolar disorders, but University of Cincinnati researchers have found a simple potential solution: metformin.

The typical approach to weight gain has been to tell the kids, “Hey, we’ve treated your bipolar issues. Deal with the weight on your own.” So the UC folks wanted to see if metformin might help; psychiatrists are iffy about prescribing it, but a study might change their minds.

After two years and almost 1,600 kids across 60 sites they found … it works. A bit.

[M]etformin had a modest but significant effect at preventing and in some cases reversing weight gain in the study’s patient population. The drug was also found to be safe, with some gastrointestinal distress symptoms being the only side effects reported.

They weren’t expecting a miracle drug, but the results showed it’s likely worthwhile to consider metformin to help patients deal with the weight gain.


Another virus type to worry about

You can almost picture the editors at the Atlantic (World’s Most Depressing Magazine™) looking for something else to fret over.

Kudos to them for finding a new angle: “Whether it begins next week, next year, or next decade, another pandemic is on its way,” writer Katherine Wu explains. But rather than a new flu or coronavirus, we need to be worried about paramyxoviruses, even if they’re less of a threat*. Because they’ve been lurking in the background, waiting for their chance to strike — when we’re not expecting it.

[L]ike flu viruses and coronaviruses, paramyxoviruses are found in a wide range of animals; more are being discovered wherever researchers look.

(But if we are expecting it, that removes one of its greatest weapons: Surprise. That leaves fear and ruthless efficiency. We shall see.)

* Although measles, one paramyxovirus, is “literally the most transmittable human virus on the planet.”

Third strike (they’re out)

Some CVS and Walgreens pharmacists are — as you read this — in the second day of a three-day strike. “The walkout, which the organizers have dubbed ‘Pharmageddon’, is the third strike by pharmacists in a little over one month.”

And remember to share your experience:

A viable ketamine study

One trouble researchers have had with studies of ketamine is that it’s hard to have a control group; people can tell if they’ve been given the drug. But Stanford researchers not only found a workaround, they also found that ketamine (or rather the lack of it) can have a strong placebo effect.

They studied patients with depression who were also about to have surgery under general anesthesia. While they were unconscious, some were given ketamine, some a placebo. (It was triple-blind: Neither the researchers, the patients, or the surgeons knew who got what.)

End result: “The researchers were amazed to find that both groups experienced the large improvement in depression symptoms usually seen with ketamine.”

Said the senior author:

“I was very surprised to see this result, especially having talked to some of those patients who said ‘My life is changed, I’ve never felt this way before,’ but they were in the placebo group.”

What does this mean? As a co-author put it, “Now all the interpretations happen.”

Instant STD test

Penn State researchers have developed a virtually instant test for two major STDs. They use the same tech as rapid Covid tests (but don’t involve swabbing the nose) and can ID chlamydia and gonorrhea with 100% accuracy in two minutes.

They also say their test tech, which can detect pathogens’ genetic signature, can be tweaked to react to other diseases. As always, more research is needed.

Snake oil, 2023-style

It’s sad but not surprising: There are clinics out there offering treatments for long Covid that just don’t work. We’re not talking silliness like horse dewormer or scented candles — they’re touting stem cell therapy and exosome treatments even though there’s no evidence they work. But they sure cost a bundle*.

The UC Irvine researchers were curious how snake-oil salesmen were adapting to Covid. And just like Dr. Montague’s Cure-All can treat rheumatism, baldness, night sweats, hangnails, and all that ails you, apparently these therapies can now treat Covid-19. They’re being offered mostly in the US and Mexico, but also around the world.

“Of the 38 businesses, 36 of them marketed stem cell and exosome products as treatments for long Covid, six advertised them as ‘immune boosters,’ five claimed they treated patients in the acute infection phase, and two claimed the products they sold were preventive in nature.”

If you question the treatments, of course, you’re just yet another sheep and a pawn of Big Pharma, yada yada yada.

* From $2,950 to $25,000, with the average being $11,322.

October 28, 2023     Andrew Kantor

Diabetes danger with common drugs

Two common types of drugs — antipsychotics like haloperidol and antibiotics like fluoroquinolones — have a scary risk for people with type 2 diabetes: They can cause sudden cardiac arrest even in people with no history of cardiovascular disease.

And it’s apparently not just a slight difference.

People with type 2 diabetes who do not have a history of CVD have almost three times the risk of SCA if they take antipsychotic medications and nearly double the risk if they take certain antibiotics that prolong the QT interval, notably, macrolides and fluoroquinolones.

One of the Dutch researchers who discovered this displayed some British understatement when he said, “Perhaps these drugs could be avoided in some cases, and GPs should be more aware of the possible consequences of their use.” Indeed.

Witness the power of this fully armed and operational pharmacy and health sciences center

Mercer’s new 65,000-square-foot pharmacy and health sciences center is now open on the university’s Atlanta campus.

It contains some of the most cutting-edge lab technology found in any academic setting, adjustable classrooms to fit the needs of individual professors, and several areas for students to study and relax between classes.

The building is looking spiffy before all those students get their grubby paws all over it

Boning up on cannabinoids

If you have a mouse with a broken bone, you might try giving it a cannabinoid like CBD or its cousin, CBG. They seem to have a surprising ability: They not only relieve pain, they actually help the bones heal.

Penn State researchers were sorta expecting the pain relief, because there’s plenty of anecdotal evidence of that. But the bone healing caught them by surprise.

In the early phase of treatment, the cannabinoids were associated with an increase in the abundance of periosteal bone progenitors, which later develop into specialized bone cells that help bone tissue form. During the later phase of healing, CBD and CBG accelerated the process by which the body absorbs minerals to strengthen newly formed bone.

Money quote: “We still have a lot to learn about the biological mechanisms behind what we observed.”

Side note: Under no circumstances should you think about the fact that the researchers had to break the mice’s bones to do this study. Karma will take care of that.

Covid: What works, what doesn’t

Cutting to the chase: Statins like simvastatin have a significant benefit for critically ill Covid patients, but vitamin C does nada.

An international team of researchers studied more than 2,600 patients in 13 countries found that simvastatin …

… was shown to have a high probability (96%) of improving outcomes […] and a 92% chance of improving survival at 3 months. This equates to one life saved for every 33 patients treated with simvastatin.

And vitamin C? It was “ineffective and probably harmful*.” Do they have a recommendation that includes a buzzword? You bet: “[T]he use of vitamin C in hospitalized COVID-19 patients should be de-adopted.”

* This would have been sad news for Mom of Buzz, who always considered vitamin C a miracle drug.

Pharmacy chains pull back

The plan had been for the big pharmacy chains to dive headlong into primary care. But that’s just not working out thanks to issues like “financial woes, leadership shuffles, [and] staff shortages” and now they’re backpedaling big time.

The problems facing the three retail pharmacies are similar, and include rising drug prices, pressure from insurers, post-pandemic changes in customer behavior that have reduced store traffic, and an alarming spike in shoplifting.

The Long Read: Pharmacists’ Burnout edition

Why the strikes? Why the stress? USA Today has a great overview with “Prescription for disaster: America’s broken pharmacy system in revolt over burnout and errors”.

Pharmacists take an oath to hold patient safety in the highest regard when preparing and dispensing medication. But rising pressures inside the nation’s largest retail chains have forced pharmacists to choose between that oath and their job.

Sneezes: Let them out

If you’re going to sneeze and you’re tempted to hold it in, don’t.

Closing your mouth or nose during a sneeze increases the pressure in the airways five to 20 times more than a normal sneeze. With no escape, this pressure has to be transmitted elsewhere and that can damage your eyes, ears or blood vessels. Though the risk is low, brain aneurysm, ruptured throat and collapsed lung have been reported.

(What if you’re hiding from an axe murderer? Try pressing under your nose to stimulate the trigeminal nerves.)

 

October 27, 2023     Andrew Kantor

Bad for the heart, good for the brain?

There’s apparently a link between higher levels of triglycerides and lower risk of dementia. That’s what Aussie researchers found when they parsed the data on more than 18,000 people over six years (average age 75). The higher someone’s triglyceride level, the lower their risk of dementia. (Which makes sense, as triglycerides are one of the brain’s main energy sources.)

Of course, this doesn’t mean one causes the other, just that there’s a link. And it doesn’t mean it’s time to load up on green eggs and ham, either. Even if there was a cause and effect, the high triglycerides come with their own set of problems, obviously.

Don’t stop thinking ’bout metformin

The article’s lede sums up the issue nicely: “Diabetes patients who stop using metformin are more likely to develop dementia.”

[R]esearchers found that patients who were prescribed metformin but stopped using it were 21% more likely to get a dementia diagnosis compared with patients who continued using metformin throughout their treatment.

The big issue, though, is that people don’t like taking metformin. The pill is big and the stomach issues can be an issue especially for people living in small apartments.

Quid pro quo

When oncologists get money from the pharma industry, they’re more likely to prescribe “non-recommended and low-value treatments.” That’s according to a group of cancer researchers and statisticians publishing in the British Medical Journal.

Docs prescribing meds from the companies that ‘take them to lunch’ isn’t new, but this is one of the first studies that looked at whether the meds were actually good for the patients. Um … nope.

One example:

The difference between the prescribing patterns of doctors was biggest for denosumab, a drug sold by Amgen as Xgeva, in castration-sensitive prostate cancer. U.S. guidelines recommend against the use of denosumab in the setting. Yet, 49.5% of patients whose doctors took pharma payments received the drug, compared to 31.4% of their counterparts whose oncologist hadn’t received payment.

And now a twist: When there was a choice between a brand-name drug and a generic, the docs who got more money were slightly more likely to prescribe the generic. So at least they’re trying to save the patients some money.

Short takes

“I ate what?

More than 7 million Americans unaware they have mild cognitive impairment.”

You can have my M&Ms when you pry them from my cold, dead fingers

Foods like ice cream, chips and candy are just as addictive as cigarettes or heroin.”

Vaguely useful bipolar test

British researchers have developed a simple blood test that they say can … well, “diagnose” is a strong word. It can reveal biomarkers associated with bipolar disorder. Well, sort of. When they say it can help diagnose it, they mean the blood test alone has about a 30% chance of hitting the mark. When combined with a mental health assessment, though, it’s more useful.

Bottom line is that it’s more of a confirmation thing.

“Psychiatric assessments are highly effective, but the ability to diagnose bipolar disorder with a simple blood test could ensure that patients get the right treatment the first time and alleviate some of the pressures on medical professionals.”

The Long Read: The Future of Pharmacy edition

With another walkout planned at chain pharmacies, stress levels high while staffing is low, robotics and AI are coming to a pharmacy near you. Maybe.

The idea is to automate the repetitive tasks (and even help with issues like medication interactions) freeing pharmacists and pharmacy technicians for the more important work.

October 26, 2023     Andrew Kantor

Bacteria for blood pressure

If you don’t make enough of a protein called ACE2, your body (and bodies of rats) will produce angiotensin II, a hormone that raises blood pressure. So how do you get more ACE2? By changing your gut bacteria, of course.

Researchers at the University of Toledo started with Lactobacillus paracasei (a friendly gut bacterium), engineered it to produce ACE2, and gave it to hypertensive rats with high blood pressure.

You’re expecting to read that it work, and it did, sort of.

[T]he blood-pressure-lowering effects were only seen in female rats. Though there was no difference in ACE2 expression between male and female rats, only the female rats saw a decrease in their blood pressure.

Why? Because, they think, “The gene encoding ACE2 is located in a region of the X-chromosome” that can sometimes be deactivated. The ladies have two copies of it, so they’ve got a backup. Regardless, they call the finding a steppingstone: “It is a real possibility that we can use bacteria to correct hypertension.”

Today’s Mercer shout-out

High-fives all around to Sharvari Kshirsagar, Sreelakshmi Menon, and Tanishka Saraf — three Mercer students who just took home half of the American Association of Indian Pharmaceutical Scientists’ annual Graduate Student Awards. W00t!

They politely sat in alphabetical order

For moms to be

Covid vax protection

When mom is vaccinated for Covid, Junior doesn’t just get protection from the virus, but also has a lower risk of a bunch of “poor outcomes” — notably NICU admission and death. That’s what Canadian researchers found when looking at the health data for more than 140,000 births in Ontario.

“Our results were consistent across the number of doses someone received during pregnancy, the trimester in which they were vaccinated, and the vaccine product they received.”

The right way to give insulin

Forget injections or even pumps. British researchers say that pregnant women with diabetes should all be using automatic insulin-delivery systems. Their study found that automatic, smartphone-based “hybrid closed-loop technology” technology for mom reduced a baby’s risk of “…premature birth, need for intensive care after birth, and being too large at birth, which increases the lifelong risk of overweight and obesity.”

“Compared to traditional insulin therapy methods, women who used the technology spent more time in the target range for pregnancy blood sugar levels — 68 percent vs 56 percent, which is equivalent to an additional two-and-a-half to three hours every day throughout pregnancy.”

Even better, they called the technology — wait for it — “game-changing.”

When OTC painkillers work just fine

When kids get “routine elbow surgery” (apparently that’s a thing), it’s tempting to give ’em opioids for the pain rather than deal with the whining. No need, say researchers at the Children’s Hospital of Philadelphia — ibuprofen and acetaminophen work just as well.

The researchers found no significant differences in pain ratings between opioid and non-opioid groups at any timepoint. Notably, 35% of patients who were prescribed opioids never took them, and 49% took only one to three doses over the entire postoperative period.

The study looked specifically at a procedure called closed reduction and percutaneous pinning (I see a few people in the audience nodding), but the docs say it might also apply to other orthopedic procedures.

RSV vax coming for younger folks

GSK reports AOK results for its RSV vax for people ages 50 to 59. It was a phase 3 trial, meaning the company is planning to submit final results to the FDA in hopes of having the shot approved for that age group — or at least people that age who are vulnerable to RSV.

The Long Read: The Cost of GLP-1s edition

GLP-1 drugs like Ozempic and Wegovy can save a lot of lives and a lot of money on healthcare, but they’re way too expensive for many of the people who could benefit. Or are they?

The New York Times explains how it’s more than just list price vs. actual price — there are plenty more reasons these drugs are going to be less expensive than we think.

Short Takes

States sue over social media

Georgia is one of 41 states (and DC) suing Facebook parent company Meta for ‘exploiting and manipulating’ children and playing a major role in the the ongoing youth mental health crisis.

Collectively, more than 40 states paint a picture of a company that brushed aside safety concerns about its products in order to addict as many young people as possible as a way of juicing its profits.

Add it to the list

“[A] flesh-eating parasite known as Leishmania mexicana is now likely spreading locally through some sand flies native to the southern U.S.

 

October 25, 2023     Andrew Kantor

DIY flu vax?

Patients may be able to give themselves the FluMist quadrivalent vaccine next year, if AstraZeneca’s request is approved by the FDA.

The company said it expects the FDA to decide on the vaccine by the first quarter of 2024, adding that it expects the vaccine to be made available for self-administration in the United States during the 2024-2025 flu season, if approved.

Diabetes treatment: The eyes have it

When you’re looking for a place to stick a device that help provide insulin, you probably wouldn’t think “in the eye.” That’s just what Swedish researchers did, though, and it wasn’t just because it sounds cool.

The miniature implants consist of a combo of insulin-producing islets of Langerhans and some electronic sensors, and they’re implanted between the iris and the cornea. Why there? First, the eye is “immune-privileged,” meaning it doesn’t have immune cells that will attack the device. Second, it’s easy for the Swedes to look into it (it being the eye and all) and see how the implant is doing.

The first tests on mice found that the implants work just fine for at least several months. It’s a proof of concept — now they want to see about adding the electronics to adjust the release of insulin as needed.

CDC: Ration the RSV vaccine

Due to shortages of the RSV vaccine — nirsevimab — the CDC is asking providers to ration their supply and only give the vaccine to the most vulnerable infants.

CDC recommends prioritizing available nirsevimab 100mg doses for infants at the highest risk for severe RSV disease: young infants (age <6 months) and infants with underlying conditions that place them at highest risk for severe RSV disease.

Captain Obvious is working overtime

Did they really need to do a study?

Drexel University released this bombshell: “Can We Trust Autism Information on TikTok? Not Always.”

[T]he research team concluded most of the information provided on TikTok appears to be misaligned with current clinical knowledge.

“Wearing an ‘I abuse drugs’ T-shirt” isn’t on the list

Canadian researchers have found a shocking list of “10 predictors linked to opioid overdose in chronic pain patients.”

  • If they’re getting high-dose opioids
  • If they’re getting fentanyl
  • If they’re using multiple pharmacies
  • If they’re using multiple prescribers
  • If they have a substance use disorder
  • If they have a history of opioid overdoses
  • If they’re suffering from mental illness, depression, or bipolar disorder
  • And the one that actually is worth noting: If they have pancreatitis

Get up and exercise

Who needs Daddy’s Little Helper? Apparently an effective alternative to Viagra is a bit of aerobic exercise*. A new study in the Journal of Sexual Medicine

…found that aerobic activities — such as walking or cycling – improved erectile function in all men with erectile dysfunction, regardless of body weight, overall health, or medication use.

And the worse the, er, problem, the more the exercise helped. On the standardized scale for this sort of thing, men with the biggest (?) issues reported an average improvement of 5 points with exercise and 4 to 8 points with Viagra or Cialis. So that’s pretty good.

This isn’t entirely new. Back in the Long Long Ago (2011), Nigerian researchers published a paper, “Effects of Aerobic Exercise in the Management of Erectile Dysfunction: A Meta Analysis Study on Randomized Controlled Trials” where they found the same thing.

* “If I could get the aerobic exercise, I wouldn’t need the Viagra!” Ha ha.

Thanks, AIP members!

A big thank-you to all the AIP members who attended AIP’s fall meeting in Peachtree City! Check out some photos on AIP VP Jonathan Marquess’s Facebook post!

Safer bone marrow transplants … with potatoes

People who get a bone marrow transplant have a big risk of graft-versus-host disease (GCHD) — we’re talking 50%. You know what can help reduce that risk? The right gut bacteria.

Researchers from Baylor College of Medicine and the University of Michigan found that the gut biome changes after a bone marrow transplant, “and that this change contributes to GVHD aggravation.” Specifically, their levels of butyrate go down.

How do you get butyrate levels up? Potato starch. People can’t digest it directly, but a specific gut bacteria can — and it produces butyrate. So add a potato starch supplement, make the right bacteria happy, and reduce the risk from GVHD.

So far they’ve confirmed that taking a supplement isn’t a problem. Now they’re beginning to see how much of a difference it’ll make for transplant patients.

October 24, 2023     Andrew Kantor

Paxlovid reactions

If you’ve got a patient who takes Paxlovid after testing positive for Covid, keep a metaphorical eye on ’em. A lot of folks who take it are taking other meds and there’s a decent chance of a drug-drug interaction.

The median number of concurrent medications was seven. Researchers found that 70% had at least one DDI, which increased to 82% in patients ages 70 and older. Most DDIs required clinical intervention, with most needing assistance from a pharmacist.

Note those last two sentences — if there’s an interaction, it’s probably not a minor one.

The most common drugs that interact, say the Canadian researchers who did the study, are “cardiovascular drugs and those for benign prostatic hyperplasia, followed by central nervous system drugs and oral antithrombotic agents.”

Yet another reason you don’t want Covid

Sure, chances are low that a Covid infection will be a big deal, but it comes with a lot of baggage. A new one to consider: Guillain-Barré syndrome.

Based on data for more than 3 million people over 18 months, the Israeli study found that contracting Covid increases your risk of GBS in the six weeks after infection. (Being vaccinated with an mRNA shot reduces that risk.)

The bad news: “[P]eople with a recent Covid infection were six times more likely to develop Guillain-Barré than those without a recent infection.”

The reality check: GBS is really, really rare, so while a 600% risk increase sounds scary, the actual numbers are still pretty small. (Also, the data show an association not a cause.)

From our friends at UGA’s College o’ Pharmacy

NOMINATE A PHARMDAWG TODAY! Do you know a PharmDawg alumnus* who deserves special recognition? The College of Pharmacy is seeking nominations for the 2023 Distinguished Alumnus, Distinguished Service, and Outstanding New Alumni Awards. Click the links below to learn more about the criteria for each award. All nominations should be submitted by Sunday, October 29, 2023.

* We assume you can also nominate an alumna. Or an … alumnex?

The new Flu Index is here! The new Flu Index is here!

So far it’s a lot lower than last year, but a bunch higher than late October before the pandemic. Take from that what you will. (Georgia has the 17th highest level of flu, and the South in general is seeing higher numbers.)

Georgia Medicaid’s slow start

Georgia Pathways, Georgia’s ‘work for Medicaid’ program, is off to a bumpy start, per the Atlanta Journal-Constitution. The plan is expected to cover about 90,000 poor adults within two years, but so far “has enrolled just 1,343 in the three months since it was opened, the state Department of Community Health reported.”

Georgia’s program is an experiment; of the 10 remaining non-Medicaid-expansion states, Georgia is the only one given permission to try this kind of enrollment, which “limits coverage to people who can prove they work 80 hours a month or perform other specified activities.”

Remember: If a new program doesn’t succeed immediately, it’s a complete and total failure and has to be scrapped*. To hit the state’s projection of 90,000 enrollees by 2025 would mean enrolling about 11,250 people every three months. So we’re behind at the moment. Maybe give it more than 90 days?

* That is sarcasm.

Obesity mastermind

What’s the biggest driver of obesity? It depends on the diet program you ask. Maybe it’s sugars. Maybe it’s fats. Maybe it’s simply calories.

The answer, say University of Colorado researchers, is all three — but behind them all, like a criminal mastermind, is fructose.

In broad strokes, fructose prevents the body from using its fat stores for energy (it “triggers our metabolism to go into low power mode”) causing us to eat more to get energy, but also to keep those fat deposits growing. We become, they say, like hibernating bears, but instead of eating a lot and storing fat just for the winter, we’re doing it every day.

As always, they say, more research is needed.

 

October 21, 2023     Andrew Kantor

Boosting Plan B with an NSAID

Taking levonorgestrel (aka Plan B) to prevent unwanted pregnancy is effective … but not 100% effective. A way to get it closer to that 100% mark might be to add piroxicam (aka Feldene).

A group of researchers from Hong Kong and Sweden found that, by blocking prostaglandin production, piroxicam makes levonorgestrel significantly more effective, especially if the Plan B is taken later rather than sooner.

The results showed that the percentage of pregnancies prevented by piroxicam-levonorgestrel co-treatment (94.7%) was significantly higher than that of the levonorgestrel emergency contraceptive pill alone (63.4%).

Benzos may not be that effective

“I love you. I love you on Xanax more.” But benzos might not be as effective as everyone’s been led to believe. That’s the conclusion of researchers at Oregon Health and Sciences University that crunched the data from five FDA-reviewed, phase 2 and 3 studies of alprazolam (aka Xanax XR).

Of the five trials the FDA reviewed, get this: Only three were published in medical journals, and only one (!) showed clearly positive results.

Using meta-analysis […] they found that alprazolam extended-release was still superior to a placebo, but not as much as the published data had conveyed. Specifically, they found that publication bias inflated the drug’s efficacy by more than 40%.

As the senior author put it, “Our study throws some cold water on the efficacy of this drug. It shows it may be less effective than people have assumed.” [But … well, insert something about the placebo effect here.]

Clearing up some compounding confusion

News stories keep appearing about how the companies selling new weight loss drugs are suing to prevent compounding pharmacies and others from dispensing their own versions. But so many news sources don’t seem to get it.

Currently it’s probably* legal to sell compounded versions of semaglutide, no matter what the brand-name companies (Lilly, Novo, etc.) say. The FDA is clear: Drugs in shortage can be compounded.

Compounded meds are not individually FDA-approved. Never have been. The active ingredients, though, are. So saying, “The FDA does not review the products for safety, quality, or efficacy” is misleading and designed as a scare tactic.

That said, is illegal to call those meds “Ozempic” or “Mounjaro” or whatever — but that’s a trademark issue. It’s also not legal to sell them without a prescription. Duh.

What’s happening is that drug companies are trying to confuse these issues to make it sound as if semaglutide compounded by legitimate compounding pharmacies is illegal and otherwise a Bad Thing. It’s not.

Take this sentence from a Fierce Pharma article:

In September, Eli Lilly filed lawsuits against eight companies in the U.S. that it claims are producing or selling compounded versions of its blockbuster diabetes drug Mounjaro.

The word “claims” makes it sound like compounding is bad or illegal. (“Smith Claims Jones is Wearing Shoes Made in Indiana” makes it sound as if there’s something shameful about Indiana shoes.) So when you see “Company X is suing over unauthorized versions of its drugs,” read the details, and don’t fall for this stuff.

* I’m not a lawyer so I’m not going to say that with certainty, but the folks at the Alliance for Pharmacy Compounding have a PDF explainer.

CVS pulls phenylephrine

Not waiting for the FDA to remove phenylephrine products from the market, CVS said it’s yanking decongestants that use it from store shelves. Of note: It’s only removing decongestant-only products like Sudafed PE, not other meds that contain phenylephrine … yet.

When vape bans backfire

The idea sounded good: Ban flavored e-cigarettes to reduce the appeal to people, especially minors. But it may be backfiring and driving them to a worse option: traditional cigarettes.

An analysis out of Yale of vape policies and sales data over 5 years found that…

During the study period, hundreds of localities and seven states restricted or prohibited flavored e-cigarette sales. While these policies did reduce per-capita vape sales, they also substantially boosted cigarette sales.

For each 0.7 milliliters of e-cigarette e-liquid not sold due to these policies, the authors calculated that 15 additional cigarettes were purchased.

What’s not clear is why people would opt for tobacco — which is obviously a lot worse for you — than for unflavored vapes. (With 71% of the cigarette sales bump for non-menthol varieties, it’s not the flavor. Maybe they just figure life isn’t worth living without flavored vapes.

Post-joint-replacement antibiotics: one and done

It’s become common after replacing a knee or hip to give patients vancomycin to prevent MRSA infection — after giving them cefazolin during surgery. That might not be a good idea.

Aussie researchers found that not only was adding vancomycin to post-surgery treatment not any better, it might even be worse:

Unexpectedly, in patients undergoing knee joint replacement, the risk of infection was higher in the group that had the added vancomycin, at almost 6%, than in the placebo group, with a roughly 4% infection rate.

Quick take

“People who eat just two servings of red meat per week may have an increased risk of developing type 2 diabetes” according to a study out of Harvard.

October 20, 2023     Andrew Kantor

Nestlé has Ozempic plans

Nestlé is so worried about the effect of new weight loss drugs on its bottom line, it’s developing ‘companion products’ to be sold to people taking Ozempic, Mounjaro, and their kin.

No, this isn’t candy or packaged food (“Now that you’re on Ozempic, you can eat what you want!”). These are supplements that can help with the “loss of lean muscle mass” from taking the drugs, and — if someone gives up the shots — can help deal with the “rapid regain of weight.”

Keep in mind that all this hubbub is because Walmart reported a slight downtick in grocery sales since GLP-1 drugs hit the market. There’s not necessarily any connection, but it’s got food companies in an uproar. Our bet: Could be a mountain, probably a molehill.

I can hear your diabetes

A US/Canadian company says its smartphone-based AI tool can detect type 2 diabetes from basic medical info and 6 to 10 seconds of voice. You read that correctly. (And it’s not just a press release — the study was published in Mayo Clinic Proceedings: Digital Health.)

“Our research highlights significant vocal variations between individuals with and without Type 2 diabetes and could transform how the medical community screens for diabetes.”

Think about how much data Big Tech already has about you next time you ask Alexa, Google, or Siri a question … and start getting info about treatment centers near you….

Pfizer doubles the price of Paxlovid

The headline says it all. With the pandemic emergency over and no longer able to suckle on the government teat, the company has announced the new price of its Covid treatment: $1,390 for a five-day course, compared to the $529 the federal government was paying for it.

Of course, patients won’t pay that much — between insurance coverage and discount programs it’ll cost a lot less out of pocket… well, directly. Insurers will have to pick up the tab, even with discounts. And when insurers pay more, they pass that cost down.

Meanwhile

In unrelated news, “Employer Sponsored Health Insurance Premiums Grew by 7% in 2023”:

The average annual premium for employer-sponsored health insurance is $8,435 for single coverage and $23,968 for family coverage.

B12 and inflammation

It seems that 95% of what ails us is caused by either gut bacteria or inflammation, and when it comes to the latter, vitamin B12 deficiency could be a driver.

A new study out of Spain found that “Higher circulating vitamin B12 is associated with lower levels of inflammatory markers in individuals at high cardiovascular risk.”

They say that the lower someone’s vitamin B12 levels were, the more interleukin-6 and C-reactive protein they had, and those are both markers of inflammation. Exactly why that’s the case isn’t clear, but the correlation was enough to raise those Spanish eyebrows.

Side note: B12 deficiency is something vegetarians need to consider. Just FYI.

Speedier approvals

In case you’re curious, the FDA approves drugs a little bit faster than its European counterpart, the EMA. It’s even faster than the Swiss, and we know how efficient they are.

The re­searchers found that over­all, the me­di­an re­view time, from sub­mis­sion to ap­proval, was 39 weeks (about nine months) in the US com­pared with 44 weeks (about 10 months) in the EU and Switzer­land.

Part of the reason is the fact that the FDA, by law, “must re­view and and act on 90% of stan­dard ap­pli­ca­tions with­in 10 months of the 60-day fil­ing date,” whereas the EU doesn’t have such a rule.

They think this is uplifting but it sounds horrific

A Swedish nursing home has installed — inside its walls — a fake bus stop for its dementia patients. You might think the idea is to make them feel … I dunno. Like they have someplace to sit? (The Dutch have created an entire village for people with dementia — “a nursing home disguised to look like the outside world.”)

In Germany there are such fake bus stops outside of retirement homes “to give wandering patients a place where they would instinctively go to sit.” And that makes sense: “Rolf got out again.” “Did you check the bus stop?”

But that’s not exactly what’s going on in Sweden. The staff clearly cares about their patients, but the description sounds like some kind of freakish psychological torture:

Staff have installed a fake bus stop in a hallway to ease the minds of anxious dementia patients eager to leave. (Emphasis ours.)

Yeah, “Some have their bags packed” as they wait on the bench.

For the bus

that

never

ever

comes.

 

October 19, 2023     Andrew Kantor

For BP, flexibility is bad

High blood pressure is bad, and it seems that so is changing blood pressure. Significant fluctuations in BP can lead to dementia and other cognitive impairments, according to a new Aussie study.

At the same time, they also found that higher variations in systolic BP (i.e., “the top number”) was linked with arterial stiffness.

“These results indicate that the different types of BP variability likely reflect different underlying biological mechanisms, and that systolic and diastolic blood pressure variation are both important for cognitive functioning in older adults.”

So it’s worth A) taking your blood pressure frequently, and B) learning to spell sphygmomanometer.

Treating the gut (and depression)

In today’s first entry for “drug for X also treats Y,” we have amitriptyline, the antidepressant. It can also treat irritable bowel syndrome. And not just a little bit, either. “[P]atients taking amitriptyline were almost twice as likely to report an overall improvement in symptoms as those taking a placebo,” according to the British scientists who published their findings.

Wondering why? According to one pharmacist, it’s not surprising that an SSRI would affect IBS: “With 90-95% of serotonin production occurring in the gut, it would seem viable that the gut can be affected by a regular dose of amitriptyline.”

Fighting bone loss (and malaria)

And in today’s second entry for “drug for X also treats Y” comes DHA (dihydroartemisinin), the malaria drug that — as predicted by one of our coming AI overlords — treated osteoporosis in mice by reducing their bone loss and preserving the bone structure.

The Chinese scientists who did the study used an AI to predict what kinds of molecule might tweak the right genes to get the body to build up its bones. And apparently that AI got it right.

Two caveats, though. First, it was in mice, and (with a few exceptions) mice aren’t people. Second, it wasn’t just popping a pill — they delivered the DHA directly to the bones using nanoparticles.

(And because the effect was predicted by an AI and uses nanotech, they get a double-buzzword score.)

Quantity over ‘quality’

Everyone knows that melanoma is the deadlier kind of skin cancer. Apparently, though, everyone is wrong. Well, sort of.

A new study out of France finds that while melanoma is deadlier in a head-to-head comparison with non-melanoma skin cancer, the latter has a lot more heads to compare. (Link is a PDF.)

In 2020, [non-melanoma skin cancer] accounted for 78% of all skin cancer cases, resulting in over 63,700 deaths. In contrast, melanoma caused an estimated 57,000 fatalities in the same year.

Formaldehyde on the chopping block

It’s been a long time coming, but the FDA is proposing to ban “formaldehyde and other formaldehyde-releasing chemicals (e.g., methylene glycol) as an ingredient in hair smoothing or hair straightening products’ — the kind used by a lot of Black women.

The agency has been warning about the chemicals for a while because they can cause a host of health issues especially if they’re breathed in (e.g., when heated in a poorly ventilated space). It’s also a carcinogen. It’s also been considering a ban for the last seven years but only got around to formally proposing it now.

The next next thing to worry about

Yellow fever. Yep, a warming climate means the mosquitoes that carry it are movin’ on up to the southern US. We’ve already seen homegrown cases of malaria, so it’s not entirely surprising. And there have been outbreaks of other diseases carried by the Aedes mosquito in the South.

The good news is that there’s a vaccine. The bad news is that we don’t have a stockpile of it, so a serious outbreak “could tear quickly through unimmunized populations across the American South, and it is unlikely that the U.S. government would be prepared to acquire and distribute vaccines in a timely manner.”

Short takes

That’ll be in aisle 3

A doctor in Virginia prescribed a woman a cat to treat her depression. (Spoiler: It worked. Teaser: It worked in the most tear-jerky way possible.)

Drugs getting high

Amazon is launching (ha!) drone delivery of prescriptions in College Station, Texas, before a planned expansion to other cities.

Artist’s conception

October 18, 2023     Andrew Kantor

Itchy, Scratchy, and bad sleep

Got patients with skin conditions? You might ask them how they’re sleeping. A new study found that itching and burning didn’t just keep people from falling asleep, it also reduced the quality of that sleep.

‘[P]atients with skin disease experienced a feeling of fatigue more often upon waking up; periods of drowsiness during the day; tingling sensations in the eyes; and repeated yawning.’

So they might not realize the connection between being tired the next day and the fact that their skin condition is affecting them while they sleep.

Nature abhors a marketing vacuum

After Fortunato Purdue Pharma got into the crosshairs of states and the federal government, it made the smart choice to dial back the marketing of OxyContin. But its competitors might have gotten the wrong lesson. Instead of trying to lay low, they increased the marketing of their own opioids.

“Unfortunately, I think, rather than serve as a warning to the rest of the industry, this lawsuit created an opportunity for competitors by weakening Purdue’s marketing grasp over its lucrative OxyContin prescribers.”

High-five to Hamrick!

The NCPA Foundation named GPhA’s own Jonathan Hamrick its 2023 Outstanding Faculty Liaison of the Year. Congrats, Jonathan!

We could’ve run the pic of him dancing at convention, but ….

Painting a target on tumors (with bacteria)

CAR-T cells are pretty good at finding leukemia or lymphoma cancer cells, but when it comes to solid tumors they get lost. So Columbia U biologist engineered a bacteria that would find the cancer and “paint solid tumors with a synthetic marker that the CAR-T cells can recognize.” (That synthetic marker is a antigen, making this “the first example of pairing engineered T cells with engineered bacteria to deliver synthetic antigens safely.”)

Next up, hopefully, are clinical trials.

The latest long-Covid explanation

This time it’s scientists at UPenn weighing in, and their hypothesis is that long Covid is caused by [spins wheel] low serotonin levels.

[S]erotonin reduction is triggered by remnants of the virus lingering in the gut. Depleted serotonin could especially explain memory problems and some neurological and cognitive symptoms of long Covid, they say.

Even better, they think this could be the Grand Unifying Theory of long Covid.

…the biological pathway that their research outlines could unite many of the major theories of what causes long Covid: lingering remnants of the virus, inflammation, increased blood clotting and dysfunction of the autonomic nervous system. “All these different hypotheses might be connected through the serotonin pathway.”

So the obvious next step: a clinical trial with Prozac (really).

Siblings, tonsils, and arthritis

Here’s an unexpected connection: If you have older siblings and have had your tonsils removed, you’re at a greater risk for a form of arthritis called ankylosing spondylitis.

In fact, the more older siblings you have, the greater the risk: 18% higher for one older sibling, 34% for two or more. But there’s a good reason: infection.

If you need your tonsils removed, there’s a good chance you’ve been exposed to something nasty. And the more older sibs you have, the more exposure you’ll get to various bugs. So no, getting your tonsils removed isn’t the risk factor. Needing them removed is.

The study found the correlation — infection as a child can mean arthritis as an adult — but haven’t teased out the cause. Yet.

ICYMI

A monkey with a kidney from a genetically engineered pig survived for two years without rejecting the organ.

[T]he researchers edited 69 of the pig’s genes. Three were involved in producing rejection-related molecules and 59 were related to retroviral DNA that became embedded in the pig genome many generations ago. The final seven involved adding human genes that are known to promote healthy organ growth, such as by preventing improper blood clotting.

Not surprisingly, “The researchers suggest that they are on the right track, but more testing is required.”